FR 2023 11 06

FEDERAL REGISTER
Vol. 88 Monday,
No. 213 November 6, 2023
Pages 76097–76624
OFFICE OF THE FEDERAL REGISTER

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II Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023
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III
Contents Federal Register

Vol. 88, No. 213
Monday, November 6, 2023
Agricultural Marketing Service Defense Department

RULES NOTICES
Beef Promotion and Research Order; Reapportionment, Meetings:
76097–76102 Defense Advisory Committee on Diversity and Inclusion;
PROPOSED RULES Federal Advisory Committee, 76192–76193
Marketing Agreement and Order: Defense Advisory Committee on Military Personnel
Milk in the Northeast and Other Marketing Areas; Testing, 76194
Hearing, 76143 Defense Advisory Committee on Women in the Services;
Federal Advisory Committee, 76193–76194
Defense Business Board, 76191–76192
Agriculture Department
Defense Science Board; Federal Advisory Committee,
See Agricultural Marketing Service
76190–76191
See Farm Service Agency
NOTICES
Education Department
Agency Information Collection Activities; Proposals, NOTICES
Submissions, and Approvals, 76164 Request for Information:
Accrediting Agencies Currently Undergoing Review for
Census Bureau the Purpose of Recognition by the United States
NOTICES Secretary of Education, 76194–76196
Agency Information Collection Activities; Proposals,
Submissions, and Approvals: Employee Benefits Security Administration
Census Household Panel Topical 2 and Topical 3 NOTICES
Operations, 76167–76168 Proposed Exemption for Certain Prohibited Transaction
Restrictions:
Fedeli Group, Inc. Employee Benefits Plan Located in
Centers for Medicare & Medicaid Services Cleveland, OH, 76253–76259
RULES
Medicare Program: Energy Department
End-Stage Renal Disease Prospective Payment System, See Federal Energy Regulatory Commission
Payment for Renal Dialysis Services Furnished to See Southeastern Power Administration
Individuals with Acute Kidney Injury, End-Stage PROPOSED RULES
Renal Disease Quality Incentive Program, and End- Energy Conservation Program:
Stage Renal Disease Treatment Choices Model, Standards for Dehumidifiers, 76510–76573
76344–76507 NOTICES
Submissions, and Approvals, 76196–76197
Civil Rights Commission
NOTICES Environmental Protection Agency
Meetings: RULES
Georgia Advisory Committee, 76167 Air Quality State Implementation Plans; Approvals and
Hawai’i Advisory Committee, 76166–76167 Promulgations:
Ohio Advisory Committee, 76166 California; Vehicle Miles Traveled Emissions Offset
U.S. Virgin Islands Advisory Committee, 76165–76166 Demonstrations for the 2015 Ozone Standards,
76139–76141
Coast Guard Florida; Miscellaneous State Implementation Plan
RULES Revision, 76137–76139
NOTICES
Safety Zones:
Atlantic Ocean, Key West, FL, 76133–76136 Ambient Air Monitoring Reference and Equivalent
Ohio River Mile Markers 2.5–3, Brunot Island, PA, Methods:
76131–76133 Designation of Two New Equivalent Methods, 76212–
PROPOSED RULES 76213
Special Local Regulations: Final Cancellation Order for Certain Chlorpyrifos
Recurring Marine Events, Sector Key West; Update, Registrations and Uses, 76213–76216
Meetings:
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76159–76162
Mobile Sources Technical Review Subcommittee, 76211–
76212
Commerce Department Privacy Act; System of Records, 76208–76211
See Census Bureau
See Foreign-Trade Zones Board Farm Service Agency
See Industry and Security Bureau NOTICES
See International Trade Administration Agency Information Collection Activities; Proposals,
See National Institute of Standards and Technology Submissions, and Approvals:
See National Oceanic and Atmospheric Administration Urban Agriculture Cooperative Agreement, 76164–76165
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IV Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Contents
Federal Aviation Administration Food and Drug Administration

RULES NOTICES
Airspace Designations and Reporting Points: Determination That Drugs Were Not Withdrawn From Sale
Level Island, AK, 76122–76123 for Reasons of Safety or Effectiveness:
Airworthiness Directives: FORADIL (Formoterol Fumarate) Inhalation Powder,
Airbus SAS Airplanes, 76107–76110 0.012 Milligrams, 76218–76219
Austro Engine GmbH Engines, 76104–76107
Dassault Aviation Airplanes, 76110–76112 Foreign-Trade Zones Board
Embraer S.A. Airplanes, 76112–76117 NOTICES
General Electric Company Engines, 76117–76122 Application for Subzone:
Rolls-Royce Deutschland Ltd and Co KG Engines, 76102– Foreign-Trade Zone 61, PR Five Vega Alta, LLC; Vega
76104 Alta, PR, 76168
Instrument Flight Rules Altitudes, 76123–76128
PROPOSED RULES General Services Administration
Airspace Designations and Reporting Points: NOTICES
Bedford, PA, 76155–76156 Agency Information Collection Activities; Proposals,
Harrison, OH, 76152–76153 Submissions, and Approvals:
Hutchinson, MN, 76153–76155 General Services Administration Acquisition Regulation;
Jackson, OH, 76158–76159 Federal Supply Schedule Contract Administration
Litchfield, MN, 76156–76158 Information, 76217–76218
Natchez, MS, 76150–76152 Meetings:
Airworthiness Directives: Acquisition Policy Federal Advisory Committee, 76218
Airbus Canada Limited Partnership (Type Certificate Federal Secure Cloud Advisory Committee, 76216–76217
Previously Held by C Series Aircraft Limited
Health and Human Services Department
Partnership (CSALP); Bombardier, Inc.) Airplanes,
See Centers for Medicare & Medicaid Services
76144–76147
See Food and Drug Administration
Airbus SAS Airplanes, 76147–76150
NOTICES
See National Institutes of Health
NOTICES
National Environmental Policy Act Compliance Procedures
Submissions, and Approvals:
to Incorporate Federal Flood Risk Management
Identification of Foreign-Registered Civil Unmanned
Standard Procedures, 76219–76221
Aircraft Operating in the United States, 76268–76269
Homeland Security Department
Federal Deposit Insurance Corporation See Coast Guard
NOTICES
Termination of Receiverships, 76216 Industry and Security Bureau
RULES
Federal Energy Regulatory Commission Entity List Additions, 76128–76131
NOTICES
Application: Institute of Museum and Library Services
ANR Pipeline Co., 76198–76199 NOTICES
Natural Gas Pipeline Company of America, LLC, 76205– Funding Opportunity:
76207 Native American Library Services Enhancement Grants,
Nature and People First New Mexico PHS, LLC, 76197 76260–76261
Combined Filings, 76199–76205 Native Hawaiian Library Services Grants, 76261–76262
Interior Department
Federal Railroad Administration See Fish and Wildlife Service
NOTICES See National Park Service
Agency Information Collection Activities; Proposals, See Surface Mining Reclamation and Enforcement Office
Submissions, and Approvals, 76269–76270
International Trade Administration
Fish and Wildlife Service NOTICES
NOTICES Antidumping or Countervailing Duty Investigations, Orders,
Environmental Assessments; Availability, etc.: or Reviews:
Marine Mammals; Proposed Incidental Harassment Cast Iron Soil Pipe Fittings from the People’s Republic of
Authorization for Southcentral Alaska Stock of China, 76172, 76184
Northern Sea Otters in Cordova, AK, 76225–76241 Certain Hot-Rolled Steel Flat Products from Japan,
Permits; Applications, Issuances, etc.: 76170–76171
Endangered Species, 76222–76225 Certain Hot-Rolled Steel Flat Products from the Republic
Foreign Endangered Species, 76241–76242 of Korea, 76178–76180
Incidental Take and Proposed Habitat Conservation Plan Certain Paper Shopping Bags from India, 76185–76187
for the Sand Skink; Lake County, FL; Categorical Certain Paper Shopping Bags from the People’s Republic
Exclusion, 76243–76244 of China, 76180–76182
Incidental Take and Proposed Habitat Conservation Plan, Common Alloy Aluminum Sheet from India, 76168–
City of Santee, CA; Categorical Exclusion, 76244– 76169
76246 Drawn Stainless Steel Sinks from the People’s Republic
Wild Bird Conservation Act; Receipt, 76242–76243 of China, 76174–76176
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Contents V
Phosphate Fertilizers from the Russian Federation, NOTICES

76182–76183 Environmental Assessments; Availability, etc.:
Stainless Steel Flanges from India, 76173–76174, 76176– Nuclear Fuel Services, Inc., U-Metal Project, 76262–
76178 76263
International Trade Commission Pipeline and Hazardous Materials Safety Administration

NOTICES NOTICES
Complaint: Agency Information Collection Activities; Proposals,
Certain Organic Light-Emitting Diode Display Modules Submissions, and Approvals:
and Components Thereof, 76252–76253 Pipeline Safety, 76270–76272
Certain Video Capable Electronic Devices, Including
Computers, Streaming Devices, Televisions, and Postal Regulatory Commission
Components and Modules Thereof, 76251–76252 NOTICES
Certain Video Capable Electronic Devices, Including New Postal Products, 76263–76264
Computers, Streaming Devices, Televisions, Cameras, Service Standard Changes, 76264–76265
and Components and Modules Thereof, 76249–76250
Postal Service
PROPOSED RULES
Labor Department
See Employee Benefits Security Administration Use of Foreign Return Addresses on Domestic Mailpieces,
76162–76163
NOTICES
National Aeronautics and Space Administration
Meetings; Sunshine Act, 76265–76266
NOTICES
Securities and Exchange Commission
PROPOSED RULES
Complaint of Discrimination Form, 76259–76260
Volume-Based Exchange Transaction Pricing for NMS
Stocks, 76282–76341
National Foundation on the Arts and the Humanities NOTICES
See Institute of Museum and Library Services Meetings; Sunshine Act, 76266
National Institute of Standards and Technology Southeastern Power Administration
NOTICES NOTICES
Request for Information: Power Marketing Policy Cumberland System of Projects,
United States Government National Standards Strategy 76207–76208
for Critical and Emerging Technology, 76187–76188
State Department
National Institutes of Health NOTICES
NOTICES Culturally Significant Objects Imported for Exhibition:
Meetings: Dining with the Sultan: The Fine Art of Feasting, 76266
National Institute Environmental Health Sciences, 76221– Volute Krater, 76266
76222
Surface Mining Reclamation and Enforcement Office
National Oceanic and Atmospheric Administration NOTICES
RULES Privacy Act; Systems of Records, 76246–76249
Fisheries of the Exclusive Economic Zone off Alaska:
Reallocation of Pacific Cod in the Western Regulatory Surface Transportation Board
Area of the Gulf of Alaska, 76141–76142 NOTICES
NOTICES Adverse Abandonment:
Agency Information Collection Activities; Proposals, GNP RLY, Inc., Snohomish County, WA, 76266–76267
Large Pelagic Fishing Survey, 76188–76190 Trade and Development Agency
Determination of Overfishing or an Overfished Condition, NOTICES
76188 Agency Information Collection Activities; Proposals,
Taking or Importing of Marine Mammals: Submissions, and Approvals, 76267–76268
Port of Alaska’s North Extension Stabilization Step 1
Project in Anchorage, AK, 76576–76623 Transportation Department
See Federal Aviation Administration
National Park Service See Federal Railroad Administration
NOTICES See Pipeline and Hazardous Materials Safety
Order: Administration
National Park Service Policies and Procedures Governing See Transportation Statistics Bureau
Housing Management, 76246 NOTICES
Rights and Protections Available under the Federal
Nuclear Regulatory Commission Antidiscrimination and Whistleblower Protection Laws,
PROPOSED RULES 76275–76276
Increased Enrichment of Conventional and Accident Transportation Services for Individuals with Disabilities:
Tolerant Fuel Designs for Light-Water Reactors, 76143– Americans with Disabilities Act Standards for
76144 Transportation Facilities, 76272–76275
VI Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Contents
Transportation Statistics Bureau Part III

NOTICES Health and Human Services Department, Centers for
Agency Information Collection Activities; Proposals, Medicare & Medicaid Services, 76344–76507
Electric Vehicle Inventory and Use Survey, 76276–76278
Safe Maritime Transportation System—Voluntary Near- Part IV
Miss Incident Reporting and Analysis System, 76278 Energy Department, 76510–76573
U.S. International Development Finance Corporation

NOTICES
Part V
Meetings, 76190 Commerce Department, National Oceanic and Atmospheric
Administration, 76576–76623
Veterans Affairs Department
NOTICES
Submissions, and Approvals: Reader Aids
Application and Training Agreement for Apprenticeship Consult the Reader Aids section at the end of this issue for
and On-the-Job Training Programs, 76278–76279 phone numbers, online resources, finding aids, and notice
of recently enacted public laws.
To subscribe to the Federal Register Table of Contents
Separate Parts In This Issue electronic mailing list, go to https://public.govdelivery.com/
accounts/USGPOOFR/subscriber/new, enter your e-mail
Part II address, then follow the instructions to join, leave, or
Securities and Exchange Commission, 76282–76341 manage your subscription.
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Contents VII
CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the
Reader Aids section at the end of this issue.
7 CFR
1260.................................76097
Proposed Rules:
1000.................................76143
10 CFR
Proposed Rules:
50.....................................76143
51.....................................76143
71.....................................76143
430...................................76510
14 CFR
39 (7 documents) ...........76102,
76104, 76107, 76110, 76112,
76114, 76117
71.....................................76122
95.....................................76123
Proposed Rules:
39 (2 documents) ...........76144,
76147
71 (6 documents) ...........76150,
76152, 76153, 76155, 76157,
76158
15 CFR
744...................................76128
17 CFR
Proposed Rules:
232...................................76282
240...................................76282
33 CFR
165 (2 documents) .........76131,
76133
Proposed Rules:
100...................................76159
39 CFR
Proposed Rules:
111...................................76162
40 CFR
52 (2 documents) ...........76137,
76139
42 CFR
413...................................76344
512...................................76344
50 CFR
679...................................76141
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76097
Rules and Regulations Federal Register

Vol. 88, No. 213
This section of the FEDERAL REGISTER benefits of available regulatory Paperwork Reduction Act
contains regulatory documents having general alternatives and, if regulation is In accordance with OMB regulations
applicability and legal effect, most of which necessary, to select regulatory
are keyed to and codified in the Code of (5 CFR part 1320) that implement the
approaches that maximize net benefits Paperwork Reduction Act of 1995 (44
Federal Regulations, which is published under (including potential economic,
50 titles pursuant to 44 U.S.C. 1510. U.S.C. 35), the information collection
environmental, public health and safety and recordkeeping requirements
The Code of Federal Regulations is sold by effects, distributive impacts, and contained in the Order and
the Superintendent of Documents. equity). Executive Order 13563 accompanying Rules and Regulations
emphasizes the importance of have previously been approved by OMB
quantifying both costs and benefits, and were assigned OMB control number
DEPARTMENT OF AGRICULTURE reducing costs, harmonizing rules, and
0581–0093.
promoting flexibility. Executive Order
Agricultural Marketing Service 14094 reaffirms, supplements, and Background
updates Executive Order 12866 and The Board was initially appointed on
7 CFR Part 1260 further directs agencies to solicit and August 4, 1986, pursuant to the
[Doc. No. AMS–LP–22–0002] consider input from a wide range of provisions of the Act (7 U.S.C. 2901–
affected and interested parties through a 2911), and the Order issued thereunder.
Beef Promotion and Research Order; variety of means. This rule is not a Domestic representation on the Board is
Reapportionment and Technical significant regulatory action within the based on cattle inventory numbers,
Amendment meaning of Executive Order 12866. while importer representation is based
Accordingly, this action has not been on the conversion of the volume of
AGENCY: Agricultural Marketing Service, reviewed by the Office of Management
USDA. imported cattle, beef, and beef products
and Budget (OMB) under section 6 of into live animal equivalencies.
ACTION: Final rule. the Executive Order.
Reapportionment
SUMMARY: This rule adjusts Executive Order 12988
representation on the Cattlemen’s Beef Section 1260.141(b) of the Order
This rule has been reviewed under
Promotion and Research Board (Board), provides that the Board shall be
E.O. 12988, Civil Justice Reform and it
established under the Beef Promotion composed of cattle producers and
is not intended to have retroactive
and Research Act of 1985 (Act), to importers appointed by the Secretary
effect.
reflect changes in domestic cattle Section 11 of the Act (7 U.S.C. 2910) from nominations submitted by certified
inventories as well as changes in levels provides that nothing in the Act may be producer and importer organizations. A
of imported cattle, beef, and beef construed to preempt or supersede any producer may only be nominated to
products that have occurred since the other program relating to beef represent the State or unit in which that
Board was last reapportioned in July promotion organized and operated producer is a resident.
2020. These adjustments are required by under the laws of the U.S. or any State. Section 1260.141(c) of the Order
the Beef Promotion and Research Order There are no administrative proceedings provides that at least every 3 years, but
(Order) and will result in a decrease in that must be exhausted prior to any not more than every 2 years, the Board
Board membership from 101 to 99, judicial challenge to the provisions of shall review the geographic distribution
effective with the Secretary of this rule. of cattle inventories throughout the
Agriculture’s (Secretary) appointments United States and the volume of
Executive Order 13175 imported cattle, beef, and beef products
from nominees requested in Spring of
2023. This final rule also updates the This rule has been reviewed under and, if warranted, shall reapportion
list of Qualified State Beef Councils Executive Order 13175, Consultation units and/or modify the number of
(QSBCs) in the Order by removing the and Coordination with Indian Tribal Board members from units in order to
Maryland Beef Industry Council which Governments, which requires agencies reflect the geographic distribution of
voted to dissolve their State beef to consider whether their rulemaking cattle production volume in the United
council. actions would have Tribal implications. States and the volume of cattle, beef, or
AMS has determined this proposed rule beef products imported into the United
DATES: This rule is effective December 6, States. Further, § 1260.141(d) allows the
is unlikely to have substantial direct
2023. board to recommend to the Secretary a
effects on one or more Indian Tribes, on
FOR FURTHER INFORMATION CONTACT: the relationship between the Federal modification in the number of cattle per
Lacey Heddlesten, Agricultural Government and Indian Tribes, or on unit necessary for representation of
Marketing Specialist, Research and the distribution of power and Board seats.
Promotion Division, Telephone: (620) responsibilities between the Federal Section 1260.141(e)(1) provides that
717–3834; or Email: Lacey.Heddlesten@ each geographic unit or State that
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Government and Indian Tribes.

usda.gov. includes a total cattle inventory equal to
SUPPLEMENTARY INFORMATION:
Congressional Review Act or greater than 500,000 head of cattle
Pursuant to the Congressional Review shall be entitled to one representative
Executive Orders 12866, 14094 and Act (5 U.S.C. 801 et seq.) the Office of on the Board. Section 1260.141(e)(2)
13563 Information and Regulatory Affairs provides that States that do not have
Executive Orders 12866 and 13563 designated this rule as not a major rule, total cattle inventories equal to or
direct agencies to assess all costs and as defined by 5 U.S.C. 804(2). greater than 500,000 head shall be
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76098 Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Rules and Regulations
grouped, to the extent practicable, into 2021, and 2022 as reported by USDA’s a combined total of the 2019, 2020, and
geographically contiguous units, each of National Agricultural Statistics Service 2021 cattle import data and the average
which have a combined total inventory (NASS). The importer representation is of the 2019, 2020, and 2021 live animal
of not less than 500,000 head. Such based on a combined total average of the equivalents for imported beef products.
grouped units are entitled to at least one 2019, 2020, and 2021 live cattle imports The method used to calculate the total
representative on the Board. Each unit as published by USDA’s Economic number of live animal equivalents was
is entitled to an additional Board Research Service (ERS) and the average the same as that used in the previous
member for each additional 1 million of the 2019, 2020, and 2021 live animal reapportionment of the Board. The live
head of cattle within the unit, as equivalents for imported beef and beef animal equivalent weight was changed
provided in § 1260.141(e)(4). Further, as products. in 2006 from 509 pounds to 592 pounds
provided in § 1260.141(e)(3), importers In considering reapportionment, the (71 FR 47074).
are represented by a single unit, with Board reviewed cattle inventories as of As discussed in the proposed rule, the
their number of Board members based January 1 in 2020, 2021, and 2022, as Board’s recommended reapportionment
on a conversion of the total volume of well as cattle, beef, and beef product plan would decrease the number of
imported cattle, beef, or beef products import data for the period of January 1, representatives on the Board from 101 to
into live animal equivalencies. 2019, to December 31, 2021. The Board 100. Based on the Board’s
Section 1260.141(f) of the Order states determined that an average of the recommendation, Idaho would gain one
in determining the volume of cattle inventory of cattle on January 1 in 2020, seat, Montana would lose one seat,
within the units, the Board and the 2021, and 2022 best reflect the number Pennsylvania would lose one seat, and
Secretary shall utilize the information of cattle in each State or unit since Wisconsin would maintain their four
received by the Board pursuant to publication of the last reapportionment seats. This final rule, however, results in
§§ 1260.201 and 1260.202 industry data rule in 2020 (85 FR 39461). The Board Wisconsin losing one seat. The States
and data published by USDA. The reviewed data published by ERS to and units affected by the
producer representation is based on an determine proper importer reapportionment plan and the current
average of the inventory of cattle in the representation. The Board and revised representation per unit are
various States on January 1 in 2020, recommended the use of the average of as follows:
Current Revised
State/unit Increase/decrease representation representation
Idaho .......................................................................................................................... +1 2 3
Montana ..................................................................................................................... ¥1 3 2
Pennsylvania .............................................................................................................. ¥1 2 1
Wisconsin ................................................................................................................... ¥1 4 3
Net Change ................................................................................................................ ¥2 .............................. ..............................
The Board reapportionment takes The majority of the comments pandemic on one state and not the
effect in the 2023 nomination process received were a form letter opposing entire cattle industry nationwide would
and the number of board members the Wisconsin losing a seat and arguing create an inequity. Accordingly, USDA
Secretary appointments to fill positions several factors including that the takes the position that as an industry the
early in the year 2024 will reduce from pandemic caused record low milk impact is widespread and thus the
101 to 99. prices. During the early part of the numbers as presented for cattle
pandemic, dairy producers in inventories as of January 1 in 2020,
Technical Amendment
Wisconsin faced a surplus of milk 2021, and 2022, are the fairest and most
The final rule updates the list of because of the rapid decrease in price. accurate representation of the current
QSBCs in the Order by removing the In addition, three producers and seven industry numbers.
Maryland Beef Industry Council which cattle, dairy, and farm associations in Another commenter argued that the
unanimously voted to dissolve their Wisconsin, stated that the average milk drought negatively impacted herd
State beef council during the September prices paid to Wisconsin farmers in numbers in the state because it changed
14, 2022, board meeting. 2020 were $18.90, in 2021 it was $17.10, Wisconsin’s place in the cattle
and by May of 2022 the price of milk production cycle.
Summary of Comments USDA acknowledges that for the
was up to $25.21. Further the
AMS published the proposed rule for commenters stated that due to increases reapportionment that took place on
public comment on May 1, 2023 (88 FR in milk price, dairy cow numbers are August 12, 2014 (79 FR 46961) for
27415). The comment period ended on expected to continue to grow; appointments that were seated in 2015,
June 1, 2023. AMS received 12 timely potentially, by January 31—putting at that time the drought that had taken
comments. AMS conducted a review of Wisconsin herd size back over 3.5 place in Texas was taken into
the comments and determined that three million. consideration. Texas was slated to lose
of the twelve comments were outside In response, USDA acknowledges that two board seats due to cattle inventory
the scope of the rulemaking. Of the a pandemic was in place from decease related to a three-year loss of
approximately from March 2020 to May cattle inventory due to severe drought.
remaining nine comments, AMS

analyzed the comments and grouped 2023, which caused unforeseen Due to the turnaround in environmental
them into the below categories. industry-wide supply chain issues. The and economic conditions along with
pandemic not only impacted the state of reports indicating that cattle were
Unforeseen Events
Wisconsin but has had a significant moving back into Texas from other
Several of the comments mentioned impact on a large portion of the U.S. and states and the total herd inventory
the COVID–19 pandemic and the the U.S. farming and cattle industry. would be back up prior to
drought’s impact on the beef industry. Thus, to only consider the impact of the reapportionment taking place, the
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Rules and Regulations 76099
USDA issued only a loss of one seat have not only impacted the state of or greater than 500,000 head of cattle
rather than two as was outlined in the Montana but has had a significant shall be entitled to one representative
proposed rule. impact on a large portion of the U.S. and on the Board. Section 1260.141(e)(4)
However, it is important to note that the U.S. farming and cattle industry and specifically states that each unit is
in the 2015 reapportionment the thus, to only consider the impact of the entitled to an additional Board member
environmental factors, in that case the drought on one state and not the entire for each additional 1 million head of
drought, significantly impacted one cattle industry nationwide would create cattle within the unit.
state in particular, Texas and lasted an inequity. Accordingly, USDA takes USDA acknowledges the Board’s
several years spanning from 2011 to the position that as an industry the recommendation as provided by
2013, with 2011 being one of the worst impact is widespread and thus the § 1260.141(d) which states that the
droughts in the State’s history. In numbers as presented for cattle Board may recommend to the Secretary
contrast, under the current inventories as of January 1 in 2020, a modification in the number of cattle
circumstances, a large portion of the 2021, and 2022, are the fairest and most per unit necessary for representation on
United States was impacted by drought accurate representation of the current the Board. However, § 1260.141(d)
over the past 3 years which affected the industry numbers. applies only to a recommended change
entire cattle inventory. According to the Lastly, although it is important to based on cattle inventory 1 and not the
USDA, Economic Research Service acknowledge these events play a role in other factors used in the Board’s current
(ERS), the Western States experienced the cattle inventory numbers, it is also recommendation for this rule.
extreme or exceptional drought and, in important to note that the Order is silent Further, the point estimates published
some cases, severe drought conditions on how Board seats would be impacted by NASS are the official USDA
the past few years, with the most severe by natural events. The Order does estimates of inventory. In preparing
conditions being reported in Nebraska, specify the formula for determining the these estimates, NASS takes into
Kansas, Oklahoma, Texas, New Mexico, number of Board seats and USDA uses account all available and relevant data
and Oregon. Based on this data, it is a 3-year average to attain a and makes the necessary adjustments
clear that the current drought conditions representative number within a State. based on factors such as response rate.
have not only impacted the state of Any change would need to be applied NASS publishes the measures of
Wisconsin but has had a significant to the entirety of the assessment-paying uncertainty to provide transparency and
impact on a large portion of the U.S. and population as the Act and Order govern context around the estimates, however
the U.S. farming and cattle industry. all cattle producers and importers and making further adjustments for these
Thus, to only consider the impact of the all geographical units. purposes would introduce
drought on one state and not the entire inconsistencies to the process and
Cattle Inventory Margin of Error and
cattle industry nationwide would create departure from the official USDA
Survey Response Rate
an inequity. Accordingly, USDA takes inventory estimates.
the position that as an industry the Eight of the nine comments stated Thus, to consider other factors such as
impact is widespread and thus the opposition to Wisconsin losing a seat the margin of error and the survey
numbers as presented for cattle due to the margin of error associated response rate to the reapportionment of
inventories as of January 1 in 2020, with the statistical methodology used
the Board, regulatory changes which
2021, and 2022, are the fairest and most for determining cattle inventory
require notice-and-comment
accurate representation of the current numbers per state for the 3-year period
rulemaking, would be necessary to make
industry numbers. reviewed. As mentioned in one of the
those clarifications to the Order. Any
One comment opposed Montana comments, Wisconsin was 33,000 head
change contemplated by additional
losing a seat similarly arguing that the short of maintaining their fourth seat on
rulemaking would need to be applied to
drought impacted the number of herds the Board. The average coefficient of
the entirety of the assessment-paying
in the state. They claimed, prior to the variation for Wisconsin’s total cattle
population as the Act and Order govern
drought, herd numbers had been inventory in 2020, 2021, and 2022 cattle
all cattle producers and importers and
consistent since the 1980’s. The drought inventory reports is 3.4 percent (+34,000
head). Since the coefficient of variation all geographical units.
caused a dip in 2021 and 2022;
however, 2023 spring moisture has been is greater than the amount by which the Diversity
promising for pastures. Further, inventory is under the 3.5 million One commenter mentioned that
according to the commentor, there is threshold, then Wisconsin should be Wisconsin is a State that includes beef
indication that Montana producers are allowed to retain their fourth seat. and dairy producers, and allowing
starting to rebuild their herd and it is According to the January 1, 2023, cattle Wisconsin to maintain their fourth seat
possible that Montana will be above 2.5 inventory numbers published, the State will ensure the Board has a strong and
million again before the final rule goes of Wisconsin was at 3.4 million. diverse representation from all sectors.
into effect. However, it was reported by the One additional commentor opposed to
Again, USDA acknowledges that a Wisconsin Ag Statistician that only 60 Montana losing a seat because the State
large portion of the United States was percent of surveys were returned, which is home to 12 tribal nations that are
impacted by drought over the past 3 questions whether the 3.4 million head already underrepresented on the Board.
years which impacted cattle inventory is an accurate reflection of current cattle It is USDA’s policy concerning
and again points out that in the previous inventory. nominations to the Board that the
reapportionment the environmental In response, the Order is silent on
Board’s membership should be open to
factors, in that case the drought, whether other factors such as cattle
all individuals without regard based on

significantly impacted one state in inventory margin of error and survey
race, color, religion, national origin, age,
particular, Texas and lasted several response rate should be taken into
sex, sexual orientation, disability,
years spanning from 2011 to 2013, with consideration when determining the
marital or familial status, political
2011 being one of the worst droughts in total cattle inventory. Section
the State’s history. Once more, based on 1260.141(e)(1) of the Order states that 1 Sections 1260.141.(c) and (e) use cattle
data provided by the USDA ERS, it is each geographic unit or State that inventories in calculating reapportionment
clear that the current drought conditions includes a total cattle inventory equal to numbers.
beliefs, parental status, receipt of public revision.3 No further breakout in the changes in domestic cattle inventory, as
assistance, or protected genetic Census of Agriculture data is made to well as in cattle and beef imports.
information. Board membership should account for the new, higher SBA Additionally, the Order § 1260.141 does
also reflect the diversity of the standard. However, the vast majority of not take into consideration the margin
industries in experience of members, cattle producers, 96 percent, would be of error when analysis is conducted.
methods of production and distribution, considered small businesses under the Therefore, the Secretary is applying the
marketing strategies, and other new SBA standards. It should be noted Order guidance without using the NASS
distinguishing factors that will bring that producers are only indirectly margin of error to adjust Board
different perspectives and ideas to the impacted by the rule. membership from 101 to 99.
tables. Emphasis should also be placed Cattle, beef, and veal importers are AMS is committed to complying with
on the knowledge, skills, and abilities of also impacted by the rule. Based on data the E-Government Act of 2002 to
the Board to serve and represent the available on membership in the Meat promote the use of the internet and
diverse interests of assessment paying Import Council of America, AMS other information technologies to
producers. estimates that approximately 190 firms provide increased opportunities for
Thus, the number of members on the import beef or beef products. AMS is citizen access to government
Board should not dictate the level of not aware of any data that reports the information and services, and for other
diversity on the Board. number of beef-importing entities that purposes.
meet the SBA definition of small
Regulatory Flexibility Act USDA has not identified any relevant
businesses.
Pursuant to the requirements set forth In addition to cattle producers, federal rules that duplicate, overlap, or
in the Regulatory Flexibility Act (RFA) affected entities under this rule change conflict with this rule.
(5 U.S.C. 601 et seq.), AMS has include meat and meat-product List of Subjects in 7 CFR Part 1260
considered the economic effect of this merchant wholesalers (wholesalers),
action on small entities and has classified under NAICS code 424470, Administrative practice and
determined that this rule will not have and meat processors from carcass procedure, Advertising, Agricultural
a significant economic impact on a (processors), classified under NAICS research, Imports, Marketing
substantial number of small entities. code 311612. The SBA thresholds for agreements, Meat and meat products,
The purpose of RFA is to fit regulatory both these businesses to qualify as small Reporting and recordkeeping
actions to the scale of businesses subject are that they have fewer than 1,000 requirements.
to such actions in order that small employees. The most current data from For the reasons set forth in the
businesses will not be unduly burdened. the Census of Manufacturing states that preamble, the Agricultural Marketing
In 2022, the Small Business all 2,376 wholesalers were small Service amends 7 CFR part 1260 as
Administration (SBA) (13 CFR part businesses (in 2017) 4 and that all 1,423 follows:
121.201) published a final rule (84 FR processors were small business (in
64013) that updated its size standards 2020).5 PART 1260—BEEF PROMOTION AND
based on income or employee numbers Recent import trade data was also RESEARCH
for various small business falling under considered for understanding the
the North American Industry overall dynamics of this industry ■ 1. The authority citation for 7 CFR
Classification System (NAICS). Within segment. The Foreign Agricultural part 1260 continues to read as follows:
that rule, the SBA threshold for ‘‘Beef Service reports monthly trade data for
Authority: 7 U.S.C. 2901–2911 and 7
Cattle Ranching and Farming’’ (NAICS traded agricultural products by product U.S.C. 7401.
code 112111) operations to qualify small type. Based on analysis of that trade
businesses was raised from annual sales data and consumption data collected in ■ 2. Revise § 1260.141 paragraph (a) and
of $1 million or less to annual sales of the USDA’s World Agricultural Demand the table immediately following to read
$2.5 million or less. and Supply Estimates, over the 2017 to as follows:
According to the NASS 2017 Census 2022 period, cattle imports ranged
of Agriculture, the number of U.S. § 1260.141 Membership of Board.
between 1.8 percent and 2.3 percent of
operations with beef cattle totaled the total cattle inventory and that beef (a) Beginning with the 2023 Board
729,046 and with cattle of any type imports ranged from 9.8 percent to 10.7 nominations and the associated
totaled 882,692.2 The same Census of percent of total supply. Veal imports appointments effective early in the year
Agriculture data shows that roughly 4 during that time were negligible as a 2024, the United States shall be divided
percent of operations with cattle, or share of domestic production. into 38 geographical units and 1 unit
31,476 operations, have annual sales The rule imposes no new burden on representing importers, for a total of 39
receipts of $1,000,000 or more, the small the industry, as it only adjusts units. The number of Board members
business standard prior to the 2022 representation on the Board to reflect from each unit shall be as follows:
TABLE 1 TO PARAGRAPH (a)—CATTLE AND CALVES 1

State/unit (1,000 head) Directors
1. Alabama ............................................................................................................................................................... 1,285 1

2. Arizona ................................................................................................................................................................. 967 1
3. Arkansas .............................................................................................................................................................. 1,733 2

4. Colorado .............................................................................................................................................................. 2,700 3
5. Florida .................................................................................................................................................................. 1,670 2
2 https://www.nass.usda.gov/AgCensus/ 4 https://data.census.gov/profile/424470__Meat_ 5 https://data.census.gov/profile/311612_-Meat_
index.php. and_meat_product_merchant_wholesalers?g= and_meat_product_merchant_wholesalers?g=

3 https://quickstats.nass.usda.gov/results/
0100000US&n=424470. 0100000US&n=311612.
758A0A38-2BF4-39CE-90EF-A581BFEA3E81.
TABLE 1 TO PARAGRAPH (a)—CATTLE AND CALVES 1—Continued

State/unit (1,000 head) Directors
6. Georgia ................................................................................................................................................................ 1,077 1

7. Idaho .................................................................................................................................................................... 2,507 3
8. Illinois ................................................................................................................................................................... 1,047 1
9. Indiana ................................................................................................................................................................. 833 1
10. Iowa ................................................................................................................................................................... 3,800 4
11. Kansas ............................................................................................................................................................... 6,483 6
12. Kentucky ............................................................................................................................................................ 2,073 2
13. Louisiana ........................................................................................................................................................... 777 1
14. Michigan ............................................................................................................................................................ 1,137 1
15. Minnesota .......................................................................................................................................................... 2,203 2
16. Mississippi ......................................................................................................................................................... 917 1
17. Missouri ............................................................................................................................................................. 4,217 4
18. Montana ............................................................................................................................................................. 2,383 2
19. Nebraska ........................................................................................................................................................... 6,800 7
20. New Mexico ....................................................................................................................................................... 1,373 1
21. New York ........................................................................................................................................................... 1,433 1
22. North Carolina ................................................................................................................................................... 798 1
23. North Dakota ..................................................................................................................................................... 1,893 2
24. Ohio ................................................................................................................................................................... 1,283 1
25. Oklahoma .......................................................................................................................................................... 5,217 5
26. Oregon ............................................................................................................................................................... 1,260 1
27. Pennsylvania ..................................................................................................................................................... 1,430 1
28. South Dakota ..................................................................................................................................................... 3,900 4
29. Tennessee ......................................................................................................................................................... 1,783 2
30. Texas ................................................................................................................................................................. 12,900 13
31. Utah ................................................................................................................................................................... 803 1
32. Virginia ............................................................................................................................................................... 1,410 1
33. Wisconsin .......................................................................................................................................................... 3,467 3
34. Wyoming ............................................................................................................................................................ 1,290 1
35. Northwest Unit:
Alaska ............................................................................................................................................................... 17 ........................
Hawaii ............................................................................................................................................................... 142 ........................
Washington ....................................................................................................................................................... 1,157 ........................
Total ........................................................................................................................................................... 1,316

36. Northeast Unit:
Connecticut ....................................................................................................................................................... 48 ........................
Delaware ........................................................................................................................................................... 13 ........................
Maine ................................................................................................................................................................ 77 ........................
Maryland ........................................................................................................................................................... 174 ........................
Massachusetts .................................................................................................................................................. 36 ........................
New Hampshire ................................................................................................................................................ 32 ........................
New Jersey ....................................................................................................................................................... 26 ........................
Rhode Island .................................................................................................................................................... 4 ........................
Vermont ............................................................................................................................................................ 248 ........................
Total ........................................................................................................................................................... 658 1

37. Mid-Atlantic Unit:
South Carolina .................................................................................................................................................. 327 ........................
West Virginia .................................................................................................................................................... 380 ........................
Total ........................................................................................................................................................... 707 1

38. Southwest Unit:
California ........................................................................................................................................................... 5,167 ........................
Nevada ............................................................................................................................................................. 465 ........................
Total ........................................................................................................................................................... 5,632 6

39. Importers Unit 2 .................................................................................................................................................. 7,466 7
1 2020, 2021, and 2022 average of January 1 cattle inventory data.
2 2019, 2020, and 2021 average of annual import data.
§ 1260.315 [Amended] No. FAA–2023–1410; or in person at 211(524)–7RR, and that these

■ 3. Amend § 1260.315 by: Docket Operations between 9 a.m. and airworthiness limitations have been
■ a. Removing paragraph (q); and 5 p.m., Monday through Friday, except identified as mandatory for continued
■ b. Redesignating paragraphs (r) Federal holidays. The AD docket airworthiness. The MCAI also states that
through (rr) as paragraphs (q) through contains this final rule, the mandatory since the original issue of TLM T–
(qq), respectively. continuing airworthiness information 211(524)–7RR, updated thresholds and
(MCAI), any comments received, and intervals were introduced for newly
Melissa Bailey,
other information. The address for designed parts. EASA AD 2013–0246
Associate Administrator, Agricultural Docket Operations is U.S. Department of was issued to require implementation of
Marketing Service.
Transportation, Docket Operations, M– the reduced cyclic life limit and
[FR Doc. 2023–24395 Filed 11–3–23; 8:45 am] replacement of HPC stage 1 and 2 disks
30, West Building Ground Floor, Room
BILLING CODE P
W12–140, 1200 New Jersey Avenue SE, before exceeding their life limit. The
Washington, DC 20590. MCAI also states that the manufacturer
Material Incorporated by Reference: published a revised engine TLM since
DEPARTMENT OF TRANSPORTATION • For service information identified EASA AD 2013–0246 was issued,
in this final rule, contact EASA, Konrad- introducing new and more restrictive
Federal Aviation Administration Adenauer-Ufer 3, 50668 Cologne, instructions. The ALS defined in the
Germany; phone: +49 221 8999 000; revised engine TLM also adds RRD
14 CFR Part 39 Model RB211–524G2–T–19, RB211–
email: ADs@easa.europa.eu; website:
[Docket No. FAA–2023–1410; Project easa.europa.eu. You may find this 524G3–T–19, RB211–524H–T–36, and
Identifier MCAI–2022–01517–E; Amendment material on the EASA website at RB211–524H2–T–19 engines to the list
39–22575; AD 2023–21–03] ad.easa.europa.eu. It is also available at of affected engines.
RIN 2120–AA64 regulations.gov under Docket No. FAA– You may examine the MCAI in the
2023–1410. AD docket at regulations.gov under
Airworthiness Directives; Rolls-Royce • You may view this service Docket No. FAA–2023–1410.
Deutschland Ltd & Co KG Engines information at the FAA, Airworthiness In the NPRM, the FAA proposed to
Products Section, Operational Safety require revising the existing approved
AGENCY: Federal Aviation engine maintenance or inspection
Branch, 1200 District Avenue,
Administration (FAA), DOT. program, as applicable, to incorporate
Burlington, MA 01803. For information
ACTION: Final rule. new and more restrictive airworthiness
on the availability of this material at the
FAA, call (817) 222–5110. limitations, which are specified in
SUMMARY: The FAA is superseding EASA AD 2022–0232 described
Airworthiness Directive (AD) 2013–26– FOR FURTHER INFORMATION CONTACT:
previously, except for any differences
10 for certain Rolls-Royce Deutschland Sungmo Cho, Aviation Safety Engineer, identified as exceptions in the
Ltd & Co KG (RRD) Model RB211– FAA, 2200 South 216th Street, Des regulatory text of this AD and as
524G2–19, RB211–524G3–19, RB211– Moines, WA 98198; phone: (781) 238– discussed under ‘‘Differences Between
524H–36, and RB211–524H2–19 7241; email: sungmo.d.cho@faa.gov. this AD and the MCAI.’’
engines. AD 2013–26–10 required a one- SUPPLEMENTARY INFORMATION:
time reduction in the cyclic life of Discussion of Final Airworthiness
certain high-pressure compressor (HPC) Background Directive
rotor stage 1 and stage 2 disks, and The FAA issued a notice of proposed Comments
removal of disks that exceed the rulemaking (NPRM) to amend 14 CFR
The FAA received a comment from
reduced cycle life. Since the FAA issued part 39 to supersede AD 2013–26–10, Air Line Pilots Association,
AD 2013–26–10, the manufacturer has Amendment 39–17719 (79 FR 1315, International (ALPA). ALPA supported
revised the engine time limits manual January 8, 2014), (AD 2013–26–10). AD the NPRM without change.
(TLM), introducing new and more 2013–26–10 applied to certain RRD
restrictive instructions. This AD is Model RB211–524G2–19, RB211– Conclusion
prompted by the manufacturer revising 524G3–19, RB211–524H–36, and These products have been approved
the engine time limits manual, RB211–524H2–19 engines. AD 2013– by the aviation authority of another
introducing new and more restrictive 26–10 required a one-time reduction in country and are approved for operation
instructions. This AD requires revisions the cyclic life of certain HPC rotor stage in the United States. Pursuant to the
to the airworthiness limitations section 1 and stage 2 disks, and removal of FAA’s bilateral agreement with this
(ALS) of the operator’s existing disks that exceed the reduced cycle life. State of Design Authority, it has notified
approved engine maintenance or The FAA issued AD 2013–26–10 to the FAA of the unsafe condition
inspection program, as applicable, as prevent the failure of certain life-limited described in the MCAI referenced
specified in a European Union Aviation parts, which could result in above. The FAA reviewed the relevant
Safety Agency (EASA) AD, which is uncontained engine damage and damage data, considered the comment received,
incorporated by reference. The FAA is to the airplane. and determined that air safety requires
issuing this AD to address the unsafe The NPRM published in the Federal adopting the AD as proposed.
condition on these products. Register on July 11, 2023 (88 FR 44075). Accordingly, the FAA is issuing this AD
DATES: This AD is effective December The NPRM was prompted by AD 2022– to address the unsafe condition on these
0232, dated November 28, 2022 (EASA
11, 2023. products. Except for minor editorial

The Director of the Federal Register AD 2022–0232) (referred to after this as changes, this AD is adopted as proposed
approved the incorporation by reference the MCAI), issued by EASA which is the in the NPRM.
of a certain publication listed in this AD Technical Agent for the Member States
as of December 11, 2023. of the European Union. The MCAI states Related Service Information Under 1
ADDRESSES: that the ALS for RB211–524G/H CFR Part 51
AD Docket: You may examine the AD engines, which is approved by EASA, is The FAA reviewed EASA AD 2022–
docket at regulations.gov under Docket defined and published in TLM T– 0232, which specifies instructions for
accomplishing the actions specified in have access to it through their normal existing approved engine maintenance
the applicable TLM, including course of business or by the means or inspection program, as applicable,
performing maintenance tasks, replacing identified in ADDRESSES. within 90 days after the effective date of
life-limited parts, and revising the Differences Between This AD and the this AD.
existing approved maintenance or MCAI Costs of Compliance
inspection program, as applicable, by
Where paragraph (3) of EASA AD
incorporating the limitations, tasks, and The FAA estimates that this AD
2022–0232 specifies revising the
associated thresholds and intervals affects 22 engines installed on airplanes
approved Aircraft Maintenance
described in the TLM. Programme within 12 months after the of U.S. registry.
This service information is reasonably effective date of EASA AD 2022–0232, The FAA estimates the following
available because the interested parties this AD requires revising the ALS of the costs to comply with this AD:
ESTIMATED COSTS
Cost per Cost on U.S.
Action Labor cost Parts cost product operators
Revise the ALS of the existing approved en- 1 work-hour × $85 per hour = $85 ................. $0 $85 $1,870
gine maintenance or inspection program.
Authority for This Rulemaking List of Subjects in 14 CFR Part 39 (d) Subject
Joint Aircraft System Component (JASC)
Title 49 of the United States Code Air transportation, Aircraft, Aviation Code 7230, Turbine Engine Compressor
specifies the FAA’s authority to issue safety, Incorporation by reference, Section.
rules on aviation safety. Subtitle I, Safety.
section 106, describes the authority of (e) Unsafe Condition
the FAA Administrator. Subtitle VII: The Amendment This AD was prompted by the
Aviation Programs, describes in more manufacturer revising the engine time limits
Accordingly, under the authority manual, introducing new and more
detail the scope of the Agency’s delegated to me by the Administrator, restrictive instructions. The FAA is issuing
authority. the FAA amends 14 CFR part 39 as this AD to prevent failure of certain life-
The FAA is issuing this rulemaking follows: limited parts. The unsafe condition, if not
under the authority described in addressed, could result in uncontained
Subtitle VII, Part A, Subpart III, Section PART 39—AIRWORTHINESS engine damage and damage to the airplane.
44701: General requirements. Under DIRECTIVES (f) Compliance
that section, Congress charges the FAA
Comply with this AD within the
with promoting safe flight of civil ■ 1. The authority citation for part 39 compliance times specified, unless already
aircraft in air commerce by prescribing continues to read as follows: done.
regulations for practices, methods, and
Authority: 49 U.S.C. 106(g), 40113, 44701. (g) Required Actions
procedures the Administrator finds
necessary for safety in air commerce. § 39.13 [Amended] Except as specified in paragraph (h) of this
This regulation is within the scope of AD: Perform all required actions within the
that authority because it addresses an ■ 2. The FAA amends § 39.13 by: compliance times specified in, and in
accordance with, European Union Aviation
unsafe condition that is likely to exist or ■ a. Removing Airworthiness Directive Safety Agency (EASA) AD 2022–0232, dated
develop on products identified in this 2013–26–10, Amendment 39–17719 (79 November 28, 2022 (EASA AD 2022–0232).
rulemaking action. FR 1315, January 8, 2014); and
(h) Exceptions to EASA AD 2022–0232
Regulatory Findings ■ b. Adding the following new
(1) Where EASA AD 2022–0232 defines the
airworthiness directive: AMP as the ‘‘approved Aircraft Maintenance
The FAA has determined that this AD
will not have federalism implications 2023–21–03 Rolls-Royce Deutschland Ltd & Programme which contains the tasks on the
under Executive Order 13132. This AD Co KG: Amendment 39–22575; Docket basis of which the scheduled maintenance is
No. FAA–2023–1410; Project Identifier conducted to ensure the continuing
will not have a substantial direct effect airworthiness of each operated engine,’’
MCAI–2022–01517–E.
on the States, on the relationship replace that text with the ‘‘Aircraft
between the national government and (a) Effective Date Maintenance Program which contains the
the States, or on the distribution of This airworthiness directive (AD) is tasks of which the operator or the owner
power and responsibilities among the effective December 11, 2023. ensures the continuing airworthiness of each
various levels of government. operated airplane.’’
(b) Affected ADs (2) Where EASA AD 2022–0232 refers to its
For the reasons discussed above, I
This AD replaces AD 2013–26–10, effective date, this AD requires using the
certify that this AD: Amendment 39–17719 (79 FR 1315, January effective date of this AD.
(1) Is not a ‘‘significant regulatory 8, 2014). (3) This AD does not require compliance
action’’ under Executive Order 12866, with paragraph (1) of EASA AD 2022–0232.
(c) Applicability (4) This AD does not require compliance

(2) Will not affect intrastate aviation
in Alaska, and This AD applies to Rolls-Royce with paragraph (2) of EASA AD 2022–0232.
Deutschland Ltd & Co KG (RRD) Model (5) Where paragraph (3) of EASA AD 2022–
(3) Will not have a significant RB211–524G2–19, RB211–524G2–T–19, 0232 specifies revising the approved Aircraft
economic impact, positive or negative, RB211–524G3–19, RB211–524G3–T–19, Maintenance Programme within 12 months
on a substantial number of small entities RB211–524H–36, RB211–524H–T–36, after the effective date of EASA AD 2022–
under the criteria of the Regulatory RB211–524H2–19, and RB211–524H2–T–19 0232, this AD requires revising the
Flexibility Act. engines. airworthiness limitations section (ALS) of the
existing approved engine maintenance or the availability of this material at NARA, W12–140, 1200 New Jersey Avenue SE,
inspection program, as applicable, within 90 email: fr.inspection@nara.gov, or go to: Washington, DC 20590.
days after the effective date of this AD. www.archives.gov/federal-register/cfr/ibr- Material Incorporated by Reference:
(6) This AD does not require compliance locations.html. • For service information identified
with paragraph (4) of EASA AD 2022–0232.
Issued on October 18, 2023. in this final rule, contact Austro Engine
(7) This AD does not require compliance
with paragraph (5) of EASA AD 2022–0232. Ross Landes, GmbH, Rudolf-Diesel-Strasse 11, A–
(8) This AD does not adopt the Remarks Deputy Director for Regulatory Operations, 2700 Weiner Neustadt, Austria; phone:
paragraph of EASA AD 2022–0232. Compliance & Airworthiness Division, +43 2622 23000; website:
Aircraft Certification Service. austroengine.at.
(i) Provisions for Alternative Actions and
Intervals [FR Doc. 2023–24383 Filed 11–3–23; 8:45 am] • You may view this service
BILLING CODE 4910–13–P information at the FAA, Airworthiness
After performing the actions required by
paragraph (g) of this AD, no alternative
Products Section, Operational Safety
actions and associated thresholds and Branch, 1200 District Avenue,
intervals, including life limits, are allowed DEPARTMENT OF TRANSPORTATION Burlington, MA 01803. For information
unless they are approved as specified in the on the availability of this material at the
provisions of the ‘‘Ref. Publications’’ section Federal Aviation Administration FAA, call (817) 222–5110. It is also
of EASA AD 2022–0232. available at regulations.gov under
14 CFR Part 39 Docket No. FAA–2023–1412.
(j) Alternative Methods of Compliance
(AMOCs) [Docket No. FAA–2023–1412; Project FOR FURTHER INFORMATION CONTACT:
(1) The Manager, AIR–520 Continued Identifier MCAI–2022–01588–E; Amendment Barbara Caufield, Aviation Safety
Operational Safety Branch, FAA, has the 39–22562; AD 2023–20–03] Engineer, FAA, 1600 Stewart Avenue,
authority to approve AMOCs for this AD, if RIN 2120–AA64 Suite 410, Westbury, NY 11590; phone:
requested using the procedures found in 14 (781) 238–7146; email:
CFR 39.19. In accordance with 14 CFR 39.19, Airworthiness Directives; Austro barbara.caufield@faa.gov.
send your request to your principal inspector
or responsible Flight Standards Office, as Engine GmbH Engines SUPPLEMENTARY INFORMATION:
appropriate. If sending information directly AGENCY: Federal Aviation Background
to the manager of the AIR–520 Continued
Operational Safety Branch, send it to the
Administration (FAA), DOT. The FAA issued a notice of proposed
attention of the person identified in ACTION: Final rule. rulemaking (NPRM) to amend 14 CFR
paragraph (k) of this AD and email to: ANE- part 39 by adding an AD that would
AD-AMOC@faa.gov. SUMMARY: The FAA is adopting a new apply to certain Austro Engine GmbH
(2) Before using any approved AMOC, airworthiness directive (AD) for certain Model E4 and E4P engines. The NPRM
notify your appropriate principal inspector, Austro Engine GmbH Model E4 and E4P published in the Federal Register on
or lacking a principal inspector, the manager engines. This AD is prompted by reports
of the local flight standards district office/ July 14, 2023 (88 FR 45118). The NPRM
of piston failures and the determination was prompted by European Union
certificate holding district office. that certain batches of pistons were Aviation Safety Agency (EASA) AD
(k) Additional Information manufactured with a dimensional 2022–0240R1, dated December 15, 2022
For more information about this AD, deviation in the piston pin bore and (referred to after this as the MCAI),
contact Sungmo Cho, Aviation Safety piston diameter. This AD requires issued by EASA, which is the Technical
Engineer, FAA, 2200 South 216th Street, Des repetitive engine oil analysis for Agent for the Member States of the
Moines, WA 98198; phone: (781) 238–7241; aluminum content outside the
email: sungmo.d.cho@faa.gov. European Union. The MCAI states that
acceptable limits and, if necessary, a manufacturer investigation into
(l) Material Incorporated by Reference replacement of the pistons, piston rings, reports of piston failures determined
(1) The Director of the Federal Register con-rods assembly, and crankcase or, as that certain batches of pistons were
approved the incorporation by reference of an alternative, replacement of the manufactured with a dimensional
the service information listed in this engine core. The FAA is issuing this AD deviation in the piston pin bore and in
paragraph under 5 U.S.C. 552(a) and 1 CFR to address the unsafe condition on these the piston diameter, which could cause
part 51. products.
(2) You must use this service information piston failure, with consequent loss of
DATES: This AD is effective December oil, loss of engine power, and reduced
as applicable to do the actions required by
this AD, unless the AD specifies otherwise. 11, 2023. control of the airplane. To address the
(i) European Union Aviation Safety Agency The Director of the Federal Register unsafe condition, EASA issued EASA
(EASA) AD 2022–0232, dated November 28, approved the incorporation by reference AD 2022–0240, dated December 6, 2022
2022. of a certain publication listed in this AD (EASA AD 2022–0240), to specify
(ii) [Reserved] as of December 11, 2023. repetitive oil analyses and replacement
(3) For EASA AD 2022–0232, contact ADDRESSES: of the pistons, piston rings, con-rods
EASA, Konrad-Adenauer-Ufer 3, 50668
Cologne, Germany; phone: +49 221 8999 000;
AD Docket: You may examine the AD assembly, and crankcase, or as an
email: ADs@easa.europa.eu; website: docket at regulations.gov under Docket alternative, replacement of the engine
easa.europa.eu. You may find this EASA AD No.FAA–2023–1412; or in person at core. EASA AD 2022–0240 also
on the EASA website at ad.easa.europa.eu. Docket Operations between 9 a.m. and prohibited release to service of an
(4) You may view this service information 5 p.m., Monday through Friday, except airplane until receipt of the results for
at FAA, Airworthiness Products Section, Federal holidays. The AD docket
each oil analysis.

Operational Safety Branch, 1200 District contains this final rule, the mandatory Since EASA AD 2022–0240 was
Avenue, Burlington, MA 01803. For continuing airworthiness information issued, the manufacturer determined
information on the availability of this
material at the FAA, call (817) 222–5110.
(MCAI), any comments received, and that aluminum levels outside of the
(5) You may view this service information other information. The address for acceptable limits would be found during
that is incorporated by reference at the Docket Operations is U.S. Department of the first oil analysis, and are unlikely to
National Archives and Records Transportation, Docket Operations, M– be found during subsequent oil
Administration (NARA). For information on 30, West Building Ground Floor, Room analyses. As a result, EASA revised
EASA AD 2022–0240 and issued the Discussion of Final Airworthiness changes, this AD is adopted as proposed
MCAI to allow release to service of Directive in the NPRM.
airplanes for a limited number of flight Comments Related Service Information Under 1
hours immediately after the second and CFR Part 51
subsequent oil samples are taken for The FAA received no comments on
analyses. the NPRM or on the determination of The FAA reviewed Austro Engine
the costs. GmbH Mandatory Service Bulletin No.
In the NPRM, the FAA proposed to MSB–E4–039/1, Revision 1, dated April
require initial and repetitive engine oil Conclusion 24, 2023, which specifies procedures for
analysis for aluminum content outside oil analysis and replacement of the
the acceptable limits and, if necessary, These products have been approved pistons, piston rings, con-rods assembly,
replacement of the pistons, piston rings, by the aviation authority of another crankcase, and engine core.
con-rods assembly, and crankcase, or as country and are approved for operation This service information is reasonably
an alternative, replacement of the in the United States. Pursuant to the available because the interested parties
engine core. The FAA is issuing this AD FAA’s bilateral agreement with this have access to it through their normal
to address the unsafe condition on these State of Design Authority, it has notified course of business or by the means
products. the FAA of the unsafe condition identified in ADDRESSES.
described in the MCAI referenced
You may examine the MCAI in the Costs of Compliance
above. The FAA reviewed the relevant
AD docket at regulations.gov under
data and determined that air safety The FAA estimates that this AD
Docket No. FAA–2023–1412.
requires adopting this AD as proposed. affects 357 engines installed on
Accordingly, the FAA is issuing this AD airplanes of U.S. registry.
to address the unsafe condition on these The FAA estimates the following
products. Except for minor editorial costs to comply with this AD:
ESTIMATED COSTS
Oil Analysis ..................................................... .25 work-hours × $85 per hour = $21.25 ....... $0 $21.25 $7,586.25
The FAA estimates the following results of the inspection. The agency has aircraft that might need these
costs to do any necessary replacements no way of determining the number of replacements:
that would be required based on the
ON-CONDITION COSTS
Cost per
Action Labor cost Parts cost product
Replace engine core .................................................... 50 work-hours × $85 per hour = $4,250 ...................... $15,524 $19,774
Replace pistons, piston rings, and con-rods assembly 60 work-hours × 85 per hour = 5,100 .......................... 2,216 7,316
Replace pistons, piston rings, con-rods assembly, and 70 work-hours × 85 per hour = 5,950 .......................... 4,141 10,091
crankcase.
The FAA has included all known aircraft in air commerce by prescribing (1) Is not a ‘‘significant regulatory
costs in its cost estimate. According to regulations for practices, methods, and action’’ under Executive Order 12866,
the manufacturer, however, some of the procedures the Administrator finds (2) Will not affect intrastate aviation
costs of this AD may be covered under necessary for safety in air commerce. in Alaska, and
warranty, thereby reducing the cost This regulation is within the scope of
impact on affected operators. that authority because it addresses an (3) Will not have a significant
unsafe condition that is likely to exist or economic impact, positive or negative,
Authority for This Rulemaking on a substantial number of small entities
develop on products identified in this
Title 49 of the United States Code rulemaking action. under the criteria of the Regulatory
specifies the FAA’s authority to issue Flexibility Act.
rules on aviation safety. Subtitle I, Regulatory Findings
section 106, describes the authority of This AD will not have federalism List of Subjects in 14 CFR Part 39
the FAA Administrator. Subtitle VII: implications under Executive Order Air transportation, Aircraft, Aviation
Aviation Programs, describes in more 13132. This AD will not have a
safety, Incorporation by reference,
detail the scope of the Agency’s substantial direct effect on the States, on
Safety.
authority. the relationship between the national
The FAA is issuing this rulemaking government and the States, or on the The Amendment
under the authority described in distribution of power and
Subtitle VII, Part A, Subpart III, Section responsibilities among the various Accordingly, under the authority
44701: General requirements. Under levels of government. delegated to me by the Administrator,
that section, Congress charges the FAA For the reasons discussed above, I the FAA amends 14 CFR part 39 as
with promoting safe flight of civil certify that this AD: follows:
PART 39—AIRWORTHINESS (b) Affected ADs dimensional deviation in the piston pin bore
DIRECTIVES None. and piston diameter. The FAA is issuing this
AD to prevent piston failure. The unsafe
(c) Applicability condition, if not addressed, could result in
■ 1. The authority citation for part 39
This AD applies to Austro Engine GmbH loss of oil, loss of engine power, and reduced
continues to read as follows:
Model E4 and E4P engines with a serial control of the airplane.
Authority: 49 U.S.C. 106(g), 40113, 44701. number listed in Tables 1, 2, 3, and 4 of (f) Compliance
Austro Engine GmbH Mandatory Service
§ 39.13 [Amended] Bulletin No. MSB–E4–039/1, Revision 1, Comply with this AD within the
dated April 24, 2023 (MSB–E4–039/1). compliance times specified, unless already
■ 2. The FAA amends § 39.13 by adding
done.
the following new airworthiness (d) Subject
directive: (g) Required Actions
Joint Aircraft System Component (JASC)
2023–20–03 Austro Engine GmbH: Codes 8530, Reciprocating Engine Cylinder (1) For all affected engines, within the
Amendment 39–22562; Docket No. Section; 8550, Reciprocating Engine Oil applicable compliance times specified in
FAA–2023–1412; Project Identifier System. Table 1 to paragraph (g)(1) of this AD,
MCAI–2022–01588–E. perform an oil analysis in accordance with
(e) Unsafe Condition paragraph 2., Technical Details, Engine Oil
(a) Effective Date This AD was prompted by reports of piston Analysis of MSB–E4–039/1, and do not
This airworthiness directive (AD) is failures and the determination that certain return the engine to service until the results
effective December 11, 2023. batches of pistons were manufactured with a of the oil analysis have been determined.
TABLE 1 TO PARAGRAPH (g)(1)—OIL ANALYSIS FOR ALL AFFECTED ENGINES

Engine group Compliance time Interval
Group 1 and Group 3 ......................................... Within 15 flight hours (FHs) from the effective Before exceeding 50 FHs since last oil anal-
date of this AD. ysis.
Group 2 and Group 4 ......................................... Within 25 FHs from the effective date of this Before exceeding 100 FHs since last oil anal-
AD. ysis.
(2) Thereafter, repeat the oil analysis aluminum content of the oil is greater than rod assy replacement; as applicable, of MSB–
required by paragraph (g)(1) of this AD before the limit specified in paragraph 2., Technical E4–039/1.
exceeding the applicable interval specified in Details, Engine Oil Analysis, Table 5—Oil (5) For Group 3 and Group 4 engines,
Table 1 to paragraph (g)(1) of this AD. check analysis—Aluminum PPM allowable within the applicable compliance times
(3) Following each repetitive oil analysis, of MSB–E4–039/1, before further flight, specified in Table 2 to paragraph (g)(5) of this
the engine may be returned to service for no AD, replace the pistons, piston rings, and
replace the pistons, piston rings, con-rods
more than the applicable interval specified in con-rods assembly, or replace the engine core
assembly, and crankcase, or replace the
Table 1 to paragraph (g)(1) of this AD, until in accordance with paragraph 2., Technical
receipt of the oil analysis result. engine core in accordance with paragraph 2., Details, Engine core replacement; or Pistons,
(4) If the result of any oil analysis required Technical Details, Engine core replacement; piston rings and con-rod assy replacement, as
by paragraph (g)(1) of this AD indicates the or Pistons, piston rings, crankcase and con- applicable, of MSB–E4–039/1.
TABLE 2 TO PARAGRAPH (g)(5)—REPLACEMENT FOR GROUPS 3 AND 4 ENGINES

Engine group Compliance time
Group 3 ............ Before exceeding 900 FHs since new, or within 15 FHs after the effective date of this AD, whichever occurs later.
Group 4 ............ Before exceeding 1,000 FHs since new, or within 25 FHs after the effective date of this AD, whichever occurs later.
Note 1 to paragraph (g)(5): FHs since new (i) Definitions (k) Alternative Methods of Compliance
indicated in Table 2 to paragraph (g)(5) of (1) For the purpose of this AD, Group 1 (AMOCs)
this AD are FHs accumulated by the engine engines are engines having a serial number (1) The Manager, International Validation
since first installation on an airplane or since (S/N) listed in Table 1 of MSB–E4–039/1. Branch, FAA, has the authority to approve
last overhaul as of the effective date of this (2) For the purpose of this AD, Group 2 AMOCs for this AD, if requested using the
AD. engines are engines having an S/N listed in procedures found in 14 CFR 39.19. In
(h) Terminating Action Table 2 of MSB–E4–039/1. accordance with 14 CFR 39.19, send your
(3) For the purpose of this AD, Group 3 request to your principal inspector or local
(1) Replacement of the pistons, piston engines are engines having an S/N listed in Flight Standards District Office, as
rings, con-rods assembly, and crankcase, or Table 3 of MSB–E4–039/1. appropriate. If sending information directly
replacement of the engine core, as specified (4) For the purpose of this AD, Group 4 to the manager of the International Validation
in paragraph (g)(4) of this AD, constitutes engines are engines having an S/N listed in Branch, send it to the attention of the person
terminating action for the repetitive oil Table 4 of MSB–E4–039/1. identified in paragraph (l)(2) of this AD and
analysis required by paragraph (g)(2) of this

email to: ANE-AD-AMOC@faa.gov.
AD. (j) Credit for Previous Actions
(2) Before using any approved AMOC,
(2) Replacement of the pistons, piston You may take credit for the actions notify your appropriate principal inspector,
rings, and con-rods assembly, or replacement required by paragraph (g)(1), (4), or (5) of this or lacking a principal inspector, the manager
of the engine core, as specified in paragraph AD, if you performed those actions before the of the local flight standards district office/
(g)(5) of this AD, constitutes terminating effective date of this AD using Austro Engine certificate holding district office.
action for the repetitive oil analysis required Mandatory Service Bulletin MSB–E4–039/0,
by paragraph (g)(2) of this AD. dated October 24, 2022.
(l) Additional Information Model A330–200 series, A330–200 FOR FURTHER INFORMATION CONTACT: Tim
(1) Refer to European Union Aviation Freighter series, A330–300 series, Dowling, Aviation Safety Engineer,
Safety Agency (EASA) AD 2022–0240R1, A330–800 series, and A330–900 series FAA, 1600 Stewart Avenue, Suite 410,
dated December 15, 2022, for related airplanes. AD 2022–18–14 required Westbury, NY 11590; telephone 206–
information. This EASA AD may be found in revising the existing maintenance or 231–3667; email timothy.p.dowling@
the AD docket at regulations.gov under inspection program, as applicable, to faa.gov.
Docket No. FAA–2023–1412. incorporate new or more restrictive
(2) For more information about this AD, SUPPLEMENTARY INFORMATION:
contact Barbara Caufield, Aviation Safety
airworthiness limitations. This AD was
Engineer, FAA, 1600 Stewart Avenue, Suite prompted by a determination that new Background
410, Westbury, NY 11590; phone: (781) 238– or more restrictive airworthiness The FAA issued a notice of proposed
7146; email: barbara.caufield@faa.gov. limitations are necessary. This AD rulemaking (NPRM) to amend 14 CFR
continues to require the actions in AD part 39 to supersede AD 2022–18–14,
(m) Material Incorporated by Reference
2022–18–14, and also requires revising Amendment 39–22165 (87 FR 56566,
(1) The Director of the Federal Register the existing maintenance or inspection
approved the incorporation by reference of September 15, 2022) (AD 2022–18–14).
program, as applicable to incorporate AD 2022–18–14 applied to certain
the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
additional new or more restrictive Airbus SAS Model A330–201, –202,
part 51. airworthiness limitations; as specified –203, –223, and –243 airplanes; Model
(2) You must use this service information in two European Union Aviation Safety A330–223F and –243F airplanes; Model
as applicable to do the actions required by Agency (EASA) ADs, which are A330–301, –302, –303, –321, –322,
this AD, unless the AD specifies otherwise. incorporated by reference. The FAA is –323, –341, –342, and –343 airplanes;
(i) Austro Engine GmbH Mandatory Service issuing this AD to address the unsafe Model A330–841 airplanes; and Model
Bulletin No. MSB–E4–039/1, Revision 1, condition on these products.
dated April 24, 2023.
A330–941 airplanes. AD 2022–18–14
(ii) [Reserved] DATES: This AD is effective December required revising the existing
(3) For service information identified in 11, 2023. maintenance or inspection program, as
this AD, contact Austro Engine GmbH, The Director of the Federal Register applicable, to incorporate additional
Rudolf-Diesel-Strasse 11, A–2700 Weiner approved the incorporation by reference new or more restrictive airworthiness
Neustadt, Austria; phone: +43 2622 23000; of certain publications listed in this AD limitations. The FAA issued AD 2022–
website: austroengine.at. as of December 11, 2023. 18–14 to address fatigue cracking,
(4) You may view this service information accidental damage, and corrosion in
at the FAA, Airworthiness Products Section,
The Director of the Federal Register
approved the incorporation by reference principal structural elements; such
Operational Safety Branch, 1200 District
Avenue, Burlington, MA 01803. For of certain other publication listed in this fatigue cracking, accidental damage, and
information on the availability of this AD as of October 20, 2022 (87 FR 56566, corrosion could result in reduced
material at the FAA, call (817) 222–5110. September 15, 2022). structural integrity of the airplane.
(5) You may view this material at the The NPRM published in the Federal
ADDRESSES:
National Archives and Records Register on July 28, 2023 (88 FR 48760).
Administration (NARA). For information on AD Docket: You may examine the AD The NPRM was prompted by AD 2022–
the availability of this material at NARA, docket at regulations.gov under Docket 0187, dated September 13, 2022, issued
visit www.archives.gov/federal-register/cfr/ No. FAA–2023–1642; or in person at by EASA, which is the Technical Agent
ibr-locationsoremailfr.inspection@nara.gov. Docket Operations between 9 a.m. and for the Member States of the European
Issued on October 20, 2023. 5 p.m., Monday through Friday, except Union (EASA AD 2022–0187). EASA
Ross Landes,
Federal holidays. The AD docket AD 2022–0187 states that new or more
contains this final rule, the mandatory restrictive airworthiness limitations
Deputy Director for Regulatory Operations,
Compliance & Airworthiness Division,
continuing airworthiness information have been developed.
Aircraft Certification Service. (MCAI), any comments received, and The NPRM was also prompted by
[FR Doc. 2023–24385 Filed 11–3–23; 8:45 am]
other information. The address for EASA AD 2023–0015, dated January 19,
Docket Operations is U.S. Department of 2023 (EASA AD 2023–0015). EASA AD
BILLING CODE 4910–13–P
Transportation, Docket Operations, M– 2023–0015 states that new or more
30, West Building Ground Floor, Room restrictive airworthiness limitations
DEPARTMENT OF TRANSPORTATION W12–140, 1200 New Jersey Avenue SE, have been developed. EASA AD 2023–
Washington, DC 20590. 0015 also states that it requires certain
Federal Aviation Administration Material Incorporated by Reference: tasks also required by EASA AD 2022–
• For material incorporated by 0187, and invalidates (terminates) the
14 CFR Part 39 reference in this AD, contact EASA, tasks that are also required by EASA AD
Konrad-Adenauer-Ufer 3, 50668 2022–0187. Therefore, for this AD,
[Docket No. FAA–2023–1642; Project
Identifier MCAI–2023–00183–T; Amendment Cologne, Germany; telephone +49 221 where EASA AD 2023–0015 affects the
39–22574; AD 2023–21–02] 8999 000; email ADs@easa.europa.eu; same airworthiness limitations as those
website easa.europa.eu. You may find in EASA AD 2022–0187, the
RIN 2120–AA64 this material on the EASA website at airworthiness limitations referenced in
ad.easa.europa.eu. EASA AD 2023–0015 prevail.
Airworthiness Directives; Airbus SAS
• You may view this material at the In the NPRM, the FAA proposed to
Airplanes
FAA, Airworthiness Products Section, continue to require the actions in AD
AGENCY: Federal Aviation Operational Safety Branch, 2200 South 2022–18–14, and to require revising the
Administration (FAA), DOT. 216th St., Des Moines, WA. For existing maintenance or inspection
ACTION: Final rule. information on the availability of this program, as applicable, to incorporate
material at the FAA, call 206–231–3195. additional new or more restrictive
SUMMARY: The FAA is superseding It is also available in the AD docket at airworthiness limitations, as specified
Airworthiness Directive (AD) 2022–18– regulations.gov under Docket No. FAA– in EASA ADs 2022–0187 and 2023–
14, which applied to certain Airbus SAS 2023–1642. 0015. The FAA is issuing this AD to
address fatigue cracking, accidental access to it through their normal course (2) Will not affect intrastate aviation
damage, and corrosion in principal of business or by the means identified in Alaska, and
structural elements; such fatigue in the ADDRESSES section. (3) Will not have a significant
cracking, accidental damage, and economic impact, positive or negative,
Costs of Compliance on a substantial number of small entities
corrosion could result in reduced
structural integrity of the airplane. The FAA estimates that this AD under the criteria of the Regulatory
You may examine the MCAI in the affects 120 airplanes of U.S. registry. Flexibility Act.
AD docket at regulations.gov under The FAA estimates the following costs
Docket No. FAA–2023–1642. to comply with this AD: List of Subjects in 14 CFR Part 39
The FAA estimates the total cost per Air transportation, Aircraft, Aviation
Discussion of Final Airworthiness safety, Incorporation by reference,
operator for the retained actions from
Directive
AD 2022–18–14 to be $7,650 (90 work- Safety.
Comments hours × $85 per work-hour).
The FAA has determined that revising The Amendment
The FAA received no comments on
the NPRM or on the determination of the existing maintenance or inspection Accordingly, under the authority
the cost to the public. program takes an average of 90 work- delegated to me by the Administrator,
hours per operator, although the agency the FAA amends 14 CFR part 39 as
Additional Changes Made to This AD recognizes that this number may vary follows:
The FAA revised paragraph (l) of this from operator to operator. Since
AD to specify that no alternative actions operators incorporate maintenance or PART 39—AIRWORTHINESS
(e.g., inspections) and intervals are inspection program changes for their DIRECTIVES
allowed unless they are approved as affected fleet(s), the FAA has ■ 1. The authority citation for part 39
specified in the provisions of the ‘‘Ref. determined that a per-operator estimate continues to read as follows:
Publications’’ section of EASA AD is more accurate than a per-airplane
2022–0187 or of EASA AD 2023–0015. estimate. Authority: 49 U.S.C. 106(g), 40113, 44701.
In the NPRM, the FAA inadvertently The FAA estimates the total cost per § 39.13 [Amended]
specified that the alternatives actions operator for the new actions to be
and intervals had to be approved as $7,650 (90 work-hours × $85 per work- ■ 2. The FAA amends § 39.13 by:
specified in the ‘‘Ref. Publications’’ hour). ■ a. Removing Airworthiness Directive
section of EASA AD 2022–0187 and of (AD) 2022–18–14, Amendment 39–
Authority for This Rulemaking 22165 (87 FR 56566, September 15,
EASA AD 2023–0015.
Title 49 of the United States Code 2022); and
Conclusion specifies the FAA’s authority to issue ■ b. Adding the following new AD:
This product has been approved by rules on aviation safety. Subtitle I, 2023–21–02 Airbus SAS: Amendment 39–
the aviation authority of another section 106, describes the authority of 22574; Docket No. FAA–2023–1642;
country and is approved for operation in the FAA Administrator. Subtitle VII: Project Identifier MCAI–2023–00183–T.
the United States. Pursuant to the FAA’s Aviation Programs, describes in more (a) Effective Date
bilateral agreement with this State of detail the scope of the Agency’s
This airworthiness directive (AD) is
Design Authority, it has notified the authority. effective December 11, 2023.
FAA of the unsafe condition described The FAA is issuing this rulemaking
in the MCAI referenced above. The FAA under the authority described in (b) Affected ADs
reviewed the relevant data and Subtitle VII, Part A, Subpart III, Section This AD replaces AD 2022–18–14,
determined that air safety requires 44701: General requirements. Under Amendment 39–22165 (87 FR 56566,
adopting this AD as proposed. that section, Congress charges the FAA September 15, 2022) (AD 2022–18–14).
Accordingly, the FAA is issuing this AD with promoting safe flight of civil (c) Applicability
to address the unsafe condition on this aircraft in air commerce by prescribing
This AD applies to Airbus SAS airplanes,
product. Except for minor editorial regulations for practices, methods, and identified in paragraphs (c)(1) through (5) of
changes, and any other changes procedures the Administrator finds this AD, certificated in any category, with an
described previously, this AD is necessary for safety in air commerce. original airworthiness certificate or original
adopted as proposed in the NPRM. This regulation is within the scope of export certificate of airworthiness issued on
None of the changes will increase the that authority because it addresses an or before November 18, 2022.
economic burden on any operator. unsafe condition that is likely to exist or (1) Model A330–201, –202, –203, –223, and
develop on products identified in this –243 airplanes.
Related Service Information Under 1 rulemaking action. (2) Model A330–223F and –243F airplanes.
CFR Part 51 (3) Model A330–301, –302, –303, –321,
EASA AD 2022–0187 and EASA AD Regulatory Findings –322, –323, –341, –342, and –343 airplanes.
(4) Model A330–841 airplanes.
2023–0015 specify new or more This AD will not have federalism (5) Model A330–941 airplanes.
restrictive airworthiness limitations for implications under Executive Order
airplane structures. These documents 13132. This AD will not have a (d) Subject
are distinct since they apply to different substantial direct effect on the States, on Air Transport Association (ATA) of
airplane configurations. the relationship between the national America Code 05, Time Limits/Maintenance
Checks.
This AD also requires EASA AD government and the States, or on the

2021–0261, dated November 22, 2021, distribution of power and (e) Unsafe Condition
which the Director of the Federal responsibilities among the various This AD was prompted by a determination
Register approved for incorporation by levels of government. that new or more restrictive airworthiness
reference as of October 20, 2022 (87 FR For the reasons discussed above, I limitations are necessary. The FAA is issuing
56566, September 15, 2022). certify that this AD: this AD to address fatigue cracking,
This material is reasonably available (1) Is not a ‘‘significant regulatory accidental damage, and corrosion in
because the interested parties have action’’ under Executive Order 12866, principal structural elements. The unsafe
condition, if not addressed, could result in ‘‘Ref. Publications’’ section of EASA AD (1) Alternative Methods of Compliance
reduced structural integrity of the airplane. 2021–0261. (AMOCs): The Manager, International
Validation Branch, FAA, has the authority to
(f) Compliance (j) New Revision of the Existing Maintenance approve AMOCs for this AD, if requested
Comply with this AD within the or Inspection Program using the procedures found in 14 CFR 39.19.
compliance times specified, unless already Except as specified in paragraph (k) of this In accordance with 14 CFR 39.19, send your
done. AD: Comply with all required actions and request to your principal inspector or
compliance times specified in, and in responsible Flight Standards Office, as
(g) Retained Revision of the Existing accordance with, EASA AD 2022–0187, appropriate. If sending information directly
Maintenance or Inspection Program, With to the International Validation Branch, send
dated September 13, 2022 (EASA AD 2022–
No Changes it to the attention of the person identified in
0187); and EASA AD 2023–0015, dated
This paragraph restates the requirements of January 19, 2023 (EASA AD 2023–0015); as paragraph (n) of this AD. Information may be
paragraph (i) of AD 2022–18–14, with no applicable. Where EASA AD 2023–0015 emailed to: 9-AVS-AIR-730-AMOC@faa.gov.
changes. For airplanes with an original affects the same airworthiness limitations as (i) Before using any approved AMOC,
airworthiness certificate or original export those in EASA AD 2022–0187, the notify your appropriate principal inspector,
certificate of airworthiness issued on or airworthiness limitations referenced in EASA or lacking a principal inspector, the manager
before November 2, 2021, except as specified AD 2023–0015 prevail. of the responsible Flight Standards Office.
in paragraph (h) of this AD: Comply with all (ii) The AMOC specified in letter AIR–676–
required actions and compliance times (k) New Exceptions to EASA AD 2022–0187 19–120, dated March 5, 2019, approved
specified in, and in accordance with, and to EASA AD 2023–0015 previously for AD 2018–24–04, Amendment
European Union Aviation Safety Agency (1) This AD does not adopt the 39–19508 (83 FR 60756, November 27, 2018),
(EASA) AD 2021–0261, dated November 22, requirements specified in paragraphs (1) and is approved as an AMOC for the
2021 (EASA AD 2021–0261). Accomplishing (2) of EASA AD 2022–0187 and of EASA AD corresponding provisions of EASA AD 2022–
the revision of the existing maintenance or 2023–0015. 0187 and EASA AD 2023–0015 that are
required by paragraph (j) of this AD for
inspection program required by paragraph (j) (2) Paragraph (3) of EASA AD 2022–0187
Model A330–200 and A330–300 series
of this AD terminates the requirements of this and of EASA AD 2023–0015 specifies
airplanes modified from a passenger to
paragraph. revising ‘‘the AMP’’ within 12 months after
freighter configuration under the provisions
the respective EASA AD’s effective date, but
(h) Retained Exceptions to EASA AD 2021– of FAA Supplemental Type Certificate
this AD requires revising the existing
0261, With No Changes ST04038NY.
maintenance or inspection program, as
This paragraph restates the exceptions (iii) The AMOC specified in letter AIR–
applicable, within 90 days after the effective
specified in paragraph (j) of AD 2022–18–14, 731A–20–179, dated May 11, 2020, approved
date of this AD.
with no changes. previously for AD 2019–23–02, Amendment
(3) The initial compliance time for doing
39–19795 (84 FR 64725, November 25, 2019),
(1) Where EASA AD 2021–0261 refers to its the tasks specified in paragraph (3) of EASA is approved as an AMOC for the
effective date, this AD requires using October AD 2022–0187 and of EASA AD 2023–0015 corresponding provisions of EASA AD 2022–
20, 2022 (the effective date of AD 2022–18– is at the applicable ‘‘associated thresholds’’ 0187 and of EASA AD 2023–0015 that are
14). as incorporated by the requirements of required by paragraph (j) of this AD for
(2) The requirements specified in paragraph (3) of EASA AD 2022–0187 and of Model A330–200 and A330–300 series
paragraphs (1) and (2) of EASA AD 2021– EASA AD 2023–0015, or within 90 days after airplanes modified from a passenger to
0261 do not apply to this AD. the effective date of this AD, whichever freighter configuration under the provisions
(3) Paragraph (3) of EASA AD 2021–0261 occurs later. of FAA Supplemental Type Certificate
specifies revising ‘‘the AMP’’ within 12 (4) This AD does not adopt the provisions ST04038NY.
months after its effective date, but this AD specified in paragraphs (4) and (5) of EASA (2) Contacting the Manufacturer: For any
requires revising the existing maintenance or AD 2022–0187. requirement in this AD to obtain instructions
inspection program, as applicable, within 90 (5) Where EASA AD 2022–0187 defines from a manufacturer, the instructions must
days after October 20, 2022 (the effective date ‘‘The ALS,’’ replace the text ‘‘Airbus A330 be accomplished using a method approved
of AD 2022–18–14). Airworthiness Limitations Section (ALS) Part by the Manager, International Validation
(4) The initial compliance time for doing 2 Revision 05,’’ with ‘‘Airbus A330 Branch, FAA; or EASA; or Airbus SAS’s
the tasks specified in paragraph (3) of EASA Airworthiness Limitations Section (ALS) Part EASA Design Organization Approval (DOA).
2021–0261 is at the applicable ‘‘associated 2 Revision 05 Issue 02.’’ If approved by the DOA, the approval must
thresholds’’ as incorporated by the (6) This AD does not adopt the provisions include the DOA-authorized signature.
requirements of paragraph (3) of EASA AD specified in paragraph (4) of EASA AD 2023–
2021–0261, or within 90 days after October 0015. (n) Additional Information
20, 2022 (the effective date of AD 2022–18– (7) This AD does not require incorporating For more information about this AD,
14), whichever occurs later. Section 4, ‘‘Damage Tolerant-Airworthiness contact Tim Dowling, Aviation Safety
(5) This AD does not require incorporating Limitations Items-Tasks Beyond MPPT,’’ of Engineer, FAA, 1600 Stewart Avenue, Suite
Section 4, ‘‘Damage Tolerant-Airworthiness ‘‘the ALS’’ specified in EASA AD 2022–0187 410, Westbury, NY 11590; telephone: 206–
Limitations Items-Tasks Beyond MPPT,’’ of and in EASA AD 2023–0015. 231–3667; email: timothy.p.dowling@faa.gov.
‘‘the ALS’’ specified in EASA AD 2021–0261. (8) This AD does not adopt the ‘‘Remarks’’
(6) The provisions specified in paragraphs section of EASA AD 2022–0187 and of EASA (o) Material Incorporated by Reference
(4) and (5) of EASA AD 2021–0261 do not AD 2023–0015. (1) The Director of the Federal Register
apply to this AD. approved the incorporation by reference
(7) The ‘‘Remarks’’ section of EASA AD (l) New Provisions for Alternative Actions (IBR) of the service information listed in this
2021–0261 does not apply to this AD. and Intervals paragraph under 5 U.S.C. 552(a) and 1 CFR
After the existing maintenance or part 51.
(i) Retained Restrictions on Alternative inspection program has been revised as (2) You must use this service information
Actions and Intervals, With a New Exception required by paragraph (j) of this AD, no as applicable to do the actions required by
This paragraph restates the requirements of alternative actions (e.g., inspections) and this AD, unless this AD specifies otherwise.
AD 2022–18–14, with a new exception. intervals are allowed unless they are (3) The following service information was
Except as required by paragraph (j) of this approved as specified in the provisions of the approved for IBR on December 11, 2023.
AD, after the existing maintenance or ‘‘Ref. Publications’’ section of EASA AD (i) European Union Aviation Safety Agency
inspection program has been revised as 2022–0187 or of EASA AD 2023–0015. (EASA) AD 2022–0187, dated September 13,
required by paragraph (g) of this AD, no 2022.
alternative actions (e.g., inspections) and (m) Additional AD Provisions (ii) European Union Aviation Safety
intervals are allowed unless they are The following provisions also apply to this Agency (EASA) AD 2023–0015, dated
approved as specified in the provisions of the AD: January 19, 2023.
(4) The following service information was AD, which is incorporated by reference. 2020–01–13 applied to all Dassault
approved for IBR on October 20, 2022 (87 FR The FAA is issuing this AD to address Aviation Model MYSTERE–FALCON
56566, September 15, 2022). the unsafe condition on these products. 200 airplanes. AD 2020–01–13 required
(i) European Union Aviation Safety Agency
DATES: This AD is effective December revising the existing maintenance or
(EASA) AD 2021–0261, dated November 22,
2021. 11, 2023. inspection program, as applicable, to
(ii) [Reserved] The Director of the Federal Register incorporate new or more restrictive
(5) For EASA AD 2021–0261, EASA AD approved the incorporation by reference airworthiness limitations. The FAA
2022–0187, and EASA AD 2023–0015, of a certain publication listed in this AD issued AD 2020–01–13 to address
contact EASA, Konrad-Adenauer-Ufer 3, as of December 11, 2023. fatigue cracking, damage, and corrosion
50668 Cologne, Germany; telephone +49 221 The Director of the Federal Register in principal structural elements; such
8999 000; email ADs@easa.europa.eu; approved the incorporation by reference fatigue cracking, damage, and corrosion
website easa.europa.eu. You may find these could result in reduced structural
EASA ADs on the EASA website at
of a certain other publication listed in
this AD as of March 5, 2020 (85 FR integrity of the airplane.
ad.easa.europa.eu.
5313, January 30, 2020). The NPRM published in the Federal
(6) You may view this service information
at the FAA, Airworthiness Products Section, ADDRESSES:
Register on July 19, 2023 (88 FR 46112).
Operational Safety Branch, 2200 South 216th AD Docket: You may examine the AD The NPRM was prompted by EASA AD
St., Des Moines, WA. For information on the docket at regulations.gov under Docket 2023–0045, dated March 2, 2023;
availability of this material at the FAA, call No. FAA–2023–1494; or in person at corrected March 3, 2023, issued by
206–231–3195. Docket Operations between 9 a.m. and EASA, which is the Technical Agent for
(7) You may view this material at the
5 p.m., Monday through Friday, except the Member States of the European
National Archives and Records Union (EASA AD 2023–0045) (also
Administration (NARA). For information on Federal holidays. The AD docket
referred to as the MCAI). The MCAI
the availability of this material at NARA, contains this final rule, the mandatory
states that new or more restrictive
visit www.archives.gov/federal-register/cfr/ continuing airworthiness information
airworthiness limitations have been
ibr-locations or email fr.inspection@nara.gov. (MCAI), any comments received, and
developed.
Issued on October 11, 2023. other information. The address for In the NPRM, the FAA proposed to
Victor Wicklund,
Docket Operations is U.S. Department of continue to require the actions in AD
Transportation, Docket Operations, M– 2020–01–13 and require revising the
Deputy Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
30, West Building Ground Floor, Room existing maintenance or inspection
W12–140, 1200 New Jersey Avenue SE, program, as applicable, to incorporate
[FR Doc. 2023–24406 Filed 11–3–23; 8:45 am]
Washington, DC 20590. new or more restrictive airworthiness
Material Incorporated by Reference: limitations. The FAA is issuing this AD
• For EASA ADs incorporated by to address the unsafe condition on these
reference in this AD, contact EASA, products.
DEPARTMENT OF TRANSPORTATION
Konrad-Adenauer-Ufer 3, 50668 You may examine the MCAI in the
Federal Aviation Administration Cologne, Germany; telephone +49 221 AD docket at regulations.gov under
8999 000; email ADs@easa.europa.eu; Docket No. FAA–2023–1494.
14 CFR Part 39 website easa.europa.eu. You may find
this material on the EASA website at Discussion of Final Airworthiness
[Docket No. FAA–2023–1494; Project ad.easa.europa.eu. Directive
Identifier MCAI–2023–00382–T; Amendment • For Dassault Aviation service Comments
39–22573; AD 2023–21–01] information incorporated by reference
The FAA received no comments on
RIN 2120–AA64 in this AD, contact Dassault Falcon Jet
the NPRM or on the determination of
Corporation, Teterboro Airport, P.O.
Airworthiness Directives; Dassault the cost to the public.
Box 2000, South Hackensack, NJ 07606;
Aviation Airplanes telephone 201–440–6700; website Conclusion
AGENCY: Federal Aviation dassaultfalcon.com. This product has been approved by
Administration (FAA), DOT. • You may view this service the aviation authority of another
information at the FAA, Airworthiness country and is approved for operation in
ACTION: Final rule.
Products Section, Operational Safety the United States. Pursuant to the FAA’s
SUMMARY: The FAA is superseding Branch, 2200 South 216th St., Des bilateral agreement with this State of
Airworthiness Directive (AD) 2020–01– Moines, WA. For information on the Design Authority, it has notified the
13, which applied to all Dassault availability of this material at the FAA, FAA of the unsafe condition described
Aviation Model MYSTERE–FALCON call 206–231–3195. It is also available at in the MCAI referenced above. The FAA
200 airplanes. AD 2020–01–13 required regulations.gov under Docket No. FAA– reviewed the relevant data and
revising the existing maintenance or 2023–1494. determined that air safety requires
inspection program, as applicable, to FOR FURTHER INFORMATION CONTACT: Tom adopting this AD as proposed.
incorporate new or more restrictive Rodriguez, Aviation Safety Engineer, Accordingly, the FAA is issuing this AD
airworthiness limitations. This AD was FAA, 1600 Stewart Avenue, Suite 410, to address the unsafe condition on this
prompted by a determination that new Westbury, NY 11590; phone 206–231– product. Except for minor editorial
or more restrictive airworthiness 3226; email: tom.rodriguez@faa.gov. changes, this AD is adopted as proposed
limitations are necessary. This AD
SUPPLEMENTARY INFORMATION: in the NPRM. None of the changes will

continues to require the actions in AD increase the economic burden on any
2020–01–13 and require revising the Background
operator.
existing maintenance or inspection The FAA issued a notice of proposed
program, as applicable, to incorporate rulemaking (NPRM) to amend 14 CFR Related Service Information Under 1
new or more restrictive airworthiness part 39 to supersede AD 2020–01–13, CFR Part 51
limitations; as specified in a European Amendment 39–19819 (85 FR 5313, The FAA reviewed EASA AD 2023–
Union Aviation Safety Agency (EASA) January 30, 2020) (AD 2020–01–13). AD 0045. This service information specifies
new or more restrictive airworthiness Regulatory Findings (d) Subject

limitations for airplane structures and Air Transport Association (ATA) of
safe life limits. The FAA determined that this AD
America Code: 05, Time Limits/Maintenance
will not have federalism implications
This AD also requires Chapter 5–40– Checks.
under Executive Order 13132. This AD
00, Airworthiness Limitations, Revision will not have a substantial direct effect (e) Reason
18, dated January 15, 2019, of the on the States, on the relationship This AD was prompted by a determination
Dassault Falcon 200 Maintenance between the national government and that new or more restrictive airworthiness
Manual, which the Director of the the States, or on the distribution of limitations are necessary. The FAA is issuing
Federal Register approved for power and responsibilities among the this AD to address fatigue cracking, damage,
incorporation by reference as of March various levels of government. and corrosion in principal structural
5, 2020 (85 FR 5313, January 30, 2020). elements; such fatigue cracking, damage, and
For the reasons discussed above, I
This service information is reasonably certify that this AD: corrosion could result in reduced structural
available because the interested parties integrity of the airplane.
have access to it through their normal (1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866, (f) Compliance
course of business or by the means
identified in the ADDRESSES section. (2) Will not affect intrastate aviation Comply with this AD within the
in Alaska, and compliance times specified, unless already
Costs of Compliance done.
(3) Will not have a significant
The FAA estimates that this AD economic impact, positive or negative, (g) Retained Revision of the Existing
affects 9 airplanes of U.S. registry. The on a substantial number of small entities Maintenance or Inspection Program, With
FAA estimates the following costs to under the criteria of the Regulatory No Changes
comply with this AD: Flexibility Act. This paragraph restates the requirements of
The FAA estimates the total cost per paragraph (i) of AD 2020–01–13, with no
List of Subjects in 14 CFR Part 39
operator for the retained actions from changes. Within 90 days after March 5, 2020
AD 2020–01–13 to be $7,650 (90 work- Air transportation, Aircraft, Aviation (the effective date of AD 2020–01–13), revise
hours × $85 per work-hour). safety, Incorporation by reference, the existing maintenance or inspection
Safety. program, as applicable, to incorporate the
The FAA has determined that revising information specified in Chapter 5–40–00,
the existing maintenance or inspection The Amendment Airworthiness Limitations, Revision 18,
program takes an average of 90 work- dated January 15, 2019, of the Dassault
hours per operator, although the agency Accordingly, under the authority Falcon 200 Maintenance Manual. The initial
recognizes that this number may vary delegated to me by the Administrator, compliance time for doing the tasks is at the
from operator to operator. Since the FAA amends 14 CFR part 39 as applicable time specified in Chapter 5–40–
operators incorporate maintenance or follows: 00, Airworthiness Limitations, Revision 18,
inspection program changes for their dated January 15, 2019, of the Dassault
PART 39—AIRWORTHINESS Falcon 200 Maintenance Manual; or within
affected fleet(s), the FAA has
DIRECTIVES 90 days after March 5, 2020; whichever
determined that a per-operator estimate
is more accurate than a per-airplane occurs later. Accomplishing the revision of
■ 1. The authority citation for part 39 the existing maintenance or inspection
estimate.
continues to read as follows: program required by paragraph (i) of this AD
The agency estimates the average total terminates the requirements of this
cost per operator for the new actions to Authority: 49 U.S.C. 106(g), 40113, 44701.
paragraph.
be $7,650 (90 work-hours × $85 per § 39.13 [Amended]
work-hour). (h) Retained Restrictions on Alternative
■ 2. The FAA amends § 39.13 by: Actions or Intervals, With a New Exception
Authority for This Rulemaking This paragraph restates the requirements of
■ a. Removing Airworthiness Directive
Title 49 of the United States Code (AD) 2020–01–13, Amendment 39– paragraph (j) of AD 2020–01–13, with a new
specifies the FAA’s authority to issue 19819 (85 FR 5313, January 30, 2020); exception. Except as required by paragraph
rules on aviation safety. Subtitle I, and (i) of this AD, after the existing maintenance
section 106, describes the authority of or inspection program has been revised as
■ b. Adding the following new AD:
required by paragraph (g) of this AD, no
the FAA Administrator. Subtitle VII:
2023–21–01 Dassault Aviation: alternative actions (e.g., inspections) or
Aviation Programs, describes in more Amendment 39–22573; Docket No. intervals may be used unless the actions or
detail the scope of the Agency’s FAA–2023–1494; Project Identifier intervals are approved as an alternative
authority. MCAI–2023–00382–T. method of compliance (AMOC) in
The FAA is issuing this rulemaking (a) Effective Date accordance with the procedures specified in
under the authority described in paragraph (m)(1) of this AD.
Subtitle VII, Part A, Subpart III, Section This airworthiness directive (AD) is
effective December 11, 2023. (i) New Revision of the Existing Maintenance
44701: General requirements. Under or Inspection Program
that section, Congress charges the FAA (b) Affected ADs
Except as specified in paragraph (j) of this
with promoting safe flight of civil (1) This AD replaces AD 2020–01–13,
AD: Comply with all required actions and
aircraft in air commerce by prescribing Amendment 39–19819 (85 FR 5313, January
compliance times specified in, and in
regulations for practices, methods, and 30, 2020) (AD 2020–01–13).
(2) This AD affects AD 2010–26–05, accordance with, European Union Aviation

procedures the Administrator finds Safety Agency (EASA) AD 2023–0045, dated
necessary for safety in air commerce. Amendment 39–16544 (75 FR 79952,
December 21, 2010) (AD 2010–26–05). March 2, 2023; corrected March 3, 2023
This regulation is within the scope of (EASA AD 2023–0045). Accomplishing the
that authority because it addresses an (c) Applicability revision of the existing maintenance or
unsafe condition that is likely to exist or This AD applies to all Dassault Aviation inspection program required by this
develop on products identified in this Model MYSTERE–FALCON 200 airplanes, paragraph terminates the requirements of
rulemaking action. certificated in any category. paragraph (g) of this AD.
(j) Exceptions to EASA AD 2023–0045 Engineer, FAA, 1600 Stewart Avenue, Suite ACTION: Final rule.
(1) This AD does not adopt the 410, Westbury, NY 11590; phone 206–231–
requirements specified in paragraphs (1) and 3226; email: tom.rodriguez@faa.gov. SUMMARY: The FAA is adopting a new
(2) of EASA AD 2023–0045. (o) Material Incorporated by Reference airworthiness directive (AD) for certain
(2) Paragraph (3) of EASA AD 2023–0045 Embraer S.A. (Embraer) Model EMB–
specifies revising ‘‘the approved AMP’’ (1) The Director of the Federal Register
approved the incorporation by reference 505 airplanes. This AD was prompted
within 12 months after its effective date, but by occurrences of an uncommanded
this AD requires revising the existing (IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR change in the setting of the barometric
maintenance or inspection program, as
applicable, within 90 days after the effective part 51. pressure in both primary flight displays
date of this AD. (2) You must use this service information (PFDs). This AD requires installing a
(3) The initial compliance time for doing as applicable to do the actions required by new version of the airplane avionics
the tasks specified in paragraph (3) of EASA this AD, unless this AD specifies otherwise. system software, as specified in an
(3) The following service information was
AD 2023–0045 is at the applicable
approved for IBR on December 11, 2023.
Agência Nacional de Aviação Civil
‘‘limitations’’ as incorporated by the (ANAC) AD, which is incorporated by
requirements of paragraph (3) of EASA AD (i) European Union Aviation Safety Agency
(EASA) AD 2023–0045, dated March 2, 2023; reference. The FAA is issuing this AD
2023–0045, or within 90 days after the
corrected March 3, 2023. to address the unsafe condition on these
effective date of this AD, whichever occurs
later. (ii) [Reserved]. products.
(4) This AD does not adopt the provisions (4) The following service information was DATES: This AD is effective December
specified in paragraphs (4) and (5) of EASA approved for IBR on March 5, 2020 (85 FR
5313, January 30, 2020). 11, 2023.
AD 2023–0045. The Director of the Federal Register
(5) This AD does not adopt the ‘‘Remarks’’ (i) Chapter 5–40–00, Airworthiness
Limitations, Revision 18, dated January 15, approved the incorporation by reference
section of EASA AD 2023–0045.
2019, of the Dassault Falcon 200 of a certain publication listed in this AD
(k) New Provisions for Alternative Actions Maintenance Manual. as of December 11, 2023.
and Intervals (ii) [Reserved] ADDRESSES:
After the existing maintenance or (5) For EASA AD 2023–0045, contact
EASA, Konrad-Adenauer-Ufer 3, 50668
AD Docket: You may examine the AD
inspection program has been revised as docket at regulations.gov under Docket
required by paragraph (i) of this AD, no Cologne, Germany; telephone +49 221 8999
000; email: ADs@easa.europa.eu; website: No. FAA–2023–1708; or in person at
alternative actions (e.g., inspections) and
intervals are allowed unless they are easa.europa.eu. You may find this EASA AD Docket Operations between 9 a.m. and
approved as specified in the provisions of the on the EASA website: ad.easa.europa.eu. 5 p.m., Monday through Friday, except
‘‘Ref. Publications’’ section of EASA AD (6) For Dassault Aviation service Federal holidays. The AD docket
2023–0045. information incorporated by reference in this contains this final rule, the mandatory
AD, contact Dassault Falcon Jet Corporation, continuing airworthiness information
(l) Terminating Action for AD 2010–26–05 Teterboro Airport, P.O. Box 2000, South
Hackensack, NJ 07606; telephone 201–440–
(MCAI), any comments received, and
Accomplishing the actions required by other information. The address for
paragraph (g) or (i) of this AD terminates the 6700; website dassaultfalcon.com.
requirements of paragraph (g)(1) of AD 2010– (7) You may view this service information Docket Operations is U.S. Department of
26–05, for Dassault Aviation Model at the FAA, Airworthiness Products Section, Transportation, Docket Operations, M–
MYSTERE–FALCON 200 airplanes only. Operational Safety Branch, 2200 South 216th 30, West Building Ground Floor, Room
Street, Des Moines, WA. For information on W12–140, 1200 New Jersey Avenue SE,
(m) Additional AD Provisions the availability of this material at the FAA, Washington, DC 20590.
The following provisions also apply to this call 206–231–3195. Material Incorporated by Reference:
AD: (8) You may view this material at the
• For service information identified
(1) Alternative Methods of Compliance National Archives and Records
Administration (NARA). For information on in this final rule, contact ANAC,
(AMOCs): The Manager, International
Validation Branch, FAA, has the authority to the availability of this material at NARA, Continuing Airworthiness Technical
approve AMOCs for this AD, if requested visit www.archives.gov/federal-register/cfr/ Branch (GTAC), Rua Doutor Orlando
using the procedures found in 14 CFR 39.19. ibr-locationsoremailfr.inspection@nara.gov. Feirabend Filho, 230—Centro
In accordance with 14 CFR 39.19, send your Issued on October 30, 2023. Empresarial Aquarius—Torre B—
request to your principal inspector or Andares 14 a 18, Parque Residencial
responsible Flight Standards Office, as Victor Wicklund,
Aquarius, CEP 12.246–190—São José
appropriate. If sending information directly Deputy Director, Compliance & Airworthiness
Division, Aircraft Certification Service. dos Campos—SP, Brazil; phone: 55 (12)
to the manager of the International Validation
3203–6600; email: pac@anac.gov.br;
Branch, mail it to the address identified in [FR Doc. 2023–24403 Filed 11–3–23; 8:45 am]
paragraph (n) of this AD. Information may be website: anac.gov.br/en/. You may find
emailed to: 9-AVS-AIR-730-AMOC@faa.gov. this material on the ANAC website at
Before using any approved AMOC, notify sistemas.anac.gov.br/certificacao/DA/
your appropriate principal inspector, or
DEPARTMENT OF TRANSPORTATION DAE.asp.
lacking a principal inspector, the manager of • You may view this material at the
the responsible Flight Standards Office. FAA, Airworthiness Products Section,
Federal Aviation Administration
(2) Contacting the Manufacturer: For any Operational Safety Branch, 901 Locust,
requirement in this AD to obtain instructions
14 CFR Part 39 Kansas City, MO 64106. For information
from a manufacturer, the instructions must
be accomplished using a method approved on the availability of this material at the
[Docket No. FAA–2023–1708; Project FAA, call (817) 222–5110. It is also
by the Manager, International Validation Identifier MCAI–2023–00554–A; Amendment
available in the AD docket at
Branch, FAA; or EASA; or Dassault 39–22576; AD 2023–21–04]

Aviation’s EASA Design Organization regulations.gov under Docket No. FAA–
Approval (DOA). If approved by the DOA, RIN 2120–AA64 2023–1708.
the approval must include the DOA- FOR FURTHER INFORMATION CONTACT: Jim
authorized signature. Airworthiness Directives; Embraer S.A.
Rutherford, Aviation Safety Engineer,
(n) Additional Information
Airplanes
FAA, 1600 Stewart Avenue, Suite 410,
For more information about this AD, AGENCY:Federal Aviation Westbury, NY 11590; phone: (816) 329–
contact Tom Rodriguez, Aviation Safety Administration (FAA), DOT. 4165; email: jim.rutherford@faa.gov.
SUPPLEMENTARY INFORMATION: traffic separation, or risk of controlled This material is reasonably available
flight into terrain. because the interested parties have
Background
You may examine the MCAI in the access to it through their normal course
The FAA issued a notice of proposed AD docket at regulations.gov under of business or by the means identified
rulemaking (NPRM) to amend 14 CFR Docket No. FAA–2023–1708. in ADDRESSES.
part 39 by adding an AD that would
apply to certain Embraer Model EMB– Discussion of Final Airworthiness Differences Between This AD and the
505 airplanes. The NPRM published in Directive MCAI
the Federal Register on August 14, 2023 Comments ANAC AD 2023–04–01 requires
(88 FR 54941). The NPRM was installing the software update in
prompted by AD 2023–04–01, effective The FAA received no comments on accordance with the service information
April 4, 2023, issued by ANAC, which the NPRM or on the determination of specified in ANAC AD 2023–04–01, and
is the aviation authority for Brazil the costs. this AD does not require using that
(ANAC AD 2023–04–01) (also referred Conclusion service information to install the
to as the MCAI), to correct an unsafe software update.
condition for Embraer Model EMB–505 These products have been approved Paragraph (c) of ANAC AD 2023–04–
airplanes equipped with the Garmin by the aviation authority of another 01 provides credit for performing
G3000 avionics system. The MCAI states country and are approved for operation previous actions using previous
that there have been occurrences of in the United States. Pursuant to the revisions of the service information
uncommanded change in the setting of FAA’s bilateral agreement with this specified in ANAC AD 2023–04–01.
the barometric pressure in both PFDs State of Design Authority, it has notified Paragraph (d) of ANAC AD 2023–04–01
resulting in erroneous altitude the FAA of the unsafe condition provides procedures for obtaining an
information. Erroneous altitude described in the MCAI referenced alternative method of compliance.
information on both PFDs could result above. The FAA reviewed the relevant Paragraph (e) of ANAC AD 2023–04–01
in altitude mismanagement or spatial data and determined that air safety requires using the service information
disorientation of the flight crew. requires adopting this AD as proposed. specified in ANAC AD 2023–04–01, or
In the NPRM, the FAA proposed to Accordingly, the FAA is issuing this AD future revisions approved by ANAC, to
require installing a new version of the to address the unsafe condition on these do the software update. This AD does
airplane avionics system software, as products. Except for minor editorial not require compliance with paragraphs
specified in ANAC AD 2023–04–01. The changes, this AD is adopted as proposed (c) through (e) of ANAC AD 2023–04–
FAA is issuing this AD to address the in the NPRM. 01.
uncommanded change in the setting of Related Service Information Under 1
the barometric pressure in both PFDs, Costs of Compliance
CFR Part 51
which could consequently lead to a The FAA estimates that this AD
deviation from the intended altitude ANAC AD 2023–04–01 specifies affects 183 airplanes of U.S. registry.
and loss of control of the airplane, risk procedures for installing Garmin G3000 The FAA estimates the following
of air collision due to inadequate air avionics system software updates. costs to comply with this AD:
ESTIMATED COSTS
Install software ................................................ 8 work-hours × $85 per hour = $680 ............. $50 $730 $133,590
The FAA has included all known procedures the Administrator finds (2) Will not affect intrastate aviation
costs in its cost estimate. According to necessary for safety in air commerce. in Alaska, and
the manufacturer, however, all of the This regulation is within the scope of (3) Will not have a significant
costs associated with the software that authority because it addresses an economic impact, positive or negative,
update may be covered under warranty. unsafe condition that is likely to exist or on a substantial number of small entities
Authority for This Rulemaking under the criteria of the Regulatory
rulemaking action.
Title 49 of the United States Code Flexibility Act.
specifies the FAA’s authority to issue Regulatory Findings
rules on aviation safety. Subtitle I, This AD will not have federalism
section 106, describes the authority of implications under Executive Order Air transportation, Aircraft, Aviation
the FAA Administrator. Subtitle VII: 13132. This AD will not have a safety, Incorporation by reference,
Aviation Programs, describes in more substantial direct effect on the States, on Safety.
detail the scope of the Agency’s the relationship between the national
authority. The Amendment
government and the States, or on the
The FAA is issuing this rulemaking
distribution of power and Accordingly, under the authority

under the authority described in responsibilities among the various delegated to me by the Administrator,
Subtitle VII, Part A, Subpart III, Section levels of government. the FAA amends 14 CFR part 39 as
44701: General requirements. Under
For the reasons discussed above, I follows:
that section, Congress charges the FAA
with promoting safe flight of civil certify that this AD:
aircraft in air commerce by prescribing (1) Is not a ‘‘significant regulatory
regulations for practices, methods, and action’’ under Executive Order 12866,
PART 39—AIRWORTHINESS (j) Alternative Methods of Compliance DEPARTMENT OF TRANSPORTATION

DIRECTIVES (AMOCs)
The Manager, International Validation Federal Aviation Administration
■ 1. The authority citation for part 39 Branch, FAA, has the authority to approve
continues to read as follows: AMOCs for this AD, if requested using the 14 CFR Part 39
Authority: 49 U.S.C. 106(g), 40113, 44701. procedures found in 14 CFR 39.19. In [Docket No. FAA–2023–1717; Project
accordance with 14 CFR 39.19, send your Identifier MCAI–2023–00728–A; Amendment
§ 39.13 [Amended] request to your principal inspector or local 39–22578; AD 2023–21–06]
■ 2. The FAA amends § 39.13 by adding Flight Standards District Office, as
appropriate. If sending information directly RIN 2120–AA64
the following new airworthiness
directive: to the manager of the International Validation
Branch, mail it to the address identified in Airworthiness Directives; Embraer S.A.
2023–21–04 Embraer S.A.: Amendment 39– paragraph (k) of this AD or email to: 9-AVS- Airplanes
22576; Docket No. FAA–2023–1708; AIR-730-AMOC@faa.gov. If mailing
Project Identifier MCAI–2023–00554–A. AGENCY: Federal Aviation
information, also submit information by Administration (FAA), DOT.
(a) Effective Date email. Before using any approved AMOC,
ACTION: Final rule.
This airworthiness directive (AD) is notify your appropriate principal inspector,
effective December 11, 2023. or lacking a principal inspector, the manager SUMMARY: The FAA is adopting a new
of the local Flight Standards District Office/ airworthiness directive (AD) for certain
(b) Affected ADs certificate holding district office.
None.
Embraer S.A. (Embraer) Model EMB–
(k) Additional Information 505 airplanes. This AD was prompted
(c) Applicability by analysis of certain monuments (the
For more information about this AD,
This AD applies to Embraer S.A. Model contact Jim Rutherford, Aviation Safety right-hand refreshment center and left-
EMB–505 airplanes, as identified in Engineer, FAA, 1600 Stewart Avenue, Suite hand forward cabinet) that identified
paragraph (a) of Agência Nacional de Aviação 410, Westbury, NY 11590; phone: (816) 329– the need for installing structural
Civil (ANAC) AD 2023–04–01, effective April 4165; email: jim.rutherford@faa.gov. reinforcements and replacing certain
4, 2023 (ANAC AD 2023–04–01), certificated floor support rivets. This AD requires
in any category. (l) Material Incorporated by Reference
installing structural reinforcements on
(d) Subject (1) The Director of the Federal Register certain monuments and replacing
Joint Aircraft System Component (JASC) approved the incorporation by reference of certain floor support rivets, as specified
Code 3100, Indicating/recording system. the service information listed in this in an Agência Nacional de Aviação Civil
paragraph under 5 U.S.C. 552(a) and 1 CFR (ANAC) AD, which is incorporated by
(e) Unsafe Condition part 51. reference. The FAA is issuing this AD
This AD was prompted by occurrences of (2) You must use this service information to address the unsafe condition on these
an uncommanded change in the setting of the as applicable to do the actions required by
barometric pressure in both primary flight
products.
this AD, unless the AD specifies otherwise.
displays (PFDs). The FAA is issuing this AD (i) Agência Nacional de Aviação Civil DATES: This AD is effective December
to address the uncommanded change in the (ANAC) AD 2023–04–01, effective April 4, 11, 2023.
setting of the barometric pressure in both 2023. The Director of the Federal Register
PFDs. The unsafe condition, if not addressed, (ii) [Reserved] approved the incorporation by reference
could result in altitude mismanagement or of a certain publication listed in this AD
(3) For ANAC AD 2023–04–01, contact
spatial disorientation of the flight crew, with as of December 11, 2023.
ANAC, Continuing Airworthiness Technical
consequent deviation from the intended
altitude and loss of control of the airplane, Branch (GTAC), Rua Doutor Orlando ADDRESSES:
risk of air collision due to inadequate air Feirabend Filho, 230—Centro Empresarial AD Docket: You may examine the AD
traffic separation, or risk of controlled flight Aquarius—Torre B—Andares 14 a 18, Parque docket at regulations.gov under Docket
into terrain. Residencial Aquarius, CEP 12.246–190—São No. FAA–2023–1717; or in person at
José dos Campos—SP, Brazil; phone: 55 (12) Docket Operations between 9 a.m. and
(f) Compliance 3203–6600; email: pac@anac.gov.br; website: 5 p.m., Monday through Friday, except
Comply with this AD within the anac.gov.br/en/. You may find this material Federal holidays. The AD docket
compliance times specified, unless already on the ANAC website at
done. contains this final rule, the mandatory
sistemas.anac.gov.br/certificacao/DA/ continuing airworthiness information
(g) Required Actions DAE.asp.
(4) You may view this material at the FAA,
Except as specified in paragraphs (h) and other information. The address for
(i) of this AD: Comply with all required Airworthiness Products Section, Operational
Docket Operations is U.S. Department of
actions and compliance times specified in, Safety Branch, 901 Locust, Kansas City, MO
64106. For information on the availability of
Transportation, Docket Operations, M–
and in accordance with, ANAC AD 2023–04– 30, West Building Ground Floor, Room
01. this material at the FAA, call (817) 222–5110.
(5) You may view this material at the W12–140, 1200 New Jersey Avenue SE,
(h) Exceptions to ANAC AD 2023–04–01 National Archives and Records Washington, DC 20590.
(1) Where ANAC AD 2023–04–01 refers to Administration (NARA). For information on Material Incorporated by Reference:
its effective date, this AD requires using the the availability of this material at NARA, • For the service information
effective date of this AD. visit www.archives.gov/federal-register/cfr/ identified in this final rule, contact
(2) This AD does not adopt paragraphs (c), ANAC, Continuing Airworthiness
ibr-locations or email fr.inspection@nara.gov.

(d), and (e) of ANAC AD 2023–04–01. Technical Branch (GTAC), Rua Doutor
Issued on October 26, 2023.
(i) No Reporting Required Orlando Feirabend Filho, 230—Centro
Caitlin Locke, Empresarial Aquarius—Torre B
Although the service information
Director, Compliance & Airworthiness –Andares 14 a 18, Parque Residencial
referenced in ANAC AD 2023–04–01
Division, Aircraft Certification Service. Aquarius, CEP 12.246–190—São José
specifies to submit certain information to the
manufacturer, this AD does not include that [FR Doc. 2023–24393 Filed 11–3–23; 8:45 am] dos Campos—SP, Brazil; phone: 55 (12)
requirement. BILLING CODE 4910–13–P 3203–6600; email: pac@anac.gov.br;
website: anac.gov.br/en/. You may find left-hand forward cabinet) that might data and determined that air safety
this material on the ANAC website at not withstand the loads expected for requires adopting this AD as proposed.
sistemas.anac.gov.br/certificacao/DA/ specific emergency landing conditions, Accordingly, the FAA is issuing this AD
DAE.asp. which may cause the detachment of to address the unsafe condition on these
• You may view this material at the mass items and result in injuries to the products. This AD is adopted as
FAA, Airworthiness Products Section, airplane occupants. To address this proposed in the NPRM.
Operational Safety Branch, 901 Locust, unsafe condition, the MCAI specifies
Kansas City, MO 64106. For information Related Service Information Under 1
installing structural reinforcements on
on the availability of this material at the CFR Part 51
certain monuments and replacing
FAA, call (817) 222–5110. It is also applicable floor support rivets. ANAC AD 2023–05–03 specifies
available in the AD docket at In the NPRM, the FAA proposed to procedures for installing structural
regulations.gov under Docket No. FAA– require installing structural reinforcements on certain monuments
2023–1717. reinforcements on certain monuments and replacing applicable fasteners on
FOR FURTHER INFORMATION CONTACT: Jim and replacing certain floor support the floor support.
Rutherford, Aviation Safety Engineer, rivets, as specified in ANAC AD 2023– This material is reasonably available
FAA, 1600 Stewart Avenue, Suite 410, 04–01. The FAA is issuing this AD to because the interested parties have
Westbury, NY 11590; phone: (816) 329– address the unsafe condition. access to it through their normal course
4165; email: jim.rutherford@faa.gov. You may examine the MCAI in the of business or by the means identified
SUPPLEMENTARY INFORMATION: AD docket at regulations.gov under in ADDRESSES.
Background Differences Between This AD and the
Discussion of Final Airworthiness MCAI
The FAA issued a notice of proposed Directive
rulemaking (NPRM) to amend 14 CFR The service information specified in
part 39 by adding an AD that would Comments ANAC AD 2023–05–03 allows the use of
apply to certain serial-numbered The FAA received no comments on alternative or similar parts in place of
Embraer Model EMB–505 airplanes. The the NPRM or on the determination of the ones specified in the kits, provided
NPRM published in the Federal the costs. these alternative or similar parts are
Register on August 24, 2023 (88 FR approved by Embraer, but this AD
57907). The NPRM was prompted by Conclusion requires approval from either the
AD 2023–05–03, effective June 2, 2023, These products have been approved Manager, International Validation
issued by ANAC, which is the aviation by the aviation authority of another Branch, FAA; ANAC; or ANAC’s
authority for Brazil (ANAC AD 2023– country and are approved for operation authorized Designee.
04–01) (also referred to as the MCAI), to in the United States. Pursuant to the
Costs of Compliance
correct an unsafe condition for certain FAA’s bilateral agreement with this
serial-numbered Embraer Model EMB– State of Design Authority, it has notified The FAA estimates that this AD
505 airplanes. The MCAI states that the FAA of the unsafe condition affects 208 airplanes of U.S. registry.
analysis identified certain monuments described in the MCAI referenced The FAA estimates the following
(the right-hand refreshment center and above. The FAA reviewed the relevant costs to comply with this AD:
ESTIMATED COSTS
Cost per
Action Labor cost Parts cost Cost on U.S. operators
product
Airplane groups 1 and 2—install struc- 21.50 work-hours × $85 per hour = $1,600 $3,427.50 $239,925 (70 air-
tural reinforcements. $1,827.50. planes).
Airplane groups 3, 4, 5, and 10—install 13.50 work-hours × $85 per hour = $600 $1,747.50 $214,942.50 (123 air-
structural reinforcements and replace $1,147.50. planes).
floor fasteners.
Airplane groups 6 and 8—install struc- 25.50 work-hours × $85 per hour = $2,000 $4,167.50 $37,507.50 (9 air-
tural reinforcements and replace floor $2,167.50. planes).
fasteners.
Airplane group 7—install structural rein- 19.50 work-hours × $85 per hour = $1,600 $3,257.50 $16,287.50 (5 air-
forcements. $1,657.50. planes).
Airplane group 9—install structural rein- 13.50 work-hours × $85 per hour = $1,600 $2,747.50 $2,747.50 (1 airplane).
forcements. $1,147.50.
The FAA estimates the following Service Bulletin SB505–25–0046, dated of determining the number of airplanes
costs for operators that did the actions March 31, 2021. The agency has no way that might need these actions:
in the original version of Embraer
ON-CONDITION COSTS
Action Labor cost Parts cost Cost per product
Inspect floor fasteners ............................................ 8.50 work-hours × $85 per hour = $722.50 ........... $50 $772.50
Replace floor fasteners ........................................... 1 work-hour × $85 per hour = $85 ......................... $50 $135
The FAA has included all known Authority: 49 U.S.C. 106(g), 40113, 44701. (i) No Reporting Requirement
costs in its cost estimate. According to Although the service information
§ 39.13 [Amended]
the manufacturer, however, all of the referenced in ANAC AD 2023–05–03
costs of this AD may be covered under ■ 2. The FAA amends § 39.13 by adding specifies to submit certain information to the
warranty, thereby reducing the cost the following new airworthiness manufacturer, this AD does not include that
impact on affected operators. directive: requirement.
Authority for This Rulemaking 2023–21–06 Embraer S.A.: Amendment 39– (j) Alternative Methods of Compliance
22578; Docket No. FAA–2023–1717; (AMOCs)
Title 49 of the United States Code Project Identifier MCAI–2023–00728–A.
specifies the FAA’s authority to issue The Manager, International Validation
(a) Effective Date Branch, FAA, has the authority to approve
rules on aviation safety. Subtitle I,
section 106, describes the authority of This airworthiness directive (AD) is AMOCs for this AD, if requested using the
the FAA Administrator. Subtitle VII: effective December 11, 2023. procedures found in 14 CFR 39.19. In
Aviation Programs, describes in more (b) Affected ADs accordance with 14 CFR 39.19, send your
detail the scope of the Agency’s request to your principal inspector or local
None. Flight Standards District Office, as
authority.
The FAA is issuing this rulemaking (c) Applicability appropriate. If sending information directly
This AD applies to Embraer S.A. Model to the manager of the International Validation
under the authority described in
EMB–505 airplanes, as identified in Agência Branch, mail it to the address identified in
Subtitle VII, Part A, Subpart III, Section
Nacional de Aviação Civil (ANAC) AD 2023– paragraph (k) of this AD or email to: 9-AVS-
44701: General requirements. Under AIR-730-AMOC@faa.gov. If mailing
05–03, effective June 2, 2023 (ANAC AD
that section, Congress charges the FAA 2023–05–03), certificated in any category. information, also submit information by
with promoting safe flight of civil email. Before using any approved AMOC,
aircraft in air commerce by prescribing (d) Subject
notify your appropriate principal inspector,
regulations for practices, methods, and Joint Aircraft System Component (JASC) or lacking a principal inspector, the manager
procedures the Administrator finds Code 2500, Cabin Equipment/Furnishings. of the local Flight Standards District Office/
necessary for safety in air commerce. (e) Unsafe Condition certificate holding district office.
This regulation is within the scope of
This AD was prompted by analysis of (k) Additional Information
that authority because it addresses an certain monuments (the right-hand
unsafe condition that is likely to exist or For more information about this AD,
refreshment center and left-hand forward
develop on products identified in this contact Jim Rutherford, Aviation Safety
cabinet) that identified the need for installing
rulemaking action. structural reinforcements and replacing Engineer, FAA, 1600 Stewart Avenue, Suite
applicable floor support rivets. The FAA is 410, Westbury, NY 11590; phone: (816) 329–
Regulatory Findings issuing this AD to address the unsafe 4165; email: jim.rutherford@faa.gov.
This AD will not have federalism condition. The unsafe condition, if not (l) Material Incorporated by Reference
implications under Executive Order addressed, could result in a monument not
withstanding the loads expected for specific (1) The Director of the Federal Register
13132. This AD will not have a
emergency landing conditions, which may approved the incorporation by reference of
substantial direct effect on the States, on the service information listed in this
cause the detachment of mass items and
the relationship between the national paragraph under 5 U.S.C. 552(a) and 1 CFR
result in injuries to the airplane occupants.
government and the States, or on the part 51.
distribution of power and (f) Compliance (2) You must use this service information
responsibilities among the various Comply with this AD within the as applicable to do the actions required by
levels of government. compliance times specified, unless already this AD, unless the AD specifies otherwise.
For the reasons discussed above, I done. (i) Agência Nacional de Aviação Civil
certify that this AD: (g) Required Actions (ANAC) AD 2023–05–03, effective June 2,
(1) Is not a ‘‘significant regulatory 2023.
action’’ under Executive Order 12866, Except as specified in paragraphs (h) and
(ii) [Reserved]
(2) Will not affect intrastate aviation (i) of this AD: Comply with all required
actions and compliance times specified in, (3) For ANAC AD 2023–05–03, contact
in Alaska, and and in accordance with, ANAC AD 2023–05– ANAC, Continuing Airworthiness Technical
(3) Will not have a significant 03. Branch (GTAC), Rua Doutor Orlando
economic impact, positive or negative, Feirabend Filho, 230—Centro Empresarial
on a substantial number of small entities (h) Exceptions to ANAC AD 2023–05–03 Aquarius—Torre B—Andares 14 a 18, Parque
under the criteria of the Regulatory (1) Where ANAC AD 2023–05–03 refers to Residencial Aquarius, CEP 12.246–190—São
Flexibility Act. its effective date, this AD requires using the José dos Campos—SP, Brazil; phone: 55 (12)
effective date of this AD. 3203–6600; email: pac@anac.gov.br; website:
List of Subjects in 14 CFR Part 39 (2) The service information referenced in anac.gov.br/en/. You may find this material
Air transportation, Aircraft, Aviation ANAC AD 2023–05–03 allows the use of on the ANAC website at
safety, Incorporation by reference, alternative or similar parts in place of the sistemas.anac.gov.br/certificacao/DA/
ones specified in the kits, provided that these DAE.asp.
Safety.
alternative or similar parts are approved by (4) You may view this service information
The Amendment Embraer. This AD requires approval from at the FAA, Airworthiness Products Section,
either the Manager, International Validation
Accordingly, under the authority Branch, FAA; ANAC; or ANAC’s authorized
Operational Safety Branch, 901 Locust,
delegated to me by the Administrator, Kansas City, MO 64106. For information on
Designee. If approved by the ANAC Designee,
the FAA amends 14 CFR part 39 as the approval must include the Designee’s the availability of this material at the FAA,
follows: authorized signature. call (817) 222–5110.
(3) Where the service information (5) You may view this material at the
PART 39—AIRWORTHINESS referenced in ANAC AD 2023–05–03 National Archives and Records
DIRECTIVES specifies discarding parts, this AD requires Administration (NARA). For information on
removing those parts from service. the availability of this material at NARA,
■ 1. The authority citation for part 39 (4) This AD does not adopt paragraph (d) visit www.archives.gov/federal-register/cfr/
continues to read as follows: of ANAC AD 2023–05–03. ibr-locations or email fr.inspection@nara.gov.
Issued on October 26, 2023. 5 p.m., Monday through Friday, except proposed to require replacing the main
Caitlin Locke, Federal holidays. The AD docket propeller shaft. As an optional
Director, Compliance & Airworthiness contains this final rule, any comments terminating action to these inspections,
Division, Aircraft Certification Service. received, and other information. The the SNPRM proposed to require revising
[FR Doc. 2023–24387 Filed 11–3–23; 8:45 am] address for Docket Operations is U.S. the ALS of the existing MM and the
BILLING CODE 4910–13–P Department of Transportation, Docket operator’s existing approved
Operations, M–30, West Building maintenance program or inspection
Ground Floor, Room W12–140, 1200 program, as applicable, to incorporate
DEPARTMENT OF TRANSPORTATION New Jersey Avenue SE, Washington, DC the tasks and reduced inspection
20590. thresholds for the main propeller shaft.
Federal Aviation Administration Material Incorporated by Reference: The FAA is issuing this AD to address
• For GE service information the unsafe condition on these products.
14 CFR Part 39 identified in this final rule, contact
General Electric Company, 1 Neumann Discussion of Final Airworthiness
[Docket No. FAA–2022–1314; Project
Identifier AD–2021–00811–E; Amendment Way, Cincinnati, OH 45215; phone: Directive
39–22579; AD 2023–21–07] (513) 552–3272; email: Comments
aviation.fleetsupport@ae.ge.com;
RIN 2120–AA64
website: ge.com. The FAA received comments from
Airworthiness Directives; General • You may view this service one commenter, GE Aerospace. The
Electric Company Engines information at the FAA, Airworthiness following presents the comment
Products Section, Operational Safety received on the SNPRM and the FAA’s
AGENCY: Federal Aviation Branch, 1200 District Avenue, response to that comment.
Administration (FAA), DOT. Burlington, MA 01803. For information
ACTION: Final rule. on the availability of this material at the Request To Remove Typographical
FAA, call (817) 222–5110. It is also Error From SNPRM
SUMMARY: The FAA is superseding available at regulations.gov under
Airworthiness Directive (AD) 2018–03– GE noted that there is a typological
13 for certain General Electric Company [typographical] error in the ‘‘Proposed
FOR FURTHER INFORMATION CONTACT: AD Requirements in This SNPRM’’
(GE) Model CT7–5A2, CT7–5A3, CT7– Sungmo Cho, Aviation Safety Engineer,
7A, CT7–7A1, CT7–9B, CT7–9B1, CT7– paragraph of the SNPRM in which the
FAA, 2200 South 216th Street, Des words ‘‘at least’’ are repeated in
9B2, CT7–9C, and CT7–9C3 engines. AD Moines, WA 98198; phone: (781) 238–
2018–03–13 required initial and succession.
7241; email: Sungmo.D.Cho@faa.gov.
repetitive visual inspections and The FAA agrees, however, the
fluorescent penetrant inspections (FPIs) ‘‘Proposed AD Requirements in This
of the main propeller shaft. This AD was Background SNPRM’’ paragraph is not included in
prompted by an in-flight failure of a The FAA issued a supplemental this Final Rule. The FAA did not change
main propeller shaft on a GE Model notice of proposed rulemaking (SNPRM) this AD as a result of this comment.
CT7–9B engine, resulting in the loss of to amend 14 CFR part 39 to supersede
the propeller. This AD requires initial Conclusion
AD 2018–03–13, Amendment 39–19186
and repetitive visual inspections, FPIs, (83 FR 6125, February 13, 2018) (AD The FAA reviewed the relevant data,
and ultrasonic inspections (USIs) of the 2018–03–13). AD 2018–03–13 applied considered any comments received, and
main propeller shaft. Depending on the to certain GE Model CT7–5A2, CT7– determined that air safety requires
results of these inspections, this AD 5A3, CT7–7A, CT7–7A1, CT7–9B, CT7– adopting the AD as proposed.
requires replacement of the main 9B1, CT7–9B2, CT7–9C and CT7–9C3 Accordingly, the FAA is issuing this AD
propeller shaft. As an optional engines. The SNPRM published in the to address the unsafe condition on these
terminating action to these inspections, Federal Register on July 11, 2023 (88 FR products. Except for minor editorial
this AD requires revising the 44068). The SNPRM was prompted by a changes and any other changes
airworthiness limitations section (ALS) comment from GE Aerospace on the
of the existing maintenance manual described previously, this AD is
notice of proposed rulemaking (NPRM). adopted as proposed in the SNPRM.
(MM) and the operator’s existing GE Aerospace stated that certain engine
approved maintenance program or None of the changes will increase the
models were included in incorrect economic burden on any operator.
inspection program, as applicable, to Figures within the Required Actions
incorporate incorporating the tasks and paragraph of the NPRM, which would Related Service Information Under 1
reduced inspection thresholds for the attribute inaccurate inspection CFR Part 51
main propeller shaft. The FAA is thresholds to those engine models.
issuing this AD to address the unsafe The FAA reviewed GE Service
Therefore, the FAA issued the SNPRM
condition on these products. with a revision to Figures 1 and 2 to Bulletin (SB) CT7–TP 72–0541 R01,
DATES: This AD is effective December include the correct engine models. The dated November 18, 2021 (GE SB CT7–
11, 2023. FAA also updated the affected engine TP 72–0541). This service information
The Director of the Federal Register models listed in paragraphs (g)(1) and specifies procedures for performing
approved the incorporation by reference initial and repetitive visual inspections,
(g)(2) of the SNPRM to correspond with

of a certain publication listed in this AD the corrected engine models referenced FPIs, and USIs of the main propeller
as of December 11, 2023. in Figures 1 and 2. shaft.
ADDRESSES: In the SNPRM, the FAA proposed to This service information is reasonably
AD Docket: You may examine the AD require initial and repetitive visual available because the interested parties
docket at regulations.gov under Docket inspections, FPIs, and USIs of the main have access to it through their normal
No. FAA–2022–1314; or in person at propeller shaft. Depending on the course of business or by the means
Docket Operations between 9 a.m. and results of these inspections, the SNPRM identified in the ADDRESSES section.
Costs of Compliance The FAA estimates the following

The FAA estimates that this AD costs to comply with this AD:
affects 176 engines installed on
airplanes of U.S. registry.
ESTIMATED COSTS
Visually inspect, FPI, and USI the main pro- 2 work-hours × $85 per hour = $170 ............. $0 $170 $29,920
peller shaft.
The FAA estimates the following required based on the results of the terminating action or engines that might
costs to perform the optional inspections. The agency has no way of need this replacement:
terminating action or to do any determining the number of operators
necessary replacement that would be that will perform the optional
ON-CONDITION COSTS
Cost per
Action Labor cost Parts cost product
Replace the main propeller shaft ................................. 8 work-hours × $85 per hour = $680 ........................... $48,360 $49,040
Revise the ALS of the MM ........................................... 1 work-hour × $85 per hour = $85 ............................... 0 85
Authority for This Rulemaking (2) Will not affect intrastate aviation (b) Affected ADs
Title 49 of the United States Code in Alaska, and This AD replaces AD 2018–03–13,
(3) Will not have a significant Amendment 39–19186 (83 FR 6125, February
specifies the FAA’s authority to issue
economic impact, positive or negative, 13, 2018).
rules on aviation safety. Subtitle I,
on a substantial number of small entities
Section 106, describes the authority of (c) Applicability
under the criteria of the Regulatory
the FAA Administrator. Subtitle VII,
Flexibility Act. This AD applies to General Electric
Aviation Programs, describes in more Company (GE) Model CT7–5A2, CT7–5A3,
detail the scope of the Agency’s List of Subjects in 14 CFR Part 39
CT7–7A, CT7–7A1, CT7–9B, CT7–9B1, CT7–
authority. Air transportation, Aircraft, Aviation 9B2, CT7–9C, and CT7–9C3 engines.
The FAA is issuing this rulemaking safety, Incorporation by reference,
under the authority described in (d) Subject
Safety.
Subtitle VII, Part A, Subpart III, Section Joint Aircraft System Component (JASC)
44701, General requirements. Under The Amendment Code 7210, Turbine Engine Reduction Gear.
that section, Congress charges the FAA Accordingly, under the authority
(e) Unsafe Condition
with promoting safe flight of civil delegated to me by the Administrator,
aircraft in air commerce by prescribing the FAA amends 14 CFR part 39 as This AD was prompted by an in-flight
regulations for practices, methods, and follows: failure of a main propeller shaft on a GE
procedures the Administrator finds Model CT7–9B model engine, resulting in the
necessary for safety in air commerce. PART 39—AIRWORTHINESS loss of the propeller. The FAA is issuing this
This regulation is within the scope of DIRECTIVES AD to prevent failure of the main propeller
that authority because it addresses an shaft. The unsafe condition, if not addressed,
■ 1. The authority citation for part 39 could cause in-flight loss of the propeller,
unsafe condition that is likely to exist or
continues to read as follows: loss of engine thrust control, and damage to
Authority: 49 U.S.C. 106(g), 40113, 44701. the airplane.
rulemaking action.
§ 39.13 [Amended] (f) Compliance
Regulatory Findings
■ 2. The FAA amends § 39.13 by: Comply with this AD within the
The FAA has determined that this AD compliance times specified, unless already
will not have federalism implications ■ a. Removing Airworthiness Directive
2018–03–13, Amendment 39–19186 (83 done.
under Executive Order 13132. This AD
will not have a substantial direct effect FR 6125, February 13, 2018); and (g) Required Actions
■ b. Adding the following new
on the States, on the relationship (1) For affected CT7–5A2, CT7–5A3, CT7–
between the national government and airworthiness directive:
9B, CT7–9B1, and CT7–9B2 model engines,
the States, or on the distribution of 2023–21–07 General Electric Company: using the compliance times specified in
power and responsibilities among the Amendment 39–22579; Docket No. Figure 1 to paragraph (g)(1) of this AD,
various levels of government. FAA–2022–1314; Project Identifier AD– perform initial and repetitive visual
2021–00811–E.
For the reasons discussed above, I inspections, fluorescent penetrant
certify that this AD: (a) Effective Date inspections (FPIs), and ultrasonic inspections
(1) Is not a ‘‘significant regulatory This airworthiness directive (AD) is (USIs) of the main propeller shaft.
action’’ under Executive Order 12866, effective December 11, 2023. BILLING CODE 4910–13–P
Figure 1 to Paragraph (g)(l)- Compliance Times for CT7-5A2, CT7-5A3, CT7-9B,
CT7-9Bl, and CT7-9B2 Model Engines
Inspection Type Initial inspection of the Repeat inspection interval

main propeller shaft of main propeller shaft
Cleaning and During first propeller During every propeller

visual inspection removal after the effective removal
date of this AD
FPI Before exceeding 20,000 During every propeller
cycles since new (CSN) or removal or within 2, 100 FHs
within 2, 100 flight hours from performance of the
(FHs) after the effective previous FPI, whichever
date of this AD, whichever occurs later
occurs later
USI Before exceeding 20,000 Before exceeding 5,000 FHs
CSN or within 1,600 FHs from performance of the
after the effective date of previous USI
this AD, whichever occurs
later
(2) For affected CT7–7A, CT7–7A1, CT7– compliance times specified in Figure 2 to and repetitive visual inspections, FPIs, and
9C, and CT7–9C3 model engines, using the paragraph (g)(2) of this AD, perform initial USIs of the main propeller shaft.
Figure 2 to Paragraph (g)(2)-Compliance Times for CT7-7A, CT7-7Al, CT7-9C,
and CT7-9C3 Model Engines
Inspection Type Initial inspection of the Repeat inspection interval

main propeller shaft of main propeller shaft
Cleaning and During the first propeller During every propeller

visual inspection removal after the effective removal
date of this AD
FPI Before exceeding 20,000 During every propeller
CSN or within 2,400 FHs removal or within 2,400 FHs
after the effective date of from performance of the
this AD, whichever occurs previous FPI, whichever
later occurs later
USI Before exceeding 20,000 Before exceeding 4,800 FHs
CSN or within 1,600 FHs from performance of the
after the effective date of previous USI
this AD, whichever occurs

later
ER06NO23.057</GPH>
(3) Perform the visual inspections, FPIs, (i) Prior to performance of the inspections, 3.B., of GE Service Bulletin (SB) CT7–TP 72–
and USIs required by paragraphs (g)(1) and clean the main propeller shaft flange using 0541 R01, dated November 18, 2021 (GE SB
(2) of this AD as follows: the Accomplishment Instructions, paragraph CT7–TP 72–0541).
ER06NO23.056</GPH>
(ii) Visually inspect the main propeller inspections, FPIs, or USIs required by engine model, constitutes terminating action
shaft for wear, corrosion, and cracking using paragraphs (g)(1) through (3) of this AD, for the inspections required by paragraphs
the Accomplishment Instructions, paragraph before further flight, remove the main (g)(1) through (3) of this AD.
3.C.(1), of GE SB CT7–TP 72–0541. propeller shaft from service and replace it (1) For affected CT7–5A2, CT7–5A3, CT7–
(iii) Spot-FPI the area on the main with a part eligible for installation. 7A, and CT7–7A1 model engines, revise the
propeller shaft flange face using the (5) For all affected engines, if the main
airworthiness limitations section (ALS) of the
Accomplishment Instructions, paragraph propeller shaft CSN is unknown, use the
3.C.(2)(a), of GE SB CT7–TP 72–0541. propeller gearbox (PGB) CSN. If the PGB CSN existing maintenance manual (MM) and the
(iv) USI the two dowel pin holes of the is unknown, assume the inspection threshold operator’s existing approved maintenance
main propeller shaft using the is exceeded. program or inspection program, as
Accomplishment Instructions, paragraph applicable, by incorporating the information
3.C.(3)(a), of GE SB CT7–TP 72–0541. (h) Optional Terminating Action in Figure 3 to paragraph (h)(1) of this AD.
(4) If a crack or rejectable indication is Accomplishing the actions in paragraphs
found during the initial and repetitive visual (h)(1) through (4) of this AD, as applicable by
Figure 3 to Paragraph (h)(l) - CT7-5/-7 Inspection Threshold and Interval
Inspection / Initial Repetitive Inspection / Reference

Maintenance Inspection Inspection Maintenance
Threshold Interval Requirements
(cycles since
new(CSN))
*** FOR CT7-5

Visual inspection of the At every propeller VI 72-l0-00,
main propeller shaft removal INSPECTION -
PROPELLER
GEARBOX
INSPECTION
paragraph 5.A.
Fluorescent penetrant 20000 CSN (*) At every propeller FPI 72-l0-00.
inspection (FPI) of the removal or 2IO0 Special
main propeller shaft FH, whichever is Procedure 005
greater
Ultrasonic inspection 20000 CSN (*) 5000 FH UTI 72-l0-00.
(UTI) of the main Special
propeller shaft Procedure 005
*** FOR CT7-7

Visual inspection of the At every propeller VI 72-10-00,
PROPELLER
GEARBOX
INSPECTION
paragraph 5.A.
Fluorescent penetrant 20000 CSN (*) At every propeller FPI 72-l0-00.
inspection (FPI) of the removal or 2400 Special
main propeller shaft FH, whichever is Procedure 005
greater
Ultrasonic inspection 20000 CSN (*) 4800 FH UTI 72-l0-00.
(UTI) of the main Special
propeller shaft Procedure 005
NOTE:(*) If the main propeller shaft accumulated time/cycle is unknown, inspection must be done based on
the propeller gearbox (PGB) accumulated time/cycle. If the PGB accumulated time/cycle is unknown, threshold
must be assumed exceeded.
(2) For affected CT7–9B, CT7–9B1, CT7– operator’s existing approved maintenance applicable, by incorporating the information
9B2, CT7–9C, and CT7–9C3 model engines, program or inspection program, as in Figure 4 to paragraph (h)(2) of this AD.
revise the ALS of the existing MM and the
ER06NO23.058</GPH>
Figure 4 to Paragraph (h)(2) - CT7-9 Inspection Threshold and Interval
Inspection / Initial Repetitive Inspection / Reference

Maintenance Inspection Inspection Maintenance
Threshold Interval Requirements
(cycles since
new(CSN))
*** FOR CT7-9B
PROPELLER
GEARBOX
INSPECTION
paragraph 5 .A.
Fluorescent penetrant 20000 CSN (*) At every propeller FPI 72-10-00. Special
inspection (FPI) of the removal or 2100 Procedure 005
main propeller shaft FH, whichever is
greater
Ultrasonic inspection 20000 CSN (*) 5000 FH UTI 72-10-00. Special
(UTI) of the main Procedure 005
propeller shaft
*** FOR CT7-9C/9C3

PROPELLER
GEARBOX
INSPECTION
paragraph 5 .A.
Fluorescent penetrant 20000 CSN (*) At every propeller FPI 72-10-00. Special
inspection (FPI) of the removal or 2400 Procedure 005
main propeller shaft FH, whichever is
greater
Ultrasonic inspection 20000 CSN (*) 4800 FH UTI 72-10-00. Special
(UTI) of the main Procedure 005
propeller shaft
NOTE: (*) If the main propeller shaft accumulated time/cycle is unknown, inspection must be done based on
the propeller gearbox (PGB) accumulated time/cycle. If the PGB accumulated time/cycle is unknown, threshold
must be assumed exceeded.
(3) Thereafter, except as provided in and there was no crack or rejectable or local Flight Standards District Office, as
paragraph (k) of this AD, no alternative indication. appropriate. If sending information directly
inspection times or intervals may be to the manager of the AIR–520 Continued
approved for this main propeller shaft. (j) Credit for Previous Actions
Operational Safety Branch, send it to the
(4) The optional terminating actions in You may take credit for the initial visual attention of the person identified in
paragraphs (h)(1) and (2) of this AD may be inspection, FPI, and USI required by paragraph (l) of this AD and email it to: ANE-
performed by the owner/operator (pilot) paragraphs (g)(1) through (3) of this AD if you AD-AMOC@faa.gov.
holding at least a private pilot certificate and performed these initial inspections before the
(2) Before using any approved AMOC,
must be entered into the aircraft records effective date of this AD in accordance with
notify your appropriate principal inspector,
showing compliance with this AD in GE SB CT7–TP 72–0541 R00, dated
September 9, 2021. or lacking a principal inspector, the manager
accordance with 14 CFR 43.9(a) and
of the local flight standards district office/
91.417(a)(2)(v). The record must be
(k) Alternative Methods of Compliance certificate holding district office.

maintained as required by 14 CFR 91.417,
(AMOCs)
121.380, or 135.439. (l) Additional Information
(1) The Manager, AIR–520 Continued
(i) Definition Operational Safety Branch, FAA, has the For more information about this AD,
For the purpose of this AD, a ‘‘part eligible authority to approve AMOCs for this AD, if contact Sungmo Cho, Aviation Safety
for installation’’ is a main propeller shaft that requested using the procedures found in 14 Engineer, FAA, 2200 South 216th Street, Des
has been inspected in accordance with CFR 39.19. In accordance with 14 CFR 39.19, Moines, WA 98198; phone: (781) 238–7241;
ER06NO23.059</GPH>
paragraphs (g)(1) or (2), and (3) of this AD, send your request to your principal inspector email: Sungmo.D.Cho@faa.gov.
(m) Material Incorporated by Reference ADDRESSES: A copy of the Notice of that order, FAA Order JO 7400.11H,
(1) The Director of the Federal Register Proposed Rulemaking (NPRM), all dated August 11, 2023, and effective
approved the incorporation by reference comments received, this final rule, and September 15, 2023. These updates will
(IBR) of the service information listed in this all background material may be viewed be published in the next update to FAA
paragraph under 5 U.S.C. 552(a) and 1 CFR online at www.regulations.gov using the Order JO 7400.11. That order is publicly
part 51. FAA Docket number. Electronic available as listed in the ADDRESSES
(2) You must use this service information retrieval help and guidelines are section of this document.
as applicable to do the actions required by FAA Order JO 7400.11H lists Class A,
available on the website. It is available
this AD, unless the AD specifies otherwise.
24 hours each day, 365 days each year. B, C, D, and E airspace areas, air traffic
(i) General Electric Company (GE) Service
Bulletin CT7–TP 72–0541 R01, dated FAA Order JO 7400.11H, Airspace service routes, and reporting points.
November 18, 2021. Designations and Reporting Points, and
The Rule
(ii) [Reserved] subsequent amendments can be viewed
(3) For GE service information identified in online at www.faa.gov/air_traffic/ This action amends 14 CFR part 71 by
this AD, contact General Electric Company, publications/. You may also contact the revoking Alaskan VOR Federal Airway
1 Neumann Way, Cincinnati, OH 45215; Rules and Regulations Group, Office of V–318 in its entirety.
phone: (513) 552–3272; email: Policy, Federal Aviation
aviation.fleetsupport@ae.ge.com; website: Regulatory Notices and Analyses
Administration, 800 Independence
ge.com. Avenue SW, Washington DC 20591; The FAA has determined that this
(4) You may view this service information regulation only involves an established
telephone: (202) 267–8783.
at FAA, Airworthiness Products Section, body of technical regulations for which
Operational Safety Branch, 1200 District FOR FURTHER INFORMATION CONTACT:
frequent and routine amendments are
Avenue, Burlington, MA 01803. For Steven Roff, Rules and Regulations
Group, Office of Policy, Federal necessary to keep them operationally
information on the availability of this
material at the FAA, call (817) 222–5110. Aviation Administration, 800 current. It, therefore: (1) is not a
(5) You may view this material at the Independence Avenue SW, Washington, ‘‘significant regulatory action’’ under
National Archives and Records DC 20591; telephone: (202) 267–8783. Executive Order 12866; (2) is not a
Administration (NARA). For information on ‘‘significant rule’’ under DOT
the availability of this material at NARA, Regulatory Policies and Procedures (44
visit www.archives.gov/federal-register/cfr/ Authority for This Rulemaking FR 11034; February 26, 1979); and (3)
ibr-locations or email fr.inspection@nara.gov. does not warrant preparation of a
The FAA’s authority to issue rules
Issued on October 20, 2023. regarding aviation safety is found in regulatory evaluation as the anticipated
Ross Landes, Title 49 of the United States Code. impact is so minimal. Since this is a
Deputy Director for Regulatory Operations, Subtitle I, Section 106 describes the routine matter that only affects air traffic
Compliance & Airworthiness Division, authority of the FAA Administrator. procedures and air navigation, it is
Aircraft Certification Service. Subtitle VII, Aviation Programs, certified that this rule, when
[FR Doc. 2023–24386 Filed 11–3–23; 8:45 am] describes in more detail the scope of the promulgated, does not have a significant
BILLING CODE 4910–13–C agency’s authority. This rulemaking is economic impact on a substantial
promulgated under the authority number of small entities under the
described in Subtitle VII, Part A, criteria of the Regulatory Flexibility Act.
DEPARTMENT OF TRANSPORTATION Subpart I, Section 40103. Under that Environmental Review
section, the FAA is charged with
Federal Aviation Administration prescribing regulations to assign the use The FAA has determined that this
of the airspace necessary to ensure the action of revoking Federal Airway V–
14 CFR Part 71 safety of aircraft and the efficient use of 318 and replacing it with existing route
airspace. This regulation is within the T–269 in the vicinity of Level Island,
[Docket No. FAA–2023–0916; Airspace AK qualifies for categorical exclusion
Docket No. 22–AAL–85] scope of that authority as it would
modify the route structure as necessary under the National Environmental
to preserve the safe and efficient flow of Policy Act (42 U.S.C. 4321 et seq.) and
RIN 2120–AA66
air traffic within the National Airspace its implementing regulations at 40 CFR
Revocation of Alaskan Very High System (NAS). part 1500, and in accordance with FAA
Frequency Omnidirectional Range Order 1050,1F, Environmental Impacts:
(VOR) Federal Airway V–318; Level History Policies and Procedures, paragraph 5–6–
Island, AK The FAA published an NPRM for 5a, which categorically excludes from
Docket No. FAA 2023–0916 in the further environmental impact review
AGENCY: Federal Aviation Federal Register (88 FR 23597; April 18, rulemaking actions that designate or
Administration (FAA), DOT. 2023), proposing to revoke Alaskan VOR modify classes of airspace areas,
ACTION: Final rule. Federal Airway V–318. Interested airways, routes, and reporting points
parties were invited to participate in (see 14 CFR part 71, Designation of
SUMMARY: This action revokes Alaskan this rulemaking effort by submitting Class A, B, C, D and E Airspace Areas;
VOR Federal Airway V–318 in the written comments on the proposal. No Air Traffic Service Routes; and
vicinity of Level Island, AK. The FAA comments were received. Reporting Points); and paragraph 5–
is taking this action due to the airway’s 6.5.k., which categorically excludes
lack of use. Incorporation by Reference from further environmental review the
DATES: Effective date 0901 UTC, January Alaskan VOR Federal Airways are publication of existing air traffic control
25, 2024. The Director of the Federal published in paragraph 6010 of FAA procedures that do not essentially
Register approves this incorporation by Order JO 7400.11, Airspace change existing tracks, create new
reference action under 1 CFR part 51, Designations and Reporting Points, tracks, change altitude, or change
subject to the annual revision of FAA which is incorporated by reference in 14 concentration of aircraft on these tracks.
Order JO 7400.11 and publication of CFR 71.1 on an annual basis. This As such, this action is not expected to
conforming amendments. document amends the current version of result in in any potentially significant
environmental impacts. In accordance DEPARTMENT OF TRANSPORTATION efficient use of the navigable airspace.
with FAA Order 1050.1f, paragraph 5– In addition, those various reasons or
2 regarding Extraordinary Federal Aviation Administration circumstances require making this
Circumstances, the FAA has reviewed amendment effective before the next
this action for factors and circumstances 14 CFR Part 95 scheduled charting and publication date
in which a normally categorically [Docket No. 31516; Amdt. No. 575] of the flight information to assure its
excluded action may have a significant timely availability to the user. The
environmental impact requiring further IFR Altitudes; Miscellaneous effective date of this amendment reflects
analysis. Accordingly, the FAA has Amendments those considerations. In view of the
determined that no extraordinary close and immediate relationship
AGENCY: Federal Aviation between these regulatory changes and
circumstances exist that warrant Administration (FAA), DOT.
prepared of the environmental impact safety in air commerce, I find that notice
ACTION: Final rule and public procedure before adopting
statement.
SUMMARY: This amendment adopts this amendment are impracticable and
Lists of Subjects in 14 CFR Part 71 miscellaneous amendments to the contrary to the public interest and that
required IFR (instrument flight rules) good cause exists for making the
Airspace, Incorporation by reference, amendment effective in less than 30
altitudes and changeover points for
Navigation (air). days.
certain Federal airways, jet routes, or
The Amendment direct routes for which a minimum or Conclusion
maximum en route authorized IFR
In consideration of the foregoing, the altitude is prescribed. This regulatory The FAA has determined that this
Federal Aviation Administration action is needed because of changes regulation only involves an established
amends 14 CFR part 71 as follows: occurring in the National Airspace body of technical regulations for which
System. These changes are designed to frequent and routine amendments are
PART 71—DESIGNATION OF CLASS A, provide for the safe and efficient use of necessary to keep them operationally
B, C, D, AND E AIRSPACE AREAS; AIR the navigable airspace under instrument current. It, therefore—(1) is not a
TRAFFIC SERVICE ROUTES; AND conditions in the affected areas. ‘‘significant regulatory action’’ under
REPORTING POINTS DATES: Effective 0901 UTC, November
Executive Order 12866; (2) is not a
30, 2023. ‘‘significant rule’’ under DOT
■ 1. The authority citation for 14 CFR Regulatory Policies and Procedures (44
FOR FURTHER INFORMATION CONTACT:
part 71 continues to read as follows: FR 11034; February 26, 1979); and (3)
Thomas J. Nichols, Flight Procedures
does not warrant preparation of a
Authority: 49 U.S.C. 106(f), 106(g), 40103, and Airspace Group, Flight
regulatory evaluation as the anticipated
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Technologies and Procedures Division,
impact is so minimal. For the same
1959–1963 Comp., p.389. Flight Standards Service, Federal
reason, the FAA certifies that this
Aviation Administration. Mailing
amendment will not have a significant
§ 71.1 [Amended] Address: FAA Mike Monroney
economic impact on a substantial
Aeronautical Center, Flight Procedures
■ 2. The incorporation by reference in number of small entities under the
and Airspace Group, 6500 South
14 CFR 71.1 of FAA Order JO 7400.11H, criteria of the Regulatory Flexibility Act.
MacArthur Blvd., STB Annex, Bldg 26,
Airspace Designations and Reporting Room 217, Oklahoma City, OK 73099. List of Subjects in 14 CFR Part 95
Points, dated August 11, 2023, and Telephone: (405) 954–1139.
effective September 15, 2023, is Airspace, Navigation (air).
SUPPLEMENTARY INFORMATION: This
amended as follows: amendment to part 95 of the Federal Issued in Washington, DC on, October 27,
2023.
Paragraph 6010(b) Alaskan VOR Federal Aviation Regulations (14 CFR part 95)
amends, suspends, or revokes IFR Thomas J Nichols,
Airways
altitudes governing the operation of all Manager, Aviation Safety, Flight Standards
* * * * * Service, Standards Section, Flight Procedures
aircraft in flight over a specified route
& Airspace Group, Flight Technologies and
V–318 [Remove] or any portion of that route, as well as Procedures Division.
* * * * * the changeover points (COPs) for
Federal airways, jet routes, or direct Adoption of the Amendment
Issued in Washington, DC, on September
routes as prescribed in part 95. Accordingly, pursuant to the
25, 2023.
Karen L. Chiodini, The Rule authority delegated to me by the
Administrator, part 95 of the Federal
Acting Manager, Rules and Regulations The specified IFR altitudes, when
Aviation Regulations (14 CFR part 95) is
Group. used in conjunction with the prescribed
amended as follows effective at 0901
[FR Doc. 2023–24353 Filed 11–3–23; 8:45 am] changeover points for those routes,
UTC, November 30, 2023.
ensure navigation aid coverage that is
adequate for safe flight operations and PART 95—IFR Altitudes
free of frequency interference. The
reasons and circumstances that create ■ 1. The authority citation for part 95
the need for this amendment involve continues to read as follows:

matters of flight safety and operational
Authority: 49 U.S.C. 106(g), 40103, 40113
efficiency in the National Airspace and 14 CFR 11.49(b)(2)
System, are related to published
aeronautical charts that are essential to ■ 2. Part 95 is amended to read as
the user, and provide for the safe and follows:
REVISIONS TO IFR ALTITUDES & CHANGEOVER POINT

[Amendment 575 Effective Date November 30, 2023]
From To MEA MAA
§ 95.3000 Low Altitude RNAV Routes

§ 95.3223 RNAV Route T223
Is Amended by Adding
ZIKNI, AK WP ................................................................... ROGOC, AK FIX .............................................................. 4000 17500
ROGOC, AK FIX ............................................................... CEKBA, AK FIX ............................................................... 4400 17500
CEKBA, AK FIX ................................................................ * DILLINGHAM, AK VOR/DME ........................................ 4000 17500
* 2400—MCA DILLINGHAM, AK VOR/DME, W BND
Is Amended To Delete
CAPE NEWENHAM, AK NDB/DME ................................. DILLINGHAM, AK VOR/DME .......................................... 4400 17500
Is Amended To Read in Part
DILLINGHAM, AK VOR/DME ........................................... ZUNOS, AK FIX ............................................................... 2200 17500
ZUNOS, AK FIX ................................................................ FAGIN, AK FIX ................................................................. 5000 17500
§ 95.3242 RNAV Route T242
BARROW, AK VOR/DME ................................................. WUPUV, AK WP .............................................................. * 1900 17500
* 1900—MOCA
WUPUV, AK WP ............................................................... LACIL, AK WP ................................................................. * 5900 17500
* 3000—MOCA
LACIL, AK WP .................................................................. KUTDE, AK WP ............................................................... 9500 17500
KUTDE, AK WP ................................................................ TADUE, AK WP ............................................................... 5900 17500
TADUE, AK WP ................................................................ * JOKAP, AK WP .............................................................. ** 4000 17500
* 10700—MCA JOKAP, AK WP, SE BND
** 3400—MOCA
JOKAP, AK WP ................................................................ * WEGNO, AK WP ........................................................... 15300 17500
* 12200—MCA WEGNO, AK WP, NW BND
WEGNO, AK WP .............................................................. * HUMUB, AK WP ............................................................ 4600 17500
* 3100—MCA HUMUB, AK WP, NW BND
HUMUB, AK WP ............................................................... TALKEETNA, AK VOR/DME ........................................... * 3000 17500
* TALKEETNA, AK VOR/DME .......................................... JOKAP, AK WP ................................................................ ** 16000 17500
* 12100—MCA TALKEETNA, AK VOR/DME, N BND
** 15300—MOCA
* JOKAP, AK WP .............................................................. KUTDE, AK WP ............................................................... 6000 17500
* 11500—MCA JOKAP, AK WP, S BND
KUTDE, AK WP ................................................................ LACIL, AK WP ................................................................. * 15000 17500
* 9400—MOCA
LACIL, AK WP .................................................................. BARROW, AK VOR/DME ................................................ * 8000 17500
* 1800—MOCA
§ 95.3356 RNAV Route T356 Is Amended To Read in Part
REESY, PA WP ................................................................ FOLEZ, PA WP ................................................................ 2400 17500
§ 95.3447 RNAV Route T447 Is Added To Read
SMYRNA, DE VORTAC ................................................... CHAZR, DE WP ............................................................... 1800 17500

CHAZR, DE WP ................................................................ APEER, MD WP .............................................................. 2000 17500
APEER, MD WP ............................................................... REESY, PA WP ............................................................... 2000 17500
REESY, PA WP ................................................................ FOLEZ, PA WP ................................................................ 2400 17500
FOLEZ, PA WP ................................................................. HOSKR, PA WP ............................................................... 2400 17500
HOSKR, PA WP ............................................................... POTTSTOWN, PA VORTAC ........................................... 2400 17500
POTTSTOWN, PA VORTAC ............................................ HIKES, PA FIX ................................................................. 2800 17500
HIKES, PA FIX .................................................................. EAST TEXAS, PA VOR/DME .......................................... 2900 17500
EAST TEXAS, PA VOR/DME ........................................... DIANO, PA FIX ................................................................ * 4200 17500
* 3700—MOCA
DIANO, PA FIX ................................................................. WILLIAMSPORT, PA VOR/DME ..................................... 4400 17500
WILLIAMSPORT, PA VOR/DME ...................................... DLMAR, PA WP ............................................................... 4800 17500

KITHE, PA FIX .................................................................. GEERI, PA FIX ................................................................ 2700 17500

GEERI, PA FIX ................................................................. LANCASTER, PA VOR/DME ........................................... * 2400 17500
* 1900—MOCA
LANCASTER, PA VOR/DME ............................................ KERYN, PA FIX ............................................................... 3000 17500
KERYN, PA FIX ................................................................ JUPAS, PA FIX ................................................................ 3400 17500
JUPAS, PA FIX ................................................................. CHLSE, PA FIX ................................................................ 3300 17500
CHLSE, PA FIX ................................................................ MARRC, PA FIX .............................................................. 3700 17500
REVISIONS TO IFR ALTITUDES & CHANGEOVER POINT—Continued

[Amendment 575 Effective Date November 30, 2023]
From To MEA MAA
MARRC, PA FIX ............................................................... MEGSS, PA FIX ............................................................... 3700 17500

MEGSS, PA FIX ............................................................... * MEATS, PA FIX ............................................................. 3700 17500
* 4100—MCA MEATS, PA FIX, N BND
MEATS, PA FIX ................................................................ * OYUCA, PA FIX ............................................................. 4900 17500
* 4200—MCA OYUCA, PA FIX, S BND
OYUCA, PA FIX ................................................................ BINGHAMTON, NY VOR/DME ........................................ 3700 17500
PHILIPSBURG, PA VORTAC ........................................... WILLIAMSPORT, PA VOR/DME ..................................... 4900 17500

WILLIAMSPORT, PA VOR/DME ...................................... NOSEE, PA FIX ............................................................... 4700 17500
NOSEE, PA FIX ................................................................ * HANCOCK, NY VOR/DME ............................................ 4100 17500
* 4600—MCA HANCOCK, NY VOR/DME, E BND
HANCOCK, NY VOR/DME ............................................... RIMBA, NY FIX ................................................................ 5800 17500
RIMBA, NY FIX ................................................................. * SAGES, NY FIX ............................................................. 6400 17500
* 6300—MCA SAGES, NY FIX, W BND
SAGES, NY FIX ................................................................ SASHA, MA FIX ............................................................... 6100 17500
SASHA, MA FIX ................................................................ TOMES, MA FIX .............................................................. * 4100 17500
* 3500—MOCA
TOMES, MA FIX ............................................................... BARNES, MA VORTAC ................................................... 3400 17500
BARNES, MA VORTAC .................................................... GLYDE, MA FIX ............................................................... 3000 17500
TASEY, TX WP ................................................................. RICH MOUNTAIN, OK VORTAC ..................................... 4300 17500
TASEY, TX WP ................................................................. HOT SPRINGS, AR VOR/DME ....................................... 3000 17500
DNVIL, VA WP .................................................................. ENTUK, VA FIX ............................................................... 2800 17500

ENTUK, VA FIX ................................................................ PIGGS, VA FIX ................................................................ 3500 17500
PIGGS, VA FIX ................................................................. * DEWET, VA FIX ............................................................. 3600 17500
* 4300—MCA DEWET, VA FIX, NW BND
DEWET, VA FIX ............................................................... DBRAH, VA WP ............................................................... 5300 17500
DBRAH, VA WP ................................................................ NATTS, WV FIX ............................................................... 6000 17500
NATTS, WV FIX ................................................................ VELLI, WV FIX ................................................................. 7000 17500
VELLI, WV FIX .................................................................. AHCIN, WV FIX ............................................................... 6900 17500
AHCIN, WV FIX ................................................................ ELKINS, WV VORTAC .................................................... * 5900 17500
* 5300—MOCA
§ 95.4000 High Altitude RNAV Route

§ 95.4445 RNAV Route Q445 Is Amended To Delete
PAACK, NC WP ................................................................ JAMIE, VA FIX ................................................................. * 18000 45000

* 18000–GNSS MEA
* DME/DME/IRU MEA
JAMIE, VA FIX .................................................................. CONFR, MD WP .............................................................. * 18000 45000
* 18000–GNSS MEA
* DME/DME/IRU MEA
CONFR, MD WP ............................................................... RADDS, DE FIX ............................................................... * 18000 45000
* 18000–GNSS MEA
* DME/DME/IRU MEA
RADDS, DE FIX ................................................................ WNSTN, NJ WP ............................................................... * 18000 45000
* 18000–GNSS MEA
* DME/DME/IRU MEA
WNSTN, NJ WP ............................................................... AVALO, NJ FIX ................................................................ * 18000 45000
* 18000–GNSS MEA
* DME/DME/IRU MEA
AVALO, NJ FIX ................................................................. BRIGS, NJ FIX ................................................................. * 18000 45000
* 18000–GNSS MEA
* DME/DME/IRU MEA
BRIGS, NJ FIX .................................................................. SHAUP, OA WP ............................................................... * 18000 45000
* 18000–GNSS MEA
* DME/DME/IRU MEA
From To MEA
§ 95.6001 Victor Route—U.S.

§ 95.6010 VOR Federal Airway V10 Is Amended To Delete
YOUNGSTOWN, OH VORTAC .................................................... VOLAN, PA FIX ........................................................................... * 5000

* 3000—MOCA
* 3000—GNSS MEA
VOLAN, PA FIX ............................................................................ TALLS, PA WP ............................................................................ * 5000
* 3200—MOCA
* 3300—GNSS MEA
TALLS, PA WP ............................................................................. * REVLOC, PA VOR/DME.
SE BND ....................................................................................... 4200
NW BND ...................................................................................... 5000
* 5000—MCA REVLOC, PA VOR/DME, SE BND
REVLOC, PA VOR/DME ............................................................... JUNEY, PA FIX ........................................................................... * 5000
MAA—
12000
* 5000—GNSS MEA
JUNEY, PA FIX ............................................................................. LANCASTER, PA VOR/DME ...................................................... * 5000
* 3600—MOCA
§ 95.6020 VOR Federal Airway V20 Is Amended To Read in Part
MONROEVILLE, AL VORTAC ...................................................... MONTGOMERY, AL VORTAC .................................................... 2300
BELLAIRE, OH VOR/DME ............................................................ ATWOO, OH FIX ......................................................................... * 6000

* 3100—MOCA
LA BELLE, FL VORTAC ............................................................... ROGAN, FL FIX.

SE BND ....................................................................................... * 2000
NW BND ...................................................................................... * 5000
* 2000—GNSS MEA
CLARKSBURG, WV VOR/DME .................................................... BELLAIRE, OH VOR/DME .......................................................... * 3400

* CLARKSBURG R–335 UNUSABLE, USE BELLAIR R–158
BELLAIRE, OH VOR/DME ............................................................ ATWOO, OH FIX ......................................................................... * 6000
* 3100—MOCA
ATWOO, OH FIX .......................................................................... AKRON, OH VOR/DME ............................................................... 3100
ALBANY, NY VORTAC ................................................................. CAMBRIDGE, NY VOR/DME ...................................................... * 4000

* ALBANY R–067 UNUSABLE, USE CAMBRIDGE R–248
IMPERIAL, CA VORTAC .............................................................. BRAWL, CA FIX .......................................................................... * 3700

* 2300—MOCA
REVLOC, PA VOR/DME ............................................................... BLINK, PA FIX ............................................................................. 4500

BLINK, PA FIX .............................................................................. HARRISBURG, PA VORTAC ...................................................... 4000
U.S. CANADIAN BORDER ........................................................... PATTA, ME WP ........................................................................... * 6000

* 3900—MOCA
PATTA, ME WP ............................................................................ MILLINOCKET, ME VOR/DME ................................................... * 6000
* 3900—MOCA
§ 95.6388 VOR Federal Airway V388

SEAL BEACH, CA VORTAC ........................................................ AHEIM, CA FIX ............................................................................ * 3000
* 2200—MOCA
AHEIM, CA FIX ............................................................................. DOWDD, CA FIX ......................................................................... 4000
DOWDD, CA FIX .......................................................................... PARADISE, CA VORTAC ........................................................... 4400
Is Amended To Read in Part
PARADISE, CA VORTAC ............................................................. ACINS, CA FIX.
From To MEA
W BND ......................................................................................... * 5300

E BND .......................................................................................... * 7000
* 5300—MOCA
NOGALES, AZ VOR/DME ............................................................ U.S. MEXICAN BORDER ............................................................ * 10000

* 8000—MOCA
MANKATO, MN VOR/DME ........................................................... FLYING CLOUD, MN VOR/DME ................................................ * 2900

* 2400—MOCA
JOHNSTOWN, PA VOR/DME ...................................................... ST THOMAS, PA TACAN ........................................................... 5000

ST THOMAS, PA TACAN ............................................................. BADDI, PA FIX ............................................................................ * 5000
* 4000—MOCA
BADDI, PA FIX .............................................................................. HARRISBURG, PA VORTAC ...................................................... 4000
ST THOMAS, PA TACAN ............................................................. NOENO, PA FIX .......................................................................... * 5000

* 4000—MOCA
NOENO, PA FIX ........................................................................... DELRO, PA FIX ........................................................................... * 5000
* 3400—MOCA
* 3400—GNSS MEA
DELRO, PA FIX ............................................................................ * MODENA, PA VORTAC ............................................................ ** 10000
* 10000—MCA MODENA, PA VORTAC, W BND
** 4000—GNSS MEA
MENGE, NJ FIX ............................................................................ YARDLEY, PA VOR/DME.

N BND .......................................................................................... 2000
S BND .......................................................................................... 4000
§ 95.6501 VOR Federal Airway V501
HAGERSTOWN, MD VOR ........................................................... GGRIF, PA FIX ............................................................................ 4100
GGRIF, PA FIX ............................................................................. PHILIPSBURG, PA VORTAC ...................................................... 4900
HAGERSTOWN, MD VOR ........................................................... ST THOMAS, PA TACAN ........................................................... 4000
ST THOMAS, PA TACAN ............................................................. PHILIPSBURG, PA VORTAC ...................................................... * 4500
* 4000—MOCA
§ 95.6402 Hawaii VOR Federal Airway V2 Is Amended To Read in Part
LANAI, HI VORTAC ...................................................................... KEIKI, HI FIX ............................................................................... 5000
§ 95.6421 Hawaii VOR Federal Airway V21 Is Amended To Read in Part
LANAI, HI VORTAC ...................................................................... KEIKI, HI FIX ............................................................................... 5000
Airway Segment Changeover Points
From To Distance From
§ 95.8003 VOR Federal Airways Changeover Points

V501 Is Amended To Delete Changeover Point
ST THOMAS, PA VORTAC .............................................. PHILIPSBURG, PA VORTAC .......................................... 22 ST THOM-

AS.
§ 95.8005 JET Route Changeover Points

J523 Is Amended To Modify Changeover Point
BRYCE CANYON, UT VORTAC ...................................... ELY, NV VOR/DME ......................................................... 134 BRYCE

CANYON.
[FR Doc. 2023–24424 Filed 11–3–23; 8:45 am] End-Use Based) and 746 (Embargoes • Spetstehnotreyd LLC;
BILLING CODE 4910–13–P and Other Special Controls) of the EAR. • STC Orion LLC;
The End-User Review Committee • Technical Center Windeq LLC; and
(ERC), composed of representatives of • ZALA Aero Group.
DEPARTMENT OF COMMERCE the Departments of Commerce (Chair), Uzbekistan
State, Defense, Energy and, where
appropriate, the Treasury, makes all • Mvizion LLC.
Bureau of Industry and Security
decisions regarding additions to, Savings Clause
15 CFR Part 744 removals from, or other modifications to
the Entity List. The ERC makes all For the changes being made in this
[Docket No. 231101–0257] decisions to add an entry to the Entity final rule, shipments of items removed
List by majority vote and makes all from eligibility for a License Exception
RIN 0694–AJ44 or export, reexport, or transfer (in-
decisions to remove or modify an entry
by unanimous vote. country) without a license (NLR) as a
Entity List Additions result of this regulatory action that were
AGENCY: Bureau of Industry and Entity List Decisions en route aboard a carrier to a port of
Security, Department of Commerce. Additions to the Entity List export, reexport, or transfer (in-country),
ACTION: Final rule.
on November 2, 2023, pursuant to actual
The ERC determined to add Aeroscan orders for export, reexport, or transfer
SUMMARY: In this rule, the Bureau of Limited Liability Company; (in-country) to or within a foreign
Industry and Security (BIS) amends the Alfakomponent; BIC-Inform LLC; Hartis destination, may proceed to that
Export Administration Regulations DV LLC; ID Solution LLC; OOO OMP; destination under the previous
(EAR) by adding 13 entities to the Entity Orelmetallpolimer LLC; Spel LLC; eligibility for a License Exception or
List under the destinations of Russia Spetstehnotreyd LLC; STC Orion LLC; export, reexport, or transfer (in-country)
(12), and Uzbekistan (1). These entities Technical Center Windeq LLC; and without a license (NLR) before
have been determined by the U.S. ZALA Aero Group, all under the December 4, 2023. Any such items not
Government to be acting contrary to the destination of Russia; and Mvizion LLC, actually exported, reexported or
national security or foreign policy under the destination of Uzbekistan, to transferred (in-country) before midnight,
interests of the United States. the Entity List. These entities are added on November 2, 2023, require a license
for supporting Russia’s military through in accordance with this final rule.
DATES: This rule is effective November
the procurement, development, and
2, 2023. Export Control Reform Act of 2018
proliferation of Russian unmanned
FOR FURTHER INFORMATION CONTACT: aerial vehicles (UAVs). This activity is On August 13, 2018, the President
Chair, End-User Review Committee, contrary to the national security and signed into law the John S. McCain
Office of the Assistant Secretary for foreign policy interests of the United National Defense Authorization Act for
Export Administration, Bureau of States under § 744.11(b) and these Fiscal Year 2019, which included the
Industry and Security, Department of entities qualify as military end users Export Control Reform Act of 2018
Commerce, Phone: (202) 482–5991, under §§ 744.21(e), 744.21(g), and (ECRA) (50 U.S.C. 4801–4852). ECRA
Email: ERC@bis.doc.gov. 746.8(b) of the EAR. These entities are provides the legal basis for BIS’s
SUPPLEMENTARY INFORMATION: receiving a footnote 3 designation principal authorities and serves as the
Background because the ERC has determined that authority under which BIS issues this
they are Russian or Belarusian ‘military rule.
The Entity List (supplement no. 4 to end users’ pursuant to § 744.21. A
part 744 of the EAR (15 CFR parts 730– Rulemaking Requirements
footnote 3 designation subjects these
774)) identifies entities for which there entities to the Russia/Belarus-Military 1. This rule has been determined to be
is reasonable cause to believe, based on End User Foreign Direct Product (FDP) not significant for purposes of Executive
specific and articulable facts, that the rule, detailed in § 734.9(g). The entities Order 12866.
entities have been involved, are are added with a license requirement for 2. Notwithstanding any other
involved, or pose a significant risk of all items subject to the EAR and a provision of law, no person is required
being or becoming involved in activities license review policy of denial for all to respond to or be subject to a penalty
contrary to the national security or items subject to the EAR apart from food for failure to comply with a collection
foreign policy interests of the United and medicine designated as EAR99, of information, subject to the
States, pursuant to § 744.11(b). The EAR which will be reviewed on a case-by- requirements of the Paperwork
impose additional license requirements case basis. Reduction Act of 1995 (44 U.S.C. 3501
on, and limit the availability of, most For the reasons described above, this et seq.) (PRA), unless that collection of
license exceptions for exports, final rule adds the following 13 entities, information displays a currently valid
reexports, and transfers (in-country) including aliases where appropriate, to Office of Management and Budget
when a listed entity is a party to the the Entity List: (OMB) Control Number. This regulation
transaction. The license review policy involves an information collection
for each listed entity is identified in the Russia approved by OMB under control
‘‘License Review Policy’’ column on the • Aeroscan Limited Liability number 0694–0088, Simplified Network
Entity List, and the impact on the Application Processing System. BIS
Company;
availability of license exceptions is • Alfakomponent; does not anticipate a change to the
described in the relevant Federal • BIC-Inform LLC; burden hours associated with this
Register document that added the entity • Hartis DV LLC; collection as a result of this rule.
to the Entity List. The Bureau of • ID Solution LLC; Information regarding the collection,
Industry and Security (BIS) places • OOO OMP; including all supporting materials, can
entities on the Entity List pursuant to • Orelmetallpolimer LLC; be accessed at https://www.reginfo.gov/
parts 744 (Control Policy: End-User and • Spel LLC; public/do/PRAMain.
3. This rule does not contain policies List of Subjects in 15 CFR Part 744 Comp., p. 786; Notice of November 8, 2022,
with federalism implications as that 87 FR 68015, 3 CFR, 2022 Comp., p. 563;
Exports, Reporting and recordkeeping Notice of September 7, 2023, 88 FR 62439
term is defined in Executive Order requirements, Terrorism. (September 11, 2023).
13132. Accordingly, part 744 of the Export
4. Pursuant to section 1762 of the Administration Regulations (15 CFR ■ 2. Supplement no. 4 is amended:
Export Control Reform Act of 2018, this parts 730–774) is amended as follows: ■ a. Under RUSSIA by adding, in
action is exempt from the alphabetical order, entries for ‘‘Aeroscan
Administrative Procedure Act (5 U.S.C. PART 744—END-USE AND END-USER
Limited Liability Company;’’
553) requirements for notice of CONTROLS
‘‘Alfakomponent;’’ ‘‘BIC-Inform LLC;’’
proposed rulemaking, opportunity for ‘‘Hartis DV LLC;’’ ‘‘ID Solution LLC;’’
■ 1. The authority citation for part 744
public participation, and delay in ‘‘OOO OMP;’’ ‘‘Orelmetallpolimer LLC;’’
is revised to read as follows:
effective date. ‘‘Spel LLC;’’ ‘‘Spetstehnotreyd LLC;’’
Authority: 50 U.S.C. 4801–4852; 50 U.S.C.
5. Because a notice of proposed 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C.
‘‘STC Orion LLC;’’ ‘‘Technical Center
rulemaking and an opportunity for 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 Windeq LLC;’’ ‘‘ZALA Aero Group;’’
public comment are not required to be et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR and
given for this rule by 5 U.S.C. 553, or 20947, 3 CFR, 1978 Comp., p. 179; E.O. ■ b. Under UZBEKISTAN by adding, in
by any other law, the analytical 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. alphabetical order, an entry for
requirements of the Regulatory 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994
Comp., p. 950; E.O. 13026, 61 FR 58767, 3 ‘‘Mvizion LLC’’ to read as follows:
Flexibility Act, 5 U.S.C. 601, et seq., are CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR
not applicable. Accordingly, no Supplement No. 4 to Part 744—Entity
45167, 3 CFR, 1998 Comp., p. 208; E.O. List
regulatory flexibility analysis is 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
required, and none has been prepared. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 * * * * *
License License Federal Register
Country Entity requirement review policy citation
* * * * * * *
RUSSIA .................. * * * * * *
Aeroscan Limited Liability Company, a.k.a., For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
the following two aliases: EAR. (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—Aeroscan; and 746.8(a)(3), and 744.21(b) from food and medicine
—OOO Aeroskan. of the EAR). designated as EAR99,
3 Perunovsky Pereulok, Building 2, Moscow, which will be reviewed on a
127055, Russia; and 2a Avtozavodskaya case-by-case basis. See
Street, Izhevsk, Udmurt Republic, Russia; §§ 746.8(b) and 744.21(e).
and 2 Moskovskaya, Street, Buzuluk,
Orenburgskaya Oblast, 461042, Russia;
and 3 Per. Perunovski, Street 2, Floor 2,
Pomeshch. 11, Munitsipalny Okrug Marina
Roshcha, Moscow, 127055, Russia.
* * * * * *
Alfakomponent, a.k.a., the following one For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
alias: EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—OOO Alfakomponent. 746.8(a)(3), and 744.21(b) from food and medicine
140 Leninski Prospect, Litera E, Office 407A, of the EAR). designated as EAR99,
Saint Petersburg, 198216, Russia. which will be reviewed on a
case-by-case basis. See
§§ 746.8(b) and 744.21(e).
* * * * * *
BIC-Inform LLC, a.k.a., the following two For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
aliases: EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—OOO BIC-Inform; and 746.8(a)(3), and 744.21(b) from food and medicine
—OOO BIK-Inform. of the EAR). designated as EAR99,
9 Bumazhnaya Street, K. 1, Litera A, Rooms which will be reviewed on a
201–209, Saint Petersburg, 190020, Rus- case-by-case basis. See
sia. §§ 746.8(b) and 744.21(e).
* * * * * *
Hartis DV LLC, a.k.a., the following two For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
—Trade House Alkopanel Limited Liability 746.8(a)(3), and 744.21(b) from food and medicine
Company; and of the EAR). designated as EAR99,
—OOO Khartis DV. which will be reviewed on a
35 Svobody Street, Building 5, Floor 1, Kom. case-by-case basis. See
4, Moscow, 125362, Russia. §§ 746.8(b) and 744.21(e).
* * * * * *
ID Solution LLC, a.k.a., the following one For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
alias: EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—OOO Aidi Solyushn. 746.8(a)(3), and 744.21(b) from food and medicine
Annino Plaza Business Center, 60B of the EAR). designated as EAR99,
Dorozhnaya Street, Room 421, Moscow, which will be reviewed on a
117405, Russia; and 2 Donbasskaya case-by-case basis. See
Street, Vidnoe, Moscow Oblast, 142700, §§ 746.8(b) and 744.21(e).
Russia.
* * * * * *

OOO OMP, For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
31/1 Stanislavskogo Street, Floor 1, Office 2, EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
Novosibirsk, Novosibirskaya Oblast, 746.8(a)(3), and 744.21(b) from food and medicine
630097, Russia. of the EAR). designated as EAR99,
which will be reviewed on a
§§ 746.8(b) and 744.21(e).
* * * * * *
Orelmetallpolimer LLC, a.k.a., the following For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
two aliases: EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—OMP LLC, and 746.8(a)(3), and 744.21(b) from food and medicine
—OOO Orelmetallpolimer. of the EAR). designated as EAR99,
1 Yu Avtomagistral Street, Mtsensk, which will be reviewed on a
Orovskaya Oblast, 303032, Russia; and 45 case-by-case basis. See
Olkhovskaya Street, Building 3, Floor 1, §§ 746.8(b) and 744.21(e).
Room 1/10, Munitsipalny Okrug
Krasnoselski, Moscow, 105066, Russia;
and 19B Novosushchevskaya Street, Mos-
cow, 127055, Russia; and 24/8 Vatutina
Street, Office 204, Dzerzhinsk, Nizhny
Novgorod Oblast, 606019, Russia.
* * * * * *
Spel LLC, For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
12 Gavanskaya Street, Building 2, Litera B, EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
Room 1–N, Saint Petersburg, 199106, 746.8(a)(3), and 744.21(b) from food and medicine
Russia; and 39 Morskaya Embankment, of the EAR). designated as EAR99,
Building 2A, Room 9–N, St. Petersburg, which will be reviewed on a
199155, Russia. case-by-case basis. See
§§ 746.8(b) and 744.21(e).
* * * * * *
Spetstehnotreyd LLC, a.k.a., the following For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
one alias: EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—OOO Spetstekhnotreid. 746.8(a)(3), and 744.21(b) from food and medicine
11 Mekhanizatorski Per., Office 105, Izhevsk, of the EAR). designated as EAR99,
Udmurt Republic, 426028, Russia. which will be reviewed on a
§§ 746.8(b) and 744.21(e).
* * * * * *
STC Orion LLC, a.k.a., the following three For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
—OOO NTTS Orion; 746.8(a)(3), and 744.21(b) from food and medicine
—OOO Nauchno-Tekhnicheski Tsentr Orion; of the EAR). designated as EAR99,
and which will be reviewed on a
—Limited Liability Company Scientific and case-by-case basis. See
Technical Center Orion. §§ 746.8(b) and 744.21(e).
7A Gostinichnaya, Pomeshch. 1/1, Office 1/
V–08, Munitipalny Okrug Marfino, Moscow,
127106, Russia; and 3 Perunovskiy Per.,
Annex 2, Moscow, 127055, Russia.
* * * * * *
Technical Center Windeq LLC, a.k.a., the fol- For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
lowing two aliases: EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—OOO Tekhnicheski Tsentr Vindek; and 746.8(a)(3), and 744.21(b) from food and medicine
—TC Windeq. of the EAR). designated as EAR99,
1B/3 Pokrovskaya Street, Office 69, G.O. which will be reviewed on a
Podolsk, Moscow Oblast, 142116, Russia; case-by-case basis. See
and 1 Domodedovskoye Avenue, Building §§ 746.8(b) and 744.21(e).
3, Podolskiy District, Moscow Oblast,
142116, Russia.
* * * * * *
ZALA Aero Group, a.k.a., the following four- For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
teen aliases: EAR. (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
—A-Level Aerosystems; 746.8(a)(3), and 744.21(b) from food and medicine
—CST; of the EAR. designated as EAR99,
—CST LLC; which will be reviewed on a
—CST Limited; case-by-case basis. See
—CST, OOO; §§ 746.8(b) and 744.21(e).
—TsST Limited Liability Company;
—TsST LLC;
—TsST Limited;
—TsST, OOO;

—ZALA;
—ZALA AERO;
—ZALA AERO GROUP—Bespilotniye
Sistemy;
—ZALA AERO GROUP—Unmanned Sys-
tems; and
—ZALA Aero Group Limited Liability Com-
pany.
118 40 Let Pobedy Street, Izhevsk, Udmurt
Republic, 426072, Russia; and 3
Perunovsky Per., Building 2, Floor 3,
Room 21, Moscow, 127055, Russia.
* * * * * *
UZBEKISTAN ......... * * * * * *
Mvizion LLC, For all items subject to the Policy of denial for all items 88 FR [INSERT FR PAGE
8 Katartal Street, 7th Block, Chilanzarskiy EAR (See §§ 734.9(g),3 subject to the EAR apart NUMBER] 11/6/2023.
District, Tashkent, 100113, Uzbekistan; 746.8(a)(3), and 744.21(b) from food and medicine
and 313 Gaydar Alieev Kuchasi, Tashkent, of the EAR). designated as EAR99,
Uzbekistan. which will be reviewed on a
§§ 746.8(b) and 744.21(e).
* * * * * *
* * * * * * *
3 For this entity, ‘‘items subject to the EAR’’ includes foreign-produced items that are subject to the EAR under § 734.9(g) of the EAR. See §§ 746.8 and 744.21 of
the EAR for related license requirements, license review policy, and restrictions on license exceptions.
* * * * * * *
Matthew S. Borman, daily on November 3 through November 553(b)(B), the Coast Guard finds that
Deputy Assistant Secretary for Export 6, November 11, November 12, good cause exists for not publishing a
Administration. December 2, December 3, 2023, and notice of proposed rulemaking (NPRM)
[FR Doc. 2023–24508 Filed 11–2–23; 8:45 am] January 8 through January 22, 2024. with respect to this rule because it is
BILLING CODE 3510–JT–P ADDRESSES: To view documents impracticable and contrary to the public
mentioned in this preamble as being interest. This safety zone must be
available in the docket, go to https:// established by November 3, 2023, to
DEPARTMENT OF HOMELAND www.regulations.gov, type USCG–2023– provide for the safety of life on the
SECURITY 0850 in the search box and click navigable waters during a helicopter
‘‘Search.’’ Next, in the Document Type operation, and we lack sufficient time to
Coast Guard column, select ‘‘Supporting & Related provide a reasonable comment period
Material.’’ and then consider those comments
33 CFR Part 165 before issuing this rule. Vessels inside
FOR FURTHER INFORMATION CONTACT: If of the safety zone have the potential of
[Docket Number USCG–2023–0850] you have questions on this rule, call, or getting hit by debris from the helicopter.
RIN 1625–AA00 email LTJG Eyobe Mills, Marine Safety
Under 5 U.S.C. 553(d)(3), the Coast
Unit Pittsburgh, U.S. Coast Guard, at
Guard finds that good cause exists for
Safety Zone; Ohio River Mile Markers telephone 412–221–0807, email
making this rule effective less than 30
2.5–3, Brunot Island, PA Eyobe.D.Mills@uscg.mil.
days after publication in the Federal
AGENCY: Coast Guard, Department of SUPPLEMENTARY INFORMATION: Register. Delaying the effective date of
Homeland Security (DHS). I. Table of Abbreviations this rule would be impracticable and
ACTION: Temporary final rule. contrary to the public interest because
CFR Code of Federal Regulations action is needed by November 3, 2023,
SUMMARY: The Coast Guard is proposing DHS Department of Homeland Security
FR Federal Register
to ensure the safety of the of life on the
to establish a temporary safety zone for NPRM Notice of proposed rulemaking navigable waters during a helicopter
the Ohio River several days in § Section operation.
November and December 2023, and U.S.C. United States Code
January 2024, at mile marker 2.5 to mile III. Legal Authority and Need for Rule
marker 3 from 8 a.m. through 6 p.m. II. Background Information and The Coast Guard is issuing this rule
each day. This action is necessary to Regulatory History under authority in 46 U.S.C. 70034. The
provide for the safety of life on the The Coast Guard is issuing this Captain of the Port Pittsburgh (COTP)
navigable waters during a helicopter temporary rule without prior notice and has determined that potential hazards
operation to install aerial transverse opportunity to comment pursuant to associated with a helicopter operation
wirelines. This rule prohibits persons authority under section 4(a) of the on November 3 through November 6,
and vessels from being in the safety November 11 through November 12,
Administrative Procedure Act (APA) (5

zone unless authorized by the Captain U.S.C. 553(b)). This provision December 2 through December 3, 2023,
of the Port Pittsburgh (COTP) or a authorizes an agency to issue a rule and January 8 through January 22, 2024,
designated representative. without prior notice and opportunity to will be a safety concern for anyone on
DATES: This rule is effective from 8 a.m. comment when the agency for good the Ohio River from mile markers 2.5 to
on November 3, 2023, through 6 p.m. on cause finds that those procedures are mile marker 3 from 8 a.m. to 6 p.m. The
January 22, 2024. This rule will be ‘‘impracticable, unnecessary, or contrary purpose of this rule is to ensure safety
enforced from 8 a.m. through 6 p.m. to the public interest.’’ Under 5 U.S.C. of the participant, vessels, and the
navigable waters in the safety zone This regulatory action determination C. Collection of Information
before, during, and after the scheduled is based on size, location, and duration This rule will not call for a new
event. of the temporary safety zone. This safety collection of information under the
zone only impacts a 0.5-mile stretch on Paperwork Reduction Act of 1995 (44
IV. Discussion of the Rule
the Ohio River for 10 hours each day U.S.C. 3501–3520).
This rule establishes a temporary from November 3 through November 6,
safety zone that will be enforced each November 11 through November 12, D. Federalism and Indian Tribal
day from 8 a.m. until 6 p.m. on December 2 through December 3, 2023, Governments
November 3 through November 6, and January 8 through January 22, 2024. A rule has implications for federalism
November 11 through November 12, Moreover, the Coast Guard will issue under Executive Order 13132,
December 2 through December 3, 2023, Local Notice to Mariners and Broadcast Federalism, if it has a substantial direct
and January 8 through January 22, 2024. Notice to Mariners via VHF–FM marine effect on the States, on the relationship
The safety zone will cover all navigable channel 16 about the zone and the rule between the National Government and
waters on the Ohio River from mile allows vessels to seek permission from the States, or on the distribution of
markers 2.5 to mile marker 3. The the COTP to transit the zone. power and responsibilities among the
duration of the zone is intended to B. Impact on Small Entities various levels of government. We have
protect personnel, vessels, and the analyzed this rule under that order and
marine environment in the navigable The Regulatory Flexibility Act of have determined that it is consistent
waters during an installation of aerial 1980, 5 U.S.C. 601–612, as amended, with the fundamental federalism
transverse wirelines using a helicopter. requires Federal agencies to consider principles and preemption requirements
the potential impact of regulations on described in Executive Order 13132.
No vessel or person is permitted to
small entities during rulemaking. The Also, this rule does not have tribal
enter the safety zone without obtaining term ‘‘small entities’’ comprises small
permission from the COTP or a implications under Executive Order
businesses, not-for-profit organizations 13175, Consultation and Coordination
designated representative of the COTP. that are independently owned and
A designated representative is a with Indian Tribal Governments,
operated and are not dominant in their because it does not have a substantial
commissioned, warrant, or petty officer fields, and governmental jurisdictions
of the U.S. Coast Guard (USCG) assigned direct effect on one or more Indian
with populations of less than 50,000. tribes, on the relationship between the
to units under the operational control of The Coast Guard certifies under 5 U.S.C.
the COTP. To seek permission to enter, Federal Government and Indian tribes,
605(b) that this rule will not have a or on the distribution of power and
contact the COTP or a designated significant economic impact on a
representative via VHF–FM channel 16, responsibilities between the Federal
substantial number of small entities. Government and Indian tribes.
or through Marine Safety Unit While some owners or operators of
Pittsburgh at 412–221–0807. Persons vessels intending to transit the safety E. Unfunded Mandates Reform Act
and vessels permitted to enter the safety zone may be small entities, for the The Unfunded Mandates Reform Act
zone must comply with all lawful orders reasons stated in section V.A above, this of 1995 (2 U.S.C. 1531–1538) requires
or directions issued by the COTP or rule will not have a significant Federal agencies to assess the effects of
designated representative. The COTP or economic impact on any vessel owner their discretionary regulatory actions. In
a designated representative will inform or operator. particular, the Act addresses actions
the public of the effective period for the Under section 213(a) of the Small that may result in the expenditure by a
safety zone as well as any changes in the Business Regulatory Enforcement State, local, or tribal government, in the
dates and times of enforcement through Fairness Act of 1996 (Pub. L. 104–121), aggregate, or by the private sector of
Local Notice to Mariners (LNMs), we want to assist small entities in $100,000,000 (adjusted for inflation) or
Broadcast Notices to Mariners (BNMs), understanding this rule. If the rule more in any one year. Though this rule
and/or Marine Safety Information would affect your small business, will not result in such an expenditure,
Bulletins (MSIBs), as appropriate. organization, or governmental we do discuss the effects of this rule
V. Regulatory Analyses jurisdiction and you have questions elsewhere in this preamble.
concerning its provisions or options for
We developed this rule after compliance, please call or email the F. Environment
considering numerous statutes and person listed in the FOR FURTHER We have analyzed this rule under
Executive orders related to rulemaking. INFORMATION CONTACT section. Department of Homeland Security
Below we summarize our analyses Small businesses may send comments Directive 023–01, Rev. 1, associated
based on a number of these statutes and on the actions of Federal employees implementing instructions, and
Executive orders, and we discuss First who enforce, or otherwise determine Environmental Planning COMDTINST
Amendment rights of protestors. compliance with, Federal regulations to 5090.1 (series), which guide the Coast
the Small Business and Agriculture Guard in complying with the National
A. Regulatory Planning and Review
Regulatory Enforcement Ombudsman Environmental Policy Act of 1969 (42
Executive Orders 12866 and 13563 and the Regional Small Business U.S.C. 4321–4370f), and have
direct agencies to assess the costs and Regulatory Fairness Boards. The determined that this action is one of a
benefits of available regulatory Ombudsman evaluates these actions category of actions that do not
alternatives and, if regulation is annually and rates each agency’s individually or cumulatively have a
necessary, to select regulatory responsiveness to small business. If you significant effect on the human
approaches that maximize net benefits. wish to comment on actions by environment. This rule involves a
This rule has not been designated a employees of the Coast Guard, call 1– temporary safety zone lasting 10 hours
‘‘significant regulatory action,’’ under 888–REG–FAIR (1–888–734–3247). The each day from November 3 through
Executive Order 12866. Accordingly, Coast Guard will not retaliate against November 6, November 11 through
this rule has not been reviewed by the small entities that question or complain November 12, December 2 through
Office of Management and Budget about this rule or any policy or action December 3, 2023, and January 8
(OMB). of the Coast Guard. through January 22, 2024, on the Ohio
River. It is categorically excluded from 670–7288. To seek permission, column, select ‘‘Supporting & Related
further review under paragraph L60(a) concerned traffic may reach contact the Material.’’
of Appendix A, Table 1 of DHS event organizers on channel 13 or at FOR FURTHER INFORMATION CONTACT: If
Instruction Manual 023–01–001–01, (860) 573–6646. Those in the safety you have questions on this notification
Rev. 1. A Record of Environmental zone must comply with all lawful orders of enforcement, call or email Hailye
Consideration supporting this or directions given to them by the COTP Wilson, Sector Key West Waterways
determination is available in the docket. or the COTP’s designated representative. Management Department, Coast Guard;
For instructions on locating the docket, (d) Enforcement period. This section telephone 305–292–8768; email:
see the ADDRESSES section of this will be enforced each day from 8 a.m. hailye.m.wilson@uscg.mil.
preamble. through 6 p.m. from November 3 SUPPLEMENTARY INFORMATION:
through November 6, November 11
G. Protest Activities I. Table of Abbreviations
through November 12, December 2
The Coast Guard respects the First through December 3, 2023, and January COTP Captain of the Port
Amendment rights of protesters. 8 through January 22, 2024. The CFR Code of Federal Regulations
Protesters are asked to call or email the temporary safety zone will be enforced CWA Clean Water Act
person listed in the FOR FURTHER during the 10 hour helicopter operation. DHS Department of Homeland Security
INFORMATION CONTACT section to FR Federal Register
coordinate protest activities so that your Justin R. Jolley, MTSA Maritime Transportation Security
message can be received without Commander, U.S. Coast Guard, Acting, Act
Captain of the Port, MSU Pittsburgh. NPRM Notice of proposed rulemaking
jeopardizing the safety or security of OPA90 The Oil Pollution Act of 1990
people, places, or vessels. [FR Doc. 2023–24388 Filed 11–3–23; 8:45 am]
PWSA Ports and Waterways Safety Act
List of Subjects in 33 CFR Part 165 § Section
U.S.C. United States Code
Marine Safety, Navigation (water),
Reporting, and recordkeeping DEPARTMENT OF HOMELAND II. Background Information and
requirements, Waterways. SECURITY Regulatory History
For the reasons discussed in the The Florida Keys has the potential to
Coast Guard be affected by hurricanes, tropical
preamble, the Coast Guard amends 33
CFR part 165 as follows: storms, and other disasters on a yearly
33 CFR Part 165 basis, especially between the months of
PART 165—REGULATED NAVIGATION [Docket Number: USCG–2023–0135] June and November. The Key West
AREAS AND LIMITED ACCESS AREAS COTP is establishing a safety zone to
RIN 1625–AA00 provide for the safety of life during such
■ 1. The authority citation for part 165 storms and events. In response, on May
continues to read as follows: Safety Zone; Atlantic Ocean, Key West, 2, 2023, the Coast Guard published a
Authority: 46 U.S.C. 70034, 70051, 70124; FL notice of proposed rulemaking
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; AGENCY: Coast Guard, DHS. (NPRM).1 There, we stated why we
Department of Homeland Security Delegation issued the NPRM and invited comments
No. 00170.1, Revision No. 01.3. ACTION: Final rule.
on our proposed regulatory action
■ 2. Add § 165.T08–0850 to read as SUMMARY: The Coast Guard is related to safety zone. During the
follows: establishing a safety zone to be enforced comment period that ended June 1,
in the event of hurricanes, tropical 2023, we received two comments.
§ 165.T08–0850 Safety Zone; Ohio River, Under 5 U.S.C. 553(d)(3), the Coast
Brunot Island, PA.
storms, and other disasters in the
Florida Keys, FL. This action is Guard finds that good cause exists for
(a) Location. The following area is a necessary to ensure the safety of the making this rule effective less than 30
temporary safety zone on the Ohio River waters of the Key West Captain of the days after publication in the Federal
from mile marker 2.5 to mile marker 3. Port (COTP) zone. This regulation Register. Delaying the effective date of
(b) Definitions. As used in this this rule would be impracticable and
establishes actions to be completed by
section, designated representative contrary to public interest because
parties operating on and around the
means a Coast Guard Patrol immediate action is needed to respond
navigable waterways of the Key West
Commander, including a Coast Guard to the potential safety hazards
COTP zone. This may include the
coxswain, petty officer, or other officer associated with the rapid formation of a
owners and operators, and those in
operating a Coast Guard vessel and a tropical storm or hurricane that would
management and control positions of
Federal, State, and local officer pose an imminent threat to vessels,
regulated facilities, waterfront facilities,
designated by or assisting the Captain of persons, structures, and shore areas.
and vessels, prior to landfall of
the Port Pittsburgh (COTP) in the
hurricanes, tropical storms, and other III. Legal Authority and Need for Rule
enforcement of the safety zone.
disasters threatening the Florida Keys.
Designated representative includes The Coast Guard is issuing this rule
safety boat provided by the event DATES: This rule is effective without under authority in 46 U.S.C. 70034. The
organizers. actual notice November 6, 2023. For the purpose of this rule is to protect the
(c) Regulations. (1) Under the general purposes of enforcement, actual notice general maritime public, to include
will be used from November 1, 2023,
safety zone regulations in subpart C of vessel owners, vessel operators, and

this part, you may not enter the safety until November 6, 2023. those in management and control
zone described in paragraph (a) of this ADDRESSES: To view documents positions related to facilities and
section unless authorized by the COTP mentioned in this preamble as being waterways regulated by the Coast
or the C’TP’s designated representative. available in the docket, go to https:// Guard, along with those in management
(2) To seek permission to enter, www.regulations.gov, type USCG–2023– and control positions related to any land
contact the COTP or the COTP’s 0135 in the search box and click
representative on Channel 16 or at 412– ‘‘Search.’’ Next, in the Document Type 1 88 FR 27421.
or shore area immediately adjacent to operators, along with the owners and those types of circumstances, the Coast
those waterways in the COTP Key West operators of regulated facilities and Guard will provide affected individuals
zone, in the event of a hurricane, waterfront facilities with a deeper with actual notice of the safety zone
tropical storm, and other natural understanding of how the Coast Guard prior to its enforcement or assessment of
disasters. intends to handle extreme weather- any fines or penalties. In addition to
related events so they can plan changes made to the regulatory text in
IV. Discussion of Comments, Changes,
accordingly. this final rule in response to comment,
and the Rule To address the commenter’s concerns we are making the following changes to
As noted above, we received two regarding the regarding the lack of the regulatory text.
comments on our NPRM published May clarity in the proposed regulatory text, In paragraph (a), we are adding
2, 2023. The first commenter positively the Coast Guard is making the following ‘‘regulated facilities, and ‘‘waterfront
endorsed the Coast Guard’s changes in the final rule regulatory text facilities’’ to clarify that regulated
establishment of this safety zone. They in § 165.707. facilities and waterfront facilities as
further recommended that small entities The Coast Guard is adding three defined in paragraphs (b)(6) and (b)(7)
and individuals who choose to reside in definitions for ‘‘regulated facilities,’’ respectively are covered by this safety
Florida assume all the liability, risk and ‘‘waterfront facilities,’’ and ‘‘authorized zone when port conditions are met in
responsibilities associated with law enforcement agencies’’ in paragraph accordance with the requirements in
hurricanes. They also recommended (a). The Coast Guard has the authority paragraph (c)(1) Port Condition
that tax-payer-funds not be expended to to regulate facilities and land structure WHISKEY and (c)(2) Port Condition X–
combat the effects of climate change. or shore area immediately adjacent to RAY. Additionally, in paragraph (a), we
The Coast Guard acknowledges these navigable waters under certain, specific are deleting ‘‘during specified
comments and determined no statutory and regulatory frameworks. conditions’’ because the location of the
recommended changes are needed in We are adding a definition for safety zone is intended to be constant.
response to these suggestions. ‘‘regulated facilities’’ to clarify the When the safety zone is subject to
Additionally, this commenter regulated facilities covered by this rule enforcement it will be determinate of
recommended the fossil fuel industry, are those regulated under the Ports and conditions set forth in paragraphs (c)(1)
and their shareholders bear the cost Waterways Safety Act,2 Maritime through (c)(5) of the regulatory text. In
associated with climate change. With Transportation and Security Act,3 Clean paragraph (c)(1), we are deleting ‘‘port
regards to this suggestion, the Water Act,4 and the Oil Pollution Act of facilities’’ and adding in its place,
suggestion is outside the scope of this 1990.5 These statutes give the Coast ‘‘regulated facilities and waterfront
rulemaking, which pertains to the Guard the authority and jurisdiction to facilities’’ for consistency as definitions
establishment of a safety zone to be take certain actions on certain regulated for these terms have been added in
subject to enforcement in the event of a facilities that have a maritime nexus. paragraphs (a)(6) and (a)(7). In the event
hurricane, tropical storm, and other We are adding a definition for Port Condition WHISKEY is set, all
disaster in the Florida Keys, FL. ‘‘waterfront facilities’’ to the regulatory vessels, regulated facilities, and
The second commenter raised several text which will include any land waterfront facilities within the Key West
issues regarding the lack of clarity in the structure or shore area immediately COTP zone would have to comply with
proposed regulatory text and questioned adjacent to the navigable waters of the the applicable regulations in (c)(1).
whether the rule is necessary. The rule Key West COTP zone. We also added a Additionally, in paragraph (c)(1), we
is necessary to protect the general definition for ‘‘authorized law removed the sentence, ‘‘Vessels wishing
maritime public in the COTP Key West enforcement agencies’’ to clarify that to remain in port are required to submit
zone, in the event of extreme weather or Federal, State, and local law an application to the COTP prior to
other natural disasters. While the enforcement agencies that have received setting Port Condition X–Ray.’’ In its
regulations in 33 CFR part 160, subpart specific authorization from or are place, we are adding the sentence,
B, ‘‘Control of Vessel and Facility operating in concert with the Coast ‘‘Oceangoing vessels greater than 300
Operations’’ grants the COTP the broad Guard are authorized to conduct gross tons (GT) intending to remain in
authority to direct the operations of operations related to the safety, security, the port during Port Condition Whiskey
vessels on the navigable waters, and and stability of the Key West COTP must contact the Key West COTP prior
waterfront facilities, land structures or zone. to the setting of port condition X–Ray.’’
shore areas immediately adjacent to the Additionally, the commenter raised We are taking this action to prevent
navigable waters, this rule is intended to concerns related to enforceability and vessel owners and operators from
specifically streamline the COTP’s notice requirements. The Coast Guard having to generate additional
actions and processes for specific understands that its regulations are not documentation.
scenarios that may occur in the event of enforceable on the public without In paragraph (c)(2), we are deleting
extreme weather or other natural proper notice. While the publication of ‘‘port facilities’’ and adding in its place,
disasters. this final rule document in the Federal ‘‘regulated facilities and waterfront
This rule is intended to inform the Register constitutes constructive notice facilities’’ for consistency as definitions
general maritime public, to include of the requirements within the for these terms have been added in
vessel owners and operators, regulated regulations. However, there will be paragraphs (a)(6) and (a)(7). In the event
facilities, and waterfront facilities of the circumstances where individuals are Port Condition X–RAY is set, all vessels,
Coast Guard’s expectations in the event notified by the Coast Guard of an regulated facilities, and waterfront
of a hurricane, tropical storm, or other
impending extreme weather situation facilities within the Key West COTP
disaster, thereby expediting the causing the need for the safety zone to zone would have to comply with the
enforcement of the safety zone, and be made subject to enforcement. In applicable regulations in paragraph
providing more advanced notice of the (c)(2). Additionally, in paragraph (c)(2),
Coast Guard’s expectations in the event 2 46 U.S.C. 70001 et seq. we are deleting the sentence, ‘‘The
of a hurricane, tropical storm, or other 3 46 U.S.C. 70101 et seq. COTP may require additional
natural disaster. The rule is also 4 33 U.S.C. 1251 et seq. precautions to ensure the safety of the
intended to provide vessel owners and 5 33 U.S.C. 2701 et seq. ports and waterways’’ because it is
overly vague and may cause undue This regulatory action determination small entities that question or complain
confusion for owners and operators of is based on the necessity to protect life about this rule or any policy or action
vessels and regulated facilities. and port infrastructure during a of the Coast Guard.
In paragraph (c)(3), we clarified we hurricanes, tropical storms, and other
C. Collection of Information
are only limiting cargo operations at disasters. The absence of a safe harbor
‘‘regulated facilities.’’ We also removed in the Florida Keys precludes large This rule will not call for a new
some the language that went into vessels from accessing adequate collection of information under the
specifics of cargo operations. Removing facilities to weather a substantial storm Paperwork Reduction Act of 1995 (44
the language made the regulatory text or natural disaster within the Key West U.S.C. 3501–3520).
more succinct, as the initial language COTP zone. Moreover, the Coast Guard D. Federalism and Indian Tribal
contained unnecessary redundancies. would issue a Broadcast Notice to Governments
We also clarified that only facilities Mariners via VHF–FM marine channel
regulated under the MTSA will be 16 about the safety zone, and the rule A rule has implications for federalism
required to operate in accordance with would allow vessels to seek permission under Executive Order 13132,
their security plan. to remain in port. Federalism, if it has a substantial direct
effect on the States, on the relationship
In paragraph (c)(4), we are removing B. Impact on Small Entities between the National Government and
the words ‘‘are suspended’’ and
The Regulatory Flexibility Act of the States, or on the distribution of
replacing it with, ‘‘must cease all cargo
1980, 5 U.S.C. 601–612, as amended, power and responsibilities among the
operations’’ because the phrase ‘‘are
requires Federal agencies to consider various levels of government. We have
suspended’’ may be confusing in this
the potential impact of regulations on analyzed this rule under that order and
context. By using the phrase ‘‘must
small entities during rulemaking. The have determined that it is consistent
cease all cargo operations’’ we are
term ‘‘small entities’’ comprises small with the fundamental federalism
making it clear to the regulated parties
businesses, not-for-profit organizations principles and preemption requirements
that cargo operations must stop when
that are independently owned and described in Executive Order 13132.
Port ZULU is set. Also, this rule does not have tribal
operated and are not dominant in their
In paragraph (c)(6), we are revising fields, and governmental jurisdictions implications under Executive Order
the text to clarify that the Coast Guard with populations of less than 50,000. 13175, Consultation and Coordination
Sector Key West will notify the The Coast Guard received 00 comments with Indian Tribal Governments,
maritime community, ‘‘to the furthest from the Small Business Administration because it does not have a substantial
extent practicable’’ of the periods which on this rulemaking. The Coast Guard direct effect on one or more Indian
the safety zone in paragraph (a) will be certifies under 5 U.S.C. 605(b) that this tribes, on the relationship between the
subject to enforcement via Broadcast rule will not have a significant Federal Government and Indian tribes,
Notice to Mariners or by on-scene economic impact on a substantial or on the distribution of power and
designated representatives. number of small entities. responsibilities between the Federal
We are deleting paragraph (c)(7) While some owners or operators of Government and Indian tribes.
because it is duplicative of what is vessels intending to transit the safety
contained in paragraph (c)(6). The zone may be small entities, for the E. Unfunded Mandates Reform Act
information previously described in reasons stated in section V.A above, this The Unfunded Mandates Reform Act
(c)(8) was thereby moved to (c)(7). rule will not have a significant of 1995 (2 U.S.C. 1531–1538) requires
Lastly, we are making non-substantive economic impact on any vessel owner Federal agencies to assess the effects of
editorial changes and revising or operator. their discretionary regulatory actions. In
terminology for consistency throughout Under section 213(a) of the Small particular, the Act addresses actions
the final rule regulatory text. Business Regulatory Enforcement that may result in the expenditure by a
Fairness Act of 1996 (Pub. L. 104–121), State, local, or tribal government, in the
V. Regulatory Analyses
we want to assist small entities in aggregate, or by the private sector of
We developed this rule after understanding this rule. If the rule $100,000,000 (adjusted for inflation) or
considering numerous statutes and would affect your small business, more in any one year. Though this rule
Executive orders related to rulemaking. organization, or governmental will not result in such an expenditure,
Below we summarize our analyses jurisdiction and you have questions we do discuss the effects of this rule
based on a number of these statutes and concerning its provisions or options for elsewhere in this preamble.
Executive orders, and we discuss First compliance, please call or email the
Amendment rights of protestors. person listed in the FOR FURTHER F. Environment
INFORMATION CONTACT section. We have analyzed this rule under
A. Regulatory Planning and Review Department of Homeland Security
Small businesses may send comments
Executive Orders 12866 and 13563 on the actions of Federal employees Directive 023–01, Rev. 1, associated
direct agencies to assess the costs and who enforce, or otherwise determine implementing instructions, and
benefits of available regulatory compliance with, Federal regulations to Environmental Planning COMDTINST
alternatives and, if regulation is the Small Business and Agriculture 5090.1 (series), which guide the Coast
necessary, to select regulatory Regulatory Enforcement Ombudsman Guard in complying with the National
approaches that maximize net benefits. and the Regional Small Business Environmental Policy Act of 1969 (42
This rule has not been designated a Regulatory Fairness Boards. The U.S.C. 4321–4370f), and have
‘‘significant regulatory action,’’ under Ombudsman evaluates these actions determined that this action is one of a
section 3(f) of Executive Order 12866, as annually and rates each agency’s category of actions that do not
amended by Executive Order 14094 responsiveness to small business. If you individually or cumulatively have a
(Modernizing Regulatory Review). wish to comment on actions by significant effect on the human
Accordingly, this rule has not been employees of the Coast Guard, call 1– environment. This rule involves a safety
reviewed by the Office of Management 888–REG–FAIR (1–888–734–3247). The zone that would prohibit entry in
and Budget (OMB). Coast Guard will not retaliate against certain waters of the Key West COTP for
the duration needed to ensure safe and local officers designated by or facilities within the Key West COTP
transit of vessels and industry post- assisting the COTP in the enforcement zone must ensure that potential flying
hurricane, post-storm, and post- of the regulated areas. debris is removed or secured. Hazardous
emergency. It is categorically excluded Port Condition WHISKEY means a materials/pollution hazards must be
from further review under paragraph condition set by the COTP when secured in a safe manner and away from
L60(a) of Appendix A, Table 1 of DHS weather advisories indicate sustained waterfront areas. Vessels greater than
Instruction Manual 023–01–001–01, gale force winds (39–54 mph/34–47 300 GT without an approval to remain
Rev. 1. A Record of Environmental knots) from a tropical or hurricane force in port must depart prior to the setting
Consideration supporting this storm are predicted to make landfall at of Port Condition YANKEE. Vessels
determination is available in the docket. the port within 72 hours. with the COTP’s permission to remain
For instructions on locating the docket, Port Condition X–RAY means a
in port must implement their pre-
see the ADDRESSES section of this condition set by the COTP when
weather advisories indicate sustained approved mooring arrangement.
preamble.
gale force winds (39–54 mph/34–47 Regulated facilities must prepare to
G. Protest Activities knots) from a tropical or hurricane force terminate all cargo operations.
The Coast Guard respects the First storm are predicted to make landfall at (3) Port Condition YANKEE. Affected
Amendment rights of protesters. the port within 48 hours. ports are closed to inbound vessel
Protesters are asked to call or email the Port Condition YANKEE means a traffic. All oceangoing vessels greater
person listed in the FOR FURTHER condition set by the COTP when than 300 GT must have departed
INFORMATION CONTACT section to weather advisories indicate that designated ports within the Key West
coordinate protest activities so that your sustained gale force winds (39–54 mph/ COTP zone. Regulated facilities must
message can be received without 34–47 knots) from a tropical or terminate all cargo operations, not
jeopardizing the safety or security of hurricane force storm are predicted to associated with storm preparations,
people, places or vessels. make landfall at the port within 24 unless specifically authorized by the
hours. COTP. All MTSA regulated facilities
List of Subjects in 33 CFR Part 165 Port Condition ZULU means a
must continue to operate in accordance
Harbors, Marine safety, Navigation condition set by the COTP when
(water), Reporting and recordkeeping with their approved Facility Security
weather advisories indicate that
requirements, Security measures, sustained gale force winds (39–54 mph/ Plans and comply with the requirements
Waterways. 34–47 knots) from a tropical or of the MTSA.
For the reasons discussed in the hurricane force storm are predicted to (4) Port Condition ZULU. The port is
preamble, the Coast Guard amends 33 make landfall at the port within 12 closed to all vessel traffic except as
CFR part 165 as follows: hours. specifically authorized by the COTP.
Regulated Facilities means shoreside Regulated facilities must cease all cargo
PART 165—REGULATED NAVIGATION facilities regulated by the Coast Guard operations, including bunkering and
AREAS AND LIMITED ACCESS AREAS under the Ports and Waterways Safety lightering. Waivers may be granted
Act,6 Maritime Transportation and except for when Cargo of Particular
■ 1. The authority citation for part 165 Security Act,7 Clean Water Act,8 and the
continues to read as follows: Hazard or Certain Dangerous Cargo are
Oil Pollution Act of 1990,9 and involved.
Authority: 46 U.S.C. 70034, 70051, 70124; regulations in 33 CFR parts 105, 154,
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 156, and 158. (5) Emergency Restrictions for Other
Department of Homeland Security Delegation Waterfront Facilities means any land Disasters. Any natural or other disasters
No. 00170.1, Revision No. 01.3. structure or shore area immediately that are anticipated to affect the Key
■ 2. Add § 165.707 to read as follows: adjacent to the navigable waters of the West COTP zone will result in the
Key West COTP zone. prohibition of regulated facility
§ 165.707 Safety Zone; Hurricanes, (c) Regulations—(1) Port Condition operations and vessel traffic transiting
Tropical Storms and Other Disasters in WHISKEY. All vessels, regulated or remaining in the affected port.
Florida Keys.
facilities, and waterfront facilities (6) Safety Zones Notice. Coast Guard
(a) Regulated Areas. All navigable within the Key West COTP zone must
waters, regulated facilities, and Sector Key West will notify the
exercise due diligence in preparation for maritime community, to the furthest
waterfront facilities within the Key West potential storm impacts. All regulated
Captain of the Port (COTP) zone, Key extent practicable, of the periods during
facilities and waterfront facilities must
West, Florida (as described in 33 CFR which the safety zone described in
begin removing all debris and securing
3.35–40). paragraph (a) will be subject to
potential flying hazards. Oceangoing
(b) Definitions. As used in this enforcement via Broadcast Notice to
vessels greater than 300 gross tons (GT)
section: must make plans to depart no later than Mariners or by on-scene designated
Authorized Law Enforcement the setting of Port Condition Yankee representatives.
Agencies means Federal, State, and local unless authorized by the COTP. (7) Exception. This regulation does
law enforcement agencies that have Oceangoing vessels greater than 300 GT not apply to authorized law
received specific authorization from or intending to remain in port must contact enforcement agencies operating within
are operating in concert with the Coast the COTP prior to the setting port the regulated area.
Guard to conduct operations related to condition X–Ray.

the safety, security and stability of the (2) Port Condition X–RAY. All vessels, Jason D. Ingram,
Key West COTP zone. regulated facilities, and waterfront Captain, U.S. Coast Guard, Captain of the
Designated Representative means Port, Sector Key West.
Coast Guard Patrol Commanders, 6 46 U.S.C. 70001 et seq. [FR Doc. 2023–24471 Filed 11–3–23; 8:45 am]
including Coast Guard coxswains, petty 7 46 U.S.C. 70101 et seq. BILLING CODE 9110–04–P
officers, and other officers operating 8 33 U.S.C. 1251 et seq.
Coast Guard vessels, and Federal, State, 9 33 U.S.C. 2701 et seq.
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: Thermal Treatment Facilities; 62–

AGENCY 296.511, F.A.C., Solvent Metal Cleaning,
I. Background
each state effective November 5, 2020;
40 CFR Part 52 EPA is approving certain changes to 62–296.418, F.A.C., Bulk Gasoline
the Florida SIP that were submitted by Plants; 62–296.500, F.A.C., Reasonably
[EPA–R04–OAR–2023–0056; FRL–11369–
FDEP on April 1, 2022. Specifically, Available Control Technology (RACT)—
02–R4]
EPA is approving changes to Rules 62– Volatile Organic Compounds (VOC) and
Air Plan Approval; FL; Miscellaneous 296.414, Florida Administrative Code Nitrogen Oxides (NOX) Emitting
SIP Revision (F.A.C.), Concrete Batching Plants; 62– Facilities; 62–296.512, F.A.C., Cutback
296.415, F.A.C., Soil Thermal Treatment Asphalt, each state effective August 14,
AGENCY: Environmental Protection Facilities; 62–296.418, F.A.C., Bulk 2019; and 62–296.501, F.A.C., Can
Agency (EPA). Gasoline Plants; 62–296.500, F.A.C., Coating; 62–296.502, F.A.C., Coil
ACTION: Final rule. Reasonably Available Control Coating; 62–296.503, F.A.C., Paper
Technology (RACT)—Volatile Organic Coating; 62–296.504, F.A.C., Fabric and
SUMMARY: The Environmental Protection Compounds (VOC) and Nitrogen Oxides Vinyl Coating; 62–296.505, F.A.C.,
Agency (EPA) is approving a Florida (NOX) Emitting Facilities; 62–296.501, Metal Furniture Coating; 62–296.506,
State Implementation Plan (SIP) F.A.C., Can Coating; 62–296.502, F.A.C., F.A.C., Surface Coating of Large
revision, submitted by the State of Coil Coating; 62–296.503, F.A.C., Paper Appliances; 62–296.507, F.A.C., Magnet
Florida through the Florida Department Coating; 62–296.504, F.A.C., Fabric and Wire Coating; 62–296.508, F.A.C.,
of Environmental Protection (FDEP) on Vinyl Coating; 62–296.505, F.A.C., Petroleum Liquid Storage; 62–296.510,
April 1, 2022. The SIP revision revises Metal Furniture Coating; 62–296.506, F.A.C., Bulk Gasoline Terminals; 62–
multiple stationary source rules in F.A.C., Surface Coating of Large 296.513, F.A.C., Surface Coating of
Florida’s SIP with substantive and Appliances; 62–296.507, F.A.C., Magnet Miscellaneous Metal Parts and
minor changes throughout. EPA is Wire Coating; 62–296.508, F.A.C., Products; 62–296.514, F.A.C., Surface
approving these changes pursuant to the Petroleum Liquid Storage; 62–296.510, Coating of Flat Wood Paneling; 62–
Clean Air Act (CAA or Act). F.A.C., Bulk Gasoline Terminals; 62– 296.515, F.A.C., Graphic Arts Systems;
DATES: This rule is effective December 6, 296.511, F.A.C., Solvent Metal Cleaning; and 62–296.516, F.A.C., Petroleum
2023. 62–296.512, F.A.C., Cutback Asphalt; Liquid Storage Tanks with External
62–296.513, F.A.C., Surface Coating of Floating Roofs, all state effective on July
ADDRESSES: EPA has established a
Miscellaneous Metal Parts and 10, 2014. EPA has made, and will
docket for this action under Docket
Products; 62–296.514, F.A.C., Surface continue to make, these materials
Identification No. EPA–R04–OAR–
Coating of Flat Wood Paneling; 62– generally available through
2023–0056. All documents in the docket
296.515, F.A.C., Graphic Arts Systems; www.regulations.gov and at the EPA
are listed on the www.regulations.gov
and 62–296.516, F.A.C., Petroleum Region 4 Office (please contact the
website. Although listed in the index,
Liquid Storage Tanks with External person identified in the FOR FURTHER
some information may not be publicly
Floating Roofs.1 These changes are for INFORMATION CONTACT section of this
available, i.e., Confidential Business
multiple stationary source emission preamble for more information).
Information or other information whose
standards rules in Florida’s SIP with Therefore, these materials have been
disclosure is restricted by statute.
substantive and minor changes approved by EPA for inclusion in the
Certain other material, such as throughout.
copyrighted material, is not placed on SIP, have been incorporated by
Through a notice of proposed reference by EPA into that plan, are
the internet and will be publicly rulemaking (NPRM), published on
available only in hard copy form. fully federally enforceable under
September 11, 2023, (88 FR 62303), EPA sections 110 and 113 of the CAA as of
Publicly available docket materials are proposed to approve the April 1, 2022,
available either electronically through the effective date of the final rulemaking
submission. The details of Florida’s of EPA’s approval, and will be
www.regulations.gov or in hard copy at submission, which amend various
the Air Regulatory Management Section, incorporated by reference in the next
stationary source emission standards, as update to the SIP compilation.2
Air Planning and Implementation well as EPA’s rationale for approving
Branch, Air and Radiation Division, the changes, are described in the III. Final Action
U.S. Environmental Protection Agency, September 11, 2023, NPRM. Comments EPA is finalizing the approval of the
Region 4, 61 Forsyth Street SW, Atlanta, on the September 11, 2023, NPRM were April 1, 2022, Florida SIP revision to
Georgia 30303–8960. EPA requests that due on or before October 11, 2023. EPA incorporate various changes to Rules
if at all possible, you contact the person did not receive any adverse comments 62–296.414, F.A.C., Concrete Batching
listed in the FOR FURTHER INFORMATION on the September 11, 2023, NPRM. Plants; 62–296.415, F.A.C., Soil
CONTACT section to schedule your Thermal Treatment Facilities; 62–
inspection. The Regional Office’s II. Incorporation by Reference
296.418, F.A.C., Bulk Gasoline Plants;
official hours of business are Monday In this document, EPA is finalizing 62–296.500, F.A.C., Reasonably
through Friday 8:30 a.m. to 4:30 p.m., regulatory text that includes Available Control Technology (RACT)—
excluding Federal holidays. incorporation by reference. In Volatile Organic Compounds (VOC) and
FOR FURTHER INFORMATION CONTACT: accordance with the requirements of 1 Nitrogen Oxides (NOX) Emitting
Josue Ortiz Borrero, Air Regulatory CFR 51.5, and as discussed in Section Facilities; 62–296.501, F.A.C., Can
I of this preamble, EPA is finalizing the
Management Section, Air Planning and Coating; 62–296.502, F.A.C., Coil

Implementation Branch, Air and incorporation by reference of Rules 62– Coating; 62–296.503, F.A.C., Paper
Radiation Division, U.S. Environmental 296.414, F.A.C., Concrete Batching Coating; 62–296.504, F.A.C., Fabric and
Protection Agency, Region 4, 61 Forsyth Plants; 62–296.415, F.A.C., Soil Vinyl Coating; 62–296.505, F.A.C.,
Street SW, Atlanta, Georgia 30303–8960. Metal Furniture Coating; 62–296.506,
1 The April 1, 2022, submittal transmits several
Mr. Ortiz can be reached via phone changes to other Florida SIP-approved rules. These
F.A.C., Surface Coating of Large
number (404) 562–8085 or via electronic changes are not addressed in this action and will
mail at ortizborrero.josue@epa.gov. be considered by EPA in separate rulemakings. 2 See 62 FR 27968 (May 22, 1997).
Appliances; 62–296.507, F.A.C., Magnet • Is not subject to requirements of submit a rule report to each House of
Wire Coating; 62–296.508, F.A.C., Section 12(d) of the National the Congress and to the Comptroller
Petroleum Liquid Storage; 62–296.510, Technology Transfer and Advancement General of the United States. This action
F.A.C., Bulk Gasoline Terminals; 62– Act of 1995 (15 U.S.C. 272 note) because is not a ‘‘major rule’’ as defined by 5
296.511, F.A.C., Solvent Metal Cleaning; application of those requirements would U.S.C. 804(2).
62–296.512, F.A.C., Cutback Asphalt; be inconsistent with the CAA. Under section 307(b)(1) of the Clean
62–296.513, F.A.C., Surface Coating of In addition, the SIP is not approved
Air Act, petitions for judicial review of
Miscellaneous Metal Parts and to apply on any Indian reservation land
this action must be filed in the United
Products; 62–296.514, F.A.C., Surface or in any other area where EPA or an
States Court of Appeals for the
Coating of Flat Wood Paneling; 62– Indian tribe has demonstrated that a
296.515, F.A.C., Graphic Arts Systems; tribe has jurisdiction. In those areas of appropriate circuit by January 5, 2024.
and 62–296.516, F.A.C., Petroleum Indian country, the rule does not have Filing a petition for reconsideration by
Liquid Storage Tanks with External tribal implications and will not impose the Administrator of this final rule does
Floating Roofs, from the Florida SIP. substantial direct costs on Tribal not affect the finality of this action for
EPA is approving these changes because Governments or preempt tribal law as the purposes of judicial review nor does
they will not interfere with the specified by Executive Order 13175 (65 it extend the time within which a
attainment or maintenance of the FR 67249, November 9, 2000). petition for judicial review may be filed,
NAAQS or any other applicable Executive Order 12898 (Federal and shall not postpone the effectiveness
requirement of the CAA. Actions to Address Environmental of such rule or action. This action may
Justice in Minority Populations and not be challenged later in proceedings to
IV. Statutory and Executive Order enforce its requirements. (See section
Low-Income Populations, 59 FR 7629,
Reviews 307(b)(2).)
February 16, 1994) directs Federal
Under the CAA, the Administrator is agencies to identify and address
required to approve a SIP submission List of Subjects in 40 CFR Part 52
‘‘disproportionately high and adverse
that complies with the provisions of the human health or environmental effects’’ Environmental protection, Air
CAA and applicable Federal regulations. of their actions on minority populations pollution control, Incorporation by
See 42 U.S.C. 7410(k); 40 CFR 52.02(a). and low-income populations to the reference, Intergovernmental relations,
Thus, in reviewing SIP submissions, greatest extent practicable and Nitrogen dioxide, Ozone, Particulate
EPA’s role is to approve state choices, permitted by law. EPA defines matter, Reporting and recordkeeping
provided that they meet the criteria of environmental justice (EJ) as ‘‘the fair
the CAA. Accordingly, this action requirements, Sulfur oxides.
treatment and meaningful involvement
merely approves state law as meeting of all people regardless of race, color, Dated: October 24, 2023.
Federal requirements and does not national origin, or income with respect Jeaneanne Gettle,
impose additional requirements beyond to the development, implementation, Acting Regional Administrator, Region 4.
those imposed by state law. For that and enforcement of environmental laws,
reason, this action: regulations, and policies.’’ EPA further For the reasons stated in the
• Is not a significant regulatory action defines the term fair treatment to mean preamble, the EPA amends 40 CFR part
subject to review by the Office of that ‘‘no group of people should bear a 52 as follows:
Management and Budget under
disproportionate burden of
Executive Orders 12866 (58 FR 51735, PART 52—APPROVAL AND
environmental harms and risks,
October 4, 1993) and 14094 (88 FR PROMULGATION OF
including those resulting from the
21879, April 11, 2023); IMPLEMENTATION PLANS
• Does not impose an information negative environmental consequences of
collection burden under the provisions industrial, governmental, and
commercial operations or programs and ■ 1. The authority citation for part 52
of the Paperwork Reduction Act (44 continues to read as follows:
U.S.C. 3501 et seq.); policies.’’
• Is certified as not having a FDEP did not evaluate EJ Authority: 42 U.S.C. 7401 et seq.
significant economic impact on a considerations as part of its SIP
substantial number of small entities submittal; the CAA and applicable Subpart K—Florida
under the Regulatory Flexibility Act (5 implementing regulations neither
U.S.C. 601 et seq.); prohibit nor require such an evaluation. ■ 2. In § 52.520(c), amend the table by
• Does not contain any unfunded EPA did not perform an EJ analysis and revising the entries for ‘‘62–296.414,’’
mandate or significantly or uniquely did not consider EJ in this action. Due ‘‘62–296.415,’’ ‘‘62–62–296.418,’’ ‘‘62–
affect small governments, as described to the nature of the action being taken 296.500,’’ ‘‘62–296.501,’’ ‘‘62–296.502,’’
in the Unfunded Mandates Reform Act here, this action is expected to have a ‘‘62–296.503,’’ ‘‘62–296.504,’’ ‘‘62–
of 1995 (Pub. L. 104–4); neutral to positive impact on the air 296.505,’’ ‘‘62–296.506,’’ ‘‘62–296.507,’’
• Does not have federalism quality of the affected area. ‘‘62–296.508,’’ ‘‘62–296.510,’’ ‘‘62–
implications as specified in Executive Consideration of EJ is not required as 296.511,’’ ‘‘62–296.512,’’ ‘‘62–296.513,’’
Order 13132 (64 FR 43255, August 10, part of this action, and there is no ‘‘62–296.514,’’ ‘‘62–296.515,’’ and ‘‘62–
1999); information in the record inconsistent 296.516.’’
• Is not subject to Executive Order with the stated goal of E.O. 12898 of
13045 (62 FR 19885, April 23, 1997) achieving EJ for people of color, low- The revisions read as follows:
because it approves a state program; income populations, and Indigenous § 52.520 Identification of plan.
• Is not a significant regulatory action peoples.
subject to Executive Order 13211 (66 FR This action is subject to the * * * * *
28355, May 22, 2001); and Congressional Review Act, and EPA will (c) * * *
EPA-APPROVED FLORIDA LAWS AND REGULATIONS

State citation State effective
Title/subject EPA approval date Explanation
(section) date
* * * * * * *
Chapter 62–296 Stationary Sources—Emission Standards
62–296.414 ........... Concrete Batching Plants .................. 11/5/2020 11/6/2023, [Insert citation of publica-
tion].
62–296.415 ........... Soil Thermal Treatment Facilities ...... 11/5/2020 11/6/2023, [Insert citation of publica-
tion].
62–296.418 ........... Bulk Gasoline Plants ......................... 8/14/2019 11/6/2023, [Insert citation of publica-
tion].
* * * * * * *
62–296.500 ........... Reasonably Available Control Tech- 8/14/2019 11/6/2023, [Insert citation of publica-
nology (RACT)—Volatile Organic tion].
Compounds (VOC) and Nitrogen
Oxides (NOX) Emitting Facilities.
62–296.501 ........... Can Coating ....................................... 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.502 ........... Coil Coating ....................................... 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.503 ........... Paper Coating .................................... 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.504 ........... Fabric and Vinyl Coating ................... 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.505 ........... Metal Furniture Coating ..................... 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.506 ........... Surface Coating of Large Appliances 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.507 ........... Magnet Wire Coating ......................... 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.508 ........... Petroleum Liquid Storage .................. 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.510 ........... Bulk Gasoline Terminals .................... 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.511 ........... Solvent Metal Cleaning ...................... 11/5/2020 11/6/2023, [Insert citation of publica-
tion].
62–296.512 ........... Cutback Asphalt ................................. 8/14/2019 11/6/2023, [Insert citation of publica-
tion].
62–296.513 ........... Surface Coating of Miscellaneous 7/10/2014 11/6/2023, [Insert citation of publica-
Metal Parts and Products. tion].
62–296.514 ........... Surface Coating of Flat Wood Pan- 7/10/2014 11/6/2023, [Insert citation of publica-
eling. tion].
62–296.515 ........... Graphic Arts Systems ........................ 7/10/2014 11/6/2023, [Insert citation of publica-
tion].
62–296.516 ........... Petroleum Liquid Storage Tanks with 7/10/2014 11/6/2023, [Insert citation of publica-
External Floating Roofs. tion].
* * * * * * *
* * * * * ENVIRONMENTAL PROTECTION approve revisions to the California state

[FR Doc. 2023–23833 Filed 11–3–23; 8:45 am] AGENCY implementation plan (SIP) concerning
BILLING CODE 6560–50–P vehicle miles traveled (VMT) offset
40 CFR Part 52 demonstrations for the Los Angeles–
[EPA–R09–OAR–2022–0681; FRL–10386– South Coast Air Basin (South Coast),
02–R9] Riverside County (Coachella Valley),
Los Angeles–San Bernadino Counties
Approval of Air Quality Implementation (West Mojave Desert), and San Joaquin
Plans; Vehicle Miles Traveled Valley nonattainment areas (NAAs) for
Emissions Offset Demonstrations for the 2015 ozone national ambient air
the 2015 Ozone Standards; California quality standards (2015 ozone NAAQS).
AGENCY: Environmental Protection The EPA is taking action to approve
Agency (EPA). these revisions because they
ACTION: Final rule.
demonstrate that California has added
or implemented specific enforceable
SUMMARY: The Environmental Protection transportation control strategies and
Agency (EPA) is taking final action to transportation control measures to offset
the growth in emissions from growth in control measures to offset any growth in Additionally, on December 28, 2020,
VMT and vehicle trips. We are taking emissions from growth in vehicle miles CARB submitted to the EPA a staff
final action to approve these revisions traveled or number of vehicle trips in report titled ‘‘West Mojave Desert VMT
under the Clean Air Act (CAA or ‘‘the such area.’’ Herein, we refer to this SIP Offset Demonstration’’ (‘‘December 2020
Act’’), which establishes VMT offset requirement as the ‘‘VMT emissions submittal’’) for the West Mojave Desert
demonstration requirements for ozone offset requirement.’’ In addition, we ozone NAA.6
nonattainment areas classified as refer to the SIP revision intended to In our proposal, we evaluated the
‘‘Severe’’ or ‘‘Extreme.’’ demonstrate compliance with the VMT portions of the July 2020 submittal that
DATES: This action will be effective on emissions offset requirement as the address the South Coast, Coachella
December 6, 2023. ‘‘VMT emissions offset demonstration.’’ Valley, and San Joaquin Valley VMT
In Association of Irritated Residents v. offset demonstrations and the December
ADDRESSES: The EPA has established a
EPA, the Ninth Circuit ruled that 2020 submittal of the West Mojave
docket for this action under Docket ID
additional transportation control Desert VMT offset demonstration
No. EPA–R09–OAR–2022–0681. All
measures are required whenever vehicle against the statutory and regulatory
documents in the docket are listed on
emissions are projected to be higher
the https://www.regulations.gov requirements of CAA section
than they would have been had VMT
website. Although listed in the index, 182(d)(1)(A) and 40 CFR 51.1302, and
not increased, even when aggregate
some information is not publicly detailed our consideration of relevant
vehicle emissions are decreasing.2 In
available, e.g., confidential business Agency guidance and court rulings. The
August 2012, the EPA issued a
information or other information whose full evaluation and discussion of our
memorandum titled ‘‘Implementing
disclosure is restricted by stature. review of the State’s submittals can be
Clean Air Act Section 182(d)(1)(A):
Certain other material, such as found in our proposal. Therein we
Transportation Control Measures and
copyrighted material, is not placed on proposed approval of the submittals as
Transportation Control Strategies to
the internet and will be publicly revisions to the California SIP on the
Offset Growth in Emissions Due to
available in hard copy form. Publicly Growth in Vehicle Miles Travelled’’ basis that they met the VMT emissions
available docket materials are available (‘‘August 2012 Guidance’’).3 The August offset requirements of CAA section
through https://www.regulations.gov, or 2012 Guidance discusses the meaning of 182(d)(1)(A) and 40 CFR 51.1302 for the
please contact the person identified in ‘‘transportation control strategies’’ and 2015 ozone NAAQS.
the FOR FURTHER INFORMATION CONTACT ‘‘transportation control measures’’ and II. Public Comments and EPA
section for additional availability recommends that both be included in Responses
information. If you need assistance in a the calculations made for the purpose of
language other than English or if you are determining the degree to which any The 30-day public comment period
a person with a disability who needs a hypothetical growth in emissions due to for the notice of proposed rulemaking
reasonable accommodation at no cost to growth in VMT should be offset. The closed on January 19, 2023. We did not
you, please contact the person identified proposed rulemaking for this action receive any public comments.
in the FOR FURTHER INFORMATION outlines the August 2012 Guidance in
CONTACT section. III. Final Action
further detail and how states may
FOR FURTHER INFORMATION CONTACT: demonstrate that their VMT emissions For the reasons discussed in our
Michael Dorantes, Geographic Strategies offset demonstrations can satisfactorily proposed rule and summarized in this
and Modeling Section (AIR–2–2), EPA conform with Court’s ruling in document, we are finalizing our
Region IX, (415) 972–3934, Association of Irritated Residents. approval of the following as revisions to
dorantes.michael@epa.gov. The California Air Resources Board the California SIP:
SUPPLEMENTARY INFORMATION: (CARB) provided two separate
submittals as VMT emissions offset D VMT emissions offset
Throughout this document, ‘‘we,’’ ‘‘us,’’ demonstration element in the July 27,
and ‘‘our’’ refer to the EPA. demonstrations for California’s Severe
and Extreme ozone NAAs. On July 27, 2020 CARB submittal for the Los
Table of Contents Angeles–South Coast Air Basin (South
I. Summary of Proposed Action 2020, CARB submitted a staff report to
the EPA titled ‘‘70 ppb Ozone SIP Coast), Riverside County (Coachella
II. Public Comments and EPA Responses
III. Final Action Submittal’’ (‘‘July 2020 submittal’’).4 In Valley), and San Joaquin Valley ozone
IV. Statutory and Executive Order Reviews part, the July 2020 submittal contains nonattainment areas as meeting the
the VMT offset demonstrations for the requirements of CAA section
I. Summary of Proposed Action 182(d)(1)(A) and 40 CFR 51.1302 for the
South Coast, Coachella Valley, and San
On December 20, 2022, the EPA Joaquin Valley ozone NAAs.5 2015 ozone NAAQS.
proposed to approve a revision to the D VMT emissions offset
California SIP concerning VMT 2 See Association of Irritated Residents v. EPA,
demonstration element in the December
emissions offset demonstrations 632 F.3d. 584, at 596–597 (9th Cir. 2011), reprinted 28, 2020 CARB submittal for the Los
as amended on January 27, 2012, 686 F.3d 668,
required for the Coachella Valley and further amended February 13, 2012 (‘‘Association of Angeles–San Bernadino Counties (West
West Mojave Desert Severe ozone NAAs Irritated Residents’’). Mojave Desert) ozone nonattainment
and for the South Coast and San Joaquin 3 Memorandum dated August 30, 2012, Karl area as meeting the requirements of
Valley Extreme ozone NAAs.1 Section Simon, Director Transportation and Climate CAA section 182(d)(1)(A) and 40 CFR
182(d)(1)(A) of the Act and 40 CFR Division, Office of Transportation and Air Quality,
to Carl Edland, Director, Multimedia Planning and
51.1302 for the 2015 ozone NAAQS.
51.1302 require a state to submit, for Permitting Division, EPA Region VI, and Deborah
each ozone nonattainment area Jordan, Director, Air Division, EPA Region IX. 2020 submittal as meeting the base year emissions
classified as Severe or above, a SIP 4 Letter dated July 24, 2020, from Richard W. inventory requirements for the 18 areas addressed
revision that ‘‘identifies or adopts Corey, Executive Officer, CARB, to John Busterud, in the submittal on September 29, 2022, (87 FR
Regional Administrator, EPA Region IX (submitted 59015).
specific enforceable transportation electronically July 27, 2020). 6 Letter dated December 28, 2020, from Richard
control strategies and transportation 5 The July 2020 submittal also addresses base year W. Corey, Executive Officer, CARB, to John
emissions inventory requirements for 18 of the 21 Busterud, Regional Administrator, EPA Region IX
1 87 FR 77774 (December 20, 2022). NAAs in California. The EPA approved the July (submitted electronically December 29, 2020).
IV. Statutory and Executive Order Low-Income Populations, 59 FR 7629, Subpart F—California
Reviews Feb. 16, 1994) directs Federal agencies
to identify and address ■ 2. Section 52.220 is amended by
Under the Clean Air Act, the
‘‘disproportionately high and adverse adding paragraphs (c)(589)(ii)(A)(2) and
Administrator is required to approve a
human health or environmental effects’’ (c)(605) to read as follows:
SIP submission that complies with the
provisions of the Act and applicable of their actions on minority populations
§ 52.220 Identification of plan—in part.
federal regulations. 42 U.S.C. 7410(k); and low-income populations to the
greatest extent practicable and * * * * *
40 CFR 52.02(a). Thus, in reviewing SIP (c) * * *
submissions, the EPA’s role is to permitted by law. The EPA defines
environmental justice (EJ) as ‘‘the fair (589) * * *
approve state choices, provided that (ii) * * *
they meet the criteria of the Clean Air treatment and meaningful involvement
of all people regardless of race, color, (A) * * *
Act. Accordingly, this action merely (2) California Air Resources Board ‘‘70
approves state law as meeting Federal national origin, or income with respect
to the development, implementation, ppb Ozone SIP Submittal,’’ section III,
requirements and does not impose ‘‘VMT Offset Demonstration,’’ adopted
additional requirements beyond those and enforcement of environmental laws,
regulations, and policies.’’ The EPA on June 25, 2020.
imposed by state law. For that reason,
further defines the term fair treatment to * * * * *
this action:
(605) The following materials were
• Is not a ‘‘significant regulatory mean that ‘‘no group of people should
bear a disproportionate burden of submitted electronically on December
action’’ subject to review by the Office
environmental harms and risks, 29, 2020, by the Governor’s designee as
of Management and Budget under
including those resulting from the an attachment to a letter dated
Executive Orders 12866 (58 FR 51735,
negative environmental consequences of December 28, 2020.
October 4, 1993) and 14094 (88 FR
industrial, governmental, and (i) [Reserved]
21879, April 11, 2023);
• Does not impose an information commercial operations or programs and (ii) Additional materials.
collection burden under the provisions policies.’’ (A) California Air Resources Board.
of the Paperwork Reduction Act (44 (1) ‘‘West Mojave Desert Vehicle-
The State did not evaluate Miles Traveled Offset Demonstration,’’
U.S.C. 3501 et seq.); environmental justice considerations as
• Is certified as not having a adopted on October 22, 2020.
part of its SIP submittal; the CAA and (2) [Reserved]
significant economic impact on a applicable implementing regulations
substantial number of small entities (B) [Reserved]
neither prohibit nor require such an
under the Regulatory Flexibility Act (5 [FR Doc. 2023–24001 Filed 11–3–23; 8:45 am]
evaluation. The EPA did not perform an
U.S.C. 601 et seq.); EJ analysis and did not consider EJ in BILLING CODE 6560–50–P
• Does not contain any unfunded this action. This final action is expected
mandate or significantly or uniquely to have a neutral to positive impact on
affect small governments, as described the air quality of the affected area. DEPARTMENT OF COMMERCE
in the Unfunded Mandates Reform Act Consideration of EJ is not required as
of 1995 (Pub. L. 104–4); part of this action, and there is no National Oceanic and Atmospheric
• Does not have federalism information in the record inconsistent
Administration
implications as specified in Executive with the stated goal of Executive Order
Order 13132 (64 FR 43255, August 10, 50 CFR Part 679
12898 of achieving environmental
1999); justice for people of color, low-income [Docket No. 230224–0053; RTID 0648–
• Is not an economically significant populations, and Indigenous peoples. XD509]
regulatory action based on health or
safety risks subject to Executive Order List of Subjects in 40 CFR Part 52 Fisheries of the Exclusive Economic
13045 (62 FR 19885, April 23, 1997); Zone Off Alaska; Reallocation of
• Is not a significant regulatory action Environmental protection, Air
Pacific Cod in the Western Regulatory
subject to Executive Order 13211 (66 FR pollution control, Incorporation by
Area of the Gulf of Alaska
28355, May 22, 2001); and reference, Intergovernmental relations,
• Is not subject to requirements of Ozone, Reporting and recordkeeping AGENCY: National Marine Fisheries
Section 12(d) of the National requirements. Service (NMFS), National Oceanic and
Technology Transfer and Advancement Authority: 42 U.S.C. 7401 et seq. Atmospheric Administration (NOAA),
Act of 1995 (15 U.S.C. 272 note) because Commerce.
Dated: October 25, 2023.
application of those requirements would ACTION: Temporary rule; reallocation.
be inconsistent with the Clean Air Act. Martha Guzman Aceves,
In addition, the SIP is not approved Regional Administrator, Region IX. SUMMARY: NMFS is reallocating the
to apply on any Indian reservation land projected unused amount of Pacific cod
or in any other area where the EPA or For the reasons stated in the from catcher vessels using trawl gear
an Indian tribe has demonstrated that a preamble, the EPA amends part 52, and vessels using pot gear to catcher
tribe has jurisdiction. In those areas of chapter I, title 40 of the Code of Federal vessels using hook-and-line gear and
Indian country, this rulemaking does Regulations as follows: catcher/processors using hook-and-line
gear in the Western Regulatory Area of
not have tribal implications and will not

PART 52—APPROVAL AND the Gulf of Alaska (GOA). This action is
impose substantial direct costs on tribal
PROMULGATION OF necessary to allow the 2023 total
governments or preempt tribal law as
IMPLEMENTATION PLANS allowable catch (TAC) of Pacific cod to
specified by Executive Order 13175 (65
FR 67249, November 9, 2000). be harvested.
Executive Order 12898 (Federal ■ 1. The authority citation for part 52 DATES: Effective November 1, 2023,
Actions to Address Environmental continues to read as follows: through 2400 hours, Alaska local time
Justice in Minority Populations and Authority: 42 U.S.C. 7401, et seq. (A.l.t.), December 31, 2023.
FOR FURTHER INFORMATION CONTACT: of the GOA is 1,009 mt, as established Act. This action is required by 50 CFR
Adam Zaleski, 907–586–7228. by the final 2023 and 2024 harvest part 679, which was issued pursuant to
SUPPLEMENTARY INFORMATION: NMFS specifications for groundfish in the GOA section 304(b), and is exempt from
manages the groundfish fishery in the (88 FR 13238, March 2, 2023). review under Executive Order 12866.
GOA according to the Fishery The Administrator, Alaska Region,
NMFS, (Regional Administrator) has Pursuant to 5 U.S.C. 553(b)(B), there
Management Plan for Groundfish of the is good cause to waive prior notice and
Gulf of Alaska (FMP) prepared by the determined that catcher vessels using
trawl gear will not be able to harvest 430 an opportunity for public comment on
North Pacific Fishery Management this action, as notice and comment
Council under authority of the mt of the 2023 Pacific cod TAC
allocated to those vessels under would be impracticable and contrary to
Magnuson-Stevens Fishery the public interest. This requirement is
Conservation and Management Act § 679.20(a)(12)(i)(A)(3), and vessels
using pot gear will not be able to harvest impracticable and contrary to the public
(Magnuson-Stevens Act). Regulations
220 mt of the 2023 Pacific cod TAC interest as it would prevent NMFS from
governing fishing by U.S. vessels in
allocated to those vessels under responding to the most recent fisheries
accordance with the FMP appear at
subpart H of 50 CFR parts 600 and 679. § 679.20(a)(12)(i)(A)(5). data in a timely fashion and would
Therefore, in accordance with allow for harvests that exceed the
The 2023 Pacific cod TAC specified
§ 679.20(a)(12)(ii)(B), NMFS apportions originally specified apportionment of
for catcher vessels using trawl gear in 430 mt of Pacific cod from catcher
the Western Regulatory Area of the GOA the Pacific cod TAC. NMFS was unable
vessels using trawl gear to the annual to publish a notice providing time for
is 1,956 metric tons (mt), as established amount specified for catcher/processors
by the final 2023 and 2024 harvest public comment because the most
using hook-and-line gear, and 220 mt of recent, relevant data only became
specifications for groundfish in the GOA Pacific cod from vessels using pot gear
(88 FR 13238, March 2, 2023). available as of October 31, 2023.
to the annual amount specified for
The 2023 Pacific cod TAC specified catcher vessels using hook-and-line The Assistant Administrator for
for vessels using pot gear in the Western gear. Fisheries, NOAA also finds good cause
Regulatory Area of the GOA is 1,936 mt, The harvest specifications for 2023 to waive the 30-day delay in the
as established by the final 2023 and Pacific cod included in the final 2023 effective date of this action under 5
2024 harvest specifications for and 2024 harvest specifications for U.S.C. 553(d)(3). This finding is based
groundfish in the GOA (88 FR 13238, groundfish in the Western Regulatory upon the reasons provided above for
March 2, 2023). Area of the GOA (88 FR 13238, March waiver of prior notice and opportunity
The 2023 Pacific cod TAC specified 2, 2023) is revised as follows: 1,526 mt for public comment.
for catcher vessels using hook-and-line to catcher vessels using trawl gear, 1,716
gear in the Western Regulatory Area of Authority: 16 U.S.C. 1801 et seq.
mt to vessels using pot gear, 291 mt to
the GOA is 71 mt, as established by the catcher vessels using hook-and-line Dated: November 1, 2023.
final 2023 and 2024 harvest gear, and 1,439 mt to catcher/processors Jennifer M. Wallace,
specifications for groundfish in the GOA using hook-and-line gear. Acting Director, Office of Sustainable
(88 FR 13238, March 2, 2023).
Classification Fisheries, National Marine Fisheries Service.
The 2023 Pacific cod TAC specified
[FR Doc. 2023–24461 Filed 11–1–23; 4:15 pm]
for catcher/processors using hook-and- NMFS issues this action pursuant to
line gear in the Western Regulatory Area section 305(d) of the Magnuson-Stevens BILLING CODE 3510–22–P
76143
Proposed Rules Federal Register

Vol. 88, No. 213
This section of the FEDERAL REGISTER Notice of Hearing: Published July 24, to amend the NRC’s regulations related
contains notices to the public of the proposed 2023 (88 FR 47396). to the use of conventional and accident
issuance of rules and regulations. The Notice is hereby given that the tolerant light-water reactor fuel designs.
purpose of these notices is to give interested hearing, which was recessed in Carmel, The public comment period was
persons an opportunity to participate in the Indiana, on October 11, 2023, by the originally scheduled to close on
rule making prior to the adoption of the final
rules.
Administrative Law Judge designated to November 22, 2023. The NRC has
hold said hearing and preside thereof, decided to extend the public comment
will reconvene at 1 p.m. ET on Monday, period to allow more time for members
DEPARTMENT OF AGRICULTURE November 27, 2023, at the 502 East of the public to develop and submit
Event Centre, 502 East Carmel Drive, their comments.
Agricultural Marketing Service Carmel, Indiana 46032. If the hearing is DATES: The due date of comments
not completed by 5 p.m. ET on Friday, requested in the document published on
7 CFR Part 1000 December 1, 2023, the hearing will September 8, 2023 (88 FR 61986) is
[Doc. No. 23–J–0067; AMS–DA–23–0031]
reconvene at 8 a.m. ET on Monday, extended. Comments should be filed no
December 4, 2023, at the Palomino later than January 22, 2024. Comments
Milk in the Northeast and Other Ballroom, 481 South County Road 1200 received after this date will be
Marketing Areas; Notice of Hearing on East, Zionsville, Indiana 46077. With considered, if it is practical to do so, but
Proposed Amendments to Marketing the exception of Monday, November 27, the NRC is able to ensure consideration
Agreements and Orders the hearing will be held from 8 a.m. only for comments received on or before
until 5 p.m. each weekday. If not this date.
AGENCY: Agricultural Marketing Service, completed, the hearing will recess at 5 ADDRESSES: You may submit comments
USDA. p.m. ET on Friday, December 8, 2023, by any of the following methods;
ACTION: Notice of reconvened public and reconvene at a later date. however, the NRC encourages electronic
hearing on proposed rulemaking. Dairy farmer virtual testimony will no comment submission through the
SUMMARY: This notice announces the longer be available. Dairy farmers may Federal rulemaking website:
reconvening of the national public continue to testify in person at any time • Federal Rulemaking Website: Go to
hearing, which began on August 23, during the reconvened hearing. Dairy https://www.regulations.gov and search
2023, in Carmel, Indiana, to consider farmers testifying in person are not for Docket ID NRC–2020–0034. Address
and take evidence on proposals to required to pre-submit testimony or questions about NRC dockets to Dawn
amend the pricing formulas in the 11 exhibits. Forder; telephone: 301–415–3407;
Federal Milk Marketing Orders List of Subjects in 7 CFR Part 1000 email: Dawn.Forder@nrc.gov. For
(FMMOs). technical questions contact the
Milk marketing orders. individuals listed in the FOR FURTHER
DATES: The hearing will reconvene at 1
Erin Morris, INFORMATION CONTACT section of this
p.m. ET on Monday, November 27,
2023. Associate Administrator, Agricultural document.
Marketing Service. • Email comments to:
ADDRESSES: The reconvened hearing, for Rulemaking.Comments@nrc.gov. If you
[FR Doc. 2023–24389 Filed 11–3–23; 8:45 am]
the week of November 27, 2023, will be do not receive an automatic email reply
BILLING CODE P
held at the 502 East Event Centre, 502 confirming receipt, then contact us at
East Carmel Drive, Carmel, Indiana 301–415–1677.
46032. Telephone (317) 843–1234. If the • Fax comments to: Secretary, U.S.
hearing is not completed by 5 p.m. ET NUCLEAR REGULATORY Nuclear Regulatory Commission at 301–
Friday, December 1, 2023, the hearing COMMISSION 415–1101.
will reconvene at 8 a.m. ET on Monday, • Mail comments to: Secretary, U.S.
December 4, 2023, at the Palomino 10 CFR Parts 50, 51, and 71 Nuclear Regulatory Commission,
Ballroom, 481 South County Road 1200 [NRC–2020–0034] Washington, DC 20555–0001, ATTN:
East, Zionsville, Indiana 46077. Rulemakings and Adjudications Staff.
Telephone (317) 769–4180. RIN 3150–AK79 • Hand deliver comments to: 11555
FOR FURTHER INFORMATION CONTACT: Erin Rockville Pike, Rockville, Maryland
Increased Enrichment of Conventional 20852, between 7:30 a.m. and 4:15 p.m.
Taylor, Director, Order Formulation and
and Accident Tolerant Fuel Designs for eastern time, Federal workdays;
Enforcement Division, USDA/AMS/
Light-Water Reactors; Extension of telephone: 301–415–1677.
Dairy Programs, Stop 0225—Room 2530,
Comment Period For additional direction on obtaining
1400 Independence Avenue SW,
ddrumheller on DSK120RN23PROD with PROPOSALS1
Washington, DC 20250–0225, (202) 720– AGENCY: Nuclear Regulatory information and submitting comments,
7311, Email: Erin.Taylor@usda.gov. Commission. see ‘‘Obtaining Information and
Persons requiring a sign language ACTION: Regulatory basis; extension of
Submitting Comments’’ in the
interpreter or other special SUPPLEMENTARY INFORMATION section of
comment period.
accommodations should contact this document.
FMMOHearing@usda.gov a minimum of SUMMARY: On September 8, 2023, the FOR FURTHER INFORMATION CONTACT:
five days before the start of the hearing. U.S. Nuclear Regulatory Commission Philip Benavides, Office of Nuclear
SUPPLEMENTARY INFORMATION: Prior (NRC) requested comments on the Materials Safety and Safeguards,
documents in this proceeding: regulatory basis to support a rulemaking telephone: 301–415–3246, email:
VerDate Sep<11>2014 16:42 Nov 03, 2023 Jkt 262001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\06NOP1.SGM 06NOP1
76144 Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Proposed Rules
Philip.Benavides@nrc.gov and Carla If you are requesting or aggregating receive alerts when changes or additions
Roque-Cruz, Office of Nuclear Reactor comments from other persons for occur in a docket folder. To subscribe:
Regulation, telephone: 301–415–1455, submission to the NRC, then you should (1) navigate to the docket folder (NRC–
email: Carla.Roque-Cruz@nrc.gov. Both inform those persons not to include 2020–0034); (2) click the ‘‘Subscribe’’
are staff of the U.S. Nuclear Regulatory identifying or contact information that link; and (3) enter an email address and
Commission, Washington, DC 20555– they do not want to be publicly click on the ‘‘Subscribe’’ link.
0001. disclosed in their comment submission. Dated: October 31, 2023.
Your request should state that the NRC
For the Nuclear Regulatory Commission.
does not routinely edit comment
I. Obtaining Information and Catherine E. Kanatas,
submissions to remove such information
Submitting Comments before making the comment Acting Deputy Director, Division of
submissions available to the public or Rulemaking, Environmental, and Financial
A. Obtaining Information Support, Office of Nuclear Material Safety
entering the comment into ADAMS. and Safeguards.
Please refer to Docket ID NRC–2020–
0034 when contacting the NRC about II. Discussion [FR Doc. 2023–24396 Filed 11–3–23; 8:45 am]
the availability of information for this On September 8, 2023, the NRC BILLING CODE 7590–01–P
action. You may obtain publicly requested comments on a regulatory
available information related to this basis titled ‘‘Increased Enrichment of
action by any of the following methods: Conventional and Accident Tolerant DEPARTMENT OF TRANSPORTATION
• Federal Rulemaking Website: Go to Fuel Designs for Light-Water Reactors’’
https://www.regulations.gov and search to support a rulemaking that would Federal Aviation Administration
for Docket ID NRC–2020–0034. amend the NRC’s regulations to
• NRC’s Agencywide Documents facilitate the use of light-water reactor 14 CFR Part 39
Access and Management System fuel containing uranium enriched to [Docket No. FAA–2023–2146; Project
(ADAMS): You may obtain publicly greater than 5.0 weight percent Identifier MCAI–2023–00646–T]
available documents online in the uranium-235 (U–235) in part 50 of title
ADAMS Public Documents collection at 10 of the Code of Federal Regulations RIN 2120–AA64
https://www.nrc.gov/reading-rm/ (10 CFR), ‘‘Domestic Licensing of
adams.html. To begin the search, select Production and Utilization Facilities,’’ Airworthiness Directives; Airbus
‘‘Begin Web-based ADAMS Search.’’ For 10 CFR part 51, ‘‘Environmental Canada Limited Partnership (Type
problems with ADAMS, please contact Protection Regulations for Domestic Certificate Previously Held by C Series
the NRC’s Public Document Room (PDR) Licensing and Related Regulatory Aircraft Limited Partnership (CSALP);
reference staff at 1–800–397–4209, 301– Functions,’’ and 10 CFR part 71, Bombardier, Inc.) Airplanes
415–4737, or by email to ‘‘Packaging and Transportation of AGENCY: Federal Aviation
PDR.Resource@nrc.gov. The regulatory Radioactive Material.’’ This rulemaking Administration (FAA), DOT.
basis, ‘‘Increased Enrichment of would allow the NRC to prepare for the
ACTION: Notice of proposed rulemaking
Conventional and Accident Tolerant effective and efficient licensing of
Fuel Designs for Light-Water Reactors, is applications using fuels enriched to (NPRM).
available in ADAMS under Accession greater than 5.0 and less than 20.0 SUMMARY: The FAA proposes to adopt a
No. ML23032A504. weight percent U–235 without new airworthiness directive (AD) for
• NRC’s PDR: The PDR, where you compromising reasonable assurance of certain Airbus Canada Limited
may examine and order copies of adequate protection of public health and Partnership Model BD–500–1A10 and
publicly available documents, is open safety, reduce the need for exemptions BD–500–1A11 airplanes. This proposed
by appointment. To make an from existing regulations and license AD was prompted by a report of
appointment to visit the PDR, please amendment requests, provide licensees possible chafing of a power harness at
send an email to PDR.Resource@nrc.gov operational flexibility and certainty in fuselage frame (FR) 65. This proposed
or call 1–800–397–4209 or 301–415– licensing of accident tolerant fuel, and AD would require rerouting the power
4737, between 8 a.m. and 4 p.m. eastern support the principles of good harness, as specified in a Transport
time, Monday through Friday, except regulation. The rule changes would Canada AD, which is proposed for
Federal holidays. apply to any light-water power reactor incorporation by reference. The FAA is
application submitted to the NRC under proposing this AD to address the unsafe
B. Submitting Comments 10 CFR part 50 and part 52, ‘‘Licenses, condition on these products.
The NRC encourages electronic Certifications, and Approvals for
comment submission through the Nuclear Power Plants.’’ DATES: The FAA must receive comments
Federal Rulemaking Website (https:// The public comment period was on this proposed AD by December 21,
www.regulations.gov). Please include originally scheduled to close on 2023.
Docket ID NRC–2020–0034 in your November 22, 2023. The NRC has ADDRESSES: You may send comments,
comment submission. decided to extend the public comment using the procedures found in 14 CFR
The NRC cautions you not to include period on this document until January 11.43 and 11.45, by any of the following
identifying or contact information that 22, 2024, to allow more time for methods:
you do not want to be publicly members of the public to submit their • Federal eRulemaking Portal: Go to
disclosed in your comment submission. comments. regulations.gov. Follow the instructions
The NRC will post all comment The NRC may post materials related for submitting comments.
submissions at https:// to this document, including public • Fax: 202–493–2251.
www.regulations.gov as well as enter the comments, on the Federal rulemaking • Mail: U.S. Department of
comment submissions into ADAMS. website at https://www.regulations.gov Transportation, Docket Operations, M–
The NRC does not routinely edit under Docket ID NRC–2020–0034. In 30, West Building Ground Floor, Room
comment submissions to remove addition, the Federal rulemaking W12–140, 1200 New Jersey Avenue SE,
identifying or contact information. website allows members of the public to Washington, DC 20590.
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Proposed Rules 76145
• Hand Delivery: Deliver to Mail substantive verbal contact received clamp on the left side stringer 11
address above between 9 a.m. and 5 about this NPRM. between fuselage FR 65 and FR 67 to
p.m., Monday through Friday, except prevent damage to the harness.
Confidential Business Information
Federal holidays. This material is reasonably available
AD Docket: You may examine the AD CBI is commercial or financial because the interested parties have
docket at regulations.gov under Docket information that is both customarily and access to it through their normal course
No. FAA–2023–2146; or in person at actually treated as private by its owner. of business or by the means identified
Docket Operations between 9 a.m. and Under the Freedom of Information Act in ADDRESSES section.
5 p.m., Monday through Friday, except (FOIA) (5 U.S.C. 552), CBI is exempt
Federal holidays. The AD docket from public disclosure. If your FAA’s Determination
contains this NPRM, the mandatory comments responsive to this NPRM This product has been approved by
continuing airworthiness information contain commercial or financial the aviation authority of another
(MCAI), any comments received, and information that is customarily treated country and is approved for operation in
other information. The street address for as private, that you actually treat as the United States. Pursuant to the FAA’s
Docket Operations is listed above. private, and that is relevant or bilateral agreement with this State of
Material Incorporated by Reference: responsive to this NPRM, it is important
• For material that is identified in Design Authority, it has notified the
that you clearly designate the submitted FAA of the unsafe condition described
this NPRM, contact Transport Canada, comments as CBI. Please mark each
Transport Canada National Aircraft in the MCAI referenced above. The FAA
page of your submission containing CBI is issuing this NPRM after determining
Certification, 159 Cleopatra Drive, as ‘‘PROPIN.’’ The FAA will treat such
Nepean, Ontario K1A 0N5, Canada; that the unsafe condition described
marked submissions as confidential previously is likely to exist or develop
telephone 888–663–3639; email under the FOIA, and they will not be
TC.AirworthinessDirectives- in other products of the same type
placed in the public docket of this design.
Consignesdenavigabilite.TC@tc.gc.ca; NPRM. Submissions containing CBI
website tc.canada.ca/en/aviation. It is should be sent to William Reisenauer, Proposed AD Requirements in This
also available at regulations.gov under Aviation Safety Engineer, FAA, 1600 NPRM
Docket No. FAA–2023–2146. Stewart Avenue, Suite 410, Westbury,
• You may view this service NY 11590; telephone: 516–228–7301;
This proposed AD would require
information at the FAA, Airworthiness accomplishing the actions specified in
email: 9-avs-nyaco-cos@faa.gov. Any
Products Section, Operational Safety Transport Canada AD CF–2023–27
commentary that the FAA receives
Branch, 2200 South 216th Street, Des described previously, except for any
which is not specifically designated as
Moines, WA. For information on the differences identified as exceptions in
CBI will be placed in the public docket
availability of this material at the FAA, the regulatory text of this proposed AD.
for this rulemaking.
call 206–231–3195. Explanation of Required Compliance
FOR FURTHER INFORMATION CONTACT: Background
Information
William Reisenauer, Aviation Safety Transport Canada, which is the
Engineer, FAA, 1600 Stewart Avenue, aviation authority for Canada, has In the FAA’s ongoing efforts to
Suite 410, Westbury, NY 11590; issued Transport Canada AD CF–2023– improve the efficiency of the AD
telephone: 516–228–7301; email: 9-avs- 27, dated May 4, 2023 (Transport process, the FAA developed a process to
nyaco-cos@faa.gov. Canada AD CF–2023–27) (also referred use some civil aviation authority (CAA)
SUPPLEMENTARY INFORMATION: to as the MCAI), to correct an unsafe ADs as the primary source of
condition for certain Airbus Canada information for compliance with
Comments Invited requirements for corresponding FAA
Limited Partnership Model BD–500–
The FAA invites you to send any 1A10 and BD–500–1A11 airplanes. The ADs. The FAA has been coordinating
written relevant data, views, or MCAI states that during production, a this process with manufacturers and
arguments about this proposal. Send possibility of chafing between a power CAAs. As a result, the FAA proposes to
your comments to an address listed harness and the left side window shade incorporate Transport Canada AD CF–
under ADDRESSES. Include ‘‘Docket No. at fuselage FR 65 was detected. Damage 2023–27 by reference in the FAA final
FAA–2023–2146; Project Identifier to the power harness can result in an rule. This proposed AD would,
MCAI–2023–00646–T’’ at the beginning emergency equipment failure, including therefore, require compliance with
of your comments. The most helpful the partial loss of the public address Transport Canada AD CF–2023–27 in its
comments reference a specific portion of system and the inability to deploy half entirety through that incorporation,
the proposal, explain the reason for any the passenger oxygen masks when except for any differences identified as
recommended change, and include required. exceptions in the regulatory text of this
supporting data. The FAA will consider The FAA is proposing this AD to proposed AD. Service information
all comments received by the closing address the unsafe condition on these required by Transport Canada AD CF–
date and may amend this proposal products. You may examine the MCAI 2023–27 for compliance will be
because of those comments. in the AD docket at regulations.gov available at regulations.gov under
Except for Confidential Business under Docket No. FAA–2023–2146. Docket No. FAA–2023–2146 after the
Information (CBI) as described in the FAA final rule is published.
following paragraph, and other Related Service Information Under 1

CFR Part 51 Costs of Compliance
information as described in 14 CFR
11.35, the FAA will post all comments Transport Canada AD CF–2023–27 The FAA estimates that this AD, if
received, without change, to specifies procedures for rerouting the adopted as proposed, would affect 29
regulations.gov, including any personal power harness, which requires the airplanes of U.S. registry. The FAA
information you provide. The agency modification of an insulation blanket estimates the following costs to comply
will also post a report summarizing each and the installation of a standoff and a with this proposed AD:
ESTIMATED COSTS FOR REQUIRED ACTIONS

Cost on U.S.
Labor cost Parts cost Cost per product operators
4 work-hours × $85 per hour = $340 ........................................................................ $10 $350 $10,150
Authority for This Rulemaking PART 39—AIRWORTHINESS (h) Exceptions to Transport Canada AD CF–
DIRECTIVES 2023–27
Title 49 of the United States Code (1) Where Transport Canada AD CF–2023–
specifies the FAA’s authority to issue 27 refers to its effective date, this AD requires
rules on aviation safety. Subtitle I, ■ 1. The authority citation for part 39
continues to read as follows: using the effective date of this AD.
section 106, describes the authority of (2) Where Transport Canada AD CF–2023–
the FAA Administrator. Subtitle VII: Authority: 49 U.S.C. 106(g), 40113, 44701. 27 refers to hours air time, this AD requires
Aviation Programs, describes in more using flight hours.
§ 39.13 [Amended]
detail the scope of the Agency’s (i) Additional AD Provisions
authority. ■ 2. The FAA amends § 39.13 by adding
The following provisions also apply to this
The FAA is issuing this rulemaking the following new airworthiness AD:
under the authority described in directive: (1) Alternative Methods of Compliance
Subtitle VII, Part A, Subpart III, Section Airbus Canada Limited Partnership (Type (AMOCs): The Manager, International
44701: General requirements. Under Certificate Previously Held by C Series Validation Branch, FAA, has the authority to
that section, Congress charges the FAA Aircraft Limited Partnership (CSALP); approve AMOCs for this AD, if requested
with promoting safe flight of civil Bombardier, Inc.): Docket No. FAA– using the procedures found in 14 CFR 39.19.
2023–2146; Project Identifier MCAI– In accordance with 14 CFR 39.19, send your
aircraft in air commerce by prescribing
2023–00646–T. request to your principal inspector or
regulations for practices, methods, and responsible Flight Standards Office, as
procedures the Administrator finds (a) Comments Due Date appropriate. If sending information directly
necessary for safety in air commerce. The FAA must receive comments on this to the International Validation Branch, send
This regulation is within the scope of airworthiness directive (AD) by December 21, it to the attention of the person identified in
that authority because it addresses an 2023. paragraph (j) of this AD. Information may be
unsafe condition that is likely to exist or emailed to: 9-AVS-AIR-730-AMOC@faa.gov.
develop on products identified in this (b) Affected ADs Before using any approved AMOC, notify
rulemaking action. None. your appropriate principal inspector, or
lacking a principal inspector, the manager of
Regulatory Findings (c) Applicability the responsible Flight Standards Office.
This AD applies to Airbus Canada Limited (2) Contacting the Manufacturer: For any
The FAA determined that this Partnership (Type Certificate previously held requirement in this AD to obtain instructions
proposed AD would not have federalism by C Series Aircraft Limited Partnership from a manufacturer, the instructions must
implications under Executive Order (CSALP); Bombardier, Inc.) Model BD–500– be accomplished using a method approved
13132. This proposed AD would not 1A10 and BD–500–1A11 airplanes, by the Manager, International Validation
have a substantial direct effect on the certificated in any category, as identified in Branch, FAA; or Transport Canada; or Airbus
States, on the relationship between the Canada Limited Partnership’s Transport
Transport Canada AD CF–2023–27, dated
Canada Design Approval Organization
national Government and the States, or May 4, 2023 (Transport Canada AD CF–
(DAO). If approved by the DAO, the approval
on the distribution of power and 2023–27).
must include the DAO-authorized signature.
responsibilities among the various (d) Subject
levels of government. (j) Additional Information
Air Transport Association (ATA) of For more information about this AD,
For the reasons discussed above, I America Code 24, Electrical power. contact William Reisenauer, Aviation Safety
certify this proposed regulation:
(e) Unsafe Condition Engineer, FAA, 1600 Stewart Avenue, Suite
(1) Is not a ‘‘significant regulatory 410, Westbury, NY 11590; telephone: 516–
action’’ under Executive Order 12866, This AD was prompted by a report of 228–7301; email: 9-avs-nyaco-cos@faa.gov.
possible chafing of a power harness at
(2) Would not affect intrastate fuselage frame (FR) 65. The FAA is issuing (k) Material Incorporated by Reference
aviation in Alaska, and this AD to address chafing of the power (1) The Director of the Federal Register
(3) Would not have a significant harness. The potential unsafe condition, if approved the incorporation by reference
economic impact, positive or negative, not addressed, could result in an emergency (IBR) of the service information listed in this
on a substantial number of small entities equipment failure, including the partial loss paragraph under 5 U.S.C. 552(a) and 1 CFR
under the criteria of the Regulatory of the public address system and the inability part 51.
to deploy half the passenger oxygen masks (2) You must use this service information
Flexibility Act.
when required. as applicable to do the actions required by
List of Subjects in 14 CFR Part 39 this AD, unless this AD specifies otherwise.
(f) Compliance (i) Transport Canada AD CF–2023–27,
Air transportation, Aircraft, Aviation Comply with this AD within the dated May 4, 2023.
safety, Incorporation by reference, compliance times specified, unless already (ii) [Reserved]
Safety. done. (3) For Transport Canada AD CF–2023–27,
contact Transport Canada, Transport Canada
The Proposed Amendment (g) Requirements National Aircraft Certification, 159 Cleopatra
Except as specified in paragraph (h) of this Drive, Nepean, Ontario K1A 0N5, Canada;
Accordingly, under the authority AD: Comply with all required actions and telephone 888–663–3639; email
delegated to me by the Administrator, compliance times specified in, and in TC.AirworthinessDirectives-
the FAA proposes to amend 14 CFR part accordance with, Transport Canada AD CF– Consignesdenavigabilite.TC@tc.gc.ca;
39 as follows: 2023–27. website tc.canada.ca/en/aviation.
(4) You may view this service information DATES: The FAA must receive comments supporting data. The FAA will consider
at the FAA, Airworthiness Products Section, on this proposed AD by December 21, all comments received by the closing
Operational Safety Branch, 2200 South 216th 2023. date and may amend this proposal
Street, Des Moines, WA. For information on because of those comments.
the availability of this material at the FAA, ADDRESSES: You may send comments,
using the procedures found in 14 CFR Except for Confidential Business
call 206–231–3195.
(5) You may view this material at the 11.43 and 11.45, by any of the following Information (CBI) as described in the
National Archives and Records methods: following paragraph, and other
Administration (NARA). For information on • Federal eRulemaking Portal: Go to information as described in 14 CFR
the availability of this material at NARA, regulations.gov. Follow the instructions 11.35, the FAA will post all comments
visit www.archives.gov/federal-register/cfr/ for submitting comments. received, without change, to
ibr-locations or email fr.inspection@nara.gov. • Fax: 202–493–2251. regulations.gov, including any personal
Issued on October 30, 2023. • Mail: U.S. Department of information you provide. The agency
Victor Wicklund, Transportation, Docket Operations, M– will also post a report summarizing each
30, West Building Ground Floor, Room substantive verbal contact received
Deputy Director, Compliance & Airworthiness
Division, Aircraft Certification Service. W12–140, 1200 New Jersey Avenue SE, about this NPRM.
[FR Doc. 2023–24305 Filed 11–3–23; 8:45 am] Washington, DC 20590. Confidential Business Information
• Hand Delivery: Deliver to Mail
BILLING CODE 4910–13–P CBI is commercial or financial
address above between 9 a.m. and 5
information that is both customarily and
p.m., Monday through Friday, except
actually treated as private by its owner.
DEPARTMENT OF TRANSPORTATION Federal holidays.
Under the Freedom of Information Act
AD Docket: You may examine the AD
(FOIA) (5 U.S.C. 552), CBI is exempt
Federal Aviation Administration docket at regulations.gov under Docket
from public disclosure. If your
No. FAA–2023–2144; or in person at
comments responsive to this NPRM
14 CFR Part 39 Docket Operations between 9 a.m. and
contain commercial or financial
5 p.m., Monday through Friday, except
information that is customarily treated
[Docket No. FAA–2023–2144; Project Federal holidays. The AD docket
as private, that you actually treat as
Identifier MCAI–2023–00898–T] contains this NPRM, the mandatory
private, and that is relevant or
continuing airworthiness information
responsive to this NPRM, it is important
RIN 2120–AA64 that you clearly designate the submitted
other information. The street address for
comments as CBI. Please mark each
Airworthiness Directives; Airbus SAS Docket Operations is listed above.
page of your submission containing CBI
Airplanes Material Incorporated by Reference:
as ‘‘PROPIN.’’ The FAA will treat such
• For the EASA AD identified in this
marked submissions as confidential
AGENCY:Federal Aviation NPRM, contact EASA, Konrad-
under the FOIA, and they will not be
Administration (FAA), DOT. Adenauer-Ufer 3, 50668 Cologne,
placed in the public docket of this
Notice of proposed rulemaking
ACTION: Germany; telephone +49 221 8999 000;
NPRM. Submissions containing CBI
(NPRM). email ADs@easa.europa.eu; website
should be sent to Timothy Dowling,
easa.europa.eu. You may find this
Aviation Safety Engineer, FAA, 1600
SUMMARY: The FAA proposes to material on the EASA website at
Stewart Avenue, Suite 410, Westbury,
supersede Airworthiness Directive (AD) ad.easa.europa.eu. It is also available at
NY 11590; telephone 817–222–5102;
2018–14–09, which applies to certain regulations.gov under Docket No. FAA–
email timothy.p.dowling@faa.gov. Any
Airbus SAS Model A318 series 2023–2144.
commentary that the FAA receives
airplanes; Model A319 series airplanes; • You may view this material at the
which is not specifically designated as
Model A320–211, –212, –214, –216, FAA, Airworthiness Products Section,
CBI will be placed in the public docket
–231, –232, and –233 airplanes; and Operational Safety Branch, 2200 South
for this rulemaking.
Model A321–111, –112, –131, –211, 216th St., Des Moines, WA. For
–212, –213, –231, and –232 airplanes. information on the availability of this Background
AD 2018–14–09 requires repetitive material at the FAA, call 206–231–3195. The FAA issued AD 2018–14–09,
inspections for cracking of the fastener FOR FURTHER INFORMATION CONTACT: Amendment 39–19329 (83 FR 34034,
holes in certain fuselage frames, and Timothy Dowling, Aviation Safety July 19, 2018) (AD 2018–14–09), for
depending on airplane configuration, Engineer, FAA, 1600 Stewart Avenue, certain Airbus SAS Model A318 series
provides an optional terminating action Suite 410, Westbury, NY 11590; airplanes; Model A319 series airplanes;
to the repetitive inspections. Since the telephone 817–222–5102; email Model A320–211, –212, –214, –216,
FAA issued AD 2018–14–09, it was timothy.p.dowling@faa.gov. –231, –232, and –233 airplanes; and
determined that additional actions are SUPPLEMENTARY INFORMATION: Model A321–111, –112, –131, –211,
necessary beyond those required by AD –212, –213, –231, and –232 airplanes.
2018–14–09. This proposed AD would Comments Invited
AD 2018–14–09 was prompted by an
continue to require the actions in AD The FAA invites you to send any MCAI originated by EASA, which is the
2018–14–09 and would require written relevant data, views, or Technical Agent for the Member States
modified compliance times, as well as arguments about this proposal. Send of the European Union. EASA issued
further inspections and optional your comments to an address listed AD 2016–0139, dated July 14, 2016, to
terminating actions for certain airplanes, under ADDRESSES. Include ‘‘Docket No. correct an unsafe condition.
as specified in a European Union FAA–2023–2144; Project Identifier AD 2018–14–09 requires repetitive
Aviation Safety Agency (EASA) AD, MCAI–2023–00898–T’’ at the beginning inspections for cracking of the fastener
which is proposed for incorporation by of your comments. The most helpful holes in certain fuselage frames, and
reference (IBR). The FAA is proposing comments reference a specific portion of depending on airplane configuration,
this AD to address the unsafe condition the proposal, explain the reason for any provides an optional terminating action
on these products. recommended change, and include to the repetitive inspections. The FAA
issued AD 2018–14–09 to address docket at regulations.gov under Docket information for compliance with
cracking at two upper rows of fasteners No. FAA–2023–2144. requirements for corresponding FAA
of the crossbeam splicing at frame ADs. The FAA has been coordinating
Explanation of Retained Requirements
(FR)16 and FR20, on both the left-hand this process with manufacturers and
(LH) and right-hand (RH) sides, which Although this proposed AD does not CAAs. As a result, the FAA proposes to
can result in reduced structural integrity explicitly restate the requirements of AD incorporate EASA AD 2023–0150 by
of the airplane due to the failure of 2018–14–09, this proposed AD would reference in the FAA final rule. This
structural components. retain all of the requirements of AD proposed AD would, therefore, require
2018–14–09. Those requirements are compliance with EASA AD 2023–0150
Actions Since AD 2018–14–09 Was referenced in EASA AD 2023–0150, in its entirety through that
Issued which, in turn, is referenced in incorporation, except for any differences
Since the FAA issued AD 2018–14– paragraph (g) of this proposed AD. identified as exceptions in the
09, EASA superseded AD 2016–0139, regulatory text of this proposed AD.
dated July 14, 2016, and issued EASA Related Service Information Under 1
Using common terms that are the same
AD 2023–0150, dated July 20, 2023 CFR Part 51
as the heading of a particular section in
(EASA AD 2023–0150) (also referred to EASA AD 2023–0150 specifies EASA AD 2023–0150 does not mean
as the MCAI), to correct an unsafe procedures for repetitive rototest that operators need comply only with
condition for Airbus SAS A318–111, inspections for cracking of the holes in that section. For example, where the AD
A318–112, A318–121, A318–122, A319– certain fuselage frames and crossbeams requirement refers to ‘‘all required
111, A319–112, A319–113, A319–114, and applicable corrective actions actions and compliance times,’’
A319–115, A319–131, A319–132, A319– (including repairing cracking and compliance with this AD requirement is
133, A320–211, A320–212, A320–214, replacing fasteners); and, for certain not limited to the section titled
A320–215, A320–216, A320–231, A320– airplanes, procedures for modifying the ‘‘Required Action(s) and Compliance
232, A320–233, A321–111, A321–112, airplane, including cold working Time(s)’’ in EASA AD 2023–0150.
A321–131, A321–211, A321–212, A321– instructions in certain fuselage frames Service information required by EASA
213, A321–231 and A321–232 airplanes, and crossbeams, which would terminate AD 2023–0150 for compliance will be
all manufacturer serial numbers, except the inspections (optional terminating available at regulations.gov under
airplanes on which Airbus modification action). This material is reasonably Docket No. FAA–2023–2144 after the
(mod) 161255 was embodied in available because the interested parties FAA final rule is published.
production, Model A318 airplanes on have access to it through their normal
which Airbus mod 39195 was embodied Differences Between This Proposed AD
course of business or by the means
in production, or Airbus Service and the MCAI
identified in the ADDRESSES section.
Bulletin A320–00–1219 was embodied Although the applicability of EASA
in service; and Model A319 airplanes on FAA’s Determination AD 2023–0150 references Airbus
which Airbus mod 28238, mod 28162, This product has been approved by Service Bulletin A320–00–1219, the
and mod 28342 were embodied in the aviation authority of another FAA contacted Airbus and learned that
production. Model A320–215 airplanes country and is approved for operation in the referenced service information has
are not certificated by the FAA and are the United States. Pursuant to the FAA’s not been published. Therefore, this
not included on the U.S. type certificate bilateral agreement with this State of proposed AD does not include that
data sheet; this proposed AD therefore Design Authority, it has notified the service information in the applicability.
does not include those airplanes in the FAA of the unsafe condition described Where the service information
applicability. The MCAI states that in the MCAI referenced above. The FAA referenced in paragraphs (8) and (9) of
repetitive inspections were instituted is issuing this NPRM after determining EASA AD 2023–0150, i.e., ‘‘Airbus SB
due to reports of cracks on the four that the unsafe condition described A320–53–1295,’’ refers to actions when
holes of the crossbeam splicing at FR16 previously is likely to exist or develop an existing hole diameter is ‘‘more than
and FR20 on both LH and RH sides. in other products of the same type or equal to the minimum starting hole
Following further assessments, the need design. diameter,’’ paragraph (h)(6) of this
was determined for additional proposed AD specifies to replace those
inspections, reduced compliance times, Proposed AD Requirements in This words with ‘‘more than or equal to the
and an additional terminating action NPRM maximum starting hole diameter.’’ In
option. This proposed AD would retain all Airbus Operators Information Telex
For the reasons described above, this requirements of AD 2018–14–09. This (OIT) 15–0097, Revision 01, dated
proposed AD retains the requirements of proposed AD would require January 7, 2016, Airbus confirmed that
AD 2018–14–09 (which corresponds to accomplishing the actions specified in the corrective action in Airbus Service
EASA AD 2016–0139), introduces new EASA AD 2023–0150 described Bulletin A320–53–1295 that refers to
compliance times for airplanes that previously, except for any differences ‘‘more than or equal to the minimum
embody Airbus mod 20416 or mod identified as exceptions in the starting hole diameter’’ should be ‘‘more
21999, expands the inspection area for regulatory text of this proposed AD and than or equal to the maximum starting
airplanes that embody neither Airbus except as discussed under ‘‘Differences hole diameter.’’ As explained in the
mod 20416 nor mod 21999, and adds a Between this Proposed AD and the ‘‘Request to Include Corrections to
terminating action option. MCAI.’’ Service Information’’ paragraph in AD

The FAA is proposing this AD to 2018–14–09, Airbus released OIT 15–
address cracking at two upper rows of Explanation of Required Compliance 0097, Revision 01, dated January 7,
fasteners of the crossbeam splicing at Information 2016, to correct discrepancies in Airbus
FR16 and FR20, on both the LH and RH In the FAA’s ongoing efforts to Service Bulletin A320–53–1295, which
sides, which can result in reduced improve the efficiency of the AD is referred to paragraphs (k) and (m) of
structural integrity of the airplane due process, the FAA developed a process to AD 2018–14–09. The FAA added
to the failure of structural components. use some civil aviation authority (CAA) paragraph (r) to AD 2018–14–09 to
You may examine the MCAI in the AD ADs as the primary source of address the diameter hole discrepancy.
Paragraphs (k) and (m) of AD 2018–14– because the existing flight-hour interval flight hours, whichever occurs first).
09 correspond to paragraphs (8) and (9) specified in Table 1 of AD 2018–14–09 The FAA has included this exception in
of EASA AD 2023–0150. Paragraph (r) of is 54,900 flight hours. Once the initial paragraph (h)(3) of the proposed AD.
AD 2018–14–09 corresponds to inspection is done within the
Costs of Compliance
paragraph (h)(6) of this proposed AD. ‘‘Threshold’’ compliance times in Table
Where rows B and C of the 1 of EASA AD 2023–0150, the new The FAA estimates that this AD, if
‘‘Threshold’’ column in Table 1 of repetitive flight-hour interval will be adopted as proposed, would affect 1,680
EASA AD 2023–0150 refer to ‘‘54 800 54,800 flight hours (flight-hour airplanes of U.S. registry. The FAA
FH,’’ for this proposed AD, those words component only; the complete new estimates the following costs to comply
should be replaced with ‘‘54 900 FH’’ interval is 27,400 flight cycles or 54,800 with this proposed AD:
ESTIMATED COSTS FOR REQUIRED ACTIONS

Cost on U.S.
Action Labor cost Parts cost Cost per product operators
Retained actions from AD 2018–14–09 31 work-hours × $85 per hour = $2,635 $0 $2,635 $4,426,800
ESTIMATED COSTS FOR OPTIONAL ACTIONS

Labor cost Parts cost Cost per product
28 work-hours × $85 per hour = $2,380 ..................................................................................................... $3,020 $5,400
The FAA estimates the following the results of any required or optional determining the number of aircraft that
costs to do any necessary on-condition actions. The FAA has no way of might need this on-condition action:
actions that would be required based on
ESTIMATED COSTS OF ON-CONDITION REPLACEMENTS

Labor cost Parts cost Cost per product
14 work-hours × $85 per hour = $1,190 ..................................................................................................... $50 $1,240
The FAA has received no definitive implications under Executive Order PART 39—AIRWORTHINESS
data that would enable us to provide 13132. This proposed AD would not DIRECTIVES
cost estimates for the on-condition have a substantial direct effect on the
repairs specified in this proposed AD. States, on the relationship between the ■ 1. The authority citation for part 39
national Government and the States, or continues to read as follows:
Authority for This Rulemaking
on the distribution of power and Authority: 49 U.S.C. 106(g), 40113, 44701.
Title 49 of the United States Code responsibilities among the various
specifies the FAA’s authority to issue § 39.13 [Amended]
levels of government.
rules on aviation safety. Subtitle I, ■ 2. The FAA amends § 39.13 by:
section 106, describes the authority of For the reasons discussed above, I ■ a. Removing Airworthiness Directive
the FAA Administrator. Subtitle VII: certify this proposed regulation: (AD) 2018–14–09, Amendment 39–
Aviation Programs, describes in more (1) Is not a ‘‘significant regulatory 19329 (83 FR 34034, July 19, 2018); and
detail the scope of the Agency’s action’’ under Executive Order 12866, ■ b. Adding the following new AD:
authority. (2) Would not affect intrastate Airbus SAS: Docket No. FAA–2023–2144;
The FAA is issuing this rulemaking Project Identifier MCAI–2023–00898–T.
aviation in Alaska, and
under the authority described in
(3) Would not have a significant (a) Comments Due Date
Subtitle VII, Part A, Subpart III, Section
44701: General requirements. Under economic impact, positive or negative, The FAA must receive comments on this
that section, Congress charges the FAA on a substantial number of small entities airworthiness directive (AD) by December 21,
under the criteria of the Regulatory 2023.
with promoting safe flight of civil
aircraft in air commerce by prescribing Flexibility Act. (b) Affected ADs
regulations for practices, methods, and This AD replaces AD 2018–14–09,
procedures the Administrator finds List of Subjects in 14 CFR Part 39
Amendment 39–19329 (83 FR 34034, July 19,
necessary for safety in air commerce. Air transportation, Aircraft, Aviation 2018) (AD 2018–14–09).
This regulation is within the scope of safety, Incorporation by reference, (c) Applicability
that authority because it addresses an Safety. This AD applies to Airbus SAS Model
unsafe condition that is likely to exist or
A318–111, –112, –121, and –122 airplanes;
develop on products identified in this The Proposed Amendment Model A319–111, –112, –113, –114, –115,
rulemaking action. –131, –132, and –133 airplanes; Model
Accordingly, under the authority
Regulatory Findings A320–211, –212, –214, –216, –231, –232, and
delegated to me by the Administrator, –233 airplanes; and Model A321–111, –112,
The FAA determined that this the FAA proposes to amend 14 CFR part –131, –211, –212, –213, –231, and –232
proposed AD would not have federalism 39 as follows: airplanes; certificated in any category, all
manufacturer serial numbers, except the (6) Where the service information paragraph under 5 U.S.C. 552(a) and 1 CFR
airplanes specified in paragraphs (c)(1) referenced in paragraphs (8) and (9) of EASA part 51.
through (3) of this AD. AD 2023–0150 refers to actions when an (2) You must use this service information
(1) Airplanes on which Airbus existing hole diameter is ‘‘more than or equal as applicable to do the actions required by
modification 161255 has been embodied in to the minimum starting hole diameter,’’ for this AD, unless this AD specifies otherwise.
production. this AD, replace those words with ‘‘more (i) European Union Aviation Safety Agency
(2) Model A319 series airplanes on which than or equal to the maximum starting hole (EASA) AD 2023–0150, dated July 20, 2023.
Airbus modifications 28238, 28162, and diameter.’’ (ii) [Reserved]
28342 have been concurrently embodied in (7) This AD does not adopt the ‘‘Remarks’’ (3) For EASA AD 2023–0150, contact
production. section of EASA AD 2023–0150. EASA, Konrad-Adenauer-Ufer 3, 50668
(3) Model A318 series airplanes on which Cologne, Germany; telephone +49 221 8999
(i) No Reporting Requirement
Airbus modification 39195 has been 000; email ADs@easa.europa.eu; website
embodied in production. Although the service information easa.europa.eu. You may find this EASA AD
referenced in EASA AD 2023–0150 specifies on the EASA website at ad.easa.europa.eu.
(d) Subject to submit certain information to the (4) You may view this service information
Air Transport Association (ATA) of manufacturer, this AD does not include that at the FAA, Airworthiness Products Section,
America Code 53, Fuselage. requirement. Operational Safety Branch, 2200 South 216th
(j) Additional AD Provisions St., Des Moines, WA. For information on the
(e) Unsafe Condition availability of this material at the FAA, call
This AD was prompted by reports of early The following provisions also apply to this 206–231–3195.
cracking on the four holes of the crossbeam AD: (5) You may view this material at the
splicing at certain fuselage frames (FR). The (1) Alternative Methods of Compliance National Archives and Records
(AMOCs): The Manager, International Administration (NARA). For information on
FAA is issuing this AD to address cracking
Validation Branch, FAA, has the authority to the availability of this material at NARA,
at two upper rows of fasteners of the
approve AMOCs for this AD, if requested
crossbeam splicing at FR16 and FR20, on visit www.archives.gov/federal-register/cfr/
using the procedures found in 14 CFR 39.19.
both the left-hand (LH) and right-hand (RH) ibr-locations or email fr.inspection@nara.gov.
In accordance with 14 CFR 39.19, send your
sides. The unsafe condition, if not addressed, request to your principal inspector or Dated: Issued on October 30, 2023.
could result in reduced structural integrity of responsible Flight Standards Office, as
the airplane due to the failure of structural Victor Wicklund,
appropriate. If sending information directly Deputy Director, Compliance & Airworthiness
components. to the International Validation Branch, send Division, Aircraft Certification Service.
(f) Compliance it to the attention of the person identified in
paragraph (k) of this AD. Information may be [FR Doc. 2023–24300 Filed 11–3–23; 8:45 am]
Comply with this AD within the emailed to: 9-AVS-AIR-730-AMOC@faa.gov. BILLING CODE 4910–13–P
compliance times specified, unless already Before using any approved AMOC, notify
done. your appropriate principal inspector, or
(g) Requirements lacking a principal inspector, the manager of DEPARTMENT OF TRANSPORTATION
the responsible Flight Standards Office.
Except as specified in paragraph (h) of this
(2) Contacting the Manufacturer: For any Federal Aviation Administration
AD: Comply with all required actions and
requirement in this AD to obtain instructions
compliance times specified in, and in
from a manufacturer, the instructions must 14 CFR Part 71
accordance with, European Union Aviation be accomplished using a method approved
Safety Agency (EASA) AD 2023–0150, dated by the Manager, International Validation [Docket No. FAA–2023–2115; Airspace
July 20, 2023 (EASA AD 2023–0150). Branch, FAA; or EASA; or Airbus SAS’s Docket No. 23–ASO–40]
(h) Exceptions to EASA AD 2023–0150 EASA Design Organization Approval (DOA).
If approved by the DOA, the approval must RIN 2120–AA66
(1) Where EASA AD 2023–0150 refers to
include the DOA-authorized signature.
‘‘28 July 2016 [the effective date of EASA AD Amendment of Class E Airspace;
(3) Required for Compliance (RC): Except
2016–0139],’’ this AD requires using August Natchez, MS
as required by paragraphs (i) and (j)(2) of this
23, 2018 (the effective date of AD 2018–14–
AD, if any service information contains
09). AGENCY: Federal Aviation
procedures or tests that are identified as RC,
(2) Where EASA AD 2023–0150 refers to its those procedures and tests must be done to Administration (FAA), DOT.
effective date, this AD requires using the comply with this AD; any procedures or tests ACTION: Notice of proposed rulemaking
effective date of this AD. that are not identified as RC are
(3) Where rows B and C of the ‘‘Threshold’’ (NPRM).
recommended. Those procedures and tests
column in Table 1 of EASA AD 2023–0150 that are not identified as RC may be deviated
refer to ‘‘54 800 FH,’’ for this AD, replace SUMMARY: This action proposes to
from using accepted methods in accordance amend the Class E airspace at Natchez,
those words with ‘‘54 900 FH.’’ with the operator’s maintenance or
(4) Where paragraph (5) of EASA AD 2023– MS. The FAA is proposing this action
inspection program without obtaining
0150 refers to ‘‘valid within the EASA approval of an AMOC, provided the as the result of an airspace review
system,’’ for this AD, replace those words procedures and tests identified as RC can be conducted due to the decommissioning
with ‘‘approved by the FAA, EASA, Airbus’s done and the airplane can be put back in an of the Natchez very high frequency
EASA Design Organization Approval (DOA), airworthy condition. Any substitutions or omnidirectional range (VOR) as part of
or an EASA DOA (other than Airbus’s EASA changes to procedures or tests identified as the VOR Minimum Operating Network
DOA).’’ RC require approval of an AMOC. (MON) Program. The name and
(5) Where paragraph (5) of EASA AD 2023–
0150 specifies ‘‘contact that design approval (k) Additional Information geographic coordinates of the airport
holder (DAH) for assessment and repair For more information about this AD,
would also be updated to coincide with
instructions, obtain EASA AMOC approval contact Timothy Dowling, Aviation Safety the FAA’s aeronautical database. This
and accomplish those instructions Engineer, FAA, 1600 Stewart Avenue, Suite action will bring the airspace into
accordingly, as applicable,’’ for this AD, 410, Westbury, NY 11590; telephone 817– compliance with FAA orders to support
replace those words with ‘‘modify the repair 222–5102; email timothy.p.dowling@faa.gov. instrument flight rule (IFR) operations.
using a method approved by the Manager,
(l) Material Incorporated by Reference DATES: Comments must be received on
International Validation Branch, FAA; or
EASA; or Airbus’s EASA DOA. If approved (1) The Director of the Federal Register or before December 21, 2023.
by the DOA, the approval must include the approved the incorporation by reference ADDRESSES: Send comments identified
DOA-authorized signature.’’ (IBR) of the service information listed in this by FAA Docket No. FAA–2023–2115
and Airspace Docket No. 23–ASO–40 upward from 700 feet above the surface Organization, Central Service Center,
using any of the following methods: at Hardy-Anders Field/Natchez-Adams Operations Support Group, 10101
* Federal eRulemaking Portal: Go to County Airport, Natchez, MS, to support Hillwood Parkway, Fort Worth, TX
www.regulations.gov and follow the IFR operations at this airport. 76177.
online instruction for sending your
Comments Invited Incorporation by Reference
comments electronically.
* Mail: Send comments to Docket The FAA invites interested persons to Class E airspace is published in
Operations, M–30; U.S. Department of participate in this rulemaking by paragraph 6005 of FAA Order JO
Transportation, 1200 New Jersey submitting written comments, data, or 7400.11, Airspace Designations and
Avenue SE, Room W12–140, West views. Comments are specifically Reporting Points, which is incorporated
Building Ground Floor, Washington, DC invited on the overall regulatory, by reference in 14 CFR 71.1 on an
20590–0001. aeronautical, economic, environmental, annual basis. This document proposes
* Hand Delivery or Courier: Take and energy-related aspects of the to amend the current version of that
comments to Docket Operations in proposal. The most helpful comments order, FAA Order JO 7400.11H, dated
Room W12–140 of the West Building reference a specific portion of the August 11, 2023, and effective
Ground Floor at 1200 New Jersey proposal, explain the reason for any September 15, 2023. These updates
Avenue SE, Washington, DC, between 9 recommended change, and include would be published subsequently in the
a.m. and 5 p.m., Monday through supporting data. To ensure the docket next update to FAA Order JO 7400.11.
Friday, except Federal holidays. does not contain duplicate comments, That order is publicly available as listed
* Fax: Fax comments to Docket commenters should submit only one in the ADDRESSES section of this
Operations at (202) 493–2251. time if comments are filed document.
Docket: Background documents or electronically, or commenters should FAA Order JO 7400.11H lists Class A,
comments received may be read at send only one copy of written B, C, D, and E airspace areas, air traffic
www.regulations.gov at any time. comments if comments are filed in service routes, and reporting points.
Follow the online instructions for writing.
The FAA will file in the docket all The Proposal
accessing the docket or go to Docket
comments it receives, as well as a report The FAA is proposing to amend 14
Operations in Room W12–140 of the
summarizing each substantive public CFR part 71 by modifying the Class E
West Building Ground Floor at 1200
contact with FAA personnel concerning airspace extending upward from 700
New Jersey Avenue SE, Washington,
this proposed rulemaking. Before acting feet above the surface to within a 6.6-
DC, between 9 a.m. and 5 p.m., Monday
on this proposal, the FAA will consider mile (decreased from a 7-mile) radius of
through Friday, except Federal holidays.
FAA Order JO 7400.11H, Airspace all comments it received on or before Hardy-Anders Field/Natchez-Adams
Designations and Reporting Points, and the closing date for comments. The FAA County Airport, Natchez, MS; updating
subsequent amendments can be viewed will consider comments filed after the the name (previously Hardy-Anders
online at www.faa.gov/air_traffic/ comment period has closed if it is Field Natchez-Adams County Airport)
publications/. You may also contact the possible to do so without incurring and geographic coordinates of airport to
Rules and Regulations Group, Office of expense or delay. The FAA may change coincide with the FAA’s aeronautical
Policy, Federal Aviation this proposal in light of the comments database; and removing the city
Administration, 800 Independence it receives. associated with the airport from the
Privacy: In accordance with 5 U.S.C. header to comply with changes to FAA
Avenue SW, Washington, DC 20591;
553(c), DOT solicits comments from the Order JO 7400.2P, Procedures for
telephone: (202) 267–8783.
public to better inform its rulemaking Handling Airspace Matters.
FOR FURTHER INFORMATION CONTACT: process. DOT post these comments, This action is the result of an airspace
Jeffrey Claypool, Federal Aviation without edit, including any personal review conducted due to the
Administration, Operations Support information the commenter provides, to decommissioning of the Natchez VOR,
Group, Central Service Center, 10101 www.regulations.gov as described in the which provided navigation information
Hillwood Parkway, Fort Worth, TX system of records notice (DOT/ALL– to this airport, as part of the VOR MON
76177; telephone (817) 222–5711. 14FDMS), which can be reviewed at Program, and to support IFR operations
SUPPLEMENTARY INFORMATION: www.dot.gov/privacy. at this airport.
Authority for This Rulemaking Availability of Rulemaking Documents Regulatory Notices and Analyses
The FAA’s authority to issue rules An electronic copy of this document The FAA has determined that this
regarding aviation safety is found in may be downloaded through the proposed regulation only involves an
Title 49 of the United States Code. internet at www.regulations.gov. established body of technical
Subtitle I, Section 106 describes the Recently published rulemaking regulations for which frequent and
authority of the FAA Administrator. documents can also be accessed through routine amendments are necessary to
Subtitle VII, Aviation Programs, the FAA’s web page at www.faa.gov/air_ keep them operationally current. It,
describes in more detail the scope of the traffic/publications/airspace_ therefore: (1) is not a ‘‘significant
agency’s authority. This rulemaking is amendments/. regulatory action’’ under Executive
promulgated under the authority You may review the public docket Order 12866; (2) is not a ‘‘significant
described in Subtitle VII, Part A, containing the proposal, any comments rule’’ under DOT Regulatory Policies
Subpart I, Section 40103. Under that received, and any final disposition in and Procedures (44 FR 11034; February
section, the FAA is charged with person in the Dockets Office (see the 26, 1979); and (3) does not warrant
prescribing regulations to assign the use ADDRESSES section for the address, preparation of a regulatory evaluation as
of airspace necessary to ensure the phone number, and hours of the anticipated impact is so minimal.
safety of aircraft and the efficient use of operations). An informal docket may Since this is a routine matter that will
airspace. This regulation is within the also be examined during normal only affect air traffic procedures and air
scope of that authority as it would business hours at the Federal Aviation navigation, it is certified that this
amend the Class E airspace extending Administration, Air Traffic proposed rule, when promulgated, will
not have a significant economic impact DEPARTMENT OF TRANSPORTATION subsequent amendments can be viewed
on a substantial number of small entities online at www.faa.gov/air_traffic/
under the criteria of the Regulatory Federal Aviation Administration publications/. You may also contact the
Flexibility Act. Rules and Regulations Group, Office of
14 CFR Part 71 Policy, Federal Aviation
Environmental Review Administration, 800 Independence
[Docket No. FAA–2023–2118; Airspace
This proposal will be subject to an Docket No. 23–AGL–31] Avenue SW, Washington, DC 20591;
telephone: (202) 267–8783.
environmental analysis in accordance RIN 2120–AA66
with FAA Order 1050.1F, FOR FURTHER INFORMATION CONTACT:
‘‘Environmental Impacts: Policies and Amendment of Class E Airspace; Jeffrey Claypool, Federal Aviation
Procedures’’ prior to any FAA final Harrison, OH Administration, Operations Support
regulatory action. Group, Central Service Center, 10101
AGENCY: Federal Aviation Hillwood Parkway, Fort Worth, TX
List of Subjects in 14 CFR Part 71 Administration (FAA), DOT. 76177; telephone (817) 222–5711.
ACTION: Notice of proposed rulemaking
Airspace, Incorporation by reference, (NPRM).
Navigation (air). Authority for This Rulemaking
SUMMARY: This action proposes to
The Proposed Amendment amend the Class E airspace at Harrison, The FAA’s authority to issue rules
OH. The FAA is proposing this action regarding aviation safety is found in
In consideration of the foregoing, the as the result of an airspace review Title 49 of the United States Code.
Federal Aviation Administration conducted due to the decommissioning Subtitle I, Section 106 describes the
proposes to amend 14 CFR part 71 as of the Cincinnati very high frequency authority of the FAA Administrator.
follows: omnidirectional range (VOR) as part of Subtitle VII, Aviation Programs,
the VOR Minimum Operating Network describes in more detail the scope of the
PART 71—DESIGNATION OF CLASS A, (MON) Program. The geographic agency’s authority. This rulemaking is
B, C, D, AND E AIRSPACE AREAS; AIR coordinates of the airport would also be promulgated under the authority
TRAFFIC SERVICE ROUTES; AND updated to coincide with the FAA’s described in Subtitle VII, Part A,
REPORTING POINTS aeronautical database. This action will Subpart I, Section 40103. Under that
bring the airspace into compliance with section, the FAA is charged with
■ 1. The authority citation for 14 CFR FAA orders to support instrument flight prescribing regulations to assign the use
part 71 continues to read as follows: rule (IFR) operations. of airspace necessary to ensure the
DATES: Comments must be received on safety of aircraft and the efficient use of
Authority: 49 U.S.C. 106(f), 106(g); 40103, airspace. This regulation is within the
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, or before December 21, 2023.
ADDRESSES: Send comments identified
scope of that authority as it would
1959–1963 Comp., p. 389.
by FAA Docket No. FAA–2023–2118 amend the Class E airspace extending
§ 71.1 [Amended] and Airspace Docket No. 23–AGL–31 upward from 700 feet above the surface
using any of the following methods: at Cincinnati West Airport, Harrison,
■ 2. The incorporation by reference in OH, to support IFR operations at this
* Federal eRulemaking Portal: Go to
14 CFR 71.1 of FAA Order JO 7400.11H, airport.
www.regulations.gov and follow the
Airspace Designations and Reporting online instruction for sending your
Points, dated August 11, 2023, and Comments Invited
comments electronically.
effective September 15, 2023, is * Mail: Send comments to Docket The FAA invites interested persons to
amended as follows: Operations, M–30; U.S. Department of participate in this rulemaking by
Transportation, 1200 New Jersey submitting written comments, data, or
Paragraph 6005 Class E Airspace Areas Avenue SE, Room W12–140, West views. Comments are specifically
Extending Upward From 700 Feet or More invited on the overall regulatory,
Building Ground Floor, Washington, DC
Above the Surface of the Earth. aeronautical, economic, environmental,
20590–0001.
* * * * * * Hand Delivery or Courier: Take and energy-related aspects of the
comments to Docket Operations in proposal. The most helpful comments
ASO MS E5 Natchez, MS [Amended] reference a specific portion of the
Room W12–140 of the West Building
Hardy-Anders Field/Natchez-Adams County Ground Floor at 1200 New Jersey proposal, explain the reason for any
Airport, MS Avenue SE, Washington, DC, between 9 recommended change, and include
(Lat. 31°36′50″ N, long. 91°17′49″ W) a.m. and 5 p.m., Monday through supporting data. To ensure the docket
That airspace extending upward from 700 Friday, except Federal holidays. does not contain duplicate comments,
feet above the surface within a 6.6-mile * Fax: Fax comments to Docket commenters should submit only one
radius of Hardy-Anders Field/Natchez- Operations at (202) 493–2251. time if comments are filed
Adams County Airport. Docket: Background documents or electronically, or commenters should
* * * * * comments received may be read at send only one copy of written
www.regulations.gov at any time. comments if comments are filed in
Issued in Fort Worth, Texas, on November writing.

Follow the online instructions for
1, 2023. The FAA will file in the docket all
accessing the docket or go to Docket
Martin A. Skinner, Operations in Room W12–140 of the comments it receives, as well as a report
Acting Manager, Operations Support Group, West Building Ground Floor at 1200 summarizing each substantive public
ATO Central Service Center. New Jersey Avenue SE, Washington, contact with FAA personnel concerning
[FR Doc. 2023–24438 Filed 11–3–23; 8:45 am] DC, between 9 a.m. and 5 p.m., Monday this proposed rulemaking. Before acting
BILLING CODE 4910–13–P through Friday, except Federal holidays. on this proposal, the FAA will consider
FAA Order JO 7400.11H, Airspace all comments it received on or before
Designations and Reporting Points, and the closing date for comments. The FAA
will consider comments filed after the exclusionary language as it is not § 71.1 [Amended]
comment period has closed if it is required; removing the city associated ■ 2. The incorporation by reference in
possible to do so without incurring with the airport in the legal description 14 CFR 71.1 of FAA Order JO 7400.11H,
expense or delay. The FAA may change header to comply with changes to FAA Airspace Designations and Reporting
this proposal in light of the comments Order JO 7400.2P, Procedures for Points, dated August 11, 2023, and
it receives. Handling Airspace Matters; and effective September 15, 2023, is
Privacy: In accordance with 5 U.S.C. updating the geographic coordinates of amended as follows:
553(c), DOT solicits comments from the the airport to coincide with the FAA’s Paragraph 6005 Class E Airspace Areas
public to better inform its rulemaking aeronautical database. Extending Upward From 700 Feet or More
process. DOT post these comments, This action is the result of an airspace Above the Surface of the Earth.
without edit, including any personal review conducted due to the * * * * *
information the commenter provides, to decommissioning of the Cincinnati
www.regulations.gov as described in the VOR, which provided navigation AGL OH E5 Harrison, OH [Amended]
system of records notice (DOT/ALL– information to this airport, as part of the Cincinnati West Airport, OH
14FDMS), which can be reviewed at VOR MON Program, and to support IFR (Lat. 39°15′33″ N, long. 84°46′28″ W)
www.dot.gov/privacy. operations at this airport. That airspace extending upward from 700
feet above the surface within a 7.1-mile
Availability of Rulemaking Documents Regulatory Notices and Analyses radius of Cincinnati West Airport.
An electronic copy of this document The FAA has determined that this * * * * *
may be downloaded through the proposed regulation only involves an
Issued in Fort Worth, Texas, on November
internet at www.regulations.gov. established body of technical 1, 2023.
Recently published rulemaking regulations for which frequent and
Martin A. Skinner,
documents can also be accessed through routine amendments are necessary to
the FAA’s web page at www.faa.gov/air_ Acting Manager, Operations Support Group,
keep them operationally current. It,
ATO Central Service Center.
traffic/publications/airspace_ therefore: (1) is not a ‘‘significant
amendments/. [FR Doc. 2023–24435 Filed 11–3–23; 8:45 am]
regulatory action’’ under Executive
You may review the public docket Order 12866; (2) is not a ‘‘significant BILLING CODE 4910–13–P
containing the proposal, any comments rule’’ under DOT Regulatory Policies
received, and any final disposition in and Procedures (44 FR 11034; February
person in the Dockets Office (see the DEPARTMENT OF TRANSPORTATION
26, 1979); and (3) does not warrant
ADDRESSES section for the address, preparation of a regulatory evaluation as Federal Aviation Administration
phone number, and hours of the anticipated impact is so minimal.
operations). An informal docket may Since this is a routine matter that will 14 CFR Part 71
also be examined during normal only affect air traffic procedures and air
business hours at the Federal Aviation navigation, it is certified that this [Docket No. FAA–2023–2116; Airspace
Administration, Air Traffic proposed rule, when promulgated, will Docket No. 23–AGL–29]
Organization, Central Service Center, not have a significant economic impact RIN 2120–AA66
Operations Support Group, 10101 on a substantial number of small entities
Hillwood Parkway, Fort Worth, TX under the criteria of the Regulatory Amendment of Class E Airspace;
76177. Flexibility Act. Hutchinson, MN
Incorporation by Reference Environmental Review AGENCY: Federal Aviation
Class E airspace is published in Administration (FAA), DOT.
This proposal will be subject to an
paragraph 6005 of FAA Order JO environmental analysis in accordance ACTION: Notice of proposed rulemaking
7400.11, Airspace Designations and with FAA Order 1050.1F, (NPRM).
Reporting Points, which is incorporated ‘‘Environmental Impacts: Policies and
by reference in 14 CFR 71.1 on an SUMMARY: This action proposes to
Procedures’’ prior to any FAA final amend the Class E airspace at
annual basis. This document proposes regulatory action.
to amend the current version of that Hutchinson, MN. The FAA is proposing
order, FAA Order JO 7400.11H, dated List of Subjects in 14 CFR Part 71 this action as the result of an airspace
August 11, 2023, and effective review conducted due to the
Airspace, Incorporation by reference, decommissioning of the Darwin very
September 15, 2023. These updates Navigation (air).
would be published subsequently in the high frequency omnidirectional range
next update to FAA Order JO 7400.11. The Proposed Amendment (VOR) as part of the VOR Minimum
That order is publicly available as listed Operating Network (MON) Program. The
In consideration of the foregoing, the
in the ADDRESSES section of this name of the airport would also be
document. updated to coincide with the FAA’s
proposes to amend 14 CFR part 71 as
FAA Order JO 7400.11H lists Class A, aeronautical database. This action will
follows:
B, C, D, and E airspace areas, air traffic bring the airspace into compliance with
service routes, and reporting points. PART 71—DESIGNATION OF CLASS A, FAA orders to support instrument flight
B, C, D, AND E AIRSPACE AREAS; AIR rule (IFR) operations.

The Proposal TRAFFIC SERVICE ROUTES; AND DATES: Comments must be received on
The FAA is proposing to amend 14 REPORTING POINTS or before December 21, 2023.
CFR part 71 by modifying the Class E ADDRESSES: Send comments identified
airspace extending upward from 700 ■ 1. The authority citation for 14 CFR by FAA Docket No. FAA–2023–2116
feet above the surface to within a 7.1- part 71 continues to read as follows: and Airspace Docket No. 23–AGL–29
mile (increased from a 6.4-mile) radius Authority: 49 U.S.C. 106(f), 106(g); 40103, using any of the following methods:
of Litchfield Municipal Airport, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, * Federal eRulemaking Portal: Go to
Litchfield, MN; removing the 1959–1963 Comp., p. 389. www.regulations.gov and follow the
online instruction for sending your Comments Invited Incorporation by Reference

comments electronically. The FAA invites interested persons to Class E airspace is published in
* Mail: Send comments to Docket participate in this rulemaking by paragraph 6005 of FAA Order JO
Operations, M–30; U.S. Department of submitting written comments, data, or 7400.11, Airspace Designations and
Transportation, 1200 New Jersey views. Comments are specifically Reporting Points, which is incorporated
Avenue SE, Room W12–140, West invited on the overall regulatory, by reference in 14 CFR 71.1 on an
Building Ground Floor, Washington, DC aeronautical, economic, environmental, annual basis. This document proposes
20590–0001. and energy-related aspects of the to amend the current version of that
* Hand Delivery or Courier: Take proposal. The most helpful comments order, FAA Order JO 7400.11H, dated
comments to Docket Operations in reference a specific portion of the August 11, 2023, and effective
Room W12–140 of the West Building proposal, explain the reason for any September 15, 2023. These updates
Ground Floor at 1200 New Jersey recommended change, and include would be published subsequently in the
Avenue SE, Washington, DC, between 9 supporting data. To ensure the docket next update to FAA Order JO 7400.11.
a.m. and 5 p.m., Monday through does not contain duplicate comments, That order is publicly available as listed
Friday, except Federal holidays. commenters should submit only one in the ADDRESSES section of this
* Fax: Fax comments to Docket time if comments are filed document.
Operations at (202) 493–2251. electronically, or commenters should FAA Order JO 7400.11H lists Class A,
Docket: Background documents or send only one copy of written B, C, D, and E airspace areas, air traffic
comments received may be read at comments if comments are filed in service routes, and reporting points.
www.regulations.gov at any time. writing.
Follow the online instructions for The Proposal
The FAA will file in the docket all
accessing the docket or go to Docket The FAA is proposing to amend 14
comments it receives, as well as a report
Operations in Room W12–140 of the CFR part 71 by modifying the Class E
summarizing each substantive public
West Building Ground Floor at 1200 airspace extending upward from 700
contact with FAA personnel concerning
New Jersey Avenue SE, Washington, feet above the surface to within a 6.4-
this proposed rulemaking. Before acting
DC, between 9 a.m. and 5 p.m., Monday mile (decreased from a 6.6-mile) radius
on this proposal, the FAA will consider
through Friday, except Federal holidays. of Hutchinson Municipal Airport/Butler
all comments it received on or before
FAA Order JO 7400.11H, Airspace Field, Hutchinson, MN; and updating
the closing date for comments. The FAA
Designations and Reporting Points, and the name (previously Hutchinson
will consider comments filed after the Municipal Airport-Butler Field) of
subsequent amendments can be viewed comment period has closed if it is
online at www.faa.gov/air_traffic/ airport to coincide with the FAA’s
possible to do so without incurring aeronautical database.
publications/. You may also contact the expense or delay. The FAA may change
Rules and Regulations Group, Office of This action is the result of an airspace
this proposal in light of the comments review conducted due to the
Policy, Federal Aviation it receives.
Administration, 800 Independence decommissioning of the Darwin VOR,
Privacy: In accordance with 5 U.S.C. which provided navigation information
Avenue SW, Washington, DC 20591; 553(c), DOT solicits comments from the
telephone: (202) 267–8783. to this airport, as part of the VOR MON
public to better inform its rulemaking Program, and to support IFR operations
FOR FURTHER INFORMATION CONTACT: process. DOT post these comments, at this airport.
Jeffrey Claypool, Federal Aviation without edit, including any personal
Administration, Operations Support information the commenter provides, to Regulatory Notices and Analyses
Group, Central Service Center, 10101 www.regulations.gov as described in the The FAA has determined that this
Hillwood Parkway, Fort Worth, TX system of records notice (DOT/ALL– proposed regulation only involves an
76177; telephone (817) 222–5711. 14FDMS), which can be reviewed at established body of technical
SUPPLEMENTARY INFORMATION: www.dot.gov/privacy. regulations for which frequent and
Authority for This Rulemaking Availability of Rulemaking Documents routine amendments are necessary to
keep them operationally current. It,
The FAA’s authority to issue rules An electronic copy of this document therefore: (1) is not a ‘‘significant
regarding aviation safety is found in may be downloaded through the regulatory action’’ under Executive
Title 49 of the United States Code. internet at www.regulations.gov. Order 12866; (2) is not a ‘‘significant
Subtitle I, Section 106 describes the Recently published rulemaking rule’’ under DOT Regulatory Policies
authority of the FAA Administrator. documents can also be accessed through and Procedures (44 FR 11034; February
Subtitle VII, Aviation Programs, the FAA’s web page at www.faa.gov/air_ 26, 1979); and (3) does not warrant
describes in more detail the scope of the traffic/publications/airspace_ preparation of a regulatory evaluation as
agency’s authority. This rulemaking is amendments/. the anticipated impact is so minimal.
promulgated under the authority You may review the public docket Since this is a routine matter that will
described in Subtitle VII, Part A, containing the proposal, any comments only affect air traffic procedures and air
Subpart I, Section 40103. Under that received, and any final disposition in navigation, it is certified that this
section, the FAA is charged with person in the Dockets Office (see the proposed rule, when promulgated, will
prescribing regulations to assign the use ADDRESSES section for the address, not have a significant economic impact
of airspace necessary to ensure the phone number, and hours of on a substantial number of small entities
safety of aircraft and the efficient use of operations). An informal docket may under the criteria of the Regulatory
airspace. This regulation is within the also be examined during normal Flexibility Act.
scope of that authority as it would business hours at the Federal Aviation
amend the Class E airspace extending Administration, Air Traffic Environmental Review
upward from 700 feet above the surface Organization, Central Service Center, This proposal will be subject to an
at Hutchinson Municipal Airport/Butler Operations Support Group, 10101 environmental analysis in accordance
Field, Hutchinson, MN, to support IFR Hillwood Parkway, Fort Worth, TX with FAA Order 1050.1F,
operations at this airport. 76177. ‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final Notice of proposed rulemaking

ACTION: Authority for This Rulemaking
regulatory action. (NPRM).
The FAA’s authority to issue rules
List of Subjects in 14 CFR Part 71 SUMMARY: This action proposes to regarding aviation safety is found in
Airspace, Incorporation by reference, amend the Class E airspace at Bedford, Title 49 of the United States Code.
Navigation (air). PA. The FAA is proposing this action as Subtitle I, Section 106 describes the
the result of an airspace review authority of the FAA Administrator.
The Proposed Amendment conducted due to the decommissioning Subtitle VII, Aviation Programs,
In consideration of the foregoing, the of the St. Thomas very high frequency describes in more detail the scope of the
Federal Aviation Administration omnidirectional range (VOR) as part of agency’s authority. This rulemaking is
proposes to amend 14 CFR part 71 as the VOR Minimum Operating Network promulgated under the authority
follows: (MON) Program. This action will bring described in Subtitle VII, Part A,
the airspace into compliance with FAA Subpart I, Section 40103. Under that
PART 71—DESIGNATION OF CLASS A, orders to support instrument flight rule section, the FAA is charged with
B, C, D, AND E AIRSPACE AREAS; AIR (IFR) operations. prescribing regulations to assign the use
TRAFFIC SERVICE ROUTES; AND of airspace necessary to ensure the
DATES: Comments must be received on
REPORTING POINTS safety of aircraft and the efficient use of
or before December 21, 2023.
airspace. This regulation is within the
■ 1. The authority citation for 14 CFR ADDRESSES: Send comments identified scope of that authority as it would
part 71 continues to read as follows: by FAA Docket No. FAA–2023–2114 amend the Class E airspace extending
Authority: 49 U.S.C. 106(f), 106(g); 40103, and Airspace Docket No. 23–AEA–17 upward from 700 feet above the surface
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, using any of the following methods: at Bedford County Airport, Bedford, PA,
1959–1963 Comp., p. 389. * Federal eRulemaking Portal: Go to to support IFR operations at this airport.
www.regulations.gov and follow the
§ 71.1 [Amended] online instruction for sending your Comments Invited
■ 2. The incorporation by reference in comments electronically. The FAA invites interested persons to
14 CFR 71.1 of FAA Order JO 7400.11H, * Mail: Send comments to Docket participate in this rulemaking by
Airspace Designations and Reporting Operations, M–30; U.S. Department of submitting written comments, data, or
Points, dated August 11, 2023, and Transportation, 1200 New Jersey views. Comments are specifically
effective September 15, 2023, is Avenue SE, Room W12–140, West invited on the overall regulatory,
amended as follows: Building Ground Floor, Washington, DC aeronautical, economic, environmental,
Paragraph 6005 Class E Airspace Areas 20590–0001. and energy-related aspects of the
Extending Upward From 700 Feet or More * Hand Delivery or Courier: Take proposal. The most helpful comments
Above the Surface of the Earth. comments to Docket Operations in reference a specific portion of the
* * * * * Room W12–140 of the West Building proposal, explain the reason for any
Ground Floor at 1200 New Jersey recommended change, and include
AGL MN E5 Hutchinson, MN [Amended] Avenue SE, Washington, DC, between 9 supporting data. To ensure the docket
Hutchinson Municipal Airport/Butler Field, a.m. and 5 p.m., Monday through
MN
does not contain duplicate comments,
Friday, except Federal holidays. commenters should submit only one
(Lat 44°51′36″ N, long 94°22′57″ W)
* Fax: Fax comments to Docket time if comments are filed
That airspace extending upward from 700 Operations at (202) 493–2251.
feet above the surface within a 6.4-mile electronically, or commenters should
radius of Hutchinson Municipal Airport/ Docket: Background documents or send only one copy of written
Butler Field. comments received may be read at comments if comments are filed in
www.regulations.gov at any time. writing.
* * * * *
Follow the online instructions for The FAA will file in the docket all
Issued in Fort Worth, Texas, on November accessing the docket or go to Docket
1, 2023. comments it receives, as well as a report
Operations in Room W12–140 of the summarizing each substantive public
Martin A. Skinner, West Building Ground Floor at 1200 contact with FAA personnel concerning
Acting Manager, Operations Support Group, New Jersey Avenue SE, Washington,
ATO Central Service Center.
DC, between 9 a.m. and 5 p.m., Monday on this proposal, the FAA will consider
[FR Doc. 2023–24441 Filed 11–3–23; 8:45 am] through Friday, except Federal holidays. all comments it received on or before
BILLING CODE 4910–13–P FAA Order JO 7400.11H, Airspace the closing date for comments. The FAA
Designations and Reporting Points, and will consider comments filed after the
subsequent amendments can be viewed comment period has closed if it is
DEPARTMENT OF TRANSPORTATION online at www.faa.gov/air_traffic/ possible to do so without incurring
publications/. You may also contact the expense or delay. The FAA may change
Federal Aviation Administration Rules and Regulations Group, Office of this proposal in light of the comments
Policy, Federal Aviation it receives.
14 CFR Part 71 Administration, 800 Independence
Privacy: In accordance with 5 U.S.C.
[Docket No. FAA–2023–2114; Airspace 553(c), DOT solicits comments from the
Docket No. 23–AEA–17] telephone: (202) 267–8783.
public to better inform its rulemaking
FOR FURTHER INFORMATION CONTACT: process. DOT post these comments,
RIN 2120–AA66 Jeffrey Claypool, Federal Aviation without edit, including any personal
Administration, Operations Support information the commenter provides, to
Amendment of Class E Airspace; Group, Central Service Center, 10101
Bedford, PA www.regulations.gov as described in the
Hillwood Parkway, Fort Worth, TX system of records notice (DOT/ALL–
AGENCY:Federal Aviation 76177; telephone (817) 222–5711. 14FDMS), which can be reviewed at
Administration (FAA), DOT. SUPPLEMENTARY INFORMATION: www.dot.gov/privacy.
Availability of Rulemaking Documents established body of technical 13 miles southeast of the airport; and within
regulations for which frequent and 2 miles each side of the 308° bearing from the
An electronic copy of this document airport extending from the 8-mile radius to
may be downloaded through the routine amendments are necessary to
keep them operationally current. It, 14.8 miles northwest of the airport.
internet at www.regulations.gov.
therefore: (1) is not a ‘‘significant * * * * *
Recently published rulemaking
documents can also be accessed through regulatory action’’ under Executive Issued in Fort Worth, Texas, on November
the FAA’s web page at www.faa.gov/air_ Order 12866; (2) is not a ‘‘significant 1, 2023.
traffic/publications/airspace_ rule’’ under DOT Regulatory Policies Martin A. Skinner,
amendments/. and Procedures (44 FR 11034; February Acting Manager, Operations Support Group,
You may review the public docket 26, 1979); and (3) does not warrant ATO Central Service Center.
containing the proposal, any comments preparation of a regulatory evaluation as [FR Doc. 2023–24437 Filed 11–3–23; 8:45 am]
received, and any final disposition in the anticipated impact is so minimal. BILLING CODE 4910–13–P
person in the Dockets Office (see the Since this is a routine matter that will
ADDRESSES section for the address, only affect air traffic procedures and air
phone number, and hours of navigation, it is certified that this DEPARTMENT OF TRANSPORTATION
operations). An informal docket may proposed rule, when promulgated, will
also be examined during normal not have a significant economic impact Federal Aviation Administration
business hours at the Federal Aviation on a substantial number of small entities
Administration, Air Traffic under the criteria of the Regulatory 14 CFR Part 71
Organization, Central Service Center, Flexibility Act. [Docket No. FAA–2023–2117; Airspace
Operations Support Group, 10101 Environmental Review Docket No. 23–AGL–30]
Hillwood Parkway, Fort Worth, TX
76177. This proposal will be subject to an RIN 2120–AA66
environmental analysis in accordance
Incorporation by Reference with FAA Order 1050.1F, Amendment of Class E Airspace;
Class E airspace is published in ‘‘Environmental Impacts: Policies and Litchfield, MN
paragraph 6005 of FAA Order JO Procedures’’ prior to any FAA final AGENCY: Federal Aviation
7400.11, Airspace Designations and regulatory action. Administration (FAA), DOT.
Reporting Points, which is incorporated ACTION: Notice of proposed rulemaking
by reference in 14 CFR 71.1 on an (NPRM).
annual basis. This document proposes Airspace, Incorporation by reference,
to amend the current version of that Navigation (air). SUMMARY: This action proposes to
order, FAA Order JO 7400.11H, dated The Proposed Amendment amend the Class E airspace at Litchfield,
August 11, 2023, and effective MN. The FAA is proposing this action
September 15, 2023. These updates In consideration of the foregoing, the
as the result of an airspace review
would be published subsequently in the Federal Aviation Administration
conducted due to the decommissioning
next update to FAA Order JO 7400.11. proposes to amend 14 CFR part 71 as
of the Darwin very high frequency
That order is publicly available as listed follows:
omnidirectional range (VOR) as part of
in the ADDRESSES section of this PART 71—DESIGNATION OF CLASS A, the VOR Minimum Operating Network
document. B, C, D, AND E AIRSPACE AREAS; AIR (MON) Program. This action will bring
FAA Order JO 7400.11H lists Class A, the airspace into compliance with FAA
TRAFFIC SERVICE ROUTES; AND
B, C, D, and E airspace areas, air traffic orders to support instrument flight rule
REPORTING POINTS
service routes, and reporting points. (IFR) operations.
The Proposal ■ 1. The authority citation for 14 CFR DATES: Comments must be received on
part 71 continues to read as follows: or before December 21, 2023.
The FAA is proposing to amend 14
CFR part 71 by modifying the Class E Authority: 49 U.S.C. 106(f), 106(g); 40103, ADDRESSES: Send comments identified
airspace extending upward from 700 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, by FAA Docket No. FAA–2023–2117
1959–1963 Comp., p. 389. and Airspace Docket No. 23–AGL–30
feet above the surface to within an 8-
mile (decreased from a 12.5-mile) radius § 71.1 [Amended] using any of the following methods:
of Bedford County Airport, Bedford, PA; ■ 2. The incorporation by reference in * Federal eRulemaking Portal: Go to
and within 2 miles each side of the 128° 14 CFR 71.1 of FAA Order JO 7400.11H, www.regulations.gov and follow the
bearing from the airport extending from Airspace Designations and Reporting online instruction for sending your
the 8-mile radius to 13 miles southeast Points, dated August 11, 2023, and comments electronically.
of the airport; and within 2 miles each * Mail: Send comments to Docket
effective September 15, 2023, is
side of the 308° bearing from the airport Operations, M–30; U.S. Department of
amended as follows:
extending from the 8-mile radius to 14.8 Transportation, 1200 New Jersey
miles northwest of the airport. Paragraph 6005 Class E Airspace Areas Avenue SE, Room W12–140, West
Extending Upward From 700 Feet or More Building Ground Floor, Washington, DC
This action is the result of an airspace
Above the Surface of the Earth. 20590–0001.
review conducted due to the
decommissioning of the St. Thomas * * * * * * Hand Delivery or Courier: Take

VOR, which provided navigation AEA PA E5 Bedford, PA [Amended] comments to Docket Operations in
information to this airport, as part of the Bedford County Airport, PA
Room W12–140 of the West Building
VOR MON Program, and to support IFR (Lat. 40°05′10″ N, long. 78°30′49″ W) Ground Floor at 1200 New Jersey
operations at this airport. That airspace extending upward from 700
Avenue SE, Washington, DC, between 9
feet above the surface within an 8-mile radius a.m. and 5 p.m., Monday through
Regulatory Notices and Analyses Friday, except Federal holidays.
of Bedford County Airport; and within 2
The FAA has determined that this miles each side of the 128° bearing from the * Fax: Fax comments to Docket
proposed regulation only involves an airport extending from the 8-mile radius to Operations at (202) 493–2251.
Docket: Background documents or electronically, or commenters should FAA Order JO 7400.11H lists Class A,
comments received may be read at send only one copy of written B, C, D, and E airspace areas, air traffic
www.regulations.gov at any time. comments if comments are filed in service routes, and reporting points.
Follow the online instructions for writing.
accessing the docket or go to Docket The FAA will file in the docket all The Proposal
Operations in Room W12–140 of the comments it receives, as well as a report
West Building Ground Floor at 1200 summarizing each substantive public
contact with FAA personnel concerning CFR part 71 by modifying the Class E
New Jersey Avenue SE, Washington,
this proposed rulemaking. Before acting airspace extending upward from 700
DC, between 9 a.m. and 5 p.m., Monday
on this proposal, the FAA will consider feet above the surface to within a 6.4-
all comments it received on or before mile (increased from a 6.3-mile) radius
FAA Order JO 7400.11H, Airspace
Designations and Reporting Points, and the closing date for comments. The FAA of Litchfield Municipal Airport,
subsequent amendments can be viewed will consider comments filed after the Litchfield, MN; and removing the
online at www.faa.gov/air_traffic/ comment period has closed if it is Darwin VORTAC and associated
publications/. You may also contact the possible to do so without incurring extension from the airspace legal
Rules and Regulations Group, Office of expense or delay. The FAA may change description.
Policy, Federal Aviation this proposal in light of the comments This action is the result of an airspace
Administration, 800 Independence it receives. review conducted due to the
Avenue SW, Washington, DC 20591; Privacy: In accordance with 5 U.S.C.
decommissioning of the Darwin VOR,
telephone: (202) 267–8783. 553(c), DOT solicits comments from the
which provided navigation information
FOR FURTHER INFORMATION CONTACT: to this airport, as part of the VOR MON
process. DOT post these comments,
Jeffrey Claypool, Federal Aviation Program, and to support IFR operations
without edit, including any personal
Administration, Operations Support at this airport.
information the commenter provides, to
Group, Central Service Center, 10101
www.regulations.gov as described in the Regulatory Notices and Analyses
Hillwood Parkway, Fort Worth, TX
system of records notice (DOT/ALL–
76177; telephone (817) 222–5711. The FAA has determined that this
14FDMS), which can be reviewed at
SUPPLEMENTARY INFORMATION: www.dot.gov/privacy. proposed regulation only involves an
Authority for This Rulemaking established body of technical
Availability of Rulemaking Documents
regulations for which frequent and
The FAA’s authority to issue rules An electronic copy of this document routine amendments are necessary to
regarding aviation safety is found in may be downloaded through the keep them operationally current. It,
Title 49 of the United States Code. internet at www.regulations.gov. therefore: (1) is not a ‘‘significant
Subtitle I, Section 106 describes the Recently published rulemaking
authority of the FAA Administrator. regulatory action’’ under Executive
documents can also be accessed through
Subtitle VII, Aviation Programs, Order 12866; (2) is not a ‘‘significant
the FAA’s web page at www.faa.gov/air_
describes in more detail the scope of the rule’’ under DOT Regulatory Policies
traffic/publications/airspace_
agency’s authority. This rulemaking is and Procedures (44 FR 11034; February
amendments/.
promulgated under the authority You may review the public docket 26, 1979); and (3) does not warrant
described in Subtitle VII, Part A, containing the proposal, any comments preparation of a regulatory evaluation as
Subpart I, Section 40103. Under that received, and any final disposition in the anticipated impact is so minimal.
section, the FAA is charged with person in the Dockets Office (see the Since this is a routine matter that will
prescribing regulations to assign the use ADDRESSES section for the address, only affect air traffic procedures and air
of airspace necessary to ensure the phone number, and hours of navigation, it is certified that this
safety of aircraft and the efficient use of operations). An informal docket may proposed rule, when promulgated, will
airspace. This regulation is within the also be examined during normal not have a significant economic impact
scope of that authority as it would business hours at the Federal Aviation on a substantial number of small entities
amend the Class E airspace extending Administration, Air Traffic under the criteria of the Regulatory
upward from 700 feet above the surface Organization, Central Service Center, Flexibility Act.
at Litchfield Municipal Airport, Operations Support Group, 10101
Litchfield, MN, to support IFR Hillwood Parkway, Fort Worth, TX Environmental Review
operations at this airport. 76177. This proposal will be subject to an
Comments Invited Incorporation by Reference environmental analysis in accordance
The FAA invites interested persons to Class E airspace is published in with FAA Order 1050.1F,
participate in this rulemaking by paragraph 6005 of FAA Order JO ‘‘Environmental Impacts: Policies and
submitting written comments, data, or 7400.11, Airspace Designations and Procedures’’ prior to any FAA final
views. Comments are specifically Reporting Points, which is incorporated regulatory action.
invited on the overall regulatory, by reference in 14 CFR 71.1 on an List of Subjects in 14 CFR Part 71
aeronautical, economic, environmental, annual basis. This document proposes
and energy-related aspects of the to amend the current version of that Airspace, Incorporation by reference,
proposal. The most helpful comments order, FAA Order JO 7400.11H, dated Navigation (air).
reference a specific portion of the August 11, 2023, and effective
proposal, explain the reason for any September 15, 2023. These updates The Proposed Amendment
recommended change, and include would be published subsequently in the In consideration of the foregoing, the
supporting data. To ensure the docket next update to FAA Order JO 7400.11. Federal Aviation Administration
does not contain duplicate comments, That order is publicly available as listed
proposes to amend 14 CFR part 71 as
commenters should submit only one in the ADDRESSES section of this
follows:
time if comments are filed document.
PART 71—DESIGNATION OF CLASS A, bring the airspace into compliance with section, the FAA is charged with
B, C, D, AND E AIRSPACE AREAS; AIR FAA orders to support instrument flight prescribing regulations to assign the use
TRAFFIC SERVICE ROUTES; AND rule (IFR) operations. of airspace necessary to ensure the
REPORTING POINTS DATES: Comments must be received on safety of aircraft and the efficient use of
or before December 21, 2023. airspace. This regulation is within the
■ 1. The authority citation for 14 CFR ADDRESSES: Send comments identified scope of that authority as it would
part 71 continues to read as follows: by FAA Docket No. FAA–2023–2113 amend the Class E airspace extending
Authority: 49 U.S.C. 106(f), 106(g); 40103, and Airspace Docket No. 23–AGL–28 upward from 700 feet above the surface
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, using any of the following methods: at James A. Rhodes Airport, Jackson,
1959–1963 Comp., p. 389. * Federal eRulemaking Portal: Go to OH, to support IFR operations at this
www.regulations.gov and follow the airport.
§ 71.1 [Amended]
online instruction for sending your Comments Invited
■ 2. The incorporation by reference in comments electronically.
14 CFR 71.1 of FAA Order JO 7400.11H, The FAA invites interested persons to
* Mail: Send comments to Docket
Airspace Designations and Reporting participate in this rulemaking by
Operations, M–30; U.S. Department of
Points, dated August 11, 2023, and submitting written comments, data, or
Transportation, 1200 New Jersey
effective September 15, 2023, is views. Comments are specifically
Avenue SE, Room W12–140, West
amended as follows: invited on the overall regulatory,
Building Ground Floor, Washington, DC aeronautical, economic, environmental,
Paragraph 6005 Class E Airspace Areas 20590–0001. and energy-related aspects of the
Extending Upward From 700 Feet or More * Hand Delivery or Courier: Take
Above the Surface of the Earth. proposal. The most helpful comments
comments to Docket Operations in
reference a specific portion of the
* * * * * Room W12–140 of the West Building
proposal, explain the reason for any
Ground Floor at 1200 New Jersey
AGL MN E5 Litchfield, MN [Amended] recommended change, and include
Avenue SE, Washington, DC, between 9
Litchfield Municipal Airport, MN supporting data. To ensure the docket
a.m. and 5 p.m., Monday through
(Lat 45°05′50″ N, long 94°30′26″ W) does not contain duplicate comments,
Friday, except Federal holidays.
That airspace extending upward from 700 commenters should submit only one
* Fax: Fax comments to Docket
feet above the surface within a 6.4-mile time if comments are filed
Operations at (202) 493–2251.
radius of Litchfield Municipal Airport.
Docket: Background documents or electronically, or commenters should
* * * * * comments received may be read at send only one copy of written
www.regulations.gov at any time. comments if comments are filed in
1, 2023. Follow the online instructions for writing.
The FAA will file in the docket all
Martin A. Skinner, accessing the docket or go to Docket
comments it receives, as well as a report
Acting Manager, Operations Support Group, Operations in Room W12–140 of the
summarizing each substantive public
ATO Central Service Center. West Building Ground Floor at 1200
contact with FAA personnel concerning
[FR Doc. 2023–24439 Filed 11–3–23; 8:45 am] New Jersey Avenue SE, Washington,
BILLING CODE 4910–13–P DC, between 9 a.m. and 5 p.m., Monday
on this proposal, the FAA will consider
all comments it received on or before
FAA Order JO 7400.11H, Airspace
the closing date for comments. The FAA
DEPARTMENT OF TRANSPORTATION Designations and Reporting Points, and
will consider comments filed after the
subsequent amendments can be viewed
Federal Aviation Administration comment period has closed if it is
online at www.faa.gov/air_traffic/
possible to do so without incurring
publications/. You may also contact the
14 CFR Part 71 expense or dely. The FAA may change
Rules and Regulations Group, Office of
this proposal in light of the comments
[Docket No. FAA–2023–2113; Airspace
Policy, Federal Aviation
it receives.
Docket No. 23–AGL–28] Administration, 800 Independence
Privacy: In accordance with 5 U.S.C.
RIN 2120–AA66 553(c), DOT solicits comments from the
telephone: (202) 267–8783.
FOR FURTHER INFORMATION CONTACT: process. DOT post these comments,
Amendment of Class E Airspace;
Jeffrey Claypool, Federal Aviation without edit, including any personal
Jackson, OH
Administration, Operations Support information the commenter provides, to
AGENCY: Federal Aviation Group, Central Service Center, 10101 www.regulations.gov as described in the
Administration (FAA), DOT. Hillwood Parkway, Fort Worth, TX system of records notice (DOT/ALL–
ACTION: Notice of proposed rulemaking 76177; telephone (817) 222–5711. 14FDMS), which can be reviewed at
(NPRM). SUPPLEMENTARY INFORMATION: www.dot.gov/privacy.
SUMMARY: This action proposes to Authority for This Rulemaking Availability of Rulemaking Documents
amend the Class E airspace at Jackson, The FAA’s authority to issue rules An electronic copy of this document
OH. The FAA is proposing this action regarding aviation safety is found in may be downloaded through the
as the result of an airspace review Title 49 of the United States Code. internet at www.regulations.gov.
conducted due to the decommissioning Subtitle I, Section 106 describes the Recently published rulemaking
of the York very high frequency authority of the FAA Administrator. documents can also be accessed through
omnidirectional range (VOR) as part of Subtitle VII, Aviation Programs, the FAA’s web page at www.faa.gov/air_
the VOR Minimum Operating Network describes in more detail the scope of the traffic/publications/airspace_
(MON) Program. The geographic agency’s authority. This rulemaking is amendments/.
coordinates of the airport would also be promulgated under the authority You may review the public docket
updated to coincide with the FAA’s described in Subtitle VII, Part A, containing the proposal, any comments
aeronautical database. This action will Subpart I, Section 40103. Under that received, and any final disposition in
person in the Dockets Office (see the the anticipated impact is so minimal. DEPARTMENT OF HOMELAND
ADDRESSES section for the address, Since this is a routine matter that will SECURITY
phone number, and hours of only affect air traffic procedures and air
operations). An informal docket may navigation, it is certified that this Coast Guard
also be examined during normal proposed rule, when promulgated, will
business hours at the Federal Aviation not have a significant economic impact 33 CFR Part 100
Administration, Air Traffic on a substantial number of small entities
Organization, Central Service Center, under the criteria of the Regulatory [Docket Number USCG–2023–0690]
Operations Support Group, 10101 Flexibility Act.
Hillwood Parkway, Fort Worth, TX RIN 1625–AA08
76177. Environmental Review
Incorporation by Reference This proposal will be subject to an Special Local Regulations; Recurring
environmental analysis in accordance Marine Events, Sector Key West,
Class E airspace is published in Update
paragraph 6005 of FAA Order JO with FAA Order 1050.1F,
7400.11, Airspace Designations and ‘‘Environmental Impacts: Policies and
AGENCY:Coast Guard, Department of
Reporting Points, which is incorporated Procedures’’ prior to any FAA final
Homeland Security (DHS).
by reference in 14 CFR 71.1 on an regulatory action.
annual basis. This document proposes ACTION: Notice of proposed rulemaking.
to amend the current version of that
SUMMARY: The Coast Guard proposes to
order, FAA Order JO 7400.11H, dated Airspace, Incorporation by reference,
revise existing regulations by updating
August 11, 2023, and effective Navigation (air).
the table for existing events in the
September 15, 2023. These updates
The Proposed Amendment Seventh Coast Guard District Captain of
would be published subsequently in the
the Port (COTP) Key West. This action
next update to FAA Order JO 7400.11. In consideration of the foregoing, the is necessary to provide for the safety of
That order is publicly available as listed Federal Aviation Administration life on these navigable waters in Key
in the ADDRESSES section of this proposes to amend 14 CFR part 71 as West, FL. Through this notice, the
document. follows: current list of recurring special local
FAA Order JO 7400.11H lists Class A,
regulations is updated with the removal
B, C, D, and E airspace areas, air traffic PART 71—DESIGNATION OF CLASS A, of an event that no longer takes place,
service routes, and reporting points. B, C, D, AND E AIRSPACE AREAS; AIR the addition of two events, and
The Proposal TRAFFIC SERVICE ROUTES; AND revisions to existing events. When these
REPORTING POINTS special local regulations are enforced,
CFR part 71 by modifying the Class E certain restrictions are placed on marine
airspace extending upward from 700 ■ 1. The authority citation for 14 CFR traffic in specified areas. The Coast
feet above the surface to within a 6.8- part 71 continues to read as follows: Guard invites your comments on this
mile (decreased from a 7.5-mile) radius Authority: 49 U.S.C. 106(f), 106(g); 40103, proposed rulemaking.
of James A. Rhodes Airport, Jackson, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, DATES: Comments and related material
OH; updating the geographic 1959–1963 Comp., p. 389. must be received by the Coast Guard on
coordinates of airport to coincide with or before December 6, 2023.
§ 71.1 [Amended]
the FAA’s aeronautical database; and
ADDRESSES: You may submit comments
removing the city associated with the ■ 2. The incorporation by reference in identified by docket number USCG–
airport from the header to comply with 14 CFR 71.1 of FAA Order JO 7400.11H, 2023–0690 using the Federal
changes to FAA Order JO 7400.2P, Airspace Designations and Reporting eRulemaking Portal at https://
Procedures for Handling Airspace Points, dated August 11, 2023, and www.regulations.gov. See the ‘‘Public
Matters. effective September 15, 2023, is
This action is the result of an airspace Participation and Request for
amended as follows: Comments’’ portion of the
review conducted due to the
Paragraph 6005 Class E Airspace Areas SUPPLEMENTARY INFORMATION section for
decommissioning of the York VOR,
which provided navigation information Extending Upward From 700 Feet or More further instructions on submitting
Above the Surface of the Earth. comments.
to this airport, as part of the VOR MON
Program, and to support IFR operations * * * * * FOR FURTHER INFORMATION CONTACT: If
at this airport. AGL OH E5 Jackson, OH [Amended] you have questions about this proposed
Regulatory Notices and Analyses James A. Rhodes Airport, OH rulemaking, call or email Lieutenant
(Lat. 38°58′53″ N, long. 82°34′40″ W) Hailye Wilson, Sector Key West,
The FAA has determined that this Waterways Management Division, Coast
proposed regulation only involves an That airspace extending upward from 700
Guard; telephone (305) 292–8768 (ext.
established body of technical feet above the surface within a 6.8-mile
768), email Hailye.M.Wilson@uscg.mil.
regulations for which frequent and radius of the James A. Rhodes Airport.
routine amendments are necessary to SUPPLEMENTARY INFORMATION:

* * * * *
keep them operationally current. It, I. Table of Abbreviations
therefore: (1) is not a ‘‘significant
1, 2023. CFR Code of Federal Regulations
regulatory action’’ under Executive
Martin A. Skinner, COTP Captain of the Port
Order 12866; (2) is not a ‘‘significant DHS Department of Homeland Security
rule’’ under DOT Regulatory Policies Acting Manager, Operations Support Group,
FR Federal Register
and Procedures (44 FR 11034; February ATO Central Service Center.
NPRM Notice of proposed rulemaking
26, 1979); and (3) does not warrant [FR Doc. 2023–24436 Filed 11–3–23; 8:45 am] § Section
preparation of a regulatory evaluation as BILLING CODE 4910–13–P U.S.C. United States Code
II. Background, Purpose, and Legal Register, Local Notice to Mariners, and please submit a comment (see
Basis Broadcast Notice to Mariners. ADDRESSES) explaining why you think it
The Coast Guard proposes to qualifies and how and to what degree
IV. Regulatory Analyses
amending and updating the annual this rule would economically affect it.
We developed this proposed rule after Under section 213(a) of the Small
recurring special local regulations for considering numerous statutes and Business Regulatory Enforcement
events in the geographic boundaries of Executive orders related to rulemaking. Fairness Act of 1996 (Pub. L. 104–121),
the Seventh Coast Guard District Below we summarize our analyses we want to assist small entities in
Captain of the Port (COTP) Key West based on a number of these statutes and understanding this proposed rule. If the
Zone that are listed in 33 CFR 100.701, Executive orders and we discuss First rule would affect your small business,
paragraph (b) in Table 1 to § 100.701. Amendment rights of protestors. organization, or governmental
The proposed rule would ensure that
A. Regulatory Planning and Review jurisdiction and you have questions
the public is informed of the most up to
concerning its provisions or options for
date recurring special local regulations. Executive Orders 12866 and 13563 compliance, please contact the person
The current list under § 100.701, direct agencies to assess the costs and listed in the FOR FURTHER INFORMATION
paragraph (b) in Table 1 to § 100.701 benefits of available regulatory CONTACT section. The Coast Guard will
requires amendments to existing special alternatives and, if regulation is not retaliate against small entities that
local regulations, adds two new special necessary, to select regulatory question or complain about this
local regulations expected to recur approaches that maximize net benefits. proposed rule or any policy or action of
annually, and removes a special local This NPRM has not been designated a the Coast Guard.
regulation that is no longer required. ‘‘significant regulatory action,’’ under
The Coast Guard proposes this section 3(f) of Executive Order 12866, as C. Collection of Information
rulemaking under authority in 46 U.S.C. amended by Executive Order 14094 This proposed rule would not call for
70041. (Modernizing Regulatory Review). a new collection of information under
III. Discussion of Proposed Rule Accordingly, the NPRM has not been the Paperwork Reduction Act of 1995
reviewed by the Office of Management (44 U.S.C. 3501–3520).
This rule proposes to make the and Budget (OMB).
following changes in 33 CFR 100.701 to This regulatory action determination D. Federalism and Indian Tribal
paragraph (b) in Table 1 to § 100.701: is based on the size, location, and Governments
1. Removing the Yachting Key West duration of the special local regulations. A rule has implications for federalism
Race Week special local regulation These areas are limited in size and under Executive Order 13132,
(SLR) from Line 1 since this event no duration, and usually do not affect high Federalism, if it has a substantial direct
longer occurs in the COTP Key West vessel traffic areas. Moreover, the Coast effect on the States, on the relationship
zone. Guard would provide advance notice of between the National Government and
2. Moving the existing SLR in Line 2 the regulated areas to the local maritime the States, or on the distribution of
to Line 1. community by Local Notice to Mariners, power and responsibilities among the
3. Moving the SLR in Line 3 to Line Broadcast Notice to Mariners via VHF– various levels of government. We have
2 and changing the date from the ‘‘1st FM marine channel 16, and the rule analyzed this proposed rule under that
Weekend of June’’ to ‘‘One Saturday in would allow vessels to seek permission order and have determined that it is
June.’’ There will also be non- to enter the regulated area. consistent with the fundamental
substantive changes made to spelling federalism principles and preemption
and word usage for this SLR. In B. Impact on Small Entities requirements described in Executive
addition, a contingency will be added The Regulatory Flexibility Act of Order 13132.
stating, ‘‘Depending on the weather on 1980, 5 U.S.C. 601–612, as amended, Also, this proposed rule does not have
the day of race, the racecourse might requires Federal agencies to consider tribal implications under Executive
proceed counterclockwise to the potential impact of regulations on Order 13175, Consultation and
accommodate for current and wind.’’ small entities during rulemaking. The Coordination with Indian Tribal
4. Inserting a new SLR in Line 3 for term ‘‘small entities’’ comprises small Governments, because it would not have
the Annual Swim Around Key West. businesses, not-for-profit organizations a substantial direct effect on one or
5. Inserting a new SLR in Line 4 for that are independently owned and more Indian tribes, on the relationship
the Alligator Reef Lighthouse Swim/ operated and are not dominant in their between the Federal Government and
Friends of The Pool, Inc. and; fields, and governmental jurisdictions Indian tribes, or on the distribution of
6. Moving the existing SLR in Line 4 with populations of less than 50,000. power and responsibilities between the
to Line 5, and changing the event The Coast Guard certifies under 5 U.S.C. Federal Government and Indian tribes.
sponsor name from ‘‘Super Boat 605(b) that this proposed rule would not If you believe this proposed rule has
International Productions, Inc.’’ to have a significant economic impact on implications for federalism or Indian
‘‘Race World Offshore.’’ a substantial number of small entities. tribes, please contact the person listed
Marine events listed in paragraph (b) While some owners or operators of in the FOR FURTHER INFORMATION
of Table 1 to § 100.701 are listed as vessels intending to transit the safety CONTACT section.
recurring over a particular time, during zone may be small entities, for the
each month and each year. Exact dates reasons stated in section IV.A above, E. Unfunded Mandates Reform Act
are intentionally omitted since calendar this proposed rule would not have a The Unfunded Mandates Reform Act
dates for specific events change from significant economic impact on any of 1995 (2 U.S.C. 1531–1538) requires
year to year. Once dates for a marine vessel owner or operator. Federal agencies to assess the effects of
event are known, the Coast Guard If you think that your business, their discretionary regulatory actions. In
notifies the public it intends to enforce organization, or governmental particular, the Act addresses actions
the special local regulation through jurisdiction qualifies as a small entity that may result in the expenditure by a
various means including a notice of and that this rule would have a State, local, or Tribal Government, in
enforcement published in the Federal significant economic impact on it, the aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or message can be received without on the Dockets tab and then the
more in any one year. Though this jeopardizing the safety or security of proposed rule, you should see a
proposed rule would not result in such people, places, or vessels. ‘‘Subscribe’’ option for email alerts. The
an expenditure, we do discuss the option will notify you when comments
V. Public Participation and Request for
effects of this rule elsewhere in this are posted, or a final rule is published.
Comments
preamble. We review all comments received, but
We view public participation as we will only post comments that
F. Environment essential to effective rulemaking and address the topic of the proposed rule.
We have analyzed this proposed rule will consider all comments and material We may choose not to post off-topic,
under Department of Homeland received during the comment period. inappropriate, or duplicate comments
Security Directive 023–01, Rev. 1, Your comment can help shape the that we receive.
associated implementing instructions, outcome of this rulemaking. If you
Personal information. We accept
and Environmental Planning submit a comment, please include the
anonymous comments. Comments we
COMDTINST 5090.1 (series), which docket number for this rulemaking,
post to https://www.regulations.gov will
guide the Coast Guard in complying indicate the specific section of this
include any personal information you
with the National Environmental Policy document to which each comment
have provided. For more about privacy
Act of 1969 (42 U.S.C. 4321–4370f), and applies, and provide a reason for each
and submissions to the docket in
have made a preliminary determination suggestion or recommendation.
Submitting comments. We encourage response to this document, see DHS’s
that this action is one of a category of
you to submit comments through the eRulemaking System of Records notice
actions that do not individually or
Federal Decision-Making Portal at (85 FR 14226, March 11, 2020).
cumulatively have a significant effect on
the human environment. This proposed https://www.regulations.gov. To do so, List of Subjects in 33 CFR Part 100
rule involves revising an existing go to https://www.regulations.gov, type
USCG–2023–0690 in the search box and Harbors, Marine safety, Navigation
recurring event to reflect a date and time
click ‘‘Search.’’ Next, look for this (water), Reporting and recordkeeping
change for the event. Normally such
document in the Search Results column, requirements, Security measures,
actions are categorically excluded from
and click on it. Then click on the Waterways.
further review under paragraphs L61 in
Table 3–1 of Appendix A, Table 1 of Comment option. If you cannot submit For the reasons discussed in the
DHS Instruction Manual 023–01–001– your material by using https:// preamble, the Coast Guard proposes to
01, Rev. 1, because it involves a revised www.regulations.gov, call or email the amend 33 CFR parts 100 as follows:
special local regulation related to a person in the FOR FURTHER INFORMATION
marine event permit for marine parades, CONTACT section of this proposed rule PART 100—SAFETY OF LIFE ON
regattas, and other marine events. We for alternate instructions. NAVIGABLE WATERS
seek any comments or information that Viewing material in docket. To view
documents mentioned in this proposed ■ 1. The authority citation for Part 100
may lead to the discovery of a
rule as being available in the docket, continues to read as follows:
significant environmental impact from
this proposed rule. find the docket as described in the Authority: 46 U.S.C. 70041; 33 CFR 1.05–
previous paragraph, and then select 1.
G. Protest Activities ‘‘Supporting & Related Material’’ in the ■ 2. In § 100.701, revise paragraph (b) of
The Coast Guard respects the First Document Type column. Public Table 1 to § 100.701 to read as follows:
Amendment rights of protesters. comments will also be placed in our
Protesters are asked to contact the online docket and can be viewed by § 100.701 Special Local Regulations;
person listed in the FOR FURTHER following instructions on the https:// Marine Events in the Seventh Coast Guard
INFORMATION CONTACT section to www.regulations.gov Frequently Asked District.
coordinate protest activities so that your Questions webpage. Also, if you click * * * * *
TABLE 1 TO § 100.701
Number/date Event Sponsor Location
* * * * * * *
(b) COTP Zone Key West;
Special Local Regulations.
1. Last Friday in April ............ Conch Republic Navy Pa- Conch Republic Navy, LLC Location: All waters approximately 150 yards offshore from Ocean Key
rade and Battle. Sunset Pier, Mallory Square and Pier B within the Key West Harbor
in Key West, Florida.
2. One Saturday in June ....... Swim Around Key West ...... Florida Keys Community Location: Beginning at Smathers Beach in Key West, Florida. The reg-
College. ulated area will move, west to the area offshore of Fort Zachary Tay-
lor Historic State Park, north through Key West Harbor, east through
Fleming Cut, south on Cow Key Channel and west back to origin.
The center of the regulated area will at all times remain approxi-
mately 50 yards offshore of the island of Key West Florida; extend
50 yards in front of the lead safety vessel preceding the first race
participants; extend 50 yards behind the safety vessel trailing the last
race participants; and at all times extend 100 yards on either side of
the race participants and safety vessels. Depending on the weather
on the day of race, the racecourse might proceed counter-clockwise
to accommodate for current and wind.
TABLE 1 TO § 100.701—Continued
Number/date Event Sponsor Location
3. One Saturday in June ....... Annual Swim Around Key Anna Fugina ........................ Location: Beginning at Higgs Beach in Key West, Florida. The regu-
West. lated area will move, west to the area offshore of Fort Zachary Taylor
Historic State Park, north through Key West Harbor, east through
Fleming Cut, south on Cow Key Channel and west, past Smathers
Beach and back to origin. The center of the regulated area will at all
times remain approximately 50 yards offshore of the island of Key
West Florida; extend 50 yards in front of the lead safety vessel pre-
ceding the first race participants; extend 50 yards behind the safety
vessel trailing the last race participants; and at all times extend 100
yards on either side of the race participants and safety vessels. De-
pending on the weather on the day of race, the racecourse might
proceed counter-clockwise to accommodate for current and wind.
4. One Saturday in Sep- Alligator Reef Lighthouse Friends of The Pool, Inc ...... Location(s) (Primary): Beginning at a point Latitude 24°54.82′ N, lon-
tember. Swim. gitude 080°38.03′ W, thence to latitude 24°54.36′ N, longitude
080°37.72′ W, thence to latitude 24°51.07′ N, longitude 080°37.14′
W, thence to latitude 24°54.36′ N, longitude 080°37.72′ W, thence to
point of origin at latitude 24°54.82′ N, longitude 080°38.03′ W.
Location(s) (Alternate) 1: Beginning at a point Latitude 24°54.82′ N, lon-
gitude 080°38.03′ W, thence to latitude 24°53.25′ N, longitude
080°37.04′ W, thence to latitude 24°52.05′ N, longitude 080°38.85′
W, thence to latitude 24°54.36′ N, longitude 080°37.72′ W, thence to
point of origin at latitude 24°54.82′ N, longitude 080°38.03′ W.
5. 2nd week (Wednesday Key West Offshore World Race World Offshore ........... Location: In the Atlantic Ocean, off the tip of Key West, Florida, on the
through Sunday) in Novem- Championship. waters of the Key West Main Ship Channel, Key West Turning Basin,
ber. and Key West Harbor Entrance.
* * * * * * *
Jason D. Ingram, North, Washington, DC 20260. These domestic mailpieces bearing a foreign
Captain, U.S. Coast Guard, Captain of the records are available for review on return address.
Port Sector Key West. Monday through Friday, 9 a.m.–4 p.m., The Postal Service is authorized
[FR Doc. 2023–24470 Filed 11–3–23; 8:45 am] by calling 202–268–2906. pursuant to 39 U.S.C. 404(a)(1) to
BILLING CODE 9110–04–P FOR FURTHER INFORMATION CONTACT: provide for the disposition of
Catherine Knox at (202) 268–5636, undeliverable mail. However, for the
Treishawna Harris at (202) 268–2965, or Postal Service to incur destination
POSTAL SERVICE Garry Rodriguez at (202) 268–7281. country delivery charges as a result of
SUPPLEMENTARY INFORMATION: All attempting to return certain
39 CFR Part 111 submitted comments and attachments undeliverable domestic mailpieces with
are part of the public record and subject a foreign return address is not
Use of Foreign Return Addresses on to disclosure. Do not enclose any practicable. Thus, under this proposed
Domestic Mailpieces material in your comments that you rule, such mailpieces would be handled
consider to be confidential or by the Postal Service, in accordance
AGENCY: Postal ServiceTM. with Postal Service’s dead mail
inappropriate for public disclosure.
ACTION: Proposed rule. Effective April 1, 2023, DMM procedures.
subsection 602.1.5.4, Using Return In addition, if the proposed rule is
SUMMARY: The Postal Service is
Addresses, was amended by publication adopted the Postal Service would also
proposing to amend Mailing Standards
in Postal Bulletin 22619 (3–9–23) to revise a few related sections of the
of the United States Postal Service,
eliminate an exception that allowed a International Mail Manual (IMM)
Domestic Mail Manual (DMM®) in
domestic mailpiece to have a foreign including subsection 762.2,
various subsections to clarify the
return address in certain circumstances Undeliverable Domestic Mail Bearing
consequences of the use of a foreign
as a courtesy. The Postal Service is U.S. Postage and a Foreign Return
return address on a domestic mailpiece.
proposing to further amend subsection Address.
DATES: Submit comments on or before 602.1.5.4 and various other subsections The Postal Service is proposing to
December 6, 2023. in the DMM to clarify the procedures implement this change effective January
ADDRESSES: Mail or deliver written applicable to the undeliverable 1, 2024.
comments to the Director, Product domestic mailpieces bearing a foreign We believe the proposed revisions
Classification, U.S. Postal Service, 475 return address. will provide customers with a more
L’Enfant Plaza SW, Room 4446, The elimination of the courtesy efficient mailing experience. Although
Washington, DC 20260–5015. If sending exception allowing foreign return exempt from the notice and comment
comments by email, include the name addresses on domestic mailpieces under requirements of the Administrative
and address of the commenter and send certain circumstances requires Procedure Act (5 U.S.C. 553(b), (c))
to PCFederalRegister@usps.gov, with a amendment of the procedures that apply regarding proposed rulemaking by 39
subject line of ‘‘Use of Foreign Return to undeliverable domestic mailpieces U.S.C. 410(a), the Postal Service invites
Addresses’’. Faxed comments are not bearing a foreign return address, which public comment on the following
accepted. are no longer authorized under DMM proposed revisions to Mailing Standards
You may inspect and photocopy all 602.1.5.4. Therefore, the Postal Service of the United States Postal Service,
written comments, by appointment is proposing to revise DMM subsections Domestic Mail Manual (DMM),
only, at USPS® Headquarters Library, 602.1.5.4, and 609.4.3, to clarify incorporated by reference in the Code of
475 L’Enfant Plaza SW, 11th Floor procedures applicable to undeliverable Federal Regulations. See 39 CFR 111.1.
If the proposed rule is adopted, we 600 Basic Standards for All Mailing 609 Filing Indemnity Claims for Loss
will publish an appropriate amendment Services or Damage
to 39 CFR part 111 to reflect these
* * * * * * * * * *
changes.
List of Subjects in 39 CFR Part 111 602 Addressing 4.0 Claims
Administrative practice and 1.0 Elements of Addressing * * * * *
procedure, Postal Service. * * * * * 4.3 Nonpayable Claims
Accordingly, 39 CFR part 111 is
proposed to be amended as follows: 1.5 Return Addresses Indemnity is not paid for insured mail
* * * * * (including Priority Mail Express and
PART 111—[AMENDED] Priority Mail), Registered Mail, COD, or
[Revise the heading of 1.5.4 to read as
■ 1. The authority citation for 39 CFR follows:] Priority Mail and Priority Mail Express
part 111 continues to read as follows: in these situations:
1.5.4 Use of Foreign Return Addresses * * * * *
Authority: 5 U.S.C. 552(a); 13 U.S.C. 301–
307; 18 U.S.C. 1692–1737; 39 U.S.C. 101, [Revise the text of 1.5.4 to read as [Revise the text of 4.3 by adding a new
401–404, 414, 416, 3001–3018, 3201–3220, follows:] item ‘‘ag’’ to read as follows:]
3401–3406, 3621, 3622, 3626, 3629, 3631–
3633, 3641, 3681–3685, and 5001. When U.S. postage is applied to a ag. An undeliverable, registered or
domestic mailpiece, as defined under insured domestic mailpiece bearing a
■2. Revise the Mailing Standards of the
608.2.1 and 608.2.2, only a domestic foreign return address.
United States Postal Service, Domestic
Mail Manual (DMM) as follows: return address is authorized. An * * * * *
undeliverable domestic mailpiece
Mailing Standards of the United States bearing a foreign return address cannot Sarah Sullivan,
Postal Service, Domestic Mail Manual be returned to sender and will be Attorney, Ethics & Legal Compliance.
(DMM) handled as dead mail under 507.1.9. [FR Doc. 2023–24447 Filed 11–3–23; 8:45 am]
* * * * * * * * * * BILLING CODE P
76164
Notices Federal Register

Vol. 88, No. 213
This section of the FEDERAL REGISTER the collection of information unless it these surveys are used as a Principle
contains documents other than rules or displays a currently valid OMB control Economic Indicator of the United States.
proposed rules that are applicable to the number. These price estimates are also used to
public. Notices of hearings and investigations, compute Parity Prices in accordance
committee meetings, agency decisions and National Agricultural Statistics Service
with requirements of the Agricultural
rulings, delegations of authority, filing of Title: Agricultural Prices.
petitions and applications and agency
Adjustment Act of 1938 as amended
OMB Control Number: 0535–0003. (Title III, Subtitle A, Section 301(a)).
statements of organization and functions are
examples of documents appearing in this Summary of Collection: The U.S. Description of Respondents: Farms;
section. Department of Agriculture needs Business or other for-profit.
estimates of prices received by farmers Number of Respondents: 39,525.
and prices paid by farmers for Frequency of Responses: Reporting:
DEPARTMENT OF AGRICULTURE production goods and services for the Weekly; Monthly; Quarterly; Biennially;
following purposes: Annually.
Submission for OMB Review; —computing Parity Prices in accordance Total Burden Hours: 25,205.
Comment Request with requirements of the Agricultural Levi S. Harrell,
The Department of Agriculture will Adjustment Act of 1938 as amended; Departmental Information Collection
submit the following information —estimating value of production, Clearance Officer.
collection requirement(s) to OMB for inventory values, and cash receipts [FR Doc. 2023–24460 Filed 11–3–23; 8:45 am]
review and approval under the from farming; BILLING CODE 3410–20–P
Paperwork Reduction Act of 1995, —determining the level for farmer-
Public Law 104–13 on or after the date owned reserves;
of publication of this notice. Comments —providing guidelines for Risk DEPARTMENT OF AGRICULTURE
are requested regarding: (1) whether the Management Agency price selection
collection of information is necessary options; Farm Service Agency
for the proper performance of the —determining Federal disaster prices to
[Docket ID: FSA–2023–0021]
functions of the agency, including be paid;
whether the information will have —input into agricultures contribution to Information Collection Request; Urban
practical utility; (2) the accuracy of the the national income and product Agriculture Cooperative Agreement
agency’s estimate of burden including accounts (NIPA);
the validity of the methodology and —use in agricultures contribution to AGENCY: Farm Service Agency, United
assumptions used; (3) ways to enhance national gross domestic product States Department of Agriculture.
the quality, utility and clarity of the (GDP); ACTION: Notice; request for comments.
information to be collected; and (4) —establishing USDA’s net farm income
projections by the Economic Research SUMMARY: In accordance with the
ways to minimize the burden of the
Service; and Paperwork Reduction Act, the Farm
collection of information on those who
—determining the grazing fee on Service Agency (FSA) is requesting
are to respond, including through the
Federal lands. comments from all interested
use of appropriate automated,
General authority for these data individuals and organizations on a new
electronic, mechanical, or other
collection activities is granted under information collection request
technological collection techniques or
U.S. Code Title 7, Section 2204 (a). This associated with Urban Agriculture
other forms of information technology.
statute specifies that ‘‘The Secretary of Cooperative Agreements. The awarded
Comments regarding these
Agriculture shall procure and preserve cooperators are assisting FSA in
information collections are best assured
all information concerning agriculture providing outreach, education,
of having their full effect if received by
which he can obtain . . . by the resources, and technical assistance for
December 6, 2023. Written comments
collection of statistics . . . and shall urban agriculture producers to access
and recommendations for the proposed
distribute them among agriculturalists.’’ USDA programs and focus on long-term
information collection should be
Need and Use of the Information: The food sovereignty in historically
submitted within 30 days of the
NASS price program computes annual marginalized and underfunded
publication of this notice on the
U.S. weighted average prices received communities.
following website www.reginfo.gov/
public/do/PRAMain. Find this by farmers for wheat, barley, oats, corn, DATES: We will consider comments that
particular information collection by grain sorghum, rice, cotton, peanuts, we receive by January 5, 2024.
selecting ‘‘Currently under 30-day pulse crops and oilseeds based on ADDRESSES: We invite you to submit
Review—Open for Public Comments’’ or monthly marketing. Estimates of prices comments on this notice. You may
by using the search function. received are used by NASS to determine submit comments electronically through
ddrumheller on DSK120RN23PROD with NOTICES1
An agency may not conduct or the value of agricultural production. the Federal eRulemaking Portal: Go to
sponsor a collection of information Prices estimates are used by many http://www.regulations.gov and search
unless the collection of information Government agencies as a general for Docket ID FSA–2023–0021. Follow
displays a currently valid OMB control measure of commodity price changes, the online instructions for submitting
number and the agency informs economic analysis relating to farm comments.
potential persons who are to respond to income and alternative marketing All comments received will be posted
the collection of information that such policies, and for disaster and insurance without change and will be publicly
persons are not required to respond to payments. NASS estimates based on available on http://www.regulations.gov.
VerDate Sep<11>2014 17:53 Nov 03, 2023 Jkt 262001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\06NON1.SGM 06NON1
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices 76165
FOR FURTHER INFORMATION CONTACT: (2) Evaluate the accuracy of the https://www.zoomgov.com/j/
William O. Cruz, telephone: (202) 205– agency’s estimate of the burden of the 1612643265
4567; email: william.cruz@usda.gov. collection of information including the Æ Join by Phone (Audio Only): 1–833–
SUPPLEMENTARY INFORMATION: validity of the methodology and 435–1820 USA Toll Free; Meeting
assumptions used; ID: 161 264 3265#
Description of Information Collection (3) Evaluate the quality, utility, and FOR FURTHER INFORMATION CONTACT:
Request clarity of the information technology; David Barreras, Designated Federal
Title: Urban Agriculture Cooperative and Officer, at dbarreras@usccr.gov or 1–
Agreement. (4) Minimize the burden of the 202–656–8937.
OMB Control Number: 0560–0000. information collection on those who SUPPLEMENTARY INFORMATION: These
Type of Request: New. respond through the use of appropriate
Abstract: The awarded cooperators Committee meetings are available to the
automated, electronic, mechanical, or public through the meeting links above.
are working to successfully implement other technological collection
urban agriculture outreach, training, Any interested member of the public
techniques or other forms of information may attend these meetings. An open
technical assistance, and education to technology.
urban agriculture communities. With comment period will be provided to
All comments received in response to
the complex nature of some of FSA’s allow members of the public to make
this notice, including names and
programs, FSA is focusing on additional oral statements as time allows. Pursuant
addresses where provided, will be made
outreach and education to producers to the Federal Advisory Committee Act,
a matter of public record. Comments
who could benefit from additional public minutes of the meeting will
will be summarized and included in the
outreach to (1) increase knowledge, include a list of persons who are present
request for OMB approval of the
awareness, and participation in FSA at the meeting. If joining via phone,
information collection.
and USDA programs and services callers can expect to incur regular
associated with growing food in an Zach Ducheneaux, charges for calls they initiate over
urban area; (2) assist farmers with Administrator, Farm Service Agency. wireless lines, according to their
expanding their farming operations, [FR Doc. 2023–24413 Filed 11–3–23; 8:45 am] wireless plan. The Commission will not
accessing land, and implementing BILLING CODE 3410–E2–P
refund any incurred charges. Callers
climate-friendly practices that can will incur no charge for calls they
mitigate their susceptibility to natural initiate over land-line connections to
disasters in urban areas; and (3) increase COMMISSION ON CIVIL RIGHTS the toll-free telephone number. Closed
representation of underserved farmers captioning is available by selecting
serving on Urban County Committees. Notice of Public Meeting of the U.S. ‘‘CC’’ in the meeting platform. To
FSA is requesting comments on the Virgin Islands Advisory Committee to request additional accommodations,
project’s semi-annual progress reports the U.S. Commission on Civil Rights please email svillanueva@usccr.gov at
that the awarded cooperators are least 10 business days prior to the
AGENCY: U.S. Commission on Civil meeting.
required to submit to FSA. We received Rights.
OMB clearance to use the electronic Members of the public are entitled to
ACTION: Notice of virtual business submit written comments; the
submission (SF–270, SF–424 and SF–
425) in the Grants.gov. meetings. comments must be received in the
For the following estimated total regional office within 30 days following
SUMMARY: Notice is hereby given, the scheduled meeting. Written
annual burden on respondents, the pursuant to the provisions of the rules
formula used to calculate the total comments may be emailed to Sarah
and regulations of the U.S. Commission Villanueva at svillanueva@usccr.gov.
burden hour is the estimated average on Civil Rights (Commission) and the
time per responses hours multiplied by Persons who desire additional
Federal Advisory Committee Act, that information may contact the Regional
the estimated total annual responses. the U.S. Virgin Islands Advisory
Estimate of Annual Burden: Public Programs Coordination Unit at 1–202–
Committee (Committee) to the U.S. 656–8937.
reporting burden for the collection of Commission on Civil Rights will hold
information is estimated to average 10 Records generated from this meeting
public meetings via Zoom. The purpose may be inspected and reproduced at the
hours per response. of these meetings is to discuss, plan,
Respondents: Cooperators. Regional Programs Coordination Unit
and vote, as needed, on matters related Office, as they become available, both
Estimated Number of Respondents:
to the Committee’s inaugural civil rights before and after the meeting. Records of
18.
Estimated Number of Responses per project. the meetings will be available via
Respondent: 2. DATES: www.facadatabase.gov under the
Estimated Total Annual Number of • Wednesday, November 15, 2023, from Commission on Civil Rights, U.S. Virgin
Responses: 36. a.m.–1 p.m. Atlantic Time Islands Advisory Committee Advisory
Estimated Average Time per • Thursday, November 30, 2023, from Committee link. Persons interested in
Response: 10 hours. 12 p.m.–1:30 p.m. Atlantic Time the work of this Committee are directed
Estimated Total Annual Burden ADDRESSES: These meetings will be held to the Commission’s website,
Hours: 360 hours. via Zoom. www.usccr.gov, or may contact the
We are requesting comments on all • November 15th Meeting Regional Programs Coordination Unit at
aspects of the information collections to Æ Meeting Link (Audio/Visual): svillanueva@usccr.gov.

help us: https://www.zoomgov.com/j/
(1) Evaluate whether the proposed 1604313189 Agenda
collection of information is necessary Æ Join by Phone (Audio Only): 1–833– I. Welcome and Roll Call
for the proper performance of the 435–1820 USA Toll Free; Meeting II. Annoucements and Updates
functions of the agency, including ID: 160 431 3189# III. Committee Discussion
whether the information will have • November 30th Meeting IV. Next Steps
practical utility; Æ Meeting Link (Audio/Visual): V. Public Comment
76166 Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices
VI. Adjournment please email svillanueva@usccr.gov at Impact on Native Hawaiian Children

Dated: October 31, 2023. least 10 business days prior to the and Families.’’
David Mussatt,
meeting. DATES: The briefing will take place on
Members of the public are entitled to Monday, November 20, 2023, from 2
Supervisory Chief, Regional Programs Unit.
submit written comments; the p.m.–4:30 p.m. HST.
[FR Doc. 2023–24390 Filed 11–3–23; 8:45 am]
comments must be received in the
BILLING CODE P ADDRESSES:
regional office within 30 days following
Zoom Link to Join (Audio/Visual):
the scheduled meeting. Written
https://www.zoomgov.com/meeting/
comments may be emailed to Sarah
COMMISSION ON CIVIL RIGHTS register/vJIsd-2vrj8jHPPWjAz0vH_
Villanueva at svillanueva@usccr.gov.
PqGvCnayAwHg.
Notice of Public Meeting of the Ohio Persons who desire additional
information may contact the Regional Audio: (833) 435–1820; Meeting ID:
Advisory Committee to the U.S. 161 047 0496.
Commission on Civil Rights Programs Coordination Unit at 1–202–
618–4158. FOR FURTHER INFORMATION CONTACT:
AGENCY: U.S. Commission on Civil Records generated from this meeting Kayla Fajota, Designated Federal Officer
Rights. may be inspected and reproduced at the (DFO) at kfajota@usccr.gov or by phone
ACTION: Notice of virtual business Regional Programs Coordination Unit at (434) 515–2395.
meeting. Office, as they become available, both SUPPLEMENTARY INFORMATION:
before and after the meeting. Records of Committee meetings are available to the
SUMMARY: Notice is hereby given, the meetings will be available via public through the videoconference link
pursuant to the provisions of the rules www.facadatabase.gov under the above. Any interested member of the
and regulations of the U.S. Commission Commission on Civil Rights, Ohio public may listen to the meeting. An
on Civil Rights (Commission) and the Advisory Committee link. Persons open comment period will be provided
Federal Advisory Committee Act, that interested in the work of this Committee to allow members of the public to make
the Ohio Advisory Committee are directed to the Commission’s a statement as time allows. Per the
(Committee) to the U.S. Commission on website, http://www.usccr.gov, or may Federal Advisory Committee Act, public
Civil Rights will hold a public meeting contact the Regional Programs minutes of the meeting will include a
via Zoom. The purpose of the meeting Coordination Unit at svillanueva@ list of persons who are present at the
is to discuss the outline of the draft usccr.gov. meeting. If joining via phone, callers can
report on the source of income expect to incur regular charges for calls
discrimination in Ohio housing. Agenda
they initiate over wireless lines,
DATES: Wednesday, December 13, 2023, I. Welcome and Roll Call according to their wireless plan. The
from 12 p.m.–1 p.m. Eastern Time. II. Approval of Minutes Commission will not refund any
ADDRESSES: The meeting will be held III. Announcements and Updates incurred charges. Closed captions will
via Zoom. IV. Committee Discussion be provided for individuals who are
Registration Link (Audio/Visual): V. Next Steps deaf, hard of hearing, or who have
https://www.zoomgov.com/j/ VI. Public Comment certain cognitive or learning
1619236390 VII. Adjournment impairments. To request additional
Join by Phone (Audio Only): 1–833– accommodations, please email Angelica
435–1820 USA Toll Free; Meeting ID: Dated: October 31, 2023.
Trevino, Support Services Specialists, at
161 923 6390# David Mussatt,
atrevino@usccr.gov at least 10 business
FOR FURTHER INFORMATION CONTACT: Supervisory Chief, Regional Programs Unit. days prior to the meeting.
Melissa Wojnaroski, Designated Federal [FR Doc. 2023–24391 Filed 11–3–23; 8:45 am] Members of the public are entitled to
Officer, at mwojnaroski@usccr.gov or 1– BILLING CODE P make comments during the open period
202–618–4158. at the end of the meeting. Members of
SUPPLEMENTARY INFORMATION: This the public may also submit written
Committee meeting is available to the COMMISSION ON CIVIL RIGHTS comments; the comments must be
public through the registration link received in the Regional Programs Unit
Notice of Public Meeting of the Hawai’i
above. Any interested member of the within 30 days following the meeting.
Advisory Committee
public may attend this meeting. An Written comments may be emailed to
open comment period will be provided AGENCY: U.S. Commission on Civil Kayla Fajota at kfajota@usccr.gov.
to allow members of the public to make Rights. Records and documents discussed
oral statements as time allows. Pursuant ACTION: Announcement of a virtual during the meeting will be available for
to the Federal Advisory Committee Act, briefing. public viewing prior to and after the
public minutes of the meeting will meeting at https://
include a list of persons who are present SUMMARY: Notice is hereby given, www.facadatabase.gov/FACA/FACA
at the meeting. If joining via phone, pursuant to the provisions of the rules PublicViewCommitteeDetails?id=a10t00
callers can expect to incur regular and regulations of the U.S. Commission 00001gzl0AAA.
charges for calls they initiate over on Civil Rights (Commission) and the Please click on ‘‘Committee Meetings’’
wireless lines, according to their Federal Advisory Committee Act tab. Records generated from this
wireless plan. The Commission will not (FACA) that a meeting of the Hawai’i meeting may also be inspected and
refund any incurred charges. Callers Advisory Committee to the U.S. reproduced at the Regional Programs
will incur no charge for calls they Commission on Civil Rights will Unit, as they become available, both
initiate over land-line connections to convene by ZoomGov on Monday, before and after the meeting. Persons
the toll-free telephone number. Closed November 20, 2023, from 2 p.m. to 4:30 interested in the work of this Committee
captioning is available by selecting p.m. HST, to collect testimony related to are directed to the Commission’s
‘‘CC’’ in the meeting platform. To the Committee’s topic ‘‘Examining website, https://www.usccr.gov, or may
request additional accommodations, Hawai‘i’s Child Welfare System and its contact the Regional Programs Unit at
the above phone number or email wireless lines, according to their (OMB) in accordance with the
address. wireless plan. The Commission will not Paperwork Reduction Act of 1995 to
refund any incurred charges. Callers conduct the Census Household Panel
Agenda
will incur no charge for calls they recruitment and first topical operation
I. Welcome, Opening Remarks, and Roll initiate over land-line connections to (OMB No. 0607–1025, Exp. 6/20/26).
Call the toll-free telephone number. Closed The Census Household Panel is
II. Panelists Presentations captioning is available by selecting designed to ensure availability of
III. Committee Question and Answer ‘‘CC’’ in the meeting platform. To frequent data collection for nationwide
IV. Public Comment request additional accommodations, estimates on a variety of topics for a
V. Adjournment please email svillanueva@usccr.gov at variety of subgroups of the population.
Dated: October 31, 2023. least 10 business days prior to the Content for both Topical 2 and
David Mussatt, meeting. Topical 3 will consist of a modified
Supervisory Chief, Regional Programs Unit. Members of the public are entitled to version of the Household Pulse Survey
[FR Doc. 2023–24398 Filed 11–3–23; 8:45 am] submit written comments; the questionnaire. Topics covered include
comments must be received in the employment, telework, access to infant
BILLING CODE P
regional office within 30 days following formula, health and disability,
the scheduled meeting. Written children’s mental health treatment,
COMMISSION ON CIVIL RIGHTS comments may be emailed to Sarah social connection/isolation, childcare
Villanueva at svillanueva@usccr.gov. arrangements, educational enrollment,
Notice of Public Meeting of the Georgia Persons who desire additional inflation and spending, food security,
Advisory Committee to the U.S. information may contact the Regional experience of national disasters,
Commission on Civil Rights Programs Coordination Unit at 1–434– housing, COVID testing and symptoms,
515–0204. COVID vaccination uptake, and long
AGENCY: U.S. Commission on Civil Records generated from this meeting COVID. Data will be collected in
Rights. may be inspected and reproduced at the December and January to study
ACTION: Notice of public meeting. Regional Programs Coordination Unit methodological implications of having a
Office, as they become available, both repeated measure design. These data
SUMMARY: Notice is hereby given,
before and after the meeting. Records of will also be studied in conjunction with
pursuant to the provisions of the rules
the meetings will be available via the January fielding of the Household
and regulations of the U.S. Commission
www.facadatabase.gov under the Pulse Survey. The Department of
on Civil Rights (Commission) and the
Commission on Civil Rights, Georgia Commerce will submit the following
Federal Advisory Committee Act, that
Advisory Committee link. Persons information collection request to the
the Georgia Advisory Committee
interested in the work of this Committee Office of Management and Budget
(Committee) to the U.S. Commission on
are directed to the Commission’s (OMB) for review and clearance in
Civil Rights will hold a public meeting
website, http://www.usccr.gov, or may accordance with the Paperwork
via Zoom. The purpose of the meeting
contact the Regional Programs Reduction Act of 1995, on or after the
is to discuss the post-report activities of
Coordination Unit at svillanueva@ date of publication of this notice. We
the Committee’s recent civil rights
usccr.gov. invite the general public and other
project on civil asset forfeiture in
Federal agencies to comment on
Georgia. Agenda proposed, and continuing information
DATES: Friday, December 1, 2023, from I. Welcome & Roll Call collections, which helps us assess the
10 a.m.–11 a.m. Eastern Time. II. Approval of Minutes impact of our information collection
ADDRESSES: The meeting will be held III. Announcements and Updates requirements and minimize the public’s
via Zoom. IV. Discussion: Post-Report Activities reporting burden. Public comments
Registration Link (Audio/Visual): V. Next Steps were previously requested via the
https://www.zoomgov.com/j/ VI. Public Comment Federal Register on February 6, 2023,
1601357294. VII. Adjournment during a 60-day comment period. This
Join by Phone (Audio Only): 1–833– Dated: October 31, 2023. notice allows for an additional 30 days
435–1820 USA Toll-Free; Meeting ID: David Mussatt, for public comments.
160 135 7294#. Agency: U.S. Census Bureau,
Supervisory Chief, Regional Programs Unit.
FOR FURTHER INFORMATION CONTACT: Department of Commerce.
[FR Doc. 2023–24392 Filed 11–3–23; 8:45 am] Title: Census Household Panel
Melissa Wojnaroski, Designated Federal
Officer (DFO), at mwojnaroski@ BILLING CODE P Topical 2 and Topical 3 Operations.
usccr.gov or 1–202–618–4158. OMB Control Number: 0607–1025.
Form Number(s): To be determined.
SUPPLEMENTARY INFORMATION: This Type of Request: Request for a
Committee meeting is available to the DEPARTMENT OF COMMERCE
Revision of a currently approved
public through the registration link Census Bureau collection.
above. Any interested member of the Number of Respondents: 12,225 panel
public may attend this meeting. An Agency Information Collection members.
open comment period will be provided Activities; Submission to the Office of Average Hours per Response: 4 hours
to allow members of the public to make Management and Budget (OMB) for per year (20 minutes for monthly
oral statements as time allows. Pursuant Review and Approval; Comment collection).
the Federal Advisory Committee Act, Request; Census Household Panel Burden Hours: 43,956.
public minutes of the meeting will Topical 2 and Topical 3 Operations Needs and Uses: The Census
include a list of persons who are present Household Panel is a probability-based
at the meeting. If joining via phone, On June 29, 2023, the Department of nationwide nationally representative
callers can expect to incur regular Commerce received clearance from the survey panel designed to test the
charges for calls they initiate over Office of Management and Budget methods to collect data on a variety of
topics of interest, and for conducting DEPARTMENT OF COMMERCE DEPARTMENT OF COMMERCE

experimentation on alternative question
wording and methodological Foreign-Trade Zones Board International Trade Administration
approaches. The goal of the Census
Household Panel is to ensure [C–533–896]
[B–56–2023]
availability of frequent data collection
Common Alloy Aluminum Sheet From
for nationwide estimates on a variety of Foreign-Trade Zone 61; Application for India: Final Results of Countervailing
topics and a variety of subgroups of the Subzone; PR Five Vega Alta, LLC; Duty Administrative Review; 2020–
population, meeting standards for Vega Alta, Puerto Rico 2021
transparent quality reporting of the
Federal Statistical Agencies and the An application has been submitted to AGENCY: Enforcement and Compliance,
Office of Management and Budget the Foreign-Trade Zones (FTZ) Board by International Trade Administration,
(OMB). the Department of Economic Department of Commerce.
Panelists and households selected for Development and Commerce, grantee of SUMMARY: The U.S. Department of
the Panel were recruited from the FTZ 61, requesting subzone status for Commerce (Commerce) determines that
Census Bureau’s gold standard Master the facility of PR Five Vega Alta, LLC, Hindalco Industries Limited (Hindalco),
Address File. This ensures the Panel is located in Vega Alta, Puerto Rico. The a producer/exporter of common alloy
rooted in this rigorously developed and application was submitted pursuant to aluminum sheet (aluminum sheet) from
maintained frame and available for the provisions of the Foreign-Trade India received countervailable subsidies
linkage to administrative records Zones Act, as amended (19 U.S.C. 81a– during the period of review (POR),
securely maintained and curated by the 81u), and the regulations of the FTZ August 14, 2020, through December 31,
Census Bureau. Invitations to complete Board (15 CFR part 400). It was formally 2021.
the monthly surveys will be sent via docketed on November 1, 2023. DATES: Applicable November 6, 2023.
email and SMS messages and
The proposed subzone (61.9878 acres) FOR FURTHER INFORMATION CONTACT:
questionnaires will be mainly internet
is located at Carr. 690, Km. 1.3, Vega Benito Ballesteros, AD/CVD Operations,
self-response. The Panel will maintain
Alta, Puerto Rico. No authorization for Office IX, Enforcement and Compliance,
representativeness by allowing
production activity has been requested International Trade Administration,
respondents who do not use the internet
at this time. U.S. Department of Commerce, 1401
to respond via computer-assisted
Constitution Avenue NW, Washington,
telephone interviewing (CATI). All In accordance with the FTZ Board’s DC 20230; telephone: (202) 482–7425.
panelists will receive an incentive for regulations, Camille Evans of the FTZ
each complete questionnaire. Periodic SUPPLEMENTARY INFORMATION:
Staff is designated examiner to review
replenishment samples will maintain the application and make Background
representativeness and panelists will be recommendations to the FTZ Board.
replaced after a period of three years. On May 4, 2023, Commerce published
Public comment is invited from the Preliminary Results of this
Affected Public: Individuals or administrative review in the Federal
interested parties. Submissions shall be
Households. Register and invited interested parties
addressed to the FTZ Board’s Executive
Frequency: Monthly. Secretary and sent to: ftz@trade.gov. The to comment.1 On August 1, 2023,
Respondent’s Obligation: Voluntary. closing period for their receipt is Commerce extended the deadline for
Legal Authority: Title 13, United December 18, 2023. Rebuttal comments issuing the final results until October
States Code, Sections 8(b), 141, 182 and in response to material submitted 31, 2023.2 For a complete description of
193. during the foregoing period may be the events that occurred since the
submitted during the subsequent 15-day publication of the Preliminary Results,
This information collection request see the Issues and Decision
may be viewed at www.reginfo.gov. period to January 2, 2024.
Memorandum.3
Follow the instructions to view the A copy of the application will be
Department of Commerce collections available for public inspection in the Scope of the Order 4
currently under review by OMB. ‘‘Online FTZ Information Section’’ The product covered by the Order is
Written comments and section of the FTZ Board’s website, aluminum sheet.5
recommendations for the proposed which is accessible via www.trade.gov/
information collection should be ftz. 1 See Common Alloy Aluminum Sheet from India:
submitted within 30 days of the Preliminary Results of Countervailing Duty

For further information, contact Administrative Review and Partial Rescission;
publication of this notice on the
Camille Evans at Camille.Evans@ 2020–21, 88 FR 28487 (May 4, 2023) (Preliminary
following website www.reginfo.gov/ Results), and accompanying Preliminary Decision
public/do/PRAMain. Find this trade.gov.
Memorandum (PDM).
particular information collection by Dated: November 1, 2023. 2 See Memorandum, ‘‘Extension of Deadline for
selecting ‘‘Currently under 30-day Elizabeth Whiteman, Final Results,’’ dated August 1, 2023.
3 See Memorandum, ‘‘Common Alloy Aluminum
Review—Open for Public Comments’’ or Executive Secretary. Sheet from India: Issues and Decision
by using the search function and [FR Doc. 2023–24480 Filed 11–3–23; 8:45 am] Memorandum for the Final Results of the
entering either the title of the collection
Countervailing Duty Administrative Review; 2020–

BILLING CODE 3510–DS–P
or the OMB Control Number 0607–1025. 2021,’’ dated concurrently with, and hereby
adopted by, this notice (Issues and Decision
Sheleen Dumas, Memorandum).
4 See Common Alloy Aluminum Sheet from
Department PRA Clearance Officer, Office of
the Under Secretary for Economic Affairs, Bahrain, India, and the Republic of Turkey:
Commerce Department. Countervailing Duty Orders, 86 FR 22144 (April 27,
2021) (Order).
[FR Doc. 2023–24429 Filed 11–3–23; 8:45 am] 5 For a complete description of the scope of the
BILLING CODE 3510–07–P Order, see Preliminary Results PDM.
Analysis of Comments Received Memorandum can be accessed directly Act of 1930, as amended (the Act). For
All issues raised by the interested at https://access.trade.gov/public/ each of the subsidy programs found
parties in their case and rebuttal briefs FRNoticesListLayout.aspx. countervailable, we find that there is a
are addressed in the Issues and Decision subsidy, i.e., a government-provided
Changes Since the Preliminary Results
Memorandum. A list of topics discussed financial contribution that gives rise to
in the Issues and Decision Based on comments received from a benefit to the recipient, and that the
Memorandum is provided in the interested parties, we revised our subsidy is specific.7 For a full
appendix to this notice. The Issues and analysis for certain programs in this description of the methodology
Decision Memorandum is a public review.6 However, we made no changes underlying all of Commerce’s
document and is on file electronically to the calculations of the net conclusions, see the Issues and Decision
via Enforcement and Compliance’s countervailable subsidy rates for Memorandum.
Antidumping and Countervailing Duty Hindalco. Final Results of Review
Centralized Electronic Service System Methodology
(ACCESS). ACCESS is available to As a result of this review, Commerce
registered users at https:// Commerce conducted this determines the following net
access.trade.gov. In addition, a complete administrative review in accordance countervailable subsidy rates exist for
version of the Issues and Decision with section 751(a)(1)(A) of the Tariff 2020 and 2021:
Subsidy rate Subsidy rate

Company (percent ad (percent ad
valorem) 2020 valorem) 2021
Hindalco Industries Limited 8 ....................................................................................................................... 37.90 32.43
Disclosure Cash Deposit Requirements 751(a)(1) and 777(i)(1) of the Act, and 19
In accordance with section CFR 351.221(b)(5).
Normally, Commerce discloses to
interested parties the calculations for 751(a)(2)(C) of the Act, Commerce will Dated: October 31, 2023.
the final results of review within five instruct CBP to collect cash deposits of Lisa W. Wang,
estimated countervailing duties in the
days of public announcement or, if there Assistant Secretary for Enforcement and
amount established for 2021 for Compliance.
is no public announcement, within five
Hindalco with regard to shipments of
days of the date of publication of the Appendix
subject merchandise entered, or
notice of final results in the Federal withdrawn from warehouse, for
Register, in accordance with 19 CFR List of Topics Discusses in the Issues and
consumption on or after the date of Decision Memorandum
351.224(b). However, because we have publication of the final results of this
made no changes to Hindalco’s review. For all non-reviewed firms, CBP I. Summary
calculations in the final results, there II. Background
will continue to collect cash deposits of
are no calculations to disclose. III. Subsidies Valuation
estimated countervailing duties at the
IV. Analysis of Programs
Assessment Rates all-others rate or the most recent
V. Discussion of the Issues
company-specific rate applicable to the
Comment 1: Benefit Analysis—Mining
In accordance with section company, as appropriate. These cash
Rights Lease Extensions Program
751(a)(2)(C) of the Act and 19 CFR deposit requirements, when imposed,
Comment 2: Whether the Provision of Coal
351.212(b)(2), Commerce has shall remain in effect until further
for Less than Adequate Renumeration
determined, and U.S. Customs and notice. (LTAR) is Specific
Border Protection (CBP) shall assess, Administrative Protective Order Comment 3: Whether the Selection of the
countervailing duties on all appropriate Coal Benchmark Is Appropriate
This notice also serves as the final
entries covered by this review for Comment 4: Whether the Remission of
reminder to parties subject to an
Hindalco at the applicable ad valorem Duties and Taxes on Export Products
administrative protective order (APO) of
assessment rates listed for the (RODTEP) Program is Countervailable
their responsibility concerning the Comment 5: Whether to Apply Adverse
corresponding time periods. Commerce destruction of proprietary information
intends to issue assessment instructions Facts Available (AFA) to the Programs
disclosed under APO in accordance Discovered at Verification
to CBP no earlier than 35 days after the with 19 CFR 351.305(a)(3). Timely
date of publication of the final results of VI. Recommendation
written notification of the return or
this review in the Federal Register. If a destruction of APO materials or [FR Doc. 2023–24489 Filed 11–3–23; 8:45 am]
timely summons is filed at the U.S. conversion to judicial protective order is BILLING CODE 3510–DS–P
Court of International Trade, the hereby requested. Failure to comply
assessment instructions will direct CBP with the regulations and terms of an
not to liquidate relevant entries until the APO is a sanctionable violation.
time for parties to file a request for a

Notification to Interested Parties
statutory injunction has expired (i.e.,
within 90 days of publication). We are issuing and publishing these
final results in accordance with sections
6 For a full description of these revisions, see the of the Act regarding benefit; and section 771(5A) of Hindalco: Utkal Alumina International Limited. See
Issues and Decision Memorandum. the Act regarding specificity. Preliminary Results PDM at 7.
7 See sections 771(5)(B) and (D) of the Act 8 As discussed in the PDM, Commerce has found
regarding financial contribution; section 771(5)(E) the following company to be cross-owned with
DEPARTMENT OF COMMERCE respondent.5 On March 3, 2023, Global appendix to this notice. The Preliminary
Tubing LLC withdrew its review request Decision Memorandum is a public
International Trade Administration with regard to JFE, pursuant to 19 CFR document and is on file electronically
[A–588–874] 351.213(d)(1).6 As Global Tubing LLC is via Enforcement and Compliance’s
the only party that requested a review Antidumping and Countervailing Duty
Certain Hot-Rolled Steel Flat Products for JFE and the request for withdrawal Centralized Electronic Service System
From Japan: Preliminary Results and is timely, Commerce is preliminarily (ACCESS). Access to ACCESS is
Partial Rescission of Antidumping rescinding the review with respect to available to registered users at https://
Duty Administrative Review; 2021– JFE.7 Subsequently, Commerce selected access.trade.gov. In addition, a complete
2022 Tokyo Steel Manufacturing Co, Ltd. version of the Preliminary Decision
(Tokyo Steel), as a mandatory Memorandum can be accessed at
AGENCY: Enforcement and Compliance, respondent in this review.8 https://access.trade.gov/public/
International Trade Administration, On June 27, 2023, in accordance with FRNoticesListLayout.aspx.
Department of Commerce. section 751(a)(3)(A) of the Act and 19
SUMMARY: The U.S. Department of CFR 351.213(h)(1), we extended the Rescission of Administrative Review, in
Commerce (Commerce) preliminarily deadline for the preliminary results of Part
determines that one of the two this review until October 31, 2023.9 For Pursuant to 19 CFR 351.213(d)(1),
producers/exporters of hot-rolled steel a detailed description of the events that Commerce will rescind an
flat products (hot-rolled steel) from followed the initiation of this review, administrative review, in whole or in
Japan, sold subject merchandise in the see the Preliminary Decision part, if the parties that requested a
United States at prices below normal Memorandum.10 review withdraw the request within 90
value during the period of review (POR) Scope of the Order days of the date of publication of the
October 1, 2021, through September 30, notice of initiation. Commerce received
2022. The merchandise covered by the timely-filed withdrawal requests for
Order is hot-rolled steel from Japan. For JFE.12 Because the withdrawal requests
DATES: Applicable November 6, 2023.
a complete description of the scope of were timely filed and no other party
FOR FURTHER INFORMATION CONTACT: Jack the Order, see the Preliminary Decision
Zhao or Myrna Lobo, AD/CVD requested a review of JFE, in accordance
Memorandum.11 with 19 CFR 351.213(d)(1), Commerce is
Operations, Office VII, Enforcement and
Compliance, International Trade Methodology rescinding this review of the Order with
Administration, U.S. Department of respect to JFE.
Commerce is conducting this
Commerce, 1401 Constitution Avenue administrative review in accordance Preliminary Results
NW, Washington, DC 20230; telephone: with section 751(a) of the Act. Export We preliminarily determine the
(202) 482–1396 and (202) 482–2371, price and constructed export price were following estimated weighted-average
respectively. calculated in accordance with section dumping margins for the period October
SUPPLEMENTARY INFORMATION: 772 of the Act. Normal value is 1, 2021, through September 30, 2022:
calculated in accordance with section
Background 773 of the Act. For a full description of Weighted-
Commerce is conducting an the methodology underlying our average
administrative review of the conclusions, see the Preliminary Producer/exporter dumping
margin
antidumping duty order on hot-rolled Decision Memorandum. A list of topics (percent)
steel from Japan in accordance with discussed in the Preliminary Decision
section 751(a)(1)(B) of Tariff Act of Memorandum is attached as an Nippon Steel Corporation/Nippon
1930, as amended (the Act).1 Commerce Steel Nisshin Co., Ltd./Nippon
initiated this administrative review of 86 FR 47615 (August 26, 2021). In the absence of Steel Trading Corporation ....... 1.39
the Order on December 5, 2022, record information indicating that Commerce Tokyo Steel Manufacturing Co.,
should reevaluate this determination, we are Ltd ........................................... 0.00
covering three producers and/or treating these companies as a single entity for
exporters.2 We selected two companies, purposes of respondent selection.
NSC 3 and JFE 4 as the mandatory 5 See Memorandum, ‘‘Respondent Selection for Disclosure and Public Comment
the 2021–2022 Antidumping Duty Administrative We intend to disclose the calculations
1 See Certain Hot-Rolled Steel Flat Products from Review of Certain Hot-Rolled Steel Flat Products performed for these preliminary results
Australia, Brazil, Japan, the Republic of Korea, the from Japan,’’ dated February 23, 2023.
6 See Letter from Global Tubing LLC, of review to interested parties within
Netherlands, the Republic of Turkey, and the
United Kingdom: Amended Final Affirmative ‘‘Withdrawal of Global Tubing LLC’s Request for five days of the date of publication of
Antidumping Determinations for Australia, the Administrative Review of JFE Steel and JFE Shoji,’’ this notice in accordance with 19 CFR
Republic of Korea, and the Republic of Turkey and dated March 3, 2023 (JFE Letter of Withdrawal). 351.224(b). Pursuant to 19 CFR
7 See 19 CFR 351.213(d)(1).
Antidumping Duty Orders, 81 FR 67962 (October 3, 351.309(c), interested parties may
2016) (Order). 8 See Memorandum, ‘‘Respondent Selection for
2 See Initiation of Antidumping and the 2021–2022 Antidumping Duty Administrative
submit case briefs no later than 30 days
Countervailing Duty Administrative Reviews, 87 FR Review of Certain Hot-Rolled Steel Flat Products after the date of publication of this
74404 (December 5, 2022) (Initiation Notice). from Japan—Selection of Tokyo Steel notice. Rebuttal briefs, the content of
3 NSC is a single entity comprised of the Manufacturing Co., Ltd. as a Mandatory which is limited to issues raised in the
following companies: Nippon Steel Corporation; Respondent,’’ dated March 7, 2023.
case briefs, may be filed no later than
9 See Memorandum, ‘‘Extension of Deadline for

Nippon Steel Nisshin Co., Ltd.; and Nippon Steel
Trading Corporation. See Certain Hot-Rolled Steel Preliminary Results of Antidumping Duty seven days after the date for filing case
Flat Products from Japan: Notice of Final Results of Administrative Review,’’ dated June 27, 2023. briefs.13 Parties who submit case briefs
Antidumping Duty Changed Circumstances Review, 10 See Memorandum, ‘‘Decision Memorandum for or rebuttal briefs in this proceeding are
84 FR 46713 (September 5, 2019). the Preliminary Results of the Antidumping Duty encouraged to submit with each
4 JFE is a single entity comprised of JFE Shoji Administrative Reviews: Certain Hot-Rolled Steel
Flat Products from Japan; 2021–2022,’’ dated
argument: (1) a statement of the issue;
Corporation and JFE Steel Corporation. See Certain
Hot-Rolled Steel Flat Products from Japan: Results concurrently with, and hereby adopted by, this
of Antidumping Duty Administrative Review and notice (Preliminary Decision Memorandum). 12 See JFE Letter of Withdrawal.
Final Determination of No Shipments; 2018–2019, 11 Id. 13 See 19 CFR 351.309(d).
(2) a brief summary of the argument; specific ad valorem assessment rate is published for the most recently-
and (3) a table of authorities.14 Case and zero or de minimis in the final results completed segment of this proceeding in
rebuttal briefs should be filed using of review, we will instruct CBP to which the company participated; (3) if
ACCESS 15 and must be served on liquidate the appropriate entries the exporter is not a firm covered in this
interested parties.16 Executive without regard to antidumping duties in review, or the underlying investigation,
summaries should be limited to five accordance with 19 CFR 351.106(c)(2). If but the manufacturer is, then the cash
pages total, including footnotes. Note NSC’s and Tokyo Steel’s weighted- deposit rate will be the rate established
that Commerce has amended certain of average dumping margins are zero or de for the most recent segment for the
its requirements pertaining to the minimis in the final results of review, manufacturer of the merchandise; and
service of documents in 19 CFR we will instruct CBP not to assess duties (4) the cash deposit rate for all other
351.303(f).17 on any of its entries in accordance with manufacturers or exporters will
Pursuant to 19 CFR 351.310(c), the Final Modification for Reviews, i.e., continue to be 5.58 percent, the all-
interested parties who wish to request a ‘‘{w}here the weighted-average margin
hearing must submit a written request to others rate established in the less-than-
of dumping for the exporter is
the Assistant Secretary for Enforcement fair-value investigation.23 These deposit
determined to be zero or de minimis, no
and Compliance, filed via ACCESS. An antidumping duties will be assessed.’’ 21 requirements, when imposed, shall
electronically filed request must be For entries of subject merchandise remain in effect until further notice.
received successfully in its entirety by during the POR produced by NSC or Notification to Importers
5:00 p.m. Eastern Time within 30 days Tokyo Steel for which the producer did
of the date of publication of this not know its merchandise was destined This notice serves as a preliminary
notice.18 Requests should contain: (1) for the United States, we will instruct reminder to importers of their
the party’s name, address, and CBP to liquidate unreviewed entries at responsibility under 19 CFR
telephone number; (2) the number of the all-others rate if there is no rate for 351.402(f)(2) to file a certificate
participants; and (3) a list of issues the intermediate company (or regarding the reimbursement of
parties intend to discuss. If a request for companies) involved in the antidumping and/or countervailing
a hearing is made, Commerce intends to transaction.22 duties prior to liquidation of the
hold the hearing at a date and time to Commerce intends to issue relevant entries during this POR. Failure
be determined.19 Parties should confirm assessment instructions to CBP no to comply with this requirement could
the date, time, and location of the earlier than 35 days after the date of result in Commerce’s presumption that
hearing two days before the scheduled publication of the final results of this reimbursement of antidumping and/or
date. review in the Federal Register. If a countervailing duties occurred and the
Commerce intends to issue the final timely summons is filed at the U.S.
subsequent assessment of double
results of this administrative review, Court of International Trade, the
including the results of its analysis of antidumping duties.
assessment instructions will direct CBP
the issues raised in any case or rebuttal not to liquidate relevant entries until the Notification to Interested Parties
briefs, no later than 120 days after the time for parties to file a request for a
date of publication of this notice, unless statutory injunction has expired (i.e., We are issuing and publishing these
extended.20 within 90 days of publication). results in accordance with sections
751(a)(1) and 777(i)(1) of the Act.
Assessment Rates Cash Deposit Requirements
Upon completion of the The following deposit requirements
administrative review, Commerce shall will be effective upon publication of the Lisa W. Wang,
determine, and U.S. Customs and notice of final results of this Assistant Secretary for Enforcement and
Border Protection (CBP) shall assess, administrative review for all shipments Compliance.
antidumping duties on all appropriate of the subject merchandise entered, or Appendix
entries. If the weighted-average withdrawn from warehouse, for
dumping margins for NSC and Tokyo consumption on or after the date of List of Topics Discussed in the Preliminary
Steel are not zero or de minimis (i.e., publication, as provided by section Decision Memorandum
less than 0.5 percent) in the final results 751(a)(2)(C) of the Act: (1) the cash I. Summary
of this review, we will calculate deposit rate for each specific company II. Background
importer-specific ad valorem listed above will be that established in III. Scope of the Order
assessment rates for the merchandise the final results of this review, except if IV. Rescission of Administrative Review, in
based on the ratio of the total amount of the rate is less than 0.50 percent and, Part
dumping calculated for the examined therefore, de minimis within the V. Discussion of the Methodology
sales made during the POR to each meaning of 19 CFR 351.106(c)(1), in VI. Currency Conversion
importer and the total entered value of which case the cash deposit rate will be VII. Recommendation
those same sales, in accordance with 19 zero; (2) for previously investigated [FR Doc. 2023–24491 Filed 11–3–23; 8:45 am]
CFR 351.212(b)(1). Where an importer- companies not participating in this BILLING CODE 3510–DS–P
review, the cash deposit will continue
14 See 19 CFR 351.309(c)(2) and (d)(2). to be the company-specific rate
15 See, generally, 19 CFR 351.303.
16 See 19 CFR 351.303(f).

21 See Antidumping Proceedings: Calculation of
17 See Administrative Protective Order, Service,
the Weighted-Average Dumping Margin and
and Other Procedures in Antidumping and Assessment Rate in Certain Antidumping
Countervailing Duty Proceedings; Final Rule, 88 FR Proceedings; Final Modification, 77 FR 8101, 8102
67069 (September 29, 2023). (February 14, 2012) (Final Modification for
18 See 19 CFR 351.310(c).
Reviews).
19 See 19 CFR 351.310(d). 22 See Antidumping and Countervailing Duty
20 See section 751(a)(3)(A) of the Act and 19 CFR Proceedings: Assessment of Antidumping Duties, 68
351.213(h). FR 23954 (May 6, 2003). 23 See Order.
DEPARTMENT OF COMMERCE members manufacture or produce the registered users at https://access.

domestic like product in the United trade.gov. A complete version of the
International Trade Administration States. On August 2, 2023, the domestic Issues and Decision Memorandum can
[A–570–062] interested party provided a complete be accessed directly at https://access.
substantive response for this review trade.gov/public/FRNoticesListLayout.
Cast Iron Soil Pipe Fittings From the within the 30-day deadline specified in aspx.
People’s Republic of China: Final 19 CFR 351.218(d)(3)(i).5 We received
Results of the Expedited First Sunset no substantive responses from any other Final Results of Sunset Review
Review of the Antidumping Duty Order interested parties, nor was a hearing
requested. On August 22, 2023, Pursuant to sections 751(c)(1) and
AGENCY: Enforcement and Compliance, Commerce notified the U.S. 752(c)(1) and (3) of the Act, Commerce
International Trade Administration, International Trade Commission (ITC) determines that revocation of the Order
Department of Commerce. that it did not receive an adequate would be likely to lead to continuation
SUMMARY: The U.S. Department of substantive response from respondent or recurrence of dumping, and that the
Commerce (Commerce) finds that interested parties.6 As a result, pursuant magnitude of the margin likely to
revocation of the antidumping duty to section 751(c)(3)(B) of the Act and 19 prevail would be up to 360.30 percent.
(AD) order on cast iron soil pipe fittings CFR 351.218(e)(1)(ii)(C)(2), Commerce
Administrative Protective Order
(soil pipe fittings) from the People’s conducted an expedited (120-day)
Republic of China (China) would be sunset review of the Order. This notice serves as the only
likely to lead to the continuation or reminder to interested parties subject to
Scope of the Order
recurrence of dumping at the levels an administrative protective order
indicated in the ‘‘Final Results of Sunset The merchandise covered by the
Order is cast iron soil pipe fittings, (APO) of their responsibility concerning
Review’’ section of this notice. the return or destruction of proprietary
finished and unfinished, regardless of
industry or proprietary specifications, information disclosed under APO in
FOR FURTHER INFORMATION CONTACT: accordance with 19 CFR 351.305.
and regardless of size. The subject
Katherine Johnson, AD/CVD Operations, merchandise is currently provided for in Timely written notification of the return
Office VIII, Enforcement and item 7307.11.0045 of the Harmonized or destruction of APO materials or
Compliance, International Trade Tariff Schedule of the United States conversion to judicial protective order is
Administration, U.S. Department of (HTSUS). Subject merchandise may also hereby requested. Failure to comply
Commerce, 1401 Constitution Avenue enter under HTSUS 7324.29.0000 and with the regulations and terms of an
NW, Washington, DC 20230; telephone: 7307.92.3010. Although the HTSUS APO is a violation which is subject to
(202) 482–4929. subheadings are provided for sanction.
SUPPLEMENTARY INFORMATION: convenience and customs purposes, the
written description of the merchandise Notification to Interested Parties
Background
is dispositive. For a full description of We are issuing and publishing these
On August 31, 2018, Commerce the scope of the Order, see the Issues
published the AD order on soil pipe final results and notice in accordance
and Decision Memorandum.7 with sections 751(c), 752(c), and
fittings from China.1 On July 3, 2023,
Commerce published the notice of Analysis of Comments Received 777(i)(1) of the Act and 19 CFR 351.218.
initiation of the first sunset review of All issues raised in this review, Dated: October 31, 2023.
the Order, pursuant to section 751(c) of including the likelihood of continuation Lisa W. Wang,
the Tariff Act of 1930, as amended (the or recurrence of dumping in the event Assistant Secretary for Enforcement and
Act).2 On July 18, 2023, Commerce of revocation of the Order and the Compliance.
received a notice of intent to participate magnitude of the margins likely to
in this review from the Cast Iron Soil prevail if the Order were revoked, are Appendix
Pipe Institute (the domestic interested addressed in the accompanying Issues List of Topics Discussed in the Issues and
party) 3 within the deadline specified in and Decision Memorandum.8 A list of Decision Memorandum
19 CFR 351.218(d)(1)(i).4 The domestic topics discussed in the Issues and
interested party claimed interested party I. Summary
Decision Memorandum is included as
status under section 771(9)(E) of the II. Background
an appendix to this notice. The Issues
Act, and 19 CFR 351.102(b)(17) and III. Scope of the Order
and Decision Memorandum is a public
(29)(vii) as a trade or business IV. History of the Order
document and is on file electronically
association, a majority of whose V. Legal Framework
via Enforcement and Compliance’s
VI. Discussion of the Issues
Antidumping and Countervailing Duty
1 See Cast Iron Soil Pipe Fittings from the People’s 1. Likelihood of Continuation or
Centralized Electronic Service System
Republic of China: Amended Final Determination Recurrence of Dumping
of Sales at Less Than Fair Value and Antidumping (ACCESS). ACCESS is available to 2. Magnitude of the Margin of Dumping
Duty Order, 83 FR 44570 (August 31, 2018) (Order). Likely To Prevail
2 See Initiation of Five-Year (Sunset) Reviews, 88 5 See Domestic Interested Party’s Letter,
‘‘Petitioner’s Substantive Response to the Notice of

VII. Final Results of Sunset Review
FR 42688 (July 3, 2023) (Initiation Notice). In the
Initiation Notice, the product is erroneously listed Initiation,’’ dated August 2, 2023. VIII. Recommendation
as ‘‘Cast Iron Soil Pipe,’’ but the correct case 6 See Commerce’s Letter, ‘‘Sunset Reviews for
[FR Doc. 2023–24477 Filed 11–3–23; 8:45 am]
number for the Order is given. July 2023,’’ dated August 22, 2023.
3 The Cast Iron Soil Pipe Institute’s members are 7 See Memorandum, ‘‘Issues and Decision BILLING CODE 3510–DS–P
Charlotte Pipe & Foundry and McWane, Inc., the Memorandum for the Final Results of the Expedited
parent company of AB&I Foundry and Tyler Pipe, First Sunset Review of the Antidumping Duty Order
both of which were domestic producers of soil pipe on Cast Iron Soil Pipe Fittings from the People’s
fittings during the sunset period of review. Republic of China,’’ dated concurrently with, and
4 See Domestic Interested Party’s Letter, ‘‘Notice hereby adopted by, this notice (Issues and Decision
of Intent to Participate in the First Five-Year Memorandum).
Review,’’ dated July 18, 2023. 8 Id.
DEPARTMENT OF COMMERCE discussed in the Preliminary Decision any rates based solely on the facts
Memorandum is included as an available.
International Trade Administration appendix to this notice. The Preliminary Accordingly, to determine the rate for
[C–533–878] Decision Memorandum is a public companies not selected for individual
examination, Commerce’s practice is to
Stainless Steel Flanges From India: via Enforcement and Compliance’s
weight average the net subsidy rates for
Preliminary Results of Countervailing Antidumping and Countervailing Duty
Centralized Electronic Service System the selected mandatory respondents,
Duty Administrative Review and Partial excluding rates that are zero, de
Rescission of Review; 2021 (ACCESS). ACCESS is available to
registered users at https:// minimis, or based entirely on facts
AGENCY: Enforcement and Compliance, access.trade.gov. In addition, a complete available.6 We preliminarily determine
International Trade Administration, version of the Preliminary Decision that Chandan Steel Limited (Chandan)
Department of Commerce. Memorandum can be accessed directly and Pradeep Metals Limited (Pradeep)
SUMMARY: The U.S. Department of at https://access.trade.gov/public/ received countervailable subsidies that
Commerce (Commerce) preliminarily FRNoticesListLayout.aspx. are above de minimis and are not based
finds that countervailable subsidies are entirely on facts available. Therefore, we
Scope of the Order
being provided to producers and preliminarily determine to apply the
exporters of stainless steel flanges from The merchandise covered by the weighted average of the net subsidy
India during the period of review, Order is stainless steel flanges from rates calculated for Chandan and
January 1, 2021, through December 31, India. For a complete description of the Pradeep using publicly-ranged sales
2021. Additionally, Commerce is scope of the Order, see the Preliminary data submitted by those respondents to
rescinding the review with respect to Decision Memorandum. the non-selected company.7 The
one company. Interested parties are Methodology company for which a review was
invited to comment on these requested, and which was not selected
Commerce is conducting this review
preliminary results. as a mandatory respondents or found to
in accordance with section 751(a)(1)(A)
DATES: Applicable November 6, 2023. of the Act. For each of the subsidy be cross-owned with a mandatory
FOR FURTHER INFORMATION CONTACT: programs found countervailable, we respondent, is BFN Forgings Private
Eliza DeLong, AD/CVD Operations, preliminarily find that there is a Limited.
Office V, Enforcement and Compliance, subsidy, i.e., a financial contribution Partial Rescission of Administrative
International Trade Administration, that gives rise to a benefit to the Review
U.S. Department of Commerce, 1401 recipient, and the subsidy is specific.5
Constitution Avenue NW, Washington, For a full description of the Commerce’s practice is to rescind an
DC 20230; telephone: (202) 482–3878. methodology underlying our administrative review of a
SUPPLEMENTARY INFORMATION: conclusions, see the Preliminary countervailing duty order, pursuant to
Decision Memorandum. 19 CFR 351.213(d)(1), when the
Background
Company Not Selected for Individual interested party that requested a review
On October 5, 2018, Commerce Review withdraws the request within 90 days of
published the countervailing duty order publication of notice of initiation of the
on stainless steel flanges from India.1 The Act and Commerce’s regulations
do not directly address the subsidy rate requested review. On March 3, 2023, we
On December 5, 2022, Commerce received a withdrawal request for Hilton
published a notice of initiation of an to be applied to companies not selected
for individual examination where Metal Forging Limited (Hilton).8
administrative review of the Order.2 On Because no other party besides Hilton
May 30, 2023, Commerce extended the Commerce limits its examination in an
administrative review pursuant to requested a review, we are rescinding
time period for issuing these
section 777A(e)(2) of the Act. However, this review pursuant to 19 CFR
preliminary results by 120 days, in
Commerce normally determines the 351.213(d)(1) with respect to Hilton. For
accordance with section 751(a)(3)(A) of
the Tariff Act of 1930, as amended (the rates for non-selected companies in this company, Commerce intends to
Act), to no later than October 31, 2023.3 reviews in a manner that is consistent assess duties at rates equal to the cash
For a complete description of the with section 705(c)(5) of the Act, which deposits of estimated countervailing
events that followed the initiation of provides instructions for calculating the duties required at the time of entry, or
this review, see the Preliminary all-others rate in an investigation. withdrawn from warehouse, for
Decision Memorandum.4 A list of topics Section 777A(e)(2) of the Act provides consumption, during the POR, in
that ‘‘the individual countervailable accordance with 19 CFR 351.212(c)(2).
1 See Stainless Steel Flanges from India: subsidy rates determined under
Countervailing Duty Order, 83 FR 50336 (October subparagraph (A) shall be used to Preliminary Results of Review
5, 2018) (Order). determine the all-others rate under
For the period January 1, 2021,
2 See Initiation of Antidumping and
section 705(c)(5) {of the Act}.’’ Section
Countervailing Duty Administrative Reviews, 87 FR through December 31, 2021, we
705(c)(5)(A) of the Act states that for
74404 (December 5, 2022), as corrected by Initiation
companies not investigated, in general, preliminarily find that the following net
of Antidumping and Countervailing Duty subsidy rates exist:
Administrative Reviews, 88 FR 7060 (February 2, we will determine an all-others rate by
2023). weight-averaging the countervailable

3 See Memorandum, ‘‘Extension of Deadline for 6 See, e.g., Certain Pasta from Italy: Final Results
subsidy rates established for each of the
Preliminary Results of Countervailing Duty of the 13th (2008) Countervailing Duty
Administrative Review,’’ dated May 30, 2023.
companies individually investigated, Administrative Review, 75 FR 37386, 37387 (June
4 See Memorandum, ‘‘Decision Memorandum for excluding zero and de minimis rates or 29, 2010).
7 See Memorandum, ‘‘Calculation of Subsidy Rate
the Preliminary Results of the Countervailing Duty
Administrative Review: Stainless Steel Flanges 5 See sections 771(5)(B) and (D) of the Act for Non-Selected Companies Under Review,’’ dated
from India; 2021,’’ dated concurrently with, and regarding financial contribution; section 771(5)(E) concurrently with this memorandum.
hereby adopted by, this notice (Preliminary of the Act regarding benefit; and section 771(5A) of 8 See Hilton’s Letter, ‘‘AD/CVD Review Request,’’
Decision Memorandum). the Act regarding specificity. dated March 3, 2023.
Subsidy rate using ACCESS and received the issues raised by the parties in their
Producer/exporter (percent successfully in their entirety by 5:00 comments, within 120 days after
ad valorem)
p.m. Eastern Time on the due date. publication of these preliminary results.
Chandan Steel Limited ........................ 2.60
Pradeep Metals Limited ...................... 4.04 Assessment Rates Notification to Interested Parties
Consistent with section 751(a)(2)(C) of This administrative review and notice
Review-Specific Average Rate Applicable to the
Following the Act, upon issuance of the final are issued and published in accordance
results, Commerce shall determine, and with sections 751(a)(1) and 777(i)(1) of
BFN Forgings Private Limited ............. 2.82 U.S. Customs and Border Protection the Act and 19 CFR 351.213.
(CBP) shall assess, countervailing duties
Disclosure and Public Comment on all appropriate entries in accordance Dated: October 31, 2023.
with the final results of this review. If Lisa W. Wang,
We will disclose to parties to this
proceeding the calculations performed the assessment rate calculated in the Assistant Secretary for Enforcement and
for these preliminary results within five final results is zero or de minimis, we Compliance.
days of the date of publication of these will instruct CBP to liquidate all Appendix
preliminary results in accordance with appropriate entries without regard to
countervailing duties. For the company List of Topics Discussed in the Preliminary
19 CFR 351.224(b).9 Decision Memorandum
Pursuant to 19 CFR 351.309(c), for which this review is rescinded (i.e.,
interested parties may submit case briefs Hilton), Commerce will instruct CBP to I. Summary
no later than 30 days after the date of assess countervailing duties on all II. Background
appropriate entries at a rate equal to the III. Scope of the Order
publication of this notice. Rebuttal
IV. Period of Review
briefs, limited to issues raised in the cash deposit of estimated countervailing V. Rate for Non-Examined Companies
case briefs, may be filed not later than duties required at the time of entry, or VI. Subsidies Valuation Information
five days after the date for filing case withdrawal from warehouse, for VII. Benchmarks and Interest Rates
briefs.10 Parties who submit case briefs consumption, during the period January VIII. Analysis of Programs
or rebuttal briefs in this proceeding are 1, 2021, through December 31, 2021, in IX. Recommendation
encouraged to submit with each accordance with 19 CFR 351.212(c)(l)(i). [FR Doc. 2023–24481 Filed 11–3–23; 8:45 am]
argument: (1) a statement of the issue; Commerce intends to issue BILLING CODE 3510–DS–P
(2) a brief summary of the argument; assessment instructions to CBP no
and (3) a table of authorities.11 Case and earlier than 35 days after the date of
rebuttal briefs should be filed using publication of the final results of this DEPARTMENT OF COMMERCE
ACCESS 12 and must be served on review in the Federal Register. If a
interested parties. Executive summaries timely summons is filed at the U.S. International Trade Administration
should be limited to five pages total, Court of International Trade, the
including footnotes. Note that assessment instructions will direct CBP [A–570–983]
Commerce has amended certain of its not to liquidate relevant entries until the
requirements pertaining to the service of time for parties to file a request for a Drawn Stainless Steel Sinks From the
documents in 19 CFR 351.303(f).13 statutory injunction has expired (i.e., People’s Republic of China: Final
Interested parties who wish to request within 90 days of publication). Results of Antidumping Duty
a hearing must do so within 30 days of Administrative Review; 2021–2022
publication of these preliminary results Cash Deposit Requirements
by submitting a written request to the Pursuant to section 751(a)(2)(C) of the AGENCY: Enforcement and Compliance,
Assistant Secretary for Enforcement and Act, Commerce intends to instruct CBP International Trade Administration,
Compliance using Enforcement and to collect cash deposits of estimated Department of Commerce.
Compliance’s ACCESS system.14 countervailing duties in the amounts SUMMARY: The U.S. Department of
Requests should contain the party’s shown for each of the companies listed Commerce (Commerce) determines that
name, address, and telephone number, above on shipments of subject Guangdong Dongyuan Kitchenware
the number of participants, and a list of merchandise entered, or withdrawn Industrial Co., Ltd. (Dongyuan) made
the issues to be discussed. Issues raised from warehouse, for consumption on or sales of subject merchandise at prices
in the hearing will be limited to those after the date of publication of the final below normal value during the period of
raised in the respective case and results of this administrative review, review (POR) April 1, 2021, through
rebuttal briefs.15 If a request for a except where the rate calculated in the March 31, 2022. Additionally, we find
hearing is made, Commerce intends to final results is zero or de minimis, no that Guangdong Yingao Kitchen
hold the hearing at a time and date to cash deposit will be required. For all Utensils Co., Ltd. (Yingao) and
be determined. Parties should confirm non-reviewed firms, we will instruct Shenzhen Kehuaxing Industrial Ltd.
the date and time of the hearing two CBP to continue to collect cash deposits (Shenzhen Kehuaxing) have not
days before the scheduled date. Parties of estimated countervailing duties at the established their eligibility for a
are reminded that all briefs and hearing most recent company-specific or all- separate rate.
requests must be filed electronically others rate applicable to the company,
as appropriate. These cash deposit DATES: Applicable November 6, 2023.
9 See 19 CFR 351.224(b). instructions, when imposed, shall Ajay

10 See 19 CFR 351.309(c)(1)(ii) and 351.309(d)(1).
remain in effect until further notice. Menon, AD/CVD Operations, Office IX,
11 See 19 CFR 351.309(c)(2) and (d)(2).
12 See generally 19 CFR 351.303. Final Results of Review Enforcement and Compliance,
13 See Administrative Protective Order, Service, International Trade Administration,
Unless the deadline is extended U.S. Department of Commerce, 1401
and Other Procedures in Antidumping and
Countervailing Duty Proceedings; Final Rule, 88 FR
pursuant to section 751(a)(3)(A) of the Constitution Avenue NW, Washington,
67069 (September 29, 2023) Act, Commerce intends to issue the final DC 20230; telephone: (202) 482–0208.
14 See 19 CFR 351.310(c). results of this administrative review,
15 See 19 CFR 351.310. including the results of our analysis of SUPPLEMENTARY INFORMATION:
Background parties regarding the Preliminary rate of 76.45 percent.8 Furthermore,

On May 4, 2023, Commerce published Results, we have made certain changes because we find that Shenzhen
the Preliminary Results.1 On July 19, to the margin calculations for Kehuaxing and Yingao are part of the
2023, we extended the deadline for Dongyuan.6 China-wide entity, we will also instruct
these final results to October 31, 2023.2 CBP to apply an ad valorem assessment
Final Results of Review rate of 76.45 to all POR entries of subject
For a complete description of the events
As a result of this review, we are merchandise that were produced and/or
that occurred subsequent to the
assigning the following estimated exported by either Shenzhen Kehuaxing
Preliminary Results, see the Issues and
weighted-average dumping margins for or Yingao.
Decision Memorandum.3 Commerce Commerce intends to issue
conducted this review in accordance the period April 1, 2021, through March
31, 2022: assessment instructions to CBP no
with section 751(a) of the Tariff Act of earlier than 35 days after the date of
1930, as amended (the Act).
Weighted- publication of these final results. If a
Scope of the Order 4 average timely summons is filed at the U.S.
Producer or exporter dumping Court of International Trade, the
The products covered by the Order margin assessment instructions will direct CBP
are drawn stainless steel sinks from the (percent)
not to liquidate relevant entries until the
People’s Republic of China (China).5
Guangdong Dongyuan Kitchen- time for parties to file a request for a
Imports of subject merchandise are
ware Industrial Co., Ltd ........... 5.85 statutory injunction has expired (i.e.,
currently classified under the within 90 days of publication).
Guangdong Yingao Kitchen
Harmonized Tariff Schedule of the Utensils Co., Ltd ..................... 76.45
United States (HTSUS) subheadings Cash Deposit Requirements
7324.10.0000 and 7324.10.0010. While Disclosure The following cash deposit
HTSUS subheadings are provided for requirements will be effective upon
convenience and customs purposes, the Commerce intends to disclose the publication of the final results of
written description of the scope of the calculations performed in connection administrative review for all shipments
order is dispositive. with these final results to interested of subject merchandise entered, or
Analysis of Comments Received parties within five days of the date of withdrawn from warehouse, for
publication of this notice in the Federal consumption on, or after, the
We addressed all the issues raised in Register, in accordance with 19 CFR publication date of the final results of
the case and rebuttal briefs in the Issues 351.224(b). review, as provided for by section
and Decision Memorandum. A list of 751(a)(2)(C) of the Act: (1) the cash
the issues that parties raised is provided Assessment Rates
deposit rate for Dongyuan will be equal
in the appendix to this notice. The Pursuant to section 751(a)(2)(C) of the to the dumping margin established in
Issues and Decision Memorandum is a Act and 19 CFR 351.212(b), Commerce the final results of this review; (2) for a
public document and is on file determined, and U.S. Customs and previously investigated or reviewed
electronically via Enforcement and Border Protection (CBP) shall assess, exporter of subject merchandise not
Compliance’s Antidumping and antidumping duties on all appropriate listed in the final results of review that
Countervailing Duty Centralized entries of subject merchandise in has a separate rate, the cash deposit rate
Electronic Service System (ACCESS). accordance with the final results of this will continue to be the exporter’s
ACCESS is available to registered users review. existing cash deposit rate; (3) for all
at https://access.trade.gov. In addition, a Chinese exporters of subject
For Dongyuan, Commerce calculated
complete version of the Issues and merchandise that do not have a separate
importer- (or customer-) specific per-
Decision Memorandum can be accessed rate, the cash deposit rate will be the
unit duty assessment rates based on the
at https://access.trade.gov/public/ cash deposit rate established for the
ratio of the total amount of dumping
FRNoticesListLayout.aspx. China-wide entity, i.e., 76.45 percent; 9
calculated for the importer’s (or
Changes Since the Preliminary Results customer’s) examined sales to the total and (4) for all exporters of subject
sales quantity associated with those merchandise that are not located in
Based on a review of the record and China and that are not eligible for a
comments received from interested sales, in accordance with 19 CFR
351.212(b)(1). Where either Dongyuan’s separate rate, the cash deposit rate will
weighted-average dumping margin is be the rate applicable to the China
1 See Drawn Stainless Steel Sinks from the
People’s Republic of China: Preliminary Results and zero or de minimis, or an importer- exporter(s) that supplied that non-
Partial Rescission of Antidumping Duty specific rate is zero or de minimis Chinese exporter. These deposit
Administrative Review; 2021–2022, 88 FR 28485 within the meaning of 19 CFR requirements, when imposed, shall
(May 4, 2023) (Preliminary Results), and remain in effect until further notice.
accompanying Preliminary Decision Memorandum. 351.106(c)(1), we will instruct CBP to
2 See Memorandum, ‘‘Extension of Deadline for liquidate the appropriate entries Notification to Importers
Final Results,’’ dated July 19, 2023. without regard to antidumping duties. This notice serves as a final reminder
3 See Memorandum, ‘‘Issues and Decision
Memorandum for the Final Results of the 2021–

Pursuant to Commerce’s assessment to importers of their responsibility
2022 Antidumping Duty Administrative Review of practice,7 for entries that were not
Drawn Stainless Steel Sinks from the People’s reported in the U.S. sales data submitted 8 The China-wide rate determined in the
Republic of China,’’ dated concurrently with, and by Dongyuan, we will instruct CBP to investigation was 76.53 percent. See Order, 78 FR
hereby adopted by, this notice (Issues and Decision at 21594. This rate was adjusted for export
Memorandum).
liquidate such entries at the China-wide
subsidies and estimated domestic subsidy pass
4 See Drawn Stainless Steel Sinks from the through to determine the cash deposit rate (i.e.,
People’s Republic of China: Amended Final 6 For a full description of these changes, see 76.45 percent) collected for companies in the
Determination of Sales at Less Than Fair Value and Issues and Decision Memorandum. China-wide entity. See explanation in Drawn
Antidumping Duty Order, 78 FR 21592 (April 11, 7 See Non-Market Economy Antidumping Stainless Steel Sinks from the People’s Republic of
2013) (Order). Proceedings: Assessment of Antidumping Duties, 76 China: Investigation Final Determination, 78 FR
5 For a complete description of the scope of the FR 65694 (October 24, 2011), for a full discussion 13019 (February 26, 2013).
Order, see Issues and Decision Memorandum. of this practice. 9 Id.
under 19 CFR 351.402(f)(2) to file a Comment 9: Whether to Include this administrative review until October
certificate regarding the reimbursement Dongyuan’s Bank Charges Noted at 31, 2023.3 For a complete description of
of antidumping and/or countervailing Verification the events that followed the initiation of
Comment 10: Whether Commerce Should
duties prior to liquidation of the this review, see the Preliminary
Grant a Scrap Offset to Dongyuan
relevant entries during this review V. Recommendation Decision Memorandum.4
period. Failure to comply with this
[FR Doc. 2023–24478 Filed 11–3–23; 8:45 am] Scope of the Order
requirement could result in Commerce’s
presumption that reimbursement of BILLING CODE 3510–DS–P
The merchandise covered by the
antidumping and/or countervailing Order is stainless steel flanges from
duties occurred and the subsequent India. For a full description of the scope
DEPARTMENT OF COMMERCE
assessment of double antidumping of the Order, see the Preliminary
duties, and/or an increase in the amount International Trade Administration Decision Memorandum.
of antidumping duties by the amount of
[A–533–877] Partial Rescission of Administrative
the countervailing duties.
Review
Notification Regarding Administrative Stainless Steel Flanges From India: Pursuant to 19 CFR 351.213(d)(1),
Protective Order Preliminary Results of Antidumping Commerce will rescind an
This notice also serves as the final Duty Administrative Review and Partial administrative review, in whole or in
reminder to parties subject to Rescission; 2021–2022 part, if a party who requested the review
administrative protective order (APO) of AGENCY: Enforcement and Compliance, withdraws the request within 90 days of
their responsibility concerning the International Trade Administration, the date of publication of the notice of
disposition of proprietary information Department of Commerce. initiation. On March 2, 2023, we
disclosed under APO in accordance received a timely withdrawal request
SUMMARY: The U.S. Department of
with 19 CFR 351.305(a)(3). Timely from R.N. Gupta & Company Limited.5
Commerce (Commerce) preliminarily
written notification of return/ Because no other party requested a
finds that producers/exporters of
destruction of APO materials or review of this company, Commerce is
stainless steel flanges (flanges) from
conversion to judicial protective order is rescinding this review with respect to
India did not make sales of subject
hereby requested. Failure to comply R.N. Gupta & Company Limited, in
merchandise in the United States at
with the regulations and terms of an accordance with 19 CFR 351.213(d)(1).
prices below normal value (NV) during
APO is a sanctionable violation.
the period of review (POR) October 1, Methodology
Notification to Interested Parties 2021, through September 30, 2022. In
addition, we are rescinding this review Commerce is conducting this review
We are issuing and publishing these in accordance with sections 751(a) of
final results of administrative review for one company. We invite interested
parties to comment on these preliminary the Act. We calculated export price and
and notice in accordance with sections constructed export price in accordance
751(a)(1) and 777(i) of the Act, and 19 results.
with section 772 of the Act. We
CFR 351.221(b)(5). calculated NV in accordance with
Dated: October 31, 2023. FOR FURTHER INFORMATION CONTACT:
section 773 of the Act.
Lisa W. Wang,
Benito Ballesteros or Seth Brown, AD/
For a full description of the
CVD Operations, Office IX, Enforcement
Assistant Secretary for Enforcement and methodology underlying these
Compliance.
and Compliance, International Trade
preliminary results, see the Preliminary
Administration, Department of
Appendix Decision Memorandum. A list of topics
Commerce, 1401 Constitution Avenue
included in the Preliminary Decision
List of Topics Discussed in the Issues and NW, Washington, DC 20230; telephone:
Memorandum is included as Appendix
Decision Memorandum (202) 482–4725 or (202) 482–0029,
I to this notice. The Preliminary
I. Summary
respectively.
Decision Memorandum is a public
II. Background SUPPLEMENTARY INFORMATION: document and is made available to the
III. Margin Calculations public via Enforcement and
IV. Discussion of the Issues Background
Compliance’s Antidumping and
On October 9, 2018, Commerce Countervailing Duty Centralized
Select Romania as the Primary Surrogate published in the Federal Register an
Country Electronic Service System (ACCESS).
antidumping duty order on flanges from ACCESS is available to registered users
Value Stainless Steel Using Romanian India.1 On December 5, 2022, based on at https://access.trade.gov. In addition, a
Surrogate Value Data timely requests for review, Commerce complete version of the Preliminary
Comment 3: Surrogate Value Source to initiated an administrative review of the Decision Memorandum can be accessed
Value Clips Order covering 15 companies, in directly at https://access.trade.gov/
Comment 4: Whether Commerce Should accordance with section 751(a) of the
Exclude Taiwan Import Data from its
public/FRNoticesListLayout.aspx.
Tariff Act of 1930, as amended (the
Calculation of the Surrogate Value for Act).2 On June 6, 2023, we extended the 3 See Memorandum, ‘‘Extension of Deadline for
Stainless Steel
Comment 5: Whether Commerce Will
deadline for the preliminary results of Preliminary Results of 2021–2022 Antidumping
Consider Supplemental Surrogate Value Duty Administrative Review,’’ dated June 6, 2023.
1 See Stainless Steel Flanges from India: 4 See Memorandum, ‘‘Decision Memorandum for
Data for Labor
Antidumping Duty Order, 83 FR 50639 (October 9, the Preliminary Results of the Antidumping Duty
2018) (Order). Administrative Review of Stainless Steel Flanges
Apply Adverse Facts Available to Yingao 2 See Initiation of Antidumping and from India; 2021–2022,’’ dated concurrently with,
Comment 7: Whether Commerce Should Countervailing Duty Administrative Reviews, 87 FR and hereby adopted by, this notice (Preliminary
Grant Dongyuan a Double Remedies 74404 (December 5, 2022); and Initiation of Decision Memorandum).
Offset in its Margin Calculation Antidumping and Countervailing Duty 5 See R.N. Gupta’s Letter, ‘‘Withdrawal of Anti-
Comment 8: Verification Issues Related to Administrative Reviews, 88 FR 7060 (February 2, dumping Duty Administrative Review,’’ dated
Dongyuan’s Reported Product Codes 2023) (collectively, Initiation Notice). March 2, 2023.
Preliminary Results of Review determine, and U.S. Customs and Cash Deposit Requirements
We preliminarily determine the Border Protection (CBP) shall assess, The following cash deposit
following weighted-average dumping antidumping duties on all appropriate requirements will be effective for all
margins exist for the period October 1, entries. Pursuant to 19 CFR shipments of the subject merchandise
2021, through September 30, 2022: 351.212(b)(1), because the individually- entered, or withdrawn from warehouse,
examined respondents reported the for consumption on or after the
Weighted- entered value for their U.S. sales, we publication date of the final results of
average will calculate importer-specific ad this administrative review, as provided
Exporter/producer dumping valorem antidumping duty assessment
margin by section 751(a)(2)(C) of the Act: (1) the
(percent) rates based on the ratio of the total cash deposit rate for the companies
amount of antidumping duties listed above will be equal to the
Chandan Steel Limited ......... 0.00 calculated for the examined sales to the weighted-average dumping margin
Kisaan Die Tech Private Lim- total entered value of those same sales. established in the final results of this
ited .................................... 0.00 If either respondent’s weighted-average
Companies Not Selected for review, except if the rate is de minimis
dumping margin is zero or de minimis (i.e., less than 0.50 percent), in which
Individual Review 6 ............ 0.00 within the meaning of 19 CFR
case the cash deposit rate will be zero;
351.106(c), or an importer-specific rate (2) for previously reviewed or
Review-Specific Rate for Companies is zero or de minimis, we will instruct
Not Selected for Individual Review investigated companies not covered by
CBP to liquidate the appropriate entries this review, the cash deposit rate will
The Act and Commerce’s regulations without regard to antidumping duties. continue to be the company-specific rate
do not address the rate to be applied to Commerce’s ‘‘automatic assessment’’ published for the most recently-
companies not selected for individual practice will apply to entries of subject completed segment of this proceeding in
examination when Commerce limits its merchandise during the POR produced which they were examined; (3) if the
examination in an administrative review by Chandan and KDT for which these
exporter is not a firm covered in this
pursuant to section 777A(c)(2) of the companies did not know that the review, a prior review, or the LTFV
Act. Generally, Commerce looks to merchandise they sold to an investigation, but the producer is, the
section 735(c)(5) of the Act, which intermediary (e.g., a reseller, trading cash deposit rate will be the rate
provides instructions for calculating the company, or exporter) was destined for
established for the most recently-
all-others rate in a less-than-fair value the United States. We will instruct CBP completed segment of this proceeding
(LTFV) investigation, for guidance when to liquidate those entries at the all-
for the producer of the merchandise;
calculating the rate for companies others rate (i.e., 7.00 percent) 7 if there and (4) the cash deposit rate for all other
which were not selected for individual is no rate for the intermediate producers or exporters will continue to
examination in an administrative company(ies) involved in the
review. Under section 735(c)(5)(A) of be 7.00 percent, the all-others rate
transaction.8 established in the Amended Final
the Act, the all-others rate is normally For the companies which were not
an amount equal to the weighted Determination.10 These cash deposit
selected for individual review, we requirements, when imposed, shall
average of the estimated weighted- intend to assign an assessment rate
average dumping margins established remain in effect until further notice.
based on the review-specific average
for exporters and producers rate, calculated as noted in the Disclosure and Public Comment
individually investigated, excluding any ‘‘Preliminary Results of Review’’
We intend to disclose the calculations
zero or de minimis margins, and any section, above. The final results of this performed in connection with these
margins determined entirely on the review shall be the basis for the preliminary results to interested parties
basis of facts available. assessment of antidumping duties on
Where the dumping margins for within five days after the date of
entries of merchandise covered by this publication of this notice in the Federal
individually examined respondents are review and for future deposits of
zero, de minimis, or determined based Register.11 Pursuant to 19 CFR
estimated duties, where applicable.9 351.309(c), interested parties may
entirely on facts available, section Commerce intends to issue
735(c)(5)(B) of the Act provides that submit case briefs no later than 30 days
assessment instructions to CBP no after the date of publication of this
Commerce may use ‘‘any reasonable earlier than 35 days after the date of
method to establish the estimated all- notice. Rebuttal briefs, limited to issues
publication of the final results of this raised in the case briefs, may be filed
others rate for exporters and producers review in the Federal Register. If a
not individually investigated . . . .’’ In not later than seven days after the date
timely summons is filed at the U.S. for filing case briefs.12 Parties who
this review, Commerce preliminarily Court of International Trade, the
calculated weighted-average dumping submit case briefs or rebuttal briefs in
assessment instructions will direct CBP this proceeding are encouraged to
margins for Chandan Steel Limited not to liquidate relevant entries until the
(Chandan) and Kisaan Die Tech Private submit with each argument: (1) a
time for parties to file a request for a statement of the issue; (2) a brief
Limited (KDT) of zero percent. statutory injunction has expired (i.e.,
Therefore, we are preliminarily summary of the argument; and (3) a
within 90 days of publication). table of authorities.13 Case and rebuttal
assigning a rate of zero percent to the
companies not selected for individual briefs should be filed using ACCESS.14
7 See Stainless Steel Flanges from India: Notice of
examination, in accordance with section Court Decision Not in Harmony with the Final Note that Commerce has amended
735(c)(5)(B) of the Act. Determination of Antidumping Investigation; Notice

10 See Amended Final Determination, 86 FR at
of Amended Final Determination, 86 FR 50325
Assessment Rates (September 8, 2021) (Amended Final 50326.
11 See 19 CFR 351.224(b).
Determination).
Upon completion of this 8 For a full discussion of this practice, see 12 Commerce is exercising its discretion, under 19
administrative review, Commerce shall Antidumping and Countervailing Duty Proceedings: CFR 351.309(d), to alter the time limit for the filing
Assessment of Antidumping Duties, 68 FR 23954 of rebuttal briefs.
6 See Appendix II for the list of exporters and/or (May 6, 2003). 13 See 19 CFR 351.309(c)(2) and (d)(2).
producers not selected for individual review. 9 See section 751(a)(2)(C) of the Act. 14 See generally 19 CFR 351.303.
certain of its requirements pertaining to Dated: October 31, 2023. Additionally, Commerce is rescinding
the service of documents in 19 CFR Lisa W. Wang, this review with respect to 13
351.303(f).15 Assistant Secretary for Enforcement and companies. We invite interested parties
Interested parties who wish to request
Compliance. to comment on these preliminary
a hearing must do so within 30 days of Appendix I results.
publication of these preliminary results List of Topics Discussed in the Preliminary DATES: Applicable November 6, 2023.
by submitting a written request to the Decision Memorandum
Assistant Secretary for Enforcement and FOR FURTHER INFORMATION CONTACT:
I. Summary Nathan James or Kelsie Hohenberger,
Compliance using Enforcement and II. Background
Compliance’s ACCESS system.16 III. Scope of the Order AD/CVD Operations, Office V,
Hearing requests should contain: (1) the IV. Discussion of the Methodology Enforcement and Compliance,
V. Recommendation International Trade Administration,
party’s name, address, and telephone
U.S. Department of Commerce, 1401
number; (2) the number of participants: Appendix II Constitution Avenue NW, Washington,
and (3) a list of the issues to be
List of Companies Not Selected for DC 20230; telephone: (202) 482–5305 or
discussed. Oral presentations at the Individual Examination (202) 482–2517, respectively.
hearing will be limited to issues raised
1. Balkrishna Steel Forge Pvt. Ltd.
in the case and rebuttal briefs.17 Parties SUPPLEMENTARY INFORMATION:
2. BFN Forgings Private Limited; Bebitz
are reminded that all briefs and hearing Flanges Works Private Limited; Background
requests must be filed electronically Fanschen werk Bebitz GmbH; Viraj
using ACCESS and received Alloys, Ltd.; Viraj Forgings, Ltd.; Viraj On December 5, 2022, Commerce
successfully in their entirety by 5:00 Impoexpo, Ltd.; and Viraj Profiles published a notice of initiation of an
Limited 19
p.m. Eastern Time on the due date. If a 3. Echjay Forgings Private Limited
administrative review of the
request for a hearing is made, parties 4. Fivebros Forging Pvt Ltd.20 countervailing duty order on hot-rolled
will be notified of the time and date for 5. Goodluck India Limited steel from Korea.1 On January 4, 2023,
the hearing.18 6. Hilton Metal Forging Limited Commerce selected Hyundai Steel
7. Jai Auto Pvt. Ltd. Company (Hyundai Steel) and POSCO
Unless otherwise extended, 8. Jay Jagdamba Forgings Pvt Ltd as mandatory respondents in this
Commerce intends to issue the final 9. Jay Jagdamba Ltd administrative review.2 On June 15,
results of this administrative review, 10. Jay Jagdamba Profile Pvt Ltd
2023, Commerce extended the deadline
including the results of its analysis of 11. Pradeep Metals Limited
12. Shree Jay Jagdamba Flanges Pvt. Ltd. for the preliminary results of this review
the issues raised in any written briefs, to no later than October 31, 2023.3
not later than 120 days after the date of [FR Doc. 2023–24496 Filed 11–3–23; 8:45 am]
publication of this notice, pursuant to BILLING CODE 3510–DS–P For a complete description of the
section 751(a)(3)(A) of the Act and 19 events that followed the initiation of
this review, see the Preliminary
CFR 351.213(h)(1).
DEPARTMENT OF COMMERCE Decision Memorandum.4 A list of topics
Notification to Importers discussed in the Preliminary Decision
International Trade Administration Memorandum is included as an
This notice also serves as a reminder appendix to this notice. The Preliminary
[C–580–884]
to importers of their responsibility Decision Memorandum is a public
under 19 CFR 351.402(f)(2) to file a Certain Hot-Rolled Steel Flat Products document and is on file electronically
certificate regarding the reimbursement From the Republic of Korea: via Enforcement and Compliance’s
of antidumping and/or countervailing Preliminary Results and Partial Antidumping and Countervailing Duty
duties prior to liquidation of the Rescission of Countervailing Duty Centralized Electronic Service System
relevant entries during this POR. Failure Administrative Review, 2021 (ACCESS). ACCESS is available to
to comply with this requirement could registered users at https://
AGENCY: Enforcement and Compliance, access.trade.gov. In addition, a complete
result in Commerce’s presumption that
International Trade Administration, version of the Preliminary Decision
reimbursement of antidumping and/or
U.S. Department of Commerce. Memorandum can be accessed directly
countervailing duties occurred and the
SUMMARY: The U.S. Department of at https://access.trade.gov/public/
subsequent assessment of doubled
Commerce (Commerce) preliminarily FRNoticesListLayout.aspx.
antidumping duties, and/or an increase
determines that certain producers/
in the amount of antidumping duties by exporters of certain hot-rolled steel flat 1 See Initiation of Antidumping and
the amount of countervailing duties. products (hot-rolled steel) from the Countervailing Duty Administrative Reviews, 87 FR
Notification to Interested Parties Republic of Korea (Korea) received 74404 (December 5, 2022); see also Certain Hot-
countervailable subsidies during the Rolled Steel Flat Products from Brazil and the
Republic of Korea: Amended Final Affirmative
We are issuing and publishing these period of review (POR) January 1, 2021, Countervailing Duty Determinations and
results in accordance with sections through December 31, 2021. Countervailing Duty Orders, 81 FR 67960 (October
751(a)(1) and 777(i)(1) of the Act, and 19 3, 2016) (Order).
2 See Memorandum, ‘‘Respondent Selection,’’
CFR 351.213 and 351.221(b)(4). 19 Commerce has previously found BFN Forgings
Private Limited to be part of a collapsed entity. See, dated January 4, 2023.

e.g., Stainless Steel Flanges from India: Final 3 See Memorandum, ‘‘Extension of Deadline for
15 See Administrative Protective Order, Service, Affirmative Determination of Sales at Less Than Preliminary Results of Countervailing Duty
and Other Procedures in Antidumping and Fair Value and Final Affirmative Critical Administrative Review,’’ dated June 15, 2023.
Countervailing Duty Proceedings; Final Rule, 88 FR Circumstance Determination, 83 FR 40745 (August 4 See Memorandum, ‘‘Decision Memorandum for
16, 2018). The companies which are part of this the Preliminary Results of the Countervailing Duty
67069 (September 29, 2023).
collapsed entity are listed above. Administrative Review of Certain Hot-Rolled Steel
16 See 19 CFR 351.310(c).
20 We incorrectly listed this company as Flat Products from the Republic of Korea; 2021,’’
17 See 19 CFR 351.310.
‘‘Fivebros Pvt Ltd.’’ in the Initiation Notice. See dated concurrently with, and hereby adopted by,
18 See 19 CFR 351.310(d). Initiation Notice, 87 FR at 74406. this notice (Preliminary Decision Memorandum).
Scope of the Order Subsidy rate hearing, limited to issues raised in the
The merchandise covered by the Producer/exporter (percent case and rebuttal briefs, must submit a
ad valorem) written request to the Assistant
Order is hot-rolled steel from Korea. For
a complete description of the scope of Secretary for Enforcement and
Hyundai Steel Company 8 .... 0.78
the Order, see the Preliminary Decision POSCO 9 ............................... 0.88
Compliance using ACCESS within 30
Memorandum. days after the date of publication of this
notice. Requests should contain: (1) the
Rescission of Administrative Review, In Disclosure and Public Comment
party’s name, address, and telephone
Part We intend to disclose to interested number; (2) the number of participants;
Pursuant to 19 CFR 351.213(d)(1), parties the calculations performed for and (3) a list of the issues to be
Commerce will rescind an these preliminary results within five discussed. If a request for a hearing is
administrative review, in whole or in days of the date of publication of this made, Commerce intends to hold the
part, if the parties that requested a notice in accordance with 19 CFR hearing at a time and date to be
review withdraw the request within 90 351.224(b). determined. Parties should confirm the
days of the date of publication of the Case briefs or other written comments date and time of the hearing two days
notice of initiation. Commerce received may be submitted to the Assistant before the scheduled date.
a timely-filed withdrawal request from Secretary for Enforcement and
Compliance no later than 30 days after Final Results of Review
the petitioners with respect to 13
companies.5 Because the withdrawal the date of publication of the Unless the deadline is extended, we
request was timely filed, and no other preliminary results in the Federal intend to issue the final results of this
party requested a review of these Register. Rebuttal briefs, limited to administrative review, which will
companies, in accordance with 19 CFR issues raised in case briefs, may be include the results of our analysis of the
351.213(d)(1), Commerce is rescinding submitted no later than five days after issues raised in the case briefs, within
this review with respect to the following the date for case briefs.10 Pursuant to 19 120 days of publication of these
companies: (1) DCE Inc; (2) Dong Chuel CFR 351.309(c)(2) and (d)(2), parties preliminary results in the Federal
America Inc.; (3) Dong Chuel Industrial who submit case briefs or rebuttal briefs Register, pursuant to section
Co., Ltd.; (4) Dongbu Incheon Steel Co., in this review are encouraged to submit 751(a)(3)(A) of the Act and 19 CFR
Ltd.; (5) Dongbu Steel Co., Ltd.; (6) with each argument: (1) a statement of 351.213(h)(1).
Dongkuk Industries Co., Ltd.; (7) the issue; (2) a brief summary of the
argument; and (3) a table of authorities. Assessment Rates
Dongkuk Steel Mill Co., Ltd.; (8)
Hyewon Sni Corporation (H.S.I.); (9) JFE All briefs must be filed electronically Pursuant to section 751(a)(1) of the
Shoji Trade Korea Ltd.; (10) POSCO using Enforcement and Compliance’s Act and 19 CFR 351.212(b)(2), upon
Coated & Color Steel Co., Ltd.; (11) ACCESS system. Note that Commerce issuance of the final results, Commerce
POSCO Daewoo Corporation; (12) Soon has amended certain of its requirements shall determine, and CBP shall assess,
Hong Trading Co., Ltd.; and (13) Sung- pertaining to the service of documents countervailing duties on all appropriate
A Steel Co., Ltd.6 in 19 CFR 351.303(f).11 entries of subject merchandise in
Pursuant to 19 CFR 351.310(c), accordance with the final results of this
Methodology interested parties who wish to request a review. Commerce intends to issue
Commerce is conducting this review assessment instructions to CBP no
8 Hyundai Steel Company is also known as
in accordance with section 751(a)(l)(A) earlier than 35 days after the date of
‘‘Hyundai Steel Co., Ltd.’’ As discussed in the
of the Tariff Act of 1930, as amended Preliminary Decision Memorandum, Commerce has
publication of the final results of this
(the Act). For each of the subsidy found the following companies to be cross-owned review in the Federal Register. If a
programs found countervailable, we with Hyundai Steel: Hyundai Green Power Co. Ltd.; timely summons is filed at the U.S.
preliminarily determine that there is a and Hyundai ITC. Court of International Trade, the
9 As discussed in the Preliminary Decision
subsidy, i.e., a financial contribution Memorandum, Commerce has found the following
assessment instructions will direct CBP
from an authority that gives rise to a companies to be cross-owned with POSCO: Pohang not to liquidate relevant entries until the
benefit to the recipient, and that the Scrap Recycling Distribution Center Co. Ltd.; time for parties to file a request for a
subsidy is specific.7 For a full POSCO Chemical; POSCO M-Tech; POSCO Nippon statutory injunction has expired (i.e.,
Steel RHF Joint Venture Co., Ltd.; POSCO Steel
description of the methodology Processing and Service; and POSCO Terminal. The
within 90 days of publication).
underlying our conclusions, see the POSCO subsidy rate applies to all cross-owned For the companies for which we are
accompanying Preliminary Decision companies. We note that POSCO has an affiliated rescinding this administrative review,
Memorandum. trading company through which it exported certain Commerce will instruct CBP to assess
subject merchandise, i.e., POSCO International
countervailing duties on all appropriate
Preliminary Results of Review Corporation (POSCO International). POSCO
entries at a rate equal to the cash deposit
International was not selected as a mandatory
As a result of this review, we respondent, but was examined in the context of of estimated countervailing duties
preliminarily determine the net POSCO. Therefore, there is not an individually- required at the time of entry, or
countervailable subsidy rates exist for established rate for POSCO International; POSCO
International’s subsidies are accounted for in terms
withdrawal from warehouse, for
the period, January 1, 2021, through of POSCO’s total subsidy rate. Entries of subject consumption, during the period January
December 31, 2021: merchandise exported by POSCO International will 1, 2021, through December 31, 2021, in
receive the rate of the producer listed on the entry accordance with 19 CFR 351.212(c)(l)(i).
5 The petitioners are: Cleveland-Cliffs Inc.; Nucor form with U.S. Customs and Border Protection
Corporation; SSAB Enterprises, LLC; Steel (CBP). Thus, the subsidy rate applied to POSCO Cash Deposit Requirements
Dynamics; Inc.; and United States Steel (and POSCO’s cross-owned affiliates) is also
Corporation. applied to POSCO International for entries of In accordance with section 751(a)(1)
6 See Petitioners’ Letter, ‘‘Partial Withdrawal of subject merchandise produced by POSCO. of the Act, Commerce intends, upon
Request for Administrative Review,’’ dated March 10 See 19 CFR 351.309; see also 19 CFR 351.303
publication of the final results, to
6, 2023. (for general filing requirements). instruct CBP to collect cash deposits of
7 See sections 771(5)(B) and (D) of the Act 11 See Administrative Protective Order, Service,
regarding financial contribution; section 771(5)(E) and Other Procedures in Antidumping and
estimated countervailing duties in the
of the Act regarding benefit; and section 771(5A) of Countervailing Duty Proceedings; Final Rule, 88 FR amounts shown for each of the
the Act regarding specificity. 67069 (September 29, 2023). companies listed above on shipments of
subject merchandise entered, or 1, 2022, through December 31, 2022. Notice set aside a period of time for
withdrawn from warehouse, for Interested parties are invited to parties to raise issues regarding product
consumption on or after the date of comment on this preliminary coverage (scope).5 We received
publication of the final results of this determination. comments from interested parties
administrative review, except, where DATES: Applicable November 6, 2023. commented on the scope of the
the rate calculated in the final results is concurrent antidumping duty (AD) and
FOR FURTHER INFORMATION CONTACT: Seth
zero or de minimis, no cash deposit will CVD investigations as it appeared in the
Brown, AD/CVD Operations, Office IX,
be required. For all non-reviewed firms, Initiation Notice, which are listed in the
Enforcement and Compliance,
we will instruct CBP to continue to Preliminary Decision Memorandum.6
International Trade Administration,
collect cash deposits at the most recent We are currently evaluating the scope
U.S. Department of Commerce, 1401
company-specific or all-others rate comments filed by interested parties
Constitution Avenue NW, Washington,
applicable to the company. These cash and intend to issue our preliminary
DC 20230; telephone: (202) 482–0029.
deposit requirements, when imposed, decision regarding the scope of the AD
shall remain in effect until further and CVD investigations prior to or
notice. Background concurrently with the AD preliminary
This preliminary determination is determinations. We will incorporate the
Notification to Interested Parties scope decisions from the AD
made in accordance with section 703(b)
These preliminary results are issued of the Tariff Act of 1930, as amended investigations into the scope of the final
and published pursuant to sections (the Act). Commerce published the CVD determination for this
751(a)(1) and 777(i)(1) of the Act, and 19 notice of initiation of this countervailing investigation, after considering any
CFR 351.213(d)(4) and 19 CFR duty (CVD) investigation on June 26, relevant comments submitted in scope
351.221(b)(4). 2023.1 On August 7, 2023, Commerce case and rebuttal briefs.7
Dated: October 31, 2023. postponed the preliminary Preliminary Affirmative Determination
Lisa W. Wang, determination until October 30, 2023.2 of Critical Circumstances
Assistant Secretary for Enforcement and For a complete description of the
In accordance with section 703(e)(1)
Compliance. events that followed the initiation of
of the Act, we preliminarily find that
this investigation, see the Preliminary
Appendix critical circumstances exist with respect
Decision Memorandum.3 A list of topics
to imports of subject merchandise for
List of Topics Discussed in the Preliminary discussed in the Preliminary Decision
Dongzheng Paper Bag (Dalian) Factory
Decision Memorandum Memorandum is included as Appendix
(Dongzheng), Fujian Nanwang
I. Summary II to this notice. The Preliminary
Environment Protection Scien-tech Co.,
II. Background Decision Memorandum is a public
Ltd. (Fujian Nanwan) the non-
III. Period of Review document and is on file electronically
IV. Partial Rescission of Administrative
responsive companies,8 and all other
via Enforcement and Compliance’s
Review producers and/or exporters. For a full
Antidumping and Countervailing Duty
V. Scope of the Order discussion of our preliminary critical
Centralized Electronic Service System
VI. Diversification of Korea’s Economy circumstances determination, see the
(ACCESS). ACCESS is available to
VII. Subsidies Valuation Information ‘‘Critical Circumstances’’ section of the
registered users at https://access.
VIII. Analysis of Programs Preliminary Decision Memorandum.
IX. Recommendation trade.gov. In addition, a complete
version of the Preliminary Decision Methodology
[FR Doc. 2023–24475 Filed 11–3–23; 8:45 am]
Memorandum can be accessed directly Commerce is conducting this
at https://access.trade.gov/public/ investigation in accordance with section
FRNoticesListLayout.aspx. 701 of the Act. For each of the subsidy
DEPARTMENT OF COMMERCE Scope of the Investigation programs found countervailable,
Commerce preliminarily determines
The products covered by this
International Trade Administration that there is a subsidy, i.e., a financial
investigation are paper bags from China.
contribution by an ‘‘authority’’ that
[C–570–153] For a complete description of the scope
gives rise to a benefit to the recipient,
of this investigation, see Appendix I.
Certain Paper Shopping Bags From the and that the subsidy is specific.9
People’s Republic of China: Scope Comments Commerce notes that, in making these
Preliminary Affirmative Determination In accordance with the preamble to findings, it relied, in part, on facts
of Countervailable Subsidies, Commerce’s regulations,4 the Initiation 5 See Initiation Notice, 88 FR at 41380.
Preliminary Affirmative Determination 6 See Preliminary Decision Memorandum at 2–3.
of Critical Circumstances, and 1 See Certain Paper Shopping Bags from India 7 The deadline for interested parties to submit
Alignment of Final Determination With and the People’s Republic of China: Initiation of scope case and rebuttal briefs will be established in
Countervailing Duty Investigations, 88 FR 41380 the preliminary scope decision memorandum.
Final Antidumping Duty Determination (June 26, 2023) (Initiation Notice). 8 The non-responsive companies are: (1) Bagitan
2 See Certain Paper Shopping Bags from the
AGENCY: Enforcement and Compliance, People’s Republic of China and India:
Packaging; (2) Changzhou Anjucheng; (3) Courage
International Trade Administration, Packaging; (4) Evertrust Packaging; (5) Geotegrity
Postponement of Preliminary Determinations in the EcoPack; (6) GrandIntelligent; (7) Li & Fung; (8)
Department of Commerce. Countervailing Duty Investigations, 88 FR 52122 Qindao Chenyu Packaging Co., Ltd.; (9) Shanghai
SUMMARY: The U.S. Department of (August 7, 2023). Macolink Supply Chain Management Co., Ltd.; (10)
3 See Memorandum, ‘‘Decision Memorandum for
Shanghai Sanxi Paper Co., Ltd.; (11) Xiamen C&D
Commerce (Commerce) preliminarily Preliminary Affirmative Determination of the Pulp & Paper Co., Ltd.; (12) Xiamen Champion
determines that countervailable Countervailing Duty Investigation of Certain Paper FMCG; (13) Xiamen New Idea Packaging Co., Ltd.;
subsidies are being provided to Shopping Bags from the People’s Republic of and (14) Xiamen Wonderful Bag Import and Export
producers and exporters of certain paper China,’’ dated concurrently with, and hereby Co., Ltd.
adopted by, this notice (Preliminary Decision 9 See sections 771(5)(B) and (D) of the Act
shopping bags (paper bags) from the Memorandum). regarding financial contribution; section 771(5)(E)
People’s Republic of China (China). The 4 See Antidumping Duties; Countervailing Duties, of the Act regarding benefit; and section 771(5A) of
period of investigation (POI) is January Final Rule, 62 FR 27296, 27323 (May 19, 1997). the Act regarding specificity.
available, and, because it finds that one Preliminary Determination public announcement, or if there is no
or more respondents did not act to the Commerce preliminarily determines public announcement, within five days
best of their ability to respond to that the following estimated of the date of the publication of this
Commerce’s requests for information, it countervailable subsidy rates exist: notice, in accordance with 19 CFR
drew an adverse inference where 351.224(b).
appropriate in selecting from among the Subsidy rate Verification
facts otherwise available.10 For further Company (percent
information, see the ‘‘Use of Facts ad valorem) As provided in section 782(i)(1) of the
Otherwise Available and Adverse Act, Commerce intends to verify the
Bagitan Packaging ................ 144.03 information relied upon in making its
Inferences’’ section of the Preliminary Changzhou Anjucheng ......... 144.03 final determination.
Decision Memorandum. Courage Packaging .............. 144.03
Alignment Dongzheng Paperbag Public Comment
(DaLian) Factory ............... 12.43
Evertrust Packaging ............. 144.03 All interested parties will have the
In accordance with section 705(a)(1)
Fujian Nanwang Environ- opportunity to submit scope case and
of the Act and 19 CFR 351.210(b)(4),
ment Protection Scien- rebuttal briefs on the preliminary
Commerce is aligning the final CVD
Tech Co., Ltd.14 ................ 13.96 decision regarding the scope of the AD
determination in this investigation with Geotegrity EcoPack .............. 144.03 and CVD investigations. The deadlines
the final determination in the GrandIntelligent .................... 144.03 to submit scope case and rebuttal briefs
companion AD investigation of paper Li & Fung .............................. 144.03 will be provided in the preliminary
bags from China based on a request Qindao Chenyu Packaging scope decision memorandum. For all
made by the Coalition for Fair Trade in Co., Ltd ............................. 144.03
scope case and rebuttal briefs, parties
Shopping Bags (the petitioner).11 Shanghai Macolink Supply
Chain Management Co., must file identical documents
Consequently, the final CVD simultaneously on the records of the
determination will be issued on the Ltd ..................................... 144.03
Shanghai Shanxi Paper Co., ongoing AD and CVD paper bags
same date as the final AD Ltd ..................................... 144.03 investigations. No new factual
determination, which is currently Xiamen C&D Pulp & Paper information or business proprietary
scheduled to be issued no later than Co., Ltd ............................. 144.03 information may be included in either
March 11, 2024, unless postponed. Xiamen Champion FMCG .... 144.03 scope case or rebuttal briefs.
Xiamen New Idea Packaging Case briefs or other written comments
All-Others Rate Co., Ltd ............................. 144.03 on non-scope issues may be submitted
Sections 703(d) and 705(c)(5)(A) of Xiamen Wonderful Bag Im-
to the Assistant Secretary for
the Act provide that in the preliminary port and Export Co., Ltd ... 144.03
All Others .............................. 13.84 Enforcement and Compliance.
determination, Commerce shall Interested parties will be notified of the
determine an estimated all-others rate timeline for the submission of case
for companies not individually Suspension of Liquidation
briefs and written comments at a later
examined. This rate shall be an amount In accordance with section date. Rebuttal briefs, limited to issues
equal to the weighted average of the 703(e)(2)(A) of the Act, because we find raised in case briefs, may be submitted
estimated subsidy rates established for that critical circumstances exist for no later than seven days after the
those companies individually Dongzhen, Fujian Nanwang, the non- deadline date for case briefs after the
examined, excluding any zero and de response companies, and all other deadline date for case briefs.15 Pursuant
minimis rates and any rates based producers and/or exporters, Commerce to 19 CFR 351.309(c)(2) and (d)(2),
entirely under section 776 of the Act. will direct U.S. Customs and Border parties who submit case or rebuttal
In this investigation, Commerce Protection (CBP) to suspend liquidation briefs in this investigation are
preliminarily calculated individual of entries of subject merchandise as encouraged to submit with each
estimated countervailable subsidy rates described in the scope of the argument: (1) a statement of the issue;
for Dongzheng and Fujian Nanwang that investigation section entered, or (2) a brief summary of the argument;
are not zero, de minimis, or based withdrawn from warehouse, for and (3) a table of authorities. Note that
entirely on facts otherwise available.12 consumption on or after the date 90 Commerce has amended certain of its
Therefore, Commerce calculated the all- days prior to the date of publication of requirements pertaining to the service of
others rate using a weighted average of this notice in the Federal Register. documents in 19 CFR 351.303(f).16
the individually estimated subsidy rates Further, pursuant to 19 CFR 351.205(d), Pursuant to 19 CFR 351.310(c),
calculated for the examined respondents Commerce will instruct CBP to require interested parties who wish to request a
using each company’s public ranged a cash deposit equal to the rates hearing, limited to issues raised in the
data for the value of its exports of indicated above. case and rebuttal briefs, must submit a
subject merchandise to the United Disclosure written request to the Assistant
States.13 Secretary for Enforcement and
Commerce intends to disclose its Compliance, U.S. Department of
10 See
calculations and analysis performed to Commerce, within 30 days after the date
sections 776(a) and (b) of the Act.
11 See Petitioner’s Letter, ‘‘Petitioner’s Request to
interested parties in this preliminary of publication of this notice. Requests
Align Countervailing Duty Investigation Final determination within five days of its should contain the party’s name,
Determination with Antidumping Duty

Investigation Final Determination,’’ dated October
address, and telephone number, the
5, 2023. Memorandum, Commerce has found the following
number of participants, and a list of the
12 See Preliminary Decision Memorandum at
companies to be cross-owned with Fujian Nanwang:
Appendix I. Zhuhai Zhongyue Paper Cup Container Co., Ltd.; 15 See 19 CFR 351.309; see also 19 CFR 351.303
13 See Memorandum, ‘‘Calculations of ‘All Anhui Nanwang Environmental Protection (for general filing requirements).
Others’ Rate for the Preliminary Determination of Technology Co., Ltd., Xianghe Nanwang 16 See Administrative Protective Order, Service,
the Countervailing Duty Investigation of Certain Environmental Protection Technology Co., Ltd.; and and Other Procedures in Antidumping and
Paper Shopping Bags from the People’s Republic of Hubei Nanwang Environmental Protection Countervailing Duty Proceedings; Final Rule, 88 FR
China,’’ dated concurrently with this notice, at 1. Technology Co., Ltd. 67069 (September 29, 2023).
issues to be discussed. Oral finished with folded tops or for which tied and Compliance, International Trade
presentations at the hearing will be knots or t-bar aglets (made of wood, metal, Administration, U.S. Department of
limited to issues raised in the briefs. If or plastic) are used to secure the handles to Commerce, 1401 Constitution Avenue
the bags.
a request for a hearing is made, parties NW, Washington, DC 20230; telephone:
The above-referenced dimensions are
will be notified of the time and date for provided for paper bags in the opened (202) 482–6241 or (202) 482–4868,
the hearing.17 position. The height of the bag is the distance respectively.
U.S. International Trade Commission from the bottom fold edge to the top edge SUPPLEMENTARY INFORMATION:
(i.e., excluding the height of handles that
Notification extend above the top edge). The depth of the Background
In accordance with section 703(f) of bag is the distance from the front of the bag
Commerce published the preliminary
the Act, Commerce will notify the U.S. edge to the back of the bag edge (typically
measured at the bottom of the bag). The results of this administrative review on
International Trade Commission (ITC) of May 4, 2023.1 On August 4, 2023,
its preliminary determination. If the width of the bag is measured from the left to
the right edges of the front and back panels Commerce extended the deadline for the
final determination is affirmative, the (upon which the handles typically are final results of this review to no later
ITC will determine before the later of located). than October 31, 2023.2 For a
120 days after the date of this This merchandise is currently classifiable description of the events that occurred
preliminary determination or 45 days under Harmonized Tariff Schedule of the since the Preliminary Results, see the
after the final determination whether United States (HTSUS) subheadings Issues and Decision Memorandum.3
these imports are materially injuring, or 4819.30.0040 and 4819.40.0040. The HTSUS
We conducted this review in
threaten material injury to, the U.S. subheadings are provided for convenience
and customs purposes only; the written accordance with section 751 of the
industry. Tariff Act of 1930, as amended (the Act).
description of the scope is dispositive.
Notification to Interested Parties Scope of the Order 4
Appendix II
This determination is issued and
List of Topics Discussed in the Preliminary The products covered by this Order
published in accordance with sections
Decision Memorandum are phosphate fertilizers. For a complete
703(f) and 777(i)(1) of the Act, and 19
I. Summary description of the scope of this Order,
CFR 351.205(c).
II. Background see the Issues and Decision
Dated: October 30, 2023. III. Scope of the Investigation Memorandum.
Lisa W. Wang, IV. Scope Comments
Analysis of Comments Received
Assistant Secretary for Enforcement and V. Injury Test
Compliance. VI. Analysis of China’s Financial System All issues raised in interested parties’
VII. Diversification of China’s Economy case briefs are addressed in the Issues
Appendix I VIII. Use of Facts Otherwise Available and and Decision Memorandum
Scope of the Investigation Adverse Inferences accompanying this notice. A list of the
IX. Subsidies Valuation issues raised by parties, and to which
The products within the scope of this X. Benchmarks and Interest Rates
investigation are paper shopping bags with
XI. Analysis of Programs
Commerce responded in the Issues and
handles of any type, regardless of whether Decision Memorandum, is provided in
XII. Critical Circumstances
there is any printing, regardless of how the the appendix to this notice. The Issues
XIII. Recommendation
top edges are finished (e.g., folded, serrated, and Decision Memorandum is a public
or otherwise finished), regardless of color, [FR Doc. 2023–24473 Filed 11–3–23; 8:45 am]
and regardless of whether the top edges
contain adhesive or other material for sealing via Enforcement and Compliance’s
closed. Subject paper shopping bags have a Antidumping and Countervailing Duty
width of at least 4.5 inches and depth of at DEPARTMENT OF COMMERCE Centralized Electronic Service System
least 2.5 inches. (ACCESS). ACCESS is available to
Paper shopping bags typically are made of International Trade Administration registered users at https://
kraft paper but can be made from any type access.trade.gov. In addition, a complete
of cellulose fiber, paperboard, or pressboard [C–821–825]
version of the Issues and Decision
with a basis weight less than 300 grams per
Phosphate Fertilizers From the Memorandum can be accessed directly
square meter (GSM).
A non-exhaustive illustrative list of the Russian Federation: Final Results of at https://access.trade.gov/public/
types of handles on shopping bags covered Countervailing Duty Administrative FRNoticesListLayout.aspx.
by the scope include handles made from any Review; 2020–2021
materials such as twisted paper, flat paper, 1 See Phosphate Fertilizers from the Russian
yarn, ribbon, rope, string, or plastic, as well AGENCY: Enforcement and Compliance, Federation: Preliminary Results and Partial
as die-cut handles (whether the punchout is International Trade Administration, Rescission of the Countervailing Duty
fully removed or partially attached as a flap). Administrative Review; 2020–2021, 88 FR 28505,
Department of Commerce. 28506 (May 4, 2023) (Preliminary Results) and
Excluded from the scope are:
SUMMARY: The U.S. Department of accompanying Preliminary Decision Memorandum
• Paper sacks or bags that are of a 1⁄6 or 1⁄7 (PDM).
barrel size (i.e., 11.5–12.5 inches in width, Commerce (Commerce) determines that 2 See Memorandum, ‘‘Extension of Deadline for
6.5–7.5 inches in depth, and 13.5–17.5 Joint Stock Company Apatit (JSC Final Results of Countervailing Duty Administrative
inches in height) with flat paper handles or Apatit), a producer/exporter of Review,’’ dated August 4, 2023.
die-cut handles; phosphate fertilizers from the Russian 3 See Memorandum, ‘‘Issues and Decision
• Paper sacks or bags with die-cut handles, Federation (Russia), received Memorandum for the Final Results of the
a grams per square meter weight of less than countervailable subsidies during the Countervailing Duty Administrative Review of
62 GSM, and a height of less than 11.5 Phosphate Fertilizers from the Russian Federation;
period of review (POR), November 30, 2020–2021,’’ dated concurrently with, and hereby
inches; and
2020, through December 31, 2021. adopted by, this notice (Issues and Decision
• Shopping bags (i) with non-paper
DATES: Applicable November 6, 2023. Memorandum).
handles made wholly of woven ribbon or 4 See Phosphate Fertilizers from the Kingdom of
other similar woven fabric and (ii) that are FOR FURTHER INFORMATION CONTACT:
Morocco and the Russian Federation:
Shane Subler or William Horn, AD/CVD Countervailing Duty Orders, 86 FR 18037 (April 7,
17 See 19 CFR 351.310(d). Operations, Office VIII, Enforcement 2021) (Order).
Changes Since the Preliminary Results statutory injunction has expired (i.e., Comment 2d: Whether Commerce Should
within 90 days of publication). Use JSC Apatit’s Gross Profit Figure in
Based on a review of the record and the Profit Ratio Calculation
comments received from interested Cash Deposit Rates Comment 2e: Whether Commerce Should
parties regarding the Preliminary In accordance with section 751(a)(1) Subtract Certain Costs JSC Apatit
Results, and for the reasons explained in of the Act, Commerce intends to instruct Incurred to Maintain Its Post-2002
the Issues and Decision Memorandum, CBP to collect cash deposits of Licenses
we made certain revisions to the estimated countervailing duties in the Comment 2f: Whether Commerce Erred in
subsidy calculations for JSC Apatit. amount shown for JSC Apatit on Its Calculation of the Tier 3 Benchmark
These changes are explained in the shipments of the subject merchandise by Double Counting Volumes, Values,
Issues and Decision Memorandum. entered, or withdrawn from warehouse and Resulting Average Unit Values
Final Results of Administrative Review for consumption on or after the date of (AUVs) for Brazil and South Africa
publication of the final results of this Comment 2g: Whether Commerce
In accordance with 19 CFR administrative review. The cash deposit Erroneously Excluded Export Volume
351.221(b)(4)(i), we calculated an requirement, effective upon the and Value Data, and Resulting AUVs, for
individual net countervailable subsidy publication of the final results of this Togo and Iran in Its Tier 3 Benchmark
rate for JSC Apatit. Commerce review, shall remain in effect until Calculation
determines that, during the POR, the net further notice. Comment 2h: Whether Commerce Should
countervailable subsidy rate for the Calculate the Benchmark in the Manner
company under review is as follows: Administrative Protective Order Proposed by ADM
This notice also serves as a final Comment 2i: Whether Commerce Should
Subsidy rate reminder to parties subject to Adjust the South Africa Export Data to
Company (percent ad Eliminate Distorted Export Prices
valorem) administrative protective order (APO) of
their responsibility concerning the Comment 2j: Whether Commerce Should
Joint Stock Company Apatit 5 28.50 return or destruction of proprietary Rely on Benchmark Sources Other Than
information disclosed under APO in United Nations Comtrade and IHS
Disclosure accordance with 19 CFR 351.305(a)(3). Markit’s Global Trade Atlas
Timely written notification of the Comment 2k: Whether Commerce Should
Commerce intends to disclose the Revise JSC Apatit’s Cost of Sales for the
return/destruction of APO materials or
calculations performed for these final Benefit Calculation
conversion to judicial protective order is
results of review within five days of the Comment 2l: Whether Commerce Should
hereby requested. Failure to comply
date of publication of this notice in the Add International Ocean Freight Costs to
with the regulations and terms of an
Federal Register, in accordance with 19 the Benchmark
APO is a sanctionable violation.
CFR 351.224(b). Comment 2m: Whether Commerce Should
Notification to Interested Parties Place the Calculation Memorandum and
Assessment Rate
These final results are issued and Worksheets from the Preliminary Results
Pursuant to section 751(a)(2)(C) of the published in accordance with sections of the Phosphate Fertilizers from
Act and 19 CFR 351.212(b)(2), 751(a)(1) and 777(i)(1) of the Act, and 19 Morocco 2020–21 Administrative
Commerce has determined, and U.S. CFR 351.221(b)(5). Review on the Record
Customs and Border Protection (CBP) Provision of Natural Gas for LTAR
shall assess, countervailing duties on all Dated: October 31, 2023.
Comment 3a: Whether Commerce Should
appropriate entries of subject Lisa W. Wang, Reject Kazakh Export Data as a Natural
merchandise in accordance with the Assistant Secretary for Enforcement and Gas Benchmark and Use European
final results of this review, for the Compliance. International Energy Agency Data
above-listed company at the applicable Appendix Instead
ad valorem assessment rate. We intend Comment 3b: Whether Commerce Should
List of Topics Discussed in the Issues and Countervail JSC Apatit’s Natural Gas
to issue assessment instructions to CBP
Decision Memorandum
no earlier than 35 days after the date of Purchases from Independent Suppliers
publication of the final results of this I. Summary Other Program-Specific Issues
II. Background Comment 4: Whether Commerce Properly
review in the Federal Register. If a
III. Scope of the Order Determined that the Vologda Region’s
timely summons is filed with the U.S. IV. Use Of Facts Otherwise Available and
Court of International Trade, the Support of Industrial Development
Adverse Inferences
assessment instructions will direct CBP V. Subsidies Valuation Program Is De Facto Specific
not to liquidate relevant entries until the VI. Analysis of Programs Comment 5: Whether Commerce Should
time for parties to file a request for a VII. Discussion of the Issues Use a Different Interest Rate Benchmark
Comment 1: Whether Commerce Should for the Russian Export Center Joint-Stock
5 As discussed in the Preliminary Results PDM,
Calculate JSC Apatit’s Subsidy Rate Company Lending Program
Commerce finds the following companies to be
Based on Data for the Entire Period of VIII. Recommendation
cross-owned with JSC Apatit: PhosAgro Public Joint Review or Calendar Year
[FR Doc. 2023–24474 Filed 11–3–23; 8:45 am]
Stock Company; Limited Liability Company Provision of Mining Rights for Less Than
PhosAgro-Region; Limited Liability Company Adequate Remuneration (LTAR) BILLING CODE 3510–DS–P
PhosAgro-Belgorod; Limited Liability Company Comment 2a: Whether the Provision of
PhosAgro-Don; Limited Liability Company Mining Rights Provides a Financial

PhosAgro-Kuban; Limited Liability Company Contribution
PhosAgro-Lipetsk; Limited Liability Company Comment 2b: Whether Mining Rights
PhosAgro-Kursk; Limited Liability Company
Should Be Valued Based on Phosphate
PhosAgro-Orel; Limited Liability Company
PhosAgro-Stavropol; Limited Liability Company
Rock
PhosAgro-Volga; Limited Liability Company Comment 2c: Whether Commerce
PhosAgro-SeveroZapad; Limited Liability Company Unlawfully Departed from Its Practice of
PhosAgro-Tambov; and Limited Liability Company Applying a Cut-off Date with Respect to
PhosAgro-Sibir. Russia
DEPARTMENT OF COMMERCE business association, a majority of complete version of the Issues and
whose members manufacture or Decision Memorandum can be accessed
International Trade Administration produce the domestic like product in directly at https://access.trade.gov/
the United States. public/FRNoticesListLayout.aspx.
[C–570–063]
On August 2, 2023, Commerce
Final Results of Sunset Review
Cast Iron Soil Pipe Fittings From the received a complete substantive
People’s Republic of China: Final response for this review from the Pursuant to sections 751(c)(1) and
Results of the Expedited First Sunset domestic interested parties within the 752(b) of the Act, Commerce determines
Review of the Countervailing Duty 30-day deadline specified in 19 CFR that revocation of the Order would be
Order 351.218(d)(3)(i).4 We did not receive a likely to lead to the continuation or
substantive response from any other recurrence of countervailable subsidies
AGENCY: Enforcement and Compliance, interested party in this proceeding, and at the following rates:
International Trade Administration, no party requested a hearing.
Department of Commerce. On August 22, 2023, Commerce Subsidy rate
SUMMARY: As a result of this expedited notified the U.S. International Trade Producer/exporter (percent ad
sunset review, the U.S. Department of Commission (ITC) that it did not receive valorem)
Commerce (Commerce) finds that an adequate substantive response from Shanxi Xuanshi Industrial
revocation of the countervailing duty respondent interested parties.5 As a Group Co., Ltd .................. 34.87
(CVD) order on cast iron soil pipe result, pursuant to section 751(c)(3)(B) Wor-Biz International Trading
fittings (soil pipe fittings) from the of the Act and 19 CFR Co., Ltd. (Anhui) ................ 7.37
People’s Republic of China (China) 351.218(e)(1)(ii)(C)(2), Commerce Shijiazhuang Chengmei Im-
would be likely to lead to continuation conducted expedited (120-day) sunset port & Export Co., Ltd ....... 133.94
or recurrence of countervailable review of the Order. All Others .............................. 23.28
subsidies at the levels indicated in the
‘‘Final Results of Sunset Review’’ Scope of the Order Administrative Protective Order
section of this notice. The product covered by the Order is
cast iron soil pipe fittings, finished and This notice serves as the only
unfinished, regardless of industry or reminder to parties subject to
FOR FURTHER INFORMATION CONTACT: administrative protective order (APO) of
Henry Wolfe, AD/CVD Operations, proprietary specifications, and
regardless of size. The subject their responsibility concerning the
Office VIII, Enforcement and disposition of proprietary information
Compliance, International Trade merchandise is currently provided for in
item 7307.11.0045 of the Harmonized disclosed under APO in accordance
Administration, U.S. Department of with 19 CFR 351.305(a). Timely written
Commerce, 1401 Constitution Avenue Tariff Schedule of the United States
(HTSUS). Subject merchandise may also notification of the destruction of APO
NW, Washington, DC 20230; telephone: materials or conversion to judicial
(202)–482–0574. enter under HTSUS 7324.29.0000 and
7307.92.3010. Although the HTSUS protective order is hereby requested.
SUPPLEMENTARY INFORMATION: Failure to comply with the regulations
subheadings are provided for
Background convenience and customs purposes, the and terms of an APO is a sanctionable
written description of the merchandise violation.
On August 31, 2018, Commerce
published in the Federal Register the is dispositive. For a complete Notification to Interested Parties
CVD order on soil pipe fittings from description of the scope of the Order,
see the Issues and Decision We are issuing and publishing these
China.1 On July 3, 2023, Commerce final results and notice in accordance
published the notice of initiation of the Memorandum.6
with sections 751(c), 752(b), and
first sunset review of the Order, Analysis of Comments Received 777(i)(1) of the Act, and 19 CFR
pursuant to section 751(c) of the Tariff 351.218.
Act of 1930, as amended (the Act).2 All issues raised in this sunset review
Commerce received a notice of intent to are addressed in the Issues and Decision Dated: October 31, 2023.
participate from Cast Iron Soil Pipe Memorandum.7 The Issues and Decision Lisa W. Wang,
Institute and its individual members Memorandum is a public document and Assistant Secretary for Enforcement and
Charlotte Pipe & Foundry and McWane, is on file electronically via Enforcement Compliance.
Inc. (collectively, domestic interested and Compliance’s Antidumping and
Countervailing Duty Centralized Appendix
parties) within the deadlines specified
in 19 CFR 351.218(d)(1)(i).3 The Electronic Services System (ACCESS). List of Topics Discussed in the Issues and
ACCESS is available to registered users Decision Memorandum
domestic interested party claimed
at http://access.trade.gov. In addition, a I. Summary
interested party status under section
771(9)(E) of the Act, and 19 CFR II. Background
4 See Domestic Interested Parties’ Letter, ‘‘Cast
351.102(b)(17) and (29)(vii) as a trade or III. Scope of the Order
Iron Soil Pipe Fittings from the People’s Republic IV. History of the Order
of China: Petitioner’s Substantive Response to the
V. Legal Framework
1 See Cast Iron Soil Pipe Fittings From the Notice of Initiation,’’ dated August 2, 2023
(Substantive Response). VI. Discussion of the Issues
People’s Republic of China: Countervailing Duty
. Likelihood of Continuation or Recurrence
Order, 83 FR 44566 (August 31, 2018) (Order). 5 See Commerce’s Letter, ‘‘Sunset Reviews for
2 See Initiation of Five-Year (Sunset) Reviews, 88 July 2023,’’ dated August 22, 2023. of a Countervailable Subsidy
FR 42688 (July 3, 2023) (Initiation Notice). In the 6 See Memorandum, ‘‘Issues and Decision 2. Net Countervailable Subsidy Rates
Initiation Notice, the product is erroneously listed Memorandum for the Expedited First Sunset Likely to Prevail
as ‘‘Cast Iron Soil Pipe,’’ but the correct case Review of the Countervailing Duty Order of Cast 3. Nature of the Subsidies
number for the order on soil pipe fittings is given. Iron Soil Pipe Fittings from the People’s Republic VII. Final Results of Review
3 See Domestic Interested Parties’ Letter, ‘‘Cast of China,’’ dated concurrently with, and hereby VIII. Recommendation
Iron Soil Pipe Fittings from the People’s Republic adopted by, this notice (Issues and Decision
of China: Notice of Intent to Participate in the First Memorandum). [FR Doc. 2023–24476 Filed 11–3–23; 8:45 am]
Five-Year Review,’’ dated July 18, 2023. 7 Id. BILLING CODE 3510–DS–P
DEPARTMENT OF COMMERCE discussed in the Preliminary Decision ‘‘Critical Circumstances’’ section of the
Memorandum is included as Appendix Preliminary Decision Memorandum.
International Trade Administration II to this notice. The Preliminary
Methodology
[C–533–918] Decision Memorandum is a public
document and is on file electronically Commerce is conducting this
Certain Paper Shopping Bags From via Enforcement and Compliance’s investigation in accordance with section
India: Preliminary Affirmative Antidumping and Countervailing Duty 701 of the Act. For each of the subsidy
Determination of Countervailable Centralized Electronic Service System programs found to be countervailable,
Subsidies, Preliminary Affirmative (ACCESS). ACCESS is available to Commerce preliminarily determines
Determination of Critical registered users at https:// that there is a subsidy, i.e., a financial
Circumstances in Part, and Alignment access.trade.gov. In addition, a complete contribution by an ‘‘authority’’ that
of Final Determination With the Final version of the Preliminary Decision gives rise to a benefit to the recipient,
Antidumping Duty Determination Memorandum can be accessed directly and that the subsidy is specific.8
at https://access.trade.gov/public/ Commerce notes that, in making these
AGENCY: Enforcement and Compliance, FRNoticesListLayout.aspx. findings, it relied, in part, on facts
International Trade Administration, available. For further information, see
Department of Commerce. Scope of the Investigation the ‘‘Use of Facts Otherwise Available’’
SUMMARY: The U.S. Department of The products covered by this section in the Preliminary Decision
Commerce (Commerce) preliminarily investigation are paper bags from India. Memorandum.
determines that countervailable For a complete description of the scope Alignment
subsidies are being provided to of this investigation, see Appendix I. In accordance with section 705(a)(1)
producers and exporters of certain paper of the Act and 19 CFR 351.210(b)(4),
Scope Comments
shopping bags (paper bags) from India. Commerce is aligning the final CVD
The period of investigation (POI) is In accordance with the preamble to determination in this investigation with
January 1, 2022, through December 31, Commerce’s regulations,4 the Initiation the final determination in the
2022. Interested parties are invited to Notice set aside a period of time for companion AD investigation of paper
comment on this preliminary parties to raise issues regarding product bags from India based on a request made
determination. coverage, (i.e., scope).5 We received by the Coalition For Fair Trade in
DATES: Applicable November 6, 2023. comments concerning the scope of the Shopping Bags (the petitioner).9
concurrent antidumping duty (AD) and Consequently, the final CVD
FOR FURTHER INFORMATION CONTACT: Paul CVD investigations of paper bags as it
Kebker or Drew Jackson, AD/CVD determination will be issued on the
appeared in the Initiation Notice, which same date as the final AD
Operations, Office IV, Enforcement and are listed in the Preliminary Decision
Compliance, International Trade determination, which is currently
Memorandum.6 We are currently scheduled to be issued no later than
Administration, U.S. Department of
evaluating the scope comments filed by March 11, 2024, unless postponed.
Commerce, 1401 Constitution Avenue
the interested parties and intend to
NW, Washington, DC 20230; telephone: All-Others Rate
issue our preliminary decision regarding
(202) 482–2254 or (202) 482–4406,
the scope of the AD and CVD Sections 703(d) and 705(c)(5)(A) of
respectively.
investigations prior to or concurrently the Act provide that in the preliminary
SUPPLEMENTARY INFORMATION: with the AD preliminary determination, Commerce shall
determinations. We will incorporate the determine an estimated all-others rate
Background
scope decisions from the AD for companies not individually
This preliminary determination is investigations into the scope of the final examined. This rate shall normally be
made in accordance with section 703(b) CVD determination for this an amount equal to the weighted
of the Tariff Act of 1930, as amended investigation, after considering any average of the estimated subsidy rates
(the Act). Commerce published the relevant comments submitted in scope established for those companies
notice of initiation of this countervailing case and rebuttal briefs.7 individually examined, excluding any
duty (CVD) investigation on June 26, zero and de minimis rates and any rates
2023.1 On August 7, 2023, Commerce Preliminary Affirmative Determination based entirely under section 776 of the
postponed the preliminary of Critical Circumstances, in Part Act.
determination until October 30, 2023.2 In accordance with section 703(e)(1) In this investigation, Commerce
For a complete description of events of the Act, we preliminarily find that preliminarily calculated individual
that followed the initiation of this critical circumstances exist with respect estimated countervailable subsidy rates
investigation, see the Preliminary to imports of subject merchandise for for both mandatory respondents that are
Decision Memorandum.3 A list of topics Velvin Paper Products. Additionally, we not zero, de minimis, or based entirely
find that critical circumstances do not on facts otherwise available. Therefore,
1 See Certain Paper Shopping Bags from India
exist for Aero Plast Packaging Solutions Commerce calculated the all-others rate
and the People’s Republic of China: Initiation of using a weighted average of the
Countervailing Duty Investigations, 88 FR 41380
Private Limited and companies subject
(June 26, 2023) (Initiation Notice). to the all-others subsidy rate. For a full individually estimated subsidy rates
2 See Certain Paper Shopping Bags from the discussion of our preliminary critical calculated for the examined respondents
People’s Republic of China and India: circumstances determination, see the

Postponement of Preliminary Determinations in the 8 See sections 771(5)(B) and (D) of the Act
Countervailing Duty Investigations, 88 FR 52122 regarding financial contribution; section 771(5)(E)

4 See Antidumping Duties; Countervailing Duties,
(August 7, 2023). of the Act regarding benefit; and section 771(5A) of
3 See Memorandum, ‘‘Decision Memorandum for Final Rule, 62 FR 27296, 27323 (May 19, 1997). the Act regarding specificity.
5 See Initiation Notice, 88 FR at 41380–81.
the Preliminary Affirmative Determination in the 9 See Petitioner’s Letter, ‘‘Petitioner’s Request to
6 See Preliminary Decision Memorandum at 5–6.
Countervailing Duty Investigation of Certain Paper Align Countervailing Duty Investigation Final
Shopping Bags from India,’’ dated concurrently 7 The deadline for interested parties to submit Determination with Antidumping Duty
with, and hereby adopted by, this notice scope case and rebuttal briefs will be established in Investigation Final Determination,’’ dated October
(Preliminary Decision Memorandum). the preliminary scope decision memorandum. 5, 2023.
using each company’s public ranged determination within five days of its number of participants, and a list of the
data for the value of its exports of public announcement, or if there is no issues to be discussed. Oral
subject merchandise to the United public announcement, within five days presentations at the hearing will be
States.10 of the date of the publication of this limited to issues raised in the briefs. If
notice, in accordance with 19 CFR a request for a hearing is made, parties
Preliminary Determination
351.244(b). will be notified of the time and date for
Commerce preliminarily determines the hearing.15
that the following estimated Verification
countervailable subsidy rates exist: As provided in section 782(i)(1) of the U.S. International Trade Commission
Act, Commerce intends to verify the Notification
Subsidy rate information relied upon in making its In accordance with section 703(f) of
Company (percent ad final determination. the Act, Commerce will notify the U.S.
valorem)
Public Comment International Trade Commission (ITC) of
Aero Plast Packaging Solu- its preliminary determination. If the
tions Private Limited 11 ...... 5.00 All interested parties will have the final determination is affirmative, the
Velvin Paper Products 12 ...... 2.37 opportunity to submit scope case and ITC will determine before the later of
All Others .............................. 3.47 rebuttal briefs on the preliminary 120 days after the date of this
decision regarding the scope of the AD preliminary determination or 45 days
Suspension of Liquidation and CVD investigations. The deadlines after the final determination whether
to submit scope case and rebuttal briefs imports of paper bags from India are
In accordance with section
will be provided in the preliminary materially injuring, or threaten material
703(e)(2)(A) of the Act, because we find
scope decision memorandum. For all injury to, the U.S. industry.
that critical circumstances exists for
scope case and rebuttal briefs, parties
Velvin Paper Products, Commerce will Notification to Interested Parties
must file identical documents
direct U.S. Customs and Border
simultaneously on the records of the This determination is issued and
Protection (CBP) to suspend liquidation
ongoing AD and CVD investigations. No published pursuant to sections 703(f)
of entries of subject merchandise as
new factual information or business and 777(i) of the Act, and 19 CFR
described in the scope of the
proprietary information may be 351.205(c).
investigation section entered, or
included in either scope case or rebuttal
withdrawn from warehouse, for Dated: October 30, 2023.
briefs.
consumption on or after the date 90 Case briefs or other written comments Lisa W. Wang,
days prior to the date of publication of on non-scope issues may be submitted Assistant Secretary for Enforcement and
this notice in the Federal Register. to the Assistant Secretary for Compliance.
Further, pursuant to 19 CFR 351.205(d), Enforcement and Compliance.
Commerce will instruct CBP to require Appendix I
Interested parties will be notified of the
a cash deposit equal to the rates timeline for the submission of case Scope of the Investigation
indicated above. briefs and written comments at a later The products within the scope of this
For Aero Plast Packaging Solutions investigation are paper shopping bags with
date. Rebuttal briefs, limited to issues
Private Limited and companies subject handles of any type, regardless of whether
raised in case briefs, may be submitted
to the ‘‘all-others’’ subsidy rate, in there is any printing, regardless of how the
no later than seven days after the top edges are finished (e.g., folded, serrated,
accordance with section 703(d)(1)(B)
and (d)(2) of the Act, Commerce will deadline date for case briefs after the or otherwise finished), regardless of color,
direct CBP to suspend liquidation of deadline date for case briefs.13 Pursuant and regardless of whether the top edges
entries of subject merchandise as to 19 CFR 351.309(c)(2) and (d)(2), contain adhesive or other material for sealing
parties who submit case or rebuttal closed. Subject paper shopping bags have a
described in the scope of the width of at least 4.5 inches and depth of at
investigation section entered, or briefs in this investigation are
encouraged to submit with each least 2.5 inches.
withdrawn from warehouse, for Paper shopping bags typically are made of
consumption on or after the date of the argument: (1) a statement of the issue; kraft paper but can be made from any type
publication of this notice in the Federal (2) a brief summary of the argument; of cellulose fiber, paperboard, or pressboard
Register. Further, pursuant to 19 CFR and (3) a table of authorities. Note that with a basis weight less than 300 grams per
351.205(d), Commerce will instruct CBP Commerce has amended certain of its square meter (GSM).
to require a cash deposit equal to the requirements pertaining to the service of A non-exhaustive illustrative list of the
documents in 19 CFR 351.303(f).14 types of handles on shopping bags covered
rates indicated above. by the scope include handles made from any
Pursuant to 19 CFR 351.310(c),
Disclosure interested parties who wish to request a materials such as twisted paper, flat paper,
hearing, limited to issues raised in the yarn, ribbon, rope, string, or plastic, as well
Commerce intends to disclose its as die-cut handles (whether the punchout is
calculations and analysis performed to case and rebuttal briefs, must submit a fully removed or partially attached as a flap).
interested parties in this preliminary written request to the Assistant Excluded from the scope are:
Secretary for Enforcement and • Paper sacks or bags that are of a 1⁄6 or 1⁄7
10 See Memorandum, ‘‘Calculation of the Compliance, U.S. Department of barrel size (i.e., 11.5–12.5 inches in width,
Weighted-Average Dumping Margin for Companies Commerce, within 30 days after the date 6.5- 7.5 inches in depth, and 13.5–17.5
Noy Selected for Individual Examination,’’ dated of publication of this notice. Requests inches in height) with flat paper handles or
concurrently with this notice. die-cut handles;

should contain the party’s name,
address, and telephone number, the • Paper sacks or bags with die-cut handles,
Memorandum, Commerce preliminarily determines a grams per square meter paper weight of less
that Aero Plast Packaging Solutions Private Limited than 86 GSM, and a height of less than 11.5
is cross-owned with Aero Business Solutions 13 See 19 CFR 351.309; see also 19 CFR 351.303
inches; and
Private Limited and Aero Plast Limited. (for general filing requirements).
12 As discussed in the Preliminary Decision 14 See Administrative Protective Order, Service,
• Shopping bags (i) with non-paper
Memorandum, Commerce preliminarily determines and Other Procedures in Antidumping and handles made wholly of woven ribbon or
that Velvin Paper Products is cross-owned with Countervailing Duty Proceedings; Final Rule, 88 FR
Velvin Packaging Solutions Private Limited. 67069 (September 29, 2023). 15 See 19 CFR 351.310(d).
other similar woven fabric and (ii) that are until December 22, 2023. In a Request should include copies of the referenced
finished with folded tops or for which tied for Information (RFI) that published in materials. All submissions, including
knots or t-bar aglets (made of wood, metal, the Federal Register on September 7, attachments and other supporting
or plastic) are used to secure the handles to
2023, NIST requested information on materials, will become part of the public
the bags.
The above-referenced dimensions are behalf of the U.S. Department of record and subject to public disclosure.
provided for paper bags in the opened Commerce and the U.S. Government to All comments responding to this
position. The height of the bag is the distance support the development of an document will be a matter of public
from the bottom fold edge to the top edge implementation plan for the United record. Relevant comments will
(i.e., excluding the height of handles that States Government National Standards generally be available on the Federal
extend above the top edge). The depth of the Strategy for Critical and Emerging eRulemaking Portal at
bag is the distance from the front of the bag Technology (USG NSSCET). The USG www.regulations.gov. After the
edge to the back of the bag edge (typically comment period closes, relevant
NSSCET is intended to support and
measured at the bottom of the bag). The comments will generally be available on
width of the bag is measured from the left to complement existing private sector-led
the right edges of the front and back panels activities and plans, including the www.standards.gov. NIST will not
(upon which the handles typically are American National Standards Institute accept comments accompanied by a
located). (ANSI) United States Standards Strategy request that part or all of the material be
The merchandise is currently classifiable (USSS), with a focus on critical and treated confidentially because of its
under Harmonized Tariff Schedule of the emerging technology(ies) (CET). The business proprietary nature or for any
United States (HTSUS) subheadings USG NSSCET reinforces the U.S. other reason. Therefore, do not submit
4819.30.0040 and 4819.40.0040. The HTSUS confidential business information or
Government’s support of a private
subheadings are provided for convenience otherwise sensitive, protected, or
and customs purposes only; the written sector-led, open, consensus-based
description of the scope is dispositive. international standards system, personal information, such as account
corresponding to the World Trade numbers, Social Security numbers, or
Appendix II Organization (WTO) Technical Barriers names of other individuals.
List of Topics Discussed in the Preliminary to Trade (TBT) Committee decision that For Public Meetings/Webcast: NIST
Decision Memorandum articulates and elaborates on principles may hold a series of ‘‘Listening
that are fundamental to the Sessions’’ or ‘‘Stakeholder Events’’ in
I. Summary
II. Background development of an international support of the USG NSSCET
III. Scope of the Investigation standards: transparency; openness; implementation. Information on these
IV. Scope Comments impartiality and consensus; and any other NIST-sponsored events in
V. Injury Test effectiveness and relevance; and connection with the USG NSSCET
VI. Preliminary Determination of Critical coherence. To inform the USG NSSCET implementation will be announced at
Circumstances, In Part www.standards.gov.
implementation, including how to best
VII. Use of Facts Otherwise Available
VIII. Subsidies Valuation partner with relevant stakeholders, FOR FURTHER INFORMATION CONTACT: For
IX. Benchmark Interest Rates and Discount NIST is requesting information that will questions about this notice please
Rates support the identification and contact: Standards Coordination Office
X. Diversification of India’s Economy prioritization of key activities that will (SCO), NIST via email at sco@nist.gov or
XI. Analysis of Programs optimize the USG NSSCET by phone at (301) 975–5633. Please
XII. Recommendation implementation and further enhance the direct all media inquiries to Public
[FR Doc. 2023–24472 Filed 11–3–23; 8:45 am] U.S. Government’s ability to support a Affairs Office (PAO), NIST via email at
BILLING CODE 3510–DS–P private sector-led, open, consensus- inquires@nist.gov or by phone at (301)
based international standards system, to 975–2762.
which the U.S. Government is an active SUPPLEMENTARY INFORMATION: In an RFI
DEPARTMENT OF COMMERCE stakeholder and participant. that published in the Federal Register
DATES: Comments must be received by on September 7, 2023 (88 FR 61527),
National Institute of Standards and
11:59 p.m. Eastern time on December NIST requested information on behalf of
Technology
22, 2023. Comments received after the U.S. Department of Commerce and
[Docket Number: 230818–0199] November 6, 2023 and before the U.S. Government to support the
publication of this notice are deemed to development of an implementation plan
Request for Information on be timely. Submissions received after for the United States Government
Implementation of the United States December 22, 2023 may not be National Standards Strategy for Critical
Government National Standards considered. Those who have already and Emerging Technology (USG
Strategy for Critical and Emerging submitted comments need not resubmit. NSSCET). The USG NSSCET is intended
Technology (USG NSSCET); Extension ADDRESSES: Comments may be to support and complement existing
of Comment Period submitted by either of the following private sector-led activities and plans,
AGENCY: National Institute of Standards methods: including the American National
and Technology (NIST), Commerce. • Electronic submission: Submit Standards Institute (ANSI) United States
ACTION: Notice; extension of comment electronic public comments via the Standards Strategy (USSS), with a focus
period. Federal eRulemaking Portal. on critical and emerging technology(ies)
1. Go to www.regulations.gov and (CET). The U.S. standards development
SUMMARY: The National Institute of enter NIST–2023–0005 in the search system is unique because it is built
Standards and Technology (NIST) is field, upon a wide variety of processes that
extending the period for submitting 2. Click the ‘‘Comment Now!’’ icon, are open, voluntary, decentralized, and
comments to support the development complete the required fields, and led by the private sector. These
of an implementation plan for the 3. Enter or attach your comments. processes feature openness to
United States Government National Comments containing references, participation by materially interested
Standards Strategy for Critical and studies, research, and other empirical stakeholders with consensus-based
Emerging Technology (USG NSSCET) data that are not widely published decision making. Finalized standards
are primarily published by private • Carbon Capture, Removal, Utilization, overfishing, overfished, or approaching
sector standards organizations, not the and Storage an overfished condition.
U.S. Government. The U.S. Government A full list of CETs identified by the FOR FURTHER INFORMATION CONTACT:
supports standards development National Science and Technology Caroline Potter, (301) 427–8522.
activities in accordance with the World Council (NSTC) can be found https:// SUPPLEMENTARY INFORMATION: Pursuant
Trade Organization (WTO) Technical www.whitehouse.gov/wp-content/ to section 304(e)(2) of the Magnuson-
Barriers to Trade Committee decision uploads/2022/02/02-2022-Critical-and- Stevens Fishery Conservation and
that articulates principles including Emerging-Technologies-List-Update.pdf. Management Act, 16 U.S.C. 1854(e)(2),
transparency, openness, impartiality The national interest in CET and NMFS, on behalf of the Secretary, must
and consensus, effectiveness, relevance, associated areas of standardization publish a notice in the Federal Register
and coherence. The USG NSSCET demands a new and urgent level of whenever it determines that a stock or
reinforces the U.S. Government’s coordination and effort. National policy stock complex is subject to overfishing,
support of a private sector-led, open, priorities, as expressed in legislation overfished, or approaching an
consensus-based international standards and other statements of policy, will overfished condition.
system, to which the U.S. Government require new ways for public sector and NMFS has determined that summer
is an active stakeholder and participant. private sector (i.e., industry, including flounder is now subject to overfishing.
To inform the USG NSSCET start-ups and small- and medium-sized The summer flounder determination is
implementation, including how to best enterprises (SMEs), academic based on the most recent assessment,
partner with relevant stakeholders, community, and civil society completed in 2023, using data through
NIST is requesting information that will organizations) stakeholders to cooperate 2022, which indicates that the stock is
support the identification and in order to advance U.S. economic subject to overfishing because the
prioritization of key activities that will competitiveness and national security. fishing mortality rate is greater than the
optimize the USG NSSCET NIST is extending the comment maximum fishing mortality threshold.
implementation and further enhance the period announced in the September 7, NMFS has notified the Mid-Atlantic
U.S. Government’s ability to support a 2023 RFI from November 6, 2023 to Fishery Management Council of the
private sector-led, open, consensus- December 15, 2023 in response to requirement to end overfishing of
based international standards system. In stakeholder requests for more time to summer flounder.
addition to other agencies and respond to this important issue. NMFS has determined that thorny
Departments, bureaus across the U.S. For Public Meetings/Webcast: NIST skate remains overfished. The thorny
Department of Commerce are involved may hold a series of ‘‘Listening skate determination is based on an
in the USG NSSCET. They include the Sessions’’ or ‘‘Stakeholder Events’’ in update assessment completed in 2022,
International Trade Administration support of the USG NSSCET using data through 2021, which
(ITA), the Bureau of Industry and implementation. Information on these indicates that the stock remains
Security (BIS), the U.S. Patent and and any other NIST-sponsored events in overfished because the 2-year average
Trademark Office (USPTO), and the connection with the USG NSSCET biomass index is less than the minimum
National Telecommunications and implementation will be announced at stock size threshold. NMFS continues to
Information Administration (NTIA). www.standards.gov. work with the New England Fishery
CET covered under the USG NSSCET Management Council to rebuild thorny
include, but are not limited to: Alicia Chambers, skate.
• Communication and Networking NIST Executive Secretariat.
Technologies [FR Doc. 2023–24444 Filed 11–3–23; 8:45 am]
Jennifer M. Wallace,
• Communication and Networking BILLING CODE 3510–13–P
Acting Director, Office of Sustainable
Technologies Fisheries, National Marine Fisheries Service.
• Semiconductors and [FR Doc. 2023–24425 Filed 11–3–23; 8:45 am]
Microelectronics, including DEPARTMENT OF COMMERCE
Computing, Memory, and Storage
Technologies National Oceanic and Atmospheric
• Artificial Intelligence and Machine Administration
DEPARTMENT OF COMMERCE
Learning
• Biotechnologies [RTID 0648–XD435] National Oceanic and Atmospheric
• Positioning, Navigation, and Timing Administration
Services Determination of Overfishing or an
• Digital Identity Infrastructure and Overfished Condition Agency Information Collection
Distributed Ledger Technologies AGENCY: National Marine Fisheries Activities; Submission to the Office of
• Clean Energy Generation and Storage Service (NMFS), National Oceanic and Management and Budget (OMB) for
• Quantum Information Technologies Atmospheric Administration (NOAA), Review and Approval; Comment
There are also specific applications of Commerce. Request; Large Pelagic Fishing Survey
CET that departments and agencies have ACTION: Notice. AGENCY: National Oceanic &
determined will impact our global Atmospheric Administration (NOAA),
economy and national security. These SUMMARY: This action serves as a notice Commerce.
include, but are not limited to: that NMFS, on behalf of the Secretary of ACTION: Notice of information collection,
• Automated and Connected Commerce (Secretary), has found that request for comment.
Infrastructure summer flounder is now subject to
• Biobanking overfishing and thorny skate remains SUMMARY: The Department of
• Automated, Connected, and overfished. NMFS, on behalf of the Commerce, in accordance with the
Electrified Transportation Secretary, is required to provide this Paperwork Reduction Act of 1995
• Critical Minerals Supply Chains notice whenever it determines that a (PRA), invites the general public and
• Cybersecurity and Privacy stock or stock complex is subject to other Federal agencies to comment on
proposed, and continuing information Recommendation One of the NMFS formed the basis of fishery management
collections, which helps us assess the Marine Recreational Fishery (MRF) plans and used in stock assessments for
impact of our information collection Policy focuses on developing ‘‘a Atlantic highly migratory species such
requirements and minimize the public’s comprehensive data acquisition and as tunas, billfish, swordfish and sharks.
reporting burden. The purpose of this analysis system (participation, catch,
II. Method of Collection
notice is to allow for 60 days of public effort and socio-economic data) on a
comment preceding submission of the regular, continuing basis’’ in support of Dockside (in-person) interviews and
collection to OMB. the Executive Order 12962 requirement telephone interviews.
DATES: To ensure consideration, to assess the implementation and III. Data
comments regarding this proposed evaluate achievements of the
information collection must be received ‘‘Recreational Fishery Resources OMB Control Number: 0648–0380.
on or before January 5, 2024. Conservation Plan.’’ Form Number(s): None.
Because highly migratory species are Type of Review: Regular submission
ADDRESSES: Interested persons are
only sought on a relatively small (extension of a current information
invited to submit written comments to collection).
proportion of the total marine
Adrienne Thomas, NOAA PRA Officer, Affected Public: Individuals or
recreational angler fishing trips made,
at NOAA.PRA@noaa.gov. Please households; business or other for-profit
the fishing effort directed at such
reference OMB Control Number 0648– organizations.
species, and the resulting angler catches
0380 in the subject line of your Estimated Number of Respondents:
are generally not estimated very
comments. Do not submit Confidential 15,024.
precisely or accurately by general (all
Business Information or otherwise Estimated Time Per Response: 11
species) recreational surveys. Therefore,
sensitive or protected information. minutes for a telephone interview; 5
the Large Pelagics Survey (LPS) was
FOR FURTHER INFORMATION CONTACT: designed as a specialized survey that minutes for a dockside interview, 11⁄2
Requests for additional information or would focus specifically on the minutes to respond to a follow-up
specific questions related to collection recreational fishery directed at large validation call for dockside interviews;
activities should be directed to John pelagic, also called highly migratory, 1 minute for biological sampling of
Foster, National Marine Fisheries species. This specialization has allowed catch.
Service, Office of Science and higher levels of sampling needed to Estimated Total Annual Burden
Technology, 1315 East-West Hwy./ provide more precise and accurate Hours: 3,608.
FST1, Silver Spring, MD 21910, Phone: estimates of pelagic fishing effort and Estimated Total Annual Cost to
(301) 427–8130 or john.foster@noaa.gov. catches of large pelagic species. Public: $0 in recordkeeping/reporting
SUPPLEMENTARY INFORMATION: The LPS consists of two costs.
complementary surveys: a directory Respondent’s Obligation: Mandatory.
I. Abstract Legal Authority: Magnuson-Stevens
frame telephone survey of tuna and/or
This request is for the extension of a HMS permit holders to obtain fishing Fishery Conservation and Management
currently approved information effort information (Large Pelagic Act, Atlantic Tunas Convention Act.
collection. Telephone Survey or LPTS), and a
The National Marine Fisheries Service IV. Request for Comments
dockside survey which collects catch
(NMFS) is responsible for monitoring information and also estimates the We are soliciting public comments to
and managing United States (U.S.) proportion of vessels fishing for large permit the Department/Bureau to: (a)
marine fisheries resources. Collection of pelagics that are not on the telephone Evaluate whether the proposed
information regarding fishing for large frame (Large Pelagic Intercept Survey or information collection is necessary for
pelagic species (tunas, billfishes, LPIS). Results from the two survey the proper functions of the Department,
swordfish, and sharks) is necessary to components are combined to estimate including whether the information will
fulfill the following statutory total landings of Highly Migratory have practical utility; (b) Evaluate the
requirements: Atlantic Tunas Species. In addition, we are requesting accuracy of our estimate of the time and
Convention Act (16 U.S.C. 971 et seq.), approval to continue to implement the cost burden for this proposed collection,
the Magnuson-Stevens Fishery Large Pelagic Biological Survey (LPBS) including the validity of the
Conservation and Management Act (16 to collect supplemental weight and methodology and assumptions used; (c)
U.S.C. 1801 et seq.), and to meet length measurements of landed fish Evaluate ways to enhance the quality,
administrative requirements of the through independent dockside utility, and clarity of the information to
National Marine Fisheries Service sampling, as well as LPIS Validation be collected; and (d) Minimize the
(NMFS) Marine Recreational Fishery telephone calls to validate LPIS data. reporting burden on those who are to
Policy implemented to comply with Implementation of certain components respond, including the use of automated
Executive Order 12962 on Recreational will depend on fiscal year funding and collection techniques or other forms of
Fisheries. NMFS priorities. information technology.
The Atlantic Tunas Convention Act at NMFS, regional fishery management Comments that you submit in
16 U.S.C. 971d(c)(3)(I) provides the councils, interstate marine fisheries response to this notice are a matter of
Secretary of Commerce the authority to commissions, and state fishery agencies public record. We will include or
‘‘require any commercial or recreational use the data in developing, summarize each comment in our request
fisherman to obtain a permit from the implementing and monitoring fishery to OMB to approve this ICR. Before
Secretary and report the quantity of management programs. This collection including your address, phone number,
catch of a regulated species’’. Section has been the key source of data used to email address, or other personal
303(a) of the Magnuson-Stevens Act monitor recreational quotas for the identifying information in your
specifies data and analyses to be harvest of bluefin tuna in the Mid- comment, you should be aware that
included in Fishery Management Plans Atlantic and southern New England your entire comment—including your
(FMPs), as well as pertinent data, which regions. Catch distributions, harvested personal identifying information—may
shall be submitted to the Secretary of size distributions, and other indices be made publicly available at any time.
Commerce under the plan. obtained in this data collection have While you may ask us in your comment
to withhold your personal identifying DEPARTMENT OF DEFENSE discuss classified current and future
information from public review, we national security challenges and
cannot guarantee that we will be able to Office of the Secretary priorities within the DoD.
do so. [Req No. OS–2024–00032]
Agenda: The meeting will begin on
Wednesday, November 8, 2023 at 8:00
Sheleen Dumas, a.m. Eastern Standard time (EST), Ms.
Defense Science Board; Notice of
Department PRA Clearance Officer, Office of Betsy Kowalski, Designated Federal
the Under Secretary for Economic Affairs,
Federal Advisory Committee Meeting
Officer and Dr. Eric Evans, Chair of the
Commerce Department. AGENCY: Under Secretary of Defense for DSB, will provide classified opening
[FR Doc. 2023–24440 Filed 11–3–23; 8:45 am] Research and Engineering (USD(R&E)), remarks regarding ongoing studies.
BILLING CODE 3510–22–P Department of Defense (DoD). Next, the Security Assistance Group-
ACTION: Notice of Federal Advisory Ukraine will provide a classified
Committee meeting. briefing on updates regarding the
conflict in Ukraine. After a short break,
U.S. INTERNATIONAL DEVELOPMENT SUMMARY: The DoD is publishing this the DSB will receive a classified briefing
FINANCE CORPORATION notice to announce that the following from Honorable Douglas. R. Bush,
Federal Advisory Committee meeting of Acting Assistant Secretary of the Army
Notice of Public Hearing the Defense Science Board (DSB) will (Acquisition, Logistics and Technology)
take place. on the Army’s acquisition priorities.
AGENCY: U.S. International Development DATES: Closed to the public Wednesday, Following a break, Dr. Katherine
Finance Corporation. November 8, 2023, from 8:00 a.m. to McGrady and Dr. Robert Wisnieff, DSB
ACTION: Announcement of public 3:50 p.m. and Thursday, November 9, Members, will provide a classified
hearing. 2023 from 9:00 a.m. to 4:30 p.m. briefing on the Defense Science Board’s
ADDRESSES: The address of the closed Task Force to Advise Implementation
SUMMARY: The Board of Directors of the meeting is the Pentagon, Rooms 5E732 and Prioritization of National Security
U.S. International Development Finance and 3A912A, Washington, DC, 20301. Innovation Activities findings and
Corporation (‘‘DFC’’) will hold a public FOR FURTHER INFORMATION CONTACT: Ms.
recommendations, followed by a DSB
hearing on December 6, 2023. This Elizabeth J. Kowalski, Designated vote. After a break, the board will
hearing will afford an opportunity for Federal Officer (DFO): (703) 571–0081 receive a classified briefing from Mr.
any person to present views in Frederick J. Stefany, Acting Assistant
(Voice), (703) 697–1860 (Facsimile),
accordance with section 1413(c) of the Secretary of the Navy for Research,
elizabeth.j.kowalski.civ@mail.mil,
BUILD Act of 2018. Those wishing to Development and Acquisition on the
(Email). Mailing address is Defense
present at the hearing must provide Navy’s acquisition priorities. Lastly, Mr.
Science Board, 3140 Defense Pentagon,
advance notice to the agency as detailed William B. ‘‘Willie’’ Nelson, Deputy to
Washington, DC 20301–3140. Website:
below. the Commanding General, Army Futures
http://www.acq.osd.mil/dsb/. The most
Command, will provide a classified
DATES: Public hearing: 2:00 p.m. EST, up-to-date changes to the meeting
briefing on Army Future Command’s
Wednesday, December 6, 2023. agenda can be found on the website.
acquisition priorities. The meeting will
SUPPLEMENTARY INFORMATION: Due to adjourn at 3:50 p.m. EST.
Registration: To attend, present at, or
circumstances beyond the control of the The meeting will continue on
submit a written statement to the Board
Designated Federal Officer, the Defense Thursday, November 9, 2023 at 9:00
prior to the public hearing, individuals
Science Board was unable to provide a.m. EST with a classified briefing from
must notify DFC Acting Deputy
public notification required by 41 CFR Dr. Philip Root [Army Lieutenant
Corporate Secretary Abigail Wade at
102–3.150(a) concerning its November Colonel (ret), Ph.D.], Director of the
corporate.secretary@dfc.gov at by 5:00
8–9, 2023 meeting. Accordingly, the Strategic Technology Office (STO) of
p.m. EST, Tuesday, November 28, 2023.
Advisory Committee Management Defense Advanced Research Projects
Notices of intent to attend or present Officer for the Department of Defense, Agency on STO’s acquisition priorities.
at the public hearing must include the pursuant to 41 CFR 102–3.150(b), This will be followed by a classified
individual’s name, title, organization, waives the 15-calendar day notification briefing provided by Mr. Andrew P.
address, email address, phone number, requirement. Hunter, Service Acquisition Executive
and a concise summary of the subject This meeting is being held under the for the United States Air Force (USAF),
matter to be presented. Oral provisions of chapter 10 of title 5, on the USAF’s acquisition priorities.
presentations may not exceed five United States Code (U.S.C.) (commonly Following a break, Dr. Derek Tournear,
minutes and may be reduced known as the ‘‘Federal Advisory Director, Space Development Agency
proportionately, if necessary, to afford Committee Act’’ or ‘‘FACA’’), 5 U.S.C. (SDA), will provide a classified
all participants an opportunity to be 552b (commonly known as the overview of SDA’s overview. After a
heard. ‘‘Government in the Sunshine Act’’), break, Dr. Robert Grossman and Dr.
Written statements submitted to the and sections 102–3.140 and 102–3.150 Mark Maybury, DSB Members, will
Board prior to the public hearing must of title 41, Code of Federal Regulations provide a classified briefing on the
include the individual’s name, title, (CFR). DSB’s Task Force on Digital Engineering
organization, address, email address, Purpose of the Meeting: The mission Capability to Automate Testing and
and phone number. Statements must be of the DSB is to provide independent Evaluation findings and
typewritten, double-spaced, and less advice and recommendations on matters recommendations, followed by a DSB
than ten pages in length. relating to the DoD’s scientific and vote. After a break, the board will
technical enterprise. The objective of receive a classified briefing from Dr.
Deborah Papadopoulos, the meeting is to obtain, review, and David Van Wie, DSB Member, regarding
Records Management Specialist. evaluate classified information related the DSB’s Task Force on Test and
[FR Doc. 2023–24459 Filed 11–3–23; 8:45 am] to the DSB’s mission. DSB membership Evaluation findings and
BILLING CODE P will meet with DoD Leadership to recommendations, followed by a DSB
vote. The meeting will adjourn at 4:30 SUMMARY: The DoD is publishing this overview on Acquiring Capabilities for
p.m. EST. notice to announce that the following the United States Space Force (Space
Meeting Accessibility: In accordance Federal advisory committee meeting of Force) from Lieutenant Colonel Raquel
with 5 U.S.C. 1009(d) and 41 CFR 102– the Defense Business Board (‘‘the Salim, Space Force, Program Element
3.155, the DoD has determined that the Board’’) will take place. Monitor, Space Domain Awareness &
DSB meeting will be closed to the DATES: Closed to the public Tuesday, Space Control. This briefing will
public. Specifically, the USD(R&E), in November 14, 2023 from 9:15 a.m. to provide an overview of the Space Force
consultation with the DoD Office of the 11:20 a.m. Eastern Standard Time (EST) mission, organizational structure,
General Counsel, has determined in and from 5:30 p.m. to 7:35 p.m. EST and leadership, capabilities, and space
writing that the meeting will be closed on Wednesday, November 15 from 10:55 acquisition. The DFO will adjourn the
to the public because it will consider a.m. to 11:35 a.m. EST. Open to the closed session. The Board will meet in
matters covered by 5 U.S.C. 552b(c)(1). public Tuesday, November 14 from open session November 14 from 11:25
The determination is based on the 11:25 a.m. to 12:30 p.m. EST and from a.m. to 12:30 p.m. EST. The DFO will
consideration that it is expected that 1:45 p.m. to 4:45 p.m. EST and on open the public session followed by a
discussions throughout will involve Wednesday, November 15, 2023 from 9 welcome by the Board Chair. The Board
classified matters of national security a.m. to 10:45 a.m. EST. will receive an update on DoD Talent
concern. Such classified material is so ADDRESSES: The open and closed Management from Mr. Brynt Parmeter,
intertwined with the unclassified portions of the meeting will be in rooms Chief Talent Management Officer, and
material that it cannot reasonably be 1E840 and 4D880 in the Pentagon, Ms. Angela Cough, Chief Digital and
segregated into separate discussions Washington DC. Artificial Intelligence Office Senior
without defeating the effectiveness and Advisor, Digital Workforce Talent &
FOR FURTHER INFORMATION CONTACT: Ms.
meaning of the overall meetings. To Functional Community Management.
Cara Allison Marshall, Designated
permit the meeting to be open to the After a lunch break, the Board will
Federal Officer (DFO) of the Board in
public would preclude discussion of resume their open session from 1:45
writing at Defense Business Board, 1155
such matters and would greatly p.m. to 4:45 p.m. EST. The Board Chair
Defense Pentagon, Room 5B1088A,
diminish the ultimate utility of the will provide remarks, followed by a
Washington, DC 20301–1155; or by
DSB’s findings and recommendations to discussion on Enterprise Digitization:
email at cara.l.allisonmarshall.civ@
the Secretary of Defense and to the Emerging Technologies and Ecosystem
mail.mil; or by phone at 703–614–1834.
USD(R&E). Strategy at the Speed of Artificial
Written Statements: In accordance SUPPLEMENTARY INFORMATION: Due to
circumstances beyond the control of the Intelligence from Mr. Ryan McManaus,
with 5 U.S.C. 1009(a)(3) and 41 CFR
Designated Federal Officer, the Defense Founder and CEO of Techtonic. After a
102–3.105(j) and 102–3.140, interested
Business Board was unable to provide short break, the Board will receive a
persons may submit a written statement
public notification required by 41 CFR presentation on the Board study,
for consideration by the DSB at any time
102–3.150(a) concerning its November Improving the Business Operations
regarding its mission or in response to
14–15, 2023 meeting. Accordingly, the Culture of the DoD from General (Gen.)
the stated agenda of a planned meeting.
Advisory Committee Management Larry Spencer (Ret), Chair, Talent
Individuals submitting a written
Officer for the Department of Defense, Management, Culture, & Diversity
statement must submit their statement
pursuant to 41 CFR 102–3.150(b), Subcommittee, and then the Board will
to the DSB DFO at the email address
waives the 15-calendar day notification deliberate and vote on the study. The
provided in the FOR FURTHER
requirement. DFO will then adjourn the open session.
INFORMATION CONTACT section at any
This meeting is being held under the The Board will reconvene in closed
point; however, if a written statement is
provisions of chapter 10 of title 5, session on November 14 from 5:30 p.m.
not received at least three calendar days
United States Code (U.S.C.) (commonly to 7:35 p.m. EST. The DFO will begin
prior to the meeting, which is the
known as the ‘‘Federal Advisory the closed session followed by remarks
subject of this notice, then it may not be
Committee Act’’ or ‘‘FACA’’), 5 U.S.C. by Board Chair, Hon. Deborah James
provided to or considered by the DSB
552b (commonly known as the and Deputy Secretary, Hon. Kathleen
until a later date.
‘‘Government in the Sunshine Act’’), Hicks. Next, the Board will hear a
Dated: October 30, 2023. and 41 CFR 102–3.140 and 102–3.150. classified update on the United States
Aaron T. Siegel, Purpose of the Meeting: The mission Army’s Future Development and Joint
Alternate OSD Federal Register Liaison of the Board is to examine and advise Integration from Gen. Randy George,
Officer, Department of Defense. the Secretary of Defense on overall DoD Chief of Staff of the Army. The DFO will
[FR Doc. 2023–24415 Filed 11–3–23; 8:45 am] management and governance. The Board adjourn the closed session. The Board
BILLING CODE 6001–FR–P provides independent, strategic-level, will meet in open session November 15,
private sector and academic advice and 2023 from 9:00 a.m. to 10:45 a.m. EST.
counsel on enterprise-wide business The DFO will begin the closed session
DEPARTMENT OF DEFENSE management approaches and best followed by the Chair’s welcome. Next
practices for business operations and the Board will receive a presentation on
Office of the Secretary achieving National Defense goals. the Board Space Acquisition study from
[Req No. OS–2024 00031–FR] Agenda: The Board will begin in Ms. Linnie Haynesworth, Chair,
closed session on November 14 from Business Operations Advisory
Defense Business Board; Notice of 9:15 a.m. to 11:20 a.m. EST. The DFO Subcommittee, and then the Board will
Federal Advisory Committee Meeting will begin the closed session followed deliberate and vote on the study. The
AGENCY: Office of the Deputy Secretary by a welcome by Board Chair, DFO will adjourn the open session. The
of Defense, Department of Defense Honorable (Hon.) Deborah James. The Board will reconvene in closed session
(DoD). Board will receive a classified on November 15 from 10:55 a.m. to
discussion on the DoD Budget from 11:35 a.m. EST. The DFO will begin the
ACTION: Notice of Federal advisory
Hon. Kathleen Hicks, Deputy Secretary closed session followed by a classified
committee meeting.
of Defense, followed by a classified discussion on DoD Current Affairs from
Hon. Lloyd Austin, Secretary of name, title or affiliation, address, and (voice), osd.mc-alex.ousd-p-
Defense. The DFO will then adjourn the daytime phone number. The DFO must r.mbx.dacodai@mail.mil (email).
closed session. receive written comments or statements Additional information is also available
The latest version of the agenda will submitted in response to the agenda set at the DACODAI website: https://
be available on the Board’s website at: forth in this notice by Friday, November www.dhra.mil/DACODAI.
https://dbb.dod.afpims.mil/Meetings/ 10, 2023, to be considered by the Board. SUPPLEMENTARY INFORMATION: This
Meeting-November-2023/. The DFO will review all timely meeting is being held under the
Meeting Accessibility: In accordance submitted written comments or provisions of chapter 10 of title 5,
with 5 U.S.C. 1009(d) and 41 CFR 102– statements with the Board Chair and United States Code (U.S.C.) (commonly
3.155, it is hereby determined that the ensure the comments are provided to all known as the ‘‘Federal Advisory
November 14–15 meeting of the Board members of the Board before the Committee Act’’ or ‘‘FACA’’), 5 U.S.C.
will include classified information and meeting. Written comments or 552b (commonly known as the
other matters covered by 5 U.S.C. statements received after this date may ‘‘Government in the Sunshine Act’’),
552b(c)(1) and that, accordingly, not be provided to the Board until its and 41 Code of Federal Regulations
portions of the meeting will be closed to next scheduled meeting. Please note (CFR) 102–3.140 and 102–3.150.
the public. This determination is based that all submitted comments and Availability of Materials for the
on the consideration that it is expected statements will be treated as public Meeting: Additional information,
that discussions throughout the closed documents and will be made available including the agenda or any updates to
portions will involve classified matters for public inspection, including, but not the agenda, is available on the
of national security. Such classified limited to, being posted on the Board’s DACODAI website: https://
material is so intertwined with the website. www.dhra.mil/DACODAI/. Materials
unclassified material that it cannot
reasonably be segregated into separate Dated: October 30, 2023. presented in the meeting may also be
discussions without defeating the Aaron T. Siegel, obtained on the DACODAI website.
effectiveness and meaning of these Alternate OSD Federal Register Liaison Purpose of the Meeting: The purpose of
portions of the meeting. To permit these Officer, Department of Defense. the meeting is for the DACODAI to
portions of the meeting to be open to the [FR Doc. 2023–24451 Filed 11–3–23; 8:45 am] receive briefings and have discussions
public would preclude discussion of BILLING CODE 6001–FR–P
on topics related to racial/ethnic
such matters and would greatly diversity, inclusion, and equal
diminish the ultimate utility of the opportunity within the Armed Forces of
Board’s findings and recommendations DEPARTMENT OF DEFENSE the United States. In addition, the
to the Secretary of Defense and the committee members will vote on the
Deputy Secretary of Defense. Pursuant Office of the Secretary 2023 DACODAI proposed
to 5 U.S.C. 1009(a)(1) and 41 CFR 102– [Req No. OS–2024–00033–FR] recommendations for the Secretary of
3.140, the portions of the meeting on Defense. Agenda: Thursday, December
November 14 from 11:25 a.m. to 12:30 Defense Advisory Committee on 14, 2023, from 9:00 a.m. to 12:15 p.m.
p.m. EST and from 1:45 p.m. to 4:45 Diversity and Inclusion; Notice of EST. DACODAI will begin in open
p.m. EST and on November 15, 2023 Federal Advisory Committee Meeting session on December 14, 2023, from
from 9 a.m. to 10:45 a.m. EST are open 9:00 a.m. to 12:15 p.m. EST with
AGENCY: Under Secretary of Defense for opening remarks by Ms. Shirley
to the public virtually. Persons desiring Personnel and Readiness (USD(P&R)),
to attend the public sessions are Raguindin, the DFO and the DACODAI’s
Department of Defense (DoD). Chair, General (Gen.) (Ret.) Lester Lyles,
required to register. To attend the public
ACTION: Notice of Federal Advisory The DACODAI will receive the
sessions, submit your name, affiliation/
organization, telephone number, and Committee meeting. following briefings: (1) the United States
email contact information to the Board SUMMARY: DoD is publishing this notice Africa Command (AFRICOM) on
at osd.pentagon.odam.mbx.defense- to announce that the following Federal Diversity and Inclusion by Colonel Lynn
business-board@mail.mil. Requests to Advisory Committee meeting of the Ray, Chief Diversity and Inclusion
attend the public sessions must be Defense Advisory Committee on Officer, AFRICOM (2) the Office of
received no later than 4:00 p.m. EST on Diversity and Inclusion (DACODAI) will Diversity, Equity, and Inclusion
Friday, November 10, 2023. Upon occur. Progress by Dr. Lisa Arfaa, Director,
receipt of this information, the Board Office for Diversity, Equity, and
DATES: DACODAI will hold an open-to-
will provide further instructions for Inclusion; and (3) the Defense Testing
the-public meeting—Thursday, and Assessment Center Diversity and
virtually attending the meeting. December 14, 2023, from 9:00 a.m. to
Written Comments and Statements: Inclusion Efforts by Dr. Tia Fechter.
12:15 p.m. (EST) and Friday, December Closing remarks will be provided by the
Pursuant to 41 CFR 102–3.105(j) and
15, 2023, from 9:00 a.m. to 12:20 p.m. Chair, Gen. (Ret.) Lyles, and Ms. Shirley
102–3.140 and 5 U.S.C. 1009(a)(3) of the
EST. Raguindin, DACODAI DFO, will
FACA, the public or interested
organizations may submit written ADDRESSES: The in-person meeting will adjourn the meeting.
comments or statements to the Board in be held at the Association of the United Friday, December 15, 2023, from 9:00
response to the stated agenda of the States Army (AUSA) Conference and a.m. to 12:20 p.m. EST. The DACODAI
meeting or regarding the Board’s Event Center, 2425 Wilson Blvd., will begin in an open session on
mission in general. Written comments Arlington, VA 22201. In addition, the December 15, 2023, from 9:00 a.m. to
or statements should be submitted to meeting will be held via 12:20 p.m. EST with opening remarks
Ms. Cara Allison Marshall, the DFO, via videoconference. Participant access by Ms. Shirley Raguindin, the DFO and
electronic mail (the preferred mode of information will be provided after the DACODAI’s Chair, Gen. (Ret.) Lester
submission) at the address listed in the registering. Lyles. The DACODAI will vote on
FOR FURTHER INFORMATION CONTACT FOR FURTHER INFORMATION CONTACT: proposed recommendations for the
section. Each page of the comment or Designated Federal Officer (DFO), Ms. Secretary of Defense. Closing remarks
statement must include the author’s Shirley Raguindin, (571) 645–6952 will be provided by the Chair, Gen.
(Ret.) Lyles, and Ms. Shirley Raguindin, December 8, 2023, to be considered by meeting may also be obtained on the
DACODAI DFO, will adjourn the the DACODAI membership prior to its DACOWITS website.
meeting. December 14, 2023 meeting. Purpose of the Meeting: The purpose
Meeting Accessibility: Pursuant to 5 Dated: October 31, 2023.
of the meeting is for the DACOWITS to
U.S.C. 552b and 41 CFR 102–3.140 and receive briefings and have discussions
Aaron T. Siegel,
102–3.150, this meeting is open to the on topics related to the recruitment,
public from 9:00 a.m. to 12:15 p.m. EST Alternate OSD Federal Register Liaison retention, employment, integration,
Officer, Department of Defense.
on December 14, 2023; and from 9:00 well-being, and treatment of women in
a.m. to 12:20 p.m. EST on December 15, [FR Doc. 2023–24417 Filed 11–3–23; 8:45 am] the Armed Forces of the United States.
2023. The meeting will be held via BILLING CODE 6001–FR–P Additionally, the Committee will vote
videoconference. The number of on some additional 2023
participants is limited and is on a first- recommendations.
come basis. All members of the public DEPARTMENT OF DEFENSE Agenda: Tuesday, December 5, 2023,
who wish to participate must register by from 8:00 a.m. to 3:00 p.m.—Welcome,
Office of the Secretary
contacting DACODAI at osd.mc- Introductions, Announcements, Request
alex.ousd-p-r.mbx.dacodai@mail.mil or [Req No. OS–2024–00029–FR] for Information Status Update, Briefings,
by contacting Ms. Shirley Raguindin at Public Comment Period, Vote on
(571) 645–6952 no later than Friday, Defense Advisory Committee on Recommendations, and DACOWITS
December 8, 2023 (by 5:00 p.m. EST). Women in the Services; Notice of discussion.
Once registered, the web address and/or Federal Advisory Committee Meeting Meeting Accessibility: Pursuant to 5
audio number will be provided. U.S.C. 552(b) and 41 CFR 102–3.140
Special Accommodations: Individuals AGENCY: Under Secretary of Defense for through 102–3.165, this meeting is open
requiring special accommodations to Personnel and Readiness, Department of to the public, subject to availability of
access the public meeting should Defense (DoD). space, from 8:00 a.m. to 3:00 p.m. on
contact the DFO, Ms. Shirley Raguindin ACTION: Notice of Federal Advisory December 5, 2023. The meeting will also
at osd.mc-alex.ousd-p-r.mbx.dacodai@ Committee meeting. be streamed by videoconference. The
mail.mil or (571) 645–6952 no later than number of participants is limited and is
Friday, December 8, 2023 (by 5:00 p.m. SUMMARY: The DoD is publishing this on a first-come basis. Any member of
EST) so appropriate arrangements can notice to announce that the following the public who wishes to participate via
be made. Federal Advisory Committee meeting of videoconference must register by
Written Statements: Pursuant to 41 the Defense Advisory Committee on contacting DACOWITS at
CFR 102–3.140(c) and section 10(a)(3) of Women in the Services (DACOWITS) osd.pentagon.ousd-p-r.mbx.dacowits@
the FACA, the public or interested will take place. mail.mil or by contacting Mr. Robert
parties may submit written statements DATES: DACOWITS will hold an open to Bowling at (703) 380–0116 no later than
to the DACODAI membership about the the public meeting—Tuesday, December Monday, November 27, 2023. Once
DACODAI’s mission and functions. 5, 2023, from 8:00 a.m. to 3:00 p.m. registered, the videoconference
Written statements may be submitted at (EST). information will be provided.
any time or in response to the stated Special Accommodations: Individuals
ADDRESSES: The meeting will take place
agenda of planned meetings of the requiring special accommodations to
at the Association of the United States
DACODAI. All written statements shall access the public meeting should
Army Conference Center, located at
be submitted to the DFO, Ms. Shirley contact Mr. Robert Bowling no later
2425 Wilson Boulevard, Arlington,
Raguindin, for the DACODAI, who will than Monday, November 27, 2023, so
Virginia, 22201. The meeting will also
ensure that the written statements are appropriate arrangements can be made.
be held virtually. To participate in the Written Statements: Pursuant to 41
provided to the membership for their meeting, see the Meeting Accessibility
consideration. All written statements CFR 102–3.140, and section 10(a)(3) of
section for instructions. the FACA, interested persons may
will be submitted to mailing address,
4800 Mark Center Drive, Suite 06E22, FOR FURTHER INFORMATION CONTACT: LTC submit a written statement to the
Alexandria, VA 22350. Members of the Samantha Frazier, Designated Federal DACOWITS. Individuals submitting a
public interested in making an oral Officer (DFO), (202) 650–2943 (voice), written statement must submit their
statement must submit a written Samantha.j.frazier11.mil@mail.mil statement no later than 5:00 p.m. EST,
statement. If a statement is not received (email). The most up-to-date changes to Monday, November 27, 2023, to Mr.
by Friday, December 8, 2023, it may not the meeting agenda can be found on the Robert Bowling at (703) 380–0116
be provided to or considered by the website: https://dacowits.defense.gov. (voice) or to robert.d.bowling1.mil@
DACODAI during this biannual business SUPPLEMENTARY INFORMATION: This mail.mil (email). Mailing address is
meeting. After reviewing the written meeting is being held under the 4800 Mark Center Drive, Suite 04J25–01,
statements, the Chair and the DFO will provisions of chapter 10 of title 5 United Alexandria, VA 22350. Members of the
determine if the requesting person(s) States Code (U.S.C.) (commonly known public interested in making an oral
can make an oral presentation. The DFO as the ‘‘Federal Advisory Committee statement, must submit a written
will review all timely submissions with Act’’ or ‘‘FACA’’), 5 U.S.C. 552(b) statement. If a statement is not received
the DACODAI Chair and ensure they are (commonly known as the ‘‘Government by Monday, November 27, 2023, it may
provided to the members of the in the Sunshine Act’’), and 41 Code of not be provided to or considered by the
DACODAI. Federal Regulations (CFR) 102–3.140 Committee during this quarterly

Members of the public may also email and 102–3.150. business meeting. After reviewing the
written statements to osd.mc-alex.ousd- Availability of Materials for the written statements, the Chair and the
p-r.mbx.dacodai@mail.mil. Written Meeting: Additional information, DFO will determine if the requesting
statements pertaining to the meeting including the agenda or any updates to persons are permitted to make an oral
agenda for the DACODAI’s meeting on the agenda, is available at the presentation. The DFO will review all
December 14, 2023, must be submitted DACOWITS website, https://dacowits. timely submissions with the
no later than 5:00 p.m. EST, Friday, defense.gov/. Materials presented in the DACOWITS Chair and ensure they are
provided to the members of the Additional meeting details will be 2023, as listed in the FOR FURTHER
Committee. posted on: https://dacmpt.com. INFORMATION CONTACT section.
Dated: October 26, 2023. FOR FURTHER INFORMATION CONTACT: Written Statements: Pursuant to 41
Aaron T. Siegel, Designated Federal Officer (DFO), Dr. CFR 102–3.105(j) and 102–3.140 and
Sofiya Velgach, (703) 697–9271 (Voice), section 10(a)(3) of the FACA, interested
Alternate OSD Federal Register Liaison
Officer, Department of Defense. 703 614–9272 (Facsimile), persons may submit written statements
osd.pentagon.ousd-p-r.mbx.dacmpt@ to the DACMPT at any time about its
[FR Doc. 2023–24416 Filed 11–3–23; 8:45 am]
mail.mil (Email). Mailing address is approved agenda or at any time on the
BILLING CODE 6001–FR–P
DFO, Accession Policy, Office of the DACMPT’s mission. Written statements
USD(P&R), Room 3D1066, The should be submitted to the DACMPT’s
Pentagon, Washington, DC 20301–4000. DFO at the address or facsimile number
DEPARTMENT OF DEFENSE
The most up-to-date changes to the listed in the FOR FURTHER INFORMATION
Office of the Secretary meeting can be found on the website: CONTACT section. If statements pertain to
https://dacmpt.com. a specific topic being discussed at the
[Req No. OS–2024–00030–FR] planned meeting, then these statements
SUPPLEMENTARY INFORMATION: This
meeting is being held under the must be submitted no later than five (5)
Defense Advisory Committee on
provisions of chapter 10 of title 5, business days prior to the meeting in
Military Personnel Testing; Notice of
United States Code (U.S.C.) (commonly question. Written statements received
Federal Advisory Committee Meeting
known as the ‘‘Federal Advisory after this date may not be provided to,
AGENCY: Under Secretary of Defense for Committee Act’’ or ‘‘FACA’’); 5 U.S.C. or not considered by the DACMPT until
Personnel and Readiness, (USD(P&R)) 552b (commonly known as the its next meeting. The DFO will review
Department of Defense (DoD). ‘‘Government in the Sunshine Act’’); all timely submitted written statements
ACTION: Notice of Federal Advisory and 41 Code of Federal Regulations and provide copies to all the DACMPT
Committee meeting. (CFR) 102–3.140 and 102–3.150. members before the meeting that is the
Purpose of the Meeting: The purpose subject of this notice. Please note that
SUMMARY: The DoD is publishing this of the meeting is to provide an overview since the DACMPT operates under the
notice to announce that the following and obtain DACMPT members’ provisions of the FACA, all submitted
Federal Advisory Committee meeting of recommendation on the methodology comments and public presentations will
the Defense Advisory Committee on and proposed way forward for allowing be treated as public documents and will
Military Personnel Testing (DACMPT) the use of calculators on the quantitative be made available for public inspection.
will take place. sections of the Armed Services Opportunity for public comments will
DATES: Open to the public Tuesday, Vocational Aptitude Battery (ASVAB). be provided at the end of each day.
December 19, 2023 from 1:00 p.m. to Additional information can be found at Public comments will be limited to 2
3:00 p.m., Eastern Time. https://dacmpt.com. minutes per person, as time allows.
ADDRESSES: This will be a virtual Agenda: Dated: October 30, 2023.
meeting using Microsoft Teams. Link is: Tuesday, December 19, 2023 Aaron T. Siegel,
https://usg01.safelinks.protection 1:00 p.m.–1:05 p.m. Welcome and Alternate OSD Federal Register Liaison
.office365.us/ap/t-59584e83/ Opening Remarks, Dr. Sofiya Officer, Department of Defense.
?url=https%3A%2 Velgach, Office of the Assistant [FR Doc. 2023–24402 Filed 11–3–23; 8:45 am]
F%2Fteams.microsoft.com Secretary of Defense for Manpower BILLING CODE 6001–FR–P
%2Fl%2Fmeetup-join%2F19%253 and Reserve Affairs/Accession
ameeting_MWE2Y2Q3ZmMtNWY5Z Policy
S00OWJlLTllOWI 1:05 p.m.–2:00 p.m. Calculators on DEPARTMENT OF EDUCATION
tYWRmOTNmODI4ZTQ the ASVAB, Dr. David M. Trippe,
x%2540thread.v2%2 Office of People Analytics/Defense Accrediting Agencies Currently
F0%3Fcontext%3D% Testing and Assessment Center Undergoing Review for the Purpose of
257b%2522Tid%2522% 2:00 p.m.–2:45 p.m. Immediate Recognition by the U.S. Secretary of
253a%2522ca9c4d2f-3529-4c0f-b5ad- Implementation of Calculators, Mr. Education
059f3b26b20c%2522%252c%2522O Ethan Blankenship Office of the
id%2522%253a%2522223e7d39-62a6- Assistant Secretary of Defense for AGENCY: Accreditation Group, Office of
4864-9b9d-3547a173a97f%2522% Manpower and Reserve Affairs/ Postsecondary Education, U.S.
257d&data=05%7C01%7 Accession Policy Department of Education.
Csofiya.velgach.civ% 2:45 p.m.–2:55 p.m. Public Comments ACTION: Call for written third-party
40mail.mil%7C66506e89361 2:55 p.m.–3:00 p.m. Closing comments.
c4912ff6708dbcb4 Comments. Dr. Nancy Tippins,
c6b82%7C102d0191eeae Chair SUMMARY: This notice provides
4761b1cb1a83e86ef445%7C0% Latest version of the agenda will be information to members of the public on
7C0%7C638327301326942569 posted on https://dacmpt.com. submitting written comments for
%7CUnknown Meeting Accessibility: Pursuant to 5 accrediting agencies currently
%7CTWFpbGZsb3d8eyJWIjoiMC4wLj U.S.C. 552b and 41 CFR 102–3.140 undergoing review for the purpose of
AwMDAiLCJQIjoiV2luMzIiLCJB through 102–3.165, and the availability recognition by the U.S. Secretary of
TiI6Ik1haWwiLCJXVCI of space, this meeting is virtually open Education.
6Mn0%3D%7C3000% to the public. Dial-in and access FOR FURTHER INFORMATION CONTACT:
7C%7C%7C&sdata= availability is based on first-come, first- Herman Bounds, Director, Accreditation
geeh06J4hqhVfbdPRwbl1TkmJaM served basis. All members of the public Group, Office of Postsecondary
D0070xz4Zsaq5oZE%3D&reserved=0;. who wish to attend the public meeting Education, U.S. Department of
Dial-in: (571) 429–6145; Phone must contact the DFO no later than Education, 400 Maryland Avenue SW,
Conference ID: 234 784 596#. 12:00 p.m. on Monday, December 4, Fifth Floor, Washington, DC 20202,
telephone: (202) 453–7615, or email: 2022, letter from the senior Department Alabama, Florida, Georgia, Kentucky,
herman.bounds@ed.gov. official (SDO) following the July 19, Louisiana, Mississippi, North Carolina,
SUPPLEMENTARY INFORMATION: This 2022, NACIQI meeting. The SDO letter South Carolina, Tennessee, Texas, and
request for written third-party is available under NACIQI meeting date Virginia, including the accreditation of
comments concerning the performance 7/19/2022, at https:// educational programs offered via
of accrediting agencies under review by surveys.ope.ed.gov/erecognition/#/ distance and correspondence education,
the Secretary of Education is required public-documents. and direct assessment within these
by 496(n)(1)(A) of the Higher Education 2. Association for Clinical Pastoral institutions. The accreditation status of
Act (HEA) of 1965, as amended, and Education. Scope of Recognition: The these institutions and their recognition
pertains to the winter 2025 meeting of preaccreditation and accreditation of extends to the SACSCOC Board of
the National Advisory Committee on CPE Level I/Level II programs and Trustees, Executive Council, and the
Institutional Quality and Integrity Certified Educator CPE programs, and Appeals Committee of the Collegiate
(NACIQI). The meeting date and the accreditation of these programs College Delegate Assembly on cases of
location have not been determined but offered via distance education. initial candidacy or initial accreditation
Geographic Area of Accrediting and for continued accreditation or
will be announced in a later Federal
Activities: The United States. The candidacy. The compliance report
Register notice. In addition, a later
compliance report includes findings of includes findings of noncompliance
Federal Register notice will describe
noncompliance with certain criteria in with certain criteria in 34 CFR part 602
how to register to provide oral
34 CFR part 602 identified in the identified in the November 7, 2022,
comments at the meeting. Note: Written
November 10, 2022, letter from the SDO letter from the SDO following the July
comments about the specific agencies
following the July 19, 2022, NACIQI 19, 2022, NACIQI meeting. The SDO
identified below will not be accepted or
meeting. The SDO letter is available letter is available under NACIQI
provided to NACIQI members if those
under NACIQI meeting date 7/19/2022, meeting date 7/19/2022, at https://
comments are submitted after the
at https://surveys.ope.ed.gov/ surveys.ope.ed.gov/erecognition/#/
deadline provided in this Federal erecognition/#/public-documents. public-documents.
Register notice, which is December 8, 3. Accrediting Council for Pharmacy
2023. Written comments must be Education. Scope of Recognition: The Submission of Written Comments
submitted to the mailbox identified accreditation and pre-accreditation of Regarding a Specific Accrediting
below. Do not submit written comments professional degree programs in Agency Under Review
directly to Department officials or to pharmacy leading to the degree of Written comments about the
NACIQI members. Doctor of Pharmacy, including those recognition of any of the accrediting
Agencies under Review and programs offered via distance education. agencies listed above must be received
Evaluation: The Department requests Geographic Area of Accrediting by December 8, 2023, in the
written comments from the public on Activities: The United States. The ThirdPartyComments@ed.gov mailbox.
the following accrediting agencies, compliance report includes findings of Please include in the subject line
which are currently undergoing review noncompliance with certain criteria in ‘‘Written Comments: (agency name).’’
and evaluation by the Accreditation 34 CFR part 602 identified in the The electronic mail (email) must
Group, and which will be reviewed at November 7, 2022, letter from the SDO include the name(s), title, organization/
the winter 2025 NACIQI meeting. The following the July 19, 2022, NACIQI affiliation, mailing address, email
agencies are listed by the type of meeting. The SDO letter is available address, and telephone number of the
application or report each agency has under NACIQI meeting date 7/19/2022, person(s) making the comment.
submitted. Please note, each agency’s at https://surveys.ope.ed.gov/ Comments should be submitted as a
current scope of recognition is indicated erecognition/#/public-documents. PDF, Microsoft Word document or in a
below. If any agency requested to 4. Middle States Commission on medium compatible with Microsoft
expand its scope of recognition, Secondary Schools. Scope of Word that is attached to an email or
identified are both the current scope of Recognition: The accreditation of provided in the body of an email
recognition and the requested scope of institutions with postsecondary, non- message. Comments about an agency
recognition. degree granting career and technology that has submitted a compliance report
programs, to include the accreditation of scheduled for review by the Department
Compliance Reports
postsecondary, non-degree granting must relate to the criteria for recognition
1. American Occupational Therapy institutions that offer all or part of their cited in the SDO letter that requested
Association, Accreditation Council for educational programs via distance the compliance report following the July
Occupational Therapy Education. Scope education modalities. Geographic Area 19, 2022, NACIQI meeting, or in the
of Recognition: The accreditation and of Accrediting Activities: The United Secretary’s appeal decision, if any. The
preaccreditation of occupational therapy States. The compliance report includes SDO letters for the specific agencies
educational programs offering the findings of noncompliance with certain referenced in this Federal Register
professional master’s degree and criteria in 34 CFR part 602 identified in notice are available under NACIQI
occupational therapy doctorate (OTD) the October 19, 2022, letter from the meeting date 7/19/2022, at https://
degree; the accreditation of occupational SDO following the July 19, 2022, surveys.ope.ed.gov/erecognition/#/
therapy assistant programs offering a NACIQI meeting. The SDO letter is public-documents.
baccalaureate degree and associate available under NACIQI meeting date 7/ Only written materials submitted by
degree; and the accreditation of these 19/2022, at https://surveys.ope.ed.gov/ the deadline to the email address listed
programs offered via distance education. erecognition/#/public-documents. in this notice, and in accordance with
Geographic Area of Accrediting 5. Southern Association of Colleges these instructions, become part of the
Activities: The United States. The and Schools, Commission on Colleges. official record concerning agencies
compliance report includes findings of Scope of Recognition: The accreditation scheduled for review and are considered
noncompliance with certain criteria in and pre-accreditation (‘‘Candidate for by the Department and NACIQI in their
34 Code of Federal Regulations (CFR) Accreditation’’) of degree-granting deliberations. Written comments about
part 602 identified in the October 19, institutions of higher education in the specific agencies identified in this
Federal Register notice that are Office, 1000 Independence Avenue SW, delays in providing assistance necessary
submitted after the deadline will not be Suite 4H–065, Washington, DC 20585, to reestablish the reliability of electric
considered by the Department or (240) 429–5213. service to these vulnerable residents.
provided to NACIQI for purposes of the FOR FURTHER INFORMATION CONTACT: This narrow scope in purpose
current review. However, comments Aisha Miranda Rivera, aisha.miranda- necessitates the need for a diligent
may be provided orally at the winter rivera@hq.doe.gov, or at Department of verification process to demonstrate to
2025 NACIQI meeting, which has not Energy, Grid Deployment Office, 1000 Congress, Senior Leadership, and the
yet been scheduled, but which will be Independence Avenue SW, Suite 4H– public that this specific demographic
announced in a future Federal Register 065, Washington, DC 20585, (240) 429– has been served. GDO developed an in-
notice. 5213. person application process recognizing
Electronic Access to this Document: SUPPLEMENTARY INFORMATION: Comments that the demographic served will lack
The official version of this document is are invited on: (a) Whether the extended access to broadband and have limited
the document published in the Federal collection of information is necessary mobility but that it is essential to
Register. Free internet access to the for the proper performance of the
official edition of the Federal Register program operation to verify beneficiary
functions of the agency, including eligibility for participation in the
and the Code of Federal Regulations is whether the information shall have
available via the Federal Digital System program.
practical utility; (b) the accuracy of the
at: www.gpo.gov/fdsys. At this site, you agency’s estimate of the burden of the (5) Annual Estimated Number of
can view this document, as well as all proposed collection of information, Respondents: 40,200.
other documents of the Department including the validity of the (6) Annual Estimated Number of
published in the Federal Register, in methodology and assumptions used; (c) Total Responses: 80,000.
text or Adobe Portable Document ways to enhance the quality, utility, and
Format (PDF). To use PDF, you must clarity of the information to be (7) Annual Estimated Number of
have Adobe Acrobat Reader, which is collected; and (d) ways to minimize the Burden Hours: 56,800.
available free at the site. You may also burden of the collection of information (8) Annual Estimated Reporting and
access documents of the Department on respondents, including through the Recordkeeping Cost Burden: $845,520.
published in the Federal Register by use of automated collection techniques Statutory Authority: The Consolidated
using the article search feature at: or other forms of information Appropriations Act of 2023, Public Law
www.federalregister.gov. Specifically, technology. 117–328,2 directs the Department of
through the advanced search feature at This information collection request
contains: Energy to improve the resilience of the
this site, you can limit your search to
documents published by the (1) OMB No.: 1910–5200; Puerto Rican electric grid, including
Department. (2) Information Collection Request grants for low-and-moderate-income
Authority: 20 U.S.C. 1011c; 20 U.S.C. Titled: Puerto Rico Energy Resiliency households and households that include
1099b. Fund (PR–ERF), Household Intake individuals with disabilities for the
Form. purchase and installation of renewable
Nasser Paydar, (3) Type of Review: Extension of a energy, energy storage, and other grid
Assistant Secretary for the Office of currently approved emergency technologies. This narrow scope in
Postsecondary Education. collection. purpose necessitates the need for a
[FR Doc. 2023–24434 Filed 11–3–23; 8:45 am] (4) Purpose: To authorize the use of diligent verification process to
BILLING CODE P the ‘Household Intake Form’ to collect demonstrate to Congress, Senior
homeowner data necessary to qualify Leadership, and the public that this
households as eligible to receive rooftop specific demographic has been served.
DEPARTMENT OF ENERGY solar and battery storage installations as
prescribed under the DOE Grid Signing Authority
Agency Information Collection Deployment Office’s (GDO) PR–ERF.
Extension Eligibility is limited to very low-income, This document of the Department of
single-family households that (1) reside Energy was signed on October 20, 2023,
AGENCY: Department of Energy. by Maria D. Robinson, pursuant to
in a Last Mile Community 1 or (2)
ACTION: Notice of request for comments. include an individual with an energy- delegated authority from the Secretary
dependent disability. of Energy. That document with the
SUMMARY: The Department of Energy
(DOE), pursuant to the Paperwork The PR–ERF, a $1 billion initiative original signature and date is
Reduction Act of 1995, intends to authorized by Congress under the maintained by DOE. For administrative
extend for three years, an information Consolidated Appropriations Act of purposes only, and in compliance with
collection request with the Office of 2023, Public Law 117–328, will requirements of the Office of the Federal
Management and Budget (OMB). incentivize the installation of rooftop Register, the undersigned DOE Federal
solar and battery storage technologies Register Liaison Officer has been
DATES: Comments regarding this
for eligible households. authorized to sign and submit the
proposed information collection must GDO plans to initiate installations of
be received on or before January 5, 2024. document in electronic format for
solar PV and battery storage systems publication, as an official document of
If you anticipate any difficulty in before the 2024 hurricane season to
submitting comments within that the Department of Energy. This

address the harm and risk represented administrative process in no way alters
period, contact the person listed in the by the fragility of the islands’ power
FOR FURTHER INFORMATION CONTACT the legal effect of this document upon
system. Failure to collect the
section as soon as possible. publication in the Federal Register.
information necessary to verify
ADDRESSES: Written comments may be eligibility in a timely manner will cause
sent to Aisha I. Miranda Rivera,
aisha.miranda-rivera@hq.doe.gov, or at 1 https://clausa.app.carto.com/map/9d2a8e25- 2 FY23 Summary of Appropriations
Department of Energy, Grid Deployment 2f54-4f88-b95b-7151739bd3c7. Provisions.pdf (house.gov).
Signed in Washington, DC, on November 1, of 510,000 acre-feet at a maximum WSE interventions, comments, or requests for
2023. of 6,010 feet msl; (8) a 30-foot-wide and rehearing, the public is encouraged to
Treena V. Garrett, 39,800-foot-long concrete-lined power contact OPP at (202) 502–6595 or OPP@
Federal Register Liaison Officer, U.S. conduit tunnel to North Powerhouse 1; ferc.gov. Comments, motions to
Department of Energy. (9) a 60-foot-wide, 700-foot-long, and intervene, competing applications
[FR Doc. 2023–24457 Filed 11–3–23; 8:45 am] 100-foot high subterranean North (without notices of intent), or notices of
BILLING CODE 6450–01–P Powerhouse 1 with seven pump/ intent to file competing applications
turbines each rated at 250 megawatts should be submitted within 60 days
(MW); (10) seven 12-foot-wide and from the issuance of this notice.
DEPARTMENT OF ENERGY 1,000-foot-long concrete lined North
Competing applications and notices of
Powerhouse 1 conduit tunnels
Federal Energy Regulatory intent must meet the requirements of 18
discharging into Lower Reservoir North
Commission 1; (11) a 30-foot-wide and 19,800-foot- CFR 4.36.
[Project No. 15293–001] long concrete-lined power conduit to The Commission strongly encourages
Powerhouse 2; (12) a 60-foot-wide, 700- electronic filing. Please file comments,
Nature and People First New Mexico foot-long, and 100-foot-high motions to intervene, notices of intent,
PHS, LLC; Notice of Preliminary Permit subterranean North Powerhouse 2 with and competing applications using the
Application Accepted for Filing and seven pump/turbines each rated at 250 Commission’s eFiling system at https://
Soliciting Comments, Motions To MW; (13) seven 12-foot-wide and 1,000- ferconline.ferc.gov/FERC.aspx.
Intervene, and Competing Applications foot-long concrete lined North Commenters can submit brief comments
Powerhouse 2 conduit tunnels up to 6,000 characters without prior
On July 12, 2023, Nature and People
discharging into Lower Reservoir North registration using the eComment system
First New Mexico PHS, LLC, filed an
2; (14) a 30-foot-wide and 43,300-foot- at https://ferconline..gov/
application for a preliminary permit,
long concrete-lined tunnel power QuickComment.aspx. You must include
pursuant to section 4(f) of the Federal
conduit to the Center Powerhouse; (15) your name and contact information at
Power Act (FPA), proposing to study the
a 60-foot-wide, 700-foot-long, and 100-
feasibility of the Chuska Mountain the end of your comments. For
foot-high subterranean Center
Pumped Storage Project to be located in Powerhouse with seven pump/turbines assistance, please get in touch with
San Juan and McKinley Counties, New each rated at 250 MW; (16) seven 12- FERC Online Support at
Mexico, near the San Juan River, and foot-wide and 1,000-foot-long concrete FERCOnlineSupport@ferc.gov, (866)
approximately 5.6 miles west of the lined North Powerhouse 1 conduit 208–3676 (toll-free), or (202) 502–8659
town of Two Grey Hills on Navajo tunnels discharging into Lower (TTY). Instead of electronic filing, you
Nation Lands. The sole purpose of a Reservoir Center; (17) a 45-foot-wide may submit a paper copy. Submissions
preliminary permit is to grant the permit and 30,300-foot-long concrete lined sent via the U.S. Postal Service must be
holder priority to file a license tunnel to the South Powerhouse; (18) a addressed to: Kimberly D. Bose,
application during the permit term. A 60-foot-wide, 1,400-foot-long, and 100- Secretary, Federal Energy Regulatory
preliminary permit does not authorize foot-high subterranean South Commission, 888 First Street NE, Room
the permit holder to perform any land- Powerhouse with 15 pump/turbines 1A, Washington, DC 20426.
disturbing activities or otherwise enter each rated at 250 MW; (19) fifteen 12- Submissions sent via any other carrier
upon lands or waters owned by others foot-wide, 1,000-foot-long concrete- must be addressed to: Kimberly D. Bose,
without the owners’ express permission. lined tunnels discharging into Lower
The pumped storage hydropower Secretary, Federal Energy Regulatory
Reservoir South; and (20) approximately Commission, 12225 Wilkins Avenue,
project would consist of all new 100 miles of 345-kilovolt transmission
facilities including: (1) Upper Reservoir Rockville, Maryland 20852. The first
lines for interconnection to the existing page of any filing should include docket
North with a surface area of 15,800 acres Shiprock, San Juan, and Four Corners
and a storage volume of 500,000 acre- number P–15293–001.
substations. The estimated annual
feet at a maximum water surface energy production of the project would More information about this project,
elevation (WSE) of 8,810 above mean be approximately 19,710,000 megawatt including a copy of the application, can
sea level (msl); (2) Upper Reservoir hours. be viewed on the Commission’s website
Center with a surface area of 7,400 acres Applicant Contact: Mr. Denis Payre, (http://www.ferc.gov) using the
and a storage volume of 235,000 acre- Nature and People First New Mexico ‘‘eLibrary’’ link. Enter the docket
feet at a maximum WSE of 8,810 feet PHS, LLC, 405 Waltham St., Suite 145, number (P–15293) in the docket number
msl; (3) Upper Reservoir South with a Lexington, MA 02421; email: field to access the document. For
surface area of 16,300 acres and a denis.payre@natureandpeoplefirst.com; assistance, do not hesitate to get in
storage volume of 510,000 acre-feet at a phone: (781) 491–5364. touch with FERC Online Support.
maximum WSE of 8,810 feet msl; (4) FERC Contact: Shannon Archuleta;
Lower Reservoir North 1 with a surface email: shannon.archuleta@ferc.gov; Dated: October 31, 2023.
area of 9,000 acres and a storage volume phone (503) 552–2739. Kimberly D. Bose,
of 385,000 acre-feet at a maximum WSE The Commission’s Office of Public Secretary.
of 6,010 feet msl; (5) Lower Reservoir Participation (OPP) supports meaningful [FR Doc. 2023–24465 Filed 11–3–23; 8:45 am]
North 2 with a surface area of 2,700 public engagement and participation in

acres and a storage volume of 115,000 Commission proceedings. OPP can help
acre-feet at a maximum WSE of 6,010 members of the public, including
feet msl; (6) Lower Reservoir Center landowners, environmental justice
with a surface area of 2,900 acres and communities, Tribal members, and
a storage volume of 235,000 acre-feet at others, access publicly available
a maximum WSE of 6,010 feet msl; (7) information and navigate Commission
Lower Reservoir South with a surface processes. For public inquiries and
area of 3,200 acres and a storage volume assistance with filings such as
DEPARTMENT OF ENERGY issue a Notice of Schedule for requirements specified in section

Environmental Review. If a Notice of 385.2001 5 of the Commission’s
Federal Energy Regulatory Schedule for Environmental Review is regulations. A protest may also serve as
Commission issued, it will indicate, among other a motion to intervene so long as the
[Docket No. CP24–7–000] milestones, the anticipated date for the protestor states it also seeks to be an
Commission staff’s issuance of the final intervenor.
ANR Pipeline Company; Notice of environmental impact statement (FEIS) To ensure that your comments or
Application and Establishing or environmental assessment (EA) for protests are timely and properly
Intervention Deadline this proposal. The filing of an EA in the recorded, please submit your comments
Commission’s public record for this on or before November 21, 2023.
Take notice that on October 17, 2023, proceeding or the issuance of a Notice There are three methods you can use
ANR Pipeline Company (ANR), 700 of Schedule for Environmental Review to submit your comments or protests to
Louisiana Street, Suite 1300, Houston, will serve to notify federal and state the Commission. In all instances, please
Texas 77002–2700, filed an application agencies of the timing for the reference the Project docket number
under section 7(b) of the Natural Gas completion of all necessary reviews, and CP24–7–000 in your submission.
Act (NGA), and Part 157 of the the subsequent need to complete all (1) You may file your comments
Commission’s regulations requesting federal authorizations within 90 days of electronically by using the eComment
authorization for its Abandonment of the date of issuance of the Commission feature, which is located on the
Certain Compression Facilities at EG staff’s FEIS or EA. Commission’s website at www.ferc.gov
Hill Compressor Station (Project). The under the link to Documents and
Project consists of abandoning three Public Participation
Filings. Using eComment is an easy
reciprocating compressor units and There are three ways to become method for interested persons to submit
related appurtenances, located in involved in the Commission’s review of brief, text-only comments on a project;
Hansford County, Texas. The Project this project: you can file comments on (2) You may file your comments or
will eliminate the need for future the project, you can protest the filing, protests electronically by using the
operating and maintenance and you can file a motion to intervene eFiling feature, which is located on the
expenditures on outdated facilities that in the proceeding. There is no fee or Commission’s website (www.ferc.gov)
are no longer needed to satisfy current cost for filing comments or intervening. under the link to Documents and
firm service obligations. ANR estimates The deadline for filing a motion to Filings. With eFiling, you can provide
the total cost of the Project to be intervene is 5:00 p.m. Eastern Time on comments in a variety of formats by
$482,728, all as more fully set forth in November 21, 2023. How to file attaching them as a file with your
the application which is on file with the protests, motions to intervene, and submission. New eFiling users must
Commission and open for public comments is explained below. first create an account by clicking on
inspection. The Commission’s Office of Public ‘‘eRegister.’’ You will be asked to select
In addition to publishing the full text Participation (OPP) supports meaningful the type of filing you are making; first
of this document in the Federal public engagement and participation in select ‘‘General’’ and then select
Register, the Commission provides all Commission proceedings. OPP can help ‘‘Comment on a Filing’’; or
interested persons an opportunity to members of the public, including (3) You can file a paper copy of your
view and/or print the contents of this landowners, environmental justice comments or protests by mailing them
document via the internet through the communities, Tribal members and to the following address below. Your
Commission’s Home Page others, access publicly available written comments must reference the
(www.ferc.gov) using the ‘‘eLibrary’’ information and navigate Commission Project docket number (CP24–7–000).
link. Enter the docket number excluding processes. For public inquiries and To file via USPS: Kimberly D. Bose,
the last three digits in the docket assistance with making filings such as Secretary, Federal Energy Regulatory
number field to access the document. At interventions, comments, or requests for Commission, 888 First Street NE,
this time, the Commission has rehearing, the public is encouraged to Washington, DC 20426
suspended access to the Commission’s contact OPP at (202) 502–6595 or OPP@ To file via any other courier: Kimberly
Public Reference Room. For assistance, ferc.gov. D. Bose, Secretary, Federal Energy
contact the Federal Energy Regulatory Comments Regulatory Commission, 12225 Wilkins
Commission at FercOnlineSupport@ Avenue, Rockville, Maryland 20852
ferc.gov or call toll-free, (886) 208–3676 Any person wishing to comment on The Commission encourages
or TTY (202) 502–8659. the project may do so. Comments may electronic filing of comments (options 1
Any questions regarding the proposed include statements of support or and 2 above) and has eFiling staff
project should be directed to ANR objections, to the project as a whole or available to assist you at (202) 502–8258
Pipeline Company, David A. Alonzo, specific aspects of the project. The more or FercOnlineSupport@ferc.gov.
Manager, Project Authorizations, 700 specific your comments, the more useful Persons who comment on the
Louisiana Street, Suite 1300, Houston, they will be. environmental review of this project
Texas 77002–2700 by phone at Protests will be placed on the Commission’s
832.320.5477, or by email at david_ environmental mailing list, and will
Pursuant to sections 157.10(a)(4) 2 and
alonzo@tcenergy.com. receive notification when the
Pursuant to Section 157.9 of the 385.211 3 of the Commission’s
environmental documents (EA or EIS)
Commission’s Rules of Practice and regulations under the NGA, any person 4
are issued for this project and will be
Procedure,1 within 90 days of this may file a protest to the application.
notified of meetings associated with the
Notice the Commission staff will either: Protests must comply with the
Commission’s environmental review
complete its environmental review and 2 18
process.
CFR 157.10(a)(4)
place it into the Commission’s public 3 18 CFR 385.211
The Commission considers all
record (eLibrary) for this proceeding; or 4 Persons include individuals, organizations, comments received about the project in
businesses, municipalities, and other entities. 18
1 18 CFR (Code of Federal Regulations) 157.9. CFR 385.102(d). 5 18 CFR 385.2001
determining the appropriate action to be intervene must reference the Project allows you to keep track of all formal
taken. However, the filing of a comment docket number CP24–7–000. issuances and submittals in specific
alone will not serve to make the filer a To file via USPS: Kimberly D. Bose, dockets. This can reduce the amount of
party to the proceeding. To become a Secretary, Federal Energy Regulatory time you spend researching proceedings
party, you must intervene in the Commission, 888 First Street NE, by automatically providing you with
proceeding. For instructions on how to Washington, DC 20426. notification of these filings, document
intervene, see below. To file via any other courier: Kimberly summaries, and direct links to the
D. Bose, Secretary, Federal Energy documents. For more information and to
Interventions
Regulatory Commission, 12225 Wilkins register, go to www.ferc.gov/docs-filing/
Any person, which includes Avenue, Rockville, Maryland 20852. esubscription.asp.
individuals, organizations, businesses, The Commission encourages Intervention Deadline: 5:00 p.m.
municipalities, and other entities,6 has electronic filing of motions to intervene Eastern Time on November 21, 2023.
the option to file a motion to intervene (option 1 above) and has eFiling staff Dated: October 31, 2023.
in this proceeding. Only intervenors available to assist you at (202) 502–8258
have the right to request rehearing of Kimberly D. Bose,
or FercOnlineSupport@ferc.gov.
Commission orders issued in this Secretary.
Protests and motions to intervene
proceeding and to subsequently [FR Doc. 2023–24464 Filed 11–3–23; 8:45 am]
must be served on the applicant either
challenge the Commission’s orders in by mail or email at: David A. Alonzo, BILLING CODE 6717–01–P
the U.S. Circuit Courts of Appeal. Manager, Project Authorizations, 700
To intervene, you must submit a Louisiana Street, Suite 1300, Houston,
motion to intervene to the Commission DEPARTMENT OF ENERGY
Texas 77002–2700 or at david_alonzo@
in accordance with Rule 214 of the tcenergy.com. Any subsequent
Commission’s Rules of Practice and Federal Energy Regulatory
submissions by an intervenor must be Commission
Procedure 7 and the regulations under served on the applicant and all other
the NGA 8 by the intervention deadline parties to the proceeding. Contact Combined Notice of Filings #1
for the project, which is November 21, information for parties can be
2023. As described further in Rule 214, downloaded from the service list at the Take notice that the Commission
your motion to intervene must state, to eService link on FERC Online. Service received the following electric corporate
the extent known, your position can be via email with a link to the filings:
regarding the proceeding, as well as document. Docket Numbers: EC24–14–000.
your interest in the proceeding. For an All timely, unopposed 9 motions to Applicants: Crooked Lake Solar, LLC.
individual, this could include your intervene are automatically granted by Description: Application for
status as a landowner, ratepayer, operation of Rule 214(c)(1).10 Motions to Authorization Under Section 203 of the
resident of an impacted community, or intervene that are filed after the Federal Power Act of Crooked Lake
recreationist. You do not need to have intervention deadline are untimely, and Solar, LLC.
property directly impacted by the may be denied. Any late-filed motion to Filed Date: 10/30/23.
project in order to intervene. For more intervene must show good cause for Accession Number: 20231030–5276.
information about motions to intervene, being late and must explain why the Comment Date: 5 p.m. ET 11/20/23.
refer to the FERC website at https:// time limitation should be waived and Docket Numbers: EC24–15–000.
www.ferc.gov/resources/guides/how-to/ provide justification by reference to Applicants: American Falls Solar,
intervene.asp. factors set forth in Rule 214(d) of the LLC, American Falls Solar II, LLC,
There are two ways to submit your Commission’s Rules and Regulations.11 CSOLAR IV South, LLC, CSOLAR IV
motion to intervene. In both instances, A person obtaining party status will be West, LLC.
please reference the Project docket placed on the service list maintained by Description: Joint Application for
number CP24–7–000 in your the Secretary of the Commission and Authorization Under Section 203 of the
submission. will receive copies (paper or electronic) Federal Power Act of American Falls
(1) You may file your motion to Solar, LLC, et al.
of all documents filed by the applicant
intervene by using the Commission’s Filed Date: 10/30/23.
and by all other parties.
eFiling feature, which is located on the Accession Number: 20231030–5278.
Commission’s website (www.ferc.gov) Tracking the Proceeding Comment Date: 5 p.m. ET 11/20/23.
under the link to Documents and Throughout the proceeding, Take notice that the Commission
Filings. New eFiling users must first additional information about the project received the following electric rate
create an account by clicking on will be available from the Commission’s filings:
‘‘eRegister.’’ You will be asked to select Office of External Affairs, at (866) 208–
the type of filing you are making; first Docket Numbers: ER10–1819–038;
FERC, or on the FERC website at ER10–1820–041; ER10–1818–036;
select ‘‘General’’ and then select www.ferc.gov using the ‘‘eLibrary’’ link
‘‘Intervention.’’ The eFiling feature ER10–1817–029.
as described above. The eLibrary link Applicants: Southwestern Public
includes a document-less intervention also provides access to the texts of all
option; for more information, visit Service Company, Public Service
formal documents issued by the Company of Colorado, Northern States
https://www.ferc.gov/docs-filing/efiling/ Commission, such as orders, notices,
document-less-intervention.pdf.; or Power Company, a Wisconsin
and rulemakings. corporation, Northern States Power

(2) You can file a paper copy of your
In addition, the Commission offers a Company, a Minnesota corporation.
motion to intervene, along with three
free service called eSubscription which Description: Notice of Change in
copies, by mailing the documents to the
address below. Your motion to 9 The applicant has 15 days from the submittal of
Status of Northern States Power
a motion to intervene to file a written objection to
Company, a Minnesota corporation, et
6 18 CFR 385.102(d). the intervention. al.
7 18 CFR 385.214. 10 18 CFR 385.214(c)(1). Filed Date: 10/30/23.
8 18 CFR 157.10. 11 18 CFR 385.214(b)(3) and (d). Accession Number: 20231030–5283.
Comment Date: 5 p.m. ET 11/20/23. Inc., Brookfield Renewable Trading and Description: Refund Report: SERI
Docket Numbers: ER10–2042–049; Marketing LP, BREG Aggregator LLC, UPSA Compliance (EL18–152 and
ER10–1862–042; ER10–1873–020; BIF III Holtwood LLC, BIF II Safe Harbor ER23–816) to be effective N/A.
ER10–1875–020; ER10–1876–021; Holdings, LLC, Black Bear Development Filed Date: 10/27/23.
ER10–1878–020; ER10–1883–020; Holdings, LLC, Brookfield White Pine Accession Number: 20231027–5223.
ER10–1884–020; ER10–1885–020; Hydro LLC, Black Bear SO, LLC, Blue Comment Date: 5 p.m. ET 11/17/23.
ER10–1888–020; ER10–1893–042; Sky East, LLC, Stetson Holdings, LLC, Docket Numbers: ER23–1319–001.
ER10–1934–042; ER10–1938–043; Bishop Hill Energy LLC, Vermont Wind, Applicants: Baldy Mesa Solar, LLC.
ER10–1941–020; ER10–1942–040; LLC, Safe Harbor Water Power Description: Notice of Change in
ER10–1947–021; ER10–2985–046; Corporation, Evergreen Wind Power III, Status of Baldy Mesa Solar, LLC.
ER10–3049–047; ER10–3051–047; LLC, Black Bear Hydro Partners, LLC, Filed Date: 10/30/23.
ER11–4369–027; ER12–1987–018; Rumford Falls Hydro LLC, Hawks Nest Accession Number: 20231030–5220.
ER12–2261–019; ER12–2645–013; Hydro LLC, Great Lakes Hydro America, Comment Date: 5 p.m. ET 11/20/23.
ER13–1407–015; ER16–2218–028; LLC, Brookfield Power Piney & Deep Docket Numbers: ER23–1589–001.
ER17–696–028; ER19–1127–010; ER20– Creek LLC, Stetson Wind II, LLC, Applicants: AES ES Westwing, LLC.
1699–008; ER23–944–005. Brookfield Energy Marketing LP, Bear Description: Notice of Change in
Applicants: Calpine Community Swamp Power Company LLC. Status of AES ES Westwing, LLC.
Energy, LLC, Johanna Energy Center, Description: Notice of Change in Filed Date: 10/30/23.
LLC, Calpine King City Cogen, LLC, Status of Bear Swamp Power Company Accession Number: 20231030–5238.
Calpine Energy Solutions, LLC, North LLC, et al. Comment Date: 5 p.m. ET 11/20/23.
American Power Business, LLC, CCFC Filed Date: 10/30/23. Docket Numbers: ER23–1669–002;
Sutter Energy, LLC, Pastoria Energy Accession Number: 20231030–5282. ER23–1668–002.
Facility L.L.C., Russell City Energy Comment Date: 5 p.m. ET 11/20/23. Applicants: Estrella Solar, LLC,
Company, LLC, O.L.S. Energy-Agnews, Docket Numbers: ER15–1905–014. Raceway Solar 1, LLC.
Inc., North American Power and Gas, Applicants: Amazon Energy LLC. Description: Notice of Change in
LLC, Champion Energy, LLC, Champion Description: Notice of Change in Status of Raceway Solar 1, LLC, et al.
Energy Services, LLC, Champion Energy Status of Amazon Energy LLC. Filed Date: 10/30/23.
Marketing LLC, Otay Mesa Energy Filed Date: 10/30/23. Accession Number: 20231030–5271.
Center, LLC, Calpine Construction Accession Number: 20231030–5280. Comment Date: 5 p.m. ET 11/20/23.
Finance Co., L.P., Calpine Gilroy Cogen, Comment Date: 5 p.m. ET 11/20/23. Docket Numbers: ER23–2346–001.
L.P., Calpine Power America—CA, LLC, Applicants: Oak Ridge Solar, LLC.
Docket Numbers: ER18–1197–008;
CES Marketing IX, LLC, CES Marketing Description: Notice of Change in
ER10–2125–027; ER10–2127–024;
X, LLC, Creed Energy Center, LLC, Delta Status of Oak Ridge Solar, LLC.
ER10–2128–026; ER10–2129–017; Filed Date: 10/30/23.
Energy Center, LLC, Geysers Power
ER10–2132–026; ER10–2133–027; Accession Number: 20231030–5272.
Company, LLC, Gilroy Energy Center,
ER10–2134–015; ER10–2764–026; Comment Date: 5 p.m. ET 11/20/23.
LLC, Goose Haven Energy Center, LLC,
ER11–3872–028; ER20–2444–006;
Los Esteros Critical Energy Facility, Docket Numbers: ER23–2568–001.
ER20–2445–006; ER21–1838–005;
LLC, Los Medanos Energy Center LLC, Applicants: Duke Energy Carolinas,
ER22–1999–004.
Metcalf Energy Center, LLC, Power LLC.
Applicants: Number Three Wind LLC,
Contract Financing, L.L.C., Calpine Description: Tariff Amendment: DEC-
Orangeville Energy Storage LLC,
Energy Services, L.P. Response to Letter of Deficiency to be
Prineville Solar Energy LLC, Millican
Description: Notice of Change in effective 1/1/2023.
Solar Energy LLC, Stony Creek Energy Filed Date: 10/30/23.
Status of Calpine Energy Services, L.P.,
LLC, Vantage Wind Energy LLC, Hardee Accession Number: 20231030–5227.
et al.
Filed Date: 10/30/23. Power Partners Limited, Sheldon Energy Comment Date: 5 p.m. ET 11/20/23.
Accession Number: 20231030–5219. LLC, Willow Creek Energy LLC, Grays
Docket Numbers: ER24–231–001.
Comment Date: 5 p.m. ET 11/20/23. Harbor Energy LLC, Wolverine Creek
Applicants: West Penn Power
Energy LLC, Invenergy TN LLC, Judith
Docket Numbers: ER10–2895–026; Company, PJM Interconnection, L.L.C.
Gap Energy LLC, Camilla Solar Energy
ER10–1427–007; ER10–2466–024; Description: Tariff Amendment: West
LLC.
ER10–2917–026; ER10–2921–026; Penn Power Company submits tariff
Description: Notice of Change in
ER10–2922–026; ER10–2966–026; filing per 35.17(b): Errata to West Penn
Status of Camilla Solar Energy LLC, et
ER10–3167–019; ER11–2201–029; Power Revisions to OATT, Att. H–11A
al.
ER11–2383–022; ER11–4029–023; in ER24–231 to be effective 1/1/2023.
Filed Date: 10/30/23. Filed Date: 10/30/23.
ER12–161–028; ER12–1311–023; ER12–
Accession Number: 20231030–5281. Accession Number: 20231030–5236.
2068–023; ER13–203–018; ER13–1613–
Comment Date: 5 p.m. ET 11/20/23. Comment Date: 5 p.m. ET 11/20/23.
019; ER13–2143–019; ER14–1964–018;
ER16–287–012; ER17–482–012; ER19– Docket Numbers: ER23–207–001. Docket Numbers: ER24–251–000.
529–013; ER19–1074–013; ER19–1075– Applicants: Golden Spread Electric Applicants: Duke Energy Florida,
013; ER20–1447–008; ER20–2028–003; Cooperative, Inc. LLC.
ER22–192–007; ER22–1010–005; ER23– Description: Compliance filing: Final Description: § 205(d) Rate Filing: DEF-
2481–001. Order 676J Compliance Filing to be Bartow-FPL RS No. 422 Reimbursement

Applicants: Crystal Hill Solar, LLC, effective 2/1/2024. Agmt to be effective 1/1/2024.
TerraForm IWG Acquisition Holdings II, Filed Date: 10/31/23. Filed Date: 10/30/23.
LLC, Evolugen Trading and Marketing Accession Number: 20231031–5005. Accession Number: 20231030–5201.
LP, Bitter Ridge Wind Farm, LLC, Comment Date: 5 p.m. ET 11/21/23. Comment Date: 5 p.m. ET 11/20/23.
Brookfield Energy Marketing US LLC, Docket Numbers: ER23–816–000. Docket Numbers: ER24–252–000.
Brookfield Renewable Energy Marketing Applicants: System Energy Resources, Applicants: Metropolitan Edison
US LLC, Brookfield Energy Marketing Inc. Company, PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: other information, call (866) 208–3676 Filed Date: 10/31/23.
Metropolitan Edison Company submits (toll free). For TTY, call (202) 502–8659. Accession Number: 20231031–5227.
tariff filing per 35.13(a)(2)(iii: Met-Ed The Commission’s Office of Public Comment Date: 5 p.m. ET 11/21/23.
amends Nine ECSAs (6414 6415 6416 Participation (OPP) supports meaningful Docket Numbers: ER21–9–005; ER21–
6417 6418 6485 6486 6488 6494) to be public engagement and participation in 86–005; ER21–88–005.
effective 12/31/9998. Commission proceedings. OPP can help Applicants: Orange County Energy
Filed Date: 10/30/23. members of the public, including Storage 3 LLC, Orange County Energy
Accession Number: 20231030–5204. landowners, environmental justice Storage 2 LLC, Henrietta D Energy
Comment Date: 5 p.m. ET 11/20/23. communities, Tribal members and Storage LLC.
Docket Numbers: ER24–253–000. others, access publicly available Description: Notice of Non-Material
Applicants: Northern Indiana Public information and navigate Commission Change in Status of Henrietta D Energy
Service Company LLC. processes. For public inquiries and Storage LLC, et al.
Description: § 205(d) Rate Filing: assistance with making filings such as Filed Date: 10/31/23.
Supplement to WVPA IA to be effective interventions, comments, or requests for Accession Number: 20231031–5248.
12/31/2023. rehearing, the public is encouraged to Comment Date: 5 p.m. ET 11/21/23.
Filed Date: 10/30/23. contact OPP at (202) 502–6595 or OPP@ Docket Numbers: ER21–136–005.
Accession Number: 20231030–5237. ferc.gov. Applicants: Flat Ridge 3 Wind Energy,
Comment Date: 5 p.m. ET 11/20/23. Dated: October 31, 2023. LLC.
Docket Numbers: ER24–254–000. Debbie-Anne A. Reese, Description: Notice of Change in
Applicants: Southwest Power Pool, Deputy Secretary. Status of Flat Ridge 3 Wind Energy,
Inc. LLC.
[FR Doc. 2023–24487 Filed 11–3–23; 8:45 am]
Description: § 205(d) Rate Filing: Filed Date: 10/31/23.
Central Power Electric Cooperative, Inc. Accession Number: 20231031–5243.
Formula Rate Revisions to be effective Comment Date: 5 p.m. ET 11/21/23.
1/1/2024. DEPARTMENT OF ENERGY Docket Numbers: ER21–330–004.
Filed Date: 10/31/23. Applicants: Specialty Products US,
Accession Number: 20231031–5007. Federal Energy Regulatory LLC.
Comment Date: 5 p.m. ET 11/21/23. Commission Description: Notice of Change in
Docket Numbers: ER24–255–000. Status of Specialty Products US, LLC.
Applicants: CPV Stagecoach Solar, Combined Notice of Filings #3 Filed Date: 10/31/23.
LLC. Accession Number: 20231031–5245.
Take notice that the Commission
Description: Baseline eTariff Filing: Comment Date: 5 p.m. ET 11/21/23.
received the following electric rate
Application for Market-Based Rate
filings: Docket Numbers: ER21–2137–009.
Authority to be effective 12/8/2023.
Filed Date: 10/31/23. Docket Numbers: ER10–2135–017; Applicants: IR Energy Management
Accession Number: 20231031–5013. ER10–2124–026. LLC.
Comment Date: 5 p.m. ET 11/21/23. Applicants: Spring Canyon Energy Description: Notice of Change in
LLC, Spindle Hill Energy LLC. Status of IR Energy Management LLC.
Docket Numbers: ER24–256–000. Description: Notice of Change in Filed Date: 10/31/23.
Applicants: Dominion Energy South Status of Spindle Hill Energy LLC, et al. Accession Number: 20231031–5225.
Carolina, Inc. Filed Date: 10/31/23. Comment Date: 5 p.m. ET 11/21/23.
Description: Tariff Amendment: Accession Number: 20231031–5246.
Notice of Termination of PSA with Docket Numbers: ER24–269–000.
Comment Date: 5 p.m. ET 11/21/23. Applicants: NSTAR Electric
Orangeburg to be effective 12/31/2023. Docket Numbers: ER10–2881–041;
Filed Date: 10/31/23. Company.
ER10–2882–041; ER10–2883–039; Description: Initial rate filing:
Accession Number: 20231031–5033. ER10–2884–039; ER16–2509–010;
Comment Date: 5 p.m. ET 11/21/23. NSTAR–HQUS Transfer Agreement
ER17–2400–011; ER17–2401–011; (ENE Use Rights) to be effective 11/26/
The filings are accessible in the ER17–2403–011; ER17–2404–011. 2023.
Commission’s eLibrary system (https:// Applicants: SP Sandhills Solar, LLC, Filed Date: 10/31/23.
elibrary.ferc.gov/idmws/search/ SP Pawpaw Solar, LLC, SP Decatur Accession Number: 20231031–5204.
fercgensearch.asp) by querying the Parkway Solar, LLC, SP Butler Solar, Comment Date: 5 p.m. ET 11/21/23.
docket number. LLC, Rutherford Farm, LLC, Georgia
Any person desiring to intervene, to Power Company, Mississippi Power Docket Numbers: ER24–270–000.
protest, or to answer a complaint in any Company, Southern Power Company, Applicants: Southwest Power Pool,
of the above proceedings must file in Alabama Power Company. Inc.
accordance with Rules 211, 214, or 206 Description: Notice of Non-Material Description: § 205(d) Rate Filing:
of the Commission’s Regulations (18 Change in Status of Alabama Power Revisions to Attachment AE to Clarify
CFR 385.211, 385.214, or 385.206) on or Company, et al. Resource/Load Aggregation to be
before 5:00 p.m. Eastern time on the Filed Date: 10/31/23. effective 1/3/2024.
specified comment date. Protests may be Accession Number: 20231031–5241. Filed Date: 10/31/23.
considered, but intervention is Comment Date: 5 p.m. ET 11/21/23. Accession Number: 20231031–5219.
necessary to become a party to the Docket Numbers: ER10–3050–013; Comment Date: 5 p.m. ET 11/21/23.
proceeding. ER10–3053–013. Docket Numbers: ER24–271–000.
eFiling is encouraged. More detailed Applicants: Whitewater Hill Wind Applicants: Southwestern Public
information relating to filing Partners, LLC, Cabazon Wind Partners, Service Company, Southwest Power
requirements, interventions, protests, LLC. Pool, Inc.
service, and qualifying facilities filings Description: Notice of Non-Material Description: § 205(d) Rate Filing:
can be found at: http://www.ferc.gov/ Change in Status of Cabazon Wind Southwestern Public Service Company
docs-filing/efiling/filing-req.pdf. For Partners, LLC, et al. submits tariff filing per 35.13(a)(2)(iii):
SPS Formula Rate Revisions to CFR 385.211, 385.214, or 385.206) on or Applicants: Texas Eastern
Incorporate Changes Accepted in ER23– before 5:00 p.m. Eastern time on the Transmission, LP.
2845 to be effective 1/1/2023. specified comment date. Protests may be Description: § 4(d) Rate Filing: TETLP
Filed Date: 10/31/23. considered, but intervention is PCB DEC 2023 Filing to be effective 12/
Accession Number: 20231031–5240. necessary to become a party to the 1/2023.
Comment Date: 5 p.m. ET 11/21/23. proceeding. Filed Date: 10/30/23.
Docket Numbers: ER24–272–000. eFiling is encouraged. More detailed Accession Number: 20231030–5207.
Applicants: ISO New England Inc., information relating to filing Comment Date: 5 p.m. ET 11/13/23.
The United Illuminating Company. requirements, interventions, protests, Docket Numbers: RP24–83–000.
Description: § 205(d) Rate Filing: ISO service, and qualifying facilities filings Applicants: Equitrans, L.P.
New England Inc. submits tariff filing can be found at: http://www.ferc.gov/ Description: § 4(d) Rate Filing:
per 35.13(a)(2)(iii): UI; Req for Approval docs-filing/efiling/filing-req.pdf. For Negotiated Rate Agreements—11/1/2023
of Updated Depreciation Rates & Rev. to other information, call (866) 208–3676 to be effective 11/1/2023.
Append D of Att F to be effective 9/1/ (toll free). For TTY, call (202) 502–8659. Filed Date: 10/31/23.
2023. The Commission’s Office of Public Accession Number: 20231031–5001.
Filed Date: 10/31/23. Participation (OPP) supports meaningful Comment Date: 5 p.m. ET 11/13/23.
Accession Number: 20231031–5244. public engagement and participation in Docket Numbers: RP24–84–000.
Comment Date: 5 p.m. ET 11/21/23. Commission proceedings. OPP can help Applicants: Algonquin Gas
Docket Numbers: ER24–273–000. members of the public, including Transmission, LLC.
Applicants: Goleta Energy Storage, landowners, environmental justice Description: § 4(d) Rate Filing: AGT
LLC. communities, Tribal members and FRQ 2023 Filing to be effective 12/1/
Description: Compliance filing: Notice others, access publicly available 2023.
of Non-Material Change in Status and information and navigate Commission Filed Date: 10/31/23.
Revised Market-Based Rate Tariff to be processes. For public inquiries and Accession Number: 20231031–5008.
effective 11/1/2023. assistance with making filings such as Comment Date: 5 p.m. ET 11/13/23.
Filed Date: 10/31/23. interventions, comments, or requests for
rehearing, the public is encouraged to Docket Numbers: RP24–85–000.
Accession Number: 20231031–5249. Applicants: Fayetteville Express
Comment Date: 5 p.m. ET 11/21/23. contact OPP at (202) 502–6595 or OPP@
ferc.gov. Pipeline LLC.
Take notice that the Commission Description: Compliance filing: Fuel
received the following electric securities Dated: October 31, 2023. Filing on 10–31–23 to be effective N/A.
filings: Debbie-Anne A. Reese, Filed Date: 10/31/23.
Docket Numbers: ES23–14–000. Deputy Secretary. Accession Number: 20231031–5018.
Applicants: Transource Maryland, [FR Doc. 2023–24486 Filed 11–3–23; 8:45 am] Comment Date: 5 p.m. ET 11/13/23.
LLC, Transource Missouri, LLC, BILLING CODE 6717–01–P Docket Numbers: RP24–86–000.
Transource Oklahoma, LLC, Transource Applicants: ETC Tiger Pipeline, LLC.
Pennsylvania, LLC, Transource West Description: § 4(d) Rate Filing: Fuel
Virginia, LLC. DEPARTMENT OF ENERGY Filing on 10–31–23 to be effective 12/1/
Description: Report of Securities 2023.
Issued of Transource Pennsylvania, Federal Energy Regulatory Filed Date: 10/31/23.
LLC. Commission Accession Number: 20231031–5026.
Filed Date: 10/31/23. Combined Notice of Filings Comment Date: 5 p.m. ET 11/13/23.
Accession Number: 20231031–5222. Docket Numbers: RP24–87–000.
Comment Date: 5 p.m. ET 11/21/23. Take notice that the Commission has Applicants: Trunkline Gas Company,
Take notice that the Commission received the following Natural Gas and LLC.
received the following electric Oil Pipeline Rate and Refund Report Description: Compliance filing:
reliability filings filings: Annual Interruptible Storage Revenue
Docket Numbers: RD24–1–000. Filings Instituting Proceedings Credit filed 10–31–23 to be effective N/
Applicants: North American Electric A.
Docket Numbers: RP24–80–000. Filed Date: 10/31/23.
Reliability Corporation. Applicants: Millennium Pipeline
Description: North American Electric Accession Number: 20231031–5031.
Company, LLC. Comment Date: 5 p.m. ET 11/13/23.
Reliability Corporation submits Petition Description: § 4(d) Rate Filing:
for Approval of Proposed Reliability Negotiated Rate Agmts, Eff. 11.1.23 to be Docket Numbers: RP24–88–000.
Standards EOP–011–4 and TOP–002–5 effective 11/1/2023. Applicants: Kern River Gas
and Request for Expedited Action. Filed Date: 10/30/23. Transmission Company.
Filed Date: 10/30/23. Accession Number: 20231030–5177. Description: § 4(d) Rate Filing: 2023
Accession Number: 20231030–5285. Comment Date: 5 p.m. ET 11/13/23. World Fuels Contract 1908 Amendment
Comment Date: 5 p.m. ET 11/30/23. Docket Numbers: RP24–81–000. Filing to be effective 11/1/2023.
The filings are accessible in the Applicants: Transcontinental Gas Filed Date: 10/31/23.
Commission’s eLibrary system (https:// Pipe Line Company, LLC. Accession Number: 20231031–5058.
elibrary.ferc.gov/idmws/search/ Description: § 4(d) Rate Filing: Non- Comment Date: 5 p.m. ET 11/13/23.
fercgensearch.asp) by querying the Conforming—Adelphia West Ridge Docket Numbers: RP24–89–000.
docket number. Interconnect—2023 to be effective 12/1/ Applicants: Trunkline Gas Company,
Any person desiring to intervene, to 2023. LLC.
protest, or to answer a complaint in any Filed Date: 10/30/23. Description: § 4(d) Rate Filing:
of the above proceedings must file in Accession Number: 20231030–5194. Negotiated Rate Filing—17 (NextEra
accordance with Rules 211, 214, or 206 Comment Date: 5 p.m. ET 11/13/23. Energy & Ford) to be effective 11/1/
of the Commission’s Regulations (18 Docket Numbers: RP24–82–000. 2023.
Filed Date: 10/31/23. Comment Date: 5 p.m. ET 11/13/23. elibrary.ferc.gov/idmws/search/

Accession Number: 20231031–5066. Docket Numbers: RP24–97–000. fercgensearch.asp) by querying the
Comment Date: 5 p.m. ET 11/13/23. Applicants: Texas Gas Transmission, docket number.
Docket Numbers: RP24–90–000. LLC. eFiling is encouraged. More detailed
Applicants: El Paso Natural Gas Description: § 4(d) Rate Filing: Cap information relating to filing
Company, L.L.C. Rel Neg Rate Agmts (SABIC requirements, interventions, protests,
Description: § 4(d) Rate Filing: Non- 35304,35303, 35305 to CIMA service, and qualifying facilities filings
Conforming Agreement Update 57386,57387,57384) to be effective 11/1/ can be found at: http://www.ferc.gov/
(Sterling) to be effective 11/1/2023. 2023. docs-filing/efiling/filing-req.pdf. For
Filed Date: 10/31/23. Filed Date: 10/31/23. other information, call (866) 208–3676
Accession Number: 20231031–5071. Accession Number: 20231031–5122. (toll free). For TTY, call (202) 502–8659.
Comment Date: 5 p.m. ET 11/13/23. Comment Date: 5 p.m. ET 11/13/23. The Commission’s Office of Public
Docket Numbers: RP24–91–000. Docket Numbers: RP24–98–000. Participation (OPP) supports meaningful
Applicants: Tennessee Gas Pipeline Applicants: Destin Pipeline Company, public engagement and participation in
Company, L.L.C. L.L.C. Commission proceedings. OPP can help
Description: § 4(d) Rate Filing: Non- Description: Compliance filing: Destin members of the public, including
Conforming Agreement Filing (TC Pipeline Annual Fuel Retention landowners, environmental justice
Energy 382826) to be effective 11/1/ Adjustment to be effective N/A. communities, Tribal members and
Filed Date: 10/31/23. others, access publicly available
2023. Accession Number: 20231031–5125.
Filed Date: 10/31/23. information and navigate Commission
Comment Date: 5 p.m. ET 11/13/23. processes. For public inquiries and
Accession Number: 20231031–5082.
Comment Date: 5 p.m. ET 11/13/23. Docket Numbers: RP24–99–000. assistance with making filings such as
Applicants: Wyoming Interstate interventions, comments, or requests for
Docket Numbers: RP24–92–000. Company, L.L.C. rehearing, the public is encouraged to
Applicants: Rockies Express Pipeline Description: § 4(d) Rate Filing: Fuel_ contact OPP at (202) 502–6595 or OPP@
LLC. LU Quarterly Update Filing Eff Dec ferc.gov.
Description: § 4(d) Rate Filing: REX 2023 to be effective 12/1/2023.
2023–10–31 System Map URL to be Filed Date: 10/31/23. Dated: October 31, 2023.
effective 12/1/2023. Accession Number: 20231031–5128. Debbie-Anne A. Reese,
Filed Date: 10/31/23. Comment Date: 5 p.m. ET 11/13/23. Deputy Secretary.
Accession Number: 20231031–5101. Docket Numbers: RP24–100–000. [FR Doc. 2023–24484 Filed 11–3–23; 8:45 am]
Comment Date: 5 p.m. ET 11/13/23. Applicants: Texas Eastern BILLING CODE 6717–01–P
Docket Numbers: RP24–93–000. Transmission, LP.
Applicants: Tallgrass Interstate Gas Description: § 4(d) Rate Filing:
Transmission, LLC. Negotiated Rates—Con Ed 910950 DEPARTMENT OF ENERGY
Description: § 4(d) Rate Filing: TIGT Releases 11–01–23 to be effective 11/1/
2023–10–31 System Map URL to be 2023. Federal Energy Regulatory
effective 12/1/2023. Filed Date: 10/31/23. Commission
Filed Date: 10/31/23. Accession Number: 20231031–5150.
Comment Date: 5 p.m. ET 11/13/23. Combined Notice of Filings #2
Accession Number: 20231031–5108.
Comment Date: 5 p.m. ET 11/13/23. Any person desiring to intervene, to Take notice that the Commission
Docket Numbers: RP24–94–000. protest, or to answer a complaint in any received the following exempt
Applicants: Trailblazer Pipeline of the above proceedings must file in wholesale generator filings:
Company LLC. accordance with Rules 211, 214, or 206 Docket Numbers: EG24–22–000.
Description: § 4(d) Rate Filing: TPC of the Commission’s Regulations (18 Applicants: CPV Stagecoach Solar,
2023–10–31 System Map URL to be CFR 385.211, 385.214, or 385.206) on or LLC.
effective 12/1/2023. before 5:00 p.m. Eastern time on the Description: CPV Stagecoach Solar,
Filed Date: 10/31/23. specified comment date. Protests may be LLC submits Notice of Self-Certification
Accession Number: 20231031–5109. considered, but intervention is of Exempt Wholesale Generator Status.
Comment Date: 5 p.m. ET 11/13/23. necessary to become a party to the Filed Date: 10/31/23.
proceeding. Accession Number: 20231031–5050.
Docket Numbers: RP24–95–000.
Applicants: Tennessee Gas Pipeline Filings in Existing Proceedings Comment Date: 5 p.m. ET 11/21/23.
Company, L.L.C. Docket Numbers: RP22–1033–005. Docket Numbers: EG24–23–000.
Description: § 4(d) Rate Filing: Applicants: Northern Natural Gas Applicants: Faraday Interconnection
Negotiated Rate Agreement (Con Ed Company. LLC.
389644) to be effective 11/1/2023. Description: Refund Report: 20231031 Description: Faraday Interconnection
Filed Date: 10/31/23. Refund Report to be effective N/A. LLC submits Notice of Self-Certification
Accession Number: 20231031–5114. Filed Date: 10/31/23. of Exempt Wholesale Generator Status.
Comment Date: 5 p.m. ET 11/13/23. Accession Number: 20231031–5115. Filed Date: 10/31/23.
Docket Numbers: RP24–96–000. Comment Date: 5 p.m. ET 11/13/23. Accession Number: 20231031–5116.
Applicants: Texas Gas Transmission, Any person desiring to protest in any Comment Date: 5 p.m. ET 11/21/23.
LLC. the above proceedings must file in Docket Numbers: EG24–24–000.
Description: § 4(d) Rate Filing: Cap accordance with Rule 211 of the Applicants: Faraday Solar B LLC.
Rel Neg Rate Agmt (Jay-Bee 34446 to Commission’s Regulations (18 CFR Description: Faraday Solar B LLC
Spotlight 54357) to be effective 11/1/ 385.211) on or before 5:00 p.m. Eastern submits Notice of Self-Certification of
2023. time on the specified comment date. Exempt Wholesale Generator Status.
Filed Date: 10/31/23. The filings are accessible in the Filed Date: 10/31/23.
Accession Number: 20231031–5118. Commission’s eLibrary system (https:// Accession Number: 20231031–5117.
Comment Date: 5 p.m. ET 11/21/23. LLC, Pacific Crest Power, LLC, San Docket Numbers: ER24–259–000.
Take notice that the Commission Gorgonio Westwinds II, LLC, Cameron Applicants: Startrans IO, LLC.
received the following electric rate Ridge, LLC, TGP Energy Management, Description: § 205(d) Rate Filing:
filings: LLC, Oasis Power Partners, LLC, Alta Startrans IO, LLC TRBAA 2024 Update
Docket Numbers: ER11–2029–009; Oak Realty, LLC. to be effective 1/1/2024.
ER10–2596–013; ER12–2200–009. Description: Notice of Non-Material Filed Date: 10/31/23.
Applicants: Mehoopany Wind Energy Change in Status of Alta Oak Realty, Accession Number: 20231031–5089.
LLC, Fowler Ridge II Wind Farm LLC, LLC, et al. Comment Date: 5 p.m. ET 11/21/23.
Cedar Creek II, LLC. Filed Date: 10/31/23. Docket Numbers: ER24–260–000.
Description: Notice of Change in Accession Number: 20231031–5206. Applicants: Midcontinent
Status of Cedar Creek II, LLC, et al. Comment Date: 5 p.m. ET 11/21/23. Independent System Operator, Inc.,
Filed Date: 10/31/23. Docket Numbers: ER20–391–008; Dairyland Power Cooperative.
Accession Number: 20231031–5196. ER21–2557–003; ER22–2662–003; Description: § 205(d) Rate Filing:
Comment Date: 5 p.m. ET 11/21/23. ER22–2663–003; ER22–2664–003; Midcontinent Independent System
Docket Numbers: ER16–2449–004; ER23–1275–001; ER23–1276–001; Operator, Inc. submits tariff filing per
ER21–628–004. ER23–1277–001. 35.13(a)(2)(iii: 2023–10–31_DPC
Applicants: Harry Allen Solar Energy Applicants: Aron Energy Prepay 23 Incentive Rate Request to be effective 1/
LLC, Boulder Solar II, LLC. LLC, Aron Energy Prepay 22 LLC, Aron 1/2024.
Description: Notice of Change in Energy Prepay 21 LLC, Aron Energy Filed Date: 10/31/23.
Status of Boulder Solar II, LLC, et al. Prepay 16 LLC, Aron Energy Prepay 15 Accession Number: 20231031–5120.
Filed Date: 10/31/23. LLC, Aron Energy Prepay 14 LLC, Aron Comment Date: 5 p.m. ET 11/21/23.
Accession Number: 20231031–5197. Energy Prepay 5 LLC, J. Aron & Docket Numbers: ER24–261–000.
Comment Date: 5 p.m. ET 11/21/23. Company LLC. Applicants: New York Independent
Docket Numbers: ER19–1575–010; Description: Notice of Non-Material System Operator, Inc.
ER10–2488–027; ER13–1586–022; Change in Status of J. Aron & Company Description: § 205(d) Rate Filing:
ER14–2871–021; ER15–463–020; ER15– LLC, et al. NYISO 205: EPC Agreement for CY2017
621–020; ER15–622–020; ER16–72–016; Filed Date: 10/31/23. LI System Deliverability Upgrade
ER16–182–016; ER16–902–013; ER17– Accession Number: 20231031–5213. (SA2776) to be effective 10/17/2023.
47–013; ER17–48–014; ER18–47–013; Comment Date: 5 p.m. ET 11/21/23. Filed Date: 10/31/23.
ER18–2240–009; ER18–2241–009; Docket Numbers: ER22–2419–003; Accession Number: 20231031–5123.
ER19–427–009; ER19–1660–009; ER19– ER22–2420–003. Comment Date: 5 p.m. ET 11/21/23.
1662–009; ER19–1667–009; ER20–71– Applicants: Lockhart Solar PV II, LLC, Docket Numbers: ER24–262–000.
009; ER20–72–009; ER20–75–009; Lockhart Solar PV, LLC. Applicants: Mustang Hills, LLC.
ER20–76–011; ER20–77–009; ER20–79– Description: Notice of Non-Material Description: § 205(d) Rate Filing:
009; ER21–1368–005; ER21–1369–006; Change in Status of Lockhart Solar PV, Notice of Non-Mat. Change in Status
ER21–1371–006; ER21–1373–007; LLC, et al. & MBR Tariff Revisions to be
ER21–1376–007; ER21–2782–006; Filed Date: 10/31/23. effective 12/31/2023.
ER22–149–006; ER22–1439–006; ER22– Accession Number: 20231031–5208. Filed Date: 10/31/23.
1440–006; ER22–1441–006; ER22–1442– Comment Date: 5 p.m. ET 11/21/23. Accession Number: 20231031–5129.
004; ER22–2419–002; ER22–2420–002; Docket Numbers: ER23–2562–001. Comment Date: 5 p.m. ET 11/21/23.
ER23–562–003; ER23–1048–002; ER23– Applicants: Merelec USA LLC.
Docket Numbers: ER24–263–000.
2001–002. Description: Tariff Amendment: Per
Applicants: BE-Pine 1 LLC.
Applicants: Sagebrush ESS II, LLC, Deficiency Letter (ER23–2562) to be
Description: § 205(d) Rate Filing:
Lockhart ESS, LLC, TGP Energy effective 10/3/2023.
Normal filing 2023 to be effective 11/1/
Management II, LLC, Lockhart Solar PV Filed Date: 10/31/23.
2023.
II, LLC, Lockhart Solar PV, LLC, EdSan Accession Number: 20231031–5177.
Comment Date: 5 p.m. ET 11/21/23. Filed Date: 10/31/23.
1B Group 3, LLC, EdSan 1B Group 2, Accession Number: 20231031–5130.
LLC, EdSan 1B Group 1 Sanborn, LLC, Docket Numbers: ER24–257–000. Comment Date: 5 p.m. ET 11/21/23.
EdSan 1B Group 1 Edwards, LLC, Applicants: NorthWestern
Sagebrush Line, LLC, Sagebrush ESS, Corporation, Southwest Power Pool, Inc. Docket Numbers: ER24–264–000.
LLC, ES 1A Group 3 Opco, LLC, ES 1A Description: § 205(d) Rate Filing: Applicants: DesertLink, LLC.
Group 2 Opco, LLC, Edwards Sanborn NorthWestern Corporation submits tariff Description: Compliance filing:
Storage II, LLC, Edwards Sanborn filing per 35.13(a)(2)(iii: NorthWestern DesertLink LLC Annual TRBAA Filing
Storage I, LLC, Valley Center ESS, LLC, Corp—Name Change to NorthWestern to be effective 1/1/2024.
Voyager Wind IV Expansion, LLC, Energy Public Service Corp. to be Filed Date: 10/31/23.
Painted Hills Wind Holdings, LLC, effective 1/1/2024. Accession Number: 20231031–5134.
Tehachapi Plains Wind, LLC, Oasis Filed Date: 10/31/23. Comment Date: 5 p.m. ET 11/21/23.
Alta, LLC, Coachella Wind Holdings, Accession Number: 20231031–5072. Docket Numbers: ER24–265–000.
LLC, Coachella Hills Wind, LLC, Terra- Comment Date: 5 p.m. ET 11/21/23. Applicants: Southwest Power Pool,
Gen VG Wind, LLC, Mojave 16/17/18 Docket Numbers: ER24–258–000. Inc.
LLC, Mojave 3/4/5 LLC,LUZ Solar Applicants: Southern California Description: § 205(d) Rate Filing:
Partners IX, Ltd., Garnet Wind, LLC, Edison Company. Revisions to Attachment W to Update
Yavi Energy, LLC, Voyager Wind II, Description: § 205(d) Rate Filing: Index of Grandfathered Agreements to
LLC, Terra-Gen Mojave Windfarms, TMCR termination—Amending be effective 1/1/2024.
LLC, DifWind Farms LTD VI, Voyager Appendix XI to be effective 1/1/2024. Filed Date: 10/31/23.
Wind I, LLC, Cameron Ridge II, LLC, Filed Date: 10/31/23. Accession Number: 20231031–5168.
San Gorgonio Westwinds II— Accession Number: 20231031–5076. Comment Date: 5 p.m. ET 11/21/23.
Windustries, LLC, Ridgetop Energy, Comment Date: 5 p.m. ET 11/21/23. Docket Numbers: ER24–266–000.
Applicants: Solar of Alamosa LLC. Dated: October 31, 2023. Commission’s Home Page
Description: Baseline eTariff Filing: Debbie-Anne A. Reese, (www.ferc.gov) using the ‘‘eLibrary’’
Market-Based Rate Application to be Deputy Secretary. link. Enter the docket number excluding
effective 11/1/2023. [FR Doc. 2023–24485 Filed 11–3–23; 8:45 am] the last three digits in the docket
Filed Date: 10/31/23. BILLING CODE 6717–01–P number field to access the document. At
Accession Number: 20231031–5175. this time, the Commission has
Comment Date: 5 p.m. ET 11/21/23. suspended access to the Commission’s
DEPARTMENT OF ENERGY Public Reference Room. For assistance,
Docket Numbers: ER24–267–000. contact the Federal Energy Regulatory
Applicants: Duke Energy Carolinas, Federal Energy Regulatory Commission at FercOnlineSupport@
LLC. Commission ferc.gov or call toll-free, (886) 208–3676
Description: § 205(d) Rate Filing: or TTY (202) 502–8659.
[Docket No. CP24–8–000]
DEC–DESC Orangeburg Dynamic Any questions regarding the proposed
Transfer Agmt RS No. 618 to be effective Natural Gas Pipeline Company of Project should be directed to Francisco
1/1/2024. America LLC; Notice of Application Tarin, Director, Regulatory, for Kinder
Filed Date: 10/31/23. and Establishing Intervention Deadline Morgan Inc., as Operator of Natural Gas
Accession Number: 20231031–5190. Pipeline Company of America LLC, at 2
Take notice that on October 18, 2023, North Nevada Avenue, Colorado
Comment Date: 5 p.m. ET 11/21/23.
Natural Gas Pipeline Company of Springs, Colorado 80903, at (719) 667–
Docket Numbers: ER24–268–000. America LLC (NGPL), 3250 Lacey Road, 7515, or francisco_tarin@
Applicants: Florida Power & Light Suite 700, Downers Grove, Illinois kindermorgan.com.
Company. 60515, filed an application pursuant to Pursuant to Section 157.9 of the
Description: § 205(d) Rate Filing: FPL section 7(c) of the Natural Gas Act Commission’s Rules of Practice and
OATT Updated Stated Rate for NITS & (NGA), and Part 157 of the Procedure,1 within 90 days of this
P-to-P Trans Service on FPL Pen FL Sys Commission’s regulations requesting Notice the Commission staff will either:
to be effective 1/1/2024. authorization for its Texas-Louisiana complete its environmental review and
Filed Date: 10/31/23. Expansion Project (Project). The Project place it into the Commission’s public
Accession Number: 20231031–5192. consists of construction and operation record (eLibrary) for this proceeding; or
Comment Date: 5 p.m. ET 11/21/23. of new and modified facilities at the issue a Notice of Schedule for
existing Compressor Station (CS) 302 Environmental Review. If a Notice of
The filings are accessible in the
located in Montgomery County, Texas Schedule for Environmental Review is
Commission’s eLibrary system (https:// and CS 343 located in Liberty County,
elibrary.ferc.gov/idmws/search/ issued, it will indicate, among other
Texas. The Project will create 300,000 milestones, the anticipated date for the
fercgensearch.asp) by querying the dekatherms per day of incremental firm
docket number. Commission staff’s issuance of the final
eastbound transportation capacity on environmental impact statement (FEIS)
Any person desiring to intervene, to NGPL’s existing mainline facilities or environmental assessment (EA) for
protest, or to answer a complaint in any along the Texas and Louisiana Gulf this proposal. The filing of an EA in the
of the above proceedings must file in Coast region. NGPL estimates the total Commission’s public record for this
accordance with Rules 211, 214, or 206 cost of the Project to be $72 million. proceeding or the issuance of a Notice
of the Commission’s Regulations (18 NGPL requests presumption of rolled-in of Schedule for Environmental Review
CFR 385.211, 385.214, or 385.206) on or rate treatment and proposes to establish will serve to notify federal and state
before 5:00 p.m. Eastern time on the an incremental fuel retention rate for agencies of the timing for the
specified comment date. Protests may be firm transportation service to be completion of all necessary reviews, and
considered, but intervention is provided on Project facilities, all as the subsequent need to complete all
necessary to become a party to the more fully set forth in the application federal authorizations within 90 days of
proceeding. which is on file with the Commission the date of issuance of the Commission
eFiling is encouraged. More detailed and open for public inspection. staff’s FEIS or EA.
information relating to filing Specifically, NGPL proposes to install
requirements, interventions, protests, one new 18,340 horsepower (hp) Public Participation
service, and qualifying facilities filings Electric Motor Driven (EMD) There are three ways to become
can be found at: http://www.ferc.gov/ compressor unit and to uprate existing involved in the Commission’s review of
docs-filing/efiling/filing-req.pdf. For EMD compressor Units 7 and 8 by 1,600 this project: you can file comments on
other information, call (866) 208–3676 hp each at its existing CS 302. NGPL the project, you can protest the filing,
(toll free). For TTY, call (202) 502–8659. also proposes to re-wheel the existing and you can file a motion to intervene
The Commission’s Office of Public compressor Units 7, 8, and 9 at CS 302 in the proceeding. There is no fee or
Participation (OPP) supports meaningful and Units 9 and 10 at its existing CS cost for filing comments or intervening.
public engagement and participation in 343. Finally, NGPL will install various The deadline for filing a motion to
Commission proceedings. OPP can help section 2.55(a) auxiliary facilities at CS intervene is 5:00 p.m. Eastern Time on
members of the public, including 302 and CS 343, including additional November 21, 2023. How to file
landowners, environmental justice gas cooling equipment, a motor control protests, motions to intervene, and
communities, Tribal members and center building for new gas coolers and comments is explained below.
others, access publicly available a new EMD compressor unit, a new The Commission’s Office of Public
information and navigate Commission filter separator, and station yard piping. Participation (OPP) supports meaningful
processes. For public inquiries and In addition to publishing the full text public engagement and participation in
assistance with making filings such as of this document in the Federal Commission proceedings. OPP can help
interventions, comments, or requests for Register, the Commission provides all members of the public, including
rehearing, the public is encouraged to interested persons an opportunity to landowners, environmental justice
contact OPP at (202) 502–6595 or OPP@ view and/or print the contents of this
ferc.gov. document via the internet through the 1 18 CFR (Code of Federal Regulations) 157.9.
communities, Tribal members and (3) You can file a paper copy of your property directly impacted by the
others, access publicly available comments or protests by mailing them project in order to intervene. For more
information and navigate Commission to the following address below. Your information about motions to intervene,
processes. For public inquiries and written comments must reference the refer to the FERC website at https://
assistance with making filings such as Project docket number (CP24–8–000). www.ferc.gov/resources/guides/how-to/
interventions, comments, or requests for To file via USPS: Kimberly D. Bose, intervene.asp.
rehearing, the public is encouraged to Secretary, Federal Energy Regulatory There are two ways to submit your
contact OPP at (202) 502–6595 or OPP@ Commission, 888 First Street NE, motion to intervene. In both instances,
ferc.gov. Washington, DC 20426. please reference the Project docket
To file via any other courier: Kimberly number CP24–8–000 in your
Comments D. Bose, Secretary, Federal Energy submission.
Any person wishing to comment on Regulatory Commission, 12225 Wilkins (1) You may file your motion to
the project may do so. Comments may Avenue, Rockville, Maryland 20852. intervene by using the Commission’s
include statements of support or The Commission encourages eFiling feature, which is located on the
objections, to the project as a whole or electronic filing of comments (options 1 Commission’s website (www.ferc.gov)
specific aspects of the project. The more and 2 above) and has eFiling staff under the link to Documents and
specific your comments, the more useful available to assist you at (202) 502–8258 Filings. New eFiling users must first
they will be. or FercOnlineSupport@ferc.gov. create an account by clicking on
Persons who comment on the ‘‘eRegister.’’ You will be asked to select
Protests environmental review of this project the type of filing you are making; first
Pursuant to sections 157.10(a)(4) 2 and will be placed on the Commission’s select ‘‘General’’ and then select
385.211 3 of the Commission’s environmental mailing list, and will ‘‘Intervention.’’ The eFiling feature
regulations under the NGA, any person 4 receive notification when the includes a document-less intervention
may file a protest to the application. environmental documents (EA or EIS) option; for more information, visit
Protests must comply with the are issued for this project and will be https://www.ferc.gov/docs-filing/efiling/
requirements specified in section notified of meetings associated with the document-less-intervention.pdf.; or
385.2001 5 of the Commission’s Commission’s environmental review (2) You can file a paper copy of your
regulations. A protest may also serve as process. motion to intervene, along with three
a motion to intervene so long as the The Commission considers all copies, by mailing the documents to the
protestor states it also seeks to be an comments received about the project in address below. Your motion to
intervenor. determining the appropriate action to be intervene must reference the Project
To ensure that your comments or taken. However, the filing of a comment docket number CP24–8–000.
protests are timely and properly alone will not serve to make the filer a To file via USPS: Kimberly D. Bose,
recorded, please submit your comments party to the proceeding. To become a Secretary, Federal Energy Regulatory
on or before November 21, 2023. party, you must intervene in the Commission, 888 First Street NE,
There are three methods you can use proceeding. For instructions on how to Washington, DC 20426.
intervene, see below. To file via any other courier: Kimberly
to submit your comments or protests to
D. Bose, Secretary, Federal Energy
the Commission. In all instances, please Interventions Regulatory Commission, 12225 Wilkins
reference the Project docket number
Any person, which includes Avenue, Rockville, Maryland 20852.
CP24–8–000 in your submission. The Commission encourages
(1) You may file your comments individuals, organizations, businesses,
municipalities, and other entities,6 has electronic filing of motions to intervene
electronically by using the eComment (option 1 above) and has eFiling staff
feature, which is located on the the option to file a motion to intervene
in this proceeding. Only intervenors available to assist you at (202) 502–8258
Commission’s website at www.ferc.gov or FercOnlineSupport@ferc.gov.
under the link to Documents and have the right to request rehearing of
Protests and motions to intervene
Filings. Using eComment is an easy Commission orders issued in this
must be served on the applicant either
method for interested persons to submit proceeding and to subsequently
by mail or email at: Francisco Tarin,
brief, text-only comments on a project; challenge the Commission’s orders in
Director, Regulatory, for Kinder Morgan
(2) You may file your comments or the U.S. Circuit Courts of Appeal.
To intervene, you must submit a Inc., as Operator of Natural Gas Pipeline
protests electronically by using the Company of America LLC, at 2 North
eFiling feature, which is located on the motion to intervene to the Commission
Nevada Avenue, Colorado Springs,
Commission’s website (www.ferc.gov) in accordance with Rule 214 of the
Colorado 80903 or at francisco_tarin@
under the link to Documents and Commission’s Rules of Practice and
kindermorgan.com. Any subsequent
Filings. With eFiling, you can provide Procedure 7 and the regulations under
submissions by an intervenor must be
comments in a variety of formats by the NGA 8 by the intervention deadline
served on the applicant and all other
attaching them as a file with your for the project, which is November 21,
parties to the proceeding. Contact
submission. New eFiling users must 2023. As described further in Rule 214,
information for parties can be
first create an account by clicking on your motion to intervene must state, to
downloaded from the service list at the
‘‘eRegister.’’ You will be asked to select the extent known, your position
eService link on FERC Online. Service
the type of filing you are making; first regarding the proceeding, as well as
can be via email with a link to the
your interest in the proceeding. For an
select ‘‘General’’ and then select document.

‘‘Comment on a Filing’’; or individual, this could include your All timely, unopposed 9 motions to
status as a landowner, ratepayer, intervene are automatically granted by
2 18 CFR 157.10(a)(4).
resident of an impacted community, or operation of Rule 214(c)(1).10 Motions to
3 18 CFR 385.211. recreationist. You do not need to have
4 Persons include individuals, organizations, 9 The applicant has 15 days from the submittal of
6 18 CFR 385.102(d).
businesses, municipalities, and other entities. 18 a motion to intervene to file a written objection to
CFR 385.102(d). 7 18 CFR 385.214. the intervention.
5 18 CFR 385.2001. 8 18 CFR 157.10. 10 18 CFR 385.214(c)(1).
intervene that are filed after the energy certificates (RECs). The 42 U.S.C. 7152. By Delegation Order No.
intervention deadline are untimely, and Cumberland System power marketing S1–DEL–RATES–2016, effective
may be denied. Any late-filed motion to policy was published on August 5, November 19, 2016, the Secretary of
intervene must show good cause for 1993, and is reflected in contracts for Energy delegated: (1) the authority to
being late and must explain why the the sale of system power, which are develop power and transmission rates to
time limitation should be waived and maintained in Southeastern’s the SEPA Administrator; (2) the
provide justification by reference to headquarters office. Pursuant to the authority to confirm, approve, and place
factors set forth in Rule 214(d) of the Procedure for Public Participation in the such rates into effect on an interim basis
Commission’s Rules and Regulations.11 Formulation of Marketing Policy, to the Deputy Secretary of Energy; and
A person obtaining party status will be published in the Federal Register on (3) the authority to confirm, approve,
placed on the service list maintained by July 6, 1978, Southeastern published on and place into effect on a final basis, or
the Secretary of the Commission and October 21, 2021, a notice of intent to to remand or disapprove such rates, to
will receive copies (paper or electronic) revise the power marketing policy to FERC. By Delegation Order No. S1–
of all documents filed by the applicant include provisions regarding RECs from DEL–S3–2023, effective April 10, 2023,
and by all other parties. the Cumberland System. The proposed the Secretary of Energy also delegated
revision to the Cumberland System the authority to confirm, approve, and
Tracking the Proceeding place such rates into effect on an
Power Marketing Policy was published
Throughout the proceeding, in the Federal Register on April 25, interim basis to the Under Secretary for
additional information about the project 2023. A virtual web based public Infrastructure. By Redelegation Order
will be available from the Commission’s information and comment forum was No. S3–DEL–SEPA1–2023, effective
Office of External Affairs, at (866) 208– held on June 29, 2023, with written April 10, 2023, the Under Secretary for
FERC, or on the FERC website at comments due on or before July 14, Infrastructure further redelegated the
www.ferc.gov using the ‘‘eLibrary’’ link 2023. authority to confirm, approve, and place
as described above. The eLibrary link such rates into effect on an interim basis
DATES: The power marketing policy
also provides access to the texts of all to SEPA’s Administrator.
revision will become effective December The Cumberland System consist of
formal documents issued by the
6, 2023. nine projects: Barkley, Center Hill,
Commission, such as orders, notices,
FOR FURTHER INFORMATION CONTACT: Mr. Cheatham, Cordell Hull, Dale Hollow,
and rulemakings.
In addition, the Commission offers a Douglas Spencer, Engineer, Laurel, Old Hickory, J. Percy Priest, and
free service called eSubscription which Southeastern Power Administration, Wolf Creek. The power from the projects
allows you to keep track of all formal 1166 Athens Tech Road, Elberton, GA is currently marketed to Preference
issuances and submittals in specific 30635, (706) 213–3855, Email: Customers located in the service areas of
dockets. This can reduce the amount of douglas.spencer@sepa.doe.gov. Tennessee Valley Authority, Big Rivers
time you spend researching proceedings SUPPLEMENTARY INFORMATION: Electric Corporation, Duke Energy
by automatically providing you with Progress, East Kentucky Power
Background
notification of these filings, document Cooperative, Kentucky Utilities,
summaries, and direct links to the Southeastern published a ‘‘Notice of Municipal Electric Agency of
documents. For more information and to Issuance of Final Power Marketing Mississippi, Mississippi Delta Energy
register, go to www.ferc.gov/docs-filing/ Policy Cumberland System of Projects’’ Agency, the seven-member Cooperative
esubscription.asp. in the Federal Register on August 5, Energy currently receiving Cumberland
Intervention Deadline: 5:00 p.m. 1993 (58 FR 41762). The policy power, and Southern Illinois Power
Eastern Time on November 21, 2023. establishes the marketing area for Cooperative.
system power and addresses the Southeastern has been using the
Dated: October 31, 2023. utilization of area utility systems for Generation Attribute Tracking System
Kimberly D. Bose, essential purposes. The policy also (GATS) provided through the PJM
Secretary. addresses wholesale rates, resale rates, Interconnection, LLC, for the Kerr-
[FR Doc. 2023–24463 Filed 11–3–23; 8:45 am] and conservation measures, but does not Philpott System of Projects. The
BILLING CODE 6717–01–P address RECs. attributes are unbundled from the
Under Section 5 of the Flood Control megawatt-hour of energy produced and
Act of 1944 (16 U.S.C. 825s), recorded onto a certificate. These
DEPARTMENT OF ENERGY Southeastern, through delegated certificates may be used by electricity
authority, is responsible for the suppliers and other energy market
Southeastern Power Administration transmission and disposition of electric participants to comply with relevant
power and energy from reservoir state policies and regulatory programs
Revision To Power Marketing Policy projects operated by the U.S. Army and to support voluntary ‘‘green’’
Cumberland System of Projects Corps of Engineers. Furthermore, electricity markets. Southeastern will
AGENCY: Southeastern Power Southeastern must transmit and dispose use the similar M–RETS product for
Administration, DOE. of power and energy in such a manner distributing certificates to current
ACTION: Notice of revision to power as to encourage the most widespread Preference Customers with allocations
marketing policy. use at the lowest possible rates to of power from the Cumberland System.
consumers consistent with sound Through this RECs tracking system
SUMMARY: Southeastern Power business principles. Rate schedules are Southeastern is capable of tracking
Administration (Southeastern or SEPA) developed with regard to the recovery of environmental attributes used for
announces revision to the power the cost of producing and transmitting voluntary claims in all state, provinces,
marketing policy for the Cumberland such electric energy. and territories in North America. Under
System of Projects to include a Southeastern’s authority to formulate the following revision of the 1994 power
procedure for distribution of renewable the policy and perform the functions are marketing policy, Southeastern will
derived from section 302(a) of the distribute the M–RETS created
11 18 CFR 385.214(b)(3) and (d). Department of Energy Organization Act, certificates to current Preference
Customers with allocations of power or trade transaction would be the sole statement or an environmental
from the Cumberland System. responsibility of a Preference Customer. assessment.
Transfers to each customer will be based
Public Notice and Comment Signing Authority
on the customer’s monthly invoices
Southeastern published a proposed during the same three-month period This document of the Department of
revision in the Federal Register, 88 FR (quarter). Where applicable, RECs will Energy was signed on October 23, 2023,
24981, dated April 25, 2023. be project-specific based on the by Virgil G. Hobbs III, Administrator,
Southeastern held a web-based customer’s contractual arrangements. Southeastern Power Administration,
information and comment forum on Customers receiving energy under the pursuant to the delegated authority from
June 29, 2023. Southeastern received no TVA/TVPPA contract will receive their the Secretary of Energy. That document,
comments. distributions pursuant to the with the original signature and date, is
Revision to the Power Marketing Policy percentages in TVA Area Preference maintained by DOE. For administrative
Customer 1978 Load document (revised purposes only, and in compliance with
Southeastern revises the Power March 2022). requirements of the Office of the Federal
Marketing Policy for the System to All RECs distributed by Southeastern Register, the undersigned DOE Federal
include the following additional shall be transferred within forty-five Register Liaison Officer has been
provisions for RECs associated with days of the end of a quarter. Each authorized to sign and submit the
hydroelectric generation: customer must submit to Southeastern, document in electronic format for
Renewable Energy Certificates: The by the tenth business day after the publication, as an official document of
M–RETS Tracking System creates and quarter, any notice of change to M– the Department of Energy. This
tracks certificates reporting generation RETS account or agent. Any REC administrative process in no way alters
attributes, by generating unit, for each transfers that were not claimed or if a the legal effect of this document upon
megawatt-hour (MWh) of energy transfer account was not provided to publication in the Federal Register.
produced by registered generators. The Southeastern will be forfeited if they
System projects are registered generators Signed in Washington, DC, on November 1,
become nontransferable as described in 2023.
within M–RETS. The RECs potentially the M–RETS terms of service,
satisfy Renewable Portfolio Standards, Treena V. Garrett,
procedures, policies, or definitions of
state policies, and other regulatory or Federal Register Liaison Officer, U.S.
reporting and trading periods, or any Department of Energy.
voluntary clean energy standards in a subsequent rules and procedures for
number of states. Southeastern has transfers as established.
[FR Doc. 2023–24456 Filed 11–3–23; 8:45 am]
subscribed to M–RETS and has an The initial transfer process in M– BILLING CODE 6450–01–P
account in which RECs are collected RETS will be accomplished by the
and tracked for each MWh of energy sixtieth day after the end of the first
produced from the System. Within M– completed quarter subsequent to ENVIRONMENTAL PROTECTION
RETS, certificates can be transferred to publication of the final policy revision. AGENCY
other M–RETS subscribers or to a third- Any balance of RECs that exist in
party tracking system. Southeastern’s M–RETS account, other [FRL–10082–02–OMS]
M–RETS creates a REC for every MWh than the first quarter after policy
of renewable energy produced by revision publication, may also be Privacy Act of 1974; System of
registered generators, tracks the life transferred to Preference Customers Records
cycle of each REC created, and ensures according to the customer’s invoiced
against any double-counting or double- AGENCY: Security Management Division,
energy at the time of the REC creation. Environmental Protection Agency
use of each REC. These RECs may be Rates: No rates shall be established by
used by electricity suppliers and other (EPA).
Southeastern for RECs transferred to
energy market participants to comply Preference Customers. Any cost to ACTION: Notice of a modified system of
with relevant state policies and Southeastern, such as the M–RETS records.
regulatory programs and to support subscription, will be incorporated into
voluntary ‘‘green’’ electricity markets. SUMMARY: The U.S. Environmental
marketing costs and included in Protection Agency’s (EPA or Agency)
Southeastern will distribute M–RETS- recovery through the energy and
created RECs to Preference Customers Personnel Security Branch (PSB) is
capacity rates of the System. giving notice that it proposes to modify
with allocations of power from the
System. Determination Under Executive Order a system of records pursuant to the
REC Distribution: M–RETS (or a 12866 provisions of the Privacy Act of 1974.
successor application) will be the Southeastern is exempted from The Personnel Security System (PSS)
transfer mechanism for all RECs related centralized regulatory review under 2.0 is being modified to include a new
to the System. Southeastern shall Executive Order 12866; accordingly, no module, which the Agency will use to
maintain an account with M–RETS and clearance of this notice by the Office of administer its Insider Threat Program.
collect RECs from the generation at the Management and Budget is required. The new module will collect records
System projects. Southeastern will about individuals to assist the Agency
verify the total amount of RECs each Environmental Compliance with insider threat inquiry management
month. Preference Customers with an SEPA has determined this action fits and coordination. The module will
allocation of power from the System are within the following categorical retain insider threat inquiry-related data
eligible to receive RECs by transfer from exclusions listed in appendix B to and help EPA personnel coordinate
Southeastern’s M–RETS account to their subpart D of 10 CFR part 1021: B4.1 responses to those inquiries. Collecting
M–RETS account or that of their agent. (Contracts, policies, and marketing and this data ensures the effective and
M–RETS (or a successor application) allocation plans for electric power). timely processing of records.
will be the transfer mechanism for all Categorically excluded projects and DATES: Persons wishing to comment on
RECs related to the Kerr-Philpott activities do not require preparation of this system of records notice must do so
System. Any further transfer, sale use, either an environmental impact by December 6, 2023.
ADDRESSES: Submit your comments, listed in the index, some information is personnel; reports about potential
identified by Docket ID No. EPA–HQ– not publicly available, e.g., CUI or other insider threats obtained through the
OMS–2019–0371, by one of the information for which disclosure is management and operation of the EPA
following methods: restricted by statute. Certain other Insider Threat Program; and reports
Federal eRulemaking Portal: https:// material, such as copyrighted material, about potential insider threats obtained
www.regulations.gov. Follow the online will be publicly available only in hard from other Federal Governments
instructions for submitting comments. copy. Publicly available docket sources. The records contained in this
Email: docket_oms@epa.gov. Include materials are available either system could include information
the Docket ID number in the subject line electronically in https:// related to actual, potential, or alleged
of the message. www.regulations.gov or in hard copy at criminal, or administrative violations
Fax: (202) 566–1752. the OMS Docket, EPA/DC, WJC West and law enforcement actions.
Mail: OMS Docket, Environmental Building, Room 3334, 1301 Constitution The insider threat module will
Protection Agency, Mail Code: 2822T, Ave. NW, Washington, DC 20460. The contain information relevant to insider
1200 Pennsylvania Ave. NW, Public Reading Room is normally open threat inquiries on cleared individuals
Washington, DC 20460. from 8:30 a.m. to 4:30 p.m., Monday with access to EPA resources, including
Hand Delivery: OMS Docket, EPA/DC, through Friday excluding legal holidays. facilities, information, equipment,
WJC West Building, Room 3334, 1301 The telephone number for the Public networks, and systems. The insider
Constitution Ave. NW, Washington, DC Reading Room is (202) 566–1744, and threat module may also contain
20460. Such deliveries are only the telephone number for the OMS information obtained as a result of a
accepted during the Docket’s normal Docket is (202) 566–1752. Further background investigation conducted on
hours of operation, and special information about EPA Docket Center cleared personnel. Further, at a later
arrangements should be made for services and current operating status is date, and once relevant authorities are
deliveries of boxed information. available at https://www.epa.gov/
Instructions: Direct your comments to updated, the insider threat module will
dockets. also contain information on uncleared
Docket ID No. EPA–HQ–OMS–2019–
0371. The EPA’s policy is that all FOR FURTHER INFORMATION CONTACT: John individuals with access to EPA
comments received will be included in Goldsby, Branch Chief, Personnel resources.
the public docket without change and Security Branch, Environmental SYSTEM NAME AND NUMBER:
may be made available online at https:// Protection Agency, William Jefferson Personnel Security System (PSS) 2.0,
www.regulations.gov, including any Clinton North Building, Mail Code EPA–83.
personal information provided, unless 3206A, 1200 Pennsylvania Avenue NW,
the comment includes information Washington, DC 20460; telephone SECURITY CLASSIFICATION:
claimed to be Controlled Unclassified number: (202) 564–1569; email address: Unclassified.
Information (CUI) or other information Goldsby.John@epa.gov.
SYSTEM LOCATION:
for which disclosure is restricted by SUPPLEMENTARY INFORMATION: Currently,
statute. Do not submit information that EPA’s Personnel Security Branch (PSB) The system will be managed by the
you consider to be CUI or otherwise uses PSS 2.0 to track and maintain Personnel Security Branch,
protected through https:// background investigation documents for Environmental Protection Agency, 1301
www.regulations.gov. The https:// federal and non- federal personnel Constitution Ave. NW, Washington, DC
www.regulations.gov website is an working for EPA. This includes 20460. Electronically stored information
‘‘anonymous access’’ system for the background investigation documents for is hosted at the EPA National Computer
EPA, which means the EPA will not all ‘‘covered individuals’’ who have Center (NCC), 109 TW Alexander Drive,
know your identity or contact access to classified information or who Research Triangle Park, Durham, NC
information. If you submit an electronic hold a sensitive position. EPA is 27711.
comment, the EPA recommends that required to maintain this information SYSTEM MANAGER(S):
you include your name and other for the employee onboarding process, John Goldsby, Branch Chief,
contact information in the body of your and to manage background Personnel Security Branch,
comment. If the EPA cannot read your investigations for personnel during their Environmental Protection Agency,
comment due to technical difficulties time at the EPA (i.e., when there are William Jefferson Clinton North
and cannot contact you for clarification, promotions, position changes, etc.). Building, Mail Code 3206A, 1200
the EPA may not be able to consider PSB is adding a new Insider Threat Pennsylvania Avenue NW, Washington,
your comment. If you send an email module to PSS 2.0 that provides EPA DC 20460; Telephone Number: (202)
comment directly to the EPA without with insider threat inquiry management 564–1569; Email address: goldsby.john@
going through https:// and coordination capabilities. epa.gov.
www.regulations.gov, your email Specifically, the Agency is modifying
address will be automatically captured PSS 2.0 to include an inquiry AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
and included as part of the comment management function to maintain and Executive Order 13467, Reforming
that is placed in the public docket and safeguard insider threat-related data. Processes for Security Clearances,
made available on the internet. PSS 2.0 will also allow the Agency to Suitability and Fitness for Employment,
Electronic files should avoid the use of easily share necessary information with and Credentialing, and Related Matters
special characters, any form of authorized personnel to conduct insider as amended; Code of Federal
encryption, and be free of any defects or threat inquiries. The insider threat Regulations 5, Parts 731 (Suitability),
viruses. For additional information module will contain records derived 732 (National Security Positions), 736
about the EPA public docket, visit the from EPA security incidents, (Personnel Investigations), and 1400
EPA Docket Center homepage at https:// summaries, or reports containing (Designation of National Security
www.epa.gov/dockets. information about potential insider Positions in the Competitive Service,
Docket: All documents in the docket threats or the data loss prevention and Related Matters); Executive Order
are listed in the https:// program; information related to 12968—Access to Classified
www.regulations.gov index. Although analytical efforts by EPA insider threat Information; Executive Order 13467—
Reforming Processes Related to individuals formerly in any of these devices located at the EPA National
Suitability for Government positions including individuals who Computer Center (NCC), 109 TW
Employment, Fitness for Contractor require access to EPA-controlled Alexander Drive, Research Triangle
Employees, and Eligibility for Access to facilities, information technology Park, Durham, NC 27711.
Classified National Security systems, or information classified in the
POLICIES AND PRACTICES FOR RETRIEVAL OF
Information; Executive Order 13488— interest of national security, and RECORDS:
Granting Reciprocity on Excepted applicants for employment or to work
Personal information may be retrieved
Service and Federal Contractor on a contract, grant or other activity for
using an individual’s SSN, name, date
Employee Fitness and Reinvestigating the Agency.
of birth, email address, personal
Individuals in Positions of Public Trust;
CATEGORIES OF RECORDS IN THE SYSTEM: identification number or background
Executive Order 13741—Amending E.O.
Information in the system may investigation case number. The SSN is
13467 To Establish the Roles and used in the Suitability, Credentialing
Responsibilities of the National include: an individual’s first, middle,
and last name; social security number and Security Executive Agents’ systems,
Background Investigations Bureau and and is therefore used as the connecting
Related Matters; Executive Order (SSN); date and place of birth;
employment organization; office and data to enable the various systems to
13764—Amending the Civil Service communicate with each other and
Rules, Executive Order 13488; E.O. home addresses; office, home, and cell
phone numbers; job series; pay grade; transfer data when needed. PSS 2.0
13467 To Modernize the Executive displays a reminder about the
Branch-Wide Governance Structure and current and previous employment
details; dates and locations of overseas/ appropriate PII and SPII handling
Processes for Security Clearances, procedures every time a user begins to
Suitability and Fitness for Employment, foreign travel; military service
information; financial and credit enter data for a new background
and Credentialing, and Related Matters; investigation.
Responsibilities for the Maintenance of information; court documents; biometric
Records About Individuals by Federal data including fingerprint results; Office POLICIES AND PRACTICES FOR RETENTION AND
Agencies [OMB Circular A–108, as of Personnel Management’s or Defense DISPOSAL OF RECORDS:
amended]; Trusted Workforce 2.0, Counterintelligence and Security Records are retained and disposed of
Managements Responsibility for Internal Agency’s background investigations; in accordance with National Archives
Control [OMB Circular A–123, Revised driver’s license information; passport and Records Administration (NARA)
12/21/04]; Managing Information as a and visa information; photographs; records retention schedules appropriate
Strategic Resource [OMB Circular A– emergency contacts; business or other to the retention of background
130]; Records Management by Federal involvement with foreign governments investigation related data, as well as
Agencies [44 U.S.C. 31]; Federal or foreign nationals; foreign contacts; EPA’s Records Schedules 100 & 1008.
Information Security Modernization Act ownership of foreign property
information; foreign bank account ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
(Pub. L. 104–106, sec. 5113); Electronic SAFEGUARDS:
Government Act (Pub. L. 104–347, sec. information; information on arrests in
foreign countries; and insider threat Security controls used to protect
203); the Paperwork Reduction Act of personal sensitive data in PSS 2.0 are
1995 (44 U.S.C. 3501); the Government inquiry details.
commensurate with those required for
Paperwork Elimination Act (Pub. L. RECORD SOURCE CATEGORIES: an information system rated
105–277, 44 U.S.C. 3504). The data maintained in PSS 2.0 is MODERATE for confidentiality,
PURPOSE(S) OF THE SYSTEM: obtained from subjects of a background integrity, and availability, as prescribed
The purpose of PSS 2.0 is to assist investigation, individuals interviewed in NIST Special Publication, 800–53,
PSB with coordinating and managing as part of a background investigation or ‘‘Security and Privacy Controls for
background investigations on federal insider threat inquiry, current and Information Systems and
and non-federal personnel working for prospective EPA personnel, internal Organizations,’’ Revision 5.
EPA by collecting, maintaining, and EPA systems such as the Human 1. Administrative Safeguards:
tracking the documentation associated Resources Line of Business (HRLoB) Personnel are instructed to lock their
with such background investigations. system (EPA–93), external systems such computer when they leave their desks.
Data in the system will be transferred to as the General Service Administration Personnel are regularly reminded about
the identity card management provider (GSA)’s USAccess system (GSA/GOVT– appropriate sensitive personally
so that access cards can be issued to 7), and from other external sources such identifiable information (SPII) and
personnel. The data in the system will as vendors, applicants, other federal personally identifiable information (PII)
also be used by the Agency to start the agencies, other law enforcement systems handling procedures. All personnel are
employee onboarding process, and to and other public source materials. required to take annual Information
manage personnel throughout their ROUTINE USES OF RECORDS MAINTAINED IN THE
Technology Security and Privacy
employment at EPA. Additionally, the SYSTEM, INCLUDING CATEGORIES OF USERS AND
Training. In addition to the agency’s
insider threat module will be used by PURPOSES OF SUCH USES: Rules of Behavior, PSS 2.0 users are
OHS to collect information on The routine uses below are both required to sign a PSS 2.0-specific Rules
individuals, relevant to insider threat related to and compatible with the of Behavior document prior to their
inquiries. EPA will use the insider original purpose for which the access being granted to the system.
threat module to manage information Additionally, Contracting Officer’s
information was collected.

related to the inquiries, and support General routine uses A, B, C, D, E, F, Representatives will also be required to
EPA’s responses to such inquiries. G, H, I, J, K, L, and M apply to this review and understand PSS 2.0 user
system (86 FR 62527). guides, which explain how SPII/PII
CATEGORIES OF INDIVIDUALS COVERED BY THE should be handled.
SYSTEM: POLICIES AND PRACTICES FOR STORAGE OF 2. Technical Safeguards: Electronic
Federal employees, contractors, RECORDS: records are maintained in a secure,
grantees, students, interns, volunteers, These records are maintained password-protected environment.
other non-federal employees, and electronically on computer storage Access to records is limited to those
who have a need to know. Electronic be changed and the corrective action Further, under 5 U.S.C. 552a(k)(5),
records are restricted to authorized sought and must be made in accordance investigatory material compiled solely
users with appropriate security with the procedures described in EPA’s for the purpose of determining
privileges, including the use of 2- factor Privacy Act regulations at 40 CFR part suitability, eligibility, or qualifications
PIV Card authentication and permission 16. for Federal civilian employment,
level assignments. After 15 minutes of military service, Federal contracts, or
inactivity, a user is automatically logged NOTIFICATION PROCEDURES: access to classified information that, if
out of the system. Additionally, PSS 2.0 Pursuant to 5 U.S.C. 552a(k)(2) and disclosed, would reveal the identity of
displays a reminder about the (k)(5), certain records maintained in PSS a confidential source is exempt from 5
appropriate PII and SPII handling 2.0 are exempt from specific notification U.S.C. 552a (c)(3) and (d), subject to the
procedures each time a user begins to provisions of the Privacy Act. See 40 limitations set forth in the subsections.
enter data for a new background CFR 16.12. However, EPA may, in its EPA may maintain in PSS 2.0 records
investigation. discretion, grant individual notification obtained from other agencies or
3. Physical Safeguards: All records requests if it determines that components, which have exempted
are maintained in secure, access- notification will not interfere with an those records from certain Privacy Act
controlled areas or buildings. EPA interest that the exemption is intended requirements under 5 U.S.C. 552a (j)
employees and contractors involved in to protect. Generally, individuals who and (k). As such records do not lose
the management, design, development, wish to be informed whether a Privacy exempt status when added to another
implementation, and execution of the Act system of records maintained by system, these records will continue to
program will have monitored access to EPA contains any record pertaining to be exempt in PSS 2.0 on the same basis
the application. Only individuals who them, should make a written request to and from the same requirements as in
have the proper authorization and who the EPA, Attn: Agency Privacy Officer, the source system. Although certain
perform functions related to PSS 2.0 are MC 2831T, 1200 Pennsylvania Ave. records in PSS 2.0 have been exempted
allowed to access information. NW, Washington, DC 20460, or by email from certain provisions of the Privacy
at: privacy@epa.gov. A full description Act, EPA may, in its discretion, fully
RECORD ACCESS PROCEDURES:
of EPA’s Privacy Act procedures is grant individual requests for access and
Pursuant to 5 U.S.C. 552a(k)(2), included in EPA’s Privacy Act correction if it determines that the
certain records maintained in PSS 2.0 regulations at 40 CFR part 16. exercise of these rights will not interfere
are exempt from specific access and with an interest that the exemption is
accounting provisions of the Privacy EXEMPTIONS PROMULGATED FOR THE SYSTEM: intended to protect. However, if any
Act. See 40 CFR 16.12. However, EPA individual is denied any right, privilege,
Under 5 U.S.C. 552a (k)(2), certain
may, in its discretion, grant individual or benefit that they would otherwise be
records in PSS 2.0 are exempt from the
requests for access if it determines that entitled by federal law, or for which
following provisions of the Privacy Act
the exercise of these rights will not they would otherwise be eligible, as a
of 1974, as amended, subject to the
interfere with an interest that the result of the maintenance of these
limitations set forth in this subsection:
exemption is intended to protect. records, the records shall be provided to
5 U.S.C. 552a(c)(3); (d); (e)(1). In
Requests for access must be made in the individual, except to the extent that
particular, the following types of
accordance with the procedures the disclosure of such material would
records in PSS 2.0 are exempt from the
described in EPA’s Privacy Act reveal the identity of a source who
aforementioned provisions under
regulations at 40 CFR part 16. furnished information to the
Specifically, all requests for access to subsection (k)(2): (1) background
investigation records compiled to Government under an express promise
personal records should cite the Privacy
investigate personnel/an applicant that that the identity of the source would be
Act of 1974 and reference the type of
is/would be responsible for law held in confidence.
request being made (i.e., access).
Requests must include: (1) the name and enforcement and/or national security
HISTORY:
signature of the individual making the matters; (2) background investigation
records compiled to investigate 85 FR 32380 (May 29, 2020).
request; (2) the name of the Privacy Act
system of records to which the request personnel suspected of illegal or Vaughn Noga,
relates; (3) a statement whether a inappropriate activity; (3) information Senior Agency Official for Privacy.
personal inspection of the records or a compiled to identify potential insider [FR Doc. 2023–24492 Filed 11–3–23; 8:45 am]
copy of them by mail is desired; and (4) threats and facilitate insider threat
proof of identity. A full description of inquiries; (4) information compiled to
EPA’s Privacy Act procedures for identify pattens of illegal activity, or
requesting access to records is available that may form the predicate or be the ENVIRONMENTAL PROTECTION
at 40 CFR part 16. catalyst of a law enforcement AGENCY
investigation; and (5) information
CONTESTING RECORD PROCEDURES: otherwise compiled to identify [FRL–11527–01–OAR]
Pursuant to 5 U.S.C. 552a(k)(2), violations of law or national security
breaches. Announcing Upcoming Meeting of
certain records maintained in PSS 2.0
Mobile Sources Technical Review
are exempt from specific correction and However, if any individual is denied
Subcommittee
amendment provisions of the Privacy a right, privilege, or benefit to which the
Act. See 40 CFR 16.12. However, EPA individual would otherwise be entitled AGENCY: Environmental Protection
may, in its discretion, grant individual by Federal law or for which the Agency (EPA).
requests for correction and amendment individual would otherwise be eligible, ACTION: Notice.
if it determines that the exercise of these access will be granted, except to the
rights will not interfere with an interest extent that the disclosure would reveal SUMMARY: Pursuant to the Federal
that the exemption is intended to the identity of a source who furnished Advisory Committee Act, the
protect. Requests for correction and information to the Government under an Environmental Protection Agency (EPA)
amendment must identify the record to express promise of confidentiality. announces an upcoming meeting of the
Mobile Sources Technical Review FURTHER INFORMATION CONTACT section compliance with the NAAQS. A list of
Subcommittee (MSTRS), which is a above, by Monday, November 20, 2023. all reference or equivalent methods that
subcommittee under the Clean Air Act This will help EPA ensure that have been previously designated by EPA
Advisory Committee (CAAAC). This is a sufficient participation capacity will be may be found at http://www.epa.gov/
virtual meeting and open to the public. available. ttn/amtic/criteria.html.
The meeting will include discussion of Please note that any updates made to The EPA hereby announces the
current topics and presentations about any aspect of the meeting logistics, designation of one new equivalent
activities being conducted by EPA’s including potential additional sessions, method for measuring concentrations of
Office of Transportation and Air will be posted online at https:// Pb, and one new equivalent method for
Quality. MSTRS listserv subscribers will www.epa.gov/caaac/mobile-sources- measuring concentrations of PM10 in
receive notification when the agenda is technical-review-subcommittee-mstrs- ambient air. These designations are
available on the Subcommittee website. caaac. While EPA expects the meeting made under the provisions of 40 CFR
To subscribe to the MSTRS listserv, to go forward as set forth above, please part 53, as amended on October 26,
send an email to MSTRS@epa.gov. monitor the website for any updates. 2015 (80 FR 65291–65468).
DATES: EPA will hold a virtual public The new equivalent method for Pb is
Jessica Mroz, a manual method that uses the sampling
meeting on Wednesday, November 29th
Designated Federal Officer, Mobile Source procedure specified in the Reference
from 9 a.m. to 5 p.m. eastern standard Technical Review Subcommittee, Office of
time (EST). Please monitor the website Method for the Determination of Lead in
Transportation and Air Quality. Suspended Particulate Matter Collected
https://www.epa.gov/caaac/mobile- [FR Doc. 2023–24430 Filed 11–3–23; 8:45 am]
sources-technical-review-subcommittee- from Ambient Air (High-Volume
mstrs-caaac for any changes to meeting
BILLING CODE 6560–50–P Sampler), 40 CFR part 50, appendix G,
logistics. The final meeting agenda will with a different extraction and
be posted on the website. analytical procedure. The method is
ENVIRONMENTAL PROTECTION identified as follows:
ADDRESSES: For information on the AGENCY EQL–0723–261, ‘‘Microwave Assisted
public meeting or to register to attend, Digestion and Quadrupole Inductively
please contact MSTRS@epa.gov. [FRL–11450–01–ORD]
Coupled Plasma—Mass Spectrometry
FOR FURTHER INFORMATION CONTACT: Any Ambient Air Monitoring Reference and (South Coast Air Quality Management
member of the public who wishes to Equivalent Methods; Designation of District Laboratory)’’ ‘‘Determination of
attend the meeting or provide comments Two New Equivalent Methods Lead (Pb) on TSP Hi-Volume Filters by
should express this intent by emailing Microwave Assisted Digestion and
MSTRS@epa.gov no later than Monday, AGENCY: Environmental Protection Quadrupole Inductively Coupled
November 20, 2023. Further information Agency (EPA). Plasma Mass Spectrometry (Quadrupole
concerning this public meeting and ACTION: Notice of the designation of two ICP–MS).’’ A sample of total suspended
general information concerning the new equivalent methods for monitoring particulate matter (TSP) is collected on
MSTRS can be found at: https:// ambient air quality. a glass or quartz fiber filter, using the
www.epa.gov/caaac/mobile-sources- sampler and procedure of the EPA
technical-review-subcommittee-mstrs- SUMMARY: Notice is hereby given that
Reference Method for the Determination
caaac. Other MSTRS inquiries can be the Environmental Protection Agency
of Suspended Particulate Matter in the
directed to Jessie Mroz, the Designated (EPA) has designated one new
Atmosphere (High-Volume Method) (40
Federal Officer for MSTRS, Office of equivalent method for measuring
CFR part 50, appendix B). The TSP
Transportation and Air Quality, at 202– concentrations of Lead (pb), and one
sample is extracted with a nitric acid
564–1094 or mroz.jessica@epa.gov. new equivalent method for measuring
solution and digested in a microwave
concentrations of Particulate Matter
SUPPLEMENTARY INFORMATION: During the system, centrifuged and brought to a
(PM10) in ambient air.
meeting, the Subcommittee may also final acid concentration of 2–3%. The
hear progress reports from its lead content of the sample extract is
workgroups as well as updates and Robert Vanderpool, Air Methods and analysed by Quadrupole Inductively
announcements on Office of Characterization Division (MD–D205– Coupled Plasma Mass Spectrometry
Transportation and Air Quality 03), Center for Environmental (Quadrupole ICP–MS), based on EPA
activities of general interest to Measurements and Modeling, U.S. EPA, Method IO–3.5.
attendees. Research Triangle Park, North Carolina The application for equivalent
Participation in virtual public 27711. Phone: 919–541–7877. Email: method determination for this Pb
meetings. The virtual public meeting Vanderpool.Robert@epa.gov. method was submitted by South Coast
will provide interested parties the SUPPLEMENTARY INFORMATION: In Air Quality Management District, 21865
opportunity to participate in this accordance with regulations at 40 CFR Copley Drive, Diamond Bar, CA 91765
Federal Advisory Committee meeting. part 53, the EPA evaluates various and was received by the Office of
For individuals with disabilities: For methods for monitoring the Research and Development on July 11,
information on access or services for concentrations of those ambient air 2023.
individuals with disabilities, please pollutants for which EPA has The new equivalent method for PM10
email MSTRS@epa.gov. To request established National Ambient Air is an automated monitoring method
accommodate of a disability, please Quality Standards (NAAQS) as set forth (monitor) utilizing the measurement
email MSTRS@epa.gov, preferably at in 40 CFR part 50. Monitoring methods principle based on beta-ray attenuation.
least 10 business days prior to the that are determined to meet specific This newly designated equivalent
meeting, to give EPA as much time as requirements for adequacy are method is identified as follows:
possible to process your request. designated by the EPA as either EQPM–0923–262, ‘‘Vasthi
EPA is asking all meeting attendees, reference or equivalent methods (as Instruments Pvt. Ltd Vair-9009 p.m.10
even those who do not intend to speak, applicable), thereby permitting their use Monitor,’’ beta-ray monitor operated in
to register for the meeting by sending an under 40 CFR part 58 by States and a range of 0–5mg/m3, with an
email to the address listed in the FOR other agencies for determining operational temperature range of 0 °C to
40 °C. The unit is configured for 24, 1- 03), Center for Environmental amendments to terminate uses as shown
hour average measurements of PM10 by Measurements and Modeling, U.S. in this cancellation order. Any
beta attenuation, using a glass fiber Environmental Protection Agency, distribution, sale, or use of existing
paper tape roll (VPM–1006). The unit Research Triangle Park, North Carolina stocks of these products subject to this
operates at a sample flow rate of 16.67 27711. cancellation order is permitted only in
liters/min, with PM10 inlet meeting 40 Designation of these equivalent accordance with the terms of this order.
CFR part 50 appendix L specifications, methods are intended to assist the States
in establishing and operating their air DATES:The cancellations and
and heated inlet to control sample
quality surveillance systems under 40 amendments are effective November 6,
relative humidity to 35%. Instrument
must be operated in accordance with the CFR part 58. Questions concerning the 2023.
Vair-9009 Operating Manual. This commercial availability or technical FOR FURTHER INFORMATION CONTACT:
designation applies to PM10 aspects of these methods should be Patricia Biggio, Pesticide Re-Evaluation
measurements only. directed to the applicants. Division (7508M), Office of Pesticide
This application for an equivalent Programs, Environmental Protection
Alice Gilliland,
method determination for this PM10 Agency, 1200 Pennsylvania Ave. NW,
Acting Director, Center for Environmental
method was received by the Office of Washington, DC 20460–0001; telephone
Measurements and Modeling.
Research and Development on July 11, number: (202) 566–0700; email address:
[FR Doc. 2023–24495 Filed 11–3–23; 8:45 am]
2023. This monitor is commercially OPPChlorpyrifosInquiries@epa.gov.
available from the applicant, Vasthi
Instruments, Guntur 522 001, Andhra SUPPLEMENTARY INFORMATION:
Pradesh, India. I. General Information
A representative test analyzer was ENVIRONMENTAL PROTECTION
tested in accordance with the applicable AGENCY A. Does this action apply to me?
test procedures specified in 40 CFR part [EPA–HQ–OPP–2022–0223; FRL–11467–01– This action is directed to the public
53, as amended on October 26, 2015. OCSPP]
in general and may be of interest to a
After reviewing the results of those tests wide range of stakeholders including
and other information submitted by the Final Cancellation Order for Certain
Chlorpyrifos Registrations and Uses environmental, human health, and
applicant, EPA has determined, in agricultural advocates; the chemical
accordance with 40 CFR part 53, that AGENCY: Environmental Protection industry; pesticide users; and members
these methods should be designated as Agency (EPA). of the public interested in the sale,
equivalent methods. ACTION: Notice. distribution, or use of pesticides. Since
As designated equivalent methods,
others also may be interested, the
these methods are acceptable for use by SUMMARY: The Environmental Protection
Agency has not attempted to describe all
states and other air monitoring agencies Agency (EPA) hereby announces its
the specific entities that may be affected
under the requirements of 40 CFR part final cancellation order for the
by this action.
58, Ambient Air Quality Surveillance. cancellations and amendments to
For such purposes, these methods must terminate uses voluntarily requested by B. How can I get copies of this document
be used in strict accordance with the the registrants and accepted by the and other related information?
operation or instruction manual Agency, of the products in Table 1 and
associated with the method and subject Table 2 of Unit II, pursuant to the The docket for this action, identified
to any specifications and limitations Federal Insecticide, Fungicide, and by docket identification (ID) number
(e.g., configuration or operational Rodenticide Act (FIFRA). This final EPA–HQ–OPP–2022–0223, is available
settings) specified in the designated cancellation order follows a May 3, at https://www.regulations.gov or at the
method description (see the 2023, Federal Register Notice of Receipt Office of Pesticide Programs Regulatory
identification of the methods above). of Requests from the registrants listed in Public Docket (OPP Docket) in the
Use of the methods also should be in Table 3 of Unit II, to voluntarily cancel Environmental Protection Agency
general accordance with the guidance or amend these product registrations. In Docket Center (EPA/DC), West William
and recommendations of applicable the May 3, 2023, notice, EPA indicated Jefferson Clinton Bldg., Rm. 3334, 1301
sections of the ‘‘Quality Assurance that it would issue a final order Constitution Ave. NW, Washington, DC
Handbook for Air Pollution implementing the cancellations and 20460–0001. The Public Reading Room
Measurement Systems, Volume I,’’ EPA/ amendments, unless the Agency is open from 8:30 a.m. to 4:30 p.m.,
600/R–94/038a and ‘‘Quality Assurance received substantive comments within Monday through Friday, excluding legal
Handbook for Air Pollution the 30-day comment period that would holidays. The telephone number for the
Measurement Systems, Volume II, merit further review of these requests, or Public Reading Room is (202) 566–1744.
Ambient Air Quality Monitoring unless the registrants withdrew their Please review the additional
Program,’’ EPA–454/B–13–003, (both requests. The Agency received two information about the docket available
available at http://www.epa.gov/ttn/ comments on the notice, which are at https://www.epa.gov/dockets.
amtic/qalist.html). Provisions summarized in Unit III.B. EPA’s II. What action is the Agency taking?
concerning modification of such responses to these comments and its
methods by users are specified under determination that these comments do This document announces the
section 2.8 (Modifications of Methods not merit further review of these cancellations and amendments through
by Users) of appendix C to 40 CFR part cancellation and amendment requests termination of certain uses, as requested
58. are included in Unit III.C. None of the by registrants, of products registered
Consistent or repeated noncompliance registrants withdrew their request for under FIFRA section 3 (7 U.S.C. 136a).
with any of these conditions should be these voluntary cancellations or These registrations are listed in
reported to: Director, Air Methods and amendments. Accordingly, EPA hereby sequence by registration number in
Characterization Division (MD–D205– grants the requested cancellations and Table 1 and Table 2 of this Unit.
TABLE 1—PRODUCT CANCELLATIONS

EPA registration Company No. Product name Active ingredients
No.
228–620 ............ 228 Nufarm Chlorpyrifos SPC 2.32% G Insecticide ............................................................. Chlorpyrifos.
228–621 ............ 228 Nufarm Chlorpyrifos SPC 1.0% MCB Insecticide .......................................................... Chlorpyrifos.
228–624 ............ 228 Nufarm Chlorpyrifos SPC 4 Insecticide ......................................................................... Chlorpyrifos.
228–625 ............ 228 Nufarm Chlorpyrifos SPC 2 Insecticide ......................................................................... Chlorpyrifos.
53883–394 ........ 53883 CSI 16–150 Chlorpyrifos 42 .......................................................................................... Chlorpyrifos.
53883–407 ........ 53883 CSI 16–149 Chlorpyrifos 20 .......................................................................................... Chlorpyrifos.
84229–25 .......... 84229 Chlorpyrifos 4E AG ........................................................................................................ Chlorpyrifos.
84229–26 .......... 84229 Chlorpyrifos 15G ............................................................................................................ Chlorpyrifos.
TABLE 2—CHLORPYRIFOS REGISTRATIONS WITH SPECIFIC USES TO BE TERMINATED

Registration Company No. Product name Uses to be terminated
No.
11678–58 ....... 11678 Pyrinex Chlorpyrifos Insecticide ...... Food processing plants.
66222–19 ....... 66222 Chlorpyrifos 4E AG ......................... Food processing and food manufacturing sites.
66222–233 ..... 66222 Vulcan .............................................. Food processing and food manufacturing sites.
85724–10 ....... 85724 Akofos 48 EC .................................. Food uses: Alfalfa, apple (including apple tree trunk), asparagus, cher-
ries, citrus fruits (calamondin, chironja, citrus citron, citrus hybrids,
grapefruit, kumquat, lemons, limes, mandarin (tangerine), oranges,
pummelo, satsuma mandarin, tangelo, tangor, and other citrus fruit,
small transplanted grapefruit, orange, and other citrus trees), corn,
cotton, cranberries, figs, grapes, legume vegetables (legume vegeta-
bles including adzuki bean, asparagus bean, bean, blackeyed pea,
broad bean (dry and succulent), catjang, chickpea, Chinese
longbean, cowpea, crowder pea, dwarf pea, edible pod pea, English
pea, fava bean, field bean, field pea, garbanzo bean, garden pea,
grain lupin, green pea, guar, hyacinth bean, jackbean, kidney bean,
lablab bean, lentil, lima bean, moth bean, mung bean, navy bean,
pea, pigeon pea, pinto bean, rice bean, runner bean, snap bean,
snow pea, English pea, southern pea, sugar snap pea, sweet lupin,
sword bean, tepary bean, urd bean, wax bean, white lupin, white
sweet lupin, yardlong bean), mint (peppermint and spearmint), nec-
tarines, peaches, almonds, onions, peanuts, pears, sorghum grain
(milo), soybeans, strawberries, sugar beets, sunflowers, sweet pota-
toes, tree fruits (apples, pears, plums, prunes, peaches, nectarines),
tree nuts (almonds, filberts, pecans, walnuts), vegetables (rutabaga,
broccoli, Brussels sprout, cabbage, cauliflower, Chinese cabbage,
collards, kale, kohlrabi, turnips, radishes), wheat, and food proc-
essing plants.
Nonfood uses: Tobacco.
TABLE 3—REGISTRANTS REQUESTING TABLE 3—REGISTRANTS REQUESTING filed on or before the close of the
VOLUNTARY CANCELLATION OR TER- VOLUNTARY CANCELLATION OR TER- objections period on October 29, 2021.
MINATION OF USES MINATION OF USES—Continued EPA issued an Order published in the
Federal Register on February 28, 2022
EPA com- EPA com- (87 FR 11222) (FRL–5993–05–OCSPP),
Company name and address Company name and address
pany No. pany No. denying all objections to the Final Rule
and requests for hearing on those
228 ......... NuFarm, 4020 Aerial Center 85724 ..... AAKO B.V., c/o Ceres Inter-
objections, as well as requests for stay
Pkwy., Suite 101, Morrisville, national LLC, 1087 Heartsease
Drive, West Chester, PA of the Final Rule (the ‘‘Denial Order’’).
NC 27560.
11678 ..... ADAMA US, 3120 Highwoods 19382. Since the objections process did not
Boulevard, Suite 100, Raleigh, result in any changes to the Final Rule,
NC 27604. III. Public Comments chlorpyrifos tolerances expired on
53883 ..... Control Solutions, Inc., 5903 February 28, 2022, under the terms of
Genoa Red Bluffs Road, Pasa- A. Brief History
the Final Rule. Once the tolerances
dena, TX 77507. EPA issued a rule in the Federal expired, use of pesticide products
66222 ..... ADAMA US, 3120 Highwoods containing chlorpyrifos on food or feed
Register on August 30, 2021 (86 FR
Boulevard, Suite 100, Raleigh,

NC 27604.
48315) (FRL–5993–04–OCSPP) revoking crops would result in adulterated food,
84229 ..... Tide International USA, Inc., chlorpyrifos tolerances on the grounds which cannot be sold in interstate
Agent Name: Pyxis Regulatory that they were not safe (the ‘‘Final commerce. After EPA alerted registrants
Consulting, INC., 4110 136TH Rule’’). Pursuant to the procedures set of chlorpyrifos products of the lack of
Street CT NW, Gig Harbor, WA forth in FFDCA section 408(g)(2), tolerances and the options for their
98332. objections to, requests for evidentiary products, several registrants submitted
hearings on those objections, and/or requests to voluntarily cancel their
requests for a stay of the Final Rule were registered chlorpyrifos products or
amend their chlorpyrifos pesticide voluntary cancellation of a pesticide V. What is the Agency’s authority for
products to remove food uses. The product registration at any time, taking these actions?
registrants identified in Table 3 of Unit including, for example, lack of interest Section 6(f)(1) of FIFRA (7 U.S.C.
II, among others, submitted such in maintaining the registration, market 136d(f)(1)) provides that a registrant of
requests. Notice of EPA’s receipt of conditions, costs of maintaining the a pesticide product may at any time
these requests was published for registration, or the pesticide no longer request that any of its pesticide
comment in the Federal Register on being marketed. registrations be cancelled or amended to
May 3, 2023 (‘‘Notice of Receipt’’). The terminate one or more registered uses.
30-day public comment period closed EPA cannot compel registrants to
maintain registrations if they request to Section 6(f)(1)(B) of FIFRA (7 U.S.C.
on June 2, 2023.
voluntarily cancel them. The resolution 136d(f)(1)(B)) further provides that,
B. Summary of Comments Received and timing of the litigation in the Eighth before acting on the request for
During the public comment period, Circuit is still unknown, and therefore, voluntary cancellation or amendment,
EPA received two comments in retention of the registrations could EPA must publish a notice of receipt of
response to the Notice of Receipt. The subject registrants to additional any such request in the Federal Register
comments can be found in the docket and provide a 30-day public comment
maintenance fees and responsibilities
for this action, identified by docket period on the request for voluntary
for those registrations which the
identification (ID) number EPA–HQ– cancellation or use termination.
registrants requested cancellation or Following the public comment period,
OPP–2022–0223, available at https:// amendment. See, e.g., 40 CFR part 152,
www.regulations.gov and are briefly the EPA Administrator may approve
subpart G (registrant responsibilities); 7 such a request. The notice for this action
summarized here. One comment was U.S.C. 136a–1(i)(1) (maintenance fee
submitted by the American Sugarbeet was published for comment in the
obligations); 7 U.S.C. 136e (production Federal Register on May 3, 2023 (88 FR
Growers Association, U.S. Beet Sugar
reporting requirements); 7 U.S.C. 136f 27882) (FRL–10923–01–OCSPP). The
Association, and the Beet Sugar
Development Foundation. A second (recordkeeping requirements). 30-day public comment period closed
comment was submitted anonymously Moreover, retention of these on June 2, 2023.
by a private citizen generally supporting registrations will not make chlorpyrifos VI. Provisions for Disposition of
the cancellation of the pesticide. products available for use on sugarbeets Existing Stocks
The comment from the American as the commenters desire. As noted in
Sugarbeet Growers Association, U.S. Unit III.A. above, all tolerances for Existing stocks are those stocks of
Beet Sugar Association, and the Beet residues of chlorpyrifos have been registered pesticide products that are
Sugar Development Foundation revoked. The revocation of the currently in the United States and that
opposed the voluntary cancellation of tolerances means that application of were packaged, labeled, and released for
the products in the Notice of Receipt. In shipment prior to the effective date of
chlorpyrifos to food or feed crops,
particular, these commenters specified the cancellation action.
including sugarbeets, will result in
concerns that the voluntary cancellation Because all chlorpyrifos tolerances
adulterated food and/or feed which
of chlorpyrifos registrations and expired on February 28, 2022, use of
cannot be shipped in interstate chlorpyrifos in or on food will result in
termination of certain uses is premature commerce. While cancellation of the
while there is ongoing litigation adulterated food, which cannot be
eight products in Table 1 and delivered into interstate commerce.
regarding the Final Rule and Denial
amendment of four products in Table 2 Such use would be inconsistent with
Order in the U.S. Court of Appeals for
does not terminate the last of the the provisions of FIFRA. EPA is
the Eighth Circuit, Red River Valley
chlorpyrifos products registered in the allowing existing stocks of chlorpyrifos
Sugarbeet Growers Ass’n et al., v.
Regan, et al., Nos. 22–1422, 22–1530 United States, these products (and other products identified in Tables 1 and 2
(8th Cir.). These commenters also remaining chlorpyrifos products) cannot that are already in the hands of end-
specified concerns that the loss of be applied to food crops. users to be used only for non-food uses
chlorpyrifos as a pest management tool IV. The Cancellation Order identified on the existing labels, until
will result in substantial increased those existing stocks are exhausted, as
costs, lost profits, decreased crop yields, Pursuant to FIFRA section 6(f) (7 long as such use is consistent with the
and a larger environmental impact from U.S.C. 136d(f)(1)), EPA hereby approves label. All other use of existing stocks of
more frequent use of less effective the requested cancellations and these chlorpyrifos products are
alternatives. amendments to terminate uses of the prohibited.
registrations identified in Table 1 and Because sale and distribution of
C. EPA Response to Comments chlorpyrifos products bearing labeling
Table 2 of Unit II. Accordingly, the
Regarding the comments submitted by Agency hereby orders that the product for use on food is inconsistent with the
the American Sugarbeet Growers registrations identified in Table 1 of purposes of FIFRA, all sale and
Association, U.S. Beet Sugar Unit II are cancelled and the uses distribution of the chlorpyrifos products
Association, and the Beet Sugar identified on the products listed in identified in Table 1 and Table 2 of Unit
Development Foundation, the Table 2 of Unit II are terminated. II. is prohibited with the following
cancellations and amendments exceptions:
requested by the registrants listed in The cancellations and amendments 1. Existing stocks of all products
Table 3 are appropriate at this time addressed in this Order are effective listed in Tables 1 and 2 may be sold or
because section 6(f)(1) of FIFRA allows November 6, 2023. Any distribution, distributed for export consistent with
registrants to submit, at any time, a sale, or use of existing stocks of the FIFRA section 17 (7 U.S.C. 136o) and
request that EPA cancel their products identified in Tables 1 and 2 of for proper disposal.
registrations or amend their registrations Unit II in a manner inconsistent with 2. Since the issuance of the May 3,
to terminate one or more uses. 7 U.S.C. any of the provisions for disposition of 2023, Notice, EPA has realized that
136d(f)(1)(A). A registrant may have a existing stocks set forth in Unit V will some of the products listed in Table 1
variety of reasons for requesting be a violation of FIFRA. do not bear any labeling for use on food.
Accordingly, existing stocks of those EPA notified CSI of the approval of (800) 242–5562 or email: csi-customer-
products, which are listed below, may their return program agreement on service@controlsolutionsinc.com.
be sold or distributed for one year after October 12, 2023. Dated: October 26, 2023.
the date of this cancellation order: This cancellation order also amends Mary Elissa Reaves,
• Nufarm Chlorpyrifos SPC 2.32% G the cancellation order published in the
Insecticide (EPA Reg. No. 228–620). Director, Pesticide Re-Evaluation Division,
Federal Register on May 4, 2023 (88 FR Office of Pesticide Programs.
• Nufarm Chlorpyrifos SPC 1.0% 28541) (FRL–10924–01–OCSPP) by
MCB Insecticide (EPA Reg. No. 228– [FR Doc. 2023–24462 Filed 11–3–23; 8:45 am]
clarifying that any products with the
621). EPA Reg. No. 66222–19 and bearing the
• Nufarm Chlorpyrifos SPC 4 alternate brand name of Quali-Pro
Insecticide (EPA Reg. No. 228–624). Chlorpyrifos 4E may be distributed to
• Nufarm Chlorpyrifos SPC 2
CSI pursuant to the CSI return program FEDERAL DEPOSIT INSURANCE
Insecticide (EPA Reg. No. 228–625).
3. Existing stocks of the following agreement referenced above. Products CORPORATION
products may be distributed consistent with the EPA Reg. No. 66222–19 and
with the Control Solutions, Inc. (‘‘CSI’’) bearing the primary brand name of Notice of Termination of Receiverships
return program agreement that EPA Chlorpyrifos 4E AG may continue to be
approved on October 12, 2023. returned to Adama as per the return The Federal Deposit Insurance
• CSI 16–150 Chlorpyrifos 42 (EPA program agreement approved by EPA on Corporation (FDIC or Receiver), as
Reg. No. 53883–394). April 19, 2023, under the terms of the Receiver for each of the following
• CSI 16–149 Chlorpyrifos 20 (EPA May 4 cancellation order. insured depository institutions, was
Reg. No. 53883–407). Additional information regarding the charged with the duty of winding up the
• Quali-Pro Chlorpyrifos 4E (EPA chlorpyrifos return program for Control affairs of the former institutions and
Reg. No. 66222–19). Quali-Pro Solutions, Inc. may be found in https:// liquidating all related assets. The
Chlorpyrifos 4E is an alternate brand www.regulations.gov/docket/EPA-HQ- Receiver has fulfilled its obligations and
name for Chlorpyrifos 4E AG (EPA Reg. OPP-2022-0223 or by contacting the made all dividend distributions
No. 66222–19). registrant at: Control Solutions, Inc. required by law.
NOTICE OF TERMINATION OF RECEIVERSHIPS

Termination
Fund Receivership name City State date
10047 .......... FirstCity Bank .................................................................................................... Stockbridge ...... GA 11/01/2023

10055 .......... First Bank of Idaho, FSB ................................................................................... Ketchum ........... ID 11/01/2023
10058 .......... Citizens Community Bank ................................................................................. Ridgewood ....... NJ 11/01/2023
10064 .......... Bank of Lincolnwood ......................................................................................... Lincolnwood ..... IL 11/01/2023
10100 .......... Community Bank of Nevada ............................................................................. Las Vegas ........ NV 11/01/2023
10217 .......... Tamalpais Bank ................................................................................................. San Rafael ....... CA 11/01/2023
10224 .......... Wheatland Bank ................................................................................................ Naperville .......... IL 11/01/2023
10333 .......... First Community Bank ....................................................................................... Taos ................. NM 11/01/2023
10363 .......... The Park Avenue Bank ..................................................................................... Valdosta ........... GA 11/01/2023
10396 .......... Bank of The Commonwealth ............................................................................. Norfolk .............. VA 11/01/2023
10434 .......... Bank of The Eastern Shore .............................................................................. Cambridge ........ MD 11/01/2023
The Receiver has further irrevocably GENERAL SERVICES time (EST). The agenda for the meeting
authorized and appointed FDIC- ADMINISTRATION will be made available prior to the
Corporate as its attorney-in-fact to meeting online at https://gsa.gov/fscac.
[Notice–Q–2023–05; Docket No. 2023–0002;
execute and file any and all documents Sequence No. 438] ADDRESSES: The meetings will be
that may be required to be executed by accessible via webcast. Registrants will
the Receiver which FDIC-Corporate, in Federal Secure Cloud Advisory receive the webcast information before
its sole discretion, deems necessary, Committee Notification of Upcoming the meeting.
including but not limited to releases, Meeting FOR FURTHER INFORMATION CONTACT:
discharges, satisfactions, endorsements, Michelle White, Designated Federal
assignments, and deeds. Effective on the AGENCY: Federal Acquisition Service
(Q), General Services Administration Officer (DFO), FSCAC, GSA, 703–489–
termination dates listed above, the 4160, fscac@gsa.gov. Additional
Receiverships have been terminated, the (GSA).
ACTION: Meeting notice.
information about the Committee,
Receiver has been discharged, and the including meeting materials and
Receiverships have ceased to exist as SUMMARY: As stipulated by the Federal agendas, will be available online at
legal entities. Advisory Committee Act (FACA), GSA https://gsa.gov/fscac.
(Authority: 12 U.S.C. 1819.) is hereby giving notice of an open SUPPLEMENTARY INFORMATION:
Federal Deposit Insurance Corporation. public meeting of the Federal Secure

Cloud Advisory Committee (FSCAC). Background
Dated at Washington, DC, on November 1,
Information on attending and providing GSA, in compliance with the
2023.
public comment is under the FedRAMP Authorization Act of 2022,
James P. Sheesley, SUPPLEMENTARY INFORMATION section. established the FSCAC, a statutory
Assistant Executive Secretary. DATES: The open public meeting will be advisory committee in accordance with
[FR Doc. 2023–24453 Filed 11–3–23; 8:45 am] held on Thursday, November 16, 2023, the provisions of FACA (5 U.S.C. 10).
BILLING CODE 6714–01–P from 1 p.m. to 3 p.m., eastern standard The Federal Risk and Authorization
Management Program (FedRAMP) Authorization Management Program approve an extension of a previously

within GSA is responsible for providing (FedRAMP).’’ The Committee will then approved information collection
a standardized, reusable approach to finalize and vote on their deliverable to regarding Federal Supply Schedule
security assessment and authorization the GSA Administrator regarding their contract administration information.
for cloud computing products and recommendations on the OMB memo. DATES: Submit comments on or before:
services that process unclassified The meeting agenda and draft OMB January 5, 2024.
information used by agencies. memo will be posted on https://gsa.gov/ ADDRESSES: Submit comments
Due to circumstances beyond the fscac prior to the November 16, 2023 identified by Information Collection
control of the DFO, the Federal Register meeting. 3090–0250, Federal Supply Schedule
notice for this meeting is being (FSS) Contract Administration
Meeting Attendance
published fewer than 15 calendar days Information via http://
prior to the meeting due to unforeseen This virtual meeting is open to the
www.regulations.gov. Submit comments
administrative difficulties. public. Meeting registration and
via the Federal eRulemaking portal by
The FSCAC will provide advice and information is available at https://
gsa.gov/fscac. Registration for attending searching the OMB control number
recommendations to the Administrator 3090–0250. Select the link ‘‘Comment
of GSA, the FedRAMP Board, and the virtual meeting is highly encouraged
by 5 p.m. EST, on Monday, November Now’’ that corresponds with
agencies on technical, financial, ‘‘Information Collection 3090–0250, FSS
programmatic, and operational matters 13, 2023. After registration, individuals
will receive instructions on how to Contract Administration Information’’.
regarding the secure adoption of cloud Follow the instructions provided on the
computing products and services. The attend the meeting via email.
For information on services for screen. Please include your name,
FSCAC will ensure effective and company name (if any), and
ongoing coordination of agency individuals with disabilities, or to
request accommodation for a disability, ‘‘Information Collection 3090–0250, FSS
adoption, use, authorization, Contract Administration Information’’
monitoring, acquisition, and security of please email the FSCAC staff at
FSCAC@gsa.gov at least 10 days prior to on your attached document.
cloud computing products and services Instructions: Please submit comments
to enable agency mission and the meeting date. Live captioning may
be provided virtually. only and cite Information Collection
administrative priorities. The purposes 3090–0250, FSS Contract
of the Committee are: Public Comment Administration Information, in all
• To examine the operations of correspondence related to this
FedRAMP and determine ways that Members of the public will have the
opportunity to provide oral public collection. Comments received generally
authorization processes can will be posted without change to
continuously be improved, including comment during the FSCAC meeting by
indicating their preference when regulations.gov, including any personal
the following: and/or business confidential
Æ Measures to increase agency reuse registering. Written public comments
can be submitted at any time by information provided. To confirm
of FedRAMP authorizations. receipt of your comment(s), please
Æ Proposed actions that can be completing the public comment form on
our website, https://gsa.gov/fscac. All check regulations.gov, approximately
adopted to reduce the burden,
written public comments will be two-to-three days after submission to
confusion, and cost associated with
provided to FSCAC members in advance verify posting.
FedRAMP authorizations for cloud
of the meeting if received by FOR FURTHER INFORMATION CONTACT: Ms.
service providers.
Æ Measures to increase the number of Wednesday, November 8, 2023. Vernita Misidor, Procurement Analyst,
FedRAMP authorizations for cloud at GSARpolicy@gsa.gov or 202–357–
Elizabeth Blake,
computing products and services 9681.
Senior Advisor, Federal Acquisition Service,
offered by small businesses concerns (as General Services Administration. SUPPLEMENTARY INFORMATION:
defined by section 3(a) of the Small [FR Doc. 2023–24431 Filed 11–3–23; 8:45 am] A. Purpose
Business Act (15 U.S.C. 632(a)). BILLING CODE 6820–34–P
Æ Proposed actions that can be GSA requires information from
adopted to reduce the burden and cost Federal Supply Schedule contractors
of FedRAMP authorizations for GENERAL SERVICES that will be used to conduct award
agencies. ADMINISTRATION oversight or generate mandatory reports
• Collect information and feedback during contract administration. For
on agency compliance with, and [OMB Control No. 3090–0250; Docket No. these contractors, providing commercial
implementation of, FedRAMP 2023–0001; Sequence No. 6] supplies and services, much of this
requirements. information is readily available to the
Information Collection; General
• Serve as a forum that facilitates public at large, or is routinely
Services Administration Acquisition
communication and collaboration exchanged by firms during the normal
Regulation; Federal Supply Schedule
among the FedRAMP stakeholder course of business. This general
Contract Administration Information
community. information collection covers these
The FSCAC will meet no fewer than AGENCY: Office of Acquisition Policy, contract administration requirements, as
three (3) times a calendar year. Meetings General Services Administration (GSA). outlined in GSAR Subpart 538.2—
shall occur as frequently as needed, ACTION: Notice of request for comments Establishing and Administering Federal
called, and approved by the DFO. regarding an extension to an existing Supply Schedules.
Purpose of the Meeting and Agenda OMB information collection. B. Annual Reporting Burden
The November 16, 2023 public SUMMARY: Under the provisions of the This information collection requires
meeting will be dedicated to the Paperwork Reduction Act, the no expenditure of resources to gather
Committee members’ feedback and Regulatory Secretariat Division will be the information for submission, as the
discussion on OMB’s draft memo titled submitting to the Office of Management information is often exchanged by
‘‘Modernizing the Federal Risk and Budget a request to review and commercial business firms in their
catalogs or other public documents ADDRESSES: The meeting will be include your name, organization name
during the normal course of business. accessible via webcast. Registrants will (if applicable).
The nominal amount of burden imposed receive the webcast information before
Jeffrey A. Koses,
on the public is simply to relay the the meeting.
requested information. Senior Procurement Executive, Office of
FOR FURTHER INFORMATION CONTACT: Acquisition Policy, Office of Government-
Respondents: 14,000. Boris Arratia, Designated Federal wide Policy.
Responses per Respondent: 1. Officer, OGP, 703–795–0816, or email: [FR Doc. 2023–24432 Filed 11–3–23; 8:45 am]
Total Annual Responses: 14,000. boris.arratia@gsa.gov; or Stephanie BILLING CODE 6820–RV–P
Hours per Response: 0.03 (2 minutes). Hardison, OGP, 202–258–6823, or
Total Burden Hours: 420. email: stephanie.hardison@gsa.gov.
C. Public Comments Additional information about the DEPARTMENT OF HEALTH AND
Committee, including meeting materials HUMAN SERVICES
Public comments are particularly
and agendas, are available on-line at
invited on: Whether this collection of
https://gsa.gov/policy-regulations/ Food and Drug Administration
information is necessary and whether it
policy/acquisition-policy/gsa-
will have practical utility; whether our [Docket No. FDA–2023–P–2536]
acquisition-policy-federal-advisory-
estimate of the public burden of this
committee. Determination That FORADIL
collection of information is accurate and
based on valid assumptions and SUPPLEMENTARY INFORMATION: (Formoterol Fumarate) Inhalation
methodology; and ways to enhance the Powder, 0.012 Milligrams, Was Not
quality, utility, and clarity of the Purpose of the Meeting Withdrawn From Sale for Reasons of
information to be collected. The purpose of this meeting is for Safety or Effectiveness
Obtaining Copies of Proposals: each of the three subcommittees (Policy AGENCY: Food and Drug Administration,
Requesters may obtain a copy of the and Practice, Industry Partnerships, and HHS.
information collection documents from Acquisition Workforce) to present
the Regulatory Secretariat Division, at ACTION: Notice.
recommendations to the full Committee.
GSARegSec@gsa.gov. The Committee will, in turn, deliberate SUMMARY: The Food and Drug
Please cite OMB Control No. 3090– and vote on GAP FAC recommendations Administration (FDA, the Agency, or
0250, FSS Contract Administration to be delivered to the GSA we) has determined that FORADIL
Information, in all correspondence. Administrator. (formoterol fumarate) inhalation
Jeffrey A. Koses, Meeting Agenda powder, 0.012 milligrams (mg)/
Senior Procurement Executive, Office of inhalation (inh), was not withdrawn
Acquisition Policy, Office of Government- • Opening Remarks from sale for reasons of safety or
wide Policy. • Guest Speaker effectiveness. This determination will
[FR Doc. 2023–24433 Filed 11–3–23; 8:45 am] • Acquisition Workforce Subcommittee allow FDA to approve abbreviated new
BILLING CODE 6820–14–P Recommendations and Discussion drug applications (ANDAs) for
• Vote on recommendations formoterol fumarate inhalation powder,
• Industry Partnerships Subcommittee 0.012 mg/inh, if all other legal and
GENERAL SERVICES Recommendations and Discussion regulatory requirements are met.
ADMINISTRATION FOR FURTHER INFORMATION CONTACT: Joe
• Vote on recommendations
Thomas, Center for Drug Evaluation and
[Notice-MRB–2023–06; Docket No. 2023– • Policy and Practices Subcommittee Research, Food and Drug
0002; Sequence No. 37] Recommendations and Discussion Administration, 10903 New Hampshire
• Vote on recommendations Ave., Bldg. 51, Rm. 6217, Silver Spring,
GSA Acquisition Policy Federal
Advisory Committee; Notification of • Closing Remarks and Adjourn MD 20993–0002, 202–815–5571,
Upcoming Web-Based Public Meeting Meeting Registration joseph.thomas1@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
AGENCY: Office of Government-wide This meeting is open to the public 505(j) of the Federal Food, Drug, and
Policy (OGP), General Services and will be accessible by webcast. Cosmetic Act (FD&C Act) (21 U.S.C.
Administration (GSA). Registration information is located on 355(j)) allows the submission of an
ACTION: Meeting notice. the GAP FAC website: https:// ANDA to market a generic version of a
www.gsa.gov/policy-regulations/policy/ previously approved drug product. To
SUMMARY: GSA is providing notice of a acquisition-policy/gsa-acquisition- obtain approval, the ANDA applicant
meeting of the GSA Acquisition Policy policy-federal-advisory-committee. must show, among other things, that the
Federal Advisory Committee Public attendees who want to attend generic drug product: (1) has the same
(hereinafter ‘‘the Committee’’ or ‘‘the virtually will need to register no later active ingredient(s), dosage form, route
GAP FAC’’) in accordance with the than 5 p.m. EST, on Monday, December of administration, strength, conditions
requirements of the Federal Advisory 4, 2023 to obtain the meeting webcast of use, and (with certain exceptions)
Committee Act (FACA). This meeting information. All registrants will be labeling as the listed drug, which is a
will be open to the public, accessible via asked to provide their name, affiliation, version of the drug that was previously
webcast. Information on attending and and email address. After registration, approved; and (2) is bioequivalent to the
providing written public comment is individuals will receive webcast access listed drug. ANDA applicants do not
under the SUPPLEMENTARY INFORMATION information details via email. have to repeat the extensive clinical
section. Public Comments: testing otherwise necessary to gain
DATES: The GAP FAC will hold an open Written public comments are being approval of a new drug application
public meeting on Tuesday, December accepted via email at gapfac@gsa.gov. (NDA).
5, 2023, from 1 p.m. to 4:30 p.m. eastern To submit a written public comment, Section 505(j)(7) of the FD&C Act
standard time (EST). please email at gapfac.gsa.gov and requires FDA to publish a list of all
approved drugs. FDA publishes this list has identified no data or other FOR FURTHER INFORMATION CONTACT: CDR
as part of the ‘‘Approved Drug Products information suggesting that FORADIL Leo Angelo Gumapas, Environmental
With Therapeutic Equivalence (formoterol fumarate) inhalation Engineering Program Chief, at 202–669–
Evaluations,’’ which is known generally powder, 0.012 mg/inh, was withdrawn 6942 or by email at leoangelo.gumapas@
as the ‘‘Orange Book.’’ Under FDA for reasons of safety or effectiveness. We psc.hhs.gov, for clarification of content.
regulations, drugs are removed from the have carefully reviewed our files for SUPPLEMENTARY INFORMATION:
list if the Agency withdraws or records concerning the withdrawal of
suspends approval of the drug’s NDA or FORADIL (formoterol fumarate) Background
ANDA for reasons of safety or inhalation powder, 0.012 mg/inh, from E.O. 13690 of January 30, 2015—
effectiveness or if FDA determines that sale. We have also independently Establishing a Federal Flood Risk
the listed drug was withdrawn from sale evaluated relevant literature and data Management Standard and a Process for
for reasons of safety or effectiveness (21 for possible postmarketing adverse Further Soliciting and Considering
CFR 314.162). events. We have reviewed the available Stakeholder Input—was issued to
A person may petition the Agency to evidence and determined that this drug improve the nation’s resilience to
determine, or the Agency may product was not withdrawn from sale flooding and to better prepare for the
determine on its own initiative, whether for reasons of safety or effectiveness. impacts of climate change. In amending
a listed drug was withdrawn from sale Accordingly, the Agency will
and building upon E.O. 11988—
for reasons of safety or effectiveness. continue to list FORADIL (formoterol
Floodplain Management—which was
This determination may be made at any fumarate) inhalation powder, 0.012 mg/
issued in 1977, E.O. 13690 and the
time after the drug has been withdrawn inh, in the ‘‘Discontinued Drug Product
associated FFRMS reinforce the
from sale, but must be made prior to List’’ section of the Orange Book. The
important tenets and concepts
approving an ANDA that refers to the ‘‘Discontinued Drug Product List’’
articulated in E.O. 11988, such as
listed drug (§ 314.161 (21 CFR 314.161)). delineates, among other items, drug
avoiding actions in or impacting a
FDA may not approve an ANDA that products that have been discontinued
floodplain and minimizing potential
does not refer to a listed drug. from marketing for reasons other than
FORADIL (formoterol fumarate) harm if an action must be located in a
safety or effectiveness. FDA will not
inhalation powder, 0.012 mg/inh, is the begin procedures to withdraw approval floodplain. When avoiding a floodplain
subject of NDA 020831, held by of approved ANDAs that refer to this is not possible, E.O. 13690 calls for
Novartis Pharmaceuticals Corp., and drug product. Additional ANDAs for agencies to improve the resilience of
initially approved on February 16, 2001. this drug product may also be approved communities and federal actions.
FORADIL is indicated for treatment of by the Agency as long as they meet all On August 15, 2017, E.O. 13807 was
asthma in patients 5 years of age and other legal and regulatory requirements issued, which revoked E.O. 13690.
older as an add-on to a long-term for the approval of ANDAs. If FDA Accordingly, the ‘‘Revised Guidelines
asthma control medication such as an determines that labeling for this drug for Implementing Executive Order
inhaled corticosteroid; prevention of product should be revised to meet 11988, Floodplain Management’’ and its
exercise-induced bronchospasm (EIB) in current standards, the Agency will supplementary policy were withdrawn.
patients 5 years of age and older; and advise ANDA applicants to submit such On May 20, 2021, E.O. 14030, reinstated
maintenance treatment of labeling. E.O. 13690 and all supplementary
bronchoconstriction in patients with policies.
Dated: November 1, 2023.
chronic obstructive pulmonary disease. HHS’s current floodplain management
Lauren K. Roth, procedures are published in the General
In a letter dated September 30, 2015,
Novartis Pharmaceuticals Corp. notified Associate Commissioner for Policy. Administration Manual Part 30:
FDA that FORADIL (formoterol [FR Doc. 2023–24506 Filed 11–3–23; 8:45 am] Environmental Protection (GAM–30)
fumarate) inhalation powder, 0.012 mg/ BILLING CODE 4164–01–P section 30–40–40 Floodplain
inh, was being discontinued, and FDA Management, and they are based on E.O.
moved the drug product to the 11988. The GAM–30 was last updated
‘‘Discontinued Drug Product List’’ DEPARTMENT OF HEALTH AND on February 25, 2000, and it is based on
section of the Orange Book. In the HUMAN SERVICES outdated laws and regulations. Program
Federal Register of June 21, 2018 (83 FR Support Center (PSC) √ Real Estate,
Revision of HHS National
28856), FDA announced that it was Logistics, Operations (RLO) √ Real
Environmental Policy Act Compliance
withdrawing approval of NDA 020831, Property Management Service (RPMS) √
Procedures To Incorporate Federal
effective July 23, 2018. Real Property Policy and Strategy
Flood Risk Management Standard
K&L Gates LLP submitted a citizen (RPPS) drafted HHS FFRMS procedures
Procedures
petition dated June 21, 2023 (Docket No. based on E.O. 13690 to update GAM–30
FDA–2023–P–2536), under 21 CFR AGENCY: Assistant Secretary for Section 30–40–40 Floodplain
10.30, requesting that the Agency Administration, U.S. Department of Management.
determine whether FORADIL Health and Human Services (HHS). The Council on Environmental
(formoterol fumarate) inhalation ACTION: Notice; request for comments. Quality (CEQ) reviewed HHS’s FFRMS
powder, 0.012 mg/inh, was withdrawn procedures and provided favorable
from sale for reasons of safety or SUMMARY: HHS is proposing a revision comments on December 2022.
effectiveness. to its floodplain management
After considering the citizen petition procedures to include climate science if Procedure Revisions
and reviewing Agency records and an action takes place in a floodplain. Revised General Administration
based on the information we have at this DATES: Interested parties should submit Manual, HHS Part 30, Environmental
time, FDA has determined under written comments to FOR FURTHER Protection
§ 314.161 that FORADIL (formoterol INFORMATION CONTACT section shown
Part 30—Environmental Protection
fumarate) inhalation powder, 0.012 mg/ below on or before December 6, 2023 to
inh, was not withdrawn for reasons of be considered in the formation of the 30–40 Natural Asset Review
safety or effectiveness. The petitioner final procedures. 30–40–40 Floodplain Management
Purpose: Executive Order (E.O.) 13690 additional 3 feet to the BFE and (EA) or environmental impact statement
on Establishing a Federal Flood Risk expanding to the corresponding (EIS) is required to be prepared for the
Management Standard (FFRMS) and a horizontal extent for critical actions. proposed action, a floodplain
Process for Further Soliciting and Horizontal Extent. ‘‘Horizontal assessment as described Paragraph E of
Considering Stakeholder Input (2015), Extent’’ means the horizontal land area this section, shall be included in the EA
establishes a Federal Flood Risk flooded by the vertical extent (extra or EIS.
Management Standard to ensure each flood elevation beyond the BFE).
Federal agency takes actions to enhance Floodplain Assessment (E.O. 13690)
Nature-Based Approach. HHS
the Nation’s resilience to current and OPDIVs/STAFFDIVs, where possible, Determine if Proposed Action is in a
future flooding and better prepare the must use natural systems, ecosystem FFRMS floodplain: First, determine if
United States for the impacts of climate processes, and natural features and Federally Funded Project is a critical
change, such as sea level rise and nature-based approaches in action, which impacts floodplain
extreme weather events. E.O. 13690 and development of alternatives for determinations for the FVA approach.
the associated FFRMS amended and proposed action. Second, evaluate the vertical extent and
built upon E.O. 11988 on Floodplain Vertical Extent. ‘‘Vertical Extent’’ corresponding horizontal extent to
Management (1977), which requires means the additional flood height above establish the FFRMS floodplain using
agencies to take action to reduce the risk the BFE. one of the three approaches in the
of flood loss, to minimize the impacts of 0.2-Percent-Annual-Chance (500-year) following is the order of preference
floods on human safety, health, and Flood Approach (0.2PFA). ‘‘0.2PFA’’ pending data availability:
welfare, and to restore and preserve the means the area subject to flooding by CISA
natural and beneficial values served by the 0.2-percent annual chance flood. 0.2PFA
floodplains. E.O. 13690 modernizes E.O. Responsibilities: Each OPDIV/ FVA
11988 by increasing the vertical flood STAFFDIV has the responsibility under Involve Public in Decision-making
elevation and expanding corresponding E.O. 13690 to act on Federally Funded Process: Notify the public such as a
horizontal extent of the floodplain to Projects to reduce the risk of flood loss, notice in a local newspaper or posting
consider changing flood hazards due to to minimize the impact of floods on in an accessible public space for the
climate change and other processes, and human safety, health, and welfare, and area where the action is under
by encouraging climate-conscious to restore and preserve the natural and consideration. Public notifications and
resilient design if there are no beneficial values served by floodplains all supporting communications and
practicable locations outside the in carrying out its responsibilities for: activities should be accessible to all
expanded floodplain. Acquiring, managing, and disposing of (e.g., plain language, culturally
Definitions Federal lands and facilities responsive, and accommodating),
Providing Federally undertaken, including but not limited to those with
Base Flood. ‘‘Base Flood’’ means that
financed, or assisted construction, disabilities or limited English
flood which has a one percent of greater
substantial improvements, and proficiency. All public notifications are
chance of occurrence in any given year.
Base Flood Elevation (BFE). ‘‘BFE’’ substantial damages to structures and required to follow all guidance and
means the computed elevation to which facilities regulation regarding 508 compliance,
the floodwater is anticipated to rise Conducting Federal activities and the use of plain language, and limited
during the base flood. programs affected land use, including English proficiency. If completing an EA
Base Floodplain. ‘‘Floodplain’’ means but not limited to, water and related or EIS, then include floodplain notice in
the area subject to flooding by the base land resources planning, regulating, Description of Proposed Action and
flood, the flood that has a one percent and licensing activities. Alternatives or Notice of Intent,
or greater chance of flooding in any Each OPDIV/STAFFDIV shall respectively.
given year. determine whether the site in which Identify and Evaluate Practicable
Climate-Informed Science Approach their action would occur could Alternatives to Locating in FFRMS
(CISA). ‘‘CISA’’ means the flood hazard potentially be inundated by floodwaters Floodplain: OPDIVs/STAFFDIVs shall
area (vertical flood elevation and using FFRMS and shall use this use input from public comments on
corresponding horizontal extent) that information to make an informed practicable alternatives, including, if
results from using the best-available, decision to either avoid siting in the possible, nature-based solutions.
actionable hydrologic and hydraulic determined flood hazard area or design Identify Adverse and Beneficial
data and methods that integrate current the action to be more resilient to the Impacts: Identify adverse and beneficial
and future changes in flooding based on associated flood hazard. Each OPDIV/ impacts, including stimulating
climate science. STAFFDIV shall evaluate the potential floodplain development, which may
Critical Action. ‘‘Critical Action’’ effects of any actions it may take in a result from the project. Analyze the
means any activity for which even a FFRMS floodplain in accordance with following factors: (1) Natural
slight chance of flooding is too great, the floodplain assessment procedures in environment (water resources,
e.g., elderly housing proposals. this section. It must also ensure that its hydrology, topography, habitat); (2)
Federal Flood Risk Management planning programs and budget requests Social concerns (environmental justice,
Standard (FFRMS). ‘‘FFRMS’’ means the reflect consideration of flood hazards visual quality/aesthetics, historic and
floodplain determined using one of the and floodplain management. cultural values, land use patterns), (3)
three approaches: CISA, 0.2PFA, and Integration with NEPA. OPDIVs/ Economic Aspects (costs of
FVA. STAFFDIVs are to evaluate the potential construction, transportation, relocation,
Freeboard Value Approach (FVA). effects of a proposed action in a natural features, and ecosystem
‘‘FVA’’ means the flood hazard area that floodplain in accordance with the processes), and (4) Legal considerations
results from adding an additional 2 feet procedures for National Environmental (deeds, leases).
to the BFE and expanding to the Policy Act (NEPA) review in HHS Mitigate Adverse Impacts: Minimize
corresponding horizontal extent for non- General Administration Manual Part impacts identified and restore and
critical actions, and by adding an 30–50. If an environmental assessment preserve the beneficial values served by
floodplains. The analysis shall discuss resources use appropriate risk Health Sciences ESBSC December 3–5, 2023
the following: Alternatives to the management measures to mitigate the Meeting.
proposed action that may avoid adverse degree of hazard involved. Adequate Date: December 3–5, 2023.
effects and incompatible development provision shall be made for the Closed: December 03, 2023, 7:00 p.m. to
in the floodplain, including the evaluation and consideration of flood 8:00 p.m.
hazards determined by FFRMS for the Agenda: Discussion of BSC Reviews.
alternatives of no action or location at
Place: National Institute Environmental
an alternate site. Proposed buildings licenses, permits, loan, or grant-in-aid Health Sciences (NIEHS), Rodbell
and structures located in FFRMS programs that an OPDIV/STAFFDIV Auditorium, 111 TW Alexander Drive,
floodplain shall be programmed and administers. OPDIVs/STAFFDIVs shall Research Triangle Park, NC 27709 (Hybrid
designed to latest version of the also encourage and provide appropriate Meeting).
American Society of Civil Engineers guidance to applicants to evaluate the Open: December 04, 2023, 8:30 a.m. to
‘‘Flood Resistant Design and effects of their proposal in FFRMS 10:00 a.m.
Construction’’ (ASCE/SEI 24–14) floodplains prior to submitting Agenda: Meeting Overview and Q & A
provisions to mitigate the adverse applications for Federal licenses, Session.
effects of the proposed action. permits, loans, or grants. Place: National Institute Environmental
Senior Real Property Official Authorization or Appropriation Health Sciences (NIEHS), Rodbell
Approval: No action shall take place Requests: OPDIVs/STAFFDIVs shall Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
involving HHS Federal Real Property in indicate in any requests for new Meeting).
an FFRMS floodplain without a finding authorizations or appropriations
Open: December 04, 2023, 10:15 a.m. to
by the Senior Real Property Officer that whether the proposed action is in
11:55 a.m.
the only practicable alternative accord with Executive Order 13690 if Agenda: Q & A Session.
consistent with the law and with the the proposed action will be in a Place: National Institute Environmental
policy set forth in E.O. 13690 requires floodplain. Health Sciences (NIEHS), Rodbell
siting in a FFRMS floodplain. The Guidance: The following resources Auditorium 111 TW Alexander, Drive
action involving HHS Federal Real provides guidance for Implementation Research Triangle Park, NC 27709 (Hybrid
Property proposed for Senior Real of FFRMS. FFRMS Floodplain Meeting).
Property Official approval shall be Determination Job Aid. Closed: December 04, 2023, 11:55 a.m. to
designed to minimize potential harm to Reducing Flood Losses through the 12:40 p.m.
or within the FFRMS floodplain. The International Codes: Coordinating Agenda: 1:1 Sessions with Investigators.
Senior Real Property Official shall Building Codes and Floodplain Place: National Institute Environmental
approve proposed actions requiring an Management Regulations, 5th Edition, Health Sciences (NIEHS), Rodbell
September 2019 Auditorium, 111 TW Alexander Drive,
EA or EIS on projects involving HHS
Protecting Building Utility Systems Research Triangle Park, NC 27709 (Hybrid
Federal Real Property affecting FFRMS Meeting).
floodplains. from Flood Damage: Principles and
Practices for the Design and Closed: December 04, 2023, 12:40 p.m. to
Re-Evaluate Alternatives: Use any
1:30 p.m.
new information obtained from Public Construction of Flood Resistant Agenda: Working Lunch.
Notice to determine if the proposed Building Utility Systems, Federal Place: National Institute Environmental
project is still applicable. Reissue public Emergency Management Agency Health Sciences (NIEHS), Rodbell
notice with Finding of No Significant (FEMA) P–348, Edition 2, February 2017 Auditorium, 111 TW Alexander Drive,
Impact or Record of Decision if EA or Research Triangle Park, NC 27709 (Hybrid
Cheryl R. Campbell,
EIS is drafted, respectively. Meeting).
Announce and Explain Decision to Assistant Secretary for Administration.
Open: December 04, 2023, 1:35 p.m. to 2:25
the Public (Notice): Notify the public of [FR Doc. 2023–24348 Filed 11–3–23; 8:45 am] p.m.
the draft decision by publishing such as BILLING CODE 4150–24–P Agenda: Q & A Session.
a notice in a local newspaper or posting Place: National Institute Environmental
in an accessible public space, dating the Health Sciences (NIEHS), Rodbell
notice and the posting at removal. DEPARTMENT OF HEALTH AND Auditorium, 111 TW Alexander Drive,
HUMAN SERVICES Research Triangle Park, NC 27709 (Hybrid
For programs subject to E.O. 12372, Meeting).
the public notice shall be sent to the
National Institutes of Health Closed: December 04, 2023, 2:25 p.m. to
appropriate state and local reviewing 2:40 p.m.
agencies the geographic areas affected. National Institute of Environmental Agenda: 1:1 Session with Investigator.
A public review period of 30 days after Health Sciences; Amended Notice of Place: National Institute Environmental
the issuance of the public notice shall Meeting Health Sciences (NIEHS), Rodbell
be allotted before any action is taken. Auditorium, 111 TW Alexander Drive,
Implement the Proposed Federally Notice is hereby given of a change in Research Triangle Park, NC 27709 (Hybrid
Funded Project: Implement the the meeting of the Board of Scientific Meeting).
Federally Funded Project with Counselors, National Institute Open: December 04, 2023, 2:55 p.m. to 4:25
appropriate mitigation measures. Design Environmental Health Sciences, p.m.
and construction contracts shall include December 03, 2023, 07:00 p.m. to Agenda: Poster Session.
any mitigation measures are identified December 05, 2023, 04:45 p.m., NIEHS, Place: National Institute Environmental
through the process. Ensure through Rodbell Auditorium, 111 TW Alexander Health Sciences (NIEHS), Rodbell
Drive, Research Triangle Park, NC 27709 Auditorium, 111 TW Alexander Drive,

independent 3rd party construction Research Triangle Park, NC 27709 (Hybrid
quality assurance that mitigation which was published in the Federal
Meeting).
measures are fully implemented. Register on October 05, 2023, 88 FR
Open: December 04, 2023, 3:30 p.m. to 4:20
Licenses, permits, loans, or grants: 69209.
p.m.
Each OPDIV/STAFFDIV shall take Meeting is being amended to reflect
Agenda: Q & A Session.
FFRMS into account when formulating updated agenda. Place: National Institute Environmental
or evaluating any water and land use Name of Committee: Board of Scientific Health Sciences (NIEHS), Rodbell
plans and shall require land and water Counselors, National Institute Environmental Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid applicable, the business or professional ADDRESSES: Reviewing Documents:
Meeting). affiliation of the interested person. Submit requests for copies of
Closed: December 04, 2023, 4:25 p.m. to In the interest of security, NIH has applications and other information
5:10 p.m. procedures at https://www.nih.gov/ submitted with the applications to
Agenda: Meeting with Fellows, Staff about-nih/visitor-information/campus- Karen Marlowe (see FOR FURTHER
Scientists. access-security for entrance into on- INFORMATION CONTACT). All requests and
campus and off-campus facilities. All comments should specify the applicant
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive, visitor vehicles, including taxicabs, name and application number (e.g.,
Research Triangle Park, NC 27709 (Hybrid hotel, and airport shuttles will be Mary Smith, ESPER0001234).
Meeting). inspected before being allowed on Submitting Comments: If you wish to
Closed: December 05, 2023, 8:30 a.m. to campus. Visitors attending a meeting on comment, you may submit comments by
11:15 a.m. campus or at an off-campus federal one of the following methods:
Agenda: Q & A Sessions. facility will be asked to show one form • Email (preferred method):
Place: National Institute Environmental of identification (for example, a permitsR4ES@fws.gov. Please include
Health Sciences (NIEHS), Rodbell government-issued photo ID, driver’s your name and return address in your
Auditorium, 111 TW Alexander Drive, license, or passport) and to state the email message. If you do not receive a
Research Triangle Park, NC 27709 (Hybrid purpose of their visit. confirmation from the U.S. Fish and
Meeting). Wildlife Service that we have received
Closed: December 05, 2023, 11:15 a.m. to (Catalogue of Federal Domestic Assistance your email message, contact us directly
12:00 p.m. Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
at the telephone number listed in FOR
Agenda: 1:1 Session with Investigators. FURTHER INFORMATION CONTACT.
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety • U.S. mail: U.S. Fish and Wildlife
Health Sciences (NIEHS), Rodbell Service Regional Office, Ecological
Auditorium, 111 TW Alexander Drive, Training; 93.143, NIEHS Superfund
Research Triangle Park, NC 27709 (Hybrid Hazardous Substances—Basic Research and Services, 1875 Century Boulevard,
Meeting). Education; 93.894, Resources and Manpower Atlanta, GA 30345 (Attn: Karen
Development in the Environmental Health Marlowe, Permit Coordinator).
Closed: December 05, 2023, 12:00 p.m. to Sciences; 93.113, Biological Response to
1:00 p.m. FOR FURTHER INFORMATION CONTACT:
Environmental Health Hazards; 93.114, Karen Marlowe, Permit Coordinator,
Agenda: Working Lunch. Applied Toxicological Research and Testing,
Place: National Institute Environmental 404–679–7097 (telephone) or karen_
National Institutes of Health, HHS)
Health Sciences (NIEHS), Rodbell marlowe@fws.gov (email). Individuals in
Auditorium, 111 TW Alexander Drive, Dated: November 1, 2023. the United States who are deaf,
Research Triangle Park, NC 27709 (Hybrid Miguelina Perez, deafblind, hard of hearing, or have a
Meeting). Program Analyst, Office of Federal Advisory speech disability may dial 711 (TTY,
Closed: December 05, 2023, 1:00 p.m. to Committee Policy. TDD, or TeleBraille) to access
1:50 p.m. [FR Doc. 2023–24507 Filed 11–3–23; 8:45 am] telecommunications relay services.
Agenda: Meeting with Cores/Programs; Individuals outside the United States
Closed BSC Discussion and Completion of
Individual Review Assignments by each
should use the relay services offered
Member; Closed Debriefing to NIEHS/DIR within their country to make
Leadership. international calls to the point-of-
DEPARTMENT OF THE INTERIOR contact in the United States.
Health Sciences (NIEHS), Rodbell Fish and Wildlife Service SUPPLEMENTARY INFORMATION: We, the
Auditorium, 111 TW Alexander Drive, U.S. Fish and Wildlife Service, invite
Research Triangle Park, NC 27709 (Hybrid [FWS–R4–ES–2023–N085; review and comment from the public
Meeting). FXES11140400000–245–FF04E00000] and local, State, Tribal, and Federal
Closed: December 05, 2023, 1:50 p.m. to agencies on applications we have
3:30 p.m. Endangered Species; Recovery Permit received for permits to conduct certain
Agenda: BSC Discussion and Completion Applications activities with endangered and
of Individual Review Assignments by each
threatened species under section
Member. AGENCY: Fish and Wildlife Service,
Place: National Institute Environmental 10(a)(1)(A) of the Endangered Species
Interior.
Health Sciences (NIEHS), Rodbell Act of 1973, as amended (ESA; 16
ACTION: Notice of receipt of permit U.S.C. 1531 et seq.), and our regulations
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid applications; request for comments. in the Code of Federal Regulations
Meeting). (CFR) at 50 CFR part 17. Documents and
SUMMARY: We, the U.S. Fish and
Closed: December 05, 2023, 3:45 p.m. to other information submitted with the
Wildlife Service, have received
4:45 p.m. applications are available for review,
Agenda: Debriefing to NIEHS/DIR
applications for permits to conduct
subject to the requirements of the
Leadership. activities intended to enhance the
Privacy Act of 1974, as amended (5
Place: National Institute Environmental propagation or survival of endangered
U.S.C. 552a), and the Freedom of
Health Sciences (NIEHS), Rodbell species under the Endangered Species
Information Act (5 U.S.C. 552).
Auditorium, 111 TW Alexander Drive, Act. We invite the public and local,
Research Triangle Park, NC 27709 (Hybrid State, Tribal, and Federal agencies to Background
Meeting). comment on these applications. Before

Contact Person: Darryl C. Zeldin.
With some exceptions, the ESA
issuing any of the requested permits, we prohibits take of listed species unless a
Any interested person may file will take into consideration any Federal permit is issued that authorizes
written comments with the committee information that we receive during the such take. The ESA’s definition of
by forwarding the statement to the public comment period. ‘‘take’’ includes hunting, shooting,
Contact Person listed on this notice. The DATES: We must receive written data or harming, wounding, or killing, and also
statement should include the name, comments on the applications by such activities as pursuing, harassing,
address, telephone number and when December 6, 2023. trapping, capturing, or collecting.
A recovery permit issued by us under implementing section 10(a)(1)(A) for State, Tribal, and Federal agencies, and
section 10(a)(1)(A) of the ESA these permits are found at 50 CFR 17.22 the public to submit written data, views,
authorizes the permittee to take for endangered wildlife species, 50 CFR or arguments with respect to these
endangered or threatened species while 17.32 for threatened wildlife species, 50 applications. The comments and
engaging in activities that are conducted CFR 17.62 for endangered plant species, recommendations that will be most
for scientific purposes that promote and 50 CFR 17.72 for threatened plant useful and likely to influence agency
recovery of species or for enhancement species. decisions are those supported by
of propagation or survival of species. Permit Applications Available for quantitative information or studies.
These activities often include the Review and Comment Proposed activities in the following
capture and collection of species, which The ESA requires that we invite permit requests are for the recovery and
would result in prohibited take if a public comment before issuing these enhancement of propagation or survival
permit were not issued. Our regulations permits. Accordingly, we invite local, of the species in the wild.
Permit Applicant Species Location Activity Type of take Permit action

application No.
ES37492B–2 .. Anthony Grow; Mammals: Gray bat (Myotis Alabama, Arkansas, Connecticut, Presence/prob- Mammals: enter Renewal and
Memphis, TN. grisescens), Indiana bat (Myotis Delaware, District of Columbia, able absence hibernacula or amendment.
sodalis), northern long-eared Florida, Georgia, Illinois, Indi- surveys. maternity roost
bat (Myotis septentrionalis), ana, Iowa, Kansas, Kentucky, caves, capture
Ozark big-eared bat Louisiana, Maine, Maryland, with mist nets
(Corynorhinus townsendii Massachusetts, Michigan, Min- or harp traps,
ingens), and tricolored bat nesota, Mississippi, Missouri, handle, iden-
(Perimyotis subflavus); Crusta- Montana, Nebraska, New tify, band,
ceans: Nashville crayfish Hampshire, New Jersey, New radio tag, and
(Orconectes shoupi). York, North Carolina, North Da- release; Crus-
kota, Ohio, Oklahoma, Pennsyl- taceans: cap-
vania, Rhode Island, South ture, handle,
Carolina, South Dakota, Ten- identify, and
nessee, Vermont, Virginia, West release.
Virginia, Wisconsin, and Wyo-
ming.
ES68773B–1 .. Olivia Munzer; Indiana bat (Myotis sodalis), Alabama, Arkansas, Connecticut, Presence/prob- Capture with Renewal and
Raleigh, NC. northern long-eared bat (Myotis Delaware, District of Columbia, able absence mist nets or amendment.
septentrionalis), and tricolored Florida, Georgia, Illinois, Indi- surveys. harp traps,
bat (Perimyotis subflavus). ana, Iowa, Kansas, Kentucky, handle, iden-
Louisiana, Maine, Maryland, tify, band,
Massachusetts, Michigan, Min- radio tag,
nesota, Mississippi, Missouri, swab, and re-
Montana, New Hampshire, New lease.
Jersey, New York, North Caro-
lina, North Dakota, Ohio, Penn-
sylvania, Rhode Island, South
Carolina, South Dakota, Ten-
nessee, Vermont, Virginia, West
Virginia, Wisconsin, and Wyo-
ming.
ES55292B–3 .. University of Cape Sable seaside sparrow Florida ........................................... Demographic Capture, handle, Amendment.
Florida; (Ammodramus maritimus monitoring. identify, band,
Gainesville, FL. mirabilis). collect feath-
ers, deploy
data loggers in
nests, and re-
lease.
ES027344–4 ... Chattahoochee- Red-cockaded woodpecker Georgia ......................................... Population moni- Monitor nest cav- Renewal.
Oconee Na- (Picoides borealis). toring. ities and con-
tional Forests; struct and
Eatonton, GA. monitor artifi-
cial nest cav-
ities and
restrictors.
ES84861C–1 .. Power South En- Choctaw bean (Obovaria Alabama ........................................ Presence/prob- Capture, handle, Renewal.
ergy Coopera- choctawensis), fuzzy pigtoe able absence identify, re-
tive; Anda- (Pleurobema strodeanum), nar- surveys. lease, and sal-
lusia, AL. row pigtoe (Fusconaia vage relic
escambia), southern kidneyshell shells.
(Ptychobranchus jonesi), and
southern sandshell (Hamiota
australis).
Permit Applicant Species Location Activity Type of take Permit action

application No.
ES65968A–2 .. Richard Dickey; Alabama pearlshell (Margaritifera Alabama, Florida, and Georgia .... Presence/prob- Capture, handle, Renewal.
Niskayuna, NY. marrianae), Chipola slabshell able absence identify, mark,
(Elliptio chipolaensis), Choctaw surveys and tag, release,
bean (Obovaria choctawensis), population and salvage
fat threeridge (Amblema monitoring. relic shells.
neislerii), fuzzy pigtoe
(Pleurobema strodeanum), Gulf
moccasinshell (Medionidus
penicillatus), narrow pigtoe
(Fusconaia escambia),
Ochlockonee moccasinshell
(Medionidus simpsonianus),
oval pigtoe (Pleurobema
pyriforme), purple bankclimber
(Elliptoideus sloatianus), round
ebonyshell (Fusconaia rotulata),
shinyrayed pocketbook
(Hamiota subangulata), south-
ern kidneyshell
(Ptychobranchus jonesi), south-
ern sandshell (Hamiota
australis), Suwannee
moccasinshell (Medionidus
walkeri), and tapered pigtoe
(Fusconaia burkei).
ES25612A–3 .. Stephen Tricolored bat (Perimyotis Colorado, New Mexico, and Texas Presence/prob- Enter Amendment.
Samoray; subflavus). able absence hibernacula or
Nashville, TN. surveys, stud- maternity roost
ies to docu- caves, capture
ment habitat with mist nets
use, popu- or harp traps,
lation moni- handle, iden-
toring, and to tify, band,
evaluate po- radio tag, col-
tential impacts lect hair sam-
of white-nose ples, swab,
syndrome or and release.
other threats.
ES56515D–2 .. Leslie Meade; Tricolored bat (Perimyotis Colorado, District of Columbia, Presence/prob- Enter Amendment.
Richmond, KY. subflavus). Florida, New Mexico, and Texas. able absence hibernacula or
surveys, stud- maternity roost
ies to docu- caves, capture
ment habitat with mist nets
of white-nose ples, wing
syndrome or punch, swab,
other threats. and release.
ES94849B–3 .. Copperhead En- Tricolored bat (Perimyotis Colorado, District of Columbia, Presence/prob- Enter Amendment.
vironmental subflavus). and New Mexico. able absence hibernacula or
Consulting, surveys, stud- maternity roost
Inc.; Paint ies to docu- caves, capture
Lick, KY. ment habitat with mist nets
of white-nose ples, wing
syndrome or punch, swab,
other threats. and release.
ES78383C–1 .. Joel Casto; Red-cockaded woodpecker Alabama, Arkansas, Florida, Population man- Capture, band, Renewal.
Crawfordville, (Picoides borealis). Georgia, Louisiana, Mississippi, agement and monitor nest
FL. North Carolina, Oklahoma, monitoring. cavities, con-
South Carolina, Texas, and Vir- struct and
ginia. monitor artifi-
cial nest cav-
ities and
restrictors, re-
lease, and
translocate.
ES67197D–2 .. Tyler Black; Dwarf wedgemussel (Alasmidonta Connecticut, Massachusetts, New Presence/prob- Capture, handle, Amendment.
Chapel Hill, heterodon). Hampshire, New York, and able absence identify, tag,
NC. Vermont. surveys. release, and
salvage relic
shells.
Public Availability of Comments numbers of the Southcentral Alaska TDD, or TeleBraille) to access
Written comments we receive become stock of northern sea otters (Enhydra telecommunications relay services.
part of the administrative record lutris kenyoni) for 1 year from the date Individuals outside the United States
associated with this action. Before of issuance of the incidental harassment should use the relay services offered
including your address, phone number, authorization. The applicant has within their country to make
requested this authorization for take by international calls to the point-of-
email address, or other personal
harassment that may result from contact in the United States.
identifying information in your
comment, you should be aware that activities associated with pile driving SUPPLEMENTARY INFORMATION:
your entire comment—including your and marine construction activities in
Background
personal identifying information—may Cordova, Alaska. We estimate that this
project may result in the nonlethal Section 101(a)(5)(D) of the Marine
be made publicly available at any time.
incidental take by harassment of up to Mammal Protection Act of 1972
While you can ask us in your comment (MMPA; 16 U.S.C. 1361 et seq.)
to withhold your personal identifying 82 northern sea otters from the
Southcentral stock. This proposed authorizes the Secretary of the Interior
information from public review, we (Secretary) to allow, upon request, the
cannot guarantee that we will be able to authorization, if finalized, will be for up
to 30 takes of 5 northern sea otters by incidental, but not intentional, taking by
do so. All submissions from harassment of small numbers of marine
organizations or businesses, and from Level A harassment and 790 takes of 77
northern sea otters by Level B mammals in response to requests by
individuals identifying themselves as U.S. citizens (as defined in title 50 of
representatives or officials of harassment. No lethal take is requested,
or expected, and no such take will be the Code of Federal Regulations (CFR)
organizations or businesses, will be in part 18, at 50 CFR 18.27(c)) engaged
made available for public disclosure in authorized.
in a specified activity (other than
their entirety. DATES: Comments on this proposed
commercial fishing) in a specified
incidental harassment authorization and
Next Steps geographic region during a period of not
the accompanying draft environmental
more than 1 year. The Secretary has
If we decide to issue a permit to an assessment must be received by
delegated authority for implementation
applicant listed in this notice, we will December 6, 2023.
of the MMPA to the U.S. Fish and
publish a notice in the Federal Register. ADDRESSES:
Wildlife Service (‘‘Service’’ or ‘‘we’’).
Authority Document availability: You may view
According to the MMPA, the Service
this proposed incidental harassment
We publish this notice under section shall allow this incidental taking if we
authorization, the application package,
10(c) of the Endangered Species Act of make findings that the total of such
supporting information, draft
1973, as amended (16 U.S.C. 1531 et taking for the 1-year period:
environmental assessment, and the list (1) is of small numbers of marine
seq.). of references cited herein at https:// mammals of a species or stock;
Nicole Rankin, www.regulations.gov under Docket No. (2) will have a negligible impact on
Acting Deputy Assistant Regional Director,
FWS–R7–ES–2023–0101. Alternatively, such species or stocks; and
Ecological Services, Southeast Region. you may request these documents from (3) will not have an unmitigable
[FR Doc. 2023–24494 Filed 11–3–23; 8:45 am]
the person listed under FOR FURTHER adverse impact on the availability of
INFORMATION CONTACT. these species or stocks for taking for
Comment submission: You may subsistence use by Alaska Natives.
submit comments on the proposed If the requisite findings are made, we
authorization by one of the following issue an authorization that sets forth the
DEPARTMENT OF THE INTERIOR
methods: following, where applicable:
Fish and Wildlife Service • U.S. mail: Public Comments (a) permissible methods of taking;
Processing, Attn: Docket No. FWS–R7– (b) means of effecting the least
[Docket No. FWS–R7–ES–2023–0101; ES–2023–0101, U.S. Fish and Wildlife practicable adverse impact on the
FXES111607MRG01–234–FF07CAMM00] Service, MS: PRB (JAO/3W), 5275 species or stock and its habitat and the
Leesburg Pike, Falls Church, VA 22041– availability of the species or stock for
Marine Mammals; Incidental Take
3803. subsistence uses; and
During Specified Activities; Proposed
• Electronic submission: https:// (c) requirements for monitoring and
Incidental Harassment Authorization
www.regulations.gov. Follow the reporting of such taking by harassment,
for Southcentral Alaska Stock of
instructions for submitting comments to including, in certain circumstances,
Northern Sea Otters in Cordova,
Docket No. FWS–R7–ES–2023–0101. requirements for the independent peer
Alaska; Draft Environmental We will post all comments at https://
Assessment review of proposed monitoring plans or
www.regulations.gov. You may request other research proposals.
AGENCY: Fish and Wildlife Service, that we withhold personal identifying The term ‘‘take’’ means to harass,
Interior. information from public review; hunt, capture, or kill, or to attempt to
ACTION: Notice of receipt of application;
however, we cannot guarantee that we harass, hunt, capture, or kill any marine
proposed incidental harassment will be able to do so. See Request for mammal. ‘‘Harassment’’ means any act
authorization; draft environmental Public Comments for more information. of pursuit, torment, or annoyance which
assessment; request for comments. FOR FURTHER INFORMATION CONTACT: (i) has the potential to injure a marine
Sierra Franks, by email at mammal or marine mammal stock in the

SUMMARY: We, the U.S. Fish and R7mmmregulatory@fws.gov or by wild (the MMPA defines this as ‘‘Level
Wildlife Service, in response to a telephone at 01–800–362–5148. U.S. A harassment’’), or (ii) has the potential
request under the Marine Mammal Fish and Wildlife Service, MS 341, 1011 to disturb a marine mammal or marine
Protection Act of 1972, as amended, East Tudor Road, Anchorage, AK 99503. mammal stock in the wild by causing
from the City of Cordova, Alaska, Individuals in the United States who are disruption of behavioral patterns,
propose to authorize nonlethal deaf, deafblind, hard of hearing, or have including, but not limited to, migration,
incidental take by harassment of small a speech disability may dial 711 (TTY, breathing, nursing, breeding, feeding, or
sheltering (the MMPA defines this as that are effective in reducing the impact June 2024. The City will remove 130
‘‘Level B harassment’’). of project activities, but they are not so existing 30-centimeter (cm) (12-inch
The terms ‘‘negligible impact’’ and restrictive as to make project activities (in)) diameter timber piles and 61
‘‘unmitigable adverse impact’’ are unduly burdensome or impossible to existing 30-cm (12-in) diameter steel
defined in 50 CFR 18.27 (i.e., undertake and complete. piles and will permanently install the
regulations governing small takes of If the requisite findings are made, we following types of piles: 155 41-cm (16-
marine mammals incidental to specified shall issue an IHA, which may set forth in) diameter steel piles, 140 46-cm (18-
activities) as follows: ‘‘Negligible the following, where applicable: (i) in) diameter steel piles, 30 76-cm (30-in)
impact’’ is an impact resulting from the permissible methods of taking; (ii) other diameter steel piles, and 140 steel 41-cm
specified activity that cannot be means of effecting the least practicable x 226-cm (16-in x 89-in) H piles.
reasonably expected to, and is not impact on the species or stock and its Construction will also include the
reasonably likely to, adversely affect the habitat, paying particular attention to installation and removal of 131 61-cm
species or stock through effects on rookeries, mating grounds, and areas of (24-in) diameter temporary steel piles.
annual rates of recruitment or survival. similar significance, and on the Components of the harbor that will be
‘‘Unmitigable adverse impact’’ means an availability of the species or stock for installed out of water include
impact resulting from the specified taking for subsistence uses by coastal- approximately 350 meters (m) (1,150
activity: (1) that is likely to reduce the dwelling Alaska Natives (if applicable); feet (ft)) of bulkhead wall supported by
availability of the species to a level and (iii) requirements for monitoring H piles; main walk floats, end floats,
insufficient for a harvest to meet and reporting take by harassment. and stall floats; 447 slips; pedestrian
subsistence needs by (i) causing the Summary of Request gangways; other float components
marine mammals to abandon or avoid including bull rail, floating fenders,
On February 28, 2023, the City of mooring cleats, electricity connections,
hunting areas, (ii) directly displacing Cordova (hereafter also known as ‘‘the
subsistence users, or (iii) placing potable water service, fire suppression
City’’ or ‘‘the applicant’’) submitted a
physical barriers between the marine waterlines, lighting, wireless
request to the Service for authorization
mammals and the subsistence hunters; connections, and hand rails; and an
to take by Level A and Level B
and (2) that cannot be sufficiently uplands service area with parking lot
harassment a small number of northern
mitigated by other measures to increase expansion, greenspace, and stormwater
sea otters (Enhydra lutris kenyoni)
the availability of marine mammals to treatment capabilities. Pile-driving
(hereafter, ‘‘sea otters’’ or ‘‘otters’’
allow subsistence needs to be met. activities will occur over 170 non-
unless another species is specified) from
The term ‘‘small numbers’’ is also consecutive days for approximately 434
the Southcentral Alaska stock. The
defined in 50 CFR 18.27. However, we hours over 1 year from date of issuance
Service sent requests for additional
do not rely on that definition here as it of the IHA. If the IHA is issued after the
information on March 24, May 16, and
conflates ‘‘small numbers’’ with applicant’s intended start date in
May 30, 2023. We received updated
‘‘negligible impacts.’’ We recognize September 2023, its schedule for
versions of the request on April 27, May
‘‘small numbers’’ and ‘‘negligible conducting the specified activities may
18, and June 8, 2023. The Service
impacts’’ as two separate and distinct be adjusted accordingly. Pile
determined the June 8, 2023,
considerations when reviewing requests installation will be done with a
application to be adequate and
for incidental harassment authorizations combination of impact, vibratory, and
complete. The applicant expects take by
(IHA) under the MMPA (see Natural down-the-hole (DTH) drilling.
harassment may occur during the
Res. Def. Council, Inc. v. Evans, 232 F. Temporary piles will be removed with
construction of replacements and
Supp. 2d 1003, 1025 (N.D. Cal. 2003)). the vibratory hammer. Materials and
improvements to the harbor facilities in
Instead, for our small numbers equipment will be transported via
Cordova, Alaska.
determination, we estimate the likely barges, and workers will be transported
number of takes of marine mammals Description of Specified Activities and to and from the barge work platform via
and evaluate if that take is small relative Specified Geographic Region skiff.
to the size of the species or stock. The specified activity (hereafter, Additional project details may be
The term ‘‘least practicable adverse ‘‘project’’) will include the installation reviewed in the application materials
impact’’ is not defined in the MMPA or and removal of piles and the installation available as described under ADDRESSES
its enacting regulations. For this IHA, of a bulkhead to rebuild the facilities of or may also be requested as described
we ensure the least practicable adverse the South Harbor in Cordova, Alaska under FOR FURTHER INFORMATION
impact by requiring mitigation measures (figure 1) between September 2023 and CONTACT.
Prince
William
Sound
USGS, Bureau of larld Management, EPA, NPS, USDA,
FIGURE I-SPECIFIED GEOGRAPHIC REGION OF THE PROJECT
Description of Marine Mammals in the shore, and sea otters typically remain movement distances greater than 3 km
Specified Geographic Region within 1 to 2 kilometers (km) (0.62 to (1.9 mi) at speeds up to 5.5 km per hour
1.24 miles (mi)) of shore (Riedman and (hr) (km/hr; 3.4 mi/hr) (Garshelis and
Sea Otter Biology
Estes 1990). They tend to be found Garshelis 1984).
There are three sea otter stocks in closer to shore during storms, but
Alaska: Southeast Alaska stock, Southcentral Alaska Sea Otter Stock
venture farther out during good weather
Southcentral Alaska stock, and the and calm seas (Lensink 1962, Kenyon The Southcentral Alaska sea otter
Southwest Alaska stock. Only the 1969). stock occurs in the center of the sea
Southcentral Alaska stock is represented Sea otters are nonmigratory and otter range in Alaska and extends from
in the project area. Detailed information generally do not disperse over long Cape Yakataga in the east to Cook Inlet
about the biology of this stock can be distances (Garshelis and Garshelis in the west, including Prince William
found in the most recent Southcentral 1984), usually remaining within a few Sound, the eastern Kenai Peninsula
Alaska stock assessment report (USFWS kilometers of their established feeding coast, and Kachemak Bay (USFWS
2023), which can be found at https:// grounds (Kenyon 1981). Breeding males 2023). Between 2014 and 2019, aerial
www.regulations.gov/document/FWS- stay for all or part of the year in a surveys were conducted in three regions
R7-ES-2022-0155-0012 and was breeding territory covering up to 1 km of the Southcentral Alaska sea otter
announced in the Federal Register at 88 (0.62 mi) of coastline, while adult stock: (1) Eastern Cook Inlet, (2) Outer
FR 53510, August 8, 2023. females maintain home ranges of Kenai Peninsula, and (3) Prince William
Sea otters may be distributed approximately 8 to 16 km (5 to 10 mi), Sound by aerial transects flown at 91 m
anywhere within the specified project which may include one or more male (298.56 ft) of altitude. The combined
area other than upland areas; however, territories. Juveniles move greater estimates of the three regions resulted in
they generally occur in shallow water distances between resting and foraging approximately 21,617 (SE = 2,190) sea
near the shoreline. They are most areas (Lensink 1962, Kenyon 1969, otters and an average density of 1.96 sea
commonly observed within the 40-m Riedman and Estes 1990, Tinker and otters per square kilometer (km2) for the
(131-ft) depth contour (USFWS 2023), Estes 1996). Although sea otters Southcentral Alaska stock (Esslinger et
although they can be found in areas generally remain local to an area, they al. 2021). In aerial sea otter abundance
with deeper water. Ocean depth is are capable of long-distance travel. Sea surveys of Prince William Sound,
EN06NO23.060</GPH>
generally correlated with distance to otters in Alaska have shown daily Weitzman and Esslinger (2015) found a
density of 21.15 sea otters/km2 in the vocalizations are between 3 and 8 kHz, FR 3260, January 20, 2006; 73 FR 41318,
Orca Inlet subregion. Multiple local with some energy extending above 60 July 18, 2008). Southall et al. (2007)
sources of data (Greenwood 2022; kHz (McShane et al. 1995, Ghoul and derived TTS thresholds for pinnipeds
Prince William Sound Science Center Reichmuth 2012). based on 212 dB peak and 171 dB SEL.
2022; Schinella 2022, 2023; Solstice Exposure to high levels of sound may Exposures resulting in TTS in pinnipeds
Alaska Consulting Inc. 2022) indicate a cause changes in behavior, masking of were found to range from 152 to 174 dB
higher density within the Cordova communications, temporary or (183 to 206 dB SEL) (Kastak et al. 2005),
Harbor-approximately 20 sea otters at permanent changes in hearing with a persistent TTS, if not a PTS, after
any given time within the 0.18 km2 area sensitivity, discomfort, and injury to 60 seconds of 184 dB SEL (Kastak et al.
of the harbor, or a density of 111.11 sea marine mammals. Unlike other marine 2008). Kastelein et al. (2012) found
otters/km2. We utilized both sources of mammals, sea otters do not rely on small but statistically significant TTSs
data and applied the published density sound to orient themselves, locate prey, at approximately 170 dB SEL (136 dB,
for areas outside the harbor and the or communicate under water; therefore, 60 minutes (min)) and 178 dB SEL (148
local data for areas within the harbor. masking of communications by dB, 15 min). Based on these findings,
anthropogenic sound is less of a concern Southall et al. (2019) developed TTS
Potential Impacts of the Specified than for other marine mammals. thresholds for sea otters, which are
Activities on Marine Mammals However, sea otters, especially mothers included in the ‘‘other marine
Effects of Noise on Sea Otters and pups, do use sound for carnivores’’ category, of 188 dB SEL for
communication in air (McShane et al. impulsive sounds and 199 dB SEL for
We characterized ‘‘noise’’ as sound
1995), and sea otters may monitor nonimpulsive sounds.
released into the environment from The NMFS (2018) criteria do not
human activities that exceeds ambient underwater sound to avoid predators
(Davis et al. 1987). identify thresholds for avoidance of
levels or interferes with normal sound Level B harassment. For pinnipeds
production or reception by sea otters. Exposure Thresholds (seals and sea lions), NMFS has adopted
The terms ‘‘acoustic disturbance’’ or a 160-dB threshold for Level B
‘‘acoustic harassment’’ are disturbances Underwater Sounds
harassment from exposure to impulsive
or harassment events resulting from Noise exposure criteria for identifying noise and a 120-dB threshold for
noise exposure. Potential effects of noise underwater noise levels capable of continuous noise (NMFS 1998, HESS
exposure are likely to depend on the causing Level A harassment to marine 1999, NMFS 2018). These thresholds
distance of the sea otter from the sound mammal species, including sea otters, were developed from observations of
source, the level and intensity of sound have been established using the same mysticete (baleen) whales responding to
the sea otter receives, background noise methods as those used by the National airgun operations (e.g., Malme et al.
levels, noise frequency, noise duration, Marine Fisheries Service (NMFS) 1983; Malme and Miles 1983;
and whether the noise is pulsed or (Southall et al. 2019). These criteria are Richardson et al. 1986, 1995) and from
continuous. The actual noise level based on estimated levels of sound equating Level B harassment with noise
perceived by individual sea otters will exposure capable of causing a levels capable of causing TTS in lab
also depend on whether the sea otter is permanent shift in sensitivity of hearing settings. Southall et al. (2007, 2019)
above or below water and atmospheric (i.e., a permanent threshold shift (PTS) assessed behavioral response studies
and environmental conditions. (NMFS 2018)). PTS occurs when noise and found considerable variability
Temporary disturbance of sea otters or exposure causes hairs within the inner among pinnipeds. The authors
localized displacement reactions are the ear system to die (Ketten 2012). determined that exposures between
most likely effects to occur from noise Although the effects of PTS are, by approximately 90 to 140 dB generally do
exposure. definition, permanent, PTS does not not appear to induce strong behavioral
equate to total hearing loss. responses from pinnipeds in water.
Sea Otter Hearing Sound exposure thresholds However, they found behavioral effects,
Pile driving and marine construction incorporate two metrics of exposure: the including avoidance, become more
activities will fall within the hearing peak level of instantaneous exposure likely in the range between 120 to 160
range of sea otters. Controlled sound likely to cause PTS and the cumulative dB, and most marine mammals showed
exposure trials on southern sea otters sound exposure level (SELCUM) during a some, albeit variable, responses to
(Enhydra lutris nereis) indicate that sea 24-hour period. They also include sound between 140 to 180 dB. Wood et
otters can hear frequencies between 125 weighting adjustments for the al. (2012) adapted the approach
hertz (Hz) and 38 kilohertz (kHz) with sensitivity of different species to varying identified in Southall et al. (2007) to
best sensitivity between 1.2 and 27 kHz frequencies. PTS-based injury criteria develop a probabilistic scale for marine
(Ghoul and Reichmuth 2014). Aerial were developed from theoretical mammal taxa at which 10 percent, 50
and underwater audiograms for a extrapolation of observations of percent, and 90 percent of individuals
captive adult male southern sea otter in temporary threshold shifts (TTS) exposed are assumed to produce a
the presence of ambient noise suggest detected in lab settings during sound behavioral response. For many marine
the sea otter’s hearing was less sensitive exposure trials (Finneran 2015). mammals, including pinnipeds, these
to high-frequency (greater than 22 kHz) Southall and colleagues (2019) predict response rates were set at sound
and low-frequency (less than 2 kHz) PTS for sea otters, which are included pressure levels of 140, 160, and 180 dB,
sound than terrestrial mustelids but was in the ‘‘other marine carnivores’’ respectively.
similar to that of a California sea lion category, will occur at 232 dB peak or We have evaluated these thresholds
(Zalophus californianus). However, the 203 dB SELCUM (db SEL) for impulsive and determined that the Level B
sea otter was still able to hear low- underwater sound and 219 dB SEL for threshold of 120 dB for nonimpulsive
frequency sounds, and the detection nonimpulsive (continuous) underwater noise is not applicable to sea otters. The
thresholds for sounds between 0.125–1 sound. 120-dB threshold is based on studies in
kHz were between 116–101 decibels Thresholds based on TTS have been which gray whales (Eschrichtius
(dB), respectively. Dominant used as a proxy for Level B harassment robustus) were exposed to experimental
frequencies of southern sea otter (i.e., 70 FR 1871, January 11, 2005; 71 playbacks of industrial noise (Malme et
al. 1983, Malme and Miles 1983). data are limited, the Service has set 160 Considering sound energy travels more
During these playback studies, southern dB of received underwater sound as a efficiently through water than through
sea otter responses to industrial noise threshold for Level B harassment by air, this estimation will also account for
were also monitored (Riedman 1983, disturbance for sea otters for this exposures to sea otters at the surface.
1984). Gray whales exhibited avoidance proposed IHA. Exposure to unmitigated Southall et al. (2019) have developed
to industrial noise at the 120-dB in-water noise levels between 125 Hz TTS and PTS thresholds for other
threshold; however, there was no and 38 kHz that are greater than 160 dB-
marine carnivores, which include sea
evidence of disturbance reactions or for both impulsive and nonimpulsive
otters, for airborne impulsive and non-
avoidance in southern sea otters. Thus, sound sources-will be considered by the
impulsive sounds (table 1). For project
given the different range of frequencies Service as Level B harassment.
to which sea otters and gray whales are Thresholds for Level A harassment activities that create only airborne
sensitive, the NMFS 120-dB threshold (which entails the potential for injury) sounds, such as pile driving on land, the
based on gray whale behavior is not will be 232 dB peak or 203 dB SEL for sound levels are significantly below the
appropriate for predicting sea otter impulsive sounds and 219 dB SEL for TTS thresholds developed by Southall
behavioral responses, particularly for continuous sounds (table 1). et al. 2019. NMFS has previously used
low-frequency sound. ‘‘a generalized acoustic threshold based
Based on the lack of sea otter Airborne Sounds on received level to estimate the onset
disturbance response or any other The NMFS (2018) guidance neither of behavioral harassment’’ (April 10,
reaction to the playback studies from addresses thresholds for preventing 2019, 84 FR 14314). NMFS predicts that
the 1980s, as well as the absence of a injury or disturbance from airborne all other pinniped species that are not
clear pattern of disturbance or noise, nor provides thresholds for harbor seals will be behaviorally
avoidance behaviors attributable to avoidance of Level B harassment. harassed when exposed to airborne
underwater sound levels up to about Conveyance of underwater noise into sounds above 100 dB re 20 micropascal
160 dB resulting from low-frequency the air is of little concern since the (mPa) (84 FR 14314). Since otariid
broadband noise, we assume 120 dB is effects of pressure release and pinnipeds are the closest available
not an appropriate behavioral response interference at the water’s surface physiological and anatomical proxy for
threshold for sea otters exposed to reduce underwater noise transmission sea otters, we used the NMFS criteria for
continuous underwater noise. into the air. For activities that create pinniped harassment from exposure to
Based on the best available scientific both in-air and underwater sounds, we airborne sound to estimate take by Level
information about sea otters, and closely will estimate take based on parameters B harassment from pile driving on
related marine mammals when sea otter for underwater noise transmission. shore.
TABLE 1—TEMPORARY THRESHOLD SHIFT (TTS) AND PERMANENT THRESHOLD SHIFT (PTS) THRESHOLDS ESTABLISHED
BY SOUTHALL ET AL. (2019) THROUGH MODELING AND EXTRAPOLATION FOR ‘‘OTHER MARINE CARNIVORES,’’ WHICH
INCLUDE SEA OTTERS
[Values are weighted for other marine carnivores’ hearing thresholds and given in cumulative sound exposure level (SELCUM dB re (20 μPa) in
air and SELCUM dB re (1 μPa) in water) for impulsive and nonimpulsive sounds and unweighted peak sound pressure level (SPL) in air (dB
re 20 μPa) and water (dB 1μPa) (impulsive sounds only).]
TTS PTS
nonimpulsive impulsive nonimpulsive impulsive
SELCUM SELCUM Peak SPL SELCUM SELCUM Peak SPL
Air ............................................................................ 157 146 170 177 161 176

Water ....................................................................... 199 188 226 219 203 232
Evidence From Sea Otter Studies sea otters (Riedman 1983, 1984). Further, northern sea otters appeared to
However, southern sea otters displayed become habituated to the noises within
Sea otters may be more resistant to the slight reactions to airborne engine noise 2 hours or, at most, 3–4 days (Davis et
effects of sound disturbance and human (Riedman 1983). Northern sea otters al. 1988).
activities than other marine mammals. were observed to exhibit a limited
For example, observers have noted no Noise exposure may be influenced by
response to a variety of airborne and the amount of time sea otters spend at
changes from southern sea otters in
underwater sounds, including a warble the water’s surface. Noise at the water’s
regard to their presence, density, or
behavior in response to underwater tone, sea otter pup calls, calls from surface can be attenuated by turbulence
sounds from industrial noise recordings killer whales (Orcinus orca) (which are from wind and waves more quickly
at 110 dB and a frequency range of 50 predators to sea otters), air horns, and compared to deeper water, reducing
Hz to 20 kHz and airguns, even at the an underwater noise harassment system potential noise exposure (Greene and
closest distance of 0.5 nautical miles (<1 designed to drive marine mammals Richardson 1988, Richardson et al.
km or 0.6 mi) (Riedman 1983). Southern away from crude oil spills (Davis et al. 1995). Additionally, turbulence at the
sea otters did not respond noticeably to 1988). These sounds elicited reactions water’s surface limits the transference of
noise from a single 1,638 cubic from northern sea otters, including sound from water to air. A sea otter with
centimeters (cm3) (100 cubic inches startle responses and movement away its head above water will be exposed to
[in3]) airgun, and no sea otter from noise sources. However, these only a small fraction of the sound
disturbance reactions were evident reactions were observed only when energy traveling through the water
when a 67,006 cm3 (4,089 in3) airgun northern sea otters were within 100 to beneath it. The average amount of time
array was as close as 0.9 km (0.6 mi) to 200 m (328 to 656 ft) of noise sources. that sea otters spend above the water
each day while resting and grooming which increases the amount of prey whales and eagles, and have a well-
varies between males and females and required by sea otters (Barrett 2019). developed antipredator response to
across seasons (Esslinger et al. 2014, This increased prey consumption may perceived threats. For example, the
Zellmer et al. 2021). For example, impact sea otter prey availability and presence of a harbor seal (Phoca
female sea otters foraged for an average cause sea otters to spend more time vitulina) did not appear to disturb
of 8.78 hours per day compared to male foraging and less time resting (Barrett southern sea otters, but they
sea otters, which foraged for an average 2019). Some sea otters may abandon the demonstrated a fear response in the
of 7.85 hours per day during the project area and return when the presence of a California sea lion by
summer months (Esslinger et al. 2014). disturbance has ceased. Based on the actively looking above and beneath the
Male and female sea otters spend an observed movement patterns of sea water (Limbaugh 1961).
average of 63 to 67 percent of their day otters (i.e., Lensink 1962; Kenyon 1969, Although an increase in vigilance or
at the surface resting and grooming 1981; Garshelis and Garshelis 1984; a flight response is nonlethal, a tradeoff
during the summer months (Esslinger et Riedman and Estes 1990; Tinker and occurs between risk avoidance and
al. 2014). Few studies have evaluated Estes 1996), we expect some individuals energy conservation. An animal’s
foraging times during the winter will respond to pile-driving activities by reactions to noise disturbance may
months. Garshelis et al. (1986) found dispersing to nearby areas of suitable cause stress and direct an animal’s
that foraging times increased from 5.1 habitat; however, other sea otters, energy away from fitness-enhancing
hours per day to 16.6 hours per day in especially territorial adult males, are activities such as feeding and mating
the winter; however, Gelatt et al. (2002) less likely to be displaced. (Frid and Dill 2002, Goudie and Jones
did not find a significant difference in 2004). For example, southern sea otters
Consequences of Disturbance in areas with heavy recreational boat
seasonal foraging times. It is likely that
seasonal variation is determined by The reactions of wildlife to traffic demonstrated changes in
seasonal differences in energetic disturbance can range from short-term behavioral time budgeting, showing
demand and the quality and availability behavioral changes to long-term impacts decreased time resting and changes in
of prey sources (Esslinger et al. 2014). that affect survival and reproduction. haulout patterns and distribution
These findings suggest that the large When disturbed by noise, animals may (Benham 2006, Maldini et al. 2012).
portion of the day sea otters spend at the respond behaviorally (e.g., escape Chronic stress can also lead to
surface may help limit sea otters’ response) or physiologically (e.g., weakened reflexes, lowered learning
exposure during noise-generating increased heart rate, hormonal response) responses (Welch and Welch 1970, van
operations. (Harms et al. 1997, Tempel and Polanen Petel et al. 2006), compromised
Sea otter sensitivity to industrial Gutiérrez 2003). Theoretically, the immune function, decreased body
activities may be influenced by the energy expense and associated weight, and abnormal thyroid function
overall level of human activity within physiological effects from repeated (Selye 1979).
the sea otter population’s range. In disturbance could ultimately lead to Changes in behavior resulting from
locations that lack frequent human reduced survival and reproduction (Gill anthropogenic disturbance can include
activity, sea otters appear to have a and Sutherland 2000, Frid and Dill increased agonistic interactions between
lower threshold for disturbance. Sea 2002). For example, South American sea individuals or temporary or permanent
otters in Alaska exhibited escape lions (Otaria byronia) visited by tourists abandonment of an area (Barton et al.
behaviors in response to the presence exhibited an increase in the state of 1998). Additionally, the extent of
and approach of vessels (Udevitz et al. alertness and a decrease in maternal previous exposure to humans (Holcomb
1995). Behaviors included diving or attendance and resting time on land, et al. 2009), the type of disturbance
actively swimming away from a vessel, thereby potentially reducing population (Andersen et al. 2012), and the age or
entering the water from haulouts, and size (Pavez et al. 2015). In another sex of the individuals (Shaughnessy et
disbanding groups with sea otters example, killer whales that lost feeding al. 2008, Holcomb et al. 2009) may
swimming in multiple different opportunities due to boat traffic faced a influence the type and extent of
directions (Udevitz et al. 1995). Sea substantial (18 percent) estimated response in individual sea otters.
otters in Alaska were also observed to decrease in energy intake (Williams et
al. 2006). In severe cases, such Vessel Activities
avoid areas with heavy boat traffic in
the summer and return to these areas disturbance effects could have Vessel collisions with marine
during seasons with less vessel traffic population-level consequences. For mammals can result in death or serious
(Garshelis and Garshelis 1984). In Cook example, increased disturbance by injury. Wounds resulting from vessel
Inlet, sea otters drifting on a tide tourism vessels has been associated strike may include massive trauma,
trajectory that would have taken them with a decline in abundance of hemorrhaging, broken bones, or
within 500 m (0.3 mi) of an active bottlenose dolphins (Tursiops spp.) propeller lacerations (Knowlton and
offshore drilling rig were observed to (Bejder et al. 2006, Lusseau et al. 2006). Kraus 2001). An animal may be harmed
swim in order to avoid a close approach However, these examples evaluated by a vessel when the vessel runs over
of the drilling rig despite near-ambient sources of disturbance that were longer the animal at the surface, the animal
noise levels (BlueCrest 2013). term and more consistent than the hits the bottom of a vessel while the
Individual sea otters in Orca Inlet will temporary and intermittent nature of the animal is surfacing, or the animal is cut
likely show a range of responses to specified project activities. by a vessel’s propeller.
noise from pile-driving activities. Some These examples illustrate direct Vessel strike has been documented as
sea otters will likely dive, show startle effects on survival and reproductive a cause of death across all three stocks
responses, change direction of travel, or success, but disturbances can also have of northern sea otters in Alaska. Since
prematurely surface. Sea otters reacting indirect effects. Response to noise 2002, the Service has conducted 1,433
to pile-driving activities may divert time disturbance is considered a nonlethal sea otter necropsies to determine cause
and attention from biologically stimulus that is similar to an of death, disease incidence, and the
important behaviors, such as feeding antipredator response (Frid and Dill general health status of sea otters in
and nursing pups. Sea otter responses to 2002). Sea otters are susceptible to Alaska. Vessel strike or blunt trauma
disturbance can result in energetic costs, predation, particularly from killer was identified as a definitive or
presumptive cause of death in 65 cases activity. Vessel activity during the observed in response to increased sound
(4 percent) (USFWS 2020). In most of project includes the transit of two bargeslevels, including changes in serum
these cases, trauma was determined to for materials and construction, both of biochemistry and hepatopancreatic cells
be the ultimate cause of death; however, which will remain on site, mostly in lobsters (Payne et al. 2007) and long-
there was a contributing factor, such as stationary, to support the work; term damage to the statocysts required
disease or biotoxin exposure, which additionally, a skiff will be used during for hearing in several cephalopod
incapacitated the sea otter and made it the project for transporting workers species (André et al. 2011, Solé et al.
more vulnerable to vessel strike short distances to support construction 2013). De Soto et al. (2013) found
(USFWS 2023). activities. Vessels will not be used impaired embryonic development in
Vessel speed influences the likelihood extensively or over a long duration scallop (Pecten novaezelandiae) larvae
of vessel strikes involving sea otters. during the planned work; therefore, we when exposed to 160 dB. Christian et al.
The probability of death or serious do not anticipate that sea otters will (2003) noted a reduction in the speed of
injury to a marine mammal increases as experience changes in behavior egg development of bottom-dwelling
vessel speed increases (Laist et al. 2001, indicative of tolerance or habituation. crabs following exposure to noise;
Vanderlaan and Taggart 2007). Sea however, the sound level (221 dB at 2
otters spend a considerable portion of Effects on Sea Otter Habitat and Prey
m or 6.6 ft) was far higher than the
their time at the water’s surface Physical and biological features of planned project activities will produce.
(Esslinger et al. 2014). They are habitat essential to the conservation of Industrial noise can also impact larval
typically visually aware of approaching sea otters include the benthic settlement by masking the natural
vessels and can move away if a vessel invertebrates that sea otters eat and the acoustic settlement cues for crustaceans
is not traveling too quickly. Mitigation shallow rocky areas and kelp beds that and fish (Pine et al. 2012, Simpson et al.
measures to be applied to vessel provide cover from predators. Sea otter 2016, Tidau and Briffa 2016).
operations to prevent collisions or habitat in the project area includes While these studies provide evidence
interactions are included below in the coastal areas within the 40-m (131-ft) of deleterious effects to invertebrates as
proposed authorization portion of this depth contour where high densities of a result of increased sound levels,
document under Avoidance and sea otters have been detected. Carroll et al. (2017) caution that there is
Minimization. Industrial activities, such as pile a wide disparity between results
Sea otters exhibit behavioral driving, may generate in-water noise at obtained in field and laboratory settings.
flexibility in response to vessels, and levels that can temporarily displace sea In experimental settings, changes were
their responses may be influenced by otters from important habitat and observed only when animals were
the intensity and duration of the vessel’s impact sea otter prey species. The housed in enclosed tanks, and many
activity. As noted above, sea otter primary prey species for sea otters are were exposed to prolonged bouts of
populations in Alaska were observed to sea urchins (Strongylocentrotus spp. continuous, pure tones. We would not
avoid areas with heavy vessel traffic but and Mesocentrotus spp.), abalone expect similar results in open marine
return to those same areas during (Haliotis spp.), clams (e.g., conditions. It is unlikely that noises
seasons with less vessel traffic Clinocardium nuttallii, Leukoma generated by project activities will have
(Garshelis and Garshelis 1984). Sea staminea, and Saxidomus gigantea), any lasting effect on sea otter prey given
otters have also shown signs of mussels (Mytilus spp.), crabs (e.g., the short-term duration of sounds
disturbance or escape behaviors in Metacarcinus magister, Pugettia spp., produced by each component of the
response to the presence and approach Telemessus cheiragonus, and Cancer planned work.
of survey vessels, including sea otters spp.), and squid (Loligo spp.) (Tinker Noise-generating activities that
diving and/or actively swimming away and Estes 1996, LaRoche et al. 2021). interact with the seabed can produce
from a vessel, sea otters on haulouts When preferred prey are scarce, sea vibrations, resulting in the disturbance
entering the water, and groups of sea otters will also eat kelp, slow-moving of sediment and increased turbidity in
otters disbanding and swimming in benthic fishes, sea cucumbers (e.g., the water. Although turbidity is likely to
multiple different directions (Udevitz et Apostichopus californicus), egg cases of have little impact on sea otters and prey
al. 1995). rays, turban snails (Tegula spp.), species (Todd et al. 2015), there may be
Additionally, sea otter responses to octopuses (e.g., Octopus spp.), barnacles some impacts from vibrations and
vessels may be influenced by the sea (Balanus spp.), sea stars (e.g., increased sedimentation. For example,
otter’s previous experience with vessels. Pycnopodia helianthoides), scallops mussels (Mytilus edulis) exhibited
Groups of southern sea otters in two (e.g., Patinopecten caurinus), rock changes in valve gape and oxygen
locations in California showed markedly oysters (Saccostrea spp.), worms (e.g., demand, and hermit crabs (Pagurus
different responses to kayakers Eudistylia spp.), and chitons (e.g., bernhardus) exhibited limited
approaching to within specific Mopalia spp.) (Riedman and Estes 1990, behavioral changes in response to
distances, suggesting a different level of Davis and Bodkin 2021). vibrations caused by pile driving
tolerance between the groups Several studies have addressed the (Roberts et al. 2016). Increased
(Gunvalson 2011). Benham (2006) found effects of noise on invertebrates (Tidau sedimentation is likely to reduce sea
evidence that the sea otters exposed to and Briffa 2016, Carroll et al. 2017). otter visibility, which may result in
high levels of recreational activity may Behavioral changes, such as an increase reduced foraging efficiency and a
have become more tolerant than in lobster (Homarus americanus) potential shift to less-preferred prey
individuals in less disturbed areas. Sea feeding levels (Payne et al. 2007), an species. These outcomes may cause sea
otters off the California coast showed increase in avoidance behavior by wild- otters to spend more energy on foraging
only mild interest in vessels passing caught captive reef squid (Sepioteuthis or processing the prey items; however,
within hundreds of meters and australis) (Fewtrell and McCauley the impacts of a change in energy
appeared to have habituated to vessel 2012), and deeper digging by razor expenditure are not likely seen at the
traffic (Riedman 1983, Curland 1997). clams (Sinonovacula constricta) (Peng et population level (Newsome et al. 2015).
These findings indicate that sea otters al. 2016) have been observed following Additionally, the benthic invertebrates
may adjust their responses to vessel experimental exposures to sound. may be impacted by increased
activities depending on the level of Physical changes have also been sedimentation, resulting in higher
abundances of opportunistic species of pursuit, torment, or annoyance that explicit zones of ensonification were
that recover quickly from industrial has the potential to injure a marine established around the planned
activities that increase sedimentation mammal or marine mammal stock in the construction location to estimate the
(Kotta et al. 2009). Although sea otter wild. number of otters that may be exposed to
foraging could be impacted by industrial Level B Harassment—Level B these sound levels. We determined the
activities that cause vibrations and Harassment for nonmilitary readiness number of otters present in the
increased sedimentation, it is more activities means any act of pursuit, ensonification zones using density
likely that sea otters would be torment, or annoyance that has the information generated by Weitzman and
temporarily displaced from the project potential to disturb a marine mammal or Esslinger (2015), as well as local sources
area due to impacts from noise rather marine mammal stock in the wild by of data that indicated a higher density
than vibrations and sedimentation. causing disruption of behavioral of sea otters within the harbor
Potential Impacts of the Specified patterns, including, but not limited to, (Greenwood 2022; Prince William
Activities on Subsistence Uses migration, breathing, nursing, feeding, Sound Science Center 2022; Schinella
or sheltering. Changes in behavior that 2022, 2023; Solstice Alaska Consulting
The planned specified activities will disrupt biologically significant
occur near marine subsistence harvest Inc. 2022).
behaviors or activities for the affected
areas used by Alaska Natives from animal are indicative of take by Level B The project can be divided into five
Cordova and the surrounding areas. harassment under the MMPA. major components: DTH pile driving,
Since 2013, there have been 914 sea The Service has identified the vibratory pile driving, impact pile
otters harvested by hunters from the following sea otter behaviors as driving, skiff use to support
Cordova area, and most of those were indicative of possible Level B construction, and pile driving on land.
taken prior to 2016. From 2018 through harassment: Each of these components will generate
2022, 236 sea otters were harvested from • Swimming away at a fast pace on a different type of noise. Vibratory pile
the Cordova area. belly (i.e., porpoising); driving and the use of skiffs will
The planned project would occur • Repeatedly raising the head produce nonimpulsive or continuous
within the Cordova city limits, where vertically above the water to get a better noise; impact pile driving will produce
firearm use is prohibited. The area view (spyhopping) while apparently impulsive noise; and DTH pile driving
potentially affected by the planned agitated or while swimming away; is considered to produce both impulsive
project does not significantly overlap • In the case of a pup, repeatedly and continuous noise (NMFS 2020).
with current subsistence harvest areas. spyhopping while hiding behind and
Construction activities will not preclude The level of sound anticipated from
holding onto its mother’s head; each project component was established
access to hunting areas or interfere in • Abandoning prey or feeding area;
any way with individuals wishing to using recorded data from several
• Ceasing to nurse and/or rest sources listed in tables 2 through 7. We
hunt. Despite no conflict with (applies to dependent pups);
subsistence use being anticipated, the used the NMFS Technical Guidance and
• Ceasing to rest (applies to User Spreadsheet (NMFS 2018, 2020) to
Service will notify potentially affected independent animals);
communities and stakeholders of the determine the distance at which sound
• Ceasing to use movement corridors; levels would attenuate to Level A
public comment period on this • Ceasing mating behaviors;
proposed IHA so they have an harassment thresholds, and empirical
• Shifting/jostling/agitation in a raft
opportunity to share any questions, data from the proxy projects were used
so that the raft disperses;
to determine the distance at which
concerns, or potential conflicts • Sudden diving of an entire raft; or
regarding subsistence use in those areas. • Flushing animals off a haulout. sound levels would attenuate to Level B
If any conflicts are identified in the This list is not meant to encompass all harassment thresholds (table 1). The
future, the applicant will develop a plan possible behaviors; other behavioral weighting factor adjustment included in
of cooperation specifying the steps responses may equate to take by Level the NMFS user spreadsheet accounts for
necessary to minimize any effects the B harassment. Relatively minor changes sounds created in portions of an
project may have on subsistence in behavior such as increased vigilance organism’s hearing range where they
harvest. or a short-term change in direction of have less sensitivity. We used the
travel are not likely to disrupt weighting factor adjustment for otariid
Estimated Take pinnipeds as they are the closest
biologically important behavioral
Definitions of Incidental Take Under the patterns, and the Service does not view available physiological and anatomical
Marine Mammal Protection Act such minor changes in behavior as proxy for sea otters. The spreadsheet
Below we provide definitions of three indicative of a take by Level B also incorporates a transmission loss
potential types of take of sea otters. The harassment. coefficient, which accounts for the
Service does not anticipate and is not reduction in sound level outward from
Calculating Take a sound source. We used the NMFS-
authorizing lethal take as a part of this
proposed IHA; however, the definitions We assumed all animals exposed to recommended transmission loss
of these take types are provided for underwater sound levels that meet the coefficient of 15 for coastal pile-driving
context and background: acoustic exposure criteria defined above activities to indicate practical spread
Lethal Take—Human activity may in Exposure Thresholds will experience (NMFS 2020) to determine the distance
result in biologically significant impacts take by Level A or Level B harassment at which sound levels attenuate to 160
to sea otters. In the most serious due to exposure to underwater noise. dB re 1 mPa. Due to limited data of
interactions, human actions can result Likewise, we assumed that all animals underwater sound pressure levels from
in mortality of sea otters. exposed to airborne sound levels that DTH pile driving as well as differences
Level A Harassment—Human activity meet the acoustic exposure criteria in in how PTS and TTS thresholds are
may result in the injury of sea otters. Exposure Thresholds will experience calculated, the resultant Level A
Level A harassment, for nonmilitary take by Level B harassment due to isopleths for DTH pile driving are larger
readiness activities, is defined as any act exposure to in-air noise. Spatially than the Level B isopleths.
TABLE 2—SUMMARY OF SOUND LEVEL, TIMING OF SOUND PRODUCTION, DISTANCE FROM SOUND SOURCE TO BELOW
LEVEL A HARASSMENT AND LEVEL B HARASSMENT THRESHOLDS, DAYS OF IMPACT, SEA OTTERS IN LEVEL A AND
LEVEL B HARASSMENT ENSONIFICATION AREA, AND TOTAL OTTERS EXPECTED TO BE HARASSED THROUGH BEHAV-
IORAL DISTURBANCE BY VIBRATORY PILE DRIVING
30 to 61-cm 61-cm (24- 41-cm (16-in) 46-cm (18-in)

30 to 61-cm (12-in to 24- (12-in to 24- 61-cm (24-
inch) tem- permanent permanent 76-cm (30-in) permanent
Pile size in) existing timber pile rein) existing inch) tem-
plate installa- pile installa- pile installa- pile installation
moval steel pile re- plate removal
tion tion tion
moval
Total number of piles .......... 130 .................................... 61 ................ 61 ................ 61 ................ 155 .............. 70 ................ 30.
Sound level ......................... 162 dB re 1 μPa at 10 m 161 dB re 1 μPa at 10 m (RMS) 161.9 dB re 1 μPa at 10 m
(RMS). (RMS).
Source ................................. NMFS 2023 ...................... NAVFACa 2013, 2015 Denes et al. 2016.
Timing per pile .................... 10 minutes/pile ................. 10 minutes/ 10 minutes/ 10 minutes/ 15 minutes/ 20 minutes/ 30 minutes/pile.
pile. pile. pile. pile. pile.
Maximum number of piles 25 ...................................... 25 ................ 6 .................. 10 ................ 10 ................ 10 ................ 6.
per day.
Maximum number of days 6 ........................................ 3 .................. 11 ................ 7 .................. 16 ................ 7 .................. 5.
of activity.
Sea otter density ................. 111.11 sea otters/km2
Distance to below Level A 0.9 meters ......................... 0.8 meters ... 0.4 meters ... 0.4 meters ... 0.5 meters ... 0.7 meters ... 0.7 meters.
harassment threshold.
Level A area (km2) .............. 0.0000 ............................... 0.0000 ......... 0.0000 ......... 0.0000 ......... 0.0000 ......... 0.0000 ......... 0.0000.
Potential sea otters affected 0 ........................................ 0 .................. 0 .................. 0 .................. 0 .................. 0 .................. 0.
by Level A sound per day.
by Level A sound per day
(rounded).
Total potential Level A har- 0 ........................................ 0 .................. 0 .................. 0 .................. 0 .................. 0 .................. 0.
assment events.
Distance to below Level B 14 meters .......................... 12 meters .... 12 meters .... 12 meters .... 12 meters .... 12 meters .... 13 meters.
harassment threshold.
Level B area (km2) .............. 0.0003 ............................... 0.0002 ......... 0.0002 ......... 0.0002 ......... 0.0002 ......... 0.0002 ......... 0.0002.
Potential sea otters affected 0.0333 ............................... 0.0222 ......... 0.0222 ......... 0.0222 ......... 0.0222 ......... 0.0222 ......... 0.0222.
by Level B sound per day.
by Level B sound per day
(rounded).
Total potential Level B har- 6 ........................................ 3 .................. 11 ................ 7 .................. 16 ................ 7 .................. 5.
assment events.
a Naval Facilities Engineering Command.
LEVEL A HARASSMENT THRESHOLDS, DAYS OF IMPACT, SEA OTTERS IN LEVEL A HARASSMENT ENSONIFICATION
AREA, AND TOTAL OTTERS EXPECTED TO BE TAKEN BY LEVEL A HARASSMENT BY IMPACT PILE DRIVING
41-cm (16-in) permanent pile 46-cm (18-in) permanent pile 76-cm (30-in) permanent pile
Pile size installation installation installation
Total number of piles ............................. 73 .......................................................... 35 .......................................................... 20.

Sound level ............................................ 168.3 dB (SEL)/181.1 dB (RMS)/192.8 168.3 dB (SEL)/181.1 dB (RMS)/192.8 177 dB (SEL)/190 dB (RMS)/210 dB
dB (peak) re 1 μPa at 10 m. dB (peak) re 1 μPa at 10 m. (peak) re 1 μPa at 10 m.
Source .................................................... Denes et al. 2016 NMFS 2023.
Timing per pile ....................................... 20 minutes/pile; 240 strikes/pile ........... 20 minutes/pile; 240 strikes/pile ............ 20 minutes/pile; 360 strikes/pile.
Maximum number piles per day ............ 6 ............................................................ 6 ............................................................ 6.
Maximum number of days of activity ..... 13 .......................................................... 6 ............................................................ 4.
Sea otter density .................................... 111.11 sea otters/km2
Distance to below Level A harassment 5.2 meters ............................................. 5.2 meters ............................................. 25.9 meters.
threshold.
Total Level A area (km2) ....................... 0.0001 ................................................... 0.0001 ................................................... 0.0021.
Level A area (km2) after excluding 10-m 0 ............................................................ 0 ............................................................ 0.0018.
shutdown zone (0.0003 km2).
Potential sea otters affected by Level A 0 ............................................................ 0 ............................................................ 0.2000.
sound per day.
Potential sea otters affected by Level A 0 ............................................................ 0 ............................................................ 1.
sound per day (rounded).
Total potential Level A harassment 0 ............................................................ 0 ............................................................ 4.
events.
LEVEL B HARASSMENT THRESHOLDS, DAYS OF IMPACT, SEA OTTERS IN LEVEL B ENSONIFICATION AREA, AND TOTAL
OTTERS EXPECTED TO BE TAKEN BY LEVEL B HARASSMENT BY IMPACT PILE DRIVING
41-cm (16-in) permanent pile 46-cm (18-in) permanent pile 76-cm (30-in) permanent pile
Pile size installation installation installation
Total number of piles ............................. 73 .......................................................... 35 .......................................................... 20.

Sound level ............................................ 168.3 dB (SEL)/181.1 dB (RMS)/192.8 168.3 dB (SEL)/181.1 dB (RMS)/192.8 177 dB (SEL)/190 dB (RMS)/210 dB
dB (peak) re 1 μPa at 10 m. dB (peak) re 1 μPa at 10 m. (peak) re 1 μPa at 10 m.
Source .................................................... Denes et al. 2016 NMFS 2023.
Timing per pile ....................................... 20 minutes/pile; 240 strikes/pile ........... 20 minutes/pile; 240 strikes/pile ............ 20 minutes/pile; 360 strikes/pile.
Maximum number piles per day ............ 6 ............................................................ 6 ............................................................ 6.
Maximum number of days of activity ..... 13 .......................................................... 6 ............................................................ 4.
Distance to below Level B harassment 255 meters ............................................ 255 meters ............................................ 1,000 meters.
threshold a.
Total Level B area (km2) ....................... 0.2038 ................................................... 0.2038 ................................................... 0.3137.
Level B area (km2) within harbor ........... 0.18 ....................................................... 0.18 ....................................................... 0.18.
Sea otter density inside harbor .............. 111.11 sea otters/km2
Potential sea otters affected by Level B 19.9998 ................................................. 19.9998 ................................................. 19.9998.
sound per day within harbor.
Potential sea otters affected by Level B 20 .......................................................... 20 .......................................................... 20.
sound per day within harbor (round-
ed).
Potential Level B harassment events 260 ........................................................ 120 ........................................................ 80.
within harbor.
Level B area (km2) outside harbor ........ 0.0238 ................................................... 0.0238 ................................................... 0.1337.
Sea otter density outside harbor ........... 21.15 sea otters/km2
Potential sea otters affected by Level B 0.5034 ................................................... 0.5034 ................................................... 2.8278.
sound per day outside harbor.
Potential sea otters affected by Level B 1 ............................................................ 1 ............................................................ 3.
sound per day outside harbor (round-
ed).
Potential Level B harassment events 13 .......................................................... 6 ............................................................ 12.
outside harbor.
Total potential Level B harassment 273 ........................................................ 126 ........................................................ 92.
events.
IORAL DISTURBANCE BY DOWN-THE-HOLE PILE DRIVING
41-cm (16-in) 46-cm (18-in)

Pile size permanent pile permanent pile 76-cm (30-in) permanent pile installation
installation installation
Total number of piles .......................................... 50 ............................................. 20 ............................................. 16.
Sound level ......................................................... 159 dB (SEL)/167 dB (RMS) re 1 μPa at 10 m 164 dB (SEL)/174 dB (RMS) re 1 μPa at 10 m.
Source ................................................................. Heyvaert and Reyff 2021 Reyff and Heyvaert 2019, Reyff 2020, Denes
et al. 2019.
Timing per pile .................................................... 75 minutes/pile ......................... 75 minutes/pile ......................... 75 minutes/pile.

Maximum number piles per day ......................... 4 ............................................... 4 ............................................... 4.
Maximum number of days of activity .................. 13 ............................................. 5 ............................................... 4.
Sea otter density ................................................. 111.11 sea otters/km2
Distance to below Level A harassment thresh- 35.2 meters .............................. 35.2 meters .............................. 67.1 meters.
old.
Total Level A area (km2) ..................................... 0.0039 ...................................... 0.0039 ...................................... 0.0141.
Level A area (km2) after excluding 10-m shut- 0.0036 ...................................... 0.0036 ...................................... 0.0138.
down zone (0.0003 km2).
Potential sea otters affected by Level A sound 0.4000 ...................................... 0.4000 ...................................... 1.5333.
per day.
Potential sea otters affected by Level A sound 1 ............................................... 1 ............................................... 2.

per day (rounded).
Total potential Level A harassment events ........ 13 ............................................. 5 ............................................... 8.
Distance to below Level B harassment thresh- 29 meters ................................. 29 meters ................................. 86 meters.
old a.
Level B area (km2) .............................................. 0 ............................................... 0 ............................................... 0.0091.
Potential sea otters affected by Level B sound 0 ............................................... 0 ............................................... 1.0111.
per day.
Potential sea otters affected by Level B sound 0 ............................................... 0 ............................................... 2.
per day (rounded).
IORAL DISTURBANCE BY DOWN-THE-HOLE PILE DRIVING—Continued
41-cm (16-in) 46-cm (18-in)

Pile size permanent pile permanent pile 76-cm (30-in) permanent pile installation
installation installation
Total potential Level B harassment events ........ 0 ............................................... 0 ............................................... 8.

a Due to differences in how PTS and TTS thresholds are calculated, the Level A isopleths are larger than the Level B isopleths.
IORAL DISTURBANCE BY USE OF A SKIFF
Sound source Worker transit skiff
Sound level .......................................................................................................................... 182 dB (RMS) re 1 μPa at 0.9 m.

Source .................................................................................................................................. Kipple and Gabriele 2007.
Number of days of vessel use ............................................................................................. 170.
Sea otter density .................................................................................................................. 111.11 sea otters/km2.
Distance to below Level A harassment threshold ............................................................... 0 meters.
Level A area (km2) ............................................................................................................... 0.
Potential sea otters affected by Level A sound per day ..................................................... 0.
Potential sea otters affected by Level A sound per day (rounded) .................................... 0.
Total potential Level A harassment events ......................................................................... 0.
Distance to below Level B harassment threshold ............................................................... 26.4 meters.
Total Level B area (km2) ...................................................................................................... 0.007.
Level B area after excluding 10-m shutdown zone (0.0003 km2) ....................................... 0.0067.
Potential sea otters affected by Level B sound per day ..................................................... 0.7444.
Potential sea otters affected by Level B sound per day (rounded) .................................... 1.
Total potential Level B harassment events ......................................................................... 170.
LEVEL B HARASSMENT THRESHOLDS, DAYS OF IMPACT, SEA OTTERS IN LEVEL B HARASSMENT ENSONIFICATION
AREA, AND TOTAL OTTERS EXPECTED TO BE HARASSED THROUGH BEHAVIORAL DISTURBANCE BY IN-AIR SOUND
Sound source Vibratory pile driving on shore Impact pile driving on shore
Sound level .............................................................................................................. 103.2 dB re 20 μPa at 15 m (RMS) ...... 101 dB 20 μPa at 15 m (RMS).
Source ..................................................................................................................... Laughlin 2010 ......................................... Ghebreghzabiher 2017.
Maximum number of days of activity ....................................................................... 45 ........................................................... 21.
Sea otter density ..................................................................................................... 111.11 sea otters/km.2
Distance to below Level B harassment threshold ................................................... 22 meters ............................................... 17 meters.

Total Level B area (km2) ......................................................................................... 0.0015 .................................................... 0.0009.
Level B area after excluding 10-m shutdown zone (0.0003 km2) .......................... 0.0012 .................................................... 0.0006.
Potential sea otters affected by Level B sound per day ......................................... 0.1333 .................................................... 0.0667.
Potential sea otters affected by Level B sound per day (rounded) ........................ 1 ............................................................. 1.
Total potential Level B harassment events ............................................................. 45 ........................................................... 21.
Sound levels for all underwater sound dB re 1mPa outside Cordova Harbor by sounds >100 dB re 20 mPa due to pile
sources are unweighted and given in dB the density of animals (21.15 sea otters/ driving, we multiplied the area
re 1 mPa; sound levels for airborne km2) derived from surveys conducted of ensonified to >100 dB re 20 mPa by the
sound sources are unweighted and Orca Inlet (Weitzman and Esslinger density of sea otters within the harbor
given in dB re 20 mPa. Nonimpulsive 2015), whereas the area ensonified to (111.11 sea otters/km2; Greenwood
sounds are in the form of mean >160 dB re 1mPa within Cordova Harbor 2022; Prince William Sound Science
maximum root mean square (RMS) was multiplied by the density derived Center 2022; Schinella 2022, 2023;
sound pressure level (SPL) as it is more from local knowledge (111.11 sea otters/ Solstice Alaska Consulting Inc. 2022).
conservative than cumulative sound km2; Greenwood 2022; Prince William The number of sea otters expected to be
exposure level (SEL) or peak SPL for Sound Science Center 2022; Schinella exposed to such sound levels can be
these activities. Impulsive sound 2022, 2023; Solstice Alaska Consulting found in tables 2 through 7. To calculate
sources are in the form of SEL for a Inc. 2022). We applied the same the underwater area ensonified for most
single strike. methodology to determine the number types of pile-driving activity, we used
To determine the number of sea otters of sea otters that may experience sounds pr2. Given the numerous harbor floats
that may experience in-water sounds capable of causing PTS. Similarly, to and the number of piles being removed
>160 dB re 1mPa due to pile driving, we determine the number of sea otters that and installed, it was not feasible to
multiplied the area ensonified to >160 may experience airborne construction calculate the actual area of water
ensonified for most activities, so the will implement shutdown zones ranging density to estimate take for areas
area of a circle was used for a from 10 to 100 m (33 to 328 ft), based ensonified within the harbor.
conservative estimate for pile driving on the pile size and type of pile driving We used sound source verification
activities where the ensonified area is or construction activity, where from recent pile-driving activities in a
entirely within the harbor. Likewise, to operations will cease should a sea otter number of locations within and beyond
calculate the area ensonified by pile- enter or approach the specified zone. Alaska to generate sound level estimates
driving activities on shore, we used pr2. Soft-start and zone clearance prior to for construction activities.
For the Level B underwater area startup will also limit the exposure of Environmental conditions in these
ensonified by impact pile driving 76-cm sea otters to sound levels that could locations, including water depth,
(30-in) piles, we used ArcGIS Pro to cause PTS. However, the City of substrate, and ambient sound levels, are
map the zones and calculate the area of Cordova has requested, and the Service similar to those in the project location,
the water ensonified, since it is the proposes to authorize, small numbers of but not identical. Further, estimation of
largest zone and extends beyond the take by Level A harassment during underwater ensonification zones were
harbor. The applicant proposed a impact pile driving and DTH drilling. based on sound attenuation models
universal 10-m (33-ft) shutdown zone using a practical spreading loss model;
for all project activities so that area was Critical Assumptions
estimation of in-air ensonification zones
subtracted from all calculated areas We estimate that 790 takes of 77 sea were based on sound attenuation
when estimating take. otters by Level B harassment and 30 models using a spherical spreading loss
The area ensonified by the worker takes of 5 sea otters by Level A model. These factors may lead to actual
transit skiff was estimated by harassment may occur due to the City’s sound values differing slightly from
multiplying the vessel’s anticipated planned harbor construction activities. those estimated here.
daily track length by twice the 160 dB In order to conduct this analysis and
radius plus pr2 to account for the estimate the potential amount of take by Finally, the in-water pile-driving
rounded ends of the track line. It was harassment, several critical assumptions activities described here will also create
estimated that the distance of each trip were made. in-air noise. Because sea otters spend
would be no more than 91.44 m (300 ft). Level B harassment is equated herein over half of their day with their heads
We assumed that the different types of with behavioral responses that indicate above water (Esslinger et al. 2014), they
activities would occur sequentially and harassment or disturbance. There is will be exposed to increased in-air noise
that the total number of days of work likely a portion of animals that respond from construction equipment. However,
would equal the sum of the number of in ways that indicate some level of we have calculated Level B harassment
days required to complete each type of disturbance but do not experience with the assumption that an individual
activity. While it is possible that on significant biological consequences. may be harassed only one time per 24-
some days more than one type of We used the sea otter density for Orca hour period, and underwater sound
activity will take place, which would Inlet from surveys and analyses levels will be more disturbing and
reduce the number of days of exposure conducted by Weitzman and Esslinger extend farther than in-air noise. Thus,
within a year, we cannot know this (2015) for areas ensonified outside while sea otters may be disturbed by
information in advance. As such, the Cordova Harbor. Methods and noise both in air and underwater, we
estimated number of days and, assumptions for these surveys can be have relied on the more conservative
therefore, exposures per year is the found in the original publication. underwater estimates.
maximum possible for the planned Multiple local sources (Greenwood Sum of Harassment From All Sources
work. Where the number of exposures 2022; Prince William Sound Science
expected per day was zero to three or Center 2022; Schinella 2022, 2023; The applicant plans to conduct pile
more decimal places (i.e., <0.00X), the Solstice Alaska Consulting Inc. 2022) driving and marine construction
number of exposures per day was indicated a higher density within the activities in Cordova, Alaska, over the
assumed to be zero. Cordova Harbor—approximately 20 sea course of a year from the date of
In order to minimize exposure of sea otters at any given time within the 0.18 issuance of the IHA. A summary of total
otters to sounds above Level A km2 area of the harbor, or a density of estimated take during the project, by
harassment thresholds, the applicant 111.11 sea otters/km2. We used this source, is provided in table 8.
TABLE 8—TOTAL ESTIMATED TAKES BY SOURCE OF LEVEL A AND LEVEL B HARASSMENT OF SEA OTTERS
Sea otters Total takes of Sea otters Total takes of
Number of exposed per day sea otters by exposed per day sea otters by
Source days of to Level A Level A to Level B Level B
activity harassment harassment harassment harassment
Vibratory drilling:
30-to-61-cm (12-in-to-24-in) existing timber pile removal ............. 6 0 0 1 6
30-to-61-cm (12-in-to-24-in) existing steel pile removal ................ 3 0 0 1 3
61-cm (24-in) template installation ................................................ 11 0 0 1 11
61-cm (24-in) template removal ..................................................... 7 0 0 1 7
41-cm (16-in) permanent pile installation ...................................... 16 0 0 1 16
Impact drilling:
Down-the-hole drilling:
Skiff use:
Worker transit skiff ......................................................................... 170 0 0 1 170
TABLE 8—TOTAL ESTIMATED TAKES BY SOURCE OF LEVEL A AND LEVEL B HARASSMENT OF SEA OTTERS—Continued
Sea otters Total takes of Sea otters Total takes of
Number of exposed per day sea otters by exposed per day sea otters by
Source days of to Level A Level A to Level B Level B
activity harassment harassment harassment harassment
In-air Sound:
Vibratory pile driving on shore ....................................................... 45 0 0 1 45
Impact pile driving on shore .......................................................... 21 0 0 1 21
Totals ...................................................................................... 336 5 30 77 790
Over the course of the project, we Because activities will occur during a period of this proposed IHA (see Sum of
estimate 790 instances of take by Level limited amount of time and in a Harassment from All Sources). Take of
B harassment of 77 northern sea otters localized region, the impacts associated 82 animals is 0.4 percent of the best
from the Southcentral Alaska stock due with the project are likewise temporary available estimate of the current
to behavioral responses of TTS and localized. The anticipated effects Southcentral Alaska stock size of 21,617
associated with noise exposure. are short-term behavioral reactions and animals (Esslinger et al. 2021) ((82 ÷
Although multiple instances of Level B displacement of sea otters near active 21,617) × 100 ≈ 0.4) and represents a
harassment of individual sea otters are operations. ‘‘small number’’ of sea otters of that
possible, these events are unlikely to Sea otters that encounter the specified stock.
have significant consequences for the activity may exert more energy than
they would otherwise, due to temporary Negligible Impact
health, reproduction, or survival of
affected animals, and therefore would cessation of feeding, increased We propose a finding that any
not rise to the level of an injury or Level vigilance, and retreating from the incidental take by harassment resulting
A harassment. project area. We expect that affected sea from the specified activities cannot be
The use of soft-start procedures, zone otters will tolerate this exertion without reasonably expected to, and is not
clearance prior to startup, and measurable effects on health or reasonably likely to, adversely affect the
shutdown zones is likely to decrease reproduction. Most of the anticipated sea otter through effects on annual rates
both the number of sea otters exposed takes will be due to short-term Level B of recruitment or survival and will,
to sounds above Level A harassment harassment in the form of TTS, startle therefore, have no more than a
thresholds and the exposure time of any reactions, or temporary displacement. negligible impact on the Southcentral
sea otters venturing into a Level A While mitigation measures incorporated Alaska stock of northern sea otters. In
harassment zone. This reduces the into the applicant’s request will reduce making this finding, we considered the
likelihood of losses of hearing occurrences of Level A harassment to best available scientific information,
sensitivity that might impact the health, the extent practicable, a small number including the biological and behavioral
reproduction, or survival of affected of takes by Level A harassment would characteristics of the species, the most
animals. Despite the implementation of be authorized for impact and DTH pile- recent information on species
mitigation measures, it is anticipated driving activities, which have Level A distribution and abundance within the
that some sea otters will experience harassment zone radii ranging in size area of the specified activities, the
Level A harassment via exposure to from 5.2 to 67.1 m (17 to 220 ft). current and expected future status of the
underwater sounds above threshold With the adoption of the mitigation stock (including existing and
criteria during impact and DTH pile- measures incorporated in the foreseeable human and natural
driving activities. Due to sea otters’ applicant’s request and required by this stressors), the potential sources of
small body size and low profile in the proposed IHA, anticipated take was disturbance caused by the project, and
water, as well as the relatively large size reduced. Those mitigation measures are the potential responses of marine
of the Level A harassment zone further described below. mammals to this disturbance. In
associated with these activities, we addition, we reviewed applicant-
anticipate that sea otters will at times Small Numbers provided materials, information in our
avoid detection before entering Level A To assess whether the authorized files and datasets, published reference
harassment zones for those activities. incidental taking would be limited to materials, and species experts.
We anticipate that protected species ‘‘small numbers’’ of marine mammals, Sea otters are likely to respond to
observers (PSOs) will be able to reliably the Service uses a proportional planned activities with temporary
detect and prevent take by Level A approach that considers whether the behavioral modification or temporary
harassment of sea otters up to 10 m (33 estimated number of marine mammals displacement. These reactions are not
ft) away; conversely, we anticipate that to be subjected to incidental take is anticipated to have consequences for the
at distances greater than 10 m, sea otters small relative to the population size of long-term health, reproduction, or
will at times avoid detection. the species or stock. Here, predicted survival of affected animals. Most
Throughout the project, we estimate 30 levels of take were determined based on animals will respond to disturbance by
instances of take by Level A harassment the estimated density of sea otters in the moving away from the source, which
of 5 sea otters. project area and ensonification zones may cause temporary interruption of
developed using empirical evidence foraging, resting, or other natural

Determinations and Findings from similar geographic areas. behaviors. Affected animals are
Sea otters exposed to sound from the We estimate that the City’s specified expected to resume normal behaviors
specified activities are likely to respond activities in the specified geographic soon after exposure, with no lasting
with temporary behavioral modification region will result in no more than 790 consequences. Each sea otter is
or displacement. The specified activities takes of 77 sea otters by Level B estimated to be exposed to construction
could temporarily interrupt the feeding, harassment and 30 takes of 5 sea otters noise for between 3 and 170 days per
resting, and movement of sea otters. by Level A harassment during the 1-year year, resulting in repeated exposures.
However, injuries (i.e., Level A activities, the potential effects of the Impact on Subsistence Use
harassment or PTS) due to chronic activities on sea otters, the documented The project will not preclude access
sound exposure are estimated to occur impacts of similar activities on sea to harvest areas or interfere with the
over a longer time scale (Southall et al. otters, and alternative mitigation availability of sea otters for harvest.
2019). The area that will experience measures. Additionally, the construction activities
noise greater than Level B thresholds In evaluating what mitigation take place within the Cordova Harbor,
due to pile driving is small (less than measures are appropriate to ensure the where firearm use is prohibited. We
0.0141 km2), and an animal that may be least practicable adverse impact on therefore propose a finding that the
disturbed could escape the noise by species or stocks and their habitat, as applicant’s anticipated harassment will
moving to nearby quiet areas. Further, well as subsistence uses, we considered not have an unmitigable adverse impact
sea otters spend over half of their time the manner and degree to which the on the availability of any stock of
above the surface during the summer successful implementation of the northern sea otters for taking for
months (Esslinger et al. 2014), and measures are expected to achieve this subsistence uses. In making this finding,
likely no more than 70 percent of their goal. We considered the nature of the we considered the timing and location
time foraging during winter months potential adverse impact being of the planned activities and the timing
(Gelatt et al. 2002); thus, their ears will mitigated (likelihood, scope, range), the and location of subsistence harvest
not be exposed to continuous noise, and likelihood that the measures will be activities in the project area.
the amount of time it may take for effective if implemented, and the
permanent injury is considerably longer likelihood of effective implementation. Monitoring and Reporting
than that of mammals primarily under We also considered the practicability of The purposes of the monitoring
water. Some animals may exhibit some the measures for applicant requirements are to document and
of the stronger responses typical of implementation (e.g., cost, impact on provide data for assessing the effects of
Level B harassment, such as fleeing, operations). We assessed whether any specified activities on sea otters; to
interruption of feeding, or flushing from additional practicable requirements ensure that take is consistent with that
a haulout. These responses could have could be implemented to further reduce anticipated in the small numbers,
temporary biological impacts for effects, but did not identify any. negligible impact, and subsistence use
affected individuals, but are not To reduce the potential for analyses; and to detect any
anticipated to result in measurable disturbance from acoustic stimuli unanticipated effects on the species.
changes in survival or reproduction. associated with the activities, the City of Monitoring plans include steps to
The total number of animals affected Cordova will implement mitigation document when and how sea otters are
and severity of impact are not sufficient measures, including the following: encountered and their numbers and
to change the current population • Using a project design that behaviors during these encounters. This
dynamics at the stock scale. Although incorporates the smallest diameter piles information allows the Service to
the specified activities may result in
and footprint practicable while measure encounter rates and trends and
approximately 820 incidental takes of
minimizing the overall number of piles to estimate numbers of animals
82 sea otters from the Southcentral
and area; potentially affected. To the extent
Alaska stock, we do not expect this level
• Using a project design that does not possible, monitors will record group
of harassment to affect annual rates of
include dredging or excavating below size, age, sex, reaction, duration of
recruitment or survival or result in
the high tide line; interaction, and closest approach to the
adverse effects on the stock.
Our proposed finding of negligible • Using a project design that does not project activity.
include blasting; As proposed, monitoring activities
impact applies to incidental take
associated with the specified activities • Using pile driving equipment with will be summarized and reported in
as mitigated by the avoidance and muffler systems to reduce in-air noise formal reports. The applicant must
minimization measures identified in the generation; submit monthly reports for all months
applicant’s mitigation and monitoring • Using a vibratory hammer equipped during which noise-generating work
plan. These mitigation measures are with a suppressor to reduce rattling; takes place as well as a final monitoring
designed to minimize interactions with • Using dampeners to eliminate steel- report that must submitted no later than
and impacts to sea otters. These on-steel in-air noise; 90 days after the expiration of the IHA.
measures and the monitoring and • Employing a sediment curtain We will require an approved plan for
reporting procedures are required for during all DTH pile driving to contain monitoring and reporting the effects of
the validity of our finding and are a drill spoils and to minimize turbidity; pile driving and marine construction
necessary component of the proposed • Development of a marine mammal activities on sea otters prior to issuance
IHA. For these reasons, we propose a monitoring and mitigation plan; of an IHA. We will require approval of
finding that the specified project will • Establishment of shutdown and the monitoring results for continued
have a negligible impact on the monitoring zones; operation under the IHA.
• Visual mitigation monitoring by We find that these proposed
Southcentral Alaska stock of northern
designated protected species observers monitoring and reporting requirements
sea otters.
(PSO); to evaluate the potential impacts of
Least Practicable Adverse Impacts • Site clearance before startup; planned activities will ensure that the
We find that the mitigation measures • Soft-start procedures; and effects of the activities remain
required by this proposed IHA will • Shutdown procedures. consistent with the rest of the findings.
affect the least practicable adverse The Service has not identified any Required Determinations
impacts on the stocks from any additional (i.e., not already incorporated
incidental take likely to occur in into the applicant’s request) mitigation National Environmental Policy Act
association with the specified activities. or monitoring measures that are (NEPA)
In making this finding, we considered practicable and would further reduce We have prepared a draft
the biological characteristics of sea potential impacts to sea otters and their environmental assessment in
otters, the nature of the specified habitat. accordance with the NEPA (42 U.S.C.
4321 et seq.). We have preliminarily We invite continued discussion, City of Cordova’s request. Changes to
concluded that authorizing the either about the project and its impacts the specified project without prior
nonlethal, incidental, unintentional take or about our coordination and authorization may invalidate the IHA.
by Level B harassment of up to 790 information exchange throughout the (5) The City of Cordova’s request is
takes of 77 sea otters and by Level A IHA process. approved and fully incorporated into
harassment of up to 30 takes of 5 sea this IHA unless exceptions are
Proposed Authorization specifically noted herein. The request
otters from the Southcentral Alaska
stock in the specified geographic region We propose to authorize the nonlethal includes:
during the specified activities during incidental take by Level A and Level B (i) The City of Cordova’s original
the regulatory period would not harassment of 820 takes of 82 sea otters request for an IHA, dated February 28,
significantly affect the quality of the from the Southcentral Alaska stock. 2023;
human environment and, thus, Authorized take may be caused by pile (ii) Revised requests, dated April 27,
preparation of an environmental impact driving and marine construction May 18, and June 8, 2023;
statement for this proposed IHA is not activities conducted by the City of (iii) Marine Mammal Mitigation and
required by section 102(2) of NEPA or Cordova in Cordova, Alaska, over the Monitoring Plan; and
course of a year from the date of (iv) Google Earth package;
its implementing regulations. We are (6) Operators will allow Service
accepting comments on the draft issuance of the IHA. We do not
anticipate or authorize any lethal take to personnel or the Service’s designated
environmental assessment as specified representative to visit project worksites
above in DATES and ADDRESSES. sea otters resulting from these activities.
to monitor for impacts to sea otters and
Government-to-Government A. General Conditions for the Incidental subsistence uses of sea otters at any time
Consultation Harassment Authorization (IHA) throughout project activities, so long as
It is our responsibility to (1) Activities must be conducted in it is safe to do so. ‘‘Operators’’ are all
communicate and work directly on a the manner described in the request personnel operating under the City of
Government-to-Government basis with from the City of Cordova for an IHA and Cordova’s authority, including all
federally recognized Alaska Native in accordance with all applicable contractors and subcontractors.
Tribes in developing programs for conditions and mitigation measures. B. Avoidance and Minimization
healthy ecosystems. We seek their full The taking of sea otters whenever the
(7) Construction activities must be
and meaningful participation in required conditions, mitigation,
conducted using equipment that
evaluating and addressing conservation monitoring, and reporting measures are
generates the lowest practicable levels
concerns for protected species. It is our not fully implemented as required by
of underwater sound within the range of
goal to remain sensitive to Alaska the IHA is prohibited. Failure to follow frequencies audible to sea otters.
Native culture, and to make information the measures specified both in the (8) During all pile-installation
available to Alaska Tribal organizations request and within this proposed activities, regardless of predicted sound
and communities. Our efforts are guided authorization may result in the levels, a physical interaction shutdown
by the following policies and directives: modification, suspension, or revocation zone of 10 m (33 ft) must be enforced.
(1) The Native American Policy of the of the IHA. If a sea otter enters the shutdown zone,
Service (January 20, 2016); (2) If project activities cause in-water activities must be delayed until
(2) The Alaska Native Relations Policy unauthorized take (i.e., greater than 820 either the animal has been visually
(currently in draft form); takes of 82 of the Southcentral Alaska observed outside the shutdown zone, or
(3) Executive Order 13175 (January 9, stock of northern sea otters, a form of 15 minutes have elapsed since the last
2000); take other than Level A or Level B observation time without redetection of
(4) Department of the Interior harassment, or take of one or more sea the animal.
Secretary’s Orders 3206 (June 5, 1997), otters through methods not described in (9) If the impact driver has been idled
3225 (January 19, 2001), 3317 the IHA), the City of Cordova must take for more than 30 minutes, an initial set
(December 1, 2011), and 3342 (October the following actions: of three strikes from the impact driver
21, 2016); (i) cease its activities immediately (or must be delivered at reduced energy,
(5) The Alaska Government-to- reduce activities to the minimum level followed by a 1-minute waiting period,
Government Policy (a departmental necessary to maintain safety); before full powered proofing strikes.
memorandum issued January 18, 2001); (ii) report the details of the incident (10) In-water activity must be
and to the Service within 48 hours; and conducted in daylight. If environmental
(6) The Department of the Interior’s (iii) suspend further activities until conditions prevent visual detection of
policies on consultation with Alaska the Service has reviewed the sea otters within the shutdown zone, in-
Native Tribes and organizations. circumstances and determined whether water activities must be stopped until
We have evaluated possible effects of additional mitigation measures are visibility is regained.
the specified activities on federally necessary to avoid further unauthorized (11) All in-water work along the
recognized Alaska Native Tribes and taking. shoreline must be conducted during low
organizations. The Service has (3) All operations managers, vehicle tide when the site is dewatered to the
determined that, due to this project’s operators, and machine operators must maximum extent practicable.
locations and activities, the Tribal receive a copy of this IHA and maintain
organizations and communities near access to it for reference at all times C. Mitigation Measures for Vessel
Cordova, Alaska, as well as relevant during project work. These personnel Operations
Alaska Native Claims Settlement Act must understand, be fully aware of, and Vessel operators must take every
corporations, will not be impacted by be capable of implementing the precaution to avoid harassment of sea
this project. Regardless, we will be conditions of the IHA at all times during otters when a vessel is operating near
reaching out to them to inform them of project work. these animals. The applicant must carry
the availability of this proposed IHA (4) This IHA will apply to activities out the following measures:
and offer them the opportunity to associated with the specified project as (12) Vessels must remain at least 500
consult. described in this document and in the m (0.3 mi) from rafts of sea otters, unless
safety is a factor. Vessels must reduce (i) All data will be recorded onto a number, location, distance from the
speed and maintain a distance of 100 m field form or database. sound source, and behavior of the sea
(328 ft) from all sea otters, unless safety (ii) Global positioning system data, otters; the associated project activities;
is a factor. sea state, wind force, and weather will and a description of the implementation
(13) Vessels must not be operated in be collected at the beginning and end of and effectiveness of mitigation measures
such a way as to separate members of a monitoring period, every hour in with a discussion of any specific
a group of sea otters from other between, at the change of an observer, behaviors the sea otters exhibited in
members of the group, and must avoid and upon sightings of sea otters. response to mitigation.
alongshore travel in shallow water (<20 (iii) Observation records of sea otters (26) A final report will be submitted
m (66 ft)) whenever practicable. will include date; time; the observer’s to the Service’s MMM within 90 days
(14) When weather conditions locations, heading, and speed (if after completion of work or expiration
require, such as when visibility drops, moving); weather; visibility; number of of the IHA. The report will include:
vessels must adjust speed accordingly to animals; group size and composition (i) A summary of monitoring efforts
avoid the likelihood of injury to sea (adults/juveniles); and the location of (hours of monitoring, activities
otters. the animals (or distance and direction monitored, number of PSOs, and, if
(15) Vessel operators must be from the observer). requested by the Service, the daily
provided written guidance for avoiding (iv) Observation records will also monitoring logs).
collisions and minimizing disturbances include initial behaviors of the sea (ii) A description of all project
to sea otters. Guidance will include otters, descriptions of project activities activities, along with any additional
measures identified in paragraphs and underwater sound levels being work yet to be done. Factors influencing
(C)(12) through (15) of this section. generated, the position of sea otters visibility and detectability of marine
relative to applicable monitoring and mammals (e.g., sea state, number of
D. Monitoring
mitigation zones, any mitigation observers, and fog and glare) will be
(16) Operators shall work with measures applied, and any apparent discussed.
protected species observers (PSO) to reactions to the project activities before (iii) A description of the factors
apply mitigation measures and shall and after mitigation. affecting the presence and distribution
recognize the authority of PSOs up to (v) For all sea otters in or near a of sea otters (e.g., weather, sea state, and
and including stopping work, except mitigation zone, observers will record project activities). An estimate will be
where doing so poses a significant safety the distance from the sound source to included of the number of sea otters
risk to personnel. the sea otter upon initial observation, exposed to noise at received levels
(17) Duties of the PSOs include the duration of the encounter, and the greater than or equal to 160 dB (based
watching for and identifying sea otters, distance at last observation in order to on visual observation).
recording observation details, monitor cumulative sound exposures. (iv) A description of changes in sea
documenting presence in any applicable (vi) Observers will note any instances otter behavior resulting from project
monitoring zone, identifying and of animals lingering close to or traveling activities and any specific behaviors of
documenting potential harassment, and with vessels for prolonged periods of interest.
working with operators to implement all time. (v) A discussion of the mitigation
appropriate mitigation measures. (22) Monitoring of the shutdown zone measures implemented during project
(18) A sufficient number of PSOs will must continue for 30 minutes following activities and their observed
be available to meet the following completion of pile installation. effectiveness for minimizing impacts to
criteria: 100 percent monitoring of sea otters. Sea otter observation records
exclusion zones during all daytime E. Measures To Reduce Impacts to will be provided to the Service in the
periods of underwater noise-generating Subsistence Users form of electronic database or
work; a maximum of 4 consecutive (23) Prior to conducting the work, the spreadsheet files.
hours on watch per PSO; a maximum of City of Cordova will take the following (27) Injured, dead, or distressed sea
approximately 12 hours on watch per steps to reduce potential effects on otters that are not associated with
day per PSO. subsistence harvest of sea otters: project activities (e.g., animals known to
(19) All PSOs will complete a training (i) Avoid work in areas of known sea be from outside the project area,
course designed to familiarize otter subsistence harvest; previously wounded animals, or
individuals with monitoring and data (ii) If any concerns remain, develop a carcasses with moderate to advanced
collection procedures. A field crew plan of cooperation in consultation with decomposition or scavenger damage)
leader with prior experience as a sea the Service and subsistence must be reported to the Service within
otter observer will supervise the PSO stakeholders to address these concerns. 24 hours of the discovery to either the
team. Initially, new or inexperienced Service’s MMM (1–800–362–5148,
PSOs will be paired with experienced F. Reporting Requirements
business hours), the Alaska SeaLife
PSOs so that the quality of marine (24) The City of Cordova must notify Center in Seward (1–888–774–7325, 24
mammal observations and data the Service at least 48 hours prior to hours a day), or both. Photographs,
recording is kept consistent. Resumes commencement of activities. video, location information, or any other
for candidate PSOs will be made (25) Monthly reports will be available documentation must be
available for the Service to review. submitted to the Service’s Marine provided to the Service.
(20) Observers will be provided with Mammal Management office (MMM) for (28) All reports shall be submitted by
reticule binoculars (7×50 or better), big- all months during which noise- email to fw7_mmm_reports@fws.gov.
eye binoculars or spotting scopes (30×), generating work takes place. The (29) The City of Cordova must notify
inclinometers, and range finders. Field monthly report will contain and the Service upon project completion or
guides, instructional handbooks, maps, summarize the following information: end of the work season.
and a contact list will also be made dates, times, weather, and sea
available. conditions (including the Beaufort Scale Request for Public Comments
(21) Observers will collect data using sea state and wind force conditions) If you wish to comment on this
the following procedures: when sea otters were sighted; the proposed authorization, the associated
draft environmental assessment, or both otherwise prohibited by the ESA with your comment. Provide sufficient
documents, you may submit your respect to any endangered species. information to allow us to authenticate
comments by either of the methods DATES: We must receive comments by any scientific or commercial data you
described in ADDRESSES. Please identify December 6, 2023. include. The comments and
whether you are commenting on the ADDRESSES: recommendations that will be most
proposed authorization, draft Obtaining Documents: The useful and likely to influence agency
environmental assessment, or both, decisions are: (1) Those supported by
applications, application supporting
make your comments as specific as quantitative information or studies; and
materials, and any comments and other
possible, confine them to issues (2) those that include citations to, and
materials that we receive will be
pertinent to the proposed authorization, analyses of, the applicable laws and
available for public inspection at
and explain the reason for any changes regulations.
https://www.regulations.gov in Docket
you recommend. Where possible, your
No. FWS–HQ–IA–2023–0207. B. May I review comments submitted by
comments should reference the specific
Submitting Comments: When others?
section or paragraph that you are
submitting comments, please specify the
addressing. The Service will consider
name of the applicant and the permit You may view and comment on
all comments that are received before
the close of the comment period (see number at the beginning of your others’ public comments at https://
DATES). The Service does not anticipate
comment. You may submit comments www.regulations.gov unless our
extending the public comment period by one of the following methods: allowing so would violate the Privacy
beyond the 30 days required under • Internet: https:// Act (5 U.S.C. 552a) or Freedom of
section 101(a)(5)(D)(iii) of the MMPA. www.regulations.gov. Search for and Information Act (5 U.S.C. 552).
Comments, including names and submit comments on Docket No. FWS–
HQ–IA–2023–0207. C. Who will see my comments?
street addresses of respondents, will
become part of the administrative record • U.S. mail: Public Comments If you submit a comment at https://
for this proposal. Before including your Processing, Attn: Docket No. FWS–HQ– www.regulations.gov, your entire
address, telephone number, email IA–2023–0207; U.S. Fish and Wildlife comment, including any personal
address, or other personal identifying Service Headquarters, MS: PRB/3W, identifying information, will be posted
information in your comment, be 5275 Leesburg Pike, Falls Church, VA on the website. If you submit a
advised that your entire comment, 22041–3803. hardcopy comment that includes
including your personal identifying For more information, see Public personal identifying information, such
information, may be made publicly Comment Procedures under as your address, phone number, or
available at any time. While you can ask SUPPLEMENTARY INFORMATION.
email address, you may request at the
us in your comments to withhold from FOR FURTHER INFORMATION CONTACT: top of your document that we withhold
public review your personal identifying Brenda Tapia, by phone at 703–358– this information from public review.
information, we cannot guarantee that 2185 or via email at DMAFR@fws.gov. However, we cannot guarantee that we
we will be able to do so. Individuals in the United States who are will be able to do so. Moreover, all
deaf, deafblind, hard of hearing, or have submissions from organizations or
Peter Fasbender,
a speech disability may dial 711 (TTY, businesses, and from individuals
Assistant Regional Director Fisheries and
TDD, or TeleBraille) to access identifying themselves as
Ecological Services, Alaska Region.
telecommunications relay services. representatives or officials of
[FR Doc. 2023–24428 Filed 11–3–23; 8:45 am]
Individuals outside the United States organizations or businesses, will be
should use the relay services offered made available for public disclosure in
within their country to make their entirety.
international calls to the point-of-
DEPARTMENT OF THE INTERIOR II. Background
contact in the United States.
Fish and Wildlife Service SUPPLEMENTARY INFORMATION:
To help us carry out our conservation
[Docket No. FWS–HQ–IA–2023–0207; I. Public Comment Procedures responsibilities for affected species, and
FXIA16710900000–234–FF09A30000] in consideration of section 10(c) of the
A. How do I comment on submitted Endangered Species Act of 1973, as
Foreign Endangered Species; Receipt applications? amended (ESA; 16 U.S.C. 1531 et seq.),
of Permit Applications We invite the public and local, State, we invite public comments on permit
AGENCY: Fish and Wildlife Service, Tribal, and Federal agencies to comment applications before final action is taken.
Interior. on these applications. Before issuing With some exceptions, the ESA
ACTION: Notice of receipt of permit any of the requested permits/, we will prohibits certain activities with listed
applications; request for comments. take into consideration any information species unless Federal authorization is
that we receive during the public issued that allows such activities.
SUMMARY: We, the U.S. Fish and comment period. Permits issued under section 10(a)(1)(A)
Wildlife Service, invite the public to You may submit your comments and of the ESA allow otherwise prohibited
comment on applications to conduct materials by one of the methods in activities for scientific purposes or to
certain activities with foreign species ADDRESSES. We will not consider enhance the propagation or survival of
that are listed as endangered under the comments sent by email or to an address the affected species. Service regulations
Endangered Species Act (ESA). With not in ADDRESSES. We will not consider regarding prohibited activities with
some exceptions, the ESA prohibits or include in our administrative record endangered species, captive-bred
activities with listed species unless comments we receive after the close of wildlife registrations, and permits for
Federal authorization is issued that the comment period (see DATES). any activity otherwise prohibited by the
allows such activities. The ESA also When submitting comments, please ESA with respect to any endangered
requires that we invite public comment specify the name of the applicant and species are available in title 50 of the
before issuing permits for any activity the permit number at the beginning of Code of Federal Regulations in part 17.
III. Permit Applications survival of the species. This notification requires that we invite public comment
We invite comments on the following covers activities to be conducted by the before issuing permits for any activity it
applications. applicant over a 5-year period. otherwise prohibits.
Applicant: Shawn Dooley, Belle Plaine, DATES: We must receive comments by
Applicant: University of California- December 6, 2023.
Santa Cruz, Santa Cruz, CA; Permit No. KS; Permit No. PER4621221
PER4073903 ADDRESSES: Obtaining Documents: The
The applicant requests a permit to
import a sport-hunted trophy of one application, application supporting
The applicant requests authorization materials, and any comments and other
to export biological samples collected male bontebok (Damaliscus pygargus
pygargus) culled from a captive herd materials that we receive will be
from individual animals of cetacean and available for public inspection at
pinniped species (except walrus) for the maintained under the management
program of the Republic of South Africa, https://www.regulations.gov in Docket
purpose of scientific research. Samples No. FWS–HQ–IA–2023–0183.
are collected from live wild and captive for the purpose of enhancing the
propagation or survival of the species. Submitting Comments: When
individuals or salvaged from dead wild submitting comments, please specify the
and captive individuals. This IV. Next Steps name of the applicant and the permit
notification covers activities conducted number at the beginning of your
by the applicant over a 5-year period. After the comment period closes, we
will make decisions regarding permit comment. You may submit comments
Applicant: University of California issuance. If we issue permits to any of by one of the following methods:
Santa Cruz, Santa Cruz, CA; Permit No. the applicants listed in this notice, we • internet: https://
PER4871061 will publish a notice in the Federal www.regulations.gov. Search for and
The applicant requests authorization Register. You may locate the notice submit comments on Docket No. FWS–
to import biological samples collected announcing the permit issuance by HQ–IA–2023–0183.
from individual animals of cetacean and searching https://www.regulations.gov • U.S. mail: Public Comments
pinniped species (except walrus) for the for the permit number listed above in Processing, Attn: Docket No. FWS–HQ–
purpose of scientific research. Samples this document. For example, to find IA–2023–0183; U.S. Fish and Wildlife
are collected from live wild and captive information about the potential issuance Service Headquarters, MS: PRB/3W;
individuals or salvaged from dead wild of Permit No. 12345A, you would go to 5275 Leesburg Pike; Falls Church, VA
and captive individuals. This regulations.gov and search for 22041–3803.
notification covers activities conducted ‘‘12345A’’. For more information, see Public
by the applicant over a 5-year period. Comment Procedures under
V. Authority SUPPLEMENTARY INFORMATION.
Applicant: Mario Gutierrez, San We issue this notice under the FOR FURTHER INFORMATION CONTACT:
Antonio, TX; Permit No. PER3979790 authority of the Endangered Species Act Brenda Tapia, by phone at 703–358–
The applicant requests a captive-bred of 1973, as amended (16 U.S.C. 1531 et 2185 or via email at DMAFR@fws.gov.
wildlife registration under 50 CFR seq.), and its implementing regulations. Individuals in the United States who are
17.21(g) for radiated tortoise Brenda Tapia, deaf, deafblind, hard of hearing, or have
(Astrochelys radiata), to enhance the a speech disability may dial 711 (TTY,
Supervisory Program Analyst/Data
propagation or survival of the species. Administrator, Branch of Permits, Division TDD, or TeleBraille) to access
This notification covers activities to be of Management Authority. telecommunications relay services.
conducted by the applicant over a 5- [FR Doc. 2023–24458 Filed 11–3–23; 8:45 am]
Individuals outside the United States
year period. should use the relay services offered
within their country to make
Applicant: National Marine Fisheries
international calls to the point-of-
Service, Southwest Fisheries Science
DEPARTMENT OF THE INTERIOR contact in the United States.
Center (NMFS), La Jolla, CA; Permit No.
PER4479189 SUPPLEMENTARY INFORMATION:
Fish and Wildlife Service
The applicant requests renewal of a I. Public Comment Procedures
permit to import biological samples [Docket No. FWS–HQ–IA–2023–0183;
FXIA16710900000–234–FF09A30000] A. How do I comment on submitted
collected from wild and captive-bred applications?
animals of Kemp’s ridley turtle
Wild Bird Conservation Act; Receipt of We invite the public and local, State,
(Lepidochelys kempii), hawksbill sea
Permit Application Tribal, and Federal agencies to comment
turtle (Eretmochelys imbricata),
leatherback sea turtle (Dermochelys AGENCY: Fish and Wildlife Service, on this application. Before issuing any
coriacea), green sea turtle (Chelonia Interior. requested permit, we will take into
mydas), loggerhead sea turtle (Caretta ACTION: Notice of receipt of permit consideration any information that we
caretta), and olive ridley sea turtle application; request for comments. receive during the public comment
(Lepidochelys olivacea) for the purpose period.
of scientific research. Samples are SUMMARY: We, the U.S. Fish and You may submit your comments and
collected from live or salvaged Wildlife Service (Service), invite the materials by one of the methods in
specimens. This notification covers public to comment on a permit ADDRESSES. We will not consider
activities conducted by the applicant application regarding a foreign bird comments sent by email, or to an
over a 5-year period. species for which the Service has address not in ADDRESSES. We will not
jurisdiction under the Wild Bird consider or include in our
Applicant: World Bird Sanctuary, Valley Conservation Act (WBCA). With some administrative record comments we
Park, MO; Permit No. PER5047417 exceptions, the WBCA prohibits receive after the close of the comment
The applicant requests a permit to activities with listed species unless period (see DATES).
import an Andean condor (Vultur Federal authorization is issued that When submitting comments, please
gryphus), to enhance the propagation or allows such activities. The WBCA also specify the name of the applicant and
the permit number at the beginning of Applicant: Gerald Bobak c/o David of a multi-family development in Lake
your comment. Provide sufficient Garcia, Homestead, FL; Permit No. County, Florida. We request public
information to allow us to authenticate PER0051912 comment on the application, which
any scientific or commercial data you The applicant, along with member includes the applicant’s proposed
include. The comments and habitat conservation plan (HCP), and on
Laurella Desborough, and the oversight
recommendations that will be most the Service’s preliminary determination
committee, the Organization of
useful and likely to influence agency that the proposed permitting action may
Professional Aviculturists (OPA),
decisions are: (1) Those supported by be eligible for a categorical exclusion
wishes to establish a Cooperative
quantitative information or studies; and pursuant to the Council on
Breeding Program covering the eclectus
Environmental Quality’s National
(2) those that include citations to, and parrot (Eclectus roratus).
Environmental Policy Act (NEPA)
analyses of, the applicable laws and
IV. Next Steps regulations, the Department of the
regulations. Interior’s (DOI) NEPA regulations, and
After the comment period closes, we
B. May I review comments submitted by will make decisions regarding permit the DOI Departmental Manual. To make
others? this preliminary determination, we
issuance. If we issue permits to any of
prepared a draft environmental action
the applicants listed in this notice, we
You may view and comment on statement and low-effect screening form,
will publish a notice in the Federal
others’ public comments at https:// both of which are also available for
Register. You may locate the notice
www.regulations.gov unless our public review. We invite comment from
announcing the permit issuance by
allowing so would violate the Privacy the public and local, State, Tribal, and
searching https://www.regulations.gov
Act (5 U.S.C. 552a) or Freedom of Federal agencies.
for the permit number listed above in
Information Act (5 U.S.C. 552). this document. For example, to find DATES: We must receive your written
information about the potential issuance comments on or before December 6,
C. Who will see my comments? 2023.
of Permit No. 12345A, you would go to
If you submit a comment at https:// https://www.regulations.gov and search ADDRESSES:
www.regulations.gov, your entire for ‘‘12345A’’. Obtaining Documents: You may
comment, including any personal obtain copies of the documents online
V. Authority in Docket No. FWS–R4–ES–2023–0199
identifying information, will be posted
on the website. If you submit a We issue this notice under the at https://www.regulations.gov.
hardcopy comment that includes authority of the Wild Bird Conservation Submitting Comments: If you wish to
personal identifying information, such Act of 1992 (16 U.S.C. 4901–4916). This submit comments on any of the
notice is provided pursuant to section documents, you may do so in writing by
as your address, phone number, or
112(4) of the Wild Bird Conservation one of the following methods:
email address, you may request at the • Online: https://
top of your document that we withhold Act of 1992, 50 CFR 15.26(c).
www.regulations.gov. Follow the
this information from public review. Brenda Tapia, instructions for submitting comments
However, we cannot guarantee that we Supervisory Program Analyst/Data on Docket No. FWS–R4–ES–2023–0199.
will be able to do so. Moreover, all Administrator, Branch of Permits, Division • U.S. mail: Public Comments
submissions from organizations or of Management Authority. Processing, Attn: Docket No. FWS–R4–
businesses, and from individuals [FR Doc. 2023–24449 Filed 11–3–23; 8:45 am] ES–2023–0199; U.S. Fish and Wildlife
identifying themselves as BILLING CODE 4333–15–P Service, MS: PRB/3W, 5275 Leesburg
representatives or officials of Pike, Falls Church, VA 22041–3803.
organizations or businesses, will be FOR FURTHER INFORMATION CONTACT: Erin
made available for public disclosure in DEPARTMENT OF THE INTERIOR Gawera, by U.S. mail (see ADDRESSES),
their entirety. Fish and Wildlife Service by telephone at 904–731–3121 or via
email at erin_gawera@fws.gov.
II. Background [Docket No. FWS–R4–ES–2023–0199; Individuals in the United States who are
FXES11140400000–245–FF04EF4000] deaf, deafblind, hard of hearing, or have
To help us carry out our conservation
responsibilities for affected species, and a speech disability may dial 711 (TTY,
Receipt of Incidental Take Permit TDD, or TeleBraille) to access
in consideration of section 112(4) of the Application and Proposed Habitat
Wild Bird Conservation Act of 1992 telecommunications relay services.
Conservation Plan for the Sand Skink; Individuals outside the United States
(WBCA; 16 U.S.C. 4901–4916), we Lake County, FL; Categorical should use the relay services offered
invite public comments on permit Exclusion within their country to make
applications before final action is taken.
AGENCY: Fish and Wildlife Service, international calls to the point-of-
With some exceptions, the WBCA contact in the United States.
prohibits certain activities with listed Interior.
ACTION: Notice of availability; request SUPPLEMENTARY INFORMATION: We, the
species unless Federal authorization is
for comments. Fish and Wildlife Service (Service),
issued that allows such activities.
announce receipt of an application from
Service regulations regarding permits SUMMARY: We, the Fish and Wildlife PMF Leesburg Michigan, LLC (Michigan
for any activity otherwise prohibited by Service (Service), announce receipt of Property) (applicant) for an incidental
the WBCA with respect to any wild an application from PMF Leesburg take permit (ITP) under the Endangered
birds are available in title 50 of the Code Michigan, LLC (Michigan Property) Species Act of 1973, as amended (ESA;
of Federal Regulations in part 15. (applicant) for an incidental take permit 16 U.S.C. 1531 et seq.). The applicant
III. Permit Applications (ITP) under the Endangered Species Act. requests the ITP to take federally listed
The applicant requests the ITP to take sand skinks (Neoseps reynoldsi) (skink)
We invite comments on the following the federally listed sand skink (Neoseps incidental to the construction and
application. reynoldsi) incidental to the construction operation of a multi-family development
in Lake County, Florida. We request of other past, present, and reasonably (ITP) under the Endangered Species Act
public comment on the application, foreseeable actions, would not result in (ESA). The applicant requests the ITP to
which includes the applicant’s habitat significant cumulative effects to the take the federally threatened coastal
conservation plan (HCP), and on the human environment. California gnatcatcher (Polioptila
Service’s preliminary determination that californica californica) incidental to
Next Steps
this proposed ITP qualifies as low effect, construction of the Jutras residential
and may qualify for a categorical The Service will evaluate the home project, in the City of Santee, San
exclusion pursuant to the Council on application and the comments to Diego County, California. We request
Environmental Quality’s National determine whether to issue the public comment on the application,
Environmental Policy Act (NEPA) requested permit. We will also conduct which includes the applicant’s
regulations (40 CFR 1501.4), the an intra-Service consultation pursuant proposed habitat conservation plan
Department of the Interior’s (DOI) NEPA to section 7 of the ESA to evaluate the (HCP), and the Service’s preliminary
regulations (43 CFR 46), and the DOI’s effects of the proposed take. After determination that the proposed
Departmental Manual (516 DM considering the preceding and other permitting action may be eligible for a
8.5(C)(2)). To make this preliminary matters, we will determine whether the categorical exclusion pursuant to the
determination, we prepared a draft permit issuance criteria of section Council on Environmental Quality’s
environmental action statement and 10(a)(1)(B) of the ESA have been met. If National Environmental Policy Act
low-effect screening form, both of which met, the Service will issue ITP number (NEPA) regulations, the Department of
are also available for public review. PER1345003 to PMF Leesburg Michigan, the Interior’s (DOI) NEPA regulations,
LLC (Michigan Property). and the DOI Departmental Manual. To
Proposed Project
make this preliminary determination,
The applicant requests a 5-year ITP to Public Availability of Comments
we prepared a draft environmental
take skinks via the conversion of Before including your address, phone action statement and low-effect
approximately 1.42 acres (ac) of number, email address, or other screening form, both of which are also
occupied nesting, foraging, and personal identifying information in your available for public review. We invite
sheltering skink habitat incidental to the comment, be aware that your entire comment from the public and local,
construction and operation of a multi- comment, including your personal State, Tribal, and Federal agencies.
family development on 7.78 ac on identifying information, may be made DATES: We must receive your written
Parcels 15–19–24–0605–001–00000 and available to the public. While you may comments on or before December 6,
15–19–24–0605–003–00100 in Sections request that we withhold your personal 2023.
14 and 15, Township 19 South, Range identifying information, we cannot
24 East, Lake County, Florida. The guarantee that we will be able to do so. ADDRESSES:
applicant proposes to mitigate for take Obtaining Documents: You may
of the skinks by purchasing credits Authority obtain copies of the documents this
equivalent to 2.84 ac of skink-occupied The Service provides this notice notice announces, along with any
habitat within the Lake Wales Ridge under section 10(c) of the Endangered comments and other materials that we
Conservation Bank or another Service- Species Act (16 U.S.C. 1531 et seq.) and receive, online in Docket No. FWS–R8–
approved conservation bank. The its implementing regulations (50 CFR ES–2023–0190 at https://
Service would require the applicant to 17.32) and the National Environmental www.regulations.gov.
purchase the credits prior to engaging in Policy Act (42 U.S.C. 4321 et seq.) and Submitting Comments: If you wish to
any phase of the project. its implementing regulations (40 CFR submit comments, you may do so in
1500–1508 and 43 CFR 46). writing by one of the following
Our Preliminary Determination methods:
The Service has made a preliminary Robert L. Carey, • Online: https://
determination that the applicant’s Manager, Division of Environmental Review, www.regulations.gov. Follow the
proposed project, including the Florida Ecological Services Field Office. instructions for submitting comments
construction of the buildings and [FR Doc. 2023–24493 Filed 11–3–23; 8:45 am] on Docket No. FWS–R8–ES–2023–0190.
associated infrastructure (e.g., electric, BILLING CODE 4333–15–P • U.S. mail: Public Comments
water, and sewer lines), would Processing, Attn: Docket No. FWS–R8–
individually and cumulatively have a ES–2023–0190; U.S. Fish and Wildlife
minor effect on the sand skinks and the DEPARTMENT OF THE INTERIOR Service, MS: PRB/3W; 5275 Leesburg
environment. Therefore, we have Pike; Falls Church, VA 22041–3803.:
preliminarily determined that the Fish and Wildlife Service FOR FURTHER INFORMATION CONTACT: Mr.
proposed ESA section 10(a)(1)(B) permit [Docket No. FWS–R8–ES–2023–0190; Jonathan Snyder, Assistant Field
would be a low-effect ITP that FXES11140800000–234–FF08ECAR00] Supervisor, Carlsbad Fish and Wildlife
individually or cumulatively would Office, 760–431–9440 (telephone).
have a minor effect on the sand skink Receipt of Incidental Take Permit Individuals in the United States who are
and may qualify for application of a Application and Proposed Habitat deaf, deafblind, hard of hearing, or have
categorical exclusion pursuant to the Conservation Plan, City of Santee, a speech disability may dial 711 (TTY,
Council on Environmental Quality’s California; Categorical Exclusion TDD, or TeleBraille) to access
NEPA regulations, DOI’s NEPA AGENCY: Fish and Wildlife Service, telecommunications relay services.
regulations, and the DOI Departmental Interior. Individuals outside the United States
Manual. A low-effect incidental take should use the relay services offered
ACTION: Notice of availability; request
permit is one that would result in (1) within their country to make
for comments.
minor or nonsignificant effects on international calls to the point-of-
species covered in the HCP; (2) SUMMARY: We, the Fish and Wildlife contact in the United States.
nonsignificant effects on the human Service (Service), announce receipt of SUPPLEMENTARY INFORMATION: We, the
environment; and (3) impacts that, an application from Mr. Louis Jutras U.S. Fish and Wildlife Service (Service),
when added together with the impacts (applicant) for an incidental take permit have received an application from Mr.
Louis Jutras (applicant) for a 3-year To minimize take of coastal California configuration for development of a
incidental take permit (ITP) for one gnatcatcher by the Jutras residential single-family residence on the project
covered species pursuant to section development project and offset impacts site.
10(a)(1)(B) of the Endangered Species to its habitat, the applicant proposes to
Our Preliminary Determination
Act of 1973 (ESA), as amended (16 mitigate for permanent impacts to 0.662
U.S.C. 1531 et seq.). The application ac of occupied coastal California The Service has made a preliminary
addresses the potential ‘‘take’’ of the gnatcatcher habitat through the determination that the applicant’s
threatened coastal California contribution of $54,580 for management proposed project would individually
gnatcatcher (Polioptila californica of preserved land within the City of and cumulatively have a minor effect on
californica) in the course of activities Santee. The long-term management will the California gnatcatcher and the
associated with the construction of the be carried out by the Endangered human environment. Therefore, we
Jutras residential home project, in the Habitat Conservancy and will be funded have preliminarily determined that the
City of Santee, San Diego County, by a lump-sum initial contribution by proposed ESA section 10(a)(1)(B) ITP
California. We request public comment the applicant. The applicant’s proposed would be a ‘‘low-effect’’ ITP that
on the application, which includes the HCP also contains measures to individually or cumulatively would
applicant’s habitat conservation plan minimize the effects of construction have a minor effect on the species and
(HCP), and on the Service’s preliminary activities on the coastal California may qualify for application of a
determination that this proposed ITP gnatcatcher. The clearing of DCSS will categorical exclusion pursuant to the
qualifies as ‘‘low effect, ’’ and may not take place during the gnatcatcher Council on Environmental Quality’s
qualify for a categorical exclusion breeding season (defined as February 15 NEPA regulations, DOI’s NEPA
pursuant to the Council on through August 31) when active regulations, and the DOI Departmental
Environmental Quality’s National gnatcatcher nests are present in the Manual. A ‘‘low-effect’’ ITP is one that
Environmental Policy Act (NEPA) DCSS. In the event it is not feasible to would result in (1) minor or
regulations (40 CFR 1501.4), the clear outside of the gnatcatcher breeding nonsignificant effects on species
Department of the Interior’s (DOI) NEPA season, pre-construction surveys for covered in the HCP; (2) nonsignificant
regulations (43 CFR 46), and the DOI’s nesting birds will be conducted within effects on the human environment; and
Departmental Manual (516 DM the week prior to initiating grading (3) impacts that, when added together
8.5(C)(2)). To make this preliminary activities to ensure construction with the impacts of other past, present,
determination, we prepared a draft activities do not occur within 300 feet and reasonable foreseeable actions,
environmental action statement and of an active gnatcatcher nest. A U.S. would not result in significant
low-effect screening form, both of which Fish and Wildlife Service-approved cumulative effects to the human
are also available for public review. biologist will conduct a training session environment.
for the grading contractor and will be
Proposed Project present on site during the initial Next Steps
A conservation program to avoid, clearing and grubbing activities to The Service will evaluate the
minimize, and mitigate for project ensure that the direct impacts are application and the comments received
activities would be implemented as limited to the project footprint. to determine whether to issue the
described in the proposed Habitat requested ITP. We will also conduct an
Proposed Action and Alternatives
Conservation Plan (HCP) by the intra-Service consultation pursuant to
The proposed action consists of the section 7 of the ESA to evaluate the
applicant. issuance of an incidental take permit effects of the proposed take. After
The applicant requests a 3-year ITP and implementation of the proposed considering the preceding and other
under section 10(a)(1)(B) of the ESA. If HCP, which includes measures to avoid, matters, we will determine whether the
we approve the permit, the applicant minimize, and mitigate impacts to permit issuance criteria of section
anticipates taking coastal California covered species. To comply with the 10(a)(1)(B) of the ESA have been met. If
gnatcatcher (Polioptila californica requirements for an HCP under ESA met, the Service will issue the permit to
californica) as a result of permanent section 10(a), alternatives to the project the applicant for incidental take of
impacts to 0.662 acres (ac) of habitat the and the incidental take of coastal coastal California gnatcatcher.
species uses for breeding, feeding, and California gnatcatcher were evaluated.
sheltering. The take would be incidental Under the No Action Alternative, the Public Availability of Comments
to the applicant’s activities associated project would not be constructed, and Before including your address, phone
with the construction of the Jutras no ITP would be issued. The applicant number, email address, or other
residential project in the City of Santee, would have no use of their private personal identifying information in your
California, and includes preservation of property. With implementation of the comment, you should be aware that
0.329 ac on site and funding for project, the single-family home would your entire comment—including your
management of preserved land in the be situated in the northwestern corner personal identifying information—may
City of Santee. of the project site, as close as feasible to be made publicly available at any time.
The Jutras residential project proposes the existing home to the north and to While you may ask us in your comment
to construct a single-family residence on the adjacent parcel with approved TM to withhold your personal identifying
a 1.015-ac parcel in the City of Santee. 08–04 to the west. Previous iterations of information from public review, we
The project will permanently impact the project design with the home sited cannot guarantee that we will be able to
0.662 ac of coastal California in the middle of the project site were do so.
gnatcatcher occupied habitat and 0.032 considered; however, the impacts to
ac of disturbed land as a result of Diegan coastal sage scrub were greater Authority
clearing and grading activities. The than under the current project design We provide this notice under section
remaining 0.277 ac of coastal California and would not avoid incidental take of 10 of the ESA (16 U.S.C. 1531 et seq.)
gnatcatcher-occupied Diegan coastal the coastal California gnatcatcher. and its implementing regulations (50
sage scrub (DCSS) and 0.052 ac of Therefore, the project is the most CFR 17.22 and 17.32) and the National
disturbed land would not be impacted. biologically conservative feasible Environmental Policy Act (42 U.S.C.
4321 et seq.) and its implementing and procedures for providing and • Email: DOI_Privacy@ios.doi.gov.
regulations (40 CFR 1500–1508 and 43 maintaining GFH. Include docket number [DOI–2023–
CFR 46). Public Disclosure of Comments: 0016] in the subject line of the message.
Before including your address, • U.S. Mail or Hand-Delivery: Teri
Scott A. Sobiech,
telephone number, email address, or Barnett, Departmental Privacy Officer,
Field Supervisor, Carlsbad Fish and Wildlife U.S. Department of the Interior, 1849 C
other personal identifying information
Office, Carlsbad, California.
in your comment, you should be aware Street NW, Room 7112, Washington, DC
[FR Doc. 2023–24404 Filed 11–3–23; 8:45 am]
that your entire comment—including 20240.
your personal identifying information— Instructions: All submissions received
may be made publicly available at any must include the agency name and
time. While you may ask us in your docket number [DOI–2023–0016]. All
DEPARTMENT OF THE INTERIOR comments received will be posted
comment to withhold your personal
National Park Service identifying information from public without change to https://
review, we cannot guarantee that we www.regulations.gov, including any
[NPS–WASO–PPFL–36595; PPWOPPFLF0– will be able to do so. personal information provided.
PMO00AD05.Y00000; 23XP103905] Docket: For access to the docket to
(Authority: 54 U.S.C. 100101(a) et seq.)
read background documents or
Notice of Availability and Request for Alma Ripps, comments received, go to https://
Comments on Draft Director’s Order www.regulations.gov.
Chief, Office of Policy.
#36 Concerning National Park Service
[FR Doc. 2023–24466 Filed 11–3–23; 8:45 am] FOR FURTHER INFORMATION CONTACT:
Policies and Procedures Governing
Housing Management BILLING CODE 4312–52–P Patrick Dege, Associate Privacy Officer,
Information Resource Office, Office of
AGENCY: National Park Service, Interior. Surface Mining Reclamation and
ACTION: Notice of availability. DEPARTMENT OF THE INTERIOR Enforcement, 1849 C Street NW, Mail
Stop 1200 West Corridor, Washington,
SUMMARY: The National Park Service Office of Surface Mining Reclamation
DC 20240, OSMRE_Privacy@osmre.gov
(NPS) has prepared Director’s Order #36 and Enforcement
or (202) 208–3549.
to set forth its policies and procedures
to manage Government-furnished [DOI–2023–0016; S1D1S SS08011000 SUPPLEMENTARY INFORMATION:
housing (GFH), units owned or leased SX064A000 234S180110]
I. Background
by the Government for which the
Privacy Act of 1974; System of The OSMRE maintains the
Government serves as landlord, or lease
Records INTERIOR/OSM–12, Blaster
holder. Once adopted, the policies and
Certification, system of records to
procedures in Director’s Order #36 and AGENCY: Office of Surface Mining manage the certifications of blasters in
the accompanying Reference Manual 36 Reclamation and Enforcement, Interior. Federal Program States and on Indian
will supersede and replace the policies ACTION: Notice of a modified system of Lands in compliance with the
and procedures issued in Director’s records. provisions of the Surface Mining
Order #36: Housing Management, dated
Control and Reclamation Act of 1977.
August 5, 2009. SUMMARY: Pursuant to the provisions of The OSMRE Blaster Certification system
DATES: Written comments will be the Privacy Act of 1974, as amended, of records serves as a tool for OSMRE
accepted until December 6, 2023. the Department of the Interior (DOI, to grant blaster applicants’ certificates
ADDRESSES: Draft Director’s Order #36 is Department) is issuing a public notice of for issuance, renewal, reissuance and
available online at https://www.nps.gov/ its intent to modify the Office of Surface reciprocity status, administration, and
subjects/policy/new.htm where readers Mining Reclamation and Enforcement notification procedures, as well as to
may submit comments electronically. (OSMRE) Privacy Act system of records, provide an adequate record-keeping
FOR FURTHER INFORMATION CONTACT: INTERIOR/OSM–12, Blaster system for compliance with a Federal
Alicia Overby, Housing Management Certification. The OSMRE is revising program and enable OSMRE as the
Program Manager, National Park this system of records notice (SORN) to regulatory authority to effectively
Service, at housing_management_ update the bureau designation in the monitor its program requirements.
program@nps.gov, or by telephone at system number to reflect the entirety of OSMRE is publishing this revised
202–513–7014. the bureau name, update all sections of notice to update the bureau designation
SUPPLEMENTARY INFORMATION: The NPS
the notice, and provide general and in the SORN number from ‘‘OSM–12’’ to
is updating its current system of internal administrative updates to accurately ‘‘OSMRE–12’’ in order to reflect the
written instructions. When these reflect the modified system. This bureau’s full title of Office of Surface
documents contain new policy or modified system will be included in Mining Reclamation and Enforcement;
procedural requirements that may affect DOI’s inventory of record systems. update the system location and system
parties outside the NPS, they are first DATES: This modified system will be manager and address; update legal
made available for public review and effective upon publication. New or authorities; propose new and modified
comment before being adopted. modified routine uses will be effective routine uses; update the categories of
Director’s Order #36 and a reference December 6, 2023. Submit comments on records to provide additional
manual (subsequent to the Director’s or before December 6, 2023. information on the types of data
Order) will be issued. The draft ADDRESSES: You may submit comments, maintained in the records; update the
Director’s Order provides direction to identified by docket number [DOI– records retention schedule; update the
NPS managers and employees who are 2023–0016], by any of the following sections for record access, notification,
responsible for GFH programs; guidance methods: and contesting record procedures to
of consistent application and adherence • Federal eRulemaking Portal: clarify how individuals may submit
to laws, regulations, and Department of https://www.regulations.gov. Follow the Privacy Act requests; and provide
the Interior policies; and requirements instructions for submitting comments. general and administrative updates to
remaining sections to accurately reflect sharing of information with an official Notification Procedures sections of this
the management and scope of the of another Federal agency to assist in notice.
system in accordance with the Office of reconciling or reconstructing data files The Privacy Act requires each agency
Management and Budget (OMB) or to enable that agency to respond to to publish in the Federal Register a
Circular A–108, Federal Agency an inquiry by the individual to whom description denoting the existence and
Responsibilities for Review, Reporting, the information pertains. Proposed character of each system of records that
and Publication under the Privacy Act. routine use F would allow OSMRE to the agency maintains, and the routine
OSMRE is updating its routine uses share information with agencies when uses of each system. The INTERIOR/
from a numerical to alphabetical listing relevant for hiring and retention or OSMRE–12, Blaster Certification,
and is proposing to modify existing issuance of a security clearance, license, system of records notice is published in
routine uses to provide clarity and contract, grant, or benefit. Proposed its entirety below. In accordance with 5
transparency and reflect updates routine use G would allow OSMRE to U.S.C. 552a(r), the Department has
consistent with standard Departmental share information with the National provided a report of this system of
routine uses. Routine uses A, B, D, J, Archives and Records Administration records to the Office of Management and
and O have been modified to provide (NARA) to conduct records management Budget and to Congress.
additional clarification regarding inspections. Proposed routine use H
external organizations and would allow OSMRE to share III. Public Participation
circumstances where disclosures are information with external entities, such You should be aware that your entire
proper and necessary to facilitate the as State, Tribal, territorial, and local comment, including any personally
management of blaster certifications. governments, and Tribal organizations, identifiable information, such as your
Routine use A was modified to further in response to court orders and/or for address, phone number, email address,
clarify disclosures to the Department of discovery purposes related to litigation. or any other personal information, may
Justice or other Federal agencies, when Proposed routine use I allows OSMRE to be made publicly available at any time.
necessary, in relation to litigation or share information with organizations While you may request that your
judicial proceedings. Routine use B was that perform services on the personally identifiable information be
modified to clarify disclosures to a Department’s behalf to carry out the withheld from public review, we cannot
congressional office responding to or purposes of the Blaster Certification guarantee that it will be able to do so.
resolving an individual’s request made system of records. Proposed routine use
to that office. Routine use D was SYSTEM NAME AND NUMBER:
L would allow OSMRE to share
modified to clarify the sharing of information with the OMB during the INTERIOR/OSMRE–12, Blaster
information with appropriate Federal, coordination and clearance process in Certification.
State, local, foreign agencies, or other connection with legislative affairs. SECURITY CLASSIFICATION:
public authority agencies responsible Proposed routine use M would allow
Unclassified.
for investigating or prosecuting OSMRE to share information with the
violations of, or for enforcing, or Department of the Treasury to recover SYSTEM LOCATION:
implementing, a statute, rule, debts owed to the United States. Office of Surface Mining Reclamation
regulation, order, or license. Modified Proposed routine use N would allow and Enforcement, U.S. Department of
routine use J would allow the OSMRE to share information with the the Interior, Three Parkway Center,
Department to share information with news media and the public if there is a Pittsburgh, PA 15220. Records are also
appropriate Federal agencies or entities legitimate public interest in the located at OSMRE offices in Alton,
when reasonably necessary to respond disclosure of the information. Illinois; Lakewood, Colorado; Knoxville,
to a breach of personally identifiable Tennessee; Tulsa, Oklahoma; and
information and to prevent, minimize, II. Privacy Act
Casper, Wyoming. To obtain specific
or remedy the risk of harm to The Privacy Act of 1974, as amended, addresses for the offices listed, contact
individuals or the Federal Government embodies fair information practice the System Manager at the address given
resulting from a breach in accordance principles in a statutory framework below.
with OMB Memorandum M–17–12, governing the means by which Federal
Preparing for and Responding to a agencies collect, maintain, use, and SYSTEM MANAGER(S):
Breach of Personally Identifiable disseminate individuals’ records. The OSMRE Blaster Certification
Information. Routine use O was Privacy Act applies to records about Coordinator, Office of Surface Mining
modified to include Federal and Tribal individuals that are maintained in a Reclamation and Enforcement, U.S.
officials who may have responsibility ‘‘system of records.’’ A ‘‘system of Department of the Interior, Three
for obtaining information relevant to a records’’ is a group of any records under Parkway Center, Pittsburgh, PA 15220.
Federal blaster. the control of an agency from which
OSMRE is proposing new routine uses information is retrieved by the name of AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
to facilitate the sharing of information an individual or by some identifying Surface Mining Control and
with agencies and organizations to number, symbol, or other identifying Reclamation Act of 1977 (SMCRA), 30
ensure the efficient and effective particular assigned to the individual. U.S.C. 1201–1328; Safe Explosives Act,
management of the Blaster Certification The Privacy Act defines an individual Title XI, Subtitle C of the Homeland
system of records or to carry out a as a United States citizen or lawful Security Act of 2002, Public Law 107–
Departmental or other Federal permanent resident. Individuals may 296; 18 U.S.C. 842–843; 30 CFR Chapter
Government statutory responsibility. request access to their own records that VII, Subchapter E—Indian Lands
Proposed routine use C would facilitate are maintained in a system of records in Program, Section 750.19; 30 CFR
the sharing of information with the the possession or under the control of Chapter VII, Subchapter G—Surface
Executive Office of the President to the Department by complying with Coal Mining and Reclamation
respond to an inquiry by the individual Departmental Privacy Act regulations at Operations Permits and Coal
to whom that record pertains or a third 43 CFR part 2, subpart K, and following Exploration Systems Under Regulatory
party on the individual’s behalf. the procedures outlined in the Records Programs; 30 CFR Chapter VII,
Proposed routine use E facilitates Access, Contesting Record, and Subchapter K—Permanent Program
Performance Standards, Sections, RECORD SOURCE CATEGORIES: E. To an official of another Federal

816.61 and 817.61; 30 CFR Chapter VII, Records in the system are obtained agency to provide information needed
Subchapter M—Training, Examination, from applicants for certification as in the performance of official duties
and Certification of Blasters; 30 CFR blasters in Federal Program States and related to reconciling or reconstructing
Chapter VII, Subchapter T—Programs on Indian Lands. Information related to data files or to enable that agency to
for the Conduct of Surface Mining verification of applications is obtained respond to an inquiry by the individual
Operations Within Each State, Part 900, from Federal agencies, States, Tribes, to whom the record pertains.
Part 910, Part 912, Part 921, Part 922, mining companies, and law F. To Federal, State, territorial, local,
Part 933, Part 937, Part 939, Part 941, enforcement organizations. Tribal, or foreign agencies that have
Part 942, Part 947, Part 955; and requested information relevant or
Executive Order 9397, Numbering ROUTINE USES OF RECORDS MAINTAINED IN THE
necessary to the hiring, firing or
SYSTEM, INCLUDING CATEGORIES OF USERS AND
System for Federal Accounts Relating to retention of an employee or contractor,
PURPOSES OF SUCH USES:
Individual Persons, as amended by or the issuance of a security clearance,
Executive Order 13478. In addition to those disclosures
license, contract, grant or other benefit,
generally permitted under 5 U.S.C.
PURPOSE(S) OF THE SYSTEM:
when the disclosure is compatible with
552a(b) of the Privacy Act, all or a
the purpose for which the records were
The primary purpose of the system is portion of the records or information
compiled.
to enable OSMRE to effectively issue contained in this system may be
G. To representatives of the National
blaster certificates and manage blaster disclosed outside DOI as a routine use
certifications issued to individuals Archives and Records Administration
pursuant to 5 U.S.C. 552a(b)(3) as
(blasters) to conduct blasting operations (NARA) to conduct records management
follows:
in any Federal Program State or on inspections under the authority of 44
A. To the Department of Justice (DOJ),
Indian Lands under Federal jurisdiction U.S.C. 2904 and 2906.
including Offices of the U.S. Attorneys,
while meeting the regulatory H. To State, territorial, and local
or other Federal agency conducting
performance standards of SMCRA. governments and Tribal organizations to
litigation or in proceedings before any
provide information needed in response
court, adjudicative, or administrative
CATEGORIES OF INDIVIDUALS COVERED BY THE to court order and/or discovery
SYSTEM: body, when it is relevant or necessary to
purposes related to litigation, when the
Individual members of the public who the litigation and one of the following
disclosure is compatible with the
apply to OSMRE for certification as is a party to the litigation or has an
purpose for which the records were
blasters in Federal Program States and interest in such litigation:
(1) DOI or any component of DOI; compiled.
on Indian Lands. I. To an expert, consultant, grantee,
(2) Any other Federal agency
CATEGORIES OF RECORDS IN THE SYSTEM: appearing before the Office of Hearings shared service provider, or contractor
and Appeals; (including employees of the contractor)
Records in the system include
(3) Any DOI employee or former of DOI that performs services requiring
Applications for OSMRE Blaster
employee acting in his or her official access to these records on DOI’s behalf
Certificates (OSMRE–74 form),
capacity; to carry out the purposes of the system.
application status updates, including
issuance, renewal, reissuance, (4) Any DOI employee or former J. To appropriate agencies, entities,
replacement, or reciprocity, records of employee acting in his or her individual and persons when:
denials, revocation or suspension, and capacity when DOI or DOJ has agreed to (1) DOI suspects or has confirmed that
reports on the status of blaster represent that employee or pay for there has been a breach of the system of
certifications as follows: private representation of the employee; records;
(1) Application information submitted or (2) DOI has determined that, as a
by candidates containing the following: (5) The United States Government or result of the suspected or confirmed
name, Social Security number any agency thereof, when DOJ breach, there is a risk of harm to
(voluntary), address, phone number, determines that DOI is likely to be individuals, DOI (including its
birthdate, email address and other affected by the proceeding. information systems, programs, and
contact information, gender, height and B. To a congressional office when operations), the Federal Government, or
weight, hair and eye color, employment requesting information on behalf of, and national security; and
history, blasting experience, education, at the request of, the individual who is (3) the disclosure made to such
blaster training, examination dates, the subject of the record. agencies, entities, and persons is
blaster certification history, and C. To the Executive Office of the reasonably necessary to assist in
personal affirmation of application President in response to an inquiry from connection with DOI’s efforts to respond
information; that office made at the request of the to the suspected or confirmed breach or
(2) Summary reports of Federal blaster subject of a record or a third party on to prevent, minimize, or remedy such
certificates alphabetically, numerically, that person’s behalf, or for a purpose harm.
by status or certificate type; compatible with the reason for which K. To another Federal agency or
(3) Certification Status reports that the records are collected or maintained. Federal entity, when DOI determines
contain listings of active, expired, D. To any criminal, civil, or regulatory that information from this system of
revoked, or suspended certificates along law enforcement authority (whether records is reasonably necessary to assist
with the performance history of each Federal, State, territorial, local, Tribal, the recipient agency or entity in:
blaster; and or foreign) when a record, either alone (1) responding to a suspected or
(4) Records of approval as an or in conjunction with other confirmed breach; or
‘‘Employee Possessor’’ or ‘‘Responsible information, indicates a violation or (2) preventing, minimizing, or
Party’’ issued by the Department of potential violation of law—criminal, remedying the risk of harm to
Justice, Bureau of Alcohol, Tobacco, civil, or regulatory in nature, and the individuals, the recipient agency or
Firearms and Explosives. Approval disclosure is compatible with the entity (including its information
letters are provided by the applicant and purpose for which the records were systems, programs, and operations), the
must be renewed triennially. compiled. Federal Government, or national
security, resulting from a suspected or OSMRE employees. During normal for requesting the amendment, and the
confirmed breach. hours of operation, paper records are proposed amendment to the record. The
L. To the Office of Management and maintained in locked file cabinets under request must include the requester’s full
Budget (OMB) during the coordination the control of authorized personnel. name, current address, and sufficient
and clearance process in connection Computer servers on which electronic identifying information such as date of
with legislative affairs as mandated by records are stored are in secured birth or other information required for
OMB Circular A–19. Department-controlled facilities with verification of the requester’s identity.
M. To the Department of the Treasury physical, technical, and administrative The request must be signed and dated
to recover debts owed to the United levels of security to prevent and be either notarized or submitted
States. unauthorized access to the Department’s under penalty of perjury in accordance
N. To the news media and the public, network and information assets. Access with 28 U.S.C. 1746. Requests submitted
with the approval of the Public Affairs granted to authorized personnel is based by mail must be clearly marked
Officer in consultation with counsel and on muti-factor authentication and each ‘‘PRIVACY ACT REQUEST FOR
the Senior Agency Official for Privacy, person granted access to the system AMENDMENT’’ on both the envelope
where there exists a legitimate public must be individually authorized to use and letter. A request for amendment
interest in the disclosure of the the system. A Privacy Act Warning must meet the requirements of 43 CFR
information, except to the extent it is Notice appears on computer monitor 2.246.
determined that release of the specific screens when records containing NOTIFICATION PROCEDURES:
information in the context of a information on individuals are first
particular case would constitute an displayed. Data exchanged between the An individual requesting notification
unwarranted invasion of personal servers and the system is encrypted. of the existence of records about them
privacy. should send a written inquiry to the
Backup tapes are encrypted and stored
O. To Federal, State, Tribal, or mining applicable System Manager as identified
in a locked and controlled room in a
company officials to verify whether an above. DOI instructions for submitting a
secure, off-site location. A Privacy
individual is a certified blaster under request for notification are available on
Impact Assessment was conducted to
the OSMRE Blaster Certification the DOI Privacy Act Requests website at
ensure that Privacy Act requirements
Program. https://www.doi.gov/privacy/privacy-
are met and appropriate privacy
act-requests. The request must include a
controls were implemented to safeguard
POLICIES AND PRACTICES FOR STORAGE OF general description of the records and
RECORDS:
the personally identifiable information
the requester’s full name, current
contained in the system.
Blaster certification applications address, and sufficient identifying
(OSMRE–74 forms), related records and RECORD ACCESS PROCEDURES: information such as date of birth or
information are maintained in hard An individual requesting access to other information required for
copy format such as file folders, and in their records should send a signed, verification of the requester’s identity.
digital format on servers, computers, written inquiry to the applicable System The request must be signed and dated
electronic databases, and other Manager identified above. DOI forms and be either notarized or submitted
appropriate electronic storage media. and instructions for submitting a under penalty of perjury in accordance
Privacy Act request may be obtained with 28 U.S.C. 1746. Requests submitted
POLICIES AND PRACTICES FOR RETRIEVAL OF
from the DOI Privacy Act Requests by mail must be clearly marked
RECORDS:
website at https://www.doi.gov/privacy/ ‘‘PRIVACY ACT INQUIRY’’ on both the
Records are retrieved by OSMRE envelope and letter. A request for
Blaster Certificate number and last name privacy-act-requests. The request must
include a general description of the notification must meet the requirements
filed alphabetically by applicant or of 43 CFR 2.235.
candidate. records sought and the requester’s full
name, current address, and sufficient EXEMPTIONS PROMULGATED FOR THE SYSTEM:
POLICIES AND PRACTICES FOR RETENTION AND identifying information such as date of None.
DISPOSAL OF RECORDS: birth or other information required for
Records in this system are maintained verification of the requester’s identity. HISTORY:
and disposed of in accordance with The request must be signed and dated 64 FR 17413 (April 9, 1999);
OSMRE Records Schedule N1–471–89– and be either notarized or submitted modification published at 73 FR 45244
1, Item 201–13—Blaster Certification under penalty of perjury in accordance (August 4, 2008) and 86 FR 50156
Files. The disposition for these records with 28 U.S.C. 1746. Requests submitted (September 7, 2021).
is temporary and the records are cut-off by mail must be clearly marked
Teri Barnett,
upon expiration of certification. Records ‘‘PRIVACY ACT REQUEST FOR
Departmental Privacy Officer, Department of
are destroyed two years after cut-off. ACCESS’’ on both the envelope and
the Interior.
Approved destruction methods for letter. A request for access must meet
[FR Doc. 2023–24382 Filed 11–3–23; 8:45 am]
temporary records that have met their the requirements of 43 CFR 2.238.
retention period include shredding or
CONTESTING RECORD PROCEDURES:
pulping of paper records and erasing or
degaussing electronic records in An individual requesting amendment
accordance with Departmental policy of their records should send a written INTERNATIONAL TRADE
and NARA guidelines. request to the applicable System COMMISSION
Manager as identified above. DOI

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL instructions for submitting a request for Notice of Receipt of Complaint;
SAFEGUARDS: amendment of records are available on Solicitation of Comments Relating to
The records contained in this system the DOI Privacy Act Requests website at the Public Interest
are safeguarded in accordance with 43 https://www.doi.gov/privacy/privacy- AGENCY: International Trade
CFR 2.226 and other applicable security act-requests. The request must clearly Commission.
and privacy rules and policies. Records identify the records for which
ACTION: Notice.
are accessible only by authorized amendment is being sought, the reasons
SUMMARY: Notice is hereby given that any public interest issues raised by the cover page and/or the first page. (See
the U.S. International Trade complaint or § 210.8(b) filing. Handbook for Electronic Filing
Commission has received a complaint Comments should address whether Procedures, Electronic Filing
Certain Video Capable Electronic issuance of the relief specifically Procedures).1 Please note the Secretary’s
Devices, Including Computers, requested by the complainant in this Office will accept only electronic filings
Streaming Devices, Televisions, investigation would affect the public during this time. Filings must be made
Cameras, and Components and Modules health and welfare in the United States, through the Commission’s Electronic
Thereof, DN 3705; the Commission is competitive conditions in the United Document Information System (EDIS,
soliciting comments on any public States economy, the production of like https://edis.usitc.gov.) No in-person
interest issues raised by the complaint or directly competitive articles in the paper-based filings or paper copies of
or complainant’s filing pursuant to the United States, or United States any electronic filings will be accepted
Commission’s Rules of Practice and consumers. until further notice. Persons with
Procedure. In particular, the Commission is questions regarding filing should
FOR FURTHER INFORMATION CONTACT: Lisa
interested in comments that: contact the Secretary at EDIS3Help@
(i) explain how the articles potentially usitc.gov.
R. Barton, Secretary to the Commission,
subject to the requested remedial orders Any person desiring to submit a
U.S. International Trade Commission,
are used in the United States;
500 E Street SW, Washington, DC document to the Commission in
(ii) identify any public health, safety,
20436, telephone (202) 205–2000. The confidence must request confidential
or welfare concerns in the United States
public version of the complaint can be relating to the requested remedial treatment. All such requests should be
accessed on the Commission’s orders; directed to the Secretary to the
Electronic Document Information (iii) identify like or directly Commission and must include a full
System (EDIS) at https://edis.usitc.gov. competitive articles that complainant, statement of the reasons why the
For help accessing EDIS, please email its licensees, or third parties make in the Commission should grant such
EDIS3Help@usitc.gov. United States which could replace the treatment. See 19 CFR 201.6. Documents
General information concerning the subject articles if they were to be for which confidential treatment by the
Commission may also be obtained by excluded; Commission is properly sought will be
accessing its internet server at United (iv) indicate whether complainant, treated accordingly. All information,
States International Trade Commission complainant’s licensees, and/or third including confidential business
(USITC) at https://www.usitc.gov. The party suppliers have the capacity to information and documents for which
public record for this investigation may replace the volume of articles confidential treatment is properly
be viewed on the Commission’s potentially subject to the requested sought, submitted to the Commission for
Electronic Document Information exclusion order and/or a cease and purposes of this Investigation may be
System (EDIS) at https://edis.usitc.gov. desist order within a commercially disclosed to and used: (i) by the
Hearing-impaired persons are advised reasonable time; and Commission, its employees and Offices,
that information on this matter can be (v) explain how the requested and contract personnel (a) for
obtained by contacting the remedial orders would impact United developing or maintaining the records
Commission’s TDD terminal on (202) States consumers. of this or a related proceeding, or (b) in
205–1810. Written submissions on the public internal investigations, audits, reviews,
SUPPLEMENTARY INFORMATION: The interest must be filed no later than by and evaluations relating to the
Commission has received a complaint close of business, eight calendar days programs, personnel, and operations of
and a submission pursuant to § 210.8(b) after the date of publication of this the Commission including under 5
of the Commission’s Rules of Practice notice in the Federal Register. There U.S.C. Appendix 3; or (ii) by U.S.
and Procedure filed on behalf of Nokia will be further opportunities for government employees and contract
Technologies Oy and Nokia Corporation comment on the public interest after the personnel,2 solely for cybersecurity
on October 31, 2023. The complaint issuance of any final initial purposes. All nonconfidential written
alleges violations of section 337 of the determination in this investigation. Any submissions will be available for public
Tariff Act of 1930 (19 U.S.C. 1337) in written submissions on other issues inspection at the Office of the Secretary
the importation into the United States, must also be filed by no later than the and on EDIS.3
the sale for importation, and the sale close of business, eight calendar days This action is taken under the
within the United States after after publication of this notice in the authority of section 337 of the Tariff Act
importation of certain video capable Federal Register. Complainant may file of 1930, as amended (19 U.S.C. 1337),
electronic devices, including computers, replies to any written submissions no and of §§ 201.10 and 210.8(c) of the
streaming devices, televisions, cameras, later than three calendar days after the Commission’s Rules of Practice and
and components and modules thereof. date on which any initial submissions Procedure (19 CFR 201.10, 210.8(c)).
The complaint names as respondents: were due, notwithstanding § 201.14(a) By order of the Commission.
HP, Inc. of Palo Alto, CA; Amazon.com, of the Commission’s Rules of Practice Issued: November 1, 2023.
Inc. of Seattle, WA; and Amazon.com and Procedure. No other submissions
Lisa Barton,
Services LLC of Seattle, WA. The will be accepted, unless requested by
complainant requests that the the Commission. Any submissions and Secretary to the Commission.
Commission issue a limited exclusion replies filed in response to this Notice [FR Doc. 2023–24452 Filed 11–3–23; 8:45 am]
order, cease and desist orders, and are limited to five (5) pages in length, BILLING CODE 7020–02–P
impose a bond upon respondents’ inclusive of attachments.
alleged infringing articles during the 60- Persons filing written submissions 1 Handbook for Electronic Filing Procedures:
day Presidential review period pursuant must file the original document https://www.usitc.gov/documents/handbook_on_
filing_procedures.pdf.
to 19 U.S.C. 1337(j). electronically on or before the deadlines 2 All contract personnel will sign appropriate
Proposed respondents, other stated above. Submissions should refer nondisclosure agreements.
interested parties, and members of the to the docket number (‘‘Docket No. 3 Electronic Document Information System
public are invited to file comments on 3705’’) in a prominent place on the (EDIS): https://edis.usitc.gov.
INTERNATIONAL TRADE complainant requests that the the Commission. Any submissions and
COMMISSION Commission issue a limited exclusion replies filed in response to this Notice
order, cease and desist orders, and are limited to five (5) pages in length,
Notice of Receipt of Complaint; impose a bond upon respondents’ inclusive of attachments.
Solicitation of Comments Relating to alleged infringing articles during the 60- Persons filing written submissions
the Public Interest day Presidential review period pursuant must file the original document
to 19 U.S.C. 1337(j). electronically on or before the deadlines
AGENCY: U.S. International Trade
Proposed respondents, other stated above. Submissions should refer
Commission.
interested parties, and members of the to the docket number (‘‘Docket No.
ACTION: Notice. public are invited to file comments on 3706’’) in a prominent place on the
SUMMARY: Notice is hereby given that any public interest issues raised by the cover page and/or the first page. (See
the U.S. International Trade complaint or § 210.8(b) filing. Handbook for Electronic Filing
Commission has received a complaint Comments should address whether Procedures, Electronic Filing
Certain Video Capable Electronic issuance of the relief specifically Procedures).1 Please note the Secretary’s
Devices, Including Computers, requested by the complainant in this Office will accept only electronic filings
Streaming Devices, Televisions, and investigation would affect the public during this time. Filings must be made
Components and Modules Thereof, DN health and welfare in the United States, through the Commission’s Electronic
3706; the Commission is soliciting competitive conditions in the United Document Information System (EDIS,
comments on any public interest issues States economy, the production of like https://edis.usitc.gov.) No in-person
raised by the complaint or or directly competitive articles in the paper-based filings or paper copies of
complainant’s filing pursuant to the United States, or United States any electronic filings will be accepted
Commission’s Rules of Practice and consumers. until further notice. Persons with
Procedure. In particular, the Commission is questions regarding filing should
interested in comments that: contact the Secretary at EDIS3Help@
FOR FURTHER INFORMATION CONTACT: Lisa (i) explain how the articles potentially usitc.gov.
R. Barton, Secretary to the Commission, subject to the requested remedial orders Any person desiring to submit a
U.S. International Trade Commission, are used in the United States; document to the Commission in
500 E Street SW, Washington, DC (ii) identify any public health, safety, confidence must request confidential
20436, telephone (202) 205–2000. The or welfare concerns in the United States treatment. All such requests should be
public version of the complaint can be relating to the requested remedial directed to the Secretary to the
accessed on the Commission’s orders; Commission and must include a full
Electronic Document Information (iii) identify like or directly statement of the reasons why the
System (EDIS) at https://edis.usitc.gov. competitive articles that complainant, Commission should grant such
For help accessing EDIS, please email its licensees, or third parties make in the treatment. See 19 CFR 201.6. Documents
EDIS3Help@usitc.gov. United States which could replace the for which confidential treatment by the
General information concerning the subject articles if they were to be Commission is properly sought will be
Commission may also be obtained by excluded; treated accordingly. All information,
accessing its internet server at United (iv) indicate whether complainant, including confidential business
States International Trade Commission complainant’s licensees, and/or third information and documents for which
(USITC) at https://www.usitc.gov. The party suppliers have the capacity to confidential treatment is properly
public record for this investigation may replace the volume of articles sought, submitted to the Commission for
be viewed on the Commission’s potentially subject to the requested purposes of this Investigation may be
Electronic Document Information exclusion order and/or a cease and disclosed to and used: (i) by the
System (EDIS) at https://edis.usitc.gov. desist order within a commercially Commission, its employees and Offices,
Hearing-impaired persons are advised reasonable time; and and contract personnel (a) for
that information on this matter can be (v) explain how the requested developing or maintaining the records
obtained by contacting the remedial orders would impact United of this or a related proceeding, or (b) in
Commission’s TDD terminal on (202) States consumers. internal investigations, audits, reviews,
205–1810. Written submissions on the public and evaluations relating to the
SUPPLEMENTARY INFORMATION: The interest must be filed no later than by programs, personnel, and operations of
Commission has received a complaint close of business, eight calendar days the Commission including under 5
and a submission pursuant to § 210.8(b) after the date of publication of this U.S.C. Appendix 3; or (ii) by U.S.
of the Commission’s Rules of Practice notice in the Federal Register. There government employees and contract
and Procedure filed on behalf of Nokia will be further opportunities for personnel,2 solely for cybersecurity
Technologies Oy and Nokia Corporation comment on the public interest after the purposes. All nonconfidential written
on October 31, 2023. The complaint issuance of any final initial submissions will be available for public
alleges violations of section 337 of the determination in this investigation. Any inspection at the Office of the Secretary
Tariff Act of 1930 (19 U.S.C. 1337) in written submissions on other issues and on EDIS.3
the importation into the United States, must also be filed by no later than the This action is taken under the
the sale for importation, and the sale close of business, eight calendar days authority of section 337 of the Tariff Act
within the United States after after publication of this notice in the of 1930, as amended (19 U.S.C. 1337),
importation of certain video capable Federal Register. Complainant may file and of §§ 201.10 and 210.8(c) of the
electronic devices, including computers, replies to any written submissions no
streaming devices, televisions, and later than three calendar days after the 1 Handbook for Electronic Filing Procedures:
components and modules thereof. The date on which any initial submissions https://www.usitc.gov/documents/handbook_on_
filing_procedures.pdf.
complaint names as respondents: HP, were due, notwithstanding § 201.14(a) 2 All contract personnel will sign appropriate
Inc. of Palo Alto, CA; Amazon.com, Inc. of the Commission’s Rules of Practice nondisclosure agreements.
of Seattle, WA; and Amazon.com and Procedure. No other submissions 3 Electronic Document Information System
Services LLC of Seattle, WA. The will be accepted, unless requested by (EDIS): https://edis.usitc.gov.
Commission’s Rules of Practice and the United States after importation of notice in the Federal Register. There
Procedure (19 CFR 201.10, 210.8(c)). certain organic light-emitting diode will be further opportunities for
By order of the Commission. display modules and components comment on the public interest after the
Issued: November 1, 2023.
thereof. The complaint names as issuance of any final initial
respondents: BOE Technology Group determination in this investigation. Any
Lisa Barton,
Co., Ltd. of China; Mianyang BOE written submissions on other issues
Secretary to the Commission. Optoelectronics Technology Co., Ltd. of must also be filed by no later than the
[FR Doc. 2023–24498 Filed 11–3–23; 8:45 am] China; Ordos Yuansheng close of business, eight calendar days
BILLING CODE 7020–02–P Optoelectronics Co., Ltd. of China; after publication of this notice in the
Chengdu BOE Optoeletronics Federal Register. Complainant may file
Technology Co., Ltd. of China; replies to any written submissions no
INTERNATIONAL TRADE Chongqing BOE Optoeletronics later than three calendar days after the
COMMISSION Technology Co., Ltd. of China; Wuhan date on which any initial submissions
BOE Optoeletronics Technology Co., were due, notwithstanding § 201.14(a)
Notice of Receipt of Complaint; Ltd. of China; BMOT f/k/a Kunming of the Commission’s Rules of Practice
Solicitation of Comments Relating to BOE Display Technology of China; and and Procedure. No other submissions
the Public Interest BOE Technology America Inc. of China. will be accepted, unless requested by
AGENCY: International Trade The complainant requests that the the Commission. Any submissions and
Commission. Commission issue a limited exclusion replies filed in response to this Notice
ACTION: Notice. order, cease and desist orders, and are limited to five (5) pages in length,
impose a bond upon respondents’ inclusive of attachments.
SUMMARY: Notice is hereby given that alleged infringing articles during the 60- Persons filing written submissions
the U.S. International Trade day Presidential review period pursuant must file the original document
Commission has received a complaint to 19 U.S.C. 1337(j). electronically on or before the deadlines
Certain Organic Light-Emitting Diode Proposed respondents, other stated above. Submissions should refer
Display Modules and Components interested parties, and members of the to the docket number (‘‘Docket No.
Thereof, DN 3704; the Commission is public are invited to file comments on 3704’’) in a prominent place on the
soliciting comments on any public any public interest issues raised by the cover page and/or the first page. (See
interest issues raised by the complaint complaint or § 210.8(b) filing. Handbook for Electronic Filing
or complainant’s filing pursuant to the Comments should address whether Procedures, Electronic Filing
Commission’s Rules of Practice and issuance of the relief specifically Procedures 1). Please note the
Procedure. requested by the complainant in this Secretary’s Office will accept only
FOR FURTHER INFORMATION CONTACT: Lisa investigation would affect the public electronic filings during this time.
R. Barton, Secretary to the Commission, health and welfare in the United States, Filings must be made through the
U.S. International Trade Commission, competitive conditions in the United Commission’s Electronic Document
500 E Street SW, Washington, DC States economy, the production of like Information System (EDIS, https://
20436, telephone (202) 205–2000. The or directly competitive articles in the edis.usitc.gov.)
public version of the complaint can be United States, or United States No in-person paper-based filings or
accessed on the Commission’s consumers. paper copies of any electronic filings
Electronic Document Information In particular, the Commission is will be accepted until further notice.
System (EDIS) at https://edis.usitc.gov. interested in comments that: Persons with questions regarding filing
(i) explain how the articles potentially should contact the Secretary at
For help accessing EDIS, please email
subject to the requested remedial orders EDIS3Help@usitc.gov.
EDIS3Help@usitc.gov.
are used in the United States; Any person desiring to submit a
General information concerning the
(ii) identify any public health, safety, document to the Commission in
Commission may also be obtained by
or welfare concerns in the United States confidence must request confidential
accessing its internet server at United
relating to the requested remedial treatment. All such requests should be
States International Trade Commission
orders; directed to the Secretary to the
(USITC) at https://www.usitc.gov . The (iii) identify like or directly
public record for this investigation may Commission and must include a full
competitive articles that complainant, statement of the reasons why the
be viewed on the Commission’s its licensees, or third parties make in the
Electronic Document Information Commission should grant such
United States which could replace the treatment. See 19 CFR 201.6. Documents
System (EDIS) at https://edis.usitc.gov. subject articles if they were to be
Hearing-impaired persons are advised for which confidential treatment by the
excluded; Commission is properly sought will be
that information on this matter can be (iv) indicate whether complainant,
obtained by contacting the treated accordingly. All information,
complainant’s licensees, and/or third including confidential business
Commission’s TDD terminal on (202) party suppliers have the capacity to
205–1810. information and documents for which
replace the volume of articles confidential treatment is properly
SUPPLEMENTARY INFORMATION: The potentially subject to the requested sought, submitted to the Commission for
Commission has received a complaint exclusion order and/or a cease and purposes of this Investigation may be
and a submission pursuant to § 210.8(b) desist order within a commercially
disclosed to and used: (i) by the

of the Commission’s Rules of Practice reasonable time; and Commission, its employees and Offices,
and Procedure filed on behalf of (v) explain how the requested and contract personnel (a) for
Samsung Display Co., Ltd. on October remedial orders would impact United developing or maintaining the records
31, 2023. The complaint alleges States consumers. of this or a related proceeding, or (b) in
violations of section 337 of the Tariff Written submissions on the public
Act of 1930 (19 U.S.C. 1337) in the interest must be filed no later than by 1 Handbook for Electronic Filing Procedures:
importation into the United States, the close of business, eight calendar days https://www.usitc.gov/documents/handbook_on_
sale for importation, and the sale within after the date of publication of this filing_procedures.pdf.
internal investigations, audits, reviews, submitted to the Department by evidence in written (including
and evaluations relating to the December 21, 2023. electronic) form.
programs, personnel, and operations of Exemption date: If granted, this Warning: All comments received will
the Commission including under 5 proposed exemption will be in effect on be included in the public record
U.S.C. Appendix 3; or (ii) by U.S. the date that the grant notice is without change and may be made
government employees and contract published in the Federal Register. available online at https://
personnel,2 solely for cybersecurity ADDRESSES: All written comments and www.regulations.gov, including any
purposes. All nonconfidential written requests for a hearing should be personal information provided, unless
submissions will be available for public submitted to the Employee Benefits the comment includes information
inspection at the Office of the Secretary Security Administration (EBSA), Office claimed to be confidential or other
and on EDIS.3 of Exemption Determinations, information whose disclosure is
This action is taken under the Attention: Application No. L–11954 via restricted by statute. If you submit a
authority of section 337 of the Tariff Act email to e-OED@dol.gov or online comment, EBSA recommends that you
of 1930, as amended (19 U.S.C. 1337), through https://www.regulations.gov. include your name and other contact
and of §§ 201.10 and 210.8(c) of the Any such comments or requests should information in the body of your
Commission’s Rules of Practice and be sent by the end of the scheduled comment, but DO NOT submit
Procedure (19 CFR 201.10, 210.8(c)). comment period. The application for information that you consider to be
exemption and the comments received confidential, or otherwise protected
By order of the Commission.
will be available for public inspection in (such as a Social Security number or an
Issued: October 31, 2023. unlisted phone number) or confidential
the Public Disclosure Room of the
Lisa Barton, Employee Benefits Security business information that you do not
Secretary to the Commission. Administration, U.S. Department of want publicly disclosed. However, if
[FR Doc. 2023–24409 Filed 11–3–23; 8:45 am] Labor, Room N–1515, 200 Constitution EBSA cannot read your comment due to
BILLING CODE 7020–02–P Avenue NW, Washington, DC 20210. technical difficulties and cannot contact
See SUPPLEMENTARY INFORMATION below you for clarification, EBSA might not be
for additional information regarding able to consider your comment.
DEPARTMENT OF LABOR comments. Additionally, the https://
www.regulations.gov website is an
Employee Benefits Security ‘‘anonymous access’’ system, which
Blessed Chuksorji-Keefe of the means EBSA will not know your
Administration Department, telephone (202) 693–8567. identity or contact information unless
[Exemption Application No. L–11954] (This is not a toll-free number.) you provide it in the body of your
SUPPLEMENTARY INFORMATION: comment. If you send an email directly
Proposed Exemption for Certain Comments: Persons are encouraged to to EBSA without going through https://
Prohibited Transaction Restrictions: submit all comments electronically and www.regulations.gov, your email
Fedeli Group, Inc. Employee Benefits not to follow with paper copies. address will be automatically captured
Plan Located in Cleveland, OH Comments should state the nature of the and included as part of the comment
AGENCY: Employee Benefits Security person’s interest in the proposed that is placed in the public record and
Administration, Labor. exemption and how the person would made available on the internet.
be adversely affected by the exemption,
ACTION: Notice of proposed exemption. Proposed Exemption
if granted. Any person who may be
SUMMARY: This document provides adversely affected by an exemption can The Department is considering
notice of the pendency before the request a hearing on the exemption. A granting an exemption under the
Department of Labor (the Department) of request for a hearing must state: (1) the authority of section 408(a) of the
a proposed individual exemption from name, address, telephone number, and Employee Retirement Income Security
certain of the prohibited transaction email address of the person making the Act of 1974, as amended (ERISA). If the
restrictions of the Employee Retirement request; (2) the nature of the person’s exemption is granted, the Fedeli Group,
Income Security Act of 1974 (ERISA or interest in the exemption, and the Inc. Employee Benefits Plan (the Benefit
the Act). This proposed exemption manner in which the person would be Plan) sponsored by Fedeli Group, Inc.
would permit the Fedeli Group, Inc. adversely affected by the exemption; (Fedeli Group or the Applicant) will
Employee Benefits Plan (the Benefit and (3) a statement of the issues to be enter into an insurance contract with
Plan) sponsored by Fedeli Group, Inc. addressed and a general description of THP Insurance Company, Inc. (THP), an
(Fedeli Group or the Applicant) to enter the evidence to be presented at the unrelated insurance company, and THP
into an insurance contract with THP hearing. The Department will grant a will, in turn, enter a reinsurance
Insurance Company, Inc. (THP), an request for a hearing made in arrangement with Risk Specialists LLC
unrelated insurance company, and THP accordance with the requirements above (Risk Specialists), a captive reinsurance
will, in turn, enter a reinsurance where a hearing is necessary to fully company affiliated with Fedeli Group.
arrangement with Risk Specialists LLC explore material factual issues Under the reinsurance arrangement,
(Risk Specialists), a captive reinsurance identified by the person requesting the Risk Specialists will reinsure the
company affiliated with Fedeli Group. hearing. A notice of such hearing shall insurance risks associated with the
be published by the Department in the Benefit Plan. The reinsurance
DATES:
Federal Register. The Department may arrangement would result in an indirect
Comments due: Written comments decline to hold a hearing if: (1) the transfer of premium payments from the
and requests for a public hearing on the request for the hearing does not meet Benefit Plan to Risk Specialists, LLC.
proposed exemption should be the requirements above; (2) the only This exemption requires, among other
2 All contract personnel will sign appropriate
issues identified for exploration at the things, annual reports to be prepared by
nondisclosure agreements. hearing are matters of law; or (3) the a qualified, independent fiduciary and
3 Electronic Document Information System factual issues identified can be fully submitted to the Department of Labor
(EDIS): https://edis.usitc.gov explored through the submission of confirming whether Fedeli and its
affiliates have met the exemption’s entities and is currently rated ‘‘A+’’ by interest or own account. The fiduciaries
terms and conditions.1 A.M. Best Company. of the Benefit Plan would violate ERISA
5. Transitioning the Benefit Plan to section 406(b)(1) by causing the Benefit
Summary of Facts and the Third-Party Insurer Using the Plan to pay premiums to THP, with the
Representations 2 Captive Reinsurer. Fedeli Group seeks knowledge that the premiums will
1. The Plan Sponsor. Fedeli Group is to use its captive insurance company, ultimately be directed to Risk
an S corporation based in Cleveland, Risk Specialists, to reinsure the Benefit Specialists, the captive reinsurer.
Ohio. Fedeli Group provides insurance Plan’s claims. If this proposed 9. Benefits to the ERISA-Covered Plan.
products and risk management services. exemption is granted, the Plan will The Department has the authority under
Fedeli Group is 51% owned by the enter into a Master Group Policy with ERISA section 408(a) to exempt
Umberto P. Fedeli Amended and THP, pursuant to which THP will transactions from the prohibitions of
Restated Revocable Trust (dated July 16, provide group health insurance ERISA section 406. Specifically, ERISA
2016), 29% by the Umberto P. Fedeli coverage to eligible participants under section 408(a) provides that the
2012 Discretionary Trust (dated the Benefit Plan. THP will enter into a Department may not grant an exemption
November 28, 2012) and 20% by the reinsurance agreement (the Reinsurance unless it finds that the exemption is
Umberto P. Fedeli 2009 Discretionary Agreement) with Risk Specialists. Under administratively feasible, in the
Trust (dated December 23, 2009). this arrangement, Risk Specialists will interests of the plan and the plan’s
2. The Plan. The Fedeli Group be responsible for the Benefit Plan’s participants and beneficiaries, and
sponsors and administers the Benefit insurance claims under the Master protective of the rights of the plan’s
Plan, which is a self-funded employee Group Policy with THP, and Risk participants and beneficiaries.
welfare benefit plan covering medical Specialists will indirectly receive the 10. The Department has tentatively
and hospital expenses for eligible Fedeli Benefit Plan’s premium payments to determined that the proposed
Group employees. The Benefit Plan THP. The Reinsurance Agreement reinsurance arrangement would be in
currently covers approximately 64 between THP and Risk Specialists will the interest of the Benefit Plan and its
participants. be ‘‘indemnity only,’’ which means that participants and beneficiaries. As
3. The Captive Reinsurer. Risk THP will be responsible for Benefit Plan described in further detail below, a
Specialists is a licensed property and claims under the Master Group Policy to qualified, independent fiduciary has
casualty captive insurance company the extent Risk Specialists does not concluded that the reinsurance
that operates under applicable satisfy those claims under the arrangement will reduce each Benefit
Tennessee law. Risk Specialists is 100% Reinsurance Agreement. Plan participant’s share of the Benefit
owned by Risk Specialists Captive 6. Exemptive Relief Requested. The Plan premium paid to THP by at least
Holdings, LLC (Risk Specialists Captive proposed reinsurance arrangement $2,023.20 3 per participant per year for
Holdings LLC), a limited liability would violate certain prohibited the duration of the exemption relative to
company formed in Ohio on the same transaction provisions of ERISA for the the contribution the participant would
date as Risk Specialists. Risk Specialists following reasons: otherwise have made under a non-
Captive Holdings is 51% owned by the • Fedeli Group is a party in interest captive arrangement with a competitive
Fedeli Revocable Trust, 29% owned by with respect to the Benefit Plan third party insurer receiving no more
the Fedeli 2012 Trust, and 20% owned pursuant to ERISA section 3(14)(C), than reasonable compensation within
by the Fedeli 2009 Trust. Risk because it is an employer whose the meaning of ERISA section 408(b)(2).
Specialists serves as the reinsurer with employees are covered by the Benefit Historically, Benefit Plan participants
respect to 13 different lines of insurance Plan; contributed approximately 25% towards
coverages provided to Fedeli Group and • The Trusts are parties in interest the cost of the Benefit Plan. Under the
unrelated third parties. with respect to the Benefit Plan under proposal, all the savings from the
4. The Third-Party Insurer. THP ERISA section 3(14)(E) because they Captive Approach will be used to
Insurance Company, Inc. (THP) is a collectively own 100% of Fedeli Group, reduce Benefit Plan participants’ share
domestic stock insurance company the Benefit Plan sponsor. of the Benefit Plan’s premiums, and
domiciled in West Virginia and licensed • Risk Specialists, the captive Benefit Plan participants will contribute
in both Ohio and West Virginia. THP is reinsurer, is a party in interest with no more than 17.38% of the Benefit
unrelated to all Fedeli Group-related respect to the Benefit Plan under ERISA Plan’s costs throughout the duration of
section 3(14)(G) because it is 100% the exemption.
1 The Department notes that the independent owned by the Trusts. 11. The Department requested that the
fiduciary’s annual written report is essential to the 7. ERISA section 406(a) prohibits a Applicant provide a complete and
Department’s tentative finding that this proposed wide range of transactions between
exemption is and will continue to be, in the interest accurate accounting of all benefits the
and protective of the Plan and its participants and
plans and parties in interest with Fedeli Group expects to derive from the
beneficiaries. Each report must demonstrate that the respect to those plans. As relevant here, captive reinsurance arrangement,
independent fiduciary has clearly, prudently, and ERISA section 406(a)(l)(D) prohibits a including tax and non-tax benefits. In
loyally determined whether Fedeli and its affiliates plan fiduciary from engaging in a
have complied with each term and condition of the addition, the Department requested that
exemption. The exemption’s relief is conditioned
transaction if the fiduciary knows or the Applicant provide a full explanation
on the independent fiduciary’s compliance with should know the transaction constitutes of the ‘‘economic substance of the
this requirement. a direct or indirect transfer any plan proposed transaction,’’ that is, the
2 The Department notes that availability of this
assets for the use or benefit of a party
exemption is subject to the express condition that economic impact or outcome that the
in interest. The reinsurance arrangement exemption would have on the Fedeli
the material facts and representations contained in
Application L–11954 are true and complete, and would result in an indirect transfer of Group, Fedeli-related parties and the
accurately describe all material terms of the Benefit Plan premium payments to Risk Benefit Plan’s participants and
transactions covered by the exemption. If there is Specialists, which is a party in interest beneficiaries. Both the accounting of
any material change in a transaction covered by the with respect to the Benefit Plan.
exemption, or in a material fact or representation
described in the application, the exemption will
8. ERISA section 406(b)(1) of ERISA 3 The independent fiduciary’s determination of
cease to apply to the covered transactions as of the prohibits a fiduciary from dealing with the $2,023.20 amount is described below in more
date of such change. plan assets for the fiduciary’s own detail.
expected benefits and the explanation of the Applicant’s representations and the Captive Approach will be directly
the expected economic substance of the exemption’s requirement, that no Fedeli applied to Benefit Plan participants as a
proposed transaction were reviewed and Group-related entity will receive a reduction in their contribution
confirmed by the independent fiduciary. direct or indirect profit, tax benefit, obligations.
Applicant’s Response: The Applicant investment gain or other remunerative 15. The Applicant calculated the
represents that the only benefits Fedeli benefit through the Captive Approach. monthly $161.60 contribution reduction
Group expects to receive from the The Department notes that if a Fedeli per Benefit Plan participant
proposed Captive Approach relative to Group-related entity ultimately receives ($129,485.00/12 months = $10,790.42/
the Plan’s current self-funding such a profit, benefit or gain, the Fedeli 64 participants = $168.60). The
arrangement are the incidental benefits Group must further enhance the Benefit Applicant states that this monthly
that would result from more Plan in an amount greater than the reduction in contribution obligations
predictability and better control over its $2,023.20 per participant per year will result in annual savings per
benefit funding obligations. Under contribution reduction in a manner participant of $2,023.20 ($168.60 × 12
Fedeli Group’s current self-funded consistent with the terms and months) with no reduction in medical,
arrangement, Fedeli’s benefit funding conditions of this proposed exemption. health, or other plan benefits. Further,
obligations are dependent on the timing Additionally, the Department notes that the Applicant states that these cost
and amount of participant claims. In this proposed exemption prohibits savings for Benefit Plan participants
contrast, under the Captive Approach, Fedeli Group or a related entity from will be implemented simultaneously
the Fedeli Group will only make one using any participant-related data or with the establishment of the Captive
annual premium payment. According to information generated by, or derived Approach.
the Applicant, this initial funding from, the Captive Approach in a manner 16. The Applicant represents that,
obligation will represent an estimate of that benefits the Fedeli Group or related historically, contributions to the Benefit
the anticipated claims Benefit Plan entity. Plan by Benefit Plan participants have
participants and beneficiaries will incur As described below, this exemption, if been targeted at 25% of Benefit Plan
during the year. The ability to budget for granted, requires a qualified, costs. By implementing the proposed
one up-front annual premium payment independent fiduciary to review all Captive Approach and lowering annual
instead of multiple weekly or monthly relevant financial information of Risk Benefit Plan costs by $129,485, there
claims payments would provide Fedeli Specialists and any other Fedeli-related will be a cost savings to the Benefit Plan
Group with predictability for Fedeli entity as is necessary to ensure that this of 7.62% per year. Based on the
Group’s benefit obligations.4 and the other terms and conditions Applicant’s assertions that the Captive
In addition, the Applicant represents described in this proposal are met and Approach will result in participants’
that the Captive Approach grants to annually certify in a written report savings of 7.62% per year, the
financial control to the Fedeli Group submitted to the Department that all Department is including an exemption
over insurance spending by managing requirements of the proposed exemption condition that requires participant
risks and underwriting ‘‘Fedeli specific’’ have been met. contributions to comprise no more than
risks rather than paying risk premiums 17.38% (i.e., 25%¥7.62%) of the
Applicant’s Analyses Benefit Plan’s premiums on a going-
to third-party insurers or self-insuring.
By underwriting its own risks, the 12. The Applicant represents to the forward annual basis.
Fedeli Group gains greater transparency Department that it evaluated two
different insurance-based approaches to The Independent Fiduciary
and improved data on its actual benefit
provide the benefits payable under the 17. George J. Stadtlander, President
claims cost and utilization. Fedeli also
Benefit Plan and the effects on the costs and majority owner of Consoliplex
benefits from flexibility in underwriting
from each, based on the 2023 plan year L.L.C. (Consoliplex), a health plan
and funding depending on the Fedeli service organization located in
information for the Benefit Plan. The
Group’s specific employee Cleveland, Ohio, will serve as the
Applicant’s first insurance-based
demographics and plan design that it Benefit Plan’s qualified independent
approach contemplates a Third-Party
could not receive by purchasing fiduciary (the Independent Fiduciary)
Approach, while the second insurance-
commercial insurance. with respect to the proposed
Furthermore, the Captive Approach based approach takes into account Risk
Specialists as the captive reinsurer (the transactions. Mr. Stadtlander states that
will result in reduced overall plan costs
Captive Approach). he is qualified to serve as the
because benefit expenses are paid based
13. The Applicant states that, based Independent Fiduciary for the Benefit
on actual experience, as opposed to a
on actual values from the Benefit Plan’s Plan because he: (a) is not employed by
third-party insurance carrier (the Third-
2023 financial statement, the annual Fedeli Group or its affiliates; (b) has
Party Approach) requiring a fixed
premium under the Third-Party more than thirty years of experience in
payment at a premium charged by an
Approach would have been $2,254,314, the field of health benefits, including
insurance carrier where the premium
compared to the $2,124,829 annual serving as an officer and executive vice
amount does not change regardless of
premium under the Captive Approach. president for Medical Mutual, a local
the amount of claims that are incurred.
Therefore, the Applicant calculated the health insurance company with over $2
Moreover, the Fedeli Group will not
total annual cost savings under the billion in annual premiums; (c)
bear the sole payment obligation that it
Captive Approach would be $129,485 currently owns an organization that
does under its current self-insurance
for the 2023 Plan Year. serves as a plan manager for five
arrangement. These reduced costs will

14. The cost savings under the multiple employer welfare
redound to the Benefit Plan in the form
Captive Approach will be passed on to arrangements; and (d) has managed the
of lower cost of health care coverage.
Benefit Plan participants on a pro-rata actuarial department, the underwriting
The Department’s Note: This
basis, by reducing employees’ Benefit department, network contracting,
exemption is being proposed based on
Plan contribution obligations. As of utilization management and sales
4 Under the current arrangement, the funding September 19, 2023, the Benefit Plan departments, in his capacity with the
obligation is less predictable because benefits are covered 64 participants, the $129,485 in local health local health insurance
paid out as claims are incurred. total annual cost savings under the company, which has provided him with
the experience and background for Applicant’s rationale as to why the participants would exceed the amount
forming the opinions expressed in his Captive Approach would directly of any non-monetary incidental benefit
Independent Fiduciary report. Mr. Benefit Plan participants and to the Fedeli Group and related parties; 6
Stadtlander was chosen to act as beneficiaries. Mr. Stadtlander represents (ii) create real and substantial additional
Independent Fiduciary by David M. that the Applicant’s factual assumptions benefits for the Benefit Plan and for
Deroma, the plan fiduciary responsible and related analysis were accurate and Benefit Plan participants; (iii) not be
for selecting the independent fiduciary. reasonable, and that his access to the offset by reduction in benefits/salaries
Mr. Deroma represents that Mr. Fedeli Group’s books and records will elsewhere; and (iv) be otherwise
Standtlander’s selection was based allow him to ensure that the use of the consistent with ERISA (including
solely on his qualifications to serve as Benefit Plan’s assets comply with the prudence/loyalty provisions) and the
an independent fiduciary after a requirements of ERISA. law; (d) certified, within the context of
prudent process without regard to 21. Mr. Stadtlander represents that he the captive, that the savings from the
whether Mr. Standtlander’s views were is authorized to take all appropriate Captive Approach would inure to the
likely to favor the interests of the Fedeli actions to safeguard the interests of the benefit of the participants through a
Group or related parties. Benefit Plan and its participants and combination of some or all improved
18. Mr. Stadtlander represents that he beneficiaries, including but not limited benefits or reduced contributions; (e)
understands his duties, responsibilities, to monitoring the proposed transactions confirmed that, as the Independent
and liabilities under ERISA as the to ensure the transactions remain in the Fiduciary, he had the requisite
Independent Fiduciary on behalf of the interests of the Benefit Plan and its knowledge regarding captive
Benefit Plan participants and their participants and beneficiaries, and that reinsurance arrangements to fulfill his
beneficiaries, and that, as Independent he can take appropriate actions duties under ERISA section 404 as a
Fiduciary of the Benefit Plan, he does available under the circumstances with prudent plan fiduciary; (f) confirmed
not act on behalf of the Benefit Plan respect to the proposed transactions, that he, as the Independent Fiduciary,
sponsor or take its interests into including but not limited to enforcing would monitor the reinsurance
account. Mr. Stadtlander also represents compliance with all contractual arrangement throughout the duration of
that neither he nor Consoliplex have conditions and obligations imposed on the exemption, if granted by the
received, nor will they receive, more any party dealing with the Benefit Plan. Department; (g) confirmed that the
than 1% of their annual income from 22. July 2019 Independent Fiduciary proposed captive reinsurance
Fedeli Group and its related parties. In Report. In the July 30, 2019 Independent arrangement is consistent with the
addition, Mr. Stadtlander represents Fiduciary Report, Mr. Stadtlander prudence and loyalty provisions of
that neither he nor any related parties, certified that the proposed captive ERISA section 40 and other applicable
including Consoliplex: have performed reinsurance arrangement would: (a) laws; and (h) provided analyses to
any work in connection with the primarily Benefit Plan participants and
support all representations it made to
Captive Approach on behalf of the beneficiaries and only provide non-
the Department.
Fedeli Group or its related parties; have monetary benefits to the Fedeli Group; 24. In addition, Mr. Stadtlander stated
any financial interest with respect to his (b) create real and substantial additional that he would annually determine
work as an independent fiduciary or the benefits for the Plan and Plan whether the terms and conditions of the
Captive Approach apart from his participants; (c) not be offset by exemption, if granted, had been met in
express fees for his work as an reduction in benefits/salaries elsewhere; the prior year. Specifically, the terms of
independent fiduciary for the Benefit and (d) otherwise be consistent with the proposed exemption, if granted,
Plan; or have received any other ERISA (including the prudence and
provide that Mr. Stadtlander must file
compensation or entered into any loyalty provisions) and the law.
annual certified reports with the
financial or compensation arrangements 23. December 2019 Independent
Fiduciary Report. At the Department’s Department that confirm whether all
with the Fedeli Group and related terms and conditions of the exemption
parties. Fedeli Group and its related request, Mr. Stadtlander provided
additional responses and clarifications have been met under penalty of perjury.
parties have not, and will not, Under the terms of the proposed
indemnify the Independent Fiduciary, related to the proposed transactions. Mr.
Stadtlander: (a) reviewed the exemption, each report must be
in whole or in part, for any violations
Applicant’s representations that the completed within six months from the
of state or federal law that may be
Fedeli Group and/or its related parties end of the 12-month period to which it
attributable to the Independent
would not receive a monetary benefit relates (the first 12-month period
Fiduciary in performing its duties under
(tax or non-tax, including a profit) from beginning on the effective date of the
the captive reinsurance arrangement. In
the proposed captive reinsurance exemption, if granted, and submitted to
addition, no contract or instrument
arrangement, and certified that the the Department within six months
purports to waive any liability under
Applicant’s representations were thereafter).
state or federal law for any such
accurate; 5 (b) determined that the 25. Finally, Mr. Stadtlander attached
violations.
proposed captive reinsurance his supporting analysis to the
19. As the Independent Fiduciary, Mr.
Stadtlander prepared an initial report arrangement would: (i) primarily Benefit Independent Fiduciary Report.
dated February 26, 2018 (the February Plan participants inasmuch as the Stadtlander’s analysis confirmed the
2018 Independent Fiduciary Report), financial benefits to Benefit Plan Fedeli Group’s calculations of the final
which he has updated with saving value and annual cost savings.
supplemental reports on July 30, 2019 5 In this regard, Mr. Stadtlander stated that he As stated above, the Applicant
(the July 2019 Independent Fiduciary received full disclosure of all benefits the Applicant calculated a savings of $168.60 per
Report), and December 5, 2019 (the
expected to derive from the proposed transactions. Benefit Plan participant per month
Among other things, Mr. Stadtlander reviewed
December 2019 Independent Fiduciary internal analyses of the economic benefits to the
using the Captive Approach based on an
Report), at the Department’s request. Applicant prepared by consultants and the
Applicant itself, and he received full access to all 6 As described above, Fedeli Group represents
20. February 2018 Independent data necessary to evaluate the transactions, that it would benefit by an increased predictability
Fiduciary Report. Mr. Stadtlander including submissions made by the Applicant to and greater control over its benefit funding
represents that he reviewed the state insurance departments. obligations.
overall annual cost savings to the Fiduciary that is obligated, among other reduction or a profit or any benefit
Benefit Plan of $129,485.00. things, to: (a) monitor the transactions arising from a further diversification of
described in the exemption on behalf of Risk Specialist’s risks in connection
The Department’s Findings
the Benefit Plan, on a continuing basis, with adding Plan-related insurance risks
26. The Department has the authority to ensure the transactions remain in the to Risk Specialist’s other risks.
under ERISA section 408(a) to grant an interest of the Benefit Plan; (b) take all Participants’ contributions will be
exemption from the prohibition appropriate actions to safeguard the reduced by the amount of the net benefit
transaction provisions of ERISA section interests of the Benefit Plan; and (c) (plus interest) on a pro rata basis in the
406 if the Department finds that the enforce compliance with all conditions year following the five-year period to
transaction is in the interest and of the exemption and all conditions and which the net benefit relates.
protective of the rights of the affected obligations imposed on any party
plan and its participants and Summary
dealing with the Benefit Plan. In
beneficiaries, and is administratively connection with the provision to 31. Based on Fedeli Group, Inc.
feasible.7 The Department’s findings participants in the Benefit Plan of the satisfying the conditions described
required under ERISA section 408(a) insurance coverage provided by THP or above and the representations made in
with respect to the proposed captive its successor, which is reinsured by the its exemption allocation and
reinsurance arrangement are discussed Risk Specialists, the Independent communications with the Department,
below. Fiduciary will review all contracts (and the Department has tentatively
27. The Proposed Exemption is any renewal of such contracts) of the determined that the relief sought by the
‘‘Administratively Feasible.’’ The reinsurance of risks and the receipt of Applicant satisfies the statutory
Department has tentatively determined premiums therefrom and ensure that the requirements for an exemption under
that the proposed exemption would be requirements of this exemption, and the ERISA section 408(a).
administratively feasible, because the terms of the increased benefits continue
proposed captive reinsurance Notice to Interested Persons
to be satisfied.
arrangement is subject to robust annual 30. The Proposed Exemption is ‘‘In Notice of the proposed exemption
reviews by Mr. Stadtlander and the Interests of the Plan.’’ The will be provided by the Applicant to all
included in a report he must file with Department has tentatively determined Interested Persons within 15 days of the
the Department’s Office of Exemption that the proposed exemption would be publication of the notice of proposed
Determinations. in the interest of the Benefit Plan exemption in the Federal Register, by
28. The Proposed Exemption is because, among other things, all of the first class U.S. mail to the last known
‘‘Protective of the Plan.’’ The cost savings from the Captive Approach address of all such individuals. Such
Department has tentatively determined (relative to the reasonable cost the notice will contain a copy of the notice
that the proposed exemption is Benefit Plan would otherwise have paid of proposed exemption, as published in
protective of the rights of the Benefit for comparable benefits pursuant to a the Federal Register, and a
Plan’s participants and beneficiaries non-captive arrangement with an supplemental statement, as required
because, among other things, a the unrelated, third-party insurer) will be pursuant to 29 CFR 2570.43(a)(2). The
exemption contains a number of used to reduce the amount that each supplemental statement will inform
additional conditions in addition to the Benefit Plan participant is required to interested persons of their right to
requirement discussed above, including contribute toward the premium the comment on the pending exemption.
the following: (a) no commissions will Benefit Plan pays to THP or another Written comments are due within 45
be paid by the Benefit Plan with respect fronting insurer. Specifically, based on days of the publication of the notice of
to the direct sale of any third party calculations confirmed by the proposed exemption in the Federal
insurance contract and/or any Independent Fiduciary, the captive Register. All comments will be made
reinsurance contract; and (b) the Fedeli reinsurance arrangement will reduce the available to the public.
Group will only contract on behalf of monthly contribution of each Benefit Warning: If you submit a comment,
the Benefit Plan with insurers having a Plan participant by approximately EBSA recommends that you include
financial strength rating of ‘‘A’’ or better $168.60. This monthly reduction in your name and other contact
from A.M. Best Company or the contribution obligations will result in information in the body of your
equivalent rating from another rating annual savings per participant of comment, but DO NOT submit
company. In addition, for each taxable $2,023.20 ($168.60 × 12 months). information that you consider to be
year of Risk Specialists, the gross Significantly, Benefit Plan participants confidential, or otherwise protected
premiums received in that taxable year will contribute no more than 17.38% of (such as Social Security number or an
by Risk Specialists for benefit insurance the premium paid by the Benefit Plan to unlisted phone number) or confidential
provided to Fedeli Group and its THP or another fronting insurer in any business information that you do not
employees with respect to which Risk Benefit Plan year, which is less than the want publicly disclosed. All comments
Specialists is a party in interest by 25% the participants previously may be posted on the internet and can
reason of the relationship to Fedeli contributed to Benefit Plan premiums. be retrieved by most internet search
Group as described in ERISA section In addition, the proposed exemption engines.
3(14)(E) or (G), will not exceed 50% of conditions require contributions of
the gross premiums received for all lines Benefit Plan participants to be further General Information
of insurance (i.e., benefit insurance and reduced by any net benefit received by The attention of interested persons is
non-benefit insurance) in that taxable any Fedeli Group entity, including Risk directed to the following:
year by Risk Specialists. Specialists, that is generated by the (1) The fact that a transaction is the
29. Further, the interests of the Captive Approach over each five-year subject of an exemption under ERISA
Benefit Plan and its participants and period, the first year of which would section 408(a) does not relieve a
beneficiaries are represented in the begin on the date this exemption is fiduciary or other party in interest or
covered transactions by an Independent granted. Net benefits may include, but disqualified person from certain other
are not limited to, increased earned provisions of ERISA and/or the Code,
7 ERISA section 408(a). income, increased savings, a tax including any prohibited transaction
provisions to which the exemption does reduce the amount that each Benefit (within the meaning of the law of its
not apply and the general fiduciary Plan participant is required to domiciliary State, Tennessee) by the
responsibility provisions of ERISA contribute toward the premium the Insurance Commissioner of the State of
section 404, which, among other things, Benefit Plan pays to THP or another Tennessee within five years before the
require a fiduciary to discharge their fronting insurer. The cost savings must end of the year preceding the year in
duties respecting the plan solely in the be determined relative to the reasonable which the reinsurance transaction
interest of the participants and cost the Benefit Plan would otherwise occurred;
beneficiaries of the plan and in a have paid for comparable benefits (4) Has undergone and shall continue
prudent fashion in accordance with pursuant to a non-captive arrangement to undergo an examination by an
ERISA section 404(a)(1)(B); nor does it with an unrelated, third-party insurer. independent certified public accountant
affect the requirement of Code Section In no year will the reduction in Benefit for its last completed taxable year
401(a) that the plan must operate for the Plan participant contributions be less immediately prior to the taxable year of
exclusive benefit of the employees of than $2,023.20 per participant per year. the reinsurance transaction covered by
the employer maintaining the plan and The premium reduction must benefit all this exemption; and
their beneficiaries; Plan participants equally and must be (5) Is licensed to conduct reinsurance
(2) Before an exemption may be verified by the Independent Fiduciary transactions by a state whose law
granted under ERISA section 408(a), the as described below. requires that an actuarial review of
Department must find that the (b) Benefit Plan participant reserves be conducted annually by an
exemption is administratively feasible, contributions will be further reduced by independent firm of actuaries and
in the interests of the plan and of its an amount equal to any net benefit (the reported to the appropriate regulatory
participants and beneficiaries, and Extra Benefit) any Fedeli Group entity authority;
protective of the rights of participants received that is directly or indirectly (e) The Benefit Plan pays no more
and beneficiaries of the plan; generated by the Captive Approach over than adequate consideration with
(3) The proposed exemption would be each five-year period, the first of which respect to insurance that is part of the
supplemental to, and not in derogation begins on the grant date this exemption captive reinsurance arrangement
of, any other provisions of ERISA and/ is granted. Extra Benefits include, but covered by the exemption;
are not limited to, increased earned (f) No commissions are paid by the
or the Code, including statutory or
income, increased savings, a tax Benefit Plan with respect to the direct
administrative exemptions and
reduction or a profit or any benefit sale of such contracts or the reinsurance
transitional rules. Furthermore, the fact
arising from a further diversification of thereof;
that a transaction is subject to an (g) In the initial year of any contract
administrative or statutory exemption is Risk Specialist’s risks in connection
with adding Plan-related insurance risks involving Risk Specialists and THP or
not dispositive of whether the any successor insurer, the Benefit Plan’s
transaction is, in fact, a prohibited to Risk Specialist’s other risks. The
reduction must be received by Benefit participants and beneficiaries receive an
transaction; and immediate and objectively determined
(4) The proposed exemption would be Plan participants on a pro rata basis in
the year following the five-year period benefit in the form of decreased
subject to the express condition that the participant contributions, and such
material facts and representations to which the Extra Benefit relates; plus,
an additional interest payment on the benefits will continue in all subsequent
contained in the application are true years of each contract and in every
and complete at all times and that the amount of the Extra Benefit at the
Internal Revenue Code’s federal renewal of each contract;
application accurately describes all (h) In the initial year and in
material terms of the transactions which underpayment rate established in Code
section 6621(b). The interest on the subsequent years of coverage provided
are the subject of the exemption. by THP or another fronting insurer
Extra Benefit must be calculated for the
Proposed Exemption period from the end of the Benefit Plan (either, a Fronting Insurer), the formulae
year the Extra Benefit was earned used by the Fronting Insurer to calculate
Section I. Proposed Transactions premiums must be similar to formulae
through the start of the Benefit Plan year
If the proposed exemption is granted, in which the Extra Benefit is applied to used by other insurers providing
the restrictions of ERISA sections reduce Benefit Plan participants’ comparable life insurance coverage
406(a)(1)(D)and 406(b)(1) shall not contributions. under similar programs that are not
apply to the reinsurance of risks and the (c) Benefit Plan participants captive reinsured. Furthermore, the
receipt of premiums therefrom by Risk contribute no more than 17.38% of the premium charges calculated in
Specialists Insurance Company, Inc. premium paid by the Benefit Plan to accordance with the formulae must be
(Risk Specialists), in connection with THP or another fronting insurer; reasonable and must be comparable to
insurance contracts sold by THP (d) Risk Specialists: the premiums charged by the Fronting
Insurance Company, Inc. (THP) or any (1) Is a party in interest with respect Insurer and its competitors with the
successor insurance company to THP, to the Benefit Plan by reason of a stock same or a better financial strength rating
which is unrelated to the Fedeli Group, affiliation with Fedeli Group that is providing the same coverage under
Inc., including any entity related to described in ERISA section 3(14)(E) or comparable programs that are not
Fedeli Group Inc. (collectively, Fedeli (G); captive reinsured;
Group), to provide medical and hospital (2) Is licensed to sell insurance or (i) Fedeli Group only contracts with
coverage to participants in the Fedeli conduct reinsurance operations in the insurers with a financial strength rating
Group Inc. Employee Benefit Plan (the state of Tennessee; of ‘‘A’’ or better from A.M. Best
Benefit Plan) provided that the (3) Has obtained a Certificate of Company. The reinsurance arrangement
conditions set forth in Section II are Authority from the insurance between any fronting insurer and Risk
met. commissioner of the State of Tennessee Specialists will be indemnity insurance
to transact the business of a captive only, such that the fronting insurer will
Section II. Conditions insurance company, which has neither not be relieved of any liability to the
(a) All of the savings from the captive been revoked nor suspended, and has Benefit Plan should Risk Specialists be
reinsurance arrangement will be used to undergone a financial examination unable or unwilling to cover any
liability arising from the reinsurance (n) The Benefit Plan, Fedeli Group NATIONAL AERONAUTICS AND
arrangement; and its related parties have not, and will SPACE ADMINISTRATION
(j) Participants and beneficiaries in not, indemnify the Independent
[NOTICE: 23–111]
the Benefit Plan must receive no less Fiduciary, in whole or in part, for
than the immediate and objectively negligence and/or for any violations of Name of Information Collection: NASA
determined increased benefits the state or federal law that may be Complaint of Discrimination Form 1355
participant and beneficiary received in attributable to the Independent
the initial year of each such contract Fiduciary in performing its duties under AGENCY: National Aeronautics and
involving Risk Specialists and THP in the captive reinsurance arrangement. In Space Administration (NASA).
subsequent years of every contract of addition, no contract or instrument will ACTION: Notice of information collection.
reinsurance involving Risk Specialists purport to waive any liability under
and THP; SUMMARY: The National Aeronautics and
state or federal law for any such Space Administration, as part of its
(k) For each taxable year of Risk violations. In the event a successor
Specialists, the gross premiums received continuing effort to reduce paperwork
Independent Fiduciary is appointed to and respondent burden, invites the
in that taxable year by Risk Specialists
represent the interests of the Plan with general public and other Federal
for benefit insurance provided to Fedeli
respect to the subject transaction, no agencies to take this opportunity to
Group and its employees with respect to
which Risk Specialists is a party in time shall elapse between the comment on proposed and/or
interest by reason of the relationship to resignation or termination of the former continuing information collections.
Fedeli Group as described in ERISA Independent Fiduciary and the DATES: Comments are due by December
section 3(14)(E) or (G), will not exceed appointment of the successor 6, 2023.
50% of the gross premiums received for Independent Fiduciary. ADDRESSES: Written comments and
all lines of insurance (i.e., benefit (o) No Fedeli Group entity or related recommendations for this information
insurance and non-benefit insurance) in entity may use participant-related data collection should be sent within 30 days
that taxable year by Risk Specialists; or information generated by or derived of publication of this notice to
(l) The Benefit Plan retains a qualified from the proposed arrangement in a www.reginfo.gov/public/do/PRAMain.
independent fiduciary (the Independent manner that benefits the Fedeli Group Find this particular information
Fiduciary) to analyze the transactions or related entity; collection by selecting ‘‘Currently under
covered by the exemption and render an 30-day Review—Open for Public
opinion that the terms and conditions of (p) No amount of THP’s reserves that Comments’’ or by using the search
this exemption have been satisfied; are attributable to the Plan participants’ function.
(m) The Independent Fiduciary will: contributions may be transferred to
(1) Monitor the transactions described Fedeli Group or a related party;
Requests for additional information or
here on behalf of the Benefit Plan on a (q) Fedeli Group will not evade the copies of the information collection
continuing basis to ensure such conditions in this exemption by instrument(s) and instructions should
transactions remain in the interest of the offsetting or reducing any benefits be directed to Bill Edwards-Bodmer,
Benefit Plan; provided to Fedeli Group employees to NASA Clearance Officer, NASA
(2) Take all appropriate actions to defray the costs, expenses, or Headquarters, 300 E Street SW, JF0000,
safeguard the interests of the Benefit obligations of complying with this Washington, DC 20546, 757–864–7998,
Plan; and exemption; or b.edwards-bodmer@nasa.gov.
(3) Enforce compliance with all SUPPLEMENTARY INFORMATION:
(r) All expenses associated with the
conditions of this exemption and all
exemption and the exemption I. Abstract
conditions and obligations imposed on
any party dealing with the Benefit Plan; application, including any payment to
the Independent Fiduciary, must be Federal agencies are required by
(4) Review all contracts, and any statute not to engage in discrimination
renewals of such contracts, pertaining to paid by Fedeli Group and not the Plan;
on the bases of race, color, religion, sex,
the captive reinsurance arrangement, to and national origin, age, disability, genetic
determine whether the requirements of (s) All the material facts and information, or retaliation. A federal
this exemption, and the terms of the representations set forth in the employee, former employee, or job
increased benefits continue to be Summary of Facts and Representation applicant who believes s/he was
satisfied; and are true and accurate at all times. discriminated against has a right to file
(5) Provide an annual, certified report a complaint with the agency’s office
to the Department, under penalty of Effective Date: The proposed
responsible for its Equal Employment
perjury, indicating whether the terms exemption will be in effect as of the date Opportunity (EEO) programs. Federal
and conditions of the exemption the grant notice is published in the agencies must offer pre-complaint
continue to be satisfied. Each report Federal Register. counseling or EEO alternative dispute
must be completed within six months Signed at Washington, DC. resolution (EEO ADR) to individuals
after the end of the twelve-month period George Christopher Cosby, who allege that they were discriminated
to which it relates (the first twelve- against by the agency. If pre-complaint
Director, Office of Exemption Determinations,
month period begins on the first day of counseling or EEO ADR does not resolve
Employee Benefits Security Administration,

the implementation of the captive U.S. Department of Labor. the dispute(s), the individual can file a
reinsurance arrangement covered by this formal discrimination complaint with
[FR Doc. 2023–24401 Filed 11–3–23; 8:45 am]
exemption), and be submitted to the the agency’s EEO office.
Department within 60 days thereafter. BILLING CODE 4510–29–P
The relevant report must include all the II. Methods of Collection
objective data necessary to demonstrate Title 29 of the Code of Federal
that the Primary Benefit Test has been Regulations (CFR) part 1614 section 104
met; and requires agencies to establish
procedures for processing individual included in the request for OMB Once you have found this information
and class complaints of discrimination approval of this information collection. collection request, select ‘‘Comment,’’
that include the provisions contained in They will also become a matter of and enter or upload your comment and
29 CFR 1614.105 through 1614.110 and public record. information. Alternatively, please mail
in § 1614.204, which are consistent your written comments to Office of
William Edwards-Bodmer,
with all other applicable Federal EEO Information and Regulatory Affairs,
regulations and complaint processing NASA PRA Clearance Officer. Attn.: OMB Desk Officer for Education,
requirements contained in the Equal [FR Doc. 2023–24505 Filed 11–3–23; 8:45 am] Office of Management and Budget,
Employment Opportunity Commission BILLING CODE 7510–13–P Room 10235, Washington, DC 20503, or
(EEOC) Management Directives (MD). call (202) 395–7316.
When an individual decides to pursue OMB is particularly interested in
the formal discrimination complaint NATIONAL FOUNDATION ON THE comments that help the agency to:
process, EEOC MD 110 requires that the ARTS AND THE HUMANITIES • Evaluate whether the proposed
formal complaint must be: collection of information is necessary
• In writing; Institute of Museum and Library for the proper performance of the
• Specific with regard to the claim(s) Services functions of the agency, including
that the individual raised in pre- whether the information will have
complaint counseling and that the Submission for OMB Review, practical utility;
person wishes to pursue; Comment Request, Proposed • Evaluate the accuracy of the
• Must be signed by the individual Collection: Native American Library agency’s estimate of the burden of the
and/or his or her representative; and Services Enhancement Grants Notice proposed collection of information,
• Must be filed within fifteen (15) of Funding Opportunity including the validity of the
calendar days from the date s/he AGENCY: Institute of Museum and methodology and assumptions used;
receives the Notice of Right to File a Library Services, National Foundation • Enhance the quality, utility, and
Discrimination Complaint. on the Arts and the Humanities. clarity of the information to be
Consequently, NASA established NF– ACTION: Submission for OMB Review, collected; and
1355P form to ensure the individual request for comments, collection of • Minimize the burden of the
who wishes to utilize the EEO process information. collection of information on those who
complies with the requirements listed are to respond, including through the
above. SUMMARY: The Institute of Museum and use of appropriate automated,
III. Data Library Services announces that the electronic, mechanical, or other
following information collection has technological collection techniques or
Title: Formal Discrimination been submitted to the Office of other forms of information technology
Complaint Form. Management and Budget (OMB) for (e.g., permitting electronic submission
OMB Number: 2700–0163. review and approval in accordance with of responses).
Type of review: Reinstatement of the Paperwork Reduction Act. This FOR FURTHER INFORMATION CONTACT:
Information Collection. program helps to ensure that requested Jennifer Himmelreich, Senior Program
Affected Public: Individuals who wish data can be provided in the desired Officer, Office of Library Services,
to file a formal discrimination format, reporting burden (time and Institute of Museum and Library
complaint against NASA. financial resources) is minimized,
Estimated Annual Number of Services, 955 L’Enfant Plaza North SW,
collection instruments are clearly Suite 4000, Washington, DC 20024–
Activities: 60. understood, and the impact of collection
Estimated Number of Respondents 2135. Ms. Himmelreich can be reached
requirements on respondents can be by telephone at 202–653–4797, or by
per Activity: 1. properly assessed. This Notice proposes
Annual Responses: 60. email at jhimmelreich@imls.gov.
the renewal of the clearance of the Persons who are deaf or hard of hearing
Estimated Time per Response: 30
Notice of Funding Opportunity for the (TTY users) can contact IMLS at 202–
minutes.
Native American Library Services 207–7858 via 711 for TTY-Based
Estimated Total Annual Burden
Enhancement Grants Program. A copy of Telecommunications Relay Service.
Hours: 30 hours.
the proposed information collection SUPPLEMENTARY INFORMATION: The
IV. Request for Comments request can be obtained by contacting Institute of Museum and Library
Comments are invited on: (1) Whether the individual listed below in the FOR Services is the primary source of federal
the proposed collection of information FURTHER INFORMATION CONTACT section of support for the nation’s libraries and
is necessary for the proper performance this Notice. museums. We advance, support, and
of the functions of NASA, including DATES: Written comments must be empower America’s museums, libraries,
whether the information collected has submitted to the office listed in the and related organizations through grant-
practical utility; (2) the accuracy of ADDRESSES section below on or before making, research, and policy
NASA’s estimate of the burden December 3, 2023. development. To learn more, visit
(including hours and cost) of the ADDRESSES: Written comments and www.imls.gov.
proposed collection of information; (3) recommendations for proposed Current Actions: This Notice proposes
ways to enhance the quality, utility, and information collection requests should the renewal of the clearance of the
clarity of the information to be be sent within 30 days of publication of Notice of Funding Opportunity for
collected; and (4) ways to minimize the this Notice to www.reginfo.gov/public/ IMLS’s Native American Library
burden of the collection of information do/PRAMain. Find this particular Services Enhancement Grants Program.
on respondents, including automated information collection request by The purpose of the program is to assist
collection techniques or the use of other selecting ‘‘Institute of Museum and Native American tribes in improving
forms of information technology. Library Services’’ under ‘‘Currently core library services for their
Comments submitted in response to Under Review;’’ then check ‘‘Only Show communities. IMLS recognizes that
this notice will be summarized and ICR for Public Comment’’ checkbox. information needs and approaches to
meeting them are evolving at an ACTION: Submission for OMB Review, • Minimize the burden of the
unprecedented pace in all communities, request for comments, collection of collection of information on those who
and to operate within this environment information. are to respond, including through the
effectively for the benefit of their users, use of appropriate automated,
libraries must be able to both strengthen SUMMARY: The Institute of Museum and electronic, mechanical, or other
existing services and move quickly to Library Services announces that the technological collection techniques or
adopt new and emerging technologies. following information collection has other forms of information technology
been submitted to the Office of (e.g., permitting electronic submission
The goals for this program are to
Management and Budget (OMB) for of responses).
improve digital services to support
review and approval in accordance with
needs for education, workforce the Paperwork Reduction Act. This FOR FURTHER INFORMATION CONTACT:
development, economic and business program helps to ensure that requested Jennifer Himmelreich, Senior Program
development, health information, data can be provided in the desired Officer, Office of Library Services,
critical thinking skills, and digital format, reporting burden (time and Institute of Museum and Library
literacy skills; to improve educational financial resources) is minimized, Services, 955 L’Enfant Plaza North SW,
programs related to specific topics and collection instruments are clearly Suite 4000, Washington, DC 20024–
content areas of interest to library understood, and the impact of collection 2135. Ms. Himmelreich can be reached
patrons and community-based users; requirements on respondents can be by telephone at 202–653–4797, or by
and to enhance the preservation and properly assessed. This Notice proposes email at jhimmelreich@imls.gov.
revitalization of Native American the renewal of the clearance of the Persons who are deaf or hard of hearing
cultures and languages. Notice of Funding Opportunity for the (TTY users) can contact IMLS at 202–
The 60-day Notice was published in Native Hawaiian Library Services Grants 207–7858 via 711 for TTY-Based
the Federal Register on August 22, 2023 Program. A copy of the proposed Telecommunications Relay Service.
(88 FR 57134–57135). The agency information collection request can be SUPPLEMENTARY INFORMATION: The
received no comments under this obtained by contacting the individual Institute of Museum and Library
Notice. listed below in the FOR FURTHER Services is the primary source of federal
Agency: Institute of Museum and INFORMATION CONTACT section of this support for the nation’s libraries and
Library Services. Notice. museums. We advance, support, and
Title: Native American Library DATES: Written comments must be empower America’s museums, libraries,
Services Enhancement Grants Program submitted to the office listed in the and related organizations through grant-
Notice of Funding Opportunity. ADDRESSES section below on or before making, research, and policy
OMB Control Number: 3137–0110. December 3, 2023. development. To learn more, visit
Agency Number: 3137. ADDRESSES: Written comments and
www.imls.gov.
Affected Public: Federally Recognized recommendations for proposed Current Actions: This Notice proposes
Indian Tribes. information collection requests should the clearance of a Notice of Funding
be sent within 30 days of publication of Opportunity for IMLS’s Native
Total Number of Respondents: 40.
this Notice to www.reginfo.gov/public/ Hawaiian Library Services Grants
Frequency of Response: Once per Program. The purpose of the program is
request. do/PRAMain. Find this particular
information collection request by to assist Native Hawaiian libraries in
Average Hours per Response: 35 improving core library services for their
hours. selecting ‘‘Institute of Museum and
Library Services’’ under ‘‘Currently communities. IMLS recognizes that
Total Burden Hours: 1,400 hours. information needs and approaches to
Under Review;’’ then check ‘‘Only Show
Total Annualized Capital/Startup ICR for Public Comment’’ checkbox. meeting them are evolving at an
Costs: n/a. Once you have found this information unprecedented pace in all communities,
Total Annual Cost Burden: $40,992. collection request, select ‘‘Comment,’’ and to operate within this environment
Total Annual Federal Costs: $1,744. and enter or upload your comment and effectively for the benefit of their users,
Dated: October 31, 2023. information. Alternatively, please mail libraries must be able to both strengthen
your written comments to Office of existing services and move quickly to
Suzanne Mbollo,
Information and Regulatory Affairs, adopt new and emerging technologies.
Grants Management Specialist, Institute of The 60-day Notice was published in
Museum and Library Services. Attn.: OMB Desk Officer for Education,
Office of Management and Budget, the Federal Register on August 22, 2023
[FR Doc. 2023–24419 Filed 11–3–23; 8:45 am] (88 FR 57135–57136). The agency
Room 10235, Washington, DC 20503, or
BILLING CODE 7036–01–P received no comments under this
call (202) 395–7316.
OMB is particularly interested in Notice.
comments that help the agency to: Agency: Institute of Museum and
NATIONAL FOUNDATION ON THE
• Evaluate whether the proposed Library Services.
ARTS AND THE HUMANITIES Title: Native Hawaiian Library
collection of information is necessary
Institute of Museum and Library for the proper performance of the Services Grants Program Notice of
Services functions of the agency, including Funding Opportunity.
whether the information will have OMB Control Number: 3137–0102.
Submission for OMB Review, practical utility; Agency Number: 3137.
Comment Request, Proposed • Evaluate the accuracy of the Affected Public: Nonprofit
Collection: Native Hawaiian Library agency’s estimate of the burden of the organizations that primarily serve and
Services Grants Notice of Funding proposed collection of information, represent Native Hawaiians.
Opportunity including the validity of the Total Number of Respondents: 8.
methodology and assumptions used; Frequency of Response: Once per
AGENCY: Institute of Museum and • Enhance the quality, utility, and request.
Library Services, National Foundation clarity of the information to be Average Hours per Response: 35
on the Arts and the Humanities. collected; and hours.
Total Burden Hours: 280 hours. • NRC’s Agencywide Documents 2, 1999. On August 9, 2012, the NRC
Total Annualized Capital/Startup Access and Management System renewed NFS’s license SNM–124 for a
Costs: n/a. (ADAMS): You may obtain publicly period of 25 years, which will allow
Total Annual Cost Burden: $8,199. available documents online in the operations through 2037.
Total Annual Federal Costs: $348.72. ADAMS Public Documents collection at
II. Environmental Assessment
Dated: October 31, 2023. https://www.nrc.gov/reading-rm/
Suzanne Mbollo, adams.html. To begin the search, select Description of the Proposed Action
Grants Management Specialist, Institute of ‘‘Begin Web-based ADAMS Search.’’ For
problems with ADAMS, please contact The proposed action is issuance of a
Museum and Library Services.
the NRC’s Public Document Room (PDR) license amendment to NFS’s 10 CFR
[FR Doc. 2023–24420 Filed 11–3–23; 8:45 am]
reference staff at 1–800–397–4209, at part 70 SNM license, SNM–124, to
BILLING CODE 7036–01–P authorize construction and operation of
301–415–4737, or by email to
PDR.Resource@nrc.gov. For the the U-Metal Project at the NFS facility
convenience of the reader, instructions pursuant to a contract with the U.S.
NUCLEAR REGULATORY Department of Energy’s National
about obtaining materials referenced in
COMMISSION Nuclear Security Administration
this document are provided in the
[Docket No. 70–00143; NRC–2022–0097] ‘‘Availability of Documents’’ section of (NNSA).
this document. The proposed action is described in
Nuclear Fuel Services, Inc.; U-Metal • NRC’s PDR: The PDR, where you the NFS’s application and
Project may examine and order copies of environmental report dated November
AGENCY: Nuclear Regulatory publicly available documents, is open 18, 2021, as supplemented by letters
Commission. by appointment. To make an dated on March 7, 2022, and January 31,
appointment to visit the PDR, please 2023.
ACTION: Environmental assessment and
finding of no significant impact; send an email to PDR.Resource@nrc.gov Need for the Proposed Action
issuance. or call 1–800–397–4209 or 301–415–
4737, between 8 a.m. and 4 p.m. eastern The proposed action is needed for
SUMMARY: The U.S. Nuclear Regulatory time (ET), Monday through Friday, NFS to maintain the ability to convert
Commission (NRC) is issuing a finding except Federal holidays. oxides to metal, provide a redundancy
of no significant impact (FONSI) and FOR FURTHER INFORMATION CONTACT: for the purification of uranium metals,
accompanying environmental Ashley Waldron, Office of Nuclear and hedge against the technology risk
assessment (EA) regarding the NRC’s Material Safety and Safeguards, U.S. associated with a new electrorefining
consideration of a license amendment Nuclear Regulatory Commission, facility.
request to amend a Special Nuclear Washington, DC 20555–0001; telephone: Environmental Impacts of the Proposed
Material (SNM) license, SNM–124, held 301–415–7317, email: Ashley.Waldron@ Action
by Nuclear Fuel Service, Inc. (NFS) at nrc.gov.
the NFS site located in Erwin, SUPPLEMENTARY INFORMATION: The NRC staff considered the
Tennessee. If approved, the amendment potential impacts of the proposed action
would authorize NFS to operate I. Introduction on land use, historical and cultural
uranium purification and conversion The NRC is considering issuance of a resources; visual and scenic resources;
services (U-Metal Project) at the NFS license amendment request to amend meteorology, climatology, and air
site, pursuant to a contract with the U.S. NFS’s part 70 of title 10 of the Code of quality; noise; geologic resource; water
Department of Energy’s National Federal Regulations (10 CFR) SNM resources; ecological resources;
Nuclear Security Administration. Based license, SNM–124. The license socioeconomics; public and occupation
on the EA, the NRC staff has concluded amendment would authorize a change health; transportation; environmental
that there will be no significant impacts to current operations to include a U- justice; and waste management. Given
to environmental resources from the Metal Project at NFS’s site located in that construction would occur within
requested license amendment, and Erwin, Tennessee. As required by 10 the industrial facility footprint and
therefore, a FONSI is appropriate. CFR part 51, ‘‘Environmental Protection within previous disturbed areas, and all
DATES: The EA and FONSI referenced in Regulations for Domestic Licensing and other proposed activities would occur in
this document is available on November Related Regulatory Functions,’’ the NRC an existing building, the activities
6, 2023. prepared an EA. Based on the results of associated with the proposed
ADDRESSES: Please refer to Docket ID the EA, the NRC has determined not to amendment would likely not alter any
NRC–2022–0097 when contacting the prepare an environmental impact of the current characteristics of the site.
NRC about the availability of statement (EIS) for the license Additionally, the proposed action
information regarding this document. amendment request and is issuing a would not result in significantly
You may obtain publicly available FONSI. increased effluents. The proposed
information related to this document NFS’s 10 CFR part 70 license was activities would not be expected to add
using any of the following methods: originally issued by the Atomic Energy to historical site contamination.
• Federal Rulemaking website: Go to Commission to W.R. Grace and Therefore, the proposed action would
https://www.regulations.gov and search Company, Davison Chemical Division, result in insignificant impacts and
for Docket ID NRC–2022–0097. Address on September 18, 1957. W.R. Grace and would not contribute to potential
questions about Docket IDs in Company authorized initial facility cumulative impacts when added to the
Regulations.gov to Stacy Schumann; operations with enriched uranium. past, present, or reasonably foreseeable
telephone: 301–415–0624; email: Later, the license was transferred to NFS future actions on the NFS site. Any
Stacy.Schumann@nrc.gov. For technical on December 31, 1963. The license was future proposal to conduct NRC-
questions, contact the individual listed renewed on the following dates: regulated activities beyond the scope of
in the FOR FURTHER INFORMATION November 5, 1965; January 27, 1978; the present license amendment would
CONTACT section of this document. March 16, 1979; June 9, 1992; and July be evaluated, as appropriate, as part of
a separate licensing and environmental response, the State noted that it has no III. Finding of No Significant Impact
review. concerns regarding the environmental
Based on its review of the license
impact of the proposed action. The State
Environmental Impacts of the amendment request, in accordance with
Alternatives to the Proposed Action official concurred with the EA and
the requirements of 10 CFR part 51, the
FONSI.
As an alternative to the proposed NRC staff has determined that issuing
action, the NRC staff considered denial The NRC completed consultation the requested amendment of SNM–124
of the proposed action (i.e., the ‘‘no- under section 106 of the National to add the U-Metal Project would not
action’’ alternative). Under the no-action Historic Preservation Act by consulting significantly affect the quality of human
alternative, the NRC would not amend with the Tennessee State Historic environment. No significant radiological
the license to authorize construction Preservation Office and four Federally or non-radiological impacts are
and operation of new U-Metal Project at recognized Indian Tribes in expected from the proposed action.
the NFS site. The NNSA would not have correspondence dated September 13, Therefore, the NRC staff has determined
an option for conversion services to 2022. In addition, the NRC staff, that pursuant to 10 CFR 51.31,
replace the legacy uranium processing consulted with the U.S. Fish and ‘‘Determinations based on
equipment temporarily until the new Wildlife Service (FWS) and determined environmental assessment,’’ preparation
electrorefining technology to purify that the proposed action ‘‘may affect, of an EIS is not required for the
high-enriched uranium metal is but not likely to adversely affect’’ five proposed action, and pursuant to 10
available, nor would NNSA have a threatened or endangered species, CFR 51.32, ‘‘Finding of no significant
redundancy for the purification of would have ‘‘no effect’’ on one impact,’’ a FONSI is appropriate. In
uranium metals. additional species, and would have ‘‘no accordance with 10 CFR 51.32(a)(4), this
effect’’ on critical habitat. The NRC staff FONSI incorporates the EA set forth in
Agencies and Persons Consulted provided its effect determinations to this notice by reference.
On March 29, 2023, the NRC staff FWS on August 18, 2023, and FWS
IV. Availability of Documents
provided a copy of the draft EA to the concurred with those findings on
State of Tennessee Division of September 28, 2023. Therefore, The documents identified in the
Radiological Health for its review and consultation has been completed under following table are available to
comment. In its May 4, 2023, email section 7 of the Endangered Species Act. interested persons through ADAMS.
Document description ADAMS accession No.
Nuclear Fuel Services, License Amendment Application, dated November 18, 2021 ..................................... ML21327A099.
Nuclear Fuel Services Supplemental Environmental Report, dated November 2021 and revised January ML22066B005 and ML23041A236.
2023.
Tennessee Department of Environmental Quality email response NRC Request for Review of Draft EA, ML23131A361.
dated May 4, 2023.
Letter to Tennessee State Historic Preservation Office initiating consultation under Section 106 of the Na- ML22098A154.
tional Historic Preservation Act, dated September 13, 2022.
NRC letters to Tribal nations initiating consultation under Section 106 of the National Historic Preservation ML22256A146 (package).
Act, dated September 13, 2022.
Fish and Wildlife Service, Information for Planning and Consultation identifying Threatened or Endangered ML23202A166.
Species, dated June 6, 2023.
NRC letter to FWS regarding informal Section 7 consultation, determinations of effect, dated August 18, ML23228A158.
2023.
Fish and Wildlife Service concurrence on NRC’s determinations of effect, dated September 28, 2023 ......... ML23272A109.
Final Environmental Assessment for NFS Proposed U-Metal Project, dated October 26, 2023 ..................... ML23299A062.
For the Nuclear Regulatory Commission. a negotiated service agreement. This Table of Contents
Dated: October 31, 2023. notice informs the public of the filing, I. Introduction
Michelle S. Rome, invites public comment, and takes other II. Docketed Proceeding(s)
Acting Chief, Environmental Review Materials administrative steps.
Branch, Division of Rulemaking, I. Introduction
Environmental, and Financial Support, Office DATES: Comments are due: November 7,
The Commission gives notice that the
of Nuclear Material Safety, and Safeguards. 2023.
Postal Service filed request(s) for the
[FR Doc. 2023–24408 Filed 11–3–23; 8:45 am] ADDRESSES: Submit comments Commission to consider matters related
BILLING CODE 7590–01–P electronically via the Commission’s to negotiated service agreement(s). The
Filing Online system at http:// request(s) may propose the addition or
www.prc.gov. Those who cannot submit removal of a negotiated service
POSTAL REGULATORY COMMISSION comments electronically should contact agreement from the Market Dominant or
the person identified in the FOR FURTHER the Competitive product list, or the
[Docket Nos. MC2024–29 and CP2024–29] modification of an existing product
INFORMATION CONTACT section by
New Postal Products telephone for advice on filing currently appearing on the Market
alternatives. Dominant or the Competitive product
AGENCY: Postal Regulatory Commission. list.
ACTION: Notice. FOR FURTHER INFORMATION CONTACT: Section II identifies the docket
David A. Trissell, General Counsel, at number(s) associated with each Postal
SUMMARY: The Commission is noticing a 202–789–6820. Service request, the title of each Postal
recent Postal Service filing for the Service request, the request’s acceptance
Commission’s consideration concerning SUPPLEMENTARY INFORMATION: date, and the authority cited by the
Postal Service for each request. For each SUMMARY: The Commission is providing Order No. 6688 at 8. The parties shall
request, the Commission appoints an notice that a hearing and certain email their initial information requests,
officer of the Commission to represent procedural events have been scheduled encompassing both of the disputed
the interests of the general public in the in this proceeding. This notice informs issues of fact, to the Presiding Officer
proceeding, pursuant to 39 U.S.C. 505 the public of the procedural schedule. (and cc’ing the other party) no later than
(Public Representative). Section II also DATES: Notices of intervention are due: Monday, November 6, 2023, at 4:30
establishes comment deadline(s) November 13, 2023; Prehearing p.m.3 The parties should attach their
pertaining to each request. Videoconference: December 4, 2023, at requests to the email in Microsoft Word
The public portions of the Postal 1:00 p.m., Eastern Daylight Time, format. These proposed information
Service’s request(s) can be accessed via Virtual. requests need not be filed on the
the Commission’s website (http:// Commission’s public docket. Failure to
www.prc.gov). Non-public portions of ADDRESSES: Submit notices of
submit an initial information request by
the Postal Service’s request(s), if any, intervention electronically via the the deadline without good cause may
can be accessed through compliance Commission’s Filing Online system at result in waiver of the party’s right to
with the requirements of 39 CFR https://www.prc.gov. Persons interested request discovery in this case.
3011.301.1 in intervening who cannot submit their The Presiding Officer will serve
The Commission invites comments on views electronically should contact the information requests by filing them on
whether the Postal Service’s request(s) person identified in the FOR FURTHER the Commission’s public docket.
in the captioned docket(s) are consistent INFORMATION CONTACT David A. Trissell, Answers to information requests, as
with the policies of title 39. For General Counsel, at 202–789–6820. For well as any objections or claims of
request(s) that the Postal Service states additional information, Presiding privilege, are due by the date and time
concern Market Dominant product(s), Officer’s Ruling No. 2 can be accessed specified in each information request.
applicable statutory and regulatory electronically through the Commission’s Although the Presiding Officer will
requirements include 39 U.S.C. 3622, 39 website at https://www.prc.gov. initially review the proposed
U.S.C. 3642, 39 CFR part 3030, and 39 FOR FURTHER INFORMATION CONTACT: information requests and reserves the
CFR part 3040, subpart B. For request(s) David A. Trissell, General Counsel, at right to revise or reject any proposed
that the Postal Service states concern 202–789–6820. questions on grounds such as relevance,
Competitive product(s), applicable SUPPLEMENTARY INFORMATION: the Presiding Officer’s issuance of an
statutory and regulatory requirements I. Procedural Schedule information request should not be
include 39 U.S.C. 3632, 39 U.S.C. 3633, II. Additional Case Management Procedures construed as considering or rejecting
39 U.S.C. 3642, 39 CFR part 3035, and III. Ruling any objections or claims of privilege that
39 CFR part 3040, subpart B. Comment could conceivably be raised. Procedures
deadline(s) for each request appear in I. Procedural Schedule for raising good faith objections or
section II. Intervention. The deadline to file a claims of privilege, if any, will be set
notice of intervention pursuant to 39 out in the Presiding Officer’s
II. Docketed Proceeding(s)
CFR 3010.142 is November 13, 2023. information request.
1. Docket No(s).: MC2024–29 and Discovery. Pursuant to Order No. Responses to information requests
CP2024–29; Filing Title: USPS Request 6688, the Presiding Officer shall may be transmitted via email, with the
to Add Priority Mail Express, Priority conduct limited discovery for the Presiding Officer cc’ed, by the date and
Mail & USPS Ground Advantage purpose of determining disputed issues time due. Unless otherwise indicated,
Contract 12 to Competitive Product List of fact in this case.1 responses to discovery requests need
and Notice of Filing Materials Under At the prehearing videoconference not be filed on the Commission’s public
Seal; Filing Acceptance Date: October conducted on October 30, 2023, the docket.
30, 2023; Filing Authority: 39 U.S.C. parties agreed that the discovery process Further information requests
3642, 39 CFR 3040.130 through should go forward notwithstanding submitted by the parties will be
3040.135, and 39 CFR 3035.105; Public Complainant’s two motions pending considered by the Presiding Officer only
Representative: Christopher C. Mohr; before the Commission.2 After further after the parties have submitted their
Comments Due: November 7, 2023. discussion at the videoconference, responses to the initial information
This Notice will be published in the Complainant indicated that he would requests. Pursuant to 39 CFR 3010.170,
Federal Register. file a notice on the Commission’s docket the Presiding Officer may issue
Erica A. Barker, withdrawing his motion for summary information requests on his own
Secretary. judgment without prejudice to refiling initiative, either independently or along
once the discovery process has been with requests submitted by the parties.
[FR Doc. 2023–24375 Filed 11–3–23; 8:45 am]
completed. Should the Commission The parties are advised, however, that
BILLING CODE 7710–FW–P
grant the motion for reconsideration or issuance of additional information
otherwise expand the scope of the requests will be considered on a case-
POSTAL REGULATORY COMMISSION issues, the Presiding Officer will take by-case basis and is not guaranteed,
appropriate action. particularly if the party could have
[Docket No. C2023–6; Presiding Officer’s The parties may request that the requested the information sought in its
Ruling No. 2] Presiding Officer obtain specific initial information request.
discovery, but may not independently Prehearing videoconference. A
Service Standard Changes

propound discovery on each other. prehearing videoconference is
AGENCY: Postal Regulatory Commission. scheduled to be conducted before the
ACTION: Notice. 1 Order Partially Denying United States Postal Presiding Officer on December 4, 2023,
Service’s Motion to Dismiss and Notice of Limited at 1:00 p.m. Among other things, this
Formal Proceedings, September 18, 2023, at 8
1 See Docket No. RM2018–3, Order Adopting (Order No. 6688).
videoconference will discuss
Final Rules Relating to Non-Public Information, 2 See Motion to Reconsider Order No. 6688, procedures for the presentation of
June 27, 2018, Attachment A at 19–22 (Order No. October 20, 2023; Motion for Oral Argument and
4679). Summary Judgment, October 30, 2023. 3 All times in this Ruling are Eastern Time.
evidence and legal arguments, the need The motion must be filed before the 3. Compensation and Personnel Matters
for any additional information requests, specific deadline expires and shall state 4. Executive Session
as well as the resolution of any pending whether the other party opposes the 5. Administrative Items
discovery-related disputes. Additional motion. Extensions of time or Tuesday, November 14, 2023, at 12:00
prehearing conferences may be continuances will only be granted for p.m. (Open)
scheduled as needed. good cause shown.
Presentation of evidence. The issue of Waiver or modification. If either party 1. Remarks of the Chairman of the Board
whether the hearing will involve the seeks to waive or modify the terms of of Governors
presentation of oral versus written any Presiding Officer’s Ruling, the party 2. Remarks of the Postmaster General
testimony (including whether it may be must make a good faith effort to confer and CEO
appropriate to supplement written with the opposing party to determine a 3. Approval of the Minutes
testimony with oral testimony for 4. Committee Reports
proposed mutually agreeable resolution 5. Financial Matters
certain witnesses on particular issues in before filing a motion. The Presiding a. FY2023 Annual Financial Report
dispute) will be addressed more fully at Officer may waive or modify the terms b. FY2023 10K and Financial
the December 4, 2023, prehearing of his order for good cause shown. Statements
videoconference. Oral argument. If either party requests c. Annual Report to Congress
Hearing. The date on which the to present oral argument before the d. FY2024 Integrated Financial Plan
hearing of evidence shall begin will be Presiding Officer relating to any motion and Liquidity Outlook
addressed at the December 4, 2023, or brief, the party shall include ‘‘ORAL e. FY2025 Congressional
prehearing teleconference. ARGUMENT REQUESTED’’ in the Reimbursement Request
II. Additional Case Management caption or title on page 1 of the 6. Quarterly Service Performance Report
Procedures applicable motion, response, or brief. 7. Approval of Tentative Agenda for the
February 8, 2024 Meeting
Good faith effort to confer. A good III. Ruling
8. Election of the Chairman and Vice
faith effort to confer with the opposing 1. The deadline to file a notice of Chairman
party requires at least the placing of one intervention pursuant to 39 CFR
telephone call or the transmittal of one A public comment period will begin
3010.142 is November 13, 2023. immediately following the adjournment
email message to the opposing party or 2. A prehearing videoconference will
its counsel. of the open session on November 14,
be conducted before the Presiding 2023, and shall last no more than 40
Discovery motions. The parties must
Officer on December 4, 2023, at 1:00 minutes. During the public comment
make a good faith effort to confer with
p.m. period, members of the public present at
the opposing party to attempt to resolve
3. The parties and counsel shall the meeting may comment on any item
any discovery dispute before filing any
follow the procedural schedule and case or subject listed on the agenda for the
motions related to discovery. The
management procedures established by open session. Registration of speakers at
Presiding Officer will not entertain a
this Presiding Officer’s Ruling. the public comment period is required.
motion to compel discovery, motion for
4. The Secretary shall arrange for Speakers must register online at https://
sanctions, motion for protective order,
publication of the deadline to file a www.surveymonkey.com/r/bog-11-14-
or any other discovery motions until
notice of intervention and the date of 2023. No more than 30 minutes of the
this good faith effort has been made. If
the prehearing videoconference in the public comment period shall be allotted
this good faith effort is unsuccessful, the
Federal Register. to registered speakers present at the
motion shall (1) state that a good faith
effort has been made to resolve the Erica A. Barker, meeting, and no more than three
dispute, (2) attach each disputed Secretary. minutes shall be allotted to each
discovery request, answer, and objection [FR Doc. 2023–24380 Filed 11–3–23; 8:45 am]
speaker. The time allotted to each
(if applicable), (3) provide available speaker will be determined after
BILLING CODE 7710–FW–P
dates and times for a hearing to be registration closes. Registration to speak
conducted by videoconference, and (4) during the public comment period shall
concisely state the relief sought, the end on November 9 at noon ET.
POSTAL SERVICE Additionally, a select number of written
basis therefor, and the authority relied
upon. Any party opposing the motion Sunshine Act Meetings comments will be read in whole or in
shall file a response no later than 7 days part during the public comment period
after the motion is filed. See 39 CFR TIME AND DATE: Monday, November 13, for no more than 10 minutes. Written
3010.160(b). No replies shall be 2023, at 1:00 p.m.; Tuesday, November comments on any item or subject listed
permitted without express authorization 14, 2023, at 12:00 p.m. on the agenda for the open session may
of the Presiding Officer. See 39 CFR PLACE: Washington, DC, at U.S. Postal
be submitted by United States Mail to
3010.160(c). Failure to file a timely Service Headquarters, 475 L’Enfant the address below or to the email
response may result in the motion being Plaza SW, in the Benjamin Franklin address bog-inquiries@usps.gov. If
deemed unopposed. The Presiding Room. submitted by email, written comments
Officer may decide the dispute based on must include a valid email address for
STATUS: Monday, November 13, 2023, at
the motion and any response, set a the person submitting the comment and
1:00 p.m.—Closed. Tuesday, November the words ‘‘Public Comment Period’’ in
hearing to be conducted by 14, 2023, at 12:00 p.m.—Open.
videoconference, or order further the subject line. Written comments must

MATTERS TO BE CONSIDERED: be received before November 9 at noon
briefing.
Extension of time or continuance. If Meeting of the Board of Governors ET. Participation in the public comment
either party seeks an extension of time period is governed by 39 CFR 232.1(n).
or continuance, they must make a good Monday, November 13, 2023, at 1:00 The next public comment period is
faith effort to confer with the opposing p.m. (Closed) scheduled for November 2024.
party to determine a proposed mutually 1. Strategic Issues CONTACT PERSON FOR MORE INFORMATION:
agreeable date before filing a motion. 2. Financial and Operational Matters Michael J. Elston, Secretary of the
Board, U.S. Postal Service, 475 L’Enfant Dated: November 2, 2023. DEPARTMENT OF STATE
Plaza SW, Washington, DC 20260–1000. J. Lynn Taylor,
Telephone: (202) 268–4800. [Public Notice: 12254]
Assistant Secretary.
Michael J. Elston, [FR Doc. 2023–24636 Filed 11–2–23; 4:15 pm] Notice of Determinations; Culturally
Secretary. BILLING CODE 8011–01–P Significant Object Being Imported for
[FR Doc. 2023–24527 Filed 11–2–23; 11:15 am] Exhibition—Determinations: Exhibition
of a ‘‘Volute Krater’’ Object
DEPARTMENT OF STATE SUMMARY: Notice is hereby given of the
following determinations: I hereby
[Public Notice: 12253] determine that a certain object being
SECURITIES AND EXCHANGE imported from abroad pursuant to an
COMMISSION Notice of Determinations; Culturally agreement with its foreign owner or
Significant Objects Being Imported for custodian for temporary exhibition or
Sunshine Act Meetings Exhibition—Determinations: ‘‘Dining display in the Department of Greek and
with the Sultan: The Fine Art of Roman Art of The Metropolitan
TIME AND DATE: 2:00 p.m. on Thursday, Feasting’’ Exhibition
November 9, 2023. Museum of Art, New York, New York,
PLACE: The meeting will be held via SUMMARY: Notice is hereby given of the and at possible additional exhibitions or
remote means and/or at the following determinations: I hereby venues yet to be determined, is of
Commission’s headquarters, 100 F determine that certain objects being cultural significance, and, further, that
Street NE, Washington, DC 20549. imported from abroad pursuant to its temporary exhibition or display
agreements with their foreign owners or within the United States as
STATUS: This meeting will be closed to aforementioned is in the national
the public. custodians for temporary display in the
exhibition ‘‘Dining with the Sultan: The interest. I have ordered that Public
MATTERS TO BE CONSIDERED: Fine Art of Feasting’’ at the Los Angeles Notice of these determinations be
Commissioners, Counsel to the County Museum of Art, Los Angeles, published in the Federal Register.
Commissioners, the Secretary to the California; the Detroit Institute of Arts, FOR FURTHER INFORMATION CONTACT:
Commission, and recording secretaries Detroit, Michigan; and at possible Reed Liriano, Program Coordinator,
will attend the closed meeting. Certain additional exhibitions or venues yet to Office of the Legal Adviser, U.S.
staff members who have an interest in be determined, are of cultural Department of State (telephone: 202–
the matters also may be present. significance, and, further, that their 632–6471; email: section2459@
In the event that the time, date, or temporary exhibition or display within state.gov). The mailing address is U.S.
location of this meeting changes, an the United States as aforementioned is Department of State, L/PD, 2200 C Street
announcement of the change, along with in the national interest. I have ordered NW (SA–5), Suite 5H03, Washington,
the new time, date, and/or place of the that Public Notice of these DC 20522–0505.
meeting will be posted on the determinations be published in the SUPPLEMENTARY INFORMATION: The
Commission’s website at https:// Federal Register. foregoing determinations were made
www.sec.gov.
FOR FURTHER INFORMATION CONTACT: pursuant to the authority vested in me
The General Counsel of the
Reed Liriano, Program Coordinator, by the Act of October 19, 1965 (79 Stat.
Commission, or her designee, has
Office of the Legal Adviser, U.S. 985; 22 U.S.C. 2459), Executive Order
certified that, in her opinion, one or
Department of State (telephone: 202– 12047 of March 27, 1978, the Foreign
more of the exemptions set forth in 5
632–6471; email: section2459@ Affairs Reform and Restructuring Act of
U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B)
state.gov). The mailing address is U.S. 1998 (112 Stat. 2681, et seq.; 22 U.S.C.
and (10) and 17 CFR 200.402(a)(3),
Department of State, L/PD, 2200 C Street 6501 note, et seq.), Delegation of
(a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and
NW (SA–5), Suite 5H03, Washington, Authority No. 234 of October 1, 1999,
(a)(10), permit consideration of the
DC 20522–0505. Delegation of Authority No. 236–3 of
scheduled matters at the closed meeting.
SUPPLEMENTARY INFORMATION: The August 28, 2000, and Delegation of
The subject matter of the closed
foregoing determinations were made Authority No. 523 of December 22,
meeting will consist of the following
pursuant to the authority vested in me 2021.
topics:
Institution and settlement of by the Act of October 19, 1965 (79 Stat. Nicole L. Elkon,
injunctive actions; 985; 22 U.S.C. 2459), Executive Order Deputy Assistant Secretary for Professional
Institution and settlement of 12047 of March 27, 1978, the Foreign and Cultural Exchanges, Bureau of
administrative proceedings; Affairs Reform and Restructuring Act of Educational and Cultural Affairs, Department
Resolution of litigation claims; and 1998 (112 Stat. 2681, et seq.; 22 U.S.C. of State.
Other matters relating to examinations 6501 note, et seq.), Delegation of [FR Doc. 2023–24410 Filed 11–3–23; 8:45 am]
and enforcement proceedings. Authority No. 234 of October 1, 1999, BILLING CODE 4710–05–P
At times, changes in Commission Delegation of Authority No. 236–3 of
priorities require alterations in the August 28, 2000, and Delegation of
scheduling of meeting agenda items that Authority No. 523 of December 22,
SURFACE TRANSPORTATION BOARD
may consist of adjudicatory, 2021.

examination, litigation, or regulatory [Docket No. AB 1331]
Nicole L. Elkon,
matters. Deputy Assistant Secretary for Professional Snohomish County—Adverse
CONTACT PERSON FOR MORE INFORMATION: and Cultural Exchanges, Bureau of Abandonment—GNP RLY, Inc., in
For further information; please contact Educational and Cultural Affairs, Department
of State.
Snohomish County, Wash.
Vanessa A. Countryman from the Office
of the Secretary at (202) 551–5400. [FR Doc. 2023–24411 Filed 11–3–23; 8:45 am] On October 17, 2023, Snohomish
Authority: 5 U.S.C. 552b. BILLING CODE 4710–05–P County (the County), a noncarrier, filed
an application under 49 U.S.C. 10903 the County to pursue interim trail use/ parties to this adverse abandonment
requesting that the Surface railbanking of the Line under the Trails proceeding 49 CFR 1104.12(a).
Transportation Board (the Board) Act. A Draft Environmental Assessment
authorize the third-party, or ‘‘adverse,’’ In a decision served in this (EA) (or environmental impact
abandonment of an approximately 11.9- proceeding on May 23, 2023, the County statement (EIS), if necessary) prepared
mile segment of a freight rail easement was granted exemptions from several by the Board’s Office of Environmental
owned by GNP RLY, Inc. (GNP), and statutory provisions as well as waivers Analysis (OEA) will be served upon all
located between milepost 26.38 and of certain Board regulations that the parties of record and upon any agencies
milepost 38.25, in Snohomish County, Board concluded were inapplicable and or other persons who commented
Wash. (the Line or the Snohomish unneeded in connection with the during its preparation. Any other
Segment of the Easement). The Line County’s anticipated application. persons who would like to obtain a copy
traverses U.S. Postal Service Zip Codes According to the County, the Line of the Draft EA (or EIS) may contact
98290, 98296, and 98072. may contain federally granted rights of OEA by phone at the number listed
The County explains that in a series way. The County states that any below. Draft EAs normally will be made
of transactions recorded on December documentation in its possession will be available within 33 days of the filing of
21, 2009, under the Board’s line of made available promptly to those the application, and the deadline for
precedent in Maine, Department of requesting it. The County’s entire case submission of comments on the Draft
Transportation—Acquisition & in chief for adverse abandonment was EA will generally be within 30 days of
Operation Exemption—Maine Central filed with the application. its service. The comments received will
Railroad, 8 I.C.C.2d 835 (1991), BNSF The interests of railroad employees be addressed in a Final EA (or EIS) and
Railway Company sold the physical will be protected by the conditions set the Board’s decision. A Supplemental
assets of a rail line between milepost forth in Oregon Short Line Railroad— Final EA (or EIS) may be issued where
23.8 in Woodinville, Wash., and Abandonment Portion Goshen Branch appropriate.
milepost 38.25 in Snohomish, Wash., to Between Firth & Ammon, in Bingham & Persons seeking further information
the Port of Seattle (the Port); GNP Bonneville Counties, Idaho, 360 I.C.C. concerning abandonment procedures
acquired a permanent freight rail 91 (1979). may contact the Board’s Office of Public
easement for the entirety of that rail line Any interested person may file Assistance, Governmental Affairs, and
(the Easement); and GNP entered into an comments concerning the proposed Compliance at (202) 245–0238 or refer
operations and maintenance agreement adverse abandonment or protests to the full abandonment regulations at
with the Port. The County states that the (including protestant’s entire opposition 49 CFR part 1152. Questions concerning
Easement is subject to a covenant, case) by December 1, 2023. Persons who environmental issues may be directed to
binding on all successors, requiring the may oppose the proposed adverse OEA at (202) 245–0305. If you require
holder of the Easement, upon cessation abandonment but who do not wish to an accommodation under the Americans
of rail service, either to seek voluntary participate fully in the process by with Disabilities Act, please call (202)
abandonment authority and, upon submitting verified statements of 245–0245.
request, to cooperate in railbanking the witnesses containing detailed evidence Board decisions and notices are
rail line pursuant to the National Trails should file comments. Persons opposing available at www.stb.gov.
System Act (Trails Act), 16 U.S.C. the proposed adverse abandonment who
1247(d), or to cooperate in an adverse wish to participate actively and fully in Decided: November 1, 2023.
abandonment proceeding and, upon By the Board, Mai T. Dinh, Director, Office
the process should file a protest,
of Proceedings.
request, railbanking of the rail line. observing the filing, service, and content
According to the County, in 2015, it Tammy Lowery,
requirements of 49 CFR 1152.25. The
purchased the physical assets of the County’s reply is due by December 18, Clearance Clerk.
Snohomish Segment from the Port, and 2023. [FR Doc. 2023–24479 Filed 11–3–23; 8:45 am]
the City of Woodinville (Woodinville) Any request for an interim trail use/ BILLING CODE 4915–01–P
purchased the physical assets of the railbanking condition under 16 U.S.C.
segment of the rail line between 1247(d) and 49 CFR 1152.29 must be
milepost 23.8 and milepost 26.38 in filed by December 1, 2023,1 and should TRADE AND DEVELOPMENT AGENCY
Woodinville, Wash. (the Woodinville address whether the issuance of a
Segment). certificate of interim trail use or Extension of the Agency’s Current
The County notes that GNP was abandonment in this case would be Approval for Information Collection
authorized to abandon the Woodinville consistent with the grant of an adverse
Segment of the Easement in Docket No. abandonment application. AGENCY: United States Trade and
AB 1316X, and GNP and Woodinville All pleadings, referring to Docket No. Development Agency.
subsequently entered an interim trail AB 1331, should be filed with the ACTION: Notice of information collection;
use/railbanking agreement covering that Surface Transportation Board either via request for comments.
segment. The County explains that it is e-filing on the Board’s website or in
now seeking adverse abandonment of writing addressed to 395 E Street SW, SUMMARY: In accordance with the
the Snohomish Segment of the Washington, DC 20423–0001. In Paperwork Reduction Act of 1995, this
Easement so that segment can also be addition, a copy of each pleading must notice announces the U.S. Trade and
railbanked, as required by the covenant be served on the County’s Development Agency’s (USTDA’s)
in the deed from BNSF to the Port representative, Charles H. Montagne, intention to request an extension for a
creating the Easement and by a 426 NW 162nd Street, Seattle, WA currently approved information
settlement agreement the County and 98177. Except as otherwise set forth in collection for Evaluation of USTDA
GNP entered prior to the County filing 49 CFR part 1152, every document filed Performance. USTDA invites the public
its application. The County states that with the Board must be served on all and other Federal agencies to comment
GNP supports and does not oppose the on the proposed extension of USTDA’s
County’s adverse abandonment 1 Filing fees for interim trail use/railbanking current approval for information
application and agrees to cooperate with requests can be found at 49 CFR 1002.2(f)(27). collection. All comments received will
be available for public inspection during institutions; farms; Federal, State, and DATES: Written comments should be
regular business hours. local government. submitted by January 5, 2024.
DATES: Comments on this notice must be Estimated Number of Responses: ADDRESSES: Please send written
received on or before January 2, 2024. 1,000 to 1,300 per year. comments:
Estimated Total Annual Burden on By Electronic Docket:
ADDRESSES: To access and review all of
Respondents: 334 to 434 hours per year. www.regulations.gov (Enter docket
the documents related to the data Federal Cost: $402,523.
collection listed in this notice, please number into search field)
Authority for Information Collection: By mail: Benjamin Walsh, FAA Flight
use http://www.regulations.gov by Government Performance and Results Standards Service, Emerging
searching the agency name. Comments Act of 1993 Public Law 103–62 or Technologies Division, AFS–700, 800
submitted in response to this notice GPRA; 107 Stat. 285, the Foreign Aid Independence Ave SW, Washington, DC
should be submitted electronically Transparency and Accountability Act 20591
through the Federal eRulemaking Portal (Pub. L. 114–191) or FATAA, the
at http://www.regulations.gov or via FOR FURTHER INFORMATION CONTACT:
Information Quality Act (IQA) of 2000 Benjamin Walsh by email at:
postal mail, commercial delivery, or (Pub. L. 106–554), and Foundations for
hand delivery. All submissions received ben.walsh@faa.gov; phone: 202–267–
Evidence-Based Policymaking Act of 8233
must include the agency name. Please 2018 Public Law 115–435.
note that comments submitted by fax or Abstract: USTDA will collect SUPPLEMENTARY INFORMATION:
email and those submitted after the information from various stakeholders Public Comments Invited: You are
comment period will not be accepted. on USTDA-funded activities regarding asked to comment on any aspect of this
Written requests for information or development and/or commercial information collection, including (a)
comments submitted by postal mail or benefits as well as evaluate success Whether the proposed collection of
delivery should be addressed to the regarding GPRA objectives and support information is necessary for FAA’s
Administrative Officer, U.S. Trade and evidence-based policymaking. performance; (b) the accuracy of the
Development Agency, 1101 Wilson All responses to this notice will be estimated burden; (c) ways for FAA to
Blvd., Suite 1100, Arlington, VA 22209– summarized and included in the request enhance the quality, utility and clarity
3901. for OMB approval. All comments will of the information collection; and (d)
FOR FURTHER INFORMATION CONTACT: become a matter of public record. ways that the burden could be
Contact Sheneé Turner, Administrative minimized without reducing the quality
Dated: October 31, 2023. of the collected information. The agency
Officer, Attn: PRA, U.S. Trade and
Sheneé Turner, will summarize and/or include your
Development Agency, 1101 Wilson
Blvd., Suite 1100, Arlington, VA 22209– Administrative Officer. comments in the request for OMB’s
3901; Tel.: (703) 875–4357, Fax: (703) [FR Doc. 2023–24426 Filed 11–3–23; 8:45 am] clearance of this information collection.
775–4037; Email: comments@ustda.gov. BILLING CODE 3410–34–P OMB Control Number: 2120–0782.
Title: Identification of Foreign-
SUPPLEMENTARY INFORMATION: Comments Registered Civil Unmanned Aircraft
are invited on: (1) whether the proposed Operating in the United States.
collection of information is necessary DEPARTMENT OF TRANSPORTATION
Form Numbers: N/A.
for the proper performance of the Type of Review: Renewal of an
functions of the agency, including information collection.
whether the information will have [Docket No. FAA–2023–2211] Background: The unmanned aircraft
practical utility; (2) the accuracy of the remote identification operating
agency’s estimate of the burden of the Agency Information Collection
requirements in title 14 Code of Federal
proposed collection of information Activities: Requests for Comments;
Regulations, part 89 apply to persons
including the validity of the Clearance of a Renewed Approval of
operating foreign civil unmanned
methodology and assumptions used; (3) Information Collection: Identification of
aircraft in the United States. The FAA
ways to enhance the quality, utility, and Foreign-Registered Civil Unmanned
must be able to correlate the remote
clarity of the information to be Aircraft Operating in the United States
identification message elements
collected; and (4) ways to minimize the AGENCY: Federal Aviation broadcast by foreign civil unmanned
burden of the collection of information Administration (FAA), DOT. aircraft operated in the United States
on those who are to respond, including against information that helps FAA and
ACTION: Notice and request for
the use of appropriate automated, law enforcement identify a person
comments.
electronic, mechanical, or other responsible for the operation of the
technological collection techniques or SUMMARY: In accordance with the foreign civil unmanned aircraft. Where
other forms of information technology. Paperwork Reduction Act of 1995, FAA unmanned aircraft are registered in a
Summary Collection Under Review invites public comments about our foreign jurisdiction, the FAA may not
intention to request the Office of have access to information regarding the
Type of Request: Extension of a Management and Budget (OMB) unmanned aircraft or its registered
currently approved information approval to renew an information owner. Thus, the FAA is allowing a
collection. collection. The collection involves person to operate foreign-registered civil
Expiration Date of Previous Approval: identifying information regarding unmanned aircraft with remote
01/31/2024. foreign-registered civil unmanned identification in the United States only

Title: Evaluation of USTDA aircraft operated in the airspace of the if the person submits a notice of
Performance. United States. The information to be identification to the Administrator in
Form Number: USTDA 1000E–2014a. collected will be used to associate a accordance with title 14 Code of Federal
Frequency of Use: Annually for foreign-registered unmanned aircraft Regulations § 89.130. The notice can be
duration of projects. operating in the United States with submitted online using the notice of
Type of Respondents: Business or Remote Identification to the unmanned identification form in FAA Drone Zone
other for profit; not-for-profit aircraft operator. (https://faadronezone.faa.gov/). The
notice includes the following to operating in the airspace of the Collection Clearance Officer, at email:
information to allow FAA to associate United States) are mandated to report arlette.mussington@dot.gov or
an unmanned aircraft to a responsible information to this collection. The FAA telephone: (571) 609–1285 or Ms.
person: uses information provided by operators Joanne Swafford, Information Collection
(1) An indication whether the person of foreign-registered civil unmanned Clearance Officer, at email:
operating the foreign registered civil aircraft operating in the airspace of the joanne.swafford@dot.gov or telephone:
unmanned aircraft in the United States United States to identify those aircraft. (757) 897–9908.
is an organization or an individual. Frequency: As needed prior to SUPPLEMENTARY INFORMATION: The PRA,
(2) The name of the person operating operation of a foreign-registered civil 44 U.S.C. 3501–3520, and its
the foreign registered civil unmanned unmanned aircraft in the United States. implementing regulations, 5 CFR part
aircraft in the United States, and, if Estimated Average Burden per 1320, require Federal agencies to
applicable, the person’s authorized Response: 6 minutes per response. provide 60-days’ notice to the public to
representative. Estimated Total Annual Burden: 6 allow comment on information
(3) The physical address of the person minutes per respondent, 797 hours per collection activities before seeking OMB
operating the foreign registered civil year total for all respondents. approval of the activities. See 44 U.S.C.
unmanned aircraft in the United States, Issued in Washington, DC on November 1, 3506, 3507; 5 CFR 1320.8 through
and, if applicable, the physical address 2023. 1320.12. Specifically, FRA invites
for the person’s authorized Joseph Morra, interested parties to comment on the
representative. If the operator or following ICR regarding: (1) whether the
Manager, Emerging Technologies Division,
authorized representative does not AFS–700. information collection activities are
receive mail at the physical address, a necessary for FRA to properly execute
[FR Doc. 2023–24427 Filed 11–3–23; 8:45 am]
mailing address must also be provided. its functions, including whether the
(4) The telephone number(s) where
activities will have practical utility; (2)
the person operating the foreign
the accuracy of FRA’s estimates of the
registered civil unmanned aircraft in the
DEPARTMENT OF TRANSPORTATION burden of the information collection
United States, and, if applicable, the
activities, including the validity of the
person’s authorized representative can Federal Railroad Administration methodology and assumptions used to
be reached while in the United States.
[Docket No. FRA–2023–0002–N–27] determine the estimates; (3) ways for
(5) The email address of the person
FRA to enhance the quality, utility, and
operating the foreign registered civil
Proposed Agency Information clarity of the information being
unmanned aircraft in the United States,
Collection Activities; Comment collected; and (4) ways for FRA to
and, if applicable, the email address of
Request minimize the burden of information
the person’s authorized representative.
(6) An indication whether the collection activities on the public,
AGENCY: Federal Railroad including the use of automated
unmanned aircraft is a standard remote Administration (FRA), Department of
identification unmanned aircraft or has collection techniques or other forms of
Transportation (DOT). information technology. See 44 U.S.C.
a remote identification broadcast ACTION: Notice of information collection;
module. 3506(c)(2)(A); 5 CFR 1320.8(d)(1).
request for comment. FRA believes that soliciting public
(7) The unmanned aircraft
manufacturer and model name. comment may reduce the administrative
SUMMARY: Under the Paperwork
(8) The serial number of the and paperwork burdens associated with
Reduction Act of 1995 (PRA) and its
unmanned aircraft or remote the collection of information that
implementing regulations, FRA seeks
identification broadcast module. Federal regulations mandate. In
approval of the Information Collection
(8) The country of registration of the summary, comments received will
Request (ICR) summarized below.
unmanned aircraft. advance three objectives: (1) reduce
Before submitting this ICR to the Office
(10) The registration number. reporting burdens; (2) organize
of Management and Budget (OMB) for
Once a person submits an online information collection requirements in a
approval, FRA is soliciting public
notice of identification, the FAA will ‘‘user-friendly’’ format to improve the
comment on specific aspects of the
issue a confirmation of identification. A use of such information; and (3)
activities identified in the ICR.
person operating a foreign-registered accurately assess the resources
DATES: Interested persons are invited to expended to retrieve and produce
unmanned aircraft in the United States
submit comments on or before January information requested. See 44 U.S.C.
must maintain the confirmation of
5, 2024. 3501.
identification at the unmanned aircraft’s
control station and must produce it ADDRESSES: Written comments and The summary below describes the ICR
when requested by the FAA or a law recommendations for the proposed ICR that FRA will submit for OMB clearance
enforcement officer. should be submitted on regulations.gov as the PRA requires:
The holder of a confirmation of to the docket, Docket No. FRA–2023– Title: Locomotive Crashworthiness.
identification must ensure the 0002. All comments received will be OMB Control Number: 2130–0564.
information provided under § 89.130(a) posted without change to the docket, Abstract: Under 49 CFR part 229,
remains accurate and is updated prior to including any personal information subpart D, FRA prescribes minimum
operating a foreign registered civil provided. Please refer to the assigned crashworthiness standards for certain
unmanned aircraft with remote OMB control number (2130–0564) in locomotives. These crashworthiness
identification in the United States. The any correspondence submitted. FRA standards are intended to help protect
confirmation of identification expires will summarize comments received in a locomotive cab occupants in the event
after one year and can be cancelled or subsequent 30-day notice and include of a train collision or derailment. FRA
renewed online at FAA Drone Zone. them in its information collection uses this collection of information to
Respondents: Operators of foreign- submission to OMB. ensure railroads operate locomotives
registered civil unmanned aircraft with FOR FURTHER INFORMATION CONTACT: Ms. that meet the prescribed minimum
remote identification, as needed (prior Arlette Mussington, Information performance standards and design load
requirements for newly manufactured crashworthiness design standards and Type of Request: Extension without
and re-manufactured locomotives. alternative design standards under the change (with changes in estimates) of a
In this 60-day notice, FRA makes following sections: currently approved collection.
• Under § 229.207(c), FRA is
adjustments that decrease the Affected Public: Businesses/Public/
decreasing the estimated annual burden
previously approved estimated total Interested Parties.
hours by 33.50 hours.
annual burden hours from 507 hours to • Under § 229.207(d), FRA is Form(s): N/A.
407 hours. These estimate adjustments decreasing the estimated annual burden Respondent Universe: 783 railroads, 4
reflect that FRA anticipates a decrease hours by 33.50 hours. locomotive manufacturers.
in the annual petition submissions for • Under § 229.209(b), FRA is
approval of substantive and non- decreasing the estimated annual burden Frequency of Submission: On
substantive changes to locomotive hours by 33.50 hours. occasion; one-time.
REPORTING BURDEN
Average Total annual Total cost
Respondent Total annual
CFR Section time per burden equivalent
universe responses responses hours in U.S. dollar
(A) (B) (C = A * B) (D = C * wage

rates) 1
229.207(b)—Petitions for FRA approval of 783 railroads 4 loco- 2.00 petitions ............ 50 hours 100.00 $8,593.00
new locomotive crashworthiness design motive manufactur-
standards. ers.
—(c) Petition for FRA approval of sub- 783 railroads 4 loco- 0.33 petition .............. 50 hours 16.50 1,417.85
stantive changes to FRA-approved locomotive manufactur-
motive crashworthiness design standard. ers.
—(d) Petition for FRA approval of non-sub- 783 railroads 4 loco- 0.33 petition .............. 50 hours 16.50 1,417.85
stantive changes to existing FRA ap- motive manufactur-
proved locomotive crashworthiness de- ers.
sign standard.
229.209(b)—Alternative locomotive crash- 783 railroads 4 loco- 0.33 petition .............. 50 hours 16.50 1,417.85
worthiness designs—Petition for FRA ap- motive manufactur-
proval. ers.
229.211(b)(3)—Processing petitions—Addi- 783 railroads 4 loco- 1.00 hearing .............. 24 hours 24.00 2,062.32
tional information for FRA to appropriately motive manufactur-
consider the petition. ers.
229.213(a)(3)—Locomotive manufacturing 783 railroads ............. 500 records/stickers/ 2 minutes 16.67 1,432.45
information: retention by railroads. badge plates.
229.215—(a) Retention and inspection of 4 locomotive manu- 24 locomotive records 8 hours 192.00 16,498.56
designs—Retention of records—Original facturers.
designs.
—(b) Repairs and modifications—Records .. 783 railroads ............. 6 locomotive crash- 4 hours 24.00 2,062.32
worthiness modi-
fication/repair
records.
—(c) Inspection of records ........................... 783 railroads ............. 20 records ................. 2 minutes 0.67 57.57
Total 2 ..................................................... 783 railroads ............. 554 responses .......... N/A 407 34,960
Total Estimated Annual Responses: Authority: 44 U.S.C. 3501–3520. Notice and request for
ACTION:
554. comments.
Christopher S. Van Nostrand,
Total Estimated Annual Burden: 407 Acting Deputy Chief Counsel.
hours. SUMMARY: In accordance with the
[FR Doc. 2023–24450 Filed 11–3–23; 8:45 am] Paperwork Reduction Act of 1995,
Total Estimated Annual Burden Hour BILLING CODE 4910–06–P Public Law 104–13, PHMSA invites
Dollar Cost Equivalent: $34,960.
public comments about PHMSA’s
FRA informs all interested parties that intention to request Office of
it may not conduct or sponsor, and a DEPARTMENT OF TRANSPORTATION Management and Budget (OMB)
respondent is not required to respond approval to renew six information
to, a collection of information that does Pipeline and Hazardous Materials
collections that are scheduled to expire
not display a currently valid OMB Safety Administration
in 2024. PHMSA has reviewed each
control number.
information collection and considers

[Docket No. PHMSA–2023–0076] them vital to maintaining pipeline
1 The dollar equivalent cost is derived from the safety. As such, PHMSA will request
2022 Surface Transportation Board Full Year Wage Pipeline Safety: Information Collection renewal from OMB, without change, for
A&B data series using employee group 200: Activities
(Professional & Administrative), hourly wage rate of each information collection.
$49.10. The total burden wage rate (straight time
plus 75%) used in the table is $85.93 ($49.10 × 1.75 AGENCY: Pipeline and Hazardous DATES: Interested persons are invited to
= $85.93). Materials Safety Administration submit comments on or before January
2 Totals may not add up due to rounding. (PHMSA), DOT. 5, 2024.
ADDRESSES: Comments may be commenter provides, to number 2137–0048, Recordkeeping

submitted in the following ways: www.regulations.gov, as described in Requirements for Liquefied Natural Gas
E-Gov Website: http:// the system of records notice (DOT/ALL– (LNG) Facilities (11/30/2024); (4) OMB
www.regulations.gov. This site allows 14 FDMS), which can be reviewed at control number 2137–0594, Customer-
the public to submit comments on any www.dot.gov/privacy. Owned Service Lines (11/30/2024); (5)
Federal Register notice issued by any Confidential Business Information: OMB control number 2137–0618,
agency. Confidential Business Information (CBI) Periodic Underwater Inspection and
Fax: 1–202–493–2251. is commercial or financial information Notification of Abandoned Underwater
Mail: Docket Management Facility; that is both customarily and actually Pipelines (11/30/2024); and (6) OMB
U.S. Department of Transportation treated as private by its owner. Under control number 2137–0634,
(DOT), 1200 New Jersey Avenue SE, the Freedom of Information Act (FOIA) Recordkeeping for Underground Natural
West Building, Room W12–140, (5 U.S.C. 552), CBI is exempt from Gas Storage Facilities (11/30/2024).
Washington, DC 20590–0001. public disclosure. If your comments The following information is provided
Hand Delivery: Room W12–140 on the responsive to this notice contain for these information collections: (1)
ground level of DOT, West Building, commercial or financial information Title of the information collection; (2)
1200 New Jersey Avenue SE, that is customarily treated as private, OMB control number; (3) Current
Washington, DC, between 9:00 a.m. and that you actually treat as private, and expiration date; (4) Type of request; (5)
5:00 p.m. ET, Monday through Friday, that is relevant or responsive to this Abstract of the information collection
except Federal holidays. notice, it is important that you clearly activity; (6) Description of affected
Instructions: Identify the docket designate the submitted comments as public; (7) Estimate of total annual
number, PHMSA–2023–0076, at the CBI. Pursuant to 49 CFR 190.343, you reporting and recordkeeping burden;
beginning of your comments. Note that may ask PHMSA to give confidential and (8) Frequency of collection.
all comments received will be posted treatment to information you give to the PHMSA will request a three-year term
without change to http:// Agency by taking the following steps: of approval for each of the following
www.regulations.gov, including any (1) mark each page of the original information collection activities.
personal information provided. You document submission containing CBI as PHMSA requests comments on the
should know that anyone is able to ‘‘Confidential’’; (2) send PHMSA, along following information:
search the electronic form of all with the original document, a second 1. Title: Pipeline Safety: Integrity
comments received into any of our copy of the original document with the Management Program for Gas
dockets by the name of the individual CBI deleted; and (3) explain why the Distribution Pipelines.
submitting the comment (or signing the information you are submitting is CBI. OMB Control Number: 2137–0625.
comment, if submitted on behalf of an Unless you are notified otherwise, Current Expiration Date: 5/31/2024.
association, business, labor union, etc.). PHMSA will treat such marked Type of Request: Renewal with no
Therefore, you may want to review submissions as confidential under the change of a currently approved
DOT’s complete Privacy Act Statement FOIA, and they will not be placed in the collection.
in the Federal Register published on public docket of this notice. Abstract: The Federal Pipeline Safety
April 11, 2000, (65 FR 19477) or visit Submissions containing CBI should be Regulations require operators of gas
http://www.regulations.gov before sent to Angela Hill, DOT, PHMSA, 1200 distribution pipelines to develop and
submitting any such comments. New Jersey Avenue SE, PHP–30, implement integrity management (IM)
Docket: For access to the docket or to programs. The purpose of these
Washington, DC 20590–0001. Any
read background documents or programs is to enhance safety by
commentary PHMSA receives that is not
comments, go to http:// identifying and reducing pipeline
specifically designated as CBI will be
www.regulations.gov at any time or to integrity risks. PHMSA requires that
placed in the public docket for this
Room W12–140 on the ground level of operators maintain records
matter.
DOT, West Building, 1200 New Jersey demonstrating compliance with these
Avenue SE, Washington, DC, between FOR FURTHER INFORMATION CONTACT:
Angela Hill by telephone at 202–366– requirements for 10 years and that these
9:00 a.m. and 5:00 p.m. ET, Monday records must include superseded IM
through Friday, except Federal holidays. 1246 or by email at Angela.Hill@dot.gov.
plans.
If you wish to receive confirmation of SUPPLEMENTARY INFORMATION: Title 5,
Affected Public: Operators of gas
receipt of your written comments, Code of Federal Regulations (CFR) distribution pipeline systems.
please include a self-addressed, section 1320.8(d), requires PHMSA to Annual Reporting and Recordkeeping
stamped postcard with the following provide interested members of the Burden:
statement: ‘‘Comments on: PHMSA– public and affected agencies the Estimated number of responses:
2023–0076.’’ The Docket Clerk will date opportunity to comment on information 3,882.
stamp the postcard prior to returning it collection and recordkeeping requests Estimated annual burden hours:
to you via the U.S. mail. Please note that before they are submitted to OMB for 723,192.
due to delays in the delivery of U.S. approval. This notice identifies six Frequency of collection: On occasion.
mail to Federal offices in Washington, information collection requests that 2. Title: Post-Accident Drug Testing
DC, we recommend that persons PHMSA will submit to OMB for renewal for Pipeline Operators.
consider an alternative method and requests comment from interested OMB Control Number: 2137–0632.
(internet, fax, or professional delivery parties. The information collections Current Expiration Date: 8/31/2024.
service) of submitting comments to the (including their expiration dates) are as Type of Request: Renewal with no
docket and ensuring their timely receipt follows: (1) OMB control number 2137– change of a currently approved
at DOT. 0625, Pipeline Safety: Integrity information collection.
Privacy Act Statement: DOT may Management Program for Gas Abstract: Pursuant to 49 CFR 199.227,
solicit comments from the public Distribution Pipelines (5/31/2024); (2) operators are required to maintain
regarding certain general notices. DOT OMB control number 2137–0632, Post- records of its alcohol misuse prevention
posts these comments, without edit, Accident Drug Testing for Pipeline program. The post-accident drug testing
including any personal information the Operators (8/31/2024); (3) OMB control for pipeline operators information
collection pertains specifically to 49 Annual Reporting and Recordkeeping and repairs, and notifications to the
CFR 199.227(b)(4), that requires Burden: public.
operators to maintain records of Estimated number of responses: Affected Public: Operators of
decisions not to administer post- 550,000. underground natural gas storage
accident employee alcohol tests for a Estimated annual burden hours: facilities.
minimum of three years. Operators must 9,167. Annual Reporting and Recordkeeping
make those records available to PHMSA Frequency of Collection: On occasion. Burden:
upon request. 5. Title: Periodic Underwater Estimated number of responses: 136.
Affected Public: Operators of PHMSA- Inspection and Notification of Estimated annual burden hours: 220.
regulated pipelines. Abandoned Underwater Pipelines. Frequency of Collection: On occasion.
Annual Reporting and Recordkeeping OMB Control Number: 2137–0618. Comments are invited on:
Burden: Current Expiration Date: 11/30/2024. (a) The need for the renewal and
Total Annual Responses: 609. Type of Request: Renewal with no revision of these collections of
Total Annual Burden Hours: 1,218. change of a currently approved information for the proper performance
Frequency of Collection: On occasion. information collection.
3. Title: Recordkeeping Requirements of the functions of the Agency,
Abstract: The Federal Pipeline Safety including whether the information will
for Liquefied Natural Gas Facilities. Regulations at 49 CFR 192.612 and 49
OMB Control Number: 2137–0048. have practical utility;
CFR 195.413 require operators of (b) The accuracy of the Agency’s
Current Expiration Date: 11/30/2024. pipelines in the Gulf of Mexico and its
Type of Request: Renewal with no estimate of the burden of the proposed
inlets in waters less than 15 feet (4.6 collection of information, including the
change of a currently approved
meters) deep to conduct periodic validity of the methodology and
information collection.
Abstract: Pursuant to the Federal underwater inspections to determine assumptions used;
Pipeline Safety Regulations, liquefied whether the pipelines are exposed (c) Ways to enhance the quality,
natural gas facility operators are underwater pipelines or pose a hazard utility, and clarity of the information to
required to maintain records, make to navigation. If an operator discovers be collected; and
reports, and provide information that its underwater pipeline is exposed (d) Ways to minimize the burden of
regarding their liquefied natural gas or poses a hazard to navigation, among the collection of information on those
facilities to PHMSA upon request. other remedial actions, the operator who are to respond, including the use
Affected Public: Operators of liquefied must contact the National Response of appropriate automated, electronic,
natural gas facilities. Center by telephone within 24 hours of mechanical, or other technological
Annual Reporting and Recordkeeping discovery and report the location of the collection techniques.
Burden: exposed pipeline or hazardous pipeline. Authority: The Paperwork Reduction
Estimated number of responses: PHMSA’s regulations for reporting the Act of 1995; 44 U.S.C. chapter 35, as
40,400. abandonment of underwater pipelines amended; and 49 CFR 1.48.
Estimated annual burden hours: can be found at 49 CFR 192.727 and 49
CFR 195.59. These provisions contain Issued in Washington, DC, under authority
12,120. delegated in 49 CFR 1.97.
Frequency of Collection: On occasion. certain requirements for disconnecting
4. Title: Customer-Owned Service and purging abandoned pipelines and John A. Gale,
Lines. require operators to notify PHMSA of Director, Standards and Rulemaking Division.
OMB Control Number: 2137–0594. each abandoned offshore pipeline [FR Doc. 2023–24445 Filed 11–3–23; 8:45 am]
Current Expiration Date: 11/30/2024. facility and each abandoned onshore BILLING CODE 4910–60–P
Type of Request: Renewal with no pipeline facility that crosses over,
change of a currently approved under, or through a commercially
information collection. navigable waterway. DEPARTMENT OF TRANSPORTATION
Abstract: Pursuant to 49 CFR 192.16, Affected Public: Operators of pipeline [Docket No. DOT–OST–2023–0166]
operators of gas service lines who do not facilities.
maintain their customers’ buried piping Annual Reporting and Recordkeeping Transportation Services for Individuals
between service lines and building Burden: With Disabilities: ADA Standards for
walls or gas utilization equipment are Estimated number of responses: 92. Transportation Facilities
required to send written notices to their Estimated annual burden hours:
customers prescribing the proper 1,372. AGENCY: Department of Transportation
maintenance of these gas lines and of Frequency of collection: On occasion (DOT).
the potential hazards of not properly 6. Title: Recordkeeping for ACTION: Request for information on
maintaining these gas lines. Operators Underground Natural Gas Storage accessibility improvements for
also must maintain records that include Facilities. transportation facilities.
a copy of the notice currently in use and OMB Control Number: 2137–0634.
evidence that notices were sent to Current Expiration Date: 11/30/2024. SUMMARY: The U.S. Department of
customers within the previous three Type of Request: Renewal with no Transportation (DOT, or Department) is
years. The purpose of the collection is change of a currently approved considering whether to amend the
to provide PHMSA with adequate information collection. accessibility requirements for
information about how customer-owned Abstract: The Federal Pipeline Safety transportation facilities under the
service lines are being maintained to Regulations at 49 CFR 192.12 require Americans with Disabilities Act of 1990
prevent the potential hazards associated operators of underground natural gas (ADA) currently contained in Appendix
with not maintaining the lines. storage facilities to maintain A to DOT’s regulations governing
Examples of sufficient notification documentation and provide information transportation services for individuals
include a prepared notification with the to PHMSA upon request. Examples of with disabilities. The Department may
customer’s bill. the required records include operations consider whether to improve access
Affected Public: State and local and maintenance procedures, results of beyond the minimum standards
governments. required tests, records of inspections established by the U.S. Access Board
and Appendix A. The Department seeks For legal questions related to transit, updated, and the Department is
suggestions from all transportation Bonnie Graves, FTA Office of Chief considering both physical access to and
stakeholders—including transportation Counsel, (202) 366–0944 or usability of facilities by persons with
agencies, transportation riders bonnie.graves@dot.gov. For questions sensory, cognitive, and other
(particularly those with disabilities), related to intercity or high-speed rail, disabilities. The Department strives to
community members, advocacy groups, Alana Kuhn, FRA Office of Chief provide for equitable access to persons
planning officials, States, cities, Counsel, (202) 493–0842 or with disabilities similar to that available
researchers and technology companies, alana.kuhn@dot.gov. to people without disabilities, including
and the private sector—on SUPPLEMENTARY INFORMATION: the usability of the facility, so that
enhancements that the Department persons with disabilities are able to
Background access and navigate public transit with
could consider with regard to the ADA
standards for transportation buildings 42 U.S.C. 12204 requires the the same ease, reliability, and
and facilities. The Department Architectural and Transportation independence as any other user.
specifically seeks feedback on areas Barriers Compliance Board (Access Complaints filed by the public,
including, but not limited to vertical Board) to issue minimum guidelines for feedback from the disability community,
access, communications, and accessibility under Titles II & III of the observations of and information
wayfinding. The Department also ADA. The ADA statute at 42 U.S.C. gathered by Departmental employees
invites comment on any other aspects of 12149 requires the Secretary of (with and without disabilities), media
the current accessibility requirements Transportation to develop and articles, and the results of the
for transportation facilities under the implement regulations for certain public Department’s oversight activities have
ADA contained in DOT’s regulations transportation facilities, vehicles, and led the Department to solicit feedback
governing transportation services for services consistent with the Access on the current standards. For some
individuals with disabilities. Board’s guidelines. The Secretary may disabilities, such as those affecting
issue regulations that result in greater hearing, vision, or cognitive function,
DATES: Comments should be submitted
accessibility than the minimum the Department is aware of
on or before January 5, 2024. DOT will
guidelines established by the Access technological advancements (for
consider comments filed after this date
Board. example, induction loops and mobile
to the extent practicable.
The current guidelines were device applications), that would help
ADDRESSES: You may file comments developed nearly a quarter century ago persons with those disabilities navigate
identified by docket number DOT–OST– and adopted as regulatory standards by the transportation system with ease and
2023–0166 by any of the following the Department in 2006.1 The independence. The Department is
methods: Department’s experience administering interested in learning more about these
• Federal eRulemaking Portal: Go to these minimum standards for the past technologies. For other disabilities, such
https://www.regulations.gov and follow two decades suggests that they have as those affecting mobility, the
the online instructions for submitting resulted in greater accessibility than the Department seeks feedback regarding,
comments. standards 2 that preceded them, but in for example, minimum standards that
• Mail: Docket Operations, U.S. many cases extra efforts may still be rely on a single point of access that
Department of Transportation, 1200 required on the part of people with creates a situation where a single point
New Jersey Ave. SE, West Building disabilities to enter and use a facility. of failure renders an entire facility
Ground Floor, Room W12–140, For example, accessible entrances may inaccessible and unusable by persons
Washington, DC 20590–0001. be located in isolated locations away with disabilities, while access to
• Hand Delivery or Courier: West from entrances used by members of the nondisabled persons is unaffected. The
Building Ground Floor, Room W12–140, general public who do not require an Department is interested in learning
1200 New Jersey Ave. SE, between 9:00 accessible entrance, and persons with how transportation facilities can be
a.m. and 5:00 p.m. ET, Monday through sensory disabilities may need to rely on designed and constructed such that
Friday, except Federal holidays. information on a message board at accessibility features are resilient and
• Fax: (202) 493–2251. station entrances while other members always available. The Department also
All submissions received must of the general public are informed via seeks input to assist it in understanding
include the agency name and docket public address systems. In other cases, the magnitude of potential access issues
number DOT–OST–2023–0166. All persons unable to navigate staircases that may exist in transportation facilities
comments received will be posted may be faced with lengthy ramps to and therefore requests any available
without change to www.regulations.gov, cross from one rail platform to another. information and comments stakeholders
including any personal information Such continuing barriers may mean that may have on the number of all end-
provided. For information on DOT’s many wheelchair users and persons users, not limited to users with
compliance with the Privacy Act, please with sensory, cognitive, or processing disabilities, who would benefit from
visit https://www.transportation.gov/ disabilities remain dependent on specific standards in 49 CFR part 37 that
privacy. paratransit or private transportation may be improved or implemented.
For access to the docket to read rather than being able to use integrated In addition to learning about specific
background documents or comments fixed route service. standards in 49 CFR part 37 that may be
received, go to www.regulations.gov at There have also been many improved or implemented, the
any time and search for docket number developments such as advances in Department is interested in the end-user
DOT–OST–2023–0166. technology since the standards were last experience generally. These include
FOR FURTHER INFORMATION CONTACT: For experiences in transportation facilities
general questions, Holly Ceasar-Fox, 1 The Access Board published a Notice of related to vertical access,
DOT Office of General Counsel, (202) Proposed Rulemaking in the Federal Register on communication, wayfinding, or any
366–7420 or holly.ceasarfox@dot.gov. November 16, 1999, and issued the Final Rule on other aspects of transportation facilities
July 23, 2004. The Department of Justice adopted
For program questions related to transit, the standards on September 15, 2010. that represent barriers for people with
John Day, FTA Office of Civil Rights, 2 The standards adopted by the Department on disabilities. The Department will
(202) 366–1671 or john.day@dot.gov. September 6, 1991, were in effect until 2006. consider the extent to which the
Department has authority under the 3. Many commuter and intercity rail the type typically relayed by public
ADA to remove such barriers. stations rely on long switch-back ramps address systems at transportation
Through this request for information to provide an accessible route between facilities can be provided in real-time in
(RFI), the Department seeks input as it platforms on either side of the tracks, or a visual format, such as changeable
considers whether to revise the existing to multiple platforms within a station. electronic message boards, as well as
DOT ADA requirements for These ramps, which can be hundreds of information pertaining to the number
transportation buildings and facilities feet long, often present a barrier to and placement of necessary displays
including public transportation and persons who cannot negotiate steps, but throughout a station environment,
intercity rail transportation (including also cannot travel the distances required including spacing, scale, and frequency.
Amtrak). The Department poses seven to traverse the ramp. However, the 6. In addition, the Department seeks
questions below and looks forward to simplicity of a non-mechanical ramp comment on technologies that can
feedback from all interested parties. means that maintenance costs are provide an audible component to
relatively low and repairs are few and information currently displayed in
Vertical Access visual format at transportation facilities.
far between, unlike more complex
1. It has become increasingly apparent elevators. The Department is seeking For example, many transit systems and
that elevator maintenance and reliability comment on the use of elevators in lieu intercity stations use changeable
are a critical component of ensuring the of ramps in transportation facilities, or electronic message displays to
accessibility of a multi-level a single elevator in addition to the ramp, communicate information about the
transportation facility such as subway if the vertical distance or ramp length next train scheduled to arrive at a
and rail stations. While the existing exceeds a certain threshold, including station, such as the line, number of cars,
DOT ADA regulations require information on an appropriate and estimated time of arrival. Most such
accessibility features to be maintained threshold. systems lack an audible component to
in working order, repairs can be make this information accessible to
Communications individuals who are blind or have low
complex and many entities do not have
employees with the skillset necessary to 4. The Department of Justice’s current vision. What commercially available
repair an elevator or the necessary ADA standards for buildings and technologies might be appropriate for
components readily available, which facilities contain provisions requiring deployment in a transit, Amtrak, or
can add a level of difficulty to the repair assistive listening systems in assembly commuter rail station environment to
process.3 Thus, unreliable elevators areas. See 28 CFR 35.151(c)(3); 36 CFR convey information provided visually in
create operational and administrative pt. 1191, app. B at 344. The Department an audible format? How should such
burdens for entities covered by DOT’s seeks comment on the feasibility of information be broadcast? Would an
ADA regulations and can render extending such requirements to interface with a smart device be
transportation facilities inaccessible for transportation facilities such as rail appropriate or sufficient, or should an
users for extended durations. The stations to enable real-time audible component be provided directly
Department is interested in learning announcements for persons who are on the station’s display device?
about standards that would ensure deaf or hard of hearing or because of
their disability rely on text-based Wayfinding
elevator reliability in transportation
facilities. communications to access information. 7. The Department seeks comment on
2. Elevators that are frequently out of Current requirements for transportation technologies to enable effective
service significantly impact the ability facilities stipulate only that the same wayfinding within the transit station,
of persons who cannot negotiate stairs information provided audibly must be intercity and commuter rail station
to use such transportation services. As provided visually. This often takes the environments for persons who are blind
a result, the Department understands form of messages written on a dry-erase or have low vision, and to accommodate
that many agencies involved in the board in the station entrance by neurodiversity (e.g., autism, intellectual
construction or alteration of stations personnel or information relayed disability, etc.). The Department is
initially plan for two or more elevators directly to the passenger by personnel, aware of technologies capable of real-
per bank instead of just one, so that the which prevents the transmission of real- time transcription of speech and those
station is not rendered inaccessible time announcements that often relate to involving the use of Bluetooth beacons
when one elevator requires maintenance service changes or safety/security that interface with smart devices and
or repair. Despite planners’ intentions, matters, forces passengers who are deaf seeks comment on the usability of such
budgetary considerations often result in or hard of hearing to identify systems from the end-user perspective.
the minimum legally required (not just themselves, is not reliable at larger The Department is also interested in
for accessibility), which means only a stations with multiple entrances, and is alternative technologies that may be
single elevator is provided. The not possible at unstaffed stations. The available, potentially without the use of
Department seeks public input on the Department is aware that induction loop handheld devices, and the acceptance of
impacts of the installation, for future technology is in use in some stations, technologies that do rely on such
construction and alterations, of at least enabling those with a T-coil in their devices within the general community
two elevators in transportation facilities, hearing aids to receive messages of persons who are blind, have low-
or a combination of ramps and directly, but seeks comment on how vision, and/or are neurodiverse.
elevators, where currently one elevator widespread this technology is used
among deaf and hard of hearing persons. General
is required.
The Department also seeks comment on In addition, the Department invites
3 The Department recognizes that many elevator other technologies that may provide the comment on all other areas of the
manufacturers require that only their employees same benefit to the same or a larger current DOT ADA standards, found in
work on the elevator, and that there are examples audience at transportation facilities, Appendix A to 49 CFR part 37, which
of arrangements where the third-party repair person such as real-time text-messaging. govern rail stations and stops of all
is available 7 days a week, 24 hours per day, but
the Department is also aware of arrangements where
5. The Department also seeks types, bus stops and transfer stations,
same-day, after hours, weekend, or holiday service comment on other means by which the landside facilities, office buildings
is not guaranteed (or is charged at a premium). content of audible announcements of housing transit agency personnel,
conference facilities of the type often Federal employment of the rights and 633a, 29 U.S.C. 206(d), 29 U.S.C. 791, 42
employed for board meetings and public protections available to them under the U.S.C. 2000e–16, 2000ff, 2000gg.
hearings, businesses housed in transit Federal Anti-discrimination and If you believe you have experienced
facilities, and individual elements such Whistleblower Protection Laws. unlawful discrimination on the bases of
as track crossings, ramps, parking lots FOR FURTHER INFORMATION CONTACT: race, color, religion, sex, gender
and structures, fare vending machines Yvette Rivera, Associate Director, Equity identity, sexual orientation, pregnancy,
and collection equipment, and and Access Division (S–32), national origin, age, retaliation, genetic
accessible paths of travel. If the public Departmental Office of Civil Rights, information, and/or disability and wish
has information on how these standards Office of the Secretary, Department of to pursue a legal remedy, you must
do or do not currently support equitable Transportation, 1200 New Jersey contact a DOT Equal Employment
access, please submit comments to the Avenue SE, Room W78–306, Opportunity (EEO) counselor within 45
docket for this rulemaking activity. Washington, DC 20590, 202–366–5131 calendar days of the alleged
All interested parties are encouraged or by email at Yvette.Rivera@dot.gov. discriminatory action, or in the case of
to respond to this RFI. Submissions are SUPPLEMENTARY INFORMATION: a personnel action, within 45 calendar
strictly voluntary. Individuals or entities days of the effective date of the action.
responding to this RFI should state their Electronic Access A directory of DOT EEO counselors is
role as well as knowledge of and You may retrieve this document available on the DOT Departmental
experience with the ADA in a online through the Federal Document Office of Civil Rights website at http://
transportation environment. DOT may Management System at http:// www.transportation.gov/civil-rights; you
request additional clarifying www.regulations.gov. Electronic can also contact the Departmental Office
information from any or all respondents. retrieval instructions are available under of Civil Rights by phone at 202–366–
If a respondent does not wish to be the help section of the website. 4648 for more information. Once you
contacted by DOT for additional contact the EEO counselor, you will be
No FEAR Act Notice offered the opportunity to resolve the
information, a statement to that effect
should be included in the response. All On May 15, 2002, Congress enacted matter through the informal complaint
information submitted should be the ‘‘Notification and Federal Employee process; if you are unable to resolve the
unclassified and should not contain Antidiscrimination and Retaliation Act matter through the informal complaint
proprietary information, as it will be of 2002,’’ now recognized as the No process, you can file a formal complaint
posted to www.regulations.gov without FEAR Act (Pub. L. 107–174). The No of discrimination with DOT (see, e.g., 29
changes. FEAR Act was amended on January 1, CFR part 1614). Parties who complete
DOT is not obligated to officially 2021, by the ‘‘Elijah E. Cummings the informal complaint process are
respond to the information received, but Federal Employee Antidiscrimination provided with an electronic Individual
the responses will assist DOT in its Act of 2020,’’ now recognized as the Complaint of Employment
consideration of whether to revise the Cummings Act. One purpose of the No Discrimination Form. The form can be
ADA standards for transportation FEAR Act, which was strengthened by submitted electronically at https://
buildings and facilities. the Cummings Act, is to ‘‘require that secure.dot.gov/form/eeoc or by email at
Comments may be submitted and Federal agencies be accountable for Patricia.Fields@dot.gov. You may also
viewed at Docket No. DOT–OST–2023– violations of antidiscrimination and contact the EEO Complaints and
0166 at https://www.regulations.gov. whistleblower protection laws.’’ (Pub. L. Investigations Division, Departmental
107–174, Summary). In support of this Office of Civil Rights by phone at 202–
Signed pursuant to authority delegated at
49 CFR 1.27(a) on October 31, 2023. purpose, Congress found that ‘‘agencies 366–9370 or by email at DOCR_CMB@
cannot be run effectively if those dot.gov if you need additional
Subash S. Iyer,
agencies practice or tolerate assistance.
Acting General Counsel, Department of If you believe you experienced
discrimination.’’ (Pub. L. 107–174, Title
Transportation.
I, General Provisions, section 101(1)). unlawful discrimination based on age,
[FR Doc. 2023–24422 Filed 11–3–23; 8:45 am]
The No FEAR Act also requires the you must either contact an EEO
BILLING CODE 4910–57–P counselor as noted above or file a civil
Department of Transportation (DOT) to
issue this Notice to all DOT employees, action in a United States District Court
former DOT employees, and applicants under the Age Discrimination in
DEPARTMENT OF TRANSPORTATION Employment Act against the head of the
for DOT employment. This Notice
Office of the Secretary informs such individuals of the rights alleged discriminating agency. If you
and protections available under Federal choose to file a civil action, you must
[Docket No. DOT–OST–2023–0161] antidiscrimination and whistleblower give notice of intent to sue to the Equal
protection laws. Employment Opportunity Commission
Notice of Rights and Protections (EEOC) within 180 days of the alleged
Available Under the Federal Antidiscrimination Laws discriminatory action, and not less than
Antidiscrimination and Whistleblower A Federal agency cannot discriminate 30 days before filing a civil action. You
Protection Laws against an employee or applicant with may file such notice in writing with the
AGENCY: Department of respect to the terms, conditions, or EEOC via mail at P.O. Box 77960,
Transportation—Office of the Secretary. privileges of employment because of Washington, DC 20013, the EEOC Public
ACTION: No FEAR Act notice. race, color, religion, sex, gender Portal at https://www.eeoc.gov/
identity, sexual orientation, pregnancy, employees/charge.cfm, hand delivery at

SUMMARY: This Notice implements Title national origin, age, disability, marital 131 M St. NE, Washington, DC 20507,
II of the Notification and Federal status, genetic information, political or Fax at 202–663–7022.
Employee Antidiscrimination and affiliation, or in retaliation for a If you are alleging unlawful
Retaliation Act of 2002 (No FEAR Act of protected activity. One or more of the discrimination based on marital status
2002). In doing so, the Department of following statutes prohibit or political affiliation, you may file a
Transportation notifies all employees, discrimination on these bases: 5 U.S.C. written discrimination complaint with
former employees, and applicants for 2302(b)(1), 29 U.S.C. 631, 29 U.S.C. the U.S. Office of Special Counsel (OSC)
using Form OSC–14. Form OSC–14 can 1200 New Jersey Avenue SE, West Bldg States, including the provisions of law
be submitted electronically at the OSC 7th Floor, Washington, DC 20590. specified in 5 U.S.C. 2302(d).
website http://www.osc.gov, under the Issued in Washington, DC, on October 26,
Retaliation for Engaging in Protected
tab ‘‘File a Complaint.’’ You also have 2023.
Activity
the option to call the Case Review Irene Marion,
Division at 1–800–872–9855 for A Federal agency cannot retaliate Director, Departmental Office of Civil Rights,
additional assistance. In the alternative against an employee or applicant U.S. Department of Transportation.
(or in some cases, in addition), you may because that individual exercises their [FR Doc. 2023–24446 Filed 11–3–23; 8:45 am]
pursue a discrimination complaint by rights under any of the Federal BILLING CODE 4910–9X–P
filing a grievance through the DOT antidiscrimination or whistleblower
administrative or negotiated grievance protection laws listed above. If you
procedures, if such procedures apply believe that you are the victim of DEPARTMENT OF TRANSPORTATION
and are available. retaliation for engaging in protected
If you are alleging unlawful activity, you must follow, as Bureau of Transportation Statistics
compensation discrimination pursuant appropriate, the procedures described in
to the Equal Pay Act and wish to pursue the Antidiscrimination Laws and Agency Information Collection:
your allegations through the Whistleblower Protection Laws sections Activity Under OMB Review; Electric
administrative process, you must or, if applicable, the administrative or Vehicle Inventory and Use Survey
contact an EEO counselor within 45 negotiated grievance procedures in (eVIUS)
calendar days of the alleged order to pursue any legal remedy.
discriminatory action, as such AGENCY: Bureau of Transportation
complaints are processed under EEOC’s Disciplinary Actions Statistics (BTS), Office of the Assistant
regulations at 29 CFR part 1614. Secretary for Research and Technology
Under existing laws, DOT retains the (OST–R), DOT.
Alternatively, you can file a civil action right, where appropriate, to discipline a
in a court of competent jurisdiction ACTION: Notice and Request for
DOT employee who engages in conduct Comments.
within two years, or if the violation is that is inconsistent with Federal
willful, three years of the date of the Antidiscrimination and Whistleblower SUMMARY: In accordance with the
alleged violation, regardless of whether Protection laws up to and including requirements of the Paperwork
you pursued any administrative removal from Federal service. If DOT Reduction Act of 1995, this notice
complaint processing. The filing of a
takes an adverse action under 5 U.S.C. announces the intention of the Bureau
complaint or appeal pursuant to 29 CFR
7512 against an employee for a of Transportation Statistics (BTS) to
part 1614 shall not toll the time for
discriminatory act, it must include a request the Office of Management and
filing a civil action.
notation of the adverse action and the Budget’s (OMB) approval of a new
Whistleblower Protection Laws reason for the action in the employee’s information collection related to the
A DOT employee with authority to personnel record. If OSC initiates an nation’s battery electric vehicles (BEVs)
take, direct others to take, recommend, investigation under 5 U.S.C. 1214, DOT and plug-in hybrid electric vehicles
or approve any personnel action must must seek approval from the Special (PHEVs)—collectively referred to
not use that authority to take, or fail to Counsel to discipline employees for, electric vehicles (EVs). The information
take, or threaten to take a personnel among other activities, engaging in collected will be used to produce
action against an employee or applicant prohibited retaliation (5 U.S.C. 1214). national statistics on the characteristics
because of a disclosure of information Nothing in the No FEAR Act alters and uses of EVs as well as the charging
by that individual that is reasonably existing laws or permits an agency to patterns and preferences related to EVs.
believed to evidence violations of law, take unfounded disciplinary action A summary report of survey findings
rule, or regulation; gross against a DOT employee, or to violate will also be published by BTS on the
mismanagement; gross waste of funds; the procedural rights of a DOT BTS web page: www.bts.gov.
an abuse of authority; or a substantial employee accused of discrimination. DATES: Send comments on or before
and specific danger to public health or Additional Information December 6, 2023.
safety, unless the disclosure of such FOR FURTHER INFORMATION CONTACT: Jina
information is specifically prohibited by For more information regarding the Mahmoudi, VIUS/eVIUS Program
law and such information is specifically No FEAR Act regulations, refer to 5 CFR Manager, (800) 853–1351, eVIUS@
required by Executive Order to be kept part 724, as well as the appropriate dot.gov, BTS, OST–R, Department of
secret in the interest of national defense office(s) within your agency (e.g., EEO/ Transportation, 1200 New Jersey Ave.
or the conduct of foreign affairs. civil rights offices, human resources SE, Room E34–471, Washington, DC
Retaliation against a DOT employee or offices, or legal offices). You can find 20590. Office hours are from 8 a.m. to
applicant for making a protected additional information regarding 5:30 p.m., E.T., Monday through Friday,
disclosure is prohibited (5 U.S.C. Federal antidiscrimination, except Federal holidays.
2302(b)(8)). If you believe you are a whistleblower protection, and SUPPLEMENTARY INFORMATION:
victim of whistleblower retaliation, you retaliation laws at the EEOC website at Title: Electric Vehicle Inventory and
may file a written complaint with the http://www.eeoc.gov and the OSC Use Survey (eVIUS).
U.S. Office of Special Counsel using website at http://www.osc.gov. Type of Request: Approval for a new
Form OSC–14. Form OSC–14 can be Existing Rights Unchanged information collection.
filed electronically at http:// Affected Public: Registered owners of
www.osc.gov. You may also contact the Pursuant to section 205 of the No battery electric vehicles (BEVs) and
DOT Office of Inspector General Hotline FEAR Act, neither the No FEAR Act nor plug-in hybrid electric vehicles
by phone at 1–800–424–9071, by fax at this notice creates, expands, or reduces (PHEVs).
202–366–7749, by email at hotline@ any rights otherwise available to any Background: As the pace of electric
oig.dot.gov, online at https:// employee, former employee, or vehicles’ adoption and use increases on
www.oig.dot.gov/hotline, or by mail at applicant under the laws of the United the nation’s roadways, the U.S.
Department of Transportation (U.S. Estimated Average Burden per survey estimation precision, and add to
DOT)’s Bureau of Transportation Response: The burden per respondent is the time and budget required for data
Statistics (BTS) is planning to conduct estimated to be an average of 16 minutes collection. As alternatively fueled
the first national-level Electric Vehicle (0.27 hours). This estimation is based on vehicles comprise a small proportion of
Inventory and Use Survey (eVIUS). The pre-test surveys conducted (with an the entire vehicle population in the
eVIUS will be conducted to gain an in- average respondent burden of 15 U.S., producing robust statistics will be
depth understanding of the minutes) plus an additional minute to a challenge due to a small population
characteristics, usage, and charging account for log in time. size, which leads to an inadequate
patterns of electric vehicles (EVs) as Estimated Total Annual Burden: sample size.
well as the demographics and charging Based on an estimated average burden The eVIUS sample frame is the states’
preferences of EV owners. The data of 0.27 hours per respondent and a 30% vehicle registration data; therefore, any
collected through eVIUS will inform response rate, the total annual burden is EVs registered in the states have a
policy and planning decisions on future estimated to be in the range of 4,050 chance to be sampled and included in
transportation systems and hours (for a minimum number of 50,000 the sample frame—i.e., government-
infrastructure investments. respondents) and 12,150 hours (for a owned fleets (federal, state, local) will
The survey will be administered to maximum number of 150,000 not be actively excluded. The eVIUS
owners of a nationally representative respondents). survey questionnaire includes multiple-
sample of battery electric vehicles Response to Comments: A 60-day choice questions that ask respondents
(BEVs) and plug-in hybrid electric notice requesting public comment was about the ownership type and usage
vehicles (PHEVs). The survey scope will issued in the Federal Register on March purpose of the vehicle—allowing them
be inclusive of passenger cars and light- 9, 2023 (88 FR 14667, page 14667– to select options that indicate if the
duty vehicles (up to 10,000 pounds). 14668, published 03/09/2023). Three vehicle is a government-owned vehicle
comments were received by BTS in (state or local) and if the vehicle is used
As there is no existing national-level
response to the 60-day public notice. for a government business purpose.
data source for EV use and charging
The BTS’ responses to those comments Since increasing the eVIUS scope to
patterns, the eVIUS will provide
are provided below: include alternatively fueled vehicles
valuable data and information that can BTS’ Response to Comment 1 (from
assist transportation professionals and would result in the data collection
The Association for the Work Truck operation schedule and the respondent
other stakeholders at the federal, state, Industry (NTEA):
and local levels to decipher the burden considerations becoming less
For this initial round of eVIUS, BTS flexible, it is not a feasible option for
characteristics and usage of the EVs would like to focus on light-duty
being driven on US roadways, as well as this first round of eVIUS as BTS intends
electric vehicles (EVs). The reasons for to produce timely data (within one
the charging preferences and needs of this decision are:
EV owners. The national-level data will year). BTS is considering a future data
• According to the International collection specific to the other
inform policy and planning decisions Energy Agency, the light-duty EV is
related to EV charging infrastructure in alternatively fueled vehicles, depending
becoming a fast-growing mode of on availability of funds.
the US, thereby leading to increased transportation as EV sales are increasing
mobility, safety, air quality, and equity BTS’ Response to Comment 2 (from
substantially, and the electric vehicle Alliance for Automotive Innovation):
on the nation’s roadways. (BEVs and PHEVs) sales in the United A multiple-choice format has been
Data Confidentiality Provisions: This States increased 55% in 2022 reaching used for the eVIUS as suggested.
will be a voluntary data collection. A a sales share of 8%. Since the light-duty The survey includes questions related
summary report of aggregate findings EVs (e.g., passenger cars) comprise the to vehicle background and type of use,
will be published on the BTS web page majority of EV population, to aid home base, miles traveled, long-distance
at www.bts.gov, and no individual and determination of charging infrastructure travel, general charging behavior and
company’s information or names will be gaps and inform policy decisions, it is needs, as well as demographics—
included in the published reports. The essential to collect timely data on use capturing information for most of the
Bureau of Transportation Statistics, its and charging patterns of EVs as proposed targeted questions.
employees and agents, will use the currently there is no existing source of BTS’ Response to Comment 3 (from
information provided by respondents such data and national statistics; The National Automobile Dealers
for statistical purposes only and will • Vehicles using the other suggested Association (NADA)):
hold individuals’ information in alternative fuels (i.e., hydrogen fuel cell, The eVIUS sample frame has been
confidence to the full extent permitted propane, natural gas and other possible expanded to include owners of plug-in
by law. In accordance with the future methods of propulsion) are hybrid electric vehicles (PHEVs) as
Confidential Information Protection and operated differently from EVs. suggested. For this initial round of
Statistical Efficiency Act of 2002 (Title Consequently, expansion of the scope of eVIUS, BTS will focus on light-duty EVs
5 of Pub. L. 107–347) and the the eVIUS to include these vehicles due to reasons previously outlined
Foundations for Evidence-Based would require adding many questions to (please see ‘‘BTS’ Response to Comment
Policymaking Act of 2018 (Title 3 of the survey questionnaire to measure the 1’’ above). BTS is considering future
Pub. L. 115–435) along with other characteristics and use of such vehicles. data collections focusing on vehicles
applicable Federal laws, no responses This will greatly increase the above 10,000 pounds, depending on
will not be disclosed in an identifiable complexity and length of the survey availability of funds.
form without the respondent’s informed questionnaire and add to the respondent A multiple-choice format has been
consent. Per the Federal Cybersecurity burden; used for the eVIUS as suggested.
Enhancement Act of 2016, Federal • Further, adding other alternatively A draft survey was not provided in
information systems are protected from fueled vehicles in the eVIUS survey the sixty-day notice (88 FR 14667). The
malicious activities through would require inclusion of an adequate survey questionnaire was developed
cybersecurity screening of transmitted number of such vehicles in the sample and finalized in collaboration with
data. frame, which will increase the sample subject matter experts and stakeholders.
Frequency: One time. size and potentially reduce the overall In addition, subject matter experts from
various agencies/organizations, ACTION:30-Day notice of new purposes only. BTS will not release
including academia, have provided BTS information collection and request for information that might reveal the
with suggestions for survey questions. comments. identity of individuals or organizations
These suggestions were carefully mentioned in event notices or reports
considered, and where appropriate, SUMMARY: On August 8, 2023, the without explicit consent of the
incorporated into the survey Bureau of Transportation Statistics respondent and any other affected
questionnaire. (BTS) announced its intention in a entities.
To test question understanding and Federal Register Notice to request that
the Office of Management and Budget SUPPLEMENTARY INFORMATION: The
clarity of instructions, a pre-test of the
(OMB) approve the following Federal Register Notice with a 60-day
draft survey was also conducted with
information collection: SafeMTS— comment period soliciting comments on
participation of five EV owners.
Voluntary Near-Miss Reporting and the following collection of information
Following completion of the survey, one
Analysis System, a voluntary program was published on August 8, 2023 at 88
hour long cognitive interviews were
for confidential reporting of ‘near- FR 53594.
conducted with each of the pre-testers
misses’ occurring on vessels within the Title: Near-Miss Reporting and
to collect information on their survey
Maritime Transportation System (MTS). Analysis Program for the Maritime
experience and other feedback for
BTS encouraged interested parties to Transportation System.
improving the survey. Overall, the pre-
submit comments to docket number OMB Control Number: Not yet known.
testers reported that the survey was
2023–0115 during the 60-day comment Type of Review: New collection.
clear, and they did not have any major
period. One comment was received, Respondents: Businesses in the
issues with understanding the survey
from the National Transportation Safety maritime industry that involve
questions/instructions.
Public Comments Invited: Interested Board (NTSB) expressing the agency’s ownership or operation of vessels.
parties are invited to send comments support for such a program. Estimated Number of Respondents:
regarding any aspect of this information 100, submitted on a quarterly basis.
DATES: Written comments should be
collection, including, but not limited to: Estimated Time per Response: 1 hour.
submitted within 30 days of publication Total Annual Burden: 400 hours.
(1) the necessity and utility of the of this notice.
information collection for the proper ADDRESSES: BTS seeks public comments Allison Fischman,
performance of the functions of the on its proposed information collection. Acting Director, Office of Safety Data and
DOT; (2) the accuracy of the estimated Comments should address whether the Analysis.
burden; (3) ways to enhance the quality, information will have practical utility; [FR Doc. 2023–24467 Filed 11–3–23; 8:45 am]
utility, clarity and content of the the accuracy of the estimated burden BILLING CODE 4910–9X–P
collected information; and (4) ways to hours of the proposed information
minimize the collection burden without collection, ways to enhance the quality,
reducing the quality of the collected utility, and clarity of the information to DEPARTMENT OF VETERANS
information. be collected; and ways to minimize the AFFAIRS
Send comments to the Office of burden of the collection of information
Information and Regulatory Affairs, [OMB Control No. 2900–0342]
on respondents, including the use of
Office of Management and Budget, 725– automated collection techniques or
17th Street NW, Washington, DC 20503, Agency Information Collection
other forms of information technology. Activity: Application and Training
Attention: BTS Desk Officer. Send comments to the Office of Agreement for Apprenticeship and On-
Issued in Washington, DC, on 3rd of Information and Regulatory Affairs, the-Job Training Programs
October, 2023. Office of Management and Budget, 725–
Cha-Chi Fan, 17th Street NW, Washington, DC 20503, AGENCY: Veterans Benefits
Director, Office of Data Development and Attention: BTS Desk Officer. Administration, Department of Veterans
Standards, Bureau of Transportation FOR FURTHER INFORMATION CONTACT: Affairs.
Statistics, Office of the Assistant Secretary ACTION: Notice.
Allison Fischman, Bureau of
for Research and Technology.
Transportation Statistics, Office of the
[FR Doc. 2023–24397 Filed 11–3–23; 8:45 am]
Assistant Secretary for Research and SUMMARY: Veterans Benefits
BILLING CODE 4910–9X–P
Technology, USDOT, Office of Safety Administration, Department of Veterans
Data and Analysis, RTS–34 E36–303, Affairs (VA), is announcing an
1200 New Jersey Avenue SE, opportunity for public comment on the
DEPARTMENT OF TRANSPORTATION proposed collection of certain
Washington, DC 20590–0001, Phone No.
(202) 748–0546; email: information by the agency. Under the
Bureau of Transportation Statistics Paperwork Reduction Act (PRA) of
allison.fischman@dot.gov.
[Docket Number OST–2023–0115] Data Confidentiality Provisions: The 1995, Federal agencies are required to
confidentiality of the Safe Maritime publish notice in the Federal Register
Agency Information Collection concerning each proposed collection of
Transportation System (SafeMTS) data
Activity; Notice of Request for information, including each proposed
is protected under the Confidential
Approval To Collect New Information: extension of a currently approved
Information Protection and Statistical
Safe Maritime Transportation System collection, and allow 60 days for public
Efficiency Act (CIPSEA) of 2018 (Pub.
(SafeMTS)—Voluntary Near-Miss comment in response to the notice.

L.: 115–435 Foundations for Evidence-
Incident Reporting and Analysis DATES: Written comments and
Based Policymaking Act of 2018, Title
System recommendations on the proposed
III of the Foundations for Evidence-
AGENCY: Bureau of Transportation Based Policymaking Act of 2018). In collection of information should be
Statistics (BTS), Office of the Assistant accordance with CIPSEA, only received on or before January 5, 2024.
Secretary for Research and Technology aggregated and non-identifying data will ADDRESSES: Submit written comments
(OST–R), U.S. Department of be made publicly available by BTS on the collection of information through
Transportation. through its reports for statistical Federal Docket Management System
(FDMS) at www.Regulations.gov or to burden of the proposed collection of an option for these employers to use if
Nancy J. Kessinger, Veterans Benefits information; (3) ways to enhance the they didn’t have their own training
Administration (20M33), Department of quality, utility, and clarity of the agreement or use one from their state
Veterans Affairs, 810 Vermont Avenue information to be collected; and (4) department of labor. Employers used to
NW, Washington, DC 20420 or email to ways to minimize the burden of the submit a copy of the VA Form 22–8864
nancy.kessinger@va.gov. Please refer to collection of information on or their own as a condition of the
‘‘OMB Control No. 2900–0342’’ in any respondents, including through the use Veteran receiving VA benefits. The
correspondence. During the comment of automated collection techniques or employer is still required to provide a
period, comments may be viewed online the use of other forms of information training agreement to their trainees, but
through FDMS. technology. VA no longer collects it as a condition
FOR FURTHER INFORMATION CONTACT: Authority: 10 U.S.C. 16131(d), 16136, of paying EDU benefits.
Maribel Aponte, Office of Enterprise and section 510 of chapter 31, 38 U.S.C. The Employer’s Application to
and Integration, Data Governance 3034(a)(1), 3241(a)(1), 3323(a), 3534(a), Provide Job Training, VA Form 22–8865
Analytics (008), 810 Vermont Ave. NW, 3671, 3672, 3687(a), 38 CFR 21.4150(c), (or the equivalent tool provided by the
Washington, DC 20420, (202) 266–4688 21.4261(b) and (c), 21.5250(a), SAAs) is used to ensure that training
or email maribel.aponte@va.gov. Please 21.7220(a), 21.7720, and Section 903 of programs meet the statutory and
refer to ‘‘OMB Control No. 2900–0342’’ Public Law 96–342. regulatory requirements for approval.
in any correspondence. Title: Application and Training Affected Public: Individuals and
SUPPLEMENTARY INFORMATION: Under the Agreement for Apprenticeship and On- Households.
PRA of 1995, Federal agencies must the-Job Training Programs, VA Forms Estimated Annual Burden: 1,710
obtain approval from the Office of 22–8864 and 22–8865. hours.
Management and Budget (OMB) for each OMB Control Number: 2900–0342. Estimated Average Burden Time per
collection of information they conduct Type of Review: Revision of a Respondent: 90 minutes.
or sponsor. This request for comment is currently approved collection. Frequency of Response: Once.
being made pursuant to section Abstract: The Training Agreement,
Estimated Number of Respondents:
3506(c)(2)(A) of the PRA. VA Form 22–8864 is no longer being
1,140.
With respect to the following submitted to VA, therefore it no longer
collection of information, VBA invites needs an OMB approval. VA mostly By direction of the Secretary:
comments on: (1) whether the proposed requires employers with OJT or Maribel Aponte,
collection of information is necessary Apprenticeship programs approved for VA PRA Clearance Officer, Office of
for the proper performance of VBA’s VA benefits to provide a training Enterprise and Integration/Data Governance
functions, including whether the agreement to prospective Veterans using Analytics, Department of Veterans Affairs.
information will have practical utility; VA benefits while training with their [FR Doc. 2023–24443 Filed 11–3–23; 8:45 am]
(2) the accuracy of VBA’s estimate of the company. The 22–8864 has always been BILLING CODE 8320–01–P
FEDERAL REGISTER
Vol. 88 Monday,
Part II
Securities and Exchange Commission

17 CFR Parts 232 and 240
Volume-Based Exchange Transaction Pricing for NMS Stocks; Proposed
Rule
SECURITIES AND EXCHANGE conditions may limit access to the 1. Rule 6b–1(a)—Prohibition on Volume-
COMMISSION Commission’s Public Reference Room. Based Pricing for Agency-Related
Do not include personal information in Volume
17 CFR Parts 232 and 240 2. Rule 6b–1(b)(1)—Rules To Prevent
submissions; you should submit only
Evasion
[Release No. 34–98766; File No. S7–18–23] information that you wish to make 3. Rule 6b–1(b)(2)—Policies and
available publicly. We may redact in Procedures To Prevent Evasion
RIN 3235–AN29 part or withhold entirely from 4. Rule 6b–1(c)—Transparency for Volume-
publication submitted material that is Based Pricing on Member Proprietary
Volume-Based Exchange Transaction obscene or subject to copyright. Orders
Pricing for NMS Stocks Studies, memoranda, or other C. Respondents
substantive items may be added by the D. Total Initial and Annual Reporting and
AGENCY: Securities and Exchange Recordkeeping Burdens
Commission. Commission or staff to the comment file
1. Rule 6b–1(a)—Prohibition on Volume-
ACTION: Proposed rule.
during this rulemaking. A notification of Based Pricing for Agency-Related
the inclusion in the comment file of any Volume
SUMMARY: The Securities and Exchange materials will be made available on the 2. Rule 6b–1(b)(1)—Rules To Prevent
Commission (‘‘Commission’’) is Commission’s website. To ensure direct Evasion
proposing a new rule under the electronic receipt of such notifications, 3. Rule 6b–1(b)(2)—Policies and
Securities Exchange Act of 1934 sign up through the ‘‘Stay Connected’’ Procedures To Prevent Evasion
(‘‘Exchange Act’’) to prohibit national option at www.sec.gov to receive 4. Rule 6b–1(c)—Transparency for Volume-
securities exchanges from offering notifications by email. Based Pricing on Member Proprietary
A summary of the proposal of not Orders
volume-based transaction pricing in E. Collection of Information Is Mandatory
connection with the execution of more than 100 words is posted on the
F. Confidentiality of Responses to
agency-related orders in certain stocks. Commission’s website (https:// Collection of Information
If exchanges offer such pricing for their www.sec.gov/rules/2023/10/feetiers). G. Retention Period for Recordkeeping
members’ proprietary orders, the FOR FURTHER INFORMATION CONTACT: Requirements
proposal would require the exchanges to Richard Holley III, Assistant Director, H. Request for Comments
adopt rules and written policies and Yvonne Fraticelli, Special Counsel, IV. Economic Analysis
procedures related to compliance with Terri Evans, Special Counsel, or Julia A. Introduction
the prohibition, as well as disclose, on Zhang, Special Counsel, at (202) 551– B. Baseline
1. Exchange Pricing
a monthly basis, certain information 5500, Office of Market Supervision, 2. Volume-Based Tiers and Order Routing
including the total number of members Division of Trading and Markets, Incentives
that qualified for each volume tier Securities and Exchange Commission, 3. Routing Incentives and Potential
during the month. 100 F Street NE, Washington, DC 20549. Conflicts of Interest
DATES: Comments should be received on SUPPLEMENTARY INFORMATION: The 4. The Market To Provide Exchange Access
or before January 5, 2024. Commission is proposing to add new 17 5. Lack of Tier Transparency
CFR 240.6b–1 (Rule 6b–1 under the C. Economic Effects
ADDRESSES: Comments may be 1. Effect of the Proposed Ban on Volume-
submitted by any of the following Exchange Act) and amend 17 CFR
Based Tiers for Non-Principal Orders
methods: 232.101 (Rule 101 of Regulation S–T) 2. Effects of Proposed Requirement of
and 17 CFR 232.405 (Rule 405 of Rules and Policies and Procedures To
Electronic Comments Regulation S–T). Prevent Evasion
• Use the Commission’s internet Table of Contents 3. Effects of the Transparency Provisions
comment form (https://www.sec.gov/ D. Effect on Efficiency, Competition, and
rules/2023/10/feetiers); or I. Introduction Capital Formation
• Send an email to rule-comments@ A. Background 1. Efficiency
sec.gov. Please include file number S7– B. Volume-Based Exchange Transaction 2. Competition
Pricing 3. Capital Formation
18–23 on the subject line. C. Commission Concerns E. Reasonable Alternatives
Paper Comments 1. Competition Among Members 1. Ban Volume-Based Pricing for All
2. Conflicts of Interest Orders
• Send paper comments to Secretary, 3. Exchange Competition 2. Ban Volume-Based Pricing for All
Securities and Exchange Commission, II. Description of Proposed Rule Orders Except Registered Market Makers
100 F Street NE, Washington, DC A. Overview of Proposed Rule 3. Proceed With Transparency Provisions
20549–1090. B. Prohibition on Volume-Based Exchange for All Orders Without Tiers Prohibition
All submissions should refer to file Transaction Pricing for Agency-Related 4. Banning the Linking of Volume-Based
Volume Tiers for Closing Auctions To
number S7–18–23. This file number
C. Anti-Evasion Consolidated Volume
should be included on the subject line D. Transparency for Volume-Based Pricing 5. Require Disclosures of Volume-Based
if email is used. To help the on Member Proprietary Orders Pricing in Proprietary Volume in NMS
Commission process and review your III. Paperwork Reduction Act Stocks To Be Posted on Exchange
comments more efficiently, please use A. Summary of Collections of Information Websites or Submitted Through a
only one method of submission. The 1. Rule 6b–1(a)—Prohibition on Volume- Different System
Commission will post all comments on Based Pricing for Agency-Related 6. Require a Different Structured Data
the Commission’s website (https:// Volume Language for the Disclosures of Volume-
www.sec.gov/rules/proposed.shtml). 2. Rule 6b–1(b)(1)—Rules To Prevent Based Pricing in Proprietary Volume in
Evasion NMS Stocks
Comments are also available for website
3. Rule 6b–1(b)(2)—Policies and 7. Remove Structured Data Language
viewing and printing in the Procedures To Prevent Evasion Requirement for Disclosures of Volume-
Commission’s Public Reference Room, 4. Rule 6b–1(c)—Transparency for Volume- Based Pricing in Proprietary Volume in
100 F Street NE, Washington, DC 20549, Based Pricing on Member Proprietary NMS Stocks
on official business days between the Orders F. Request for Comment
hours of 10 a.m. and 3 p.m. Operating B. Proposed Use of Information V. Regulatory Flexibility Act Certification
VI. Consideration of Impact on the Economy schedules must be publicly posted on system continue to meet the statutory
Statutory Authority the exchange’s website.7 goals and objectives as markets and
I. Introduction The Exchange Act further requires market participants evolve, the
that exchange pricing proposals, among Commission is considering the impact
A. Background other things, provide for the ‘‘equitable of volume-based exchange transaction
National securities exchanges allocation of reasonable dues, fees, and pricing in NMS stocks. Many exchanges
(‘‘exchanges’’) that trade NMS stocks 1 other charges among its members and use increasingly complex transaction
maintain pricing schedules that set forth issuers and other persons using its pricing schedules that feature
the transaction pricing they apply to facilities’’ 8 that ‘‘are not designed to differentiated incentives (e.g., lower fees
their broker-dealer members 2 that permit unfair discrimination between or higher rebates) that depend on
execute orders on their trading customers, issuers, brokers, or dealers’’ 9 member volume.15 These exchanges
platforms.3 As self-regulatory and ‘‘do not impose any burden on
organizations under the Exchange Act, competition not necessary or 15 Exchange transaction pricing for NMS stocks is
appropriate in furtherance of the characterized by three different pricing models: (1)

exchanges are subject to unique maker-taker (where the liquidity providing ‘‘maker’’
principles and processes that do not purposes of’’ the Exchange Act.10 With receives a rebate from the exchange and the ‘‘taker’’
apply to other businesses.4 For example, respect to the requirement that the rules that executes against that resting order pays a fee
all proposed rules of an exchange,5 of an exchange not impose any burden to the exchange); (2) taker-maker or inverted (where
on competition not necessary or liquidity takers are offered a rebate and liquidity
including exchange transaction pricing providers are assessed a fee); and (3) flat (where an
proposals, must be filed with the appropriate in furtherance of the exchange does not offer rebates and instead charges
purposes of the Exchange Act, the a fee to neither side of a trade, one side of a trade,
Commission.6 In addition, pricing
Senate Banking, Housing and Urban or both sides of a trade). In rebate pricing models,
Affairs Committee report that the exchange’s transaction revenue (‘‘net capture’’)
1 See 17 CFR 242.600(b)(55) (defining ‘‘NMS
is the difference between the fee it collects on one
stock’’). accompanied the 1975 amendments to side of the trade and the rebate it pays out on the
2 Exchange rules limit their membership to the Exchange Act stated that ‘‘this other side of the trade. As of Mar. 2023, nine
registered brokers or dealers. See, e.g., Cboe BZX paragraph is designed to make clear that exchanges had a maker-taker pricing model. See
Exchange, Inc. (‘‘Cboe BZX’’) Rule 2.3. a balance must be struck between Cboe BZX pricing schedule, available at https://
3 This release uses the term ‘‘price’’ or ‘‘pricing’’ www.cboe.com/us/equities/membership/fee_
to refer to the fees (charges incurred for an
regulatory objectives and competition, schedule/bzx/; Cboe EDGX Exchange, Inc. (‘‘Cboe
execution), rebates (refundable credits in and that unless an interference with EDGX’’) pricing schedule, available at https://
connection with an execution), and other incentives competition is justified in terms of the www.cboe.com/us/equities/membership/fee_
(e.g., discounts or caps that are not refundable achievement of a statutory objective, it schedule/edgx/; Nasdaq PHLX, LLC (‘‘Phlx (PSX)’’)
credits but are credited to the member’s billing pricing schedule, available at https://listingcenter.
account) that exchanges assess to their members for
cannot stand.’’ 11 nasdaq.com/rulebook/phlx/rules/phlx-equity-7; The
transactions on the exchange. Rebates are Section 11A of the Exchange Act 12 Nasdaq Stock Market LLC (‘‘Nasdaq’’) pricing
refundable because they can exceed the fees directs the Commission to facilitate the schedule, available at http://nasdaqtrader.com/
(transaction fees and other fees) that members establishment of a national market Trader.aspx?id=PriceListTrading2#rebates; NYSE
incur. See, e.g., Remarks of Chris Concannon, Cboe Arca, Inc. (‘‘NYSE Arca’’) pricing schedule,
Global Markets, before the SEC Roundtable on
system in accordance with specified available at https://www.nyse.com/publicdocs/nyse/
Market Data Products, Market Access Services, and Congressional findings. Among the markets/nyse-arca/NYSE_Arca_Marketplace_
Their Associated Fees, Oct. 25, 2018, Transcript at Congressional findings are assuring (i) Fees.pdf; NYSE American LLC (‘‘NYSE American’’)
74–75, available at https://www.sec.gov/spotlight/ fair competition among brokers and pricing schedule, available at https://
equity-market-structure-roundtables/roundtable- www.nyse.com/publicdocs/nyse/markets/nyse-
market-data-market-access-102518-transcript.pdf
dealers and among exchange markets, american/NYSE_America_Equities_Price_List.pdf;
(‘‘Five out of the top 10 get a check from us after and (ii) the practicability of brokers New York Stock Exchange, LLC (‘‘NYSE’’) pricing
the costs of their connectivity and market data. So executing investors’ orders in the best schedule, available at https://www.nyse.com/
we are cutting them a check monthly after their publicdocs/nyse/markets/nyse/NYSE_Price_
market.13 Rather than setting forth List.pdf; MEMX, LLC pricing schedule, available at
costs.’’) (‘‘Remarks of Chris Concannon’’).
4 See, e.g., 15 U.S.C. 78f and 78s.
minimum components of the national https://info.memxtrading.com/fee-schedule/; and
5 See 15 U.S.C. 78c(a)(27) (defining ‘‘rules’’) and
market system, the Exchange Act grants MIAX PEARL, LLC (‘‘MIAX Pearl’’) equities pricing
the Commission broad authority to schedule, available at https://
17 CFR 240.19b–4(c) (providing further information
www.miaxoptions.com/sites/default/files/fee_
on the phrase ‘‘stated policies, practices, and oversee the implementation, operation, schedule-files/MIAX_Pearl_Equities_Fee_Schedule_
interpretations’’). and regulation of the national market 01012023_1.pdf. As of Mar. 2023, four exchanges
6 See 15 U.S.C. 78s(b). Exchange pricing
system consistent with Congressionally had a taker-maker pricing model. See Cboe BYX
proposals are effective immediately upon filing Exchange, Inc. (‘‘Cboe BYX’’) pricing schedule,
with the Commission because the Exchange Act determined goals and objectives.14
available at https://www.cboe.com/us/equities/
does not require advance notice or Commission B. Volume-Based Exchange Transaction membership/fee_schedule/byx/; Cboe EDGA
approval before an exchange may implement a Exchange, Inc. (‘‘Cboe EDGA’’) pricing schedule,
pricing change. 15 U.S.C. 78s(b)(3)(A)(ii). Within 60 Pricing available at https://www.cboe.com/us/equities/
days after the date of filing of an immediately As part of its ongoing efforts to assess membership/fee_schedule/edga/; and NYSE
effective proposal, the Commission may summarily National, Inc. (‘‘NYSE National’’) pricing schedule,
temporarily suspend the proposal if it appears to whether aspects of the national market
available at https://www.nyse.com/publicdocs/nyse/
the Commission that a suspension is necessary or regulation/nyse/NYSE_National_Schedule_of_
appropriate in the public interest, for the protection deem the proposal to have been approved by the Fees.pdf. Nasdaq BX, Inc. (‘‘BX’’) also uses the
of investors, or otherwise in furtherance of the Commission. See 15 U.S.C. 78s(b)(2)(D) (providing taker-maker pricing model but charges a $0.0007 fee
purposes of the Exchange Act. See 15 U.S.C. when a proposed rule change shall be deemed to if a member fails to reach any liquidity removing
78s(b)(3)(C). If the Commission suspends the have been approved by the Commission). rebate tier. See BX pricing schedule, available at
proposal, the Commission will institute 7 See 17 CFR 240.19b–4(m). http://www.nasdaqtrader.com/trader.aspx?id=bx_
proceedings under section 19(b)(2)(B) (15 U.S.C. 8 15 U.S.C. 78f(b)(4). pricing. As of Mar. 2023, Investors Exchange LLC
78s(b)(2)(B)) of the Exchange Act to determine 9 15 U.S.C. 78f(b)(5). (‘‘IEX’’) and NYSE Chicago, Inc. (‘‘NYSE Chicago’’)
whether the proposal should be approved or 10 15 U.S.C. 78f(b)(8). offer a flat pricing model. See IEX pricing schedule,
disapproved. See 15 U.S.C. 78s(b)(3)(C). At the 11 Securities Acts Amendments of 1975, Report of
available at https://www.iexexchange.io/resources/
conclusion of the proceedings, the Commission trading/fee-schedule#transaction-fees and NYSE
shall approve a proposal if it finds that it is the Senate Comm. on Banking, Housing and Urban Chicago pricing schedule, available at https://
consistent with the requirements of the Exchange Affairs to Accompany S.249, S. Rep. No. 94–75, www.nyse.com/publicdocs/nyse/NYSE_Chicago_
Act, or it shall disapprove the proposal if it does 94th Cong., 1st Sess. 11 (1975), at 96 (‘‘Senate Fee_Schedule.pdf. As of Sept. 1, 2023, IEX began
not make such a finding. See 15 U.S.C. 78s(b)(2)(C). Report’’). offering a rebate of $0.0004 per share on displayed
12 15 U.S.C. 78k–1.
If the Commission does not suspend an orders that add liquidity for executions at or above
13 15 U.S.C. 78k–1(a)(1)(C)(ii) and (iv).
immediately effective filing on or before the sixtieth $1. Another exchange, Long-Term Stock Exchange,
day after the filing date, the Exchange Act does not 14 See Senate Report, supra note 11, at 8–9. Continued
offer members lower fees or higher available tiers, and possible using principal orders where no
rebates as the number of shares the combinations of some tiers,18 greatly customers are involved.
member executes on the exchange complicate exchange pricing schedules As a result of volume-based exchange
reaches successively higher predefined and that complexity can make it more transaction pricing, lower-volume
volume-based levels (‘‘tiers’’). The difficult for the public to understand members may seek to route some or all
transaction volume that qualifies a and meaningfully comment on exchange of their orders through high-volume
member for a better fee or rebate tier pricing proposals.19 members to qualify for better exchange
typically is measured as a fraction of Volume-based exchange transaction pricing.22 As that happens, the lower-
total consolidated market volume, rather pricing raises competitive concerns volume members that are otherwise
than a fixed value. Such tiers are among exchange members as well as competing with the high-volume
commonly based on a member among exchanges. With respect to members become customers of their
achieving a designated average daily members competing for customers,20 high-volume competitors. This dynamic
volume on the exchange that equals or members with lower exchange volume
exceeds a certain percentage of total can lead to order flow becoming
do not qualify for the more favorable increasingly concentrated among a
market volume in a given month (e.g., volume-based exchange transaction
an average daily volume on the small number of high-volume members,
pricing tiers available to high-volume who then qualify for even higher tiers
exchange that equals or exceeds 0.10% members. Accordingly, lower-volume
of the total consolidated market (i.e., tiers that feature lower fees or
members may find it difficult to higher rebates) as a result of that flow,
volume).16 Each member’s tier is compete for customer order flow
calculated by the exchange as of the end which further impacts the ability of
because they are unable to pass through lower-volume members to compete with
of a month and reset thereafter on a to customers the favorable exchange
monthly basis.17 The large number of them in a self-reinforcing cycle.23 This
transaction pricing or lower concentration impacts customers by
commissions that are available to reducing the number of exchange
Inc., (‘‘LTSE’’) does not charge fees to transact. See
https://ltse.com/trading/market-overview.
higher-volume members.21 Similar members capable of offering them
16 Tier criteria typically reference a member’s competitive concerns also may be competitive exchange transaction
average total daily traded share volume on the present for members as a result of pricing. Further, lower-volume
exchange during the month as a percentage of the volume-based exchange transaction exchange members provide a subsidy
average total daily market volume in stocks pricing when they trade proprietarily
reported by one or more of the consolidated tapes for the high-volume members when
(‘‘Tapes’’) during the month pursuant to effective exchanges use the higher fees and lower
national market system plans that govern the to the start of a month. See Securities Exchange Act rebates of the lower-volume members to
collection, consolidation, processing, and Release No. 96494 (Dec. 14, 2022), 87 FR 80266,
dissemination of certain national market system 80270 (Dec. 29, 2022) (File No. S7–30–22) (‘‘Access fund the lower fees and higher rebates
information. See, e.g., Nasdaq pricing schedule, Fee Proposal’’). The Commission encourages the exchange offers to high-volume
supra note 15. There currently are three such commenters to review the Access Fee Proposal to members.24 Accordingly, the
effective national market system plans. They are: (1) determine whether it might affect their comments
the Consolidated Tape Association Plan (‘‘CTA
Commission is concerned that volume-
on this release. As exchanges compete to attract
Plan’’); (2) the Consolidated Quotation Plan (‘‘CQ liquidity, frequent pricing changes (typically based exchange transaction pricing may
Plan’’); and (3) the Joint Self-Regulatory effective and/or operative on the first business day have the effect of ensuring that high-
Organization Plan Governing the Collection, of a month) are common. See, e.g., id. at 87 FR at volume members retain a persistent
Consolidation, and Dissemination of Quotation and 80311 (stating that between Jan. 2018 and June
Transaction Information for Nasdaq-Listed
competitive advantage over lower-
2022, market participants interacting with all
Securities Traded on Exchanges on an Unlisted exchanges had to adjust to an average of 155 fee volume exchange members.25
Trading Privileges Basis (‘‘UTP Plan’’) (together, the changes per year across all exchanges).
‘‘Equities Data Plans’’). The Equities Data Plans
In addition, volume-based transaction
18 See infra Table 2 (showing the number of
disseminate SIP data over three separate networks: pricing tiers may provide incentives to
available tiers at each exchange in March 2023,
(1) Tape A for securities listed on NYSE; (2) Tape ranging from 0 to 93). Some exchanges offer members of more than one exchange to
B for securities listed on exchanges other than additive incentives, including ‘‘step-up’’ rebates, route orders to one particular exchange
NYSE and Nasdaq; and (3) Tape C for securities
listed on Nasdaq. The CTA Plan governs the
that can be earned in addition to a standard tiered in order to qualify for that exchange’s
incentive. See, e.g., Cboe BZX Fee Schedule’s Step- tiers and achieve lower fees and higher
collection, consolidation, processing, and Up Tiers, available at https://www.cboe.com/us/
dissemination of last sale information for Tape A equities/membership/fee_schedule/bzx/. See also
and Tape B securities. The CQ Plan governs the
infra Tables 1 and 2. 22 See, e.g., Securities Exchange Act Release No.
collection, consolidation, processing, and 19 See Letter to Brent Fields, Secretary, 63241 (Nov. 3, 2010), 75 FR 69792 at 69793 (Nov.
dissemination of quotation information for Tape A
Commission, from Rich Steiner, RBC Capital 15, 2010) (‘‘Rule 15c3–5 Adopting Release’’)
and Tape B securities. Finally, the UTP Plan
Markets (Oct. 16, 2018) (‘‘RBC Letter’’) at 8 (discussing that certain market participants may
governs the collection, consolidation, processing,
(comment letter on File No. S7–05–18) (‘‘Our find the wide range of access arrangements,
and dissemination of last sale and quotation
analysis identifies at least 1,023 pricing paths including sponsored and/or direct market access,
information for Tape C securities. See also
across the exchanges. Over one-third, or 381, of beneficial and that such arrangements may ‘‘reduce
Securities Exchange Act Release No. 98271 (Sept.
these paths consist of rebates. These 1,023 pricing trading costs by lowering operational costs,
1, 2023), 88 FR 61630 (Sept. 7, 2023) (File No. 4–
paths are themselves determined by at least 3,762 commissions, and exchange fees’’).
757) (Order directing the exchanges and the
Financial Industry Regulatory Authority (‘‘FINRA’’) pricing variables.’’). 23 See infra section IV.B.4 (The Market to Provide
to file a national market system plan regarding 20 A ‘‘customer’’ of a member is anyone using the Exchange Access).
consolidated equity market data). services of the member to access the exchange, 24 See id.
17 Currently, as exchanges assess transaction including another exchange member, a non-member 25 See 15 U.S.C. 78f(b)(4) (requiring that the rules
pricing to their members on a monthly basis in broker-dealer, an institution, or any other person. of an exchange provide for the equitable allocation
21 See Letter from Tyler Gellasch, President and of reasonable dues, fees, and other charges among
arrears, exchanges apply the highest tier a member
achieves during a month to all of the member’s CEO, Healthy Markets Association, to Gary Gensler, its members); (b)(5) (requiring that the rules of an
executions during that month (e.g., if a member Chair, Commission, dated Nov. 16, 2022 at 4 exchange, among other things, not be designed to
qualifies for Tier 2 in June (out of 4 tiers), all of (‘‘Healthy Markets Letter’’), available at https:// permit unfair discrimination); (b)(8) (requiring that
its June volume will be assessed at the Tier 2 rate, healthymarkets.org/wp-content/uploads/2022/12/ the rules of an exchange not impose any burden on
including volume transacted at the lower Tiers 4 HMA-Ltr-re-Volume-Based-Pricing-11-16-22-1.pdf competition not necessary or appropriate in
and 3 earlier in the month). Separately, the (stating that to ‘‘the extent that different competitors furtherance of the purposes of the Exchange Act);
Commission has proposed to require exchanges to fall into different pricing tiers, it will directly and 15 U.S.C. 78k–1(a)(1)(C) (finding it in the
make the amounts of all fees and rebates impact the competitive balance between those public interest and appropriate for the protection of
determinable at the time of execution, which would firms’’). The letter also includes suggestions for investors and the maintenance of fair and orderly
require volume-based exchange transaction pricing potential reforms to exchange routing incentives markets to assure fair competition among brokers
to be applied prospectively rather than retroactively and transaction pricing fees. See id. at 4. and dealers, and among exchange markets).
rebates as a result.26 With respect to pricing tiers when members are routing session, or special program on volume
customer orders, an economic incentive customer orders to an exchange for submitted during regular trading hours
to route customer orders to a particular execution. Because the prohibition in outside that auction, trading session, or
exchange to achieve volume tiers on proposed Rule 6b–1 would be limited to program.
that specific exchange can present a agency and riskless principal orders, As discussed above, the Commission
conflict of interest between members exchanges would continue to have the is able to summarily temporarily
and customers when members do not ability to provide tiered transaction suspend individual exchange proposed
fully pass-through exchange transaction pricing for member proprietary volume, rule changes related to transaction
fees and rebates to their customers and and therefore this proposed prohibition pricing shortly after they are filed.31
instead retain for themselves the does not seek to address any potential This post hoc filing-by-filing approach,
benefits of tiered exchange transaction concerns associated with the routing of however, does not address similar
pricing.27 proprietary orders. pricing across other exchanges. The
Volume-based exchange transaction With respect to proprietary volume, Commission is proposing this rule as a
pricing also can impact competition the proposed rule would enhance cross-exchange approach intended to
among exchanges. For example, when a transparency of tiered exchange facilitate investor protection and the
primary listing exchange bases pricing transaction pricing for such volume by public interest while enhancing
in its closing auction on the volume that requiring exchanges to disclose the competition among members and among
a member executes on the exchange number of members that qualify for each exchanges.
during regular trading hours, members of their pricing tiers. This information is
that prefer (or whose customers prefer) intended to facilitate the Commission’s 1. Competition Among Members
the primary listing exchange’s closing review of proposed pricing changes and Some exchange pricing schedules
auction are incentivized to route orders provide the public with additional have evolved to the point of offering
to the exchange during the regular hours relevant information for assessing and exceptionally specific pricing tiers,
trading session in order to obtain more providing informed comment on where some observers have questioned
favorable pricing in the closing auction, exchange pricing proposals, including whether certain tiers may be available to
which could negatively affect the ability assessing exchange statements about the only a limited number of members.32
of other exchanges to compete for that number of members that may qualify for The Commission is concerned that
volume during regular trading hours.28 a proposed tier, assessing the actual exchanges’ tiered transaction pricing
As discussed below, the proposed effect of a pricing change, and assessing may confer an inappropriate benefit on
rule would prohibit exchanges from whether a tier meets the applicable a small group of members to the
offering volume-based transaction fees, statutory standards.30 detriment of other members by offering
rebates, or other incentives in the best prices (i.e., the lowest fees and
connection with the execution of agency C. Commission Concerns highest rebates) only to the exchange’s
or riskless principal orders in NMS As introduced above and further highest volume members.33 In turn, this
stocks.29 This prohibition is designed to discussed below, the Commission has advantage may significantly limit the
remove a competitive impediment several concerns about volume-based ability of lower-volume members to
between higher-volume and lower- exchange transaction pricing. First, the compete with higher-volume members
volume members when they compete Commission is concerned about the for the order flow volume necessary to
for customer business, and also to impact of volume-based exchange reach higher tiers.
mitigate the conflict of interest between transaction pricing, as tiered pricing has By design, volume-based exchange
members and customers presented by expanded and evolved, on competition transaction pricing involves an
volume-based exchange transaction among exchange members, such as exchange assessing different fees and
when broker-dealers are competing for offering different rebates and other
26 Membership can overlap across the exchanges.
customers. Second, the Commission is incentives to different members for
For example, as of Feb. 21, 2023, MIAX Pearl
Equities Exchange had 49 members and NYSE had concerned that the desire to qualify for executions of orders with identical
143 members. See https://www.miaxoptions.com/ volume-based transaction pricing tiers terms (symbol, price, size, side, order
exchange-members/pearl-equities and https:// exacerbates a conflict of interest type, etc.). The range in fees and rebates
www.nyse.com/markets/nyse/membership. Forty- between members and their customers can vary considerably, as shown below
two of those MIAX Pearl Equities Exchange’s
members were also members of NYSE. when members route customers’ orders in Table 1. While the transaction price
27 The Commission understands that full pass- for execution because the member can for each execution is small in absolute
through of exchange transaction pricing by economically benefit from its routing dollar terms, the percentage difference
members to their customers is less common. decision. Specifically, tiered transaction between what different members are
28 See, e.g., NYSE pricing schedule, supra note 15
(offering incremental per share discounts on

pricing exacerbates that conflict because
market-at-the-close orders depending on a the benefit to the member increases as 31 See supra note 6. See also 15 U.S.C.
member’s average daily trading volume that added the number of orders it executes on the 78s(b)(3)(C).
32 See John Ramsay, Chief Market Policy Officer,
liquidity to NYSE during the billing month as a exchange increases, and for the highest
percentage of CADV). According to NYSE, the IEX, Why Exchange Rebate Tiers are Anti-
proposed discounts were designed ‘‘to align
tier it meets during a month, the Competitive (June 5, 2023), available at https://
incentives among both trading on the close and member receives that higher rebate or www.iex.io/article/why-exchange-rebate-tiers-are-
intraday trading on the Exchange.’’ See Securities lower fee on all of its orders that it anti-competitive (‘‘Ramsay Article’’) (stating that
Exchange Act Release No. 94543 (Mar. 19, 2022), 87 some ‘‘exchanges offer specialized ‘bespoke’
executed on that exchange during the
FR 19544 at 19543 (Apr. 4, 2022). The NYSE further volume tiers with formulas that are so specific, they
stated ‘‘that other marketplaces provide discounts month. Finally, the Commission is can appear to be specifically designed to benefit one
based on intraday adding volume, and that aligning concerned that tiered pricing may or a few firms, and it is widely assumed that some
incentives for lower pricing at the close with impose a burden on exchange are’’ (citation omitted) and that ‘‘tailored-tier rates
additional intraday volume is thus neither novel seems to have the effect, if not the purpose, of
competition, especially when exchanges allowing the highest-volume firms that already have
nor an unreasonable stance in a competitive
marketplace.’’ Id. at 19546. base pricing for an auction, trading a competitive edge to keep it’’). See id. See also
29 While the proposed rule addresses only NMS infra Table 2.
stocks, the Commission is requesting comment 30 See supra notes 8–10 and accompanying text 33 See supra note 26 and accompanying text. See
below on whether the proposal should be applied (discussing the Exchange Act principles applicable also infra section IV.B.1.b, Volume-Based Pricing
to options. to exchange pricing proposals). Tiers.
assessed can be large, and the apply to different members engaged in range of each exchange’s basic volume-
cumulative effect may quickly add up the same activity, Table 1 shows the based transaction tiers applicable during
across the billions of shares executed primary pricing model for each equities regular trading hours.34
each trading day. To show the range of exchange and presents a general
individual tiered transaction fees that summary of the number and dollar
TABLE 1—SUMMARY OF TRANSACTION-BASED PRICING SCHEDULES FOR DISPLAYED/REGULAR ORDERS ON EQUITIES

EXCHANGES DURING REGULAR TRADING HOURS AS OF MAR. 2023
Fees and rebates for transactions at or above $1.00 on Tapes A, B & C *
Exchange Pricing model Fees (# of categories) Rebates (# of categories)
Cboe BZX .................... Maker-Taker ............... $0.0030 (Tapes A, B & C—1 each) ............... ($0.0016)–($0.0031) (Tapes A, B & C—7
each).
Cboe BYX .................... Taker-Maker ............... $0.0012–$0.0020 (Tapes A, B & C—6 each) ($0.0002)–($0.0015) (Tapes A, B & C—2
each).
Cboe EDGA ................. Taker-Maker ............... $0.0015–$0.0030 (Tapes A, B & C—4 each) ($0.0016)–($0.0022) (Tapes A, B & C—3
each).
Cboe EDGX ................. Maker-Taker ............... $0.00275–$0.0030 (Tapes A, B & C—2 each) ($0.0016)–($0.0029) (Tapes A, B & C—4
each).
BX ................................ Taker-Maker/Flat ........ $0.0012–$0.0030 (Tapes A, B & C—5 each) ($0.0004)–($0.0018) ** (Tapes A, B & C—5
each).
Phlx (PSX) ................... Maker-Taker ............... $0.0030 (Tapes A, B & C—1 each) ............... ($0.0020)–($0.0032) (Tapes A, B & C—2
each).
Nasdaq ........................ Maker-Taker ............... $0.0030 (Tapes A, B & C—1 each) ............... ($0.0013)–($0.00305) (Tapes A, B & C—11
each).
NYSE Arca .................. Maker-Taker ............... $0.0029–$0.0030 (Tape A—1, Tapes B & ($0.0016)–($0.0034) (Tape A—7, Tapes B &
C—2 each). C—10 each).
NYSE American .......... Maker-Taker ............... $0.0026–$0.0030 (Tapes A, B & C—3 each) ($0.0020)–($0.0026) (Tapes A, B & C—3
each).
NYSE ........................... Maker-Taker ............... $0.0026–$0.0030 (Tapes A & B—1 each, ($0.0012)–($0.0031) (Tape A—2, Tape B—4
Tape C—3). & Tape C—5).
NYSE National ............ Taker-Maker ............... $0.0020–$0.0029 (Tapes A, B & C—5 each) $0.000–($0.0030) (Tapes A, B & C—5 each).
NYSE Chicago ............ Flat ............................. $0.0010 (Tapes A, B & C—1 each) ............... $0.00 (0).
IEX ............................... Flat ............................. $0.0009 (Tapes A, B & C—1 each) ............... $0.000 (0).
MEMX .......................... Maker-Taker ............... $0.0029–$0.0030 (Tapes A, B & C—3 each) ($0.0018)—($0.00335) (Tapes A, B & C—5
each).
MIAX Pearl .................. Maker-Taker ............... $0.00275–$0.00295 (Tapes A, B & C—3 ($0.0029)–($0.0036) (Tapes A, B & C—4
each). each).
LTSE ............................ Free ............................ $0.0000 (0) ...................................................... $0.0000 (0).
* Table 1 reflects that, as of Mar. 2023, some exchanges apply fees and rebates according to the market data Tape on which a security is dis-
seminated, which is based on the security’s primary listing exchange. Tape A is for securities listed on NYSE, Tape B is for securities listed on
exchanges other than NYSE and Nasdaq, and Tape C is for securities listed on Nasdaq.
** BX charges a $0.0007 fee for Tapes A, B and C if a member fails to reach any liquidity removing rebate tier.
Volume-based exchange transaction executed in the opening or closing TABLE 2—COUNT OF TRANSACTION
pricing is more complicated and varied auction. To show the complexity of PRICING LEVELS THAT ARE BASED
than what is presented in Table 1. For volume-based exchange transaction ON VOLUME FOR EXECUTIONS AT OR
example, many exchanges also offer pricing, Table 2 identifies the number of ABOVE $1 AS OF MAR. 2023
additional step-up tiers that increase the volume-based pricing levels each
amount of rebates offered, as well as exchange offers.35 Volume-based
specific tiering programs for registered Exchange pricing
market-maker activity, selected order levels
types that an exchange seeks to
incentivize, or special programs like NYSE .................................... 93
retail liquidity programs. Fees also may Nasdaq ................................. 74
vary depending on whether an order is NYSE Arca ........................... 72
displayable or non-displayed or is Cboe BZX ............................. 26
34 The fees and rebates shown in Table 1 are equities). Table 1 also excludes fees and rebates tied 35 Table 2 counts separately listed fee or rebate
derived from the exchanges’ Mar. 2023 pricing to increased volume compared to a specific date levels that are based on the achievement of a
schedules. See supra note 15. Table 1 shows only because those additive rebates are not generally specified volume level and assessed on a per share
the generally available core pricing tiers, meaning available pricing tiers. Moreover, the dollar ranges basis. Additive rebates or other incentives were
it excludes fees and rebates applicable to special in Table 1 do not net together additive fees or only counted once and not added together and
activities that may not apply to every member: rebates and count them as a separate tier (e.g.,
counted separately with each applicable base price.
orders not executed on the exchange (i.e., routed to where a base rebate could be combined with a step-
Different Tapes with differing fees or rebates were
an away exchange); executions resulting from an up additive rebate) because those are in addition to
auction or specific order types (e.g., closing other tiers and the exchanges do not identify them counted separately, but Tapes with the same fee or
auctions or retail liquidity program order types or as separate named tiers. Further, the number of rebate were not counted separately. Different fees
non-displayed order types); incentives for specific categories is a count of those separately listed fees for separate order types that reference the same
purposes (e.g., setting the best bid or offer price); or rebates used in determining the range of an volume level were counted separately. Base fees
registered market-maker incentives; non-rebate exchange’s basic fees or rebates for purposes of and rebates that are not based on volume were not
incentives; and cross-asset tiers (options versus Table 1. counted.
TABLE 2—COUNT OF TRANSACTION Members at the best exchange pricing typically do not pass along the entirety
PRICING LEVELS THAT ARE BASED tiers can further widen the competitive of their transaction pricing advantage to
ON VOLUME FOR EXECUTIONS AT OR gap by using their tiered pricing their sponsored broker-dealer customers
ABOVE $1 AS OF MAR. 2023—Con- advantage to sell sponsored access 37 (thereby maintaining the sponsoring
and direct market access 38 services to members’ exchange transaction pricing
tinued customers (including other member and advantage). As a result, the sponsoring
Volume-based non-member broker-dealers with whom
members’ broker-dealer customers
Exchange pricing they compete as well as any other depend on using the services of their
levels customer that wants direct access to an competitors—the sponsoring members—
exchange), through which the customer to access any advantaged exchange
BX ......................................... 20 (including other broker-dealers) uses the transaction pricing their competitors are
Cboe EDGX .......................... 19 sponsoring member’s systems and able to obtain through these access
MEMX ................................... 13 arrangements, which the sponsored
Cboe BYX ............................. 11
connectivity to access an exchange. The
broker-dealer customers could not
NYSE National ...................... 11 sponsoring member benefits by being
NYSE American .................... 10 able to count the volume from its obtain on their own. The extent to
Cboe EDGA .......................... 8 sponsored customers toward its own which any such pass-through
MIAX Pearl ........................... 8 volume tiers, which can benefit the transaction pricing is provided to
Phlx (PSX) ............................ 4 sponsored customers if they receive sponsored customers is uncertain
IEX ........................................ 0 better pass-through pricing or lower because these arrangements are not
LTSE ..................................... 0 commissions as a result, as well as the disclosed.41
NYSE Chicago ...................... 0 sponsoring member’s proprietary
2. Conflicts of Interest
trading business that also receives that
Unless the terms of the pricing tier better transaction pricing.39 In turn, if With respect to agency brokerage
provide otherwise, a member’s customer the sponsored customer receives pass- activity, where the member transacts on
volume and its proprietary orders through pricing from the sponsoring an exchange for purposes of filling an
typically are combined for purposes of member, the sponsored customer may order for another person, the
determining whether the member be able to share in part of the sponsoring Commission is concerned that volume-
qualifies for a volume tier. Once a member’s advantaged pricing (subject to based exchange transaction pricing
member attains a volume tier, the the fees or mark-up it pays to the exacerbates a conflict of interest
pricing advantage it receives from between the member and its customer.42
sponsoring member for the services),
reaching that volume tier may turn into Specifically, when the member executes
which can result in the sponsored
a competitive advantage in two ways. 36 an agency order, it faces an economic
customer paying lower exchange fees or
First, the member can use the incentive to route the order to one
earning higher exchange rebates than if
advantaged pricing it receives to benefit it executed transactions on the exchange particular exchange over others to
its proprietary trading business (i.e., it achieve volume tier requirements on
directly.40 These private arrangements
may pay lower fees or receive higher that exchange that could result in
between a sponsoring member and its
rebates on that business compared to reduced fees or increased rebates (and,
sponsored customer, however, work to
other members that do not qualify for in both cases, the member would retain
further entrench the competitive
the favorable pricing tier). Second, the some or all of the benefit for itself if it
advantage that exchange pricing tiers
member may be able to attract does not pass through that better
provide to high-volume members
additional order flow from customers exchange transaction pricing to its
because, as the Commission
because it can offer customers the same customer).43
understands, sponsoring members
lower fees and higher rebates either While exchange fees and rebates in
directly through pass-through exchange 37 Sponsored access generally refers to an
general may contribute to a conflict of
transaction pricing or indirectly through arrangement whereby a member permits a customer interest between a member and its
lower commissions. This would allow to route orders directly to an exchange using customer when routing orders, volume-
the member to further increase and technology supplied by the customer that bypasses based fees and rebates can exacerbate
the member’s trading system but not its market
consolidate customer order flow, which access checks. See Rule 15c3–5 Adopting Release, that conflict because they present an
in turn would help the member reach supra note 22, at 69793 (describing sponsored additional economic incentive to
and maintain higher tiers. The gap in access as ‘‘referring to an arrangement whereby a
transaction pricing between base fees broker-dealer permits customers to enter orders into 41 See infra section IV.B.4.b.
a trading center that bypass the broker-dealer’s 42 While some rules may seek to address conflicts
and rebates and top-tier fees and rebates trading system and are routed directly to a trading
of interest in the context of agency brokerage
can make it more difficult for new and center . . .’’). activity, this proposal seeks to mitigate the conflict
lower-volume members to compete, 38 Generally, direct market access refers to an
specific to volume-based exchange transaction
putting both their proprietary and arrangement whereby a member permits a customer pricing at its source through the proposed
to use its trading systems to send orders directly to prohibition. See, e.g., Securities Exchange Act
customer business at a competitive a trading center. See id. at 69793 (describing direct Release No. 96496 (Dec. 14, 2022), 88 FR 5440 (Jan.
disadvantage. market access as an ‘‘arrangement whereby a 27, 2023) (‘‘Regulation Best Execution Proposing
broker-dealer permits customers to enter orders into Release’’). The Commission encourages commenters
36 See Healthy Markets Letter, supra note 21, at a trading center but such orders flow through the to review the Regulation Best Execution Proposing
5–6 (stating that pricing tiers ‘‘offer cheaper trading broker-dealer’s trading systems prior to reaching the Release to determine whether it might affect their
for larger firms with greater order volumes [which] trading center’’). comments on this release.
39 See, e.g., id. at 69793 n. 11 (stating that
puts smaller firms at a competitive disadvantage on 43 Customers could benefit from exchange tiered
order and execution prices’’ and further stating that ‘‘[e]xchange members may use access arrangements pricing if members pass some or all of the savings
as a consequence, ‘‘several larger trading firms will as a means to aggregate order flow from multiple through to the customers either directly or in the
then use their lower rates to attract greater order market participants under one MPID to achieve form of lower commissions or other subsidies. See
flow—consolidating order flow at the largest trading higher transaction volume and thereby qualify for also Access Fee Proposal, supra note 17 (proposing,
firms’’ and as ‘‘order flow has aggregated to the more favorable pricing tiers’’). among other things, revisions to the access fee cap
largest firms, this has increased their ability to 40 See id. at 69793 (discussing, in part, how direct in 17 CFR 242.610 (Rule 610 of Regulation NMS)).
garner for themselves even better rates; further market access or sponsored access arrangements The Commission encourages commenters to review
expanding the gap between themselves and smaller may help to reduce certain costs such as exchange the Access Fee Proposal to determine whether it
firms’’). fees). See also infra section IV.B.4. might affect their comments on this release.
members when selecting an exchange 3. Exchange Competition transaction pricing in connection with
for routing: the member’s desire to reach An exchange’s volume-based the execution of agency or riskless
volume tiers on an exchange to achieve transaction pricing schedule is designed principal orders in NMS stocks
preferential pricing. Specifically, to entice members to route orders to that (‘‘agency-related volume’’).48 The
volume-based pricing may incentivize exchange over other exchanges by proposed rule would not prohibit
members to route customer order flow lowering fees or increasing rebates as exchanges from offering volume-based
to certain exchanges for the purpose of volume-based transaction tiers are met. exchange transaction pricing for
meeting tier qualification, which has the Pricing tiers that are based on total member proprietary volume where the
potential to be costly to customers if it consolidated volume may create member is trading solely for its own
comes at the expense of execution additional incentives for members to account and not in connection with
quality. Moreover, this incentive may be route to certain exchanges, particularly filling an order for a customer.49
particularly enticing for members towards the end of each month as
Second, the proposed rule contains an
because customer volume can accrue members seek to achieve tier targets to
qualify for a better pricing tier on that anti-evasion clause that would require
towards the member’s total volume equities exchanges that have volume-
level, giving it the ability to achieve exchange. This dynamic may harm the
ability of other exchanges to compete for based transaction pricing for member
more favorable tiered pricing for all of proprietary volume to adopt rules to
order flow during that time.
its order flow, including proprietary Further, certain forms of exchange require members to engage in practices
orders that the member sends to the transaction pricing tiers can raise that facilitate the exchange’s ability to
exchange for its own account. The fact unique issues and concerns. For comply with the prohibition on volume-
that volume-based exchange transaction example, if a primary listing exchange based exchange transaction pricing in
pricing applies to both agency-related for a stock were to base its closing connection with the execution of
and proprietary order flow even further auction pricing on the volume a member agency-related volume.50 The proposed
exacerbates the conflict of interest executes during regular trading hours rule also would require exchanges to
between a member and its customer outside of the auction, members that establish, maintain, and enforce written
because the routing decisions a member send customer orders in that stock to the policies and procedures that are
makes with respect to its agency-related primary listing exchange’s closing reasonably designed to detect and deter
order flow can also benefit its unrelated auction may be incentivized to also members from receiving volume-based
proprietary business. Finally, it may be route to the exchange during regular exchange transaction pricing in
challenging for customers to understand hours to qualify for tiered pricing in the connection with the execution of agency
and assess the impact that tiered closing auction.46 In this scenario, the
or riskless principal orders in NMS
exchange pricing may have on broker- exchange is leveraging its role as the
stocks.51 This requirement would help
dealer routing decisions due to the primary listing exchange for a stock, in
addition to the closing auction it to promote an exchange’s compliance
complexity of the exchanges’ tiered with the proposed rule by ensuring that
pricing schedules, which makes it provides for that stock, to use members’
desire to achieve tiered pricing in the an exchange develops mechanisms that
difficult for customers to provide a would prevent its members from
closing auction as an incentive for those
check against any conflicts of interest.44 inappropriately receiving volume-based
members to also route to the exchange
Accordingly, the economic incentive during the regular trading session.
presented by tiered exchange Accordingly, the Commission is 48 See proposed Rule 6b–1(a).
transaction pricing may affect members’ concerned about the potential for 49 See infra section IV.E.1 and 2 (proposing
order routing decisions, exacerbating a exchanges to use some forms of volume- alternatives that would prohibit exchanges from
conflict of interest that can potentially offering volume-based exchange transaction pricing
based exchange transaction pricing to for member proprietary volume).
harm investors with inferior executions insulate certain portions of member 50 See proposed Rule 6b–1(b)(1). Exchanges
when members route customer orders to volume from competition while at the would have flexibility under the proposed rule as
exchanges.45 same time over-emphasizing to what rules to adopt. For example, an exchange
competition based on fee tiering, which may allow members to designate that certain of
their ports or sessions handle exclusively agency-
44 See Healthy Markets Letter, supra note 21, at can constrain innovation among related orders or exclusively proprietary orders as
4 (‘‘The inherent conflict of interest created by exchanges in other areas and impose a a means to facilitate the exchange’s ability to
different pricing tiers may also impact how brokers burden on competition among comply with the prohibition. If the member does
treat their own customers in a way that isn’t quite not use separate ports in that manner, the exchange
as transparent as simply chasing the higher rebate
exchanges that may be inconsistent with
could require members to indicate for billing
or lower fee venue. For example, a broker with a the goals of a national market system. purposes which orders are agency-related and
less-sophisticated customer may send orders to a ineligible for tiered pricing if the exchange does not
venue so that the firm would reach a certain tier II. Description of Proposed Rule
already have a mechanism to distinguish those
threshold, despite the broker’s awareness that A. Overview of Proposed Rule orders. Or, if a member does not conduct an agency
executions on that venue may result in inferior business and only trades proprietarily or does not
execution outcomes to investors. However, the The Commission is proposing a rule trade proprietarily and only trades on an agency
same broker, if faced with the same order from a designed to address its specific concerns basis, an exchange may not need to require
more-sophisticated customer, may not.’’). See also anything additional from that member for purposes
Recommendation of the SEC Investor Advisory
with volume-based exchange
of this proposed rule.
Committee Regarding Exchange Rebate Tier transaction pricing schedules.47 51 See proposed Rule 6b–1(b)(2). For example, if
Disclosure (Jan. 24, 2020), available at https:// Proposed Rule 6b–1 has three an exchange allows members to designate that
www.sec.gov/spotlight/investor-advisory- components. First, the proposed rule certain of their ports or sessions handle exclusively
committee-2012/exchange-rebate-tier- would prohibit equities exchanges from agency-related orders or exclusively proprietary
disclosure.pdf. In the recommendation, the Investor orders as a means to facilitate the exchange’s ability
Advisory Committee stated that ‘‘[t]he lack of offering volume-based exchange to comply with the prohibition, an exchange might
public disclosure concerning the structure of adopt a policy and procedure to review the ports
rebates for executing brokers’’ exacerbates ‘‘a 46 See also infra section IV.B.1.c. and sessions designated by members to make sure
principle-agency conflict in the receipt of rebates 47 The proposed rule would provide a consistent that members are not, for example, submitting
for orders executed on behalf of clients but not approach to these issues, which the Commission agency-related orders though a port or session the
shared with clients.’’ could not achieve through piecemeal suspensions member has designated as solely for proprietary
45 See infra section IV.B.3. of individual exchange pricing filings. orders.
exchange transaction pricing for agency- proposed new tier or amended tier. In The proposed prohibition would
related orders.52 addition, such information would apply broadly to all executions where a
Third, the proposed rule would provide a data point for the Commission member is executing an agency or
require equities exchanges that have to consider in determining whether a riskless principal order in an NMS stock
volume-based transaction pricing for proposed tier meets the applicable for the purpose of filling a customer
member proprietary volume to submit statutory standards and whether the order and is not trading for its own
electronically to the Commission Commission should temporarily account. For purposes of the proposed
disclosures of the number of members suspend the newly adopted pricing tier. rule, customers could include, for
that qualify for their volume-based example, other members, non-member
transaction pricing.53 Specifically, such B. Prohibition on Volume-Based
broker-dealers, institutions, an affiliate
exchanges would be required to submit Exchange Transaction Pricing for
of the member, natural persons, or any
electronic, machine-readable structured Agency-Related Volume
person that uses the member to access
data tables of their volume-based The Commission is concerned about an exchange, including through direct
transaction pricing tiers and the number the impact of exchange tiered market access or sponsored access
of members that qualify for each tier in transaction pricing on competition services.
an Interactive Data File in accordance among an exchange’s members. As The proposed rule would define
with 17 CFR 232.405 (Rule 405 of discussed above, volume-based riskless principal to mean ‘‘a transaction
Regulation S–T),54 and the public would exchange transaction pricing can in which, after having received an order
be able to access those disclosures frustrate and impede the ability of new to buy from a customer, the broker or
through the Commission’s EDGAR and lower-volume members to compete dealer purchased the security from
system.55 Additional public with high-volume members, including another person to offset a
transparency regarding the number of for customer order flow, which can contemporaneous sale to such customer
members that qualify for each pricing reduce the number of members that are or, after having received an order to sell
tier for their proprietary volume would able to offer customers the highest-tiers from a customer, the broker or dealer
help the Commission, members, and the of exchange transaction pricing.56 For sold the security to another person to
public understand how the benefits of example, if a member that qualifies for offset a contemporaneous purchase from
volume-based pricing are distributed the best pricing tier can offer a customer such customer.’’ That definition is
and the potential impact on members, pass-through of its $0.0015 take fee for consistent with other Commission
which should facilitate and inform executing on Exchange A, but a member definitions of the term.59
members’, the public’s, and other that does not qualify for a tier can only
exchanges’ efforts to submit comment offer a customer pass-through of its would need to file a proposed rule change on Form
letters on volume-based exchange $0.0030 take fee on that same exchange 19b–4 to remove any such pricing from its pricing
schedule.
transaction pricing proposals to further for execution of the same customer 59 See, e.g., 17 CFR 240.3a5–1(b) (exempting
inform the Commission as it considers order, the lower-volume member faces a banks from the definition of ‘‘dealer’’ under the
those proposals. For example, distinct and measurable disadvantage Exchange Act when acting in a riskless principal
information on the number of members even though both are members of capacity when certain conditions are met, which
that have qualified for a newly adopted states that ‘‘[f]or purposes of this section, the term
Exchange A. The Commission also is riskless principal transaction means a transaction in
pricing tier would allow the concerned that volume-based exchange which, after having received an order to buy from
Commission and interested parties to transaction pricing that applies to a customer, the bank purchased the security from
assess exchange statements regarding agency-related volume exacerbates a another person to offset a contemporaneous sale to
the number of members that the such customer or, after having received an order to
conflict of interest between members sell from a customer, the bank sold the security to
exchange estimated should qualify for a and their customers when members face another person to offset a contemporaneous
an economic incentive to earn purchase from such customer.’’); 17 CFR 240.3a5–
52 See, e.g., section 6(b)(1) of the Exchange Act,
increasingly lower fees or higher rebates 2 (exemption from the definition of ‘‘dealer’’ for
15 U.S.C. 78f(b)(1) (requiring an exchange to be so banks effecting transactions in securities issued
organized and have the capacity ‘‘to be able to carry
or other incentives from an exchange in pursuant to Regulation S); 17 CFR 255.6(c)(2) (other
out the purposes of [the Exchange Act] and to connection with the execution of more permitted proprietary trading activities); 17 CFR
comply, and . . . to enforce compliance by its customer orders on that exchange.57 240.31(a)(14) (Section 31 transaction fees); 17 CFR
members and persons associated with its members Accordingly, to address the 230.144A(a)(5) (private resales of securities to
with the provisions of [the Exchange Act], the rules institutions); and 17 CFR 230.144 (persons deemed
and regulations thereunder, and the rules of the
Commission’s concerns with member
not to be engaged in a distribution and therefore not
exchange’’). competition, as well as the conflict of underwriters) (defining the term ‘‘riskless principal
53 See proposed Rule 6b–1(c). Consistent with the interest between members and their transaction’’ generally without reference to price,
proposed disclosure requirement, the Commission customers, the prohibition on volume- but further providing in 17 CFR 230.144(f)(1)(iii)
also is proposing to amend 17 CFR 232.101 (Rule based exchange transaction pricing in the possible manners of sale, one of which is a
101 of Regulation S–T) to add the disclosure riskless principal transaction where the offsetting
required under proposed Rule 6b–1(c) as a filing proposed Rule 6b–1(a) would apply to trades are executed at the same price). Generally,
that must be submitted electronically. agency-related volume. Specifically, the the exchanges use the terms ‘‘agency’’ and ‘‘riskless
54 See proposed 17 CFR 232.405(b)(6). Rule 405
proposed rule would prohibit exchanges principal’’ in their rules without defining them
of Regulation S–T applies to the submission of from offering volume-based transaction because the terms are widely and commonly
Interactive Data Files. The Commission is proposing understood. For example, Cboe BZX refers to the
conforming changes in Rule 405 of Regulation S– fees, rebates, or other incentives in terms ‘‘agency’’ and ‘‘riskless principal’’ 12 times
T to reflect the inclusion of proposed Rule 6b–1(c). connection with the execution of agency each in its rulebook (covering equities and options
Such files must be submitted using Inline XBRL. or riskless principal orders in NMS rules), but does not separately define either term,
See proposed 17 CFR 232.405(a)(3). The stocks.58 except with respect to retail orders under its Retail
Commission also is proposing conforming changes Order Attribution Program. See Cboe BZX Rule
to Rule 101 of Regulation S–T to reflect the 11.25(a)(2) (retail order attribution program,
56 See supra sections I.B (Volume-Based
inclusion of proposed Rule 6b–1. See proposed 17 referring to a ‘‘riskless principal order that meets
CFR 232.101. Exchange Transaction Pricing), and I.C.1 the criteria of FINRA Rule 5320.03’’). Moreover,
55 As discussed below in section II.D, Request for (Competition Among Members). each of the exchange rules that implement the
57 See supra section I.C.2 (Conflicts of Interest).
Comments, the Commission is soliciting comment Consolidated Audit Trail, which requires the
on other potential metrics for the disclosures, 58 To comply with the prohibition, an exchange capture of the capacity of the member executing the
including the volume of shares at each tier and the that offers volume-based transaction fees, rebates, or order, whether principal, agency, or riskless
dollar amount of fees, rebates, or other incentives other incentives in connection with the execution principal, uses those terms in an identical manner
at each tier. of agency or riskless principal orders in NMS stocks Continued
Like agency orders, riskless principal had the defining characteristics of a exacerbated by exchange tiered pricing
orders are one way for a member to fill riskless principal trade because the where the member economically
a customer’s order. Riskless principal member did not take on the market risk benefits from its choice of exchange
orders involve contemporaneous buys of price moves in the stock and execution venue for customer orders.
and sells that are ‘‘riskless’’ to the promptly transferred the position to the The proposed rule would eliminate one
member, in that the member does not customer. A definition that includes the incentive—reaching a volume tier—for a
take on the market risk of price moves concept of ‘‘same price’’ therefore member to route a customer order to a
in the stock because it buys or sells to would not achieve the Commission’s particular exchange when doing so
promptly transfer the position to a goals of prohibiting volume-based might not be in the customer’s interest.
customer rather than retain the position exchange transaction pricing for agency-
for any significant length of time in its related volume. Request for Comments
own account. Because orders executed in the The Commission generally requests
Some rules, in contexts other than capacity of agent and riskless principal comment from the public on all aspects
exchange transaction pricing, include both are done to fill a customer order, of proposed Rule 6b–1(a), including its
definitions of the term ‘‘riskless the conflict of interest exacerbated by objectives and its terms to achieve those
principal’’ that require the price of both exchange tiered transaction pricing is objectives. More specific requests for
legs of the riskless principal trade be at equally present for both: the member comment are set forth below. As much
the same price.60 In addition, FINRA faces conflicting economic incentives as possible, commenters are requested
has a definition of riskless principal that when choosing the exchange execution to provide empirical data in support of
specifies that the member’s principal venue, and the customer bears any costs any arguments or analyses and to offer
trade and the customer fill occur at the associated with an execution that results explanations for their views.
‘‘same price.’’ 61 from that decision. The Commission 1. Do commenters believe that
The definition of riskless principal in therefore proposes to treat riskless volume-based exchange transaction
proposed Rule 6b–1 does not require the principal orders the same as agency pricing impacts competition among
principal leg and customer leg to occur orders for purposes of proposed Rule members when competing for customers
at the same price. Proposed Rule 6b–1 6b–1(a). on an agency basis? Do sponsored
uses a broader definition of riskless Finally, because proposed Rule 6b–
access and direct market access
principal to achieve the purposes of the 1(a) would prohibit exchanges from
arrangements contribute to these
proposed rule and to limit the ability of offering volume-based transaction
competitive effects when exchange
members to easily circumvent the pricing in connection with the
members compete for customers? Why
proposed rule’s prohibition by an execution of agency or riskless principal
or why not? Does volume-based
economically insignificant amount. For orders in NMS stocks, which represent
a member’s agency-related volume, it exchange transaction pricing impact
example, if the proposed rule contained competition among members when
a ‘‘same price’’ requirement in the would prohibit exchanges from
counting that agency-related volume trading proprietarily? If there is an
definition of riskless principal, a impact, is the impact greater for
member might attempt to circumvent towards any volume-based transaction
tiers applicable to the member’s members when they are competing for
the prohibition by providing an customers or when they are trading
economically insignificant different proprietary volume. For example, if a
member is engaged in proprietary proprietarily, or is the impact
price on the customer leg—one that equivalent?
varied by the smallest fraction of a trading (e.g., as a registered market
maker on the exchange) and also has a 2. Do commenters believe that
penny possible—to avoid classifying the
separate division or affiliate that is volume-based exchange transaction
transaction as ‘‘riskless principal.’’ If
engaged in a customer brokerage pricing exacerbates the conflict of
proposed Rule 6b–1 excluded such a
business (e.g., as an executing broker for interest between members and
transaction from its definition of riskless
non-member brokers), an exchange customers when members are routing
principal, the member would qualify for
could not count the member’s agency- customer orders, because of the
volume-based exchange transaction
related volume towards any volume- member’s desire to qualify for volume-
pricing on the principal leg of the
based transaction tiers the member based transaction tiers? Would complete
transaction even though the transaction
qualifies for on its proprietary volume. pass through of exchange pricing to the
without defining them. See, e.g., Nasdaq General 7, Similarly, because the proposal would member’s customer eliminate that
Section 3(a)(1)(E)(iv); BZX Rule 4.7(a)(1)(E)(iv). See prohibit volume-based exchange conflict? Why or why not? To what
also Limited Liability Company Agreement of transaction pricing in connection with extent do members completely or
Consolidated Audit Trail, LLC, Article VI, Section the execution of agency or riskless partially pass through all exchange
6.3(d)(v)(D). Those terms also are not defined
within the CAT NMS Plan. principal orders in NMS stocks, it pricing to their customer? Do customers
60 See, e.g., 17 CFR 242.201(a)(8) (concerning would prohibit exchanges from basing prefer pass through exchange
‘‘short exempt’’ order marking for certain riskless transaction pricing in an auction on transaction pricing or broker
principal orders) and 17 CFR 240.10b–18 agency-related volume executed within commissions, and for what reasons? Is
(purchases of certain equity securities by the issuer the Commission’s understanding correct
and others).
or outside the auction. In either case, an
61 See, e.g., FINRA Rule 5320.03 (excluding exchange could count only the that full and partial pass-through of
riskless principal transactions from FINRA’s member’s proprietary volume to exchange transaction pricing by
Prohibition Against Trading Ahead of Customer determine the pricing tier for the members to their customers is less
Orders) and FINRA Rule 6380B(d)(3)(B) (concerning member’s proprietary trades. common? For sponsored access and
reporting to the FINRA/NYSE Trade Reporting
Facility). The FINRA rule prohibiting trading ahead
Prohibiting volume-based exchange direct market access arrangements, how
of customer orders generally prohibits members transaction pricing for agency-related common is pass-through of exchange
from trading for their own account at a price that orders is intended to promote transaction fees? What types of pass-
would satisfy the customer order, subject to an competition among members for through arrangements are most common
exception for riskless principal orders. Exchanges
have incorporated FINRA’s rule by reference or
customer business. It also is intended to and how much does the sponsoring
have adopted similar rules. See, e.g., FINRA Rule mitigate the conflict of interest between member typically retain as
5320.03 and BZX Rule 12.6.03. members and customers that is compensation?
3. To what extent does volume-based 9. Is the proposed definition of orders from exchange registered market
exchange transaction pricing impact riskless principal in proposed Rule 6b– makers in their registered or appointed
competition among exchanges, and/or 1(a) appropriate? Why or why not? If the symbols? 63 Should such an exception
between exchanges and off-exchange definition included a ‘‘same price’’ be limited to registered exchange market
venues, such as alternative trading requirement, do commenters agree that makers that are subject to minimum
systems (‘‘ATSs’’) and wholesaler the Commission would not be able to quantitative and qualitative quotation
broker-dealers? achieve its objectives for the proposed requirements that meet or exceed the
4. To what extent is volume-based rule? Why or why not? highest such standards in place among
exchange transaction pricing used by 10. Do exchanges have rules and national securities exchanges to avoid
exchanges to attract specific types of policies and procedures in place that conferring a benefit without meaningful
members or customers of members, such require members to mark their orders for corresponding obligations that protect
as proprietary traders, registered market transaction billing purposes in a manner investors? Would continuing to allow
makers, or agency customers? Among that would readily allow exchanges to volume-based exchange transaction
agency customers, are any particular comply with the proposed prohibition, pricing for displayed liquidity-adding
types of customers particularly attracted or would those rules and policies and orders from such exchange registered
by volume-based exchange transaction procedures need to be revised to market-makers in their registered or
pricing, such as long-term investors, accommodate the proposed prohibition? appointed symbols be an appropriate
short-term traders, investment advisers, 11. Should the Commission also benefit to encourage members to become
and institutional investors? prohibit volume-based exchange and remain registered market makers
5. To what extent is the ability of an transaction pricing for member and to provide publicly displayed
exchange to attract order flow from proprietary volume (i.e., should the quotes, consistent with their quoting
specific types of members or customers Commission prohibit exchanges from obligations? Would tiered pricing
through volume-based exchange offering volume-based transaction encourage greater quoted depth or
pricing for all volume in NMS narrower quoted spreads, or both, for
transaction pricing or other forms of
stocks)? 62 Why or why not? Would displayed quotes? If the Commission
targeted pricing necessary to support
doing so obviate the need for the anti- adopted a broader prohibition on
competition between exchanges and off-
evasion provisions in proposed Rule volume-based transaction pricing with a
exchange venues? For example, if
6b–1(b) and the proposed disclosures in carve-out for registered market makers,
exchanges lack the ability to offer such
proposed Rule 6b–1(c) since tiered would the anti-evasion provisions in
pricing on agency-related order flow,
pricing would no longer be permitted? proposed Rule 6b–1(b) and the
could that potentially make off-
Would a broader prohibition that transparency disclosures in proposed
exchange venues relatively more
includes both agency-related and Rule 6b–1(c) be less relevant in
attractive as a destination for that flow?
proprietary orders address the circumstances where the only reportable
If so, should the Commission address
Commission’s concerns, discussed activity would be the activity of
such a competitive disparity? For above in section I.C, about competition
example, should the Commission registered market makers who are
among members and competition among subject to exchange market making
expand the scope of the prohibition on exchanges, as well as the conflict of
volume-based transaction pricing for rules?
interest between members and 13. Instead of prohibiting volume-
agency-related volume in certain stocks customers with respect to agency- based exchange transaction pricing,
to off-exchange venues such as ATSs? related order flow? How would a should the Commission instead allow
6. How consistently do individual broader prohibition affect exchange fees exchanges to offer volume-based pricing
exchange members hit specific tiers over and rebates compared to what they offer to attract order flow, but require the
time? How do members respond to today? Would exchanges be able to volume tiers to be based on total
volume-based exchange transaction extend their best fee and rebate pricing aggregate volume submitted to the
pricing changes and how do those to all members? Why or why not? If not, exchange, with the associated tiered
member responses differ across different and if the purpose of tiered transaction pricing applied to all members
exchanges? pricing is to attract more order flow uniformly? For example, an exchange
7. How does using volume-based from members, why would exchanges could establish a volume-based pricing
exchange transaction pricing as a means not be able to offer the best pricing to tier that considers cumulative exchange-
of compensating liquidity providers all members to attract the greatest level liquidity-adding activity, where all
compare to other fee and non-fee possible volume? liquidity-adding volume executions
methods of attracting those liquidity 12. If the Commission extends the from all members is combined to count
providers? Do exchange-registered prohibition on volume-based exchange towards the tier, and, after a tier
market makers react differently from transaction pricing to member threshold is reached, the enhanced
other members that provide liquidity to proprietary volume, should displayed rebate would be available to all
exchange transaction pricing? Does liquidity-adding orders from an members equally. Would this alternative
volume-based exchange transaction exchange’s registered market makers in address the Commission’s concerns
pricing affect liquidity taking orders their registered or appointed symbols regarding competition among members?
differently from liquidity providing not be subject to the prohibition in order Would it impose a burden on
orders? to provide exchanges with a means to competition among exchanges and a
8. Would the proposed prohibition on incentivize displayed quotes from their conflict of interest between members
volume-based exchange transaction registered market makers? In other and customers when routing customer
pricing in connection with the words, should the Commission prohibit orders because of the incentives to reach
execution of agency or riskless principal exchanges from offering volume-based tiers? Would that burden and conflict be
orders in NMS stocks address the transaction pricing for all volume in greater than, or less than, under the
concerns the Commission identified NMS stocks, but subject to a carve-out current tiering structure? Would this
about member competition and conflicts only for displayed liquidity providing alternative obviate the need for the anti-
of interests between members and
customers? Why or why not? 62 See infra section IV.E.1. 63 See infra section IV.E.2.
evasion provisions in proposed Rule volume-based exchange transaction a prohibition also apply to listed
6b–1(b) and the transparency pricing and apply it to all NMS options? Why or why not?
disclosures in proposed Rule 6b–1(c)? securities (including NMS stocks and
14. If exchanges continue to offer C. Anti-Evasion
listed options), should it carve-out
volume-based transaction pricing for displayed liquidity-adding orders from The prohibition in proposed Rule 6b–
member proprietary orders, should the an exchange’s registered market makers 1(a) is intended in part to address the
Commission prohibit an exchange from in their assigned options classes and conflict of interest between members
basing tiers on total consolidated series from such a prohibition? Should and customers that is exacerbated by
volume (‘‘TCV’’), or another metric that there be any particular minimum volume-based exchange transaction
is based on volume transacted on other pricing schedules when members route
quantitative and qualitative quoting
exchanges and off-exchange, and customer orders to an exchange, as well
requirements to qualify for the carve-
instead limit volume-based transaction as address burdens on competition that
out? Would such a carve-out for listed
tiers to volume that occurs solely on the volume-based exchange transaction
options be an appropriate benefit to
exchange as a means of promoting pricing can impose on members
encourage members to become and competing for customer business. In
competition among exchanges? Do tiers
remain registered market makers and light of the combination of these
based on TCV constrain competition
undertake registered market making conflicts and potential competitive
among exchanges by seeking primarily
to preserve relative exchange market obligations in the same way that it advantages, the Commission is
share? Why or why not? Even if tiers would for NMS stocks? Does tiered concerned that members may have a
were not permitted to be based on TCV, pricing encourage greater quoted depth financial incentive to mischaracterize
could exchanges effectively circumvent or narrower quoted spreads, or both, for their agency-related orders to continue
such a prohibition by replicating a listed options in a similar manner to to qualify for volume-based pricing.
similar approach using absolute NMS stocks? If the Commission were to To mitigate this incentive to
numbers and updating them on a allow exchanges to offer volume-based mischaracterize order capacities,
monthly basis based on future estimates transaction pricing but require that tiers proposed Rule 6b–1(b)(1) would require
of total consolidated market volume? be aggregated across all members and an equities exchange that offers volume-
Why or why not? the associated pricing be applicable to based transaction pricing for member
15. If exchanges continue to offer all members uniformly, should that proprietary orders to have a rule to
volume-based transaction pricing for condition apply to listed options as well require its members to engage in
member proprietary orders, should the as NMS stocks? practices that facilitate the exchange’s
Commission prohibit exchanges from 18. Instead of prohibiting volume- ability to comply with the prohibition
basing tiers in an auction, trading based exchange transaction pricing for on volume-based exchange transaction
session, or special program or order agency and riskless principal orders, pricing in connection with the
types (e.g., retail liquidity program) on should the Commission instead prohibit execution of agency-related volume.64
volume done outside that auction, exchanges from offering tiers that are The proposed rule would provide
trading session, or program or order reasonably achievable by only one or a exchanges with flexibility to adopt a
type? For example, should the few members based on those members’ rule that is tailored to its needs,
Commission prohibit exchanges from order flow? Why or why not? If such a systems, and members. For example, an
basing tiers in the closing auction on prohibition were adopted, would it be exchange rule could require members to
volume transacted during regular appropriate, for example, to prohibit identify, for transaction pricing and
trading hours in order to prevent an billing purposes, their proprietary
tiers for which fewer than 50% of an
exchange from leveraging its closing orders for their own account and submit
exchange’s members could have met the
auction in a manner that harms the or mark them in a distinct manner from
tier criteria during the prior month?
ability of other exchanges to compete all other orders. Similarly, an exchange
Would assuring that exchanges set tier
with it in the regular hours trading could adopt or enhance any existing
criteria at levels for which at least 50%
session? Do these types of arrangements rule that requires members to properly
impact competition among exchanges of the exchange’s members are capable
of meeting based on order flow they label orders or identify which types of
and among members? Why or why not? orders are submitted through specific
16. Should the Commission prohibit route help assure that such tiered
pricing meets the applicable statutory ports or sessions to ensure the accuracy
volume-based exchange transaction of order marking and ensure that
pricing for agency-related orders also for standards because at least a majority of
members would be eligible to receive it? members do not mislabel or misdirect
listed options? Why or why not? Would orders specifically for transaction billing
extending the prohibition to listed Would such a prohibition increase
competition among members for purposes.65 Proposed Rule 6b–1(b)(1)
options implicate the same costs and would support proposed Rule 6b–1(a)’s
benefits that would apply to a customers while providing exchanges
with the ability to offer tiered pricing at prohibition on volume-based
prohibition on volume-based exchange transaction fees, rebates, or other
transaction pricing for NMS stocks, or levels that incentivize members to
contribute additional liquidity to the incentives in connection with the
are there unique aspects of the listed execution of agency or riskless principal
options markets that would apply exchange? Alternatively, would it be
orders in NMS stocks.
different costs or result in different appropriate, for example, to prohibit
Second, proposed Rule 6b–1(b)(2)
benefits? What would those differences tiers for which only one, two, three, or would require the exchange to establish,
be? four members are capable of qualifying
17. If the Commission also prohibits to prevent tiers that are only achievable 64 If an exchange does not offer volume-based
volume-based exchange transaction by only a few members and help assure transaction pricing, then it would not be required
pricing for member proprietary volume that tiers meet the applicable statutory to adopt such a rule.
65 Many exchanges already have rules requiring
in NMS stocks, should listed options standards? Should any of the above
members to accurately mark their orders. See, e.g.,
also be included within the broader prohibitions also be applied to Nasdaq General 3, Rule 1032(a)(6) (requiring
prohibition? If the Commission were to proprietary orders for the account of a members to ‘‘input [ ] accurate information into the
adopt a broader prohibition on all member? Why or why not? Should such System. . . .’’).
maintain, and enforce written policies the execution of proprietary orders in an exchange’s pricing tiers, and how
and procedures reasonably designed to NMS stocks for the account of a members have responded to tiered
detect and deter members from member.67 For purposes of proposed pricing changes (e.g., by looking at
receiving volume-based pricing in Rule 6b–1(c), proprietary orders are month-to-month disclosures to see how
connection with the execution of those where the member is trading many members moved up to a new or
agency-related volume. While solely for its own account and not in revised tier to qualify for a more
exchanges generally already establish, connection with filling an order for a generous pricing incentive). That
maintain, and enforce written policies customer. Proprietary orders are information could be useful in helping
to detect and deter non-compliance with principal capacity orders and are not the Commission and public commenters
their rules and the Federal securities agency or riskless principal capacity assess whether pricing tier changes are
laws and rules to ensure compliance orders. reasonable, equitably allocated, not
with their obligations under the Disclosing information about the unfairly discriminatory, and do not
Exchange Act,66 the Commission is manner in which an exchange’s tiered impose a burden on competition that is
adding a specific and complementary transaction pricing applies across its not necessary or appropriate in
requirement in proposed Rule 6b–1 to membership would enhance public furtherance of the purposes of the
help ensure exchange compliance with transparency regarding the application Exchange Act.72
the proposed rule. Proposed Rule 6b– of an exchange’s tiered pricing structure Specifically, proposed Rule 6b–1(c)
1(a) would apply specifically to for member proprietary volume. In turn, would require equities exchanges to
exchange pricing schedules and how the increased transparency would submit electronically to the
exchanges assess and collect fees and enhance the ability of members, other Commission, within five calendar days
offer rebates and other incentives to exchanges, and the public in after the end of each calendar month,
members. For example, exchanges could considering and commenting on the information described below. Given
develop written policies and procedures whether proposed volume-based pricing that exchanges assess transaction prices
to audit member activity to ensure the changes applicable to member to their members on a monthly basis
proper marking of orders and review proprietary volume provide for the according to their respective pricing
trading records to ensure that the ‘‘equitable allocation of reasonable dues, tiers, the Commission believes that such
exchange is not unintentionally offering fees, and other charges’’ 68 that are ‘‘not information should be readily available
tiered transaction pricing on agency- designed to permit unfair to exchanges, since they are already
related volume. Proposed Rule 6b– discrimination’’ between broker- familiar with the pricing tier for which
1(b)(2) would complement existing dealers 69 and that do not ‘‘impose any each member qualifies. Further,
exchange rules requiring the accurate burden on competition not necessary or submitting the disclosures within five
marking of orders and thereby facilitate appropriate in furtherance of the calendar days after the end of each
the ability of exchanges to comply with purposes’’ 70 of the Exchange Act. For calendar month would help ensure that
proposed Rule 6b–1(a). example, monthly disclosures would the information is available in a timely
provide timely information during the manner for the Commission and the
Request for Comments 60 day suspension period of an public’s consideration after an exchange
The Commission generally requests exchange’s proposed pricing change that implements a new pricing change to
comment from the public on all aspects would allow the public to see the show the impact of the pricing change
of proposed Rule 6b–1(b), including its impact of a new or revised pricing tier during the first month that it was billed
objectives and its terms to achieve those during the first month it was in effect.
to members. This timing would allow
objectives. More specific requests for The Commission and the public could
time for the Commission and the public
comment are set forth below. As much use that information to assess exchange
to review this data before the expiration
as possible, commenters are requested statements about the number of
of the period within which the
to provide empirical data in support of members that the exchange expected to
Commission is able to summarily
any arguments or analyses and to offer qualify for a proposed tier, and
temporarily suspend a proposed rule
explanations for their views. commenters could use that information
change.73
19. Is the anti-evasion clause in to provide comment as to whether a tier
proposed Rule 6b–1(b) appropriately The content of the disclosures is
change meets the applicable statutory
designed to ensure exchange intended to show a high-level and
standards.
compliance with the proposed The Commission also believes that the anonymized summary of the volume-
prohibition on volume-based exchange public disclosure of such information based transaction tiers applicable to the
transaction pricing in connection with would be consistent with section 11A of execution of proprietary orders in NMS
the execution of agency or riskless the Exchange Act in that it could assist stocks for the account of a member and
principal orders? Why or why not? To in assuring ‘‘fair competition among how many members qualify for each
what extent are practices or systems brokers and dealers, [and] among tier. Monthly tables would show, for
already in place that could facilitate exchange markets’’ and ‘‘the example, the potential impact of any
members accurately marking orders so practicability of brokers executing recent tiered transaction pricing change
that exchanges can distinguish investors’ orders in the best market.’’ 71 for member proprietary orders during
proprietary and agency orders for For example, the proposed disclosures the month that it was first in effect
transaction billing purposes? would allow interested parties to see following the exchange’s proposed rule
how many members have qualified for change as well as how members qualify
D. Transparency for Volume-Based over time for pricing tiers that do not
Pricing on Member Proprietary Orders 67 Exchanges that do not offer any volume-based change. While the Commission reviews
Proposed Rule 6b–1(c) would add a transaction pricing would not be required to submit each proposed rule change, the actual
the disclosures required under proposed Rule 6b–
new public disclosure requirement for 1(c). 72 Under the proposed rule, an exchange would
exchanges that offer volume-based 68 15 U.S.C. 78f(b)(4).
not have to identify its members by name in the
transaction pricing in connection with 69 15 U.S.C. 78f(b)(5).
proposed transparency disclosures.
70 15 U.S.C. 78f(b)(8). 73 See supra note 6 and accompanying text
66 See, e.g., 15 U.S.C. 78s(g)(1). 71 15 U.S.C. 78k–1(a)(1)(C)(ii) and (iv). (discussing suspensions).
effect of a pricing change cannot be Second, proposed Rule 6b–1(c)(2) In addition, having this information in
known in advance or guaranteed. The would require every exchange that structured data format would allow data
information in the proposed disclosures offers volume-based transaction fees, analysis and computations to be
is intended to provide the Commission rebates, or other incentives in performed, which would facilitate
and the public with insight into the connection with the execution of comparisons over time and across
application of an exchange’s volume- proprietary orders in NMS stocks to exchanges.
based transaction pricing schedule, disclose a structured data table for each 5. The total number of members that
which would allow interested persons volume-based transaction fee, rebate, qualified for the base fee, base rebate, or
to better assess an exchange’s volume and other incentive that includes each tier during the month. This
tiers, particularly where the highest information to promote transparency disclosure would provide important
rebate or lowest tiers on an exchange are regarding how that tier applies among transparency into the application of
occupied by only one or a few members. the exchange’s membership. Exchanges volume-based exchange transaction
Therefore, having more timely and would be required to submit pricing and how the prices apply among
readily available information with electronically to the Commission each an exchange’s membership. Among
respect to the actual effect of an calendar month, within five calendar other things, it could provide members
exchange transaction pricing change days after the end of the month, the with insight as to the tiers that other
would be useful to the Commission in following information for each month: members with whom they compete
determining whether to summarily 1. A label to identify the ‘‘base’’ fee qualify, which could be useful in
temporarily suspend a proposed rule and rebate. Showing the base fee or considering whether an exchange’s
change before the deadline to rebate allows the reader of the table to pricing is imposing a burden on the
compare and evaluate each tiered member’s ability to compete with those
summarily temporarily suspend expires.
pricing level against what the exchange other members. It also may provide
Further, the Commission also believes
otherwise would assess to its members insight into how an exchange’s fees and
such information would be useful to the
in the absence of volume-based rebates are distributed among members
public in assessing the impact of the
pricing.76 The inclusion of the base fee and whether those fees that fund the
proposed rule change and further and rebate information in structured
informing their comments on a rebates the exchange offers, as well as
data format also would allow data fund part of the exchange’s operations,
proposed pricing change. analysis and computations to be constitute an equitable allocation among
First, proposed Rule 6b–1(c)(1) would performed, which would facilitate members. It also would provide data
require every exchange that offers comparisons over time and across against which exchange representations
volume-based transaction fees, rebates, exchanges. made as part of or in connection with
or other incentives in connection with 2. A label to identify each pricing tier. proposed pricing changes could be
the execution of proprietary orders in For example, ‘‘Liquidity Providing verified.
NMS stocks to submit electronically to Rebate Tier 1,’’ ‘‘Step-up Rebate Tier 1,’’ Proposed Rule 6b–1(c) would require
the Commission each calendar month, or ‘‘Removing Tier 2.’’ The label used in that the information be provided in an
within five calendar days after the end the disclosure would be required to easily understandable table format,
of the month, the number of members correspond to the label the exchange using structured data specified by the
that executed proprietary orders in NMS uses in its pricing schedule so that the Commission.77 Exchanges would be
stocks on the exchange for the member’s public can easily locate the tier on the required to retain those records and
account. The proposed rule would exchange’s pricing schedule. Providing information pursuant to 17 CFR
require monthly submissions because a label in structured data format also
240.17a–1 (Rule 17a–1).78
exchange fees are typically effective at would allow for data analysis using
the beginning of a calendar month and those labels to identify each pricing tier. Request for Comments
revised as frequently as monthly.74 The Results from such analysis would then The Commission generally requests
Commission believes that this be easily referenced against the comment from the public on all aspects
information could be used to better exchange’s pricing schedule. of proposed Rule 6b–(c), including its
understand the impact of an exchange’s 3. The amount of the fee, rebate, or
objectives and its terms to achieve those
volume-based transaction pricing other incentive. This information would
objectives. More specific requests for
allow the reader of the table to
structure across its members. comment are set forth below. As much
understand what pricing applies to each
Specifically, this number would provide as possible, commenters are requested
pricing tier without having to consult
the baseline denominator against which to provide empirical data in support of
the exchange’s pricing schedule. In
one could calculate percentages of any arguments or analyses and to offer
addition, the inclusion of the pricing
members that met a specific tier.75 explanations for their views.
amount in a structured data format
Seeing the total number of members 20. Is the definition of proprietary
would allow data analysis and
with proprietary orders during a month order described in section II.D.
computations to be performed, which
would thus provide the baseline against appropriate? If the definition described
would facilitate comparisons over time
which the number of members in section II.D. is not appropriate, what
and across exchanges.
qualifying for any one tier in that month 4. An explanation of the tier definition should the Commission use
could be understood. requirements. Including this for purposes of Rule 6b–1? Should the
Commission include the definition
explanation would allow the reader of

74 See supra note 17 and accompanying text.
the table to understand the requirements
Further, as discussed above, monthly disclosure 77 See proposed Rule 6b–1(c)(3). Under proposed
would also provide the Commission with timely

for achieving each tier without having to Rule 6b–1(c)(3), exchanges would be required to
information to consider whether to temporarily consult the exchange’s pricing schedule. provide information using Interactive Data File in
suspend a proposed rule change within the accordance with Rule 405 of Regulation S–T.
statutory deadline of 60 days beginning on the date 76 The base fee would be the highest fee that the 78 17 CFR 240.17a–1. Generally, Rule 17a–1(b)
of filing of such proposed rule change. See 15 exchange assesses to members by default if no requires national securities exchanges to retain
U.S.C. 78s(b)(3)(C). incentives apply. Similarly, the base rebate would specified documents for a period of not less than
75 See infra section II.D., Request for Comments be the lowest rebate that the exchange provides to five years, the first two years in an easily accessible
(requesting comment on other benchmarks). members if no incentives apply. place.
described in section II.D (or another program that has its own volume-based g. the average transaction fee paid and
definition) in Rule 6b–1, or is the term transaction pricing in order to be able to rebate received by members during the
commonly understood without needing compute percentages specific to the month.
to be defined in the rule? program? For example, tiers specific to 25. Would additional columns allow
21. Does the proposed 5 calendar day Tape A, B, and C, to stocks under $1, easier sorting and analysis of the tables
deadline for exchanges to submit the to a retail liquidity program, or to the by machine or otherwise? If so, please
transparency disclosures after the end of closing auction. Would that more explain.
each calendar month under proposed granular level of information be useful 26. Should the transparency
Rule 6b–1(c) provide exchanges with to commenters in commenting on disclosures under proposed Rule 6b–
sufficient time to prepare and submit specific individual pricing proposals 1(c) require exchanges to report every
the disclosures? If an exchange files a that affect such programs? For example, net price combination for any volume-
proposed rule change related to if an exchange has tiers for Tape B and based fee, rebate, or other incentive,
transaction pricing that becomes reports only ten members that qualified including all additive or creditable
effective on the first day of a month, for them in a month, would it be useful pricing (e.g., a liquidity providing rebate
does the proposed 5 calendar day to know that only 12 out of forty of $0.0028 plus a step-up tier of $0.0003
deadline after the end of that month members transacted in Tape B stocks on would be reported as its own pricing
provide sufficient time for the the exchange that month so that tier of $0.0031)? Would doing so be
Commission and commenters to percentages can be calculated out of helpful to show whether volume-based
consider the disclosures before the eligible entities rather than all transaction tiers are customized to a
expiration of the 60-day statutory members? Why or why not? specific member?
deadline to summarily temporarily 24. Should the transparency 27. Should the transparency
suspend the proposed rule change at disclosures under proposed Rule 6b–
disclosure under proposed Rule 6b–1(c)
issue? If 5 calendar days is not sufficient 1(c) be posted on an exchange’s website
also require exchanges to report the
for exchanges to submit the in addition to, or instead of, being
following:
transparency disclosures, would a 7 or submitted electronically to the
a. the applicable trading session (e.g.,
10 calendar day deadline provide Commission? Why or why not?
pre-market, opening auction, regular 28. Are there uses beyond those
sufficient time? If an exchange files a hours, closing auction, post-market) to
proposed rule change related to identified in this release for the
allow readers of the tables to more transparency disclosures? For example,
transaction pricing that becomes quickly identify with certainty which
effective on the first day of a month, would having volume-based exchange
tiers apply to which trading session and transaction fees in a structured data
would a 7 or 10 calendar day deadline allow researchers to be able to use
after the end of that month provide format help members as well as other
electronic means to parse that data; market participants and academics
sufficient time for the Commission and
b. the applicable securities (e.g., Tape parse the pricing schedules across
commenters to consider the disclosures
A, B, or C; sub-$1, exchange traded exchanges and track changes over time?
before the expiration of the 60-day
funds, etc.) to allow readers of the tables Would the transparency disclosures
statutory deadline to summarily
to more quickly identify with certainty affect routing preferences among
temporarily suspend the proposed rule
which tiers apply to which securities members trading proprietarily? Would
change at issue?
22. Should the transparency and allow researchers to be able to use members use the disclosures to
disclosures under proposed Rule 6b– electronic means to parse that data; comment on exchange proposed rule
1(c) also require exchanges to report the c. whether the fee, rebate, or other change filings or advocate for exchanges
number of their registered market incentive is applicable to adding or to change their transaction pricing if
makers on the exchange during a month removing liquidity to allow readers of they have more transparency of the tiers
if an exchange offers volume-based the tables to more quickly identify with for which their competitors qualify?
transaction pricing tiers solely certainty which tiers apply to which Would that transparency provide a
applicable to its market makers, in order types of activity and allow researchers useful datapoint to assess whether
to allow the public to see how many to be able to use electronic means to volume-based exchange transaction
registered market makers qualify for parse that data; pricing proposals meet the applicable
exchange tiered pricing that is d. the number of MPIDs qualifying for statutory standards? Why or why not?
applicable only to such members? the price level during the month to 29. Would the proposed disclosure
Would that information be useful to provide a different metric to assess how provision raise any issues related to
calculate percentages for the volume- many members qualify for each pricing disclosures of proprietary trading
based transaction tiers that apply tier; information or other confidentiality
specifically to market makers (e.g., to be e. the cumulative volume of shares concerns, especially if the disclosures
able to calculate that 10% of registered qualifying for the tier during the month were read in conjunction with broker-
market makers qualified for the market- to provide more context to understand dealer Rule 605/606 reports?
maker liquidity providing rebate Tier the amount of volume that qualifies at 30. Do exchanges enter into
2)? Would that information be helpful to each pricing tier, which the number of arrangements with members about
better understand the impact of members alone would not capture, and transaction pricing for proprietary and/
exchange tiered transaction pricing on to allow comparison with the or agency-related orders that result in or
competition between registered market exchange’s overall volume; are connected to an exchange proposal
maker members and members that trade f. the cumulative dollar amount of to adopt or amend a specific volume-
proprietarily but not as registered fees, rebates, or other incentives (as based transaction pricing tier? If so,
market makers? applicable) at the tier during the month what types of terms and conditions
23. Should the transparency to better understand the financial might such an arrangement include? To
disclosure under proposed Rule 6b–1(c) impact of each pricing tier, both on what extent are these arrangements
also require exchanges to separately members and on the exchange, and memorialized in writing? How many
report the number of members that allow comparison of that impact such arrangements, if any, do exchanges
participated during the month in any between tiers; and enter into each year? If such
arrangements exist but are not ability to comply with the prohibition in procedures reasonably designed to
commonly memorialized in writing, proposed Rule 6b–1(a). detect and deter members from
should the Commission add a provision receiving volume-based exchange
3. Rule 6b–1(b)(2)—Policies and
to proposed Rule 6b–1 to require transaction pricing in connection with
Procedures To Prevent Evasion
exchanges to ‘‘document any the execution of agency or riskless
arrangement, whether written or oral, Proposed Rule 6b–1(b)(2) would principal orders in NMS stocks.
concerning volume-based transaction require an equities exchange that offers
pricing, including the parties to the volume-based transaction pricing in 4. Rule 6b–1(c)—Transparency for
arrangement, all qualitative and connection with the execution of Volume-Based Pricing on Member
quantitative terms concerning the proprietary orders in NMS stocks for the Proprietary Orders
arrangement, and the date and terms of account of a member to establish,
maintain, and enforce written policies The disclosure of information about
any changes to the arrangement’’? how an exchange’s volume-based
and procedures reasonably designed to
III. Paperwork Reduction Act detect and deter members from transaction pricing for member
receiving volume-based pricing in proprietary orders applies across its
Certain provisions of proposed Rule
connection with the execution of agency membership would enhance the
6b–1 contain ‘‘collection of information
requirements’’ within the meaning of or riskless principal orders in NMS transparency of an exchange’s tiered
the Paperwork Reduction Act of 1995 stocks. pricing structure. In turn, the increased
(‘‘PRA’’).79 The Commission is transparency would enhance the ability
4. Rule 6b–1(c)—Transparency for of members, other exchanges, and the
submitting these collections of Volume-Based Pricing on Member
information to the Office of public in considering and commenting
Proprietary Orders on proposed volume-based pricing
Management and Budget (‘‘OMB’’) for
review in accordance with 44 U.S.C. Proposed Rule 6b–1(c) would require changes applicable to member
3507(d) and 5 CFR 1320.11.80 An an equities exchange that offers volume- proprietary volume.
agency may not conduct or sponsor, and based transaction fees, rebates, or other
incentives in connection with the C. Respondents
a person is not required to respond to,
execution of proprietary orders in NMS The respondents to these collections
a collection of information unless the
stocks for the account of a member to of information would be national
agency displays a currently valid
submit electronically to the Commission securities exchanges that offer volume-
control number.81 The title of the new
information regarding those fees, based transaction fees, rebates, or other
collection of information is ‘‘Volume-
rebates, or other incentives, including
Based Exchange Transaction Pricing for incentives in connection with the
how many members qualify for such
NMS Stocks.’’ execution of orders in NMS stocks.
fees, rebates, or other incentives on a
Currently, while there are 16 national
A. Summary of Collections of monthly basis.
securities exchanges that trade NMS
Information B. Proposed Use of Information stocks, only 13 offer volume-based
The proposed rule includes collection transaction pricing. Therefore, there are
of information requirements within the 1. Rule 6b–1(a)—Prohibition on
13 estimated respondents.
meaning of the PRA. Volume-Based Pricing for Agency-
Related Volume D. Total Initial and Annual Reporting
1. Rule 6b–1(a)—Prohibition on The collection of information and Recordkeeping Burdens
Volume-Based Pricing for Agency- associated with Rule 6b–1(a) would be
Related Volume 1. Rule 6b–1(a)—Prohibition on
exchange rule filings with the Volume-Based Pricing for Agency-
As discussed above, proposed Rule Commission to eliminate volume-based Related Volume
6b–1(a) provides that equities exchanges pricing for agency-related orders from
shall not offer volume-based transaction their pricing schedules. The collection As discussed above, proposed Rule
fees, rebates, or other incentives in of information would bring the 6b–1(a) would require equities
connection with the execution of agency exchanges into compliance with Rule exchanges that currently offer volume-
or riskless principal orders in NMS 6b–1(a), which would foster based transaction pricing to file a rule
stocks. This prohibition would require competition among broker-dealers and change with the Commission to update
equities exchanges that currently offer mitigate conflicts of interest for agency- their price list, if necessary, to eliminate
volume-based transaction pricing for related volume. any existing volume-based pricing that
agency-related orders to file a proposed would not comply with the proposed
2. Rule 6b–1(b)(1)—Rules To Prevent
rule change with the Commission to rule. This would be a one-time initial
Evasion
update their price lists. burden, and exchanges should not incur
Proposed Rule 6b–1(b)(1) would assist an ongoing burden once they have
2. Rule 6b–1(b)(1)—Rules To Prevent exchanges in complying with proposed
Evasion updated their rules. However, the PRA
Rule 6b–1(a) by requiring exchanges to burden associated with the collection of
Proposed Rule 6b–1(b)(1) would impose rules that require members to information resulting from exchange
require an equities exchange that offers engage in practices, such as accurate rule filings that would be required
volume-based transaction pricing in order marking, to better enable the pursuant to proposed Rule 6b–1(a)
connection with the execution of exchange to assess its pricing in would be covered by the existing PRA
proprietary orders in NMS stocks for the compliance with the proposed rule. burden estimates for Rule 19b–4
account of a member to adopt a rule to 3. Rule 6b–1(b)(2)—Policies and because those changes would be filed on
require its members to engage in Procedures To Prevent Evasion Form 19b–4.82
practices that facilitate the exchange’s
Proposed Rule 6b–1(b)(2) would assist 82 See SEC File No. 270–38, OMB Control No.
79 44 U.S.C. 3501 et seq. national securities exchanges in 3235–0045 (June 21, 2023), available at https://
80 44 U.S.C. 3507; 5 CFR 1320.11. complying with proposed Rule 6b–1(a) www.reginfo.gov/public/do/PRAViewICR?ref_
81 5 CFR 1320.11(l). by requiring them to adopt policies and nbr=202304-3235-017.
2. Rule 6b–1(b)(1)—Rules To Prevent 650 burden hours across 13 exchanges because they calculate the fees, rebates,
Evasion that have volume-based transaction and other incentives applicable to their
Proposed Rule 6b–1(b)(1) would pricing.84 members on a monthly basis.
The 13 equities exchanges that have Consequently, the proposed rule would
require an equities exchange that offers
volume-based transaction pricing would not require exchanges to acquire or
volume-based transaction pricing to
incur annual ongoing burden hours to record an entirely new and unfamiliar
have rules to require its members to
maintain and review their policies and set of information. The exchanges,
engage in practices that facilitate the
procedures adopted under proposed however, would be required to present
exchange’s ability to comply with the
Rule 6b–1(b)(2) to ensure their the required information and data in a
prohibition in proposed Rule 6b–1(a).
effectiveness. Those exchanges also new structured data format and submit
Similar to the burden for Rule 6b–1(a),
would need to review for compliance such information electronically to the
this would be a one-time initial burden,
pursuant to their policies and Commission on a monthly basis.
although an exchange may decide to Exchange pricing schedules are
procedures. The Commission estimates
amend the rule it adopts pursuant to publicly available and identify all of the
that each exchange would likely spend
proposed Rule 6b–1(b)(1) from time to exchange’s volume-based transaction
an average of 25 hours per year on an
time. However, the PRA burden fees, rebates, and other incentives. To
ongoing basis, for a total of 325 hours
associated with the collection of comply with proposed Rule 6b–1(c)(2),
across all 13 exchanges.85
information resulting from exchange the exchange would have to identify
rule filings that would be required 4. Rule 6b–1(c)—Transparency for each volume-based transaction fee,
pursuant to proposed Rule 6b–1(b)(1) Volume-Based Pricing on Member rebate, and other incentive, and: (i) use
would also be covered by the existing Proprietary Orders a label to identify the base fee or rebate,
PRA burden estimates for Rule 19b–4 Proposed Rule 6b–1(c) would require (ii) use a label to identify each pricing
because those changes would be filed on exchanges that offer volume-based tier that corresponds to the label used in
Form 19b–4.83 The Commission transaction pricing for the execution of the exchange’s pricing schedule, (iii)
encourages comments on this point. proprietary orders in NMS stocks for the identify the amount of the fee, rebate, or
3. Rule 6b–1(b)(2)—Policies and account of a member to submit other incentive, (iv) provide an
Procedures To Prevent Evasion electronically to the Commission explanation of the tier requirement, and
aggregated information regarding how (v) provide the total number of members
Proposed Rule 6b–1(b)(2) would many members qualify for those pricing that qualified for the base fee, base
require exchanges to establish, tiers. These submissions would be rebate, or each tier during the month.
maintain, and enforce written policies accessible to the public via the EDGAR Parts (i) through (iv) would require the
and procedures to detect and deter system and would reflect each exchange to take information from its
members from receiving volume-based exchange’s particular pricing structure. publicly accessible pricing schedule and
exchange transaction pricing in The exchanges would likely incur an put it into the required structured data
connection with the execution of agency initial burden and an annual ongoing format. The information required for
or riskless principal orders in NMS burden associated with Rule 6b–1(c). part (v) would be readily available to the
stocks. Exchanges would incur an initial Exchanges have ready access to all of exchange since it assesses transaction
burden and an annual ongoing burden the underlying information and data prices to its members on a monthly
associated with proposed Rule 6b– necessary to comply with proposed Rule basis in accordance with its pricing
1(b)(2). The Commission believes that 6b–1(c) because the disclosures are schedule and thus knows which
many exchanges generally already have summaries of the pricing schedules that members qualify for which tiers though
rules and policies and procedures in exchanges maintain and the exchanges exchanges currently are not required to
place to ensure that members are know the number of members that publicly disclose a tally of that
correctly marking their orders, though qualify for a particular pricing tier information by tier.
those policies and procedures may need Furthermore, proposed Rule 6b–
to be updated to ensure compliance 84 The Commission derived the total estimated 1(c)(1) requires the exchange to identify
with the proposed rule in the context of burdens from the following estimates: (Attorney at the number of members that executed
exchange transaction pricing. 30 hours) + (Compliance Counsel at 10 hours) + proprietary orders in NMS stocks for the
Exchanges, at a minimum, would be (Chief Compliance Officer at 5 hours) + (General member’s account on the exchange
Counsel at 5 hours) = 50 burden hours. 50 burden
required to review their existing policies hours per exchange × 13 respondents = 650 total during the month. Exchanges do not
and procedures. Certain exchanges may burden hours. The Commission’s estimate is currently publicly disclose a tally of this
need to supplement or revise their informed by the estimated filing burden for Form information. However, exchanges
policies and procedures to ensure that 19b–4 (34 hours). See Supporting Statement for the generally have ready access to trading
Paperwork Reduction Act Information Collection
they are reasonably designed to deter Submission for Form 19b–4 (Apr. 18, 2023),
information of their members that
and detect members from receiving available at https://www.reginfo.gov/public/do/ would reveal this information and
tiered pricing on orders for which tiered PRAViewDocument?ref_nbr=202304-3235-017. The exchanges generally know which of
pricing is prohibited. Although the Commission believes that the policies and their members are engaged in an agency
procedures required under proposed Rule 6b–
exact nature and extent of compliance 1(b)(2) may require more effort to prepare than the
business, which are engaged in
with proposed Rule 6b–1(b)(2) would proposed rule change required under proposed Rule proprietary trading, and which are
likely differ based on the existing 6b–1(b)(1). engaged in both because exchanges
policies and procedures of each 85 The Commission derived the total estimated
broadly know about what lines of
respondent, the Commission estimates burdens from the following estimates: (Compliance business their members are engaged in
Attorney at 12 hours) + (Compliance Manager at 8
that the one-time, initial burden to hours) + (Business analyst at 5 hours) = 25 burden as part of their membership registration.
update or adopt any additional written hours. 25 burden hours per exchange × 13 Accordingly, the burden on exchanges
policies and procedures required under respondents = 325 total burden hours. The ongoing to calculate the number of members
proposed Rule 6b–1(b)(2) would be burden hours associated with proposed Rule 6b– engaged in proprietary trading would be
1(b)(2) is estimated to be lower than the initial
approximately 50 hours per exchange or burdens because the Commission expects it to be low.
less burdensome to maintain and review existing The Commission estimates that each
83 See id. policies and procedures than to establish new ones. exchange would incur 58 initial burden
hours for the creation of new tables to Commission solicits comment on the electronically updated information each
ensure that data responsive to the accuracy of these estimates. month. An exchange generally would
proposed disclosure requirements is Furthermore, because exchanges are not need to update the disclosure
correctly collected and formatted, and to not currently subject to EDGAR filing information required under proposed
set up automated programs where requirements, equities exchanges would Rule 6b–1(c)(2)(i)–(iv) unless the
appropriate, or 754 total initial burden incur a one-time compliance burden of exchange amends its pricing schedule,
hours across 13 exchanges.86 The submitting Form ID in order to be able in which case the exchange would need
Commission does not believe the to submit the disclosures electronically to make targeted changes to these
to the Commission through EDGAR. disclosures in accordance with the
information required to be aggregated
Respondents would apply for access to changes it makes to its pricing schedule.
and included in disclosures made
EDGAR using Form ID and receive The Commission expects that the
pursuant to proposed Rule 6b–1(c) access codes to submit documents
would require respondents to acquire disclosures required by proposed Rule
through the EDGAR system. The
new hardware or systems to process the 6b–1(c)(1) and Rule 6b–1(c)(2)(v) would
Commission estimates that each filer
information required in the reports. possibly change and could need to be
that currently does not have access to
Rather, the exchanges’ initial burden EDGAR would incur an initial, one-time updated as frequently as each month.
would consist of creating and formatting burden of 0.30 hours to complete and The Commission believes the exchanges
a table that would be responsive to the submit a Form ID.87 However, the PRA would use automated programs to meet
requirements of proposed Rule 6b–1(c). burden associated with completing and the ongoing monthly reporting
As described above, this would require submitting a Form ID would be covered obligation under proposed Rule 6b–1(c)
the exchanges to convert a portion of the by the existing PRA burden estimates but each report may require staff to
information available on their publicly for Form ID.88 verify the accuracy of the information.
accessible pricing schedules into a The 13 equities exchanges that have The Commission estimates that each
structured data format. Once created, volume-based transaction pricing also exchange would incur 8 burden hours
these tables should not change unless would incur annual ongoing burden per monthly report for a total of 96
the exchanges create new pricing tiers hours to aggregate and disseminate the ongoing burden hours on an annual
or change the requirements or dollar information required under proposed basis.89 Therefore, the Commission
amounts of existing tiers. The Rule 6b–1(c). Proposed Rule 6b–1(c) estimates 1,248 total ongoing annual
would require exchanges to submit burden hours across 13 exchanges.90
TABLE 3—PRA SUMMARY TABLE

Ongoing
burden hours Total ongoing
Initial burden
Number of Total initial per burden hours
Rule hours per
respondents burden hours respondent on on annual
respondent annual basis
basis
Rule 6b–1(b)(2) .................................................................... 13 50 650 25 325

Rule 6b–1(c) ........................................................................ 13 58 754 96 1,248
Total .............................................................................. 108 1,404 121 1,573
E. Collection of Information Is information under proposed Rule 6b– how the exchange detects and deters
Mandatory 1(c) also would not be confidential. members from receiving volume-based
Rather, each exchange would be transaction pricing in connection with
The collection of information required to submit electronically to the the execution of agency and riskless
discussed above would be a mandatory Commission the information required principal orders in NMS stocks.
collection of information. under proposed Rule 6b–1(c) and this Accordingly, where the Commission
F. Confidentiality of Responses to information would be made publicly requests that an exchange produce those
Collection of Information available. The collection of information documents, an exchange can request
under proposed Rule 6b–1(b)(2) confidential treatment of the
The collection of information under concerning the written policies and information. If such confidential
proposed Rule 6b–1(a) and 6b–1(b)(1) procedures would contain information treatment request is made, the
would not be confidential because about an exchange’s regulatory program
Commission anticipates that it will keep
exchange proposed rule changes filed because those materials would provide
the information confidential subject to
with the Commission are public details on how the exchange enforces
information. Similarly, the collection of compliance with its rules, specifically applicable law.
86 The Commission derived the total estimated organizations who seek access to file electronically PRAViewDocument?ref_nbr=202112-3235-003
burdens from the following estimates: (Sr. on EDGAR. Accordingly, a filer that does not (stating that it takes 0.3 hours to prepare Form ID).
Programmer at 25 hours) + (Sr. Systems Analyst at already have access to EDGAR must submit a Form 88 See id.
10 hours) + (Compliance Manager at 10 hours) + ID, along with the notarized signature of an 89 The Commission derived the total estimated
(Compliance Attorney at 8 hours) + (Director of authorized individual, to obtain an EDGAR burdens from the following estimates: (Compliance
Compliance at 5 hour) = 58 burden hours. 58 identification number and access codes to file on Attorney at 6 hours) + (Compliance Manager at 2
burden hours per exchange × 13 respondents = 754 EDGAR. See Supporting Statement for the hours) = 8 burden hours per monthly filing. 8
total burden hours.
Paperwork Reduction Act Information Collection burden hours × 12 months = 96 annual burden
87 Form ID (OMB control number 3235–0328) hours per respondent.
Submission for Form ID (Dec. 20, 2021), available 90 96 annual burden hours per exchange × 13
must be completed and filed with the Commission
at https://www.reginfo.gov/public/do/
by all individuals, companies, and other respondents = 1,248 total burden hours per year.
G. Retention Period for Recordkeeping 3(f) of the Exchange Act provides that agency-related orders the proposed rule
Requirements when engaging in rulemaking that would help simplify pricing for agency-
National securities exchanges would requires the Commission to consider or related order flow whilst the proposed
be required to retain records and determine whether an action is disclosure provisions will help promote
information pursuant to Rule 17a–1 necessary or appropriate in the public transparency for principal order flow,
under the Exchange Act 91 for a period interest, to also consider, in addition to for which volume-based transaction
of five years. the protection of investors, whether the pricing will continue to be permitted.
action will promote efficiency, While exchanges compete, in part, on
H. Request for Comments competition, and capital formation.92 the basis of their price schedules,
The Commission requests comment Section 23(a)(2) of the Exchange Act volume-based transaction pricing may
on whether the estimates for burden also requires the Commission to reduce competition among executing
hours and costs are reasonable. Pursuant consider the effect that the proposed brokers, which could increase costs for
to 44 U.S.C. 3506(c)(2)(B), the rule would have on competition, and it investors. With volume-based
Commission solicits comments to: (1) prohibits the Commission from adopting transaction pricing, rebates go up and
evaluate whether the proposed any rule that would impose a burden on fees go down as a broker-dealer’s
collections of information are necessary competition not necessary or volume increases, meaning that such
for the proper performance of the appropriate in furtherance of the pricing gives higher-volume broker-
functions of the Commission, including Exchange Act.93 The analysis below dealers lower trading costs. As a result,
whether the information would have addresses the likely economic effects of smaller firms, such as new entrants, face
practical utility; (2) evaluate the the proposed rule, including the higher trading costs relative to high-
accuracy of the Commission’s estimate anticipated benefits and costs of the volume incumbent broker-dealers,
of the burden of the proposed amendments and their likely effects on potentially reducing competition and
collections of information; (3) determine efficiency, competition, and capital raising costs for investors.
whether there are ways to enhance the formation. The Commission also The implementation of volume-based
quality, utility, and clarity of the discusses the potential economic effects transaction fee and rebate pricing
information to be collected; and (4) of certain alternatives to the approaches introduce additional incentives to
taken in this proposal. concentrate order flow on a given
determine whether there are ways to
The Commission is proposing to exchange. Volume-based tiers may
minimize the burden of the collections
prohibit volume-based transaction fees, encourage the concentration of a
of information on those who are to
rebates, or other incentives in member’s order flow on the exchange by
respond, including through the use of
connection with the execution of agency offering more favorable pricing to a
automated collection techniques or
or riskless principal orders in NMS member who executes greater trading
other forms of information technology.
Persons submitting comments on the stocks, as well as the disclosure of, volume on their platform. Not only does
collection of information requirements among other things, the number of volume-based transaction price tiering
should direct them to the Office of exchange members that qualify for incentivize the concentration of order
different transaction pricing tiers. flow, it also indirectly increases the
Management and Budget, Attention:
The proliferation of tiered transaction opportunity cost of routing orders to a
Desk Officer for the Securities and
pricing schedules across many competing venue, because by doing so
Exchange Commission, Office of
exchanges has resulted in a complex the exchange member lowers the
Information and Regulatory Affairs,
system of transaction-based fees, which, likelihood that it will qualify for a better
Washington, DC 20503, and should also
along with a lack of transparency pricing tier. This concentration also
send a copy of their comments to
regarding how many members qualify directly reduces the ability of an
Secretary, Securities and Exchange
for the various pricing tiers, makes it exchange not offering rebates to
Commission, 100 F Street NE,
difficult for market participants to compete with those that do. Rebates
Washington, DC 20549–1090, with
assess the tiered transaction pricing themselves are a less transparent means
reference to File Number S7–18–23. schedules’ impact on the fees and of incentivizing liquidity as compared
Requests for materials submitted to rebates ultimately realized across with bid-ask spreads. Thus, the
OMB by the Commission with regard to exchange members. Further, it may be proliferation of volume-based tiers may
this collection of information should be the case that some tiers only have a reduce efficiency by making a non-
in writing, with reference to File single market participant that ultimately rebate-focused model difficult to
Number S7–18–23 and be submitted to qualifies for that tier in a given month. sustain.
the Securities and Exchange This lack of transparency presents a The application of volume-based
Commission, Office of FOIA/PA challenge to other exchange members, pricing to non-principal order flow adds
Services, 100 F Street NE, Washington, exchanges, and interested parties to to the conflict of interest between a
DC 20549–2736. As OMB is required to assess for themselves whether an broker and its customer as broker-
make a decision concerning the exchange’s proposed transaction price dealers may be incentivized to execute
collection of information between 30 schedule meets the applicable statutory customer orders in a manner that would
and 60 days after publication, a standards, so that they can comment on not be consistent with the broker-
comment to OMB is best assured of such a proposed fee rule. It is also dealer’s duty of best execution (to
having its full effect if OMB receives it possible that the general complexity of execute customer trades at the most
within 30 days of publication. the tiers inhibits the ability of all market favorable terms reasonably available
IV. Economic Analysis participants to understand the price of under the circumstances).94 Tier
exchange services and understand the qualification is based on the exchange
A. Introduction impact of the particular price schedules member’s total monthly trading volume
The Commission is mindful of the implemented. By prohibiting the
94 The Commission has previously described a
economic effects, including the benefits application of volume-based pricing for
non-exhaustive list of factors that may be relevant
and costs, of the proposed rule. Section to a broker-dealers’ best execution analysis. See
92 See 15 U.S.C. 78c(f). Securities Exchange Act Release No. 51808 (June 9,
91 17 CFR 240.17a–1. 93 See 15 U.S.C. 78w(a)(2). 2005), 70 FR 37496 at 37538 (June 29, 2005).
and upon qualification the pricing of would be useful to market participants. Many exchanges incorporate volume-
that tier applies to the entirety of the Knowledge of this would aid exchange based transaction tiers into their pricing
member’s trading volume on the members, other exchanges, and the schedules, meaning that they offer
exchange. Diverting order flow to other public in considering and commenting improved pricing terms to members that
trading venues may risk the member on whether proposed volume-based execute more trading volume on the
losing out on higher rebates or lower pricing changes are equitable and not exchange, typically as a percent of total
fees for a whole swath of their order unfairly discriminatory. The consolidated volume. These pricing
flow. Volume-based pricing tiers Commission does not believe that the tiers provide an incentive for exchange
thereby generate the potential for exchanges themselves can be expected members to concentrate their order flow
exchange members to concentrate to rectify the lack of tier transparency on a subset of exchanges, rather than
customer order flow onto particular because doing so may reveal valuable route their orders more broadly across
exchanges in order to increase the information to their competitors as well all competing exchanges, so as to
likelihood of tier qualification possibly as risk potential reputational costs.96 increase their chances of qualifying for
contrary to the interests of individual Along with the proposed prohibition of a higher tier on a specific exchange. In
customers. volume-based pricing for agency-related turn, this also helps to secure an
Exchanges, particularly those with the order flow the Commission is proposing exchange’s share of the market, and in
largest market share, are unlikely to to require exchanges to disclose the some cases may affect competition
unilaterally reduce the use of number of members which qualify for among exchanges.
transaction pricing tiers or address the each pricing tier. Given the proposed a. Transaction Fees and Rebates
advantages that the application of these prohibition of volume-based tiers for
pricing tiers to agency-related volume agency order flow the proposed Exchanges generally seek to increase
creates for high-volume broker- disclosures would relate to tiers that the amount of trading that occurs on
dealers.95 An exchange may perceive would only apply to principal order their respective venue. Exchanges
that unilaterally excluding agency flow. The Commission expects that the generate revenue, in part, from trade
trading volume from volume-based proposed disclosures would provide executions 97 by charging transaction
transaction pricing tiers would reduce important information to interested fees net of any rebate they pay out,
one incentive for members to parties to provide comment on future subject to a fee cap.98 Because some
concentrate agency orders on their proposed changes to an exchange’s market participants are sensitive to the
exchange, risking that their members pricing schedule. Observing the level of fees and rebates, exchange fee
instead direct that order flow to schedules would affect an exchange’s
distribution of principal volume tier
competing exchanges with volume- market share. Given that most
qualification and its variation over time
based pricing tiers. Because of this exchanges set their access fees at or near
would allow interested parties to better
incentive to concentrate order flow, an the access fee cap it is particularly the
assess if pricing tiers had been narrowly
exchange that unilaterally eliminated variation in the rebates they offer which
tailored for the benefit of some members
volume-based transaction pricing tiers is more likely to influence an
and could be judged to be unfair. The
for agency-related order flow could exchange’s market share.99
disclosure of more information on how A major component of the market to
experience a loss of trading volume, many members qualify for each provide trade executions is the
especially if competing venues continue principal pricing tier would add costs competition among exchanges in
to reward agency-related order flow and could lead to reputational damage attracting competitively priced liquidity
concentration. If all existing exchanges to an exchange if the exchange’s pricing as a means of capturing more order
moved to exclude agency-related structure is publicly perceived to be flow.100 Competitive quotes increase the
volume from volume-based transaction unfair. likelihood that marketable orders will
pricing tiers, the potential gains from a flow to an exchange which result in
single exchange (or new entrant) B. Baseline
trades.101 Exchanges aim to attract
deviating and charging volume-based 1. Exchange Pricing
prices could be very high, reducing the 97 Exchanges also generate significant revenue
likelihood that such an effort would be As discussed above in section I.B,
from selling access to the data generated by the
successful without the aid of a many stock exchanges utilize a exchange as well by charging fees for connectivity.
regulatory prohibition. In this case the transaction pricing model that involves 98 See 17 CFR 242.610 (Rule 610(c)), which
exchanges, particularly those with charging one party to a trade a per-share prohibits trading centers from imposing a fee
fee while offering the other party a per- exceeding $0.0030 to access a quote in stock priced
members with high-volume agency at or greater than $1.00. This level is commonly
order flow, may also lose activity as the share rebate. While exchange referred to as 30 mils with 1 mil defined as $0.0001.
reduced incentive to concentrate order transaction pricing structures vary, with For quotes priced less than $1.00 the fee cap is at
flow may result in broker-dealers some exchanges charging both sides a 0.3% of the quotation price.
routing order-flow to other venues. fee or no fee at all, most of the on- 99 For instance, an exchange stated in a proposed
exchange volume goes to exchanges rule change that ‘‘[t]he Exchange first notes that it
Exchanges are required to file changes operates in a highly competitive market in which
to their price schedules with the which provide a rebate to the resting market participants can readily direct order flow to
Commission and publish their pricing limit order and charge the fee to the competing venues if they deem fee levels at a
schedules online. However, when filing marketable order. This type of fee particular venue to be excessive or incentives to be
structure is referred to as ‘‘maker-taker’’ insufficient.’’ See Securities Exchange Act Release
such proposed rule changes and No. 94252 (Feb. 15, 2022) 87 FR 9780 at 9781 (Feb.
publishing such pricing schedules, they pricing. Exchanges may employ maker- 22, 2022) (SR–CboeBZX–2022–008).
typically refrain from disclosing the taker fees as a means of attracting 100 Exchanges also compete with off-exchange
number of members that qualify for competitively priced liquidity to post on trading venues such as ATSs and wholesaler
an exchange, which, in turn, helps broker-dealers to attract transactions.
their different tiers, information which 101 Exchanges can try to attract such quotes by
attract trading to the exchange.
paying rebates on limit orders. By offering to pay
95 Agency-related order flow represents a the market participant who sends a limit order to
substantial share of trading volume, comprising 96 See section IV.C.3.b.ii for a discussion of the an exchange a rebate should the limit be hit, the
56% of trading volume across the equities potential reputational costs that the disclosure of exchange may be able to increase to total number
exchanges in Jan. 2023. See infra Table 4. tier qualification numbers may have. limit orders sent to it. This may increase likelihood
competitively priced quotes because, exchanges typically adopt one of three on different exchanges being the same,
holding other considerations constant, it different forms of transaction pricing a trader would be expected to prefer
is generally in market participants’ models, including maker-taker, routing its marketable order to either an
interest to route their order to the venue inverted, or flat.105 The ‘‘maker-taker’’ inverted or free venue over a maker-
with the best prices insofar as doing so pricing model encourages liquidity taker venue to avoid the access fee and
would be consistent with the duty of provision by paying rebates to limit potentially earn a rebate instead.
best execution that broker-dealers have orders (i.e., the ‘‘makers’’) that the However, a market observer has stated
with regard to customer orders. In exchange funds by charging fees on that the occurrence of equivalently
addition to these incentives, the Order marketable orders. priced quotes at the NBBO between
Protection Rule also contributes to the Outside of the maker-taker pricing maker-taker exchanges and non-maker-
competition for order flow by requiring model, other exchanges have adopted taker exchanges is an infrequent
that, with specified exceptions,102 inverted or flat pricing models. These occurrence.106 The infrequency of this
orders must execute at prices that are exchanges collectively represent a occurrence may be due, in part, to the
equal to or superior to the prevailing smaller portion of the overall market lack of rebates for limit orders on these
national best bid and offer (NBBO). share. As reported in Table 4, inverted non-maker-taker exchanges.
pricing venues, which charge a fee to
The competitive environment that has passive limit orders and pay a rebate to Three exchange groups together make
emerged from the desire to attract marketable orders, accounted for only up a large majority of the market share
competitively priced liquidity 6% of traded share volume in January in the exchange landscape with the
contributes to the predominance of 2023. Flat venues accounted for roughly Nasdaq group (Nasdaq, BX, Phlx (PSX))
maker-taker pricing across exchanges.103 5% of traded share volume in January making up 30% of the market by trading
In January 2023, 9 of the 16 exchanges 2023. volume, the Intercontinental Exchange
employed maker-taker pricing and the It is likely that the lack of an incentive group (NYSE, NYSE American, NYSE
trading volume on those 9 exchanges to post limit orders in the form of a Arca, NYSE Chicago, NYSE National)
make up 89% of trading volume which transaction rebate contributes to the making up 34% and Cboe Global
occurred on the exchanges.104 As limited share of these non-maker-taker Markets (Cboe BZX, Cboe BYX, Cboe
discussed above in section I.B., venues. Conditional on the quoted price EDGA, Cboe EDGX) making up 24%.
TABLE 4—EXCHANGE TRADING VOLUME AND SHARE BY LIQUIDITY TYPE, JAN. 2023
[The following table breaks apart the total buy and sell executed order flow from all exchange members using a sample of CAT data for the
month of Jan 2023. Exchange members are identified as the set of unique CRD IDs in CAT which have directly routed orders to any of the
national equities exchanges in the month. Exchange member CRDs are also verified in the CAT Industry Member Identifier List daily ref-
erence data. For each exchange the number of shares executed under the CAT allowable trade capacities of Agency, Principal, and Risk-
less Principal are reported. Trade capacity in CAT is defined by the exchange member for its side of a trade and represents the capacity in
which the exchange member acted at trade time. Trades with the sale condition codes–M—Market Center Official Close, –Q—Market Center
Official Open, –V—Contingent Trade, –7—Qualified Contingent Trade (QCT), –8—Placeholder for 611 Exempt, and –9—Corrected Consoli-
dated Close (per listing market) were excluded. The share of total trading volume across all exchanges for orders of a specific capacity are
reported under the trading volume. The fourth column, ‘‘Total’’ reports the total trading volume for each exchange with the exchange’s vol-
ume-based exchange market share reported below.]
Riskless
Exchange Agency Principal Total
principal
Nasdaq b (Maker-Taker) ................................................................... 42,381,231,425 26,084,186,949 256,443,292 68,721,861,666

32.04% 24.37% 13.90% 28.50%
NYSE a (Maker-Taker) ..................................................................... 23,578,087,344 15,663,850,087 145,114,774 39,387,052,205
17.82% 14.64% 7.86% 16.33%
NYSE Arca a (Maker-Taker) ............................................................. 19,581,312,954 19,600,669,528 129,269,046 39,311,251,528
14.80% 18.31% 7.00% 16.30%
Cboe EDGX c (Maker-Taker) ........................................................... 13,478,973,097 12,512,933,159 677,345,568 26,669,251,824
10.19% 11.69% 36.70% 11.06%
Cboe BZX c (Maker-Taker) .............................................................. 9,612,667,056 10,242,339,878 367,462 19,855,374,396
7.27% 9.57% 0.02% 8.23%
MEMX (Maker-Taker) ...................................................................... 6,308,673,864 6,746,470,107 186,541,931 13,241,685,902
4.77% 6.30% 10.11% 5.49%
IEX ...................................................................................................
(Flat) ................................................................................................. 6,860,652,435 3,905,276,620 7,011,129 10,772,940,184
5.19% 3.65% 0.38% 4.47%
Cboe EDGA c ...................................................................................
(Inverted) .......................................................................................... 3,401,951,122 2,289,187,280 109,407,328 5,800,545,730
2.57% 2.14% 5.93% 2.41%
Cboe BYX c ......................................................................................
(Inverted) .......................................................................................... 1,950,854,778 2,582,413,642 131,506,520 4,664,774,940
1.47% 2.41% 7.13% 1.93%
that the exchange ends up with the best-priced limit to the price of a protected quotation). The 105 See supra section I.B (describing the different
order in a given symbol. prevention of trade-throughs means that marketable exchange pricing models).
102 See 17 CFR 242.611 (Rule 611). The rule 106 For a discussion of how long different
orders are more likely to be executed on trading
requires trading centers to ‘‘establish, maintain, and venues with competitively priced quotations at the exchanges spend quoting at the NBBO, see Phil
enforce written policies and procedures that are NBBO. Mackintosh, Three Charts That Show the
reasonably designed to prevent trade-throughs on 103 See supra note 15. Importance of a Competitive Bid/Offer NBBO (Dec.
that trading center of protected quotations in NMS 4, 2018), available at https://www.nasdaq.com/
104 See Table 4.
stocks’’ (a trade-through occurs when one trading articles/three-charts-that-show-the-importance-of-a-
center executes an order at a price that is inferior competitive-bid-offer-nbbo-2018-12-04.
TABLE 4—EXCHANGE TRADING VOLUME AND SHARE BY LIQUIDITY TYPE, JAN. 2023—Continued
[The following table breaks apart the total buy and sell executed order flow from all exchange members using a sample of CAT data for the
month of Jan 2023. Exchange members are identified as the set of unique CRD IDs in CAT which have directly routed orders to any of the
national equities exchanges in the month. Exchange member CRDs are also verified in the CAT Industry Member Identifier List daily ref-
erence data. For each exchange the number of shares executed under the CAT allowable trade capacities of Agency, Principal, and Risk-
less Principal are reported. Trade capacity in CAT is defined by the exchange member for its side of a trade and represents the capacity in
which the exchange member acted at trade time. Trades with the sale condition codes–M—Market Center Official Close, –Q—Market Center
Official Open, –V—Contingent Trade, –7—Qualified Contingent Trade (QCT), –8—Placeholder for 611 Exempt, and –9—Corrected Consoli-
dated Close (per listing market) were excluded. The share of total trading volume across all exchanges for orders of a specific capacity are
reported under the trading volume. The fourth column, ‘‘Total’’ reports the total trading volume for each exchange with the exchange’s vol-
ume-based exchange market share reported below.]
Riskless
Exchange Agency Principal Total
principal
MIAX Pearl (Maker-Taker) ............................................................... 1,803,716,409 2,527,733,474 153,910,919 4,485,360,802

1.36% 2.36% 8.34% 1.86%
NYSE National a ...............................................................................
(Inverted) .......................................................................................... 827,209,968 1,489,403,927 1,340,645 2,317,954,540
0.63% 1.39% 0.07% 0.96%
Phlx (PSX) b (Maker-Taker) ............................................................. 877,534,988 1,342,954,596 53,580 2,220,543,164
0.66% 1.25% 0.00% 0.92%
BX b ..................................................................................................
(Inverted) .......................................................................................... 713,708,890 965,538,116 32,818,578 1,712,065,584
0.54% 0.90% 1.78% 0.71%
NYSE American a (Maker-Taker) ..................................................... 712,130,625 818,767,495 14,185,250 1,545,083,370
0.54% 0.77% 0.77% 0.64%
NYSE Chicago a ...............................................................................
(Flat) ................................................................................................. 177,946,002 254,499,006 120,789 432,565,797
0.13% 0.24% 0.01% 0.18%
LTSE ................................................................................................
(Free) ............................................................................................... 10,749,491 1,411,063 0 12,160,554
0.01% 0.00% 0.00% 0.01%
Total .......................................................................................... 132,277,400,448 107,027,634,927 1,845,436,811 241,150,472,186

100.00% 100.00% 100.00% ............................
54.85% 44.38% 0.77%
a Part of NYSE/ICE Exchange group of exchanges.
b Part of the Nasdaq group of exchanges.
c Part of the Cboe group of exchanges.
The Commission estimates revenues revenue of $46,498,861,109 and a third of $19,391,292 for January 2023.112 The
generated from net transaction fees for exchange group had revenue of remaining two exchanges are not
the different exchange groups using $10,828,089.110 publicly-traded issuers and do not
volume-weighted average net capture The four exchanges outside of those publicly disclose their net capture rates.
rates which were made publicly three exchange groups made up the The Commission understands based on
available either through 10–Q filings or remaining 11.81% of the market in Staff conversations with industry
published online; the reported net January 2023. One exchange is a free members that the net capture for non-
capture rates are averages for all the exchange, meaning that it does not auction trading in stocks is likely close
charge access fees (nor does it pay out to $0.0002 per share and uses this
different transactions occurring across
transaction rebates) and hence does not assumed net capture rate when
the various equities exchanges in each
generate revenue from transaction net estimating the transaction revenues for
exchange group.107 The Commission capture fees.111 Another exchange these exchanges.113 Using the assumed
estimates that one exchange group had charges a flat fee of $0.0009 per share net capture of $0.0002, or 2 mils, the
revenue generated from net transaction to both liquidity providers and liquidity Commission estimates the January 2023
fees in its US equities exchanges of takers leading to net capture of $0.0018 transaction revenues for these two
approximately $37,347,258 in January and an estimated transactions revenue exchanges to be $2,648,337 and
2023,108 another exchange group had $897,072 respectively.114
transactions was approximately 4.5 mils in Q1 The maker-taker transaction pricing
107 The Commission is making the assumption 2023.
that the reported average net capture rates collected 109 Nasdaq did not report its net capture in its
model and higher rebates play an
from public disclosure hold for the trading volume Form 10–K filing, however, Nasdaq provides important role in attracting
reported in Table 4. The publicly sourced data information on its investor relations web page competitively priced quotes and
regarding average net capture rates for the which indicates that the average net capture across capturing market share, as suggested by
exchanges which are publicly-traded issuers all Nasdaq platforms for U.S. equities transactions
include the period of analysis, January 2023, as the in Q1 2023 was 6.4 mils. See Nasdaq 2023/2022
the market share statistics of Table 4.
disclosures pertain to Q1 2023. See infra notes 126, Monthly Volumes, NASDAQ, available at https://
112 See IEX pricing schedule, supra note 15.
127, 128. ir.nasdaq.com/static-files/465d2157-c476-4546-
108 The revenue numbers are calculated as the a9f7-8d7ad0c9be77. 113 The assumption that the remaining two
sum of the total trading volume for the venues in 110 Cboe reports in its Form 10–Q filing for the exchanges (MEMX & MIAX Pearl) earn an estimated
an exchange group reported in Table 4 by their three months ending Mar 31, 2023, that its net 2 mils net capture per transaction is in line with
average net capture rate. Intercontinental Exchange, capture for U.S. equities transactions was prior Commission discussions and would put them
the parent firm of NYSE, reports on page 38 of its approximately 1.9 mils for Q1 2023. in line with the net capture rate reported by the
Form 10–Q filing for the three months ending Mar. 111 The exchange, LTSE does not charge fees to Cboe group. See supra note 110.
31, 2023 that its net capture for U.S. equities transact. See supra note 15. 114 See supra note 98 defining the term ‘‘mil’’.
There are important factors which serve which also analyzed the Nasdaq expressed as a percentage of the total
to limit the liquidity of lower volume experiment.117 consolidated volume reported by one or
exchanges; these exchanges are not the Both the Nasdaq reports and the Swan all consolidated tapes for the month.121
primary listing market for any securities Study found that Nasdaq’s market share It is common that tier thresholds are
as they are newer, and they also tend to fell in traded stocks, with Nasdaq defined relative to the trading volume of
be more specialized or structured to reporting an average decline of 1.8 the market as a whole; it is seldom the
facilitate specific trading strategies. percentage points. The Swan Study case that tier thresholds are set as an
The idea that the maker-taker found that the Nasdaq share loss was absolute number of shares.
transaction pricing model and rebates captured by the two highest rebate- The Commission understands that
offered play an important role in paying stock exchanges. As the exchanges make use of volume-based
exchange market share is also supported experiment also reduced fees in tiers as a means of encouraging their
by the results of an experiment run by addition to rebates, the reported members to execute orders on their
one maker-taker exchange, Nasdaq, in reduction in market share was a net venue. Volume-based tiers encourage
which it reduced both its fees and effect of both reductions, it is likely that exchange members to concentrate, or
rebates. The experiment resulted in less the reduction in market share would be execute a larger share of their order
competitive liquidity being supplied to greater had access fees not also been flow, on the exchange in order to qualify
the exchange along with a decrease in reduced.118 Other factors which may for the higher rebates or lower fees
the exchange’s market share in the have contributed to the decrease in offered by higher volume pricing
treated stocks. That market share fell market share include the improved fill tiers.122
despite the reduction in transaction fees rates and fill times, as well as narrower The pricing terms of the tiers reserved
being greater than the reduction in effective and realized spreads net of for high volume exchange members may
rebates suggests that changes in the transaction rebates and fees on be subsidized through higher net
transaction pricing applicable to competing exchanges which were capture rates of lower-volume members
liquidity-providing order flow may have reported in the Swan Study. or via other lines of business such as
a greater effect on exchange market those earned from providing
b. Volume-Based Pricing Tiers connectivity and market data.123 The
share than similar changes in the
Stock exchange transaction pricing fact that many exchanges offer high-tier
transaction pricing applicable to
schedules often operate with a tiered rebates that exceed the Rule 610 access
liquidity-demanding order flow. In this
system that relies on the volume an fee cap in magnitude implies a need for
experiment, the exchange unilaterally
exchange member brings to the cross-subsidization to support these
reduced both access fees and rebates for
exchange to determine its transaction rebate tiers. In a 2018 roundtable on
a set of 14 stocks. Over the course of the
pricing tier for a given month. market data and market access, one
experiment Nasdaq reported a Qualification to different rebate and fee exchange that participated in the
significant drop in a number of liquidity tiers is determined at the end of each roundtable stated that five out of their
provision measures.115 Per the Nasdaq month and typically is based on a ten largest members by trading volume
reports, the average number of shares member’s average daily share volume receive payment from the exchange
displayed by Nasdaq at the NBBO in the for the month as a percentage of the even after factoring in the costs of
experiment declined by 45%, average total consolidated volume that connectivity and market data.124 This
time at the NBBO declined by 4.7 month.119 This kind of pricing method suggests that the rebates an exchange
percentage points from 92.7% to 88.0%, where exchanges offer different fee and pays to those members may be
liquidity share 116 fell from 29% to 19%, rebate levels to members based on the subsidized by the net transaction fees
and the share of liquidity provided by amount of trading volume each member paid by other exchange members or the
the exchange’s top five liquidity executes on the exchange is referred to fees paid for other services such as data
providers prior to the experiment as volume-based exchange transaction and connectivity.
decreased from 44.5% to 28.7%. These pricing.120 The tier threshold is often Newer or smaller exchanges may find
changes align with the findings of one it difficult to attract order-flow away
academic study (the ‘‘Swan Study’’) 117 See Yiping Lin, Peter Lawrence Swan, and
from the larger legacy exchanges given
Frederick H. deB. Harris, ‘‘Why Maker-Taker Fees that a sizable portion of order flow is
115 Nasdaq produced two reports concerning their Improve Exchange Quality: Theory and Natural
Experimental Evidence’’ (Mar. 14, 2019), available provided by the high-volume exchange
access fee experiment. See Frank Hatheway, Nasdaq
Access Fee Experiment (Mar. 2015), available at at https://ssrn.com/abstract=3034901 (retrieved
https://pages.stern.nyu.edu/∼jhasbrou/ from SSRN Elsevier database). 121 For example, an exchange may require a
SternMicroMtg/Old/SternMicroMtg2015/ 118 Conditional on compliance with Rule 611 and member to accumulate, on a specific tape, an
Supplemental/Access%20Fee%20Experiment%20- keeping all else equal, including other amount of adding trading volume (trade volume
%20Month%20One%20Report%20Final.pdf. See considerations of execution quality, traders from trades which executed against a member’s
also Frank Hatheway, Nasdaq Access Fee typically would prefer to route their marketable liquidity providing order) greater than X% of the
Experiment Report II (Mar. 2015), available at order to a trading venue with a lower access fee. total consolidated trading volume for that specific
https://pages.stern.nyu.edu/∼jhasbrou/ Thus, a reduction in access fees would help attract tape.
SternMicroMtg/Old/SternMicroMtg2015/ marketable orders and increase trading volume. 122 See infra section IV.B.2 for a discussion of the
Supplemental/Access%20Fee%20Experiment%20- 119 See supra note 17 (discussing the incentives introduced by volume-based pricing
%20Second%20Report%20Final.pdf (‘‘Nasdaq Commission’s Access Fee Proposal that would tiers.
Access Fee Experiment Report II’’). require exchanges to make the amounts of all fees 123 A flat pricing schedule does not allow an
116 ‘‘Liquidity Share’’ is a measure of an and rebates determinable at the time of execution, exchange to offer some traders a higher rebate
exchange’s displayed liquidity, factoring in both the which would require volume-based transaction (lower fee) by offering others a lower rebate (higher
frequency it is at the NBBO and the size of its quote. pricing tiers to be applied prospectively rather than fee). In principle the cross-subsidization of rebates
The calculation involves weighing the average size retroactively to the start of a month). from other business lines could occur in the
quoted by an exchange that is concurrently quoting 120 Volume-based tiers in trading often have absence of pricing tiers though this is likely to be
at the NBBO by the duration of time spent quoting different qualifications. For instance, some tiers more costly since the flat nature of the pricing
at the NBBO to yield a quantity which is referred require adding Average Daily Volume (‘‘ADV’’), schedule would mean that the trading of all
to as ‘‘Average Liquidity.’’ This value is then while others consider total ADV (both add and members would have to subsidized rather than,
divided by the total average liquidity of all remove volume), and some tiers are tape dependent. potentially, just the trades of the members which
exchanges quoting the stock to compute the There are also specific tiers for mid-point liquidity qualify for the preferential pricing tiers.
liquidity share. See Nasdaq Access Fee Experiment (‘‘MPL’’) orders, non-displayed limit orders, and 124 See Remarks of Chris Concannon, supra note
Report II, supra note 115. opening/closing auction trading, to name a few. 3, Transcript at 74–75.
members which qualify for the top tiers regard the range of volume-based closing auctions. For this reason, index
and similar terms would have to be discounts as a form of product funds and exchange-traded funds are
offered to those members to pull them proliferation, a preemptive strategy for motivated to concentrate flow in the
away. As previously discussed, limiting the range of profitable choices closing auctions so as to minimize
exchanges are able to use volume-based available for newer and smaller tracking errors.129
pricing as a means of increasing the exchanges. Reminiscent of behavior by Listing exchanges operate closing
rebates earned by a few high-volume established firms when attempting to auctions that set an official closing price
exchange members often at the expense corner the market across other industry for their listed securities.130 This makes
of members with less trading volume; settings,127 the range of pricing bundles them an obvious means by which a
the lack of a large trading base could offered by the dominant exchanges may market participant can get its trades
make it difficult to profitably subsidize likewise have partial exclusionary executed at the official closing price.
the top tiers from the trades of other effects. Some alternatives do exist, for example,
exchange members. Smaller or newer c. Tying Closing Auction Fees to some broker-dealers may offer to
exchanges looking to compete with Consolidated Volume internalize customer orders at the
larger exchanges would find it difficult closing auction price,131 once it is
to compete with larger exchanges by The daily closing price of NMS determined on the listing exchange.
cutting transaction fees. In the case of a equities is typically established by Another example of an alternative is the
maker-taker exchange, cutting take fees means of the closing auction, which is pre-match close offered by one exchange
may require lower rebates for liquidity run at the end of each trading day by the for market-on-close orders.132 However,
provision by lowering the degree to primary listing exchange for the if a market participant wishes to execute
which those rebates can be funded via respective equity. Because of the an on-exchange trade at the official
take fees. Cutting make rebates relative significance of the closing price to a closing price determined by the primary
to those offered on other exchanges variety of financial market functions, listing exchange, and use a limit-on-
would likely hamper an exchange’s including the measuring of tracking close order for that trade, the only
tendency to attract competitively priced error in index funds, many market option is to send that order to the listing
limit orders putting the exchange in a participants are highly desirous of exchange’s closing auction.
competitively disadvantageous position. executing trades at precisely the daily Some primary listing exchanges
In the case of an inverted or flat venue, closing price, an outcome that can be implement closing auction pricing tiers
cutting make fees could help an facilitated by participating in the closing that involve discounts which are based
auction on the listing exchange. Listing
exchange attract more liquidity however on the member’s overall trading volume
exchanges may be able to exploit this
because these exchanges by their very on the same exchange.133 Specifically,
demand for participation in the closing
nature, charge fees rather than pay the exchange pricing schedule is such
auction by offering discounts on auction
rebates to liquidity providers, makes that higher consolidated volume (overall
orders to members who send volume
them less attractive as a venue to post volume from both auctions and regular
into the intraday trading sessions. This
a competitive quote, all else being equal. trading hours) helps broker-dealers
practice may help listing exchanges
Alternatively, smaller or newer qualify for more favorable fees and
preserve or extend their market power,
exchanges could try to compete with the rebates on auction orders. Industry
potentially at the expense of reducing
larger maker-taker exchanges on the practitioners refer to ‘‘auction linked
the welfare of the exchange members.
basis of offering larger make rebates, A number of factors contribute to high pricing’’ as a discount on auction orders
lacking substantial trading volume and growing 128 demand for based on the continuous trading
could make cross-subsidization of participation in closing auctions. One volume.134 This practice is a form of
rebates difficult possibly meaning that significant reason for this is that an tying or conditional pricing. The related
the exchange may need to operate their important performance metric for literature, referenced in the following
trading business at a loss in order to passive funds, the tracking error, is tied paragraph, has shown that tying can
match or beat the top rebates of other to the daily closing price set by these reduce competition and has potential
exchanges.125 The lack of a similar
membership base, trading volume, and 127 See Jean Tirole, The Theory of Industrial
129 Yanbin Wu, ‘‘Closing Auction, Passive
data and connectivity subscribers make Investing, and Stock Prices,’’ supra note 128.
Organization, 346–52 (1988) for a discussion of 130 The exchanges that currently have listings are
it difficult for smaller exchanges to leading firms’ incentive to pack the product space
Nasdaq, NYSE, NYSE Arca, and Cboe’s BZX. See
sustainably provide volume-based tiers so as constrain the market niche for new or minor
firms. A motivating example is ‘‘the Swedish Cboe’s ‘‘The Impact Closing Auctions Have on
competitive with the top tiers offered by Tobacco Company, upon losing its legal monopoly Volumes’’ (Nov. 18, 2020), available at https://
the largest exchanges. position in 1961, reacted by offering twice as many www.cboe.com/insights/posts/the-impact-closing-
auctions-have-on-volumes/.
An alternative view on the complexity brands.’’ Id. at 346. Dominant firm’s preemptive
131 Staff experience suggests that some broker-
of pricing schemes offered by the decision to introduce a menu of latent choices is
also analyzed in Yong Chao, Guofu Tan, and Adam dealers aim to enhance their volumes and attract
dominant exchange families 126 is to Chi Leung Wong, ‘‘Optimal Nonlinear Pricing by a flow by guaranteeing the listing market’s official
Dominant Firm under Competition’’, 14 Am. Econ. closing price at no additional cost.
125 For example, a new exchange in 2020 132 See https://www.cboe.com/us/equities/
J.: Microeconomics 240 (May 2022).
implemented a pricing schedule with high rebate 128 For S&P 500 stocks, the daily average fraction trading/offerings/cboe_market_close/.
tiers which would generate losses while the venue of a stock’s closing auction trades over total shares 133 See Nasdaq Rule 118(d)(2): Section 118.
tried to establish market share. See Shanny Basar, traded increased from 3.5% in 2010 to 10% in 2018. Nasdaq Market Center Order Execution and Routing
New Exchange MEMX Details ‘Smart’ Pricing See Yanbin Wu, ‘‘Closing Auction, Passive for a description of Nasdaq closing auction tiers that
Structure (Sept. 15, 2020) available at https:// Investing, and Stock Prices,’’ 9 (Aug. 2019), include volume criteria based on continuous
www.tradersmagazine.com/am/memx-unveils- available at https://papers.ssrn.com/sol3/ volume: https://listingcenter.nasdaq.com/rulebook/
smart-pricing-structure/. papers.cfm?abstract_id=3440239. Another source nasdaq/rules/Nasdaq%20Equity%207#section_
126 Most of the public exchanges are organized reports that the shares that the NYSE closing 118_nasdaq_market_center_order_execution_and_
based on families of affiliated exchanges, where the auctions commanded doubled over a five-year routing.
exchanges within a family are owned by the same period to nearly 7% of NYSE-listed volume in 134 MEMX comment letter to Regulation NMS:
holding company but may employ distinct business recent years. See ‘‘Behind the Scenes—An Insider’s Minimum Pricing Increments, Access Fees, and
models (e.g., charging a ‘‘make’’ fee on taker-maker Guide to the NYSE Closing Auction,’’ available at Transparency of Better Priced Orders, https://
exchanges or a ‘‘take’’ fee on maker-taker https://www.nyse.com/article/nyse-closing-auction- www.sec.gov/comments/s7-30-22/s73022-20163328-
exchanges). insiders-guide. 333796.pdf.
exclusionary effects. There is a lack of Because of the high value placed on gains from executing trades during the
consensus within the economic executing in the closing auction closing auction but who might
literature on the anti-competitive described above, listing exchanges are otherwise have lower valuation for
potential of offering price discounts for able to offer a relatively unique trading intraday trading on that exchange.
allocating a target purchasing level in a mechanism. This is in contrast to While the exchanges may benefit from
bundled goods context. However, the intraday trading, where the orders may auction-linked pricing, the impact on
theoretical literature has provided potentially interact with multiple broker-dealers and their customers is
examples arguing that tying the sales of trading platforms.140 The use of volume ambiguous. In general, depending on
a monopolized or dominant product to discounts that apply across both the particular situation price
other product(s) can be a profitable way mechanisms may enable the listing discrimination can either increase
for a firm to protect its market power, exchanges to leverage their position as consumer welfare or decrease it.
oftentimes through partially foreclosing the sole primary listing exchange and Nevertheless, a significant number of
the more competitive portion of the provider of a closing auction to increase academic studies have found that
market to competitors.135 In other order flow to their intraday trading.141 bundling decreases consumer
imperfectly competitive market settings, As described above, the economic surplus.144 Consumer surplus (i.e.,
offering more generous terms for literature shows that this may reduce consumer welfare), is typically defined
purchasing a bundle of different goods the welfare of the exchange members. as the net benefit the buyer derives from
can also result in greater producer In addition to leveraging market his optimal consumption bundle, after
surplus.136 Bundling arrangements may power, the economic literature suggests adjusting for the price he incurs from
have partial exclusionary effects when a that bundling can increase exchange his preferred purchase.
dominant firm takes advantage of its profit by averaging (through aggregating)
2. Volume-Based Tiers and Order
captive (non-contestable) portion of consumer preferences.142 To the extent
Routing Incentives
demand and ties its captive demand that broker-dealers differ in their
with part of its contestable demand.137 willingness to participate in the closing Volume-based tiering serves
More generally, both the theoretical and auction and intraday trading, tying exchanges by incentivizing their
empirical literatures have offered execution fees for the closing auctions members to concentrate their order-flow
evidence that bundling, or offering to total volume may help the listing onto their platform. The following
discounts for purchasing a portfolio of exchanges capture greater demand from analysis presents evidence consistent
different goods, can result in greater a segment of the participants. By with this notion.145 Maker-taker
producer surplus,138 but sometimes at drawing in broker-dealers who might exchanges with a higher number of
the expense of consumer surplus.139 otherwise have little interest in pricing tiers are not only larger but have
The same forces analyzed in the participating on one of the venues (e.g., a higher proportion of their members
literature on bundling and tying may be closing auction or intraday trading), the execute a plurality of their order flow on
present in the case of listing exchanges listing exchanges may earn greater their platform; plurality members are
and their closing auction discounts. revenue than what would be possible also responsible for a greater proportion
with component (unbundled) pricing for of the trading volume executed on these
135 Dennis W. Carlton and Michael Waldman, closing auction and intraday trading. exchanges. The analysis also finds that
‘‘The Strategic Use of Tying to Preserve and Create To the extent exchanges are engaged individual member order flows are on
Market Power in Evolving Industries,’’ 33 Rand J. in imperfect competition for order flow average more concentrated than they
Econ. 194 (Summer 2002). Michael D. Whinston,
‘‘Tying, Foreclosure, and Exclusion’’, 80 Am. Econ. across heterogeneous broker-dealers, would be had their executed order flow
Rev. 837 (Sept. 1990). See also a discussion of tying bundling as a product differentiation been split in line with the relative
from W. Kip Viscusi, Joseph E. Harrington, and strategy could also help a listing market shares of the exchanges. Order
David E. M. Sappington, Economics of Regulation exchange extract more order flow.143 flow deviations from the relative market
and Antitrust, Chapter 7 Vertical Mergers and
Vertical Restraints, 296–312 (5th ed. 2018). Yong
Auction linked pricing may be weights which contribute to higher
Chao, Guofu Tan, and Adam Chi Leung Wong, ‘‘All- particularly effective in attracting order concentration measures tend to be those
Units Discounts as a Partial Foreclosure Device’’, 49 flow from broker-dealers who value which place more weight on maker-
Rand J. Econ. 155 (2018). taker exchanges with the most pricing
136 For example, in the context of firms competing
140 The introduction of Reg NMS, in particular the
tiers.
to attract demand from customers who differ in Order Protection Rule, requires investors to interact
their preferences over different goods, some firms The use of volume-based pricing tiers
with the exchange(s) offering the most favorable
may use bundling as a way differentiate their execution prices throughout the regular trading
by exchanges can affect the routing
products, and thereby soften price competition. For session. decisions of their members through the
a numerical example of bundling as a way for firms 141 Specifically, tying closing auction fees to incentives it introduces. Volume-based
to differentiate their products in a price intraday trading encourages broker-dealers who
discrimination context see Paul Belleflamme and pricing encourages members to
value participation in the closing auction to direct
Martin Peitz, Industrial Organization: Markets and more order flow to the primary exchanges, in order
concentrate their order flow on
Strategies, Chapter 11.3.1 Bundling as a Way to to benefit from volume-based discounts during the exchanges where members hope to
Soften Price Competition, 274 (2010). closing auctions. increase their chances of qualifying for
137 By tying part of the competitive portion to its
captive portion, the dominant firm draws sales

142 Chenghuan S. Chu, Phillip Leslie, and Alan
a preferential pricing tier. Qualifying for
Sorensen, ‘‘Bundle-Size Pricing as an a better pricing tier can result in both
away from its capacity-constrained rival in Yong Approximation to Mixed Bundling’’, American
Chao, Guofu Tan, and Adam Chi Leung Wong, ‘‘All- Economic Review 101, 263–303 (2011). Gregory S.
Units Discounts as a Partial Foreclosure Device’’, 49 Crawford, ‘‘The Discriminatory Incentives to 144 Consumer surplus is the analog of investor
Rand J. Econ. 155 (2018). Bundle in the Cable Television Industry’’, 6 surplus from the exchange setting.
138 Katherine Ho, Justin Ho, & Julie Holland
Quantitative Mktg. & Econ. 41 (2008). Katherine Ho, 145 Throughout this section the analysis relies on
Mortimer, ‘‘The Use of Full-Line Forcing Contracts Justin Ho, & Julie Holland Mortimer, ‘‘The Use of a population of only 16, a small sample reduces the
in the Video Rental Industry’’, 102 Am. Econ. Rev. Full-Line Forcing Contracts in the Video Rental statistical confidence (the probability that an
686 (2012). Industry’’, 102 Am. Econ. Rev. 686 (2012). estimated quantity is not the result of random
139 Yong Chao, Guofu Tan, and Adam Chi Leung 143 For a numerical example of bundling as a way chance) in the estimation of any relationships
Wong, ‘‘All-Units Discounts as a Partial Foreclosure for firms to differentiate their products in a price between variables. Despite this limitation, the
Device’’, 49 Rand J. Econ. 155 (2018). Gregory S. discrimination context see Paul Belleflamme and evidence presented in this section is consistent
Crawford, ‘‘The Discriminatory Incentives to Martin Peitz, Industrial Organization: Markets and with volume-based price tiering promoting the
Bundle in the Cable Television Industry’’, 6 Strategies, Chapter 11.3.1 Bundling as a Way to concentration of order flow rather than resulting
Quantitative Mktg. & Econ. 41 (2008). Soften Price Competition, 274 (2010). from random chance.
saving on transaction costs (or even member customers access to the the number of tiers on an exchange.
profiting from net rebates), and exchanges.146 Panel A of Table 5 shows that the
potentially obtaining a competitive The following table examines the average share of member order flow
advantage in the market to provide non- relationship between market share, the which is directed to the exchange tends
average share of member order flow, and to be greater for exchanges with more
tiers, in particular the maker-taker
146 See infra section IV.B.4 (discussing the market exchanges.
to provide exchange access to non-members). BILLING CODE 8011–01–P
Table 5 - Exchange Tiers, Pricing, Market Share, and Plurality Members
This table lists out market share,# of tiers, base rebates and fees, and order flow concentration statistics
for the 16 national equities exchanges using the total executed buy and sell order flow from all
exchange members using a sample of CAT data for the month of Jan. 2023. Exchange members are
identified as the set of unique CRD IDs in CAT which have directly routed orders to any of the national
equities exchanges in the month. Exchange member CRDs are also verified in the CAT Industry
Member Identifier List daily reference data. For each exchange the number of shares executed under
the CAT allowable trade capacities of Agency, Principal, and Riskless Principal are reported. Trade
capacity in CAT is defined by the exchange member for its side of a trade and represents the capacity
in which the exchange member acted at trade time. Trades with the sale condition codes-M - Market
Center Official Close, -Q - Market Center Official Open, -V- Contingent Trade, - 7 - Qualified
Contingent Trade (QCT), -8 - Placeholder for 611 Exempt, and-9 - Corrected Consolidated Close (per
listing market) were excluded. Market share measures are pulled from Table 4 and the number of tiers
correspond to the count of the number of tiers reported are collected from the exchange price schedules
which were effective for the month of Jan. 2023 in the same method as for Table 1.
Panel A: Base Rebates and Average Member Order flow shares. Base Rebate and Fees correspond
to the default pricing for orders which do not qualify for any tiers listed on an exchange' s pricing
schedule. Average member order flow share is a simple average of the proportion of trading volume
that an exchange member executed on the exchange relative to the total trading volume across all the
other exchanges they are a member of. Member order flow share is calculated as the number of shares
executed by an exchange member during regular trading hours over the month of Jan. 2023 divided by
the total number of shares the exchange member executed across all national stock exchanges during
regular trading hours over the month of Jan. 2023.
Avg
Market # of Base Member
Exchange Base Fee
Share Tiers Rebate Orderflow
Share
Nasdaq 28.46% 74 -30 13 51.52%
NYSE 16.45% 93 -30 12 35.43%
NYSE Arca 16.28% 72 -30 20 31.59%
Cboe EDGX 11.04% 19 -30 16 15.28%
Cboe BZX 8.22% 26 -30 16 14.17%
MEMX 5.48% 13 -30 20 8.59%
MIAX Pearl 1.86% 8 -29 29 3.41%
Phlx (PSX) 0.92% 4 -30 20 5.89%
NYSE American 0.64% 10 -30 20 4.82%
IEX 4.46% 0 -9 0 22.58%
Cboe EDGA 2.40% 8 -30 16 7.59%
Cboe BYX 1.93% 11 -20 2 3.88%
NYSE National 0.96% 11 -29 0 1.30%
BX 0.71% 20 -30 -7 0.94%
NYSE Chicago 0.18% 0 -10 0 10.28%
LTSE 0.01% 0 0 0 0.01%

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Panel B: Plurality Members and Plurality Order flow. A plurality member for an exchange is any
exchange member who executes the largest share of their order flow on that exchange. For each
exchange member the member order flow share (described above in panel A) is computed for every
exchange for which they are a member of, the member is considered to be a plurality member for the
exchange for which their member order flow share is highest. Exchange members are identified as the
set of unique CRD IDs in CAT which have directly routed orders to any of the national equities
exchanges in the month. Exchange member CRDs are also verified in the CAT Industry Member
Identifier List daily reference data. The "percent of plurality members" is computed as the proportion
of exchange members who are plurality members. "Average plurality order flow share" is a simple
average of the proportion of order flow executed on the exchange across plurality members only.
"Volume Due to Plurality members" is the proportion of exchange total volume which is attributable to
plurality members. The last column, average number of exchanges of plurality members ("Avg # of
Exgs of Plurality Members"), is a simple average of the number of exchanges for which a plurality
member is a member of.
Average Volume Avg# of
Percent of
Market # of Plurality Due to Exgs of
Exchange Plurality
Share Tiers Orderflow Plurality Plurality
Members
Share Members Members
Nasdaq 28.46% 74 64.71% 70.35% 89.93% 5.9
NYSE 16.45% 93 29.21% 91.47% 17.97% 2.7
NYSE Arca 16.28% 72 31.48% 64.75% 15.98% 5.4
Cboe EDGX 11.04% 19 11.76% 64.48% 11.83% 4.9
Cboe BZX 8.22% 26 7.69% 89.79% 0.16% 2.3
MEMX 5.48% 13 3.85% 52.53% 1.02% 9.5
MIAX Pearl 1.86% 8 2.78% 30.48% 1.77% 10
Phx (PSX) 0.92% 4 4.44% 100.00% 0.06% 1
NYSE American 0.64% 10 3.70% 100.00% 0.49% 1
IEX 4.46% 0 22.99% 79.08% 10.17% 4.5
Cboe EDGA 2.40% 8 5.56% 98.46% 0.01% 1.3
Cboe BYX 1.93% 11 1.41% 100.00% 0.01% 1
NYSE National 0.96% 11 0.00% 0.00%
BX 0.71% 20 0.00% 0.00%
NYSE Chicago 0.18% 0 10.00% 100.00% 0.62% 1.0
LTSE 0.01% 0 0.00% 0.00%
BILLING CODE 8011–01–C smallest three maker-taker exchanges, discussed in section IV.B.1, the
Panel A of Table 5 shows that an with a combined market share of 3.42%, evidence presented here is consistent
exchange’s market share is more have a volume-weighted average base with the notion that tiered rebate rates
associated with the number of pricing rebate of 23.7 mils which is are more important than the base
tiers than they are with either the base substantially larger than the 13.5 mil rebates. This is not to suggest that
fee or rebate. The coefficient of average base rebate for the three largest merely having a greater number of
correlation between the number of tiers maker-taker exchanges which make up pricing tiers would result in greater
and market share is 0.87 whereas the over 60% of the market. On the other market share but rather that if the
coefficients of correlation of market hand, Table 5 shows a clearer number of tiers serves as a viable proxy
share with the base fee and rebate are correspondence between the count of for how important tiering is for an
¥0.34 and 0.20 respectively. Focusing tiers on a maker-taker exchange’s price exchange’s pricing then the apparent
on the maker-taker exchanges, the base schedule and its market share with the association between the market share
take fees are all set at 30 mils with a three largest exchanges having a
and number of tiers is consistent with
single exception at 29 mils. Among the volume-weighted average of 61 tiers and
the hypothesis that tiers incentivize the
maker-taker exchanges there does not the three smallest maker-taker
appear to exist a clear relationship exchanges having 3.4 tiers on average.
between the base rebate paid out and an To the extent that rebates may play a
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exchange’s observed market share. The role in order-routing considerations, as
concentration of order flow and increase equal to the median number of tiers pro-rata HHI is computed for each
market share.147 (<=11) is 1.46%. The average proportion individual exchange member and
Consistent with the idea that price of plurality member trading volume for category of order flow using the relative
tiering incentivizes the concentration of the three largest exchanges by number market shares of exchanges, this
order flow, there appears to be a of tiers, 41.8%, is roughly 20 times the contrasts with the member HHI
positive association between the average for every other exchange, computation which is calculated with
number of tiers on an exchange’s pricing 2.01%. the relative share of the member’s order
schedule and that exchange’s share of It is important to note that these flow. The pro-rata HHI has a
members which execute at least a observations do not prove a causal straightforward interpretation; it reflects
plurality of their trading volume on the relationship between tiering and market what an individual member’s HHI
exchange; the correlation coefficient share and the Commission would have been had it distributed its
between the two variables is 0.76. Panel acknowledges that there may exist other order flow across its member exchanges
B of Table 5 reports statistics regarding factors that could drive the patterns in proportion to their relative market
those exchange members which execute observed. For instance, it may be the shares.151
a plurality of their trading volume on case that maintaining a complex pricing
each exchange. The three exchanges schedule may be costly and, as a result, Deviations in the share of order flow
with the largest number of tiers on their exchanges with larger market shares routed to an exchange from the relative
pricing schedules have an average of may find it more feasible to employ a market weight can either contribute to
41.8% of their members executing at pricing schedule with more tiers than an increasing or decreasing member HHI
least a plurality of their trading volume exchange with a smaller market share. relative to the pro-rata HHI.152 Most
on the exchanges. This is in contrast Another reason for differences in market order flow deviations which contribute
with the 3 exchanges with no tiering for share across exchanges could be the to higher order flow concentration are
which 11% of members, on average, widely documented fact that stocks associated with maker-taker exchanges
execute a plurality of their orders on trade more heavily on their primary with more pricing tiers and these
their exchanges. Restricting to those listing venue particularly with respect deviations are positive and of larger
exchanges with price tiering, the three to trading at the close.149 magnitude relative to those of other
exchanges with the lowest number of The following analysis directly exchanges. In contrast, deviations in
tiers have an average of 4.26% of their measures the degree of concentration for order flow which contribute to lower
members sending them a plurality of the order flow of individual members HHI measures tend to be negative for the
order flow. Three exchanges (NYSE and examines how they deviate from a maker-taker exchanges with the highest
National, BX, LTSE) did not have any market benchmark on average. The number of pricing tiers and are positive
members with a plurality of their Herfindahl-Hirschman Index (HHI) is for the other exchanges. This is to say
trading volume on the exchanges and employed to gauge the degree to which that when broker-dealers concentrate
for three other exchanges (Phlx (PSX), each individual exchange member their order flow, they tend to increase
NYSE American, and NYSE Chicago) diversifies or concentrates its order flow the share of order flow sent to those
the only members which execute a across the exchanges of which it is a exchanges with more pricing tiers,
plurality of their orders on those member. The HHI is widely used for consistent with the notion that tiering
exchanges do so only because they did measuring market concentration or promotes the concentration of order
not execute any order flow on any other dispersion.150 Member HHIs are flow. Table 6 reports each exchange’s
exchange.148 Moreover ‘‘plurality computed based on the relative order share of the total order flow deviations
members’’ constitute a greater share of flow dispatched to the exchanges by the which either increase or decrease
the total exchange trading volume for individual exchange member. This concentration and the volume-weighted
exchanges with more tiers relative to calculation is performed for each average size of the deviation for each
those with fewer tiers. The measure of exchange member’s principal orders, the exchange.
correlation between the number of combination of agency and riskless BILLING CODE 8011–01–P
pricing tiers and the share of exchange principal orders, as well as their overall
volume from plurality members is 0.64. order flow. 151 To illustrate the computation of member and
For exchanges with above median The concept of a ‘‘pro-rata HHI’’ is pro-rata HHIs consider the case of a broker-dealer
number of tiers (≤11) an average of introduced to serve as a benchmark that directs principal orders to three different
19.56% of their total trading volume which encapsulates the inherent exchanges they are a member of. If the broker-dealer
sends 60% of their principal order flow to one
originate from plurality members disparities in market shares among exchange and 20% to each of the other two, then
whereas for exchanges with less than/ exchange. As with the member HHI, a the broker-dealer’s member HHI for their principal
orders be 0.44 (0.602 + 0.202 + 0.202). If the relative
147 Aside from order flow concentration, higher 149 See Maureen O’Hara, and Mao Ye ‘‘Is Market market share for the exchanges, using the
rebate/lower fee pricing tiers could increase trading Fragmentation Harming Market Quality?’’, 100 J. executions of principal orders, are 30%, 30%, and
volume and therefore market share by incentivizing Fin. Econ. 459 (2011). 40% then the pro-rata HHI would be 0.34. In this
the submission of limit orders which would have 150 The HHI is generally calculated as the sum of case because the member HHI of 0.44 is greater than
otherwise not been submitted absent the tiers. squared weights which normally add up to one. The the pro-rata HHI of 0.34, then the member
148 A plurality member is defined for a particular HHI ranges from (0,1) with lower values indicating concentrates their order flow to a greater degree
than would be expected had they routed their order
exchange as a member who executes the largest a more even split between the constituent weights
share (a plurality) of their order flow on that and higher values indicative of a more uneven flow in accordance to exchange size.
exchange. If a broker-dealer is a member of only one distribution with a max value of one indicative of 152 Overall, the executed member order flow was
exchange they are necessarily a plurality member of a single entity with a 100% weight. Conditional on more concentrated relative to the pro-rata HHI. For
that exchange since 100% of the order flow they the number of entities N, the lowest possible HHI the month of Jan. 2023, the volume-weighted
execute across all the exchanges (for which they are value is 1/N which corresponds to the case when average pro-rata HHI was 0.18 whereas the volume-
a member) occur on that exchange. all weights are equal to one-another (equal to 1/N). weighted average member HHI was 0.20.
Table 6 - Order flow deviation from relative market weights and shares of deviating order flow
The following table splits deviations in exchange member order flow from their relative market
benchmark into those which increase or decrease member order flow concentration using the
sample of CAT data for the month of Jan. 2023 described in Table 4." Member order flow share is
calculated as the number of shares executed by an exchange member in any capacity (e.g.
principal, agency, riskless principal) during regular trading hours over the month of Jan. 2023
divided by the total number of shares the exchange member executed across all national stock
exchanges during regular trading hours over the month ofJan. 2023. The share volume-weighted
average deviation (in percentage points) for deviations which increase concentration and decrease
concentration are reported under columns "Avg Deviation From Market", this is the difference
between the percentage of order flow sent to the exchange by members and the relative market
share of that exchange for that member. Columns titled "Share of Deviating Flow" denotes the
share of total deviating order flow which either increases or decreases member concentration.
Increase Concentration Decrease Concentration
Share of Share of
Avg Deviation Avg Deviation
Exchange # of Tiers Deviating Deviating
From Market From Market
Flow Flow
NYSE 93 13.2% 20.7% -3.7% 15.3%
NSDQ 74 19.2% 39.8% -4.8% 50.6%
ARCA 72 7.4% 13.4% -3.3% 14.2%
BZX 26 2.3% 3.9% -1.6% 0.9%
EDGX 19 9.3% 11.9% -2.8% 6.8%
MEMX 13 3.2% 3.7% 1.2% 0.6%
AMER 10 -0.2% 0.0% 1.7% 0.4%
PEARLEQ 8 2.3% 0.3% 2.9% 2.8%
PSX 4 3.4% 0.3% 6.0% 1.9%
BX 20 -0.3% 0.0% 1.7% 0.5%
NSX 11 -0.5% 0.0% 2.7% 1.2%
BYX 11 -0.6% 0.1% 2.2% 1.8%
EDGA 8 3.6% 1.2% 1.9% 1.2%
IEX 0 7.4% 4.8% 1.9% 1.7%
CHX 0 -0.1% 0.0% 1.0% 0.1%
LTSE 0 0.0% 0.0% 0.0% 0.0%
• For each exchange member (index i) a deviation from the relative market weight for an exchange (index})
is defined by the difference dy=Sy-My where Sy denotes the share of member order flow and My denotes the
relative market weight. Share of member order flow Sy is calculated as the order flow executed by the
member i on exchange j divided by the total order flow executed by member i across all the exchanges they
are a member of. The relative market weight My is calculated as the total order flow executed on exchange
j divided by the sum of total order flow executed across all the exchanges for which i is a member. N;
denotes the number of exchanges that the exchange member i is a member of. Conditional on My> JIN;, a
deviation dy contributes to a decreased member HHI if 2(My-JINJ<dy<O and increases it otherwise.
Conditional on My< JIN;, a deviation dy contributes to a decreased member HHI if O<dy<2 (My-JINJ and
increases it otherwise. In the case My= JIN; then any deviation dy>O would contribute to a greater member
HHI. The size of a deviation is calculated as the product between the deviation dy and total share volume
member i executed on the exchange.
BILLING CODE 8011–01–C 3. Routing Incentives and Potential exchanges introduces a potential
Conflicts of Interest conflict of interest between exchange
members and their non-member
In the case of agency-related volume customers without exchange access.
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the use of volume-based pricing tiers by
Volume-based pricing for agency order members directly benefit from fees tend to be associated with lower fill
flow may give exchange members an qualifying for a better tier since the rates and execution speeds for non-
incentive to route customer order flow preferential pricing would not only marketable orders, and standing limit
to certain exchanges for the purposes of extend to their own principal orders but orders directed to high take-fee
tier qualification rather than would also improve their ability to exchanges tend to face greater adverse
maximizing other aspects of execution attract more customer flow by allowing selection costs.158 One academic paper
quality. The Commission finds evidence them to pass through more savings. The makes the claim that brokers typically
that agency and riskless principal order concentration of agency order flow has route customer limit orders to
flow is overall more concentrated than the potential to be costly to the exchanges where the broker will receive
principal order flow; however, relative customers of exchange members if it a rebate and that the rebate is typically
to the relevant benchmark HHI, comes at the cost of other factors of not passed on to the customer.159
principal order flow is more execution quality such as fill rates, time Another study examining four high
concentrated.153 However, Commission to execution, the availability of better- volume retail brokers which appear to
analysis suggests that the lower priced liquidity, and the likelihood of route all nonmarketable limit orders in
principal concentration is due in part to being adversely selected, each of which a manner consistent with maximizing
less concentration in marketable orders may vary across exchanges. However, it rebates find that the expected rebate
compared to similar agency-related may not always be the case that revenue offered by high take-fee venues
order flow.154 Additionally concentration for the purpose of tier may be insufficient to justify the
concentration of order flow may not qualification comes at the expense of opportunity cost, or potential loss in
always be contrary to customer the customer, particularly if the member execution quality concurrently available
interests. It is therefore unclear if passes through large proportions of the on low take-fee venues.160
differences in order flow concentration cost savings from the tier qualification, Member broker-dealers may have an
between principal and agency order then the reduction in costs for incentive to profit to the detriment of
flow are attributable to broker-dealers customers may on-balance leave the the customer by choosing to concentrate
acting on the conflict of interest. customer better off. agency orders onto a limited number of
The potential for a conflict of interest In contrast, when exchange members specific exchanges not because routing
emerges since broker-dealers can trade for their own account using to those specific exchanges is
typically enjoy the benefits of the principal orders, the incentives of the necessarily in the interests of the
qualifying for a better pricing tier as a members are more straightforward. A customer but rather to increase the
result of concentrating customer order member can choose to route an order to member’s chances of qualifying for a
flow without having to internalize the a particular exchange primarily out of a particular volume-based pricing tier
costs of that concentration.155 Exchange desire to make a profitable trade or to without necessarily passing some or all
concentrate order flow and obtain a of the benefits of doing so back to the
153 The overall member HHIs for principal order volume discount at its own customer.161
flow is 0.21 whereas it is 0.24 for agency+riskless discretion.156
principal order flow; relative to their benchmark Results from relevant academic There are forces in the market for
pro-rata HHI the principal member HHI is 31%
research suggest that routing customer equity brokerage services that serve to
greater whereas agency member HHI is 11% greater limit the extent to which this conflict of
than its benchmark. See infra Table 7. The order flow in a rebate maximizing
benchmark pro-rata HHIs differ between the two manner comes at the cost of execution interest can alter behavior. For example,
since the principal pro-rata HHI is computed using quality. Brokers routing limit orders because of the Order Protection Rule, a
relative market weights taking only into account
may also be motivated by liquidity broker-dealer looking to concentrate
principal orders whereas the relative market order flow on a particular exchange
weights used for the agency pro-rata HHI are rebates. Different sources document that
computed using only agency or riskless principal limit order execution quality tends to be could not do so if doing so resulted in
order flow. For a more detailed discussion of the lower on exchanges with high take fees trading through the NBBO. In addition,
calculations of member and pro-rata HHIs see supra
and low make rebates.157 Execution the Commission understands that it is
section IV.B.2. common for some institutional
154 The Commission finds that the member HHI quality can be measured along the
customers to monitor their broker-
for principal order flow computed using only different dimensions of fill rates,
liquidity taking orders was 0.19 whereas it was 0.24 dealers on a trade-by-trade basis which
execution speeds, realized spreads, and
for agency order flow. When member HHI is would be expected to influence order
adverse selection costs. Higher access
calculated using only liquidity making orders it was routing decisions.
0.24 for principal order flow and 0.26 for agency
order flow. execution quality for agency orders and potential
158 Execution quality of non-marketable orders
155 Contracting solutions/payment arrangements rebate revenue for both agency and principal orders.
between a broker and its customer may mitigate but Meanwhile, investors typically only partially accrue decreasing on exchanges with high take-fees is
not fully eliminate the incentive conflict. Investors the rebates/transaction fees on agency orders under expected as liquidity takers tend to route their
may have difficulty in fully assessing execution negotiated arrangements with their brokers. marketable orders to venues with the lowest take
quality, and broker-dealers may sacrifice execution 156 The member would still be subject to certain fees, all else equal.
159 See James J. Angel, Lawrence E. Harris, and
quality on agency order flow, especially in restrictions such as the Order Protection Rule.
situations where firms have concentrated sufficient 157 See Costis Maglaras, Ciamac Moallemi, and Chester S. Spatt, ‘‘Equity Trading in the 21st
principal order flow on an exchange to be near top- Hua Zheng, ‘‘Optimal Execution in a Limit Order Century’’, 1 Q. J. Fin. 1 (2011).
160 See Robert Battalio, Shane Corwin, and Robert
tier thresholds. If additional agency flow helps the Book and an Associated Microstructure Market
broker-dealer cross the threshold for achieving a Impact Model,’’ (working paper May 13, 2015), Jennings, ‘‘Can Brokers Have It All? On the Relation
desirable tier, the broker-dealer has an incentive to available at https://papers.ssrn.com/sol3/ between Make-Take Fees and Limit Order
direct agency orders to the exchange. In doing do, papers.cfm?abstract_id=2610808 (retrieved from Execution Quality’’, 71 J. Fin. 2193 (Oct. 2016).
the broker-dealer could be trading off limit order SSRN Elsevier database). 161 See supra note 155.
TABLE 7—EXCHANGE MEMBER AND PRO-RATA HHI FOR OVERALL, AGENCY OR RISKLESS PRINCIPAL, AND PRINCIPAL
ORDER FLOW
[This table uses a sample of CAT data of NMS stocks traded on the national equities exchanges for Jan. 2023 and reports share volume-weight-
ed measures of market and member HHI values using all, agency-related, and principal order executions.a See Table 4 for a description of
how exchange members are identified as well as how agency, riskless principal, and principal transactions are identified. The table also re-
ports the percentage difference between member and pro-rata HHIs; this is calculated as the difference between the member HHI and pro-
rata HHI divided by the pro-rata HHI. Also reported are the share volume-weighted average HHI measures for different order capacities
using only liquidity taking orders (Remove) and liquidity making orders (Add). The CAT liquidity categories specify if the side of the trade
was adding or removing liquidity. As the HHI measurement is influenced by the number of entities involved in its calculation, market and
member HHIs are also separately calculated among broker-dealers who are members of many (>10) and few (<=10) exchanges.]
HHI HHI
Order capacity Pro-rata HHI Member HHI % Difference (remove) (add)
Overall (100%) ............................ All ................................................................ 0.18 0.20 16 0.18 0.23

Agency Or Riskless Principal ...................... 0.22 0.24 11 0.24 0.26
Principal ....................................................... 0.16 0.21 31 0.19 0.24
>10 Exchanges (95%) ................. All ................................................................ 0.16 0.18 14 0.16 0.20
Principal ....................................................... 0.15 0.19 32 0.18 0.22
<=10 Exchanges (5%) ................ All ................................................................ 0.48 0.61 27 0.57 0.61
Principal ....................................................... 0.38 0.48 29 0.45 0.49
a For a more detailed discussion of the calculations of member and pro-rata HHIs see section IV.B.2.
Table 7 reports the volume-weighted member HHI is calculated over a low flows are likely to be more responsive
average market and member HHIs number of exchanges. For instance, the to any changes in the market.
derived from the individual exchange HHI will, by definition, be equal to one
4. The Market To Provide Exchange
members. Consistent with section when the broker-dealer is a member of
Access
IV.B.2, individual members appear to be a single exchange meaning that 100% of
more concentrated (0.20) than would be its order flow is executed on that single Broker-dealer exchange members
expected by the relative market shares exchange.163 Consistent with this, Table compete to provide access to the
of the exchanges (0.18). Both market and 7 shows that the various HHI measures exchanges for investors, as well as for
member HHIs computed using agency or are generally greater when calculated for proprietary traders and other broker-
riskless principal trades are greater than broker-dealers with 10 or fewer dealers who give up orders to an
they are when using only principal exchanges of which they are a member. exchange member. There is significant
order flow in absolute terms. However, For the subset of broker-dealers with 10 variation in the size of the exchange
when measured relative to their or fewer exchanges the differences members, as measured by total order
benchmarks, agency related member between principal and agency flow. In each of these markets, volume-
HHI is only 11% greater than the pro- concentration measures are greater. based transaction pricing for agency-
rata HHI whereas principal member HHI While agency-related order flow related volume may provide a
is 31% greater.162 Broker-dealers appears to be more concentrated than competitive advantage to the larger
typically have more discretion when principal order flow it deviates less exchange members.
routing non-marketable orders since the from its respective benchmark pro-rata a. The Current Effect of Volume-Based
routing of non-marketable orders is not HHI measure than principal order flow. Tiers on the Market for Broker-Dealer
directly constrained by the Order This result suggests that the broker- Services
Protection Rule. Therefore, the fact that dealers who concentrate their principal
the difference between agency-related order flow do so on a greater variety of The tiered transaction pricing
and principal HHIs appears to be venues whereas agency order flow schedules create competitive advantages
smaller when only considering the across broker-dealers should for high-volume broker-dealers in the
execution of non-marketable limit concentrate more on the same market to provider brokerage services to
orders suggests that the observed exchanges across broker-dealers.164 As investors. These tiered schedules may
differences in concentration between the pro-rata HHI encapsulates also be contributing to a trend of
agency-related and principal order flow commonalities in the distribution of increased concentration in the executing
may not be driven by routing decisions order flow, larger deviations from the broker industry.
taken where broker-dealers have the pro-rata HHI suggest that distribution of The current equities exchange tiered
most discretion. order flow is less dependent on those transaction pricing schedules create
As the HHI measurement is commonalities. For this reason, the differences in the fees and rebates
influenced by the number of entities Commission believes principal order applied across members. Tiered
involved in its calculation, market and transaction pricing currently affords
member HHIs are separately calculated 163 It is worth noting that a broker-dealer can still high-volume broker-dealers
among broker-dealers who are members route orders through to an exchange of which it is substantially cheaper trading, placing
not a member but would have to do so through an them at a competitive advantage over
of many (>10) and few (<=10) intermediary which is a member of the target
exchanges. This approach ensures a exchange, and that order flow would count towards
the smaller firms. One commenter
more accurate representation of market the trading volume of the intermediary member suggested that ‘‘[a] smaller firm’s trading
concentration since the average HHI rather than the original broker-dealer. costs for any given trade on an exchange
could be skewed by instances where the
164 If broker-dealers all choose to concentrate
may be 30% or more of the costs of a
order flow in the exact same proportions on the larger competitor—for the exact same
same choice of exchanges, then the market and
162 A possible explanation of this could be that member HHI would be equal. If instead broker- trade.’’ 165 Lower-volume exchange
there may be a greater degree of correlation between dealers chose to concentrate their order flow on
agency trading decisions than between trading different exchanges then the difference between 165 Letter from Tyler Gellasch, President and CEO,
principal trades. market and member HHI would be large. Healthy Markets Association to Mr. Brent J. Fields,
members may be providing a subsidy for the fixed costs of being an executing investments in infrastructure (e.g.,
a handful of the high-volume broker. In contrast, broker commission trading algorithms), connectivity (low
members.166 One exchange group pools and rates that have long been in versus high latency), and market data
suggested that its highest volume decline because, as some broker-dealers tend to be fixed costs that do not scale
members receive rebates exceeding the have become more efficient through in proportion of trading volume. High-
trading fees, data, and connectivity fees automating most trades, competition for volume broker-dealers tend to have
combined.167 A representative of one customers forced other broker-dealers to lower trading costs, in part due to
exchange group has stated that ‘‘[there streamline or offer price cuts.172 In volume-based pricing, which better
are just the] top 10 firms across our four addition, high-volume broker-dealers position them to offer lower
exchanges by market share. [. . .] Five may be better positioned to attract commissions or fees.177 If these lower
of the top 10 get a check from us after customers through performance along fees allow them to attract greater order
the costs of their connectivity and dimensions other than commission. For flow from customers and non-member
market data. So we are cutting them a example, high-volume broker-dealers broker-dealers, they will be able to
check monthly after their costs. [. . . At may be better equipped with attain more favorable pricing tiers.
the same time, the] top 10 firms on our algorithmic tools and other technologies Thus, volume-based transaction
exchange eat up 50 percent of the that facilitate execution quality, or they discounts create a self-reinforcing cycle
capacity on our exchanges.’’ 168 While may be better positioned to bundle that amplifies the competitive advantage
the highest volume traders are either execution services with other offerings, of the members with the highest existing
trading at heavily discounted rates or such as research. According to one volumes. This self-reinforcing cycle may
making a profit from exchange survey from 2021, because of the large be further exacerbated to the extent to
transaction rebates, the revenue to brokers’ various perceived strengths, which lower-volume exchange
supply such discounts may come, in 28% of buy-side asset managers members, or their customers, find it
part, from lower-volume broker-dealers anticipate doing more business with more economically viable to route
who do not qualify for volume high-volume brokers versus only 10% orders through a higher volume
discounts.169 who expected less.173 In sum, increasing exchange member which can qualify for
There has been increased concentration in the broker/dealer space more preferential pricing tiers. Some
concentration in the executing broker hints at competitive pressure to observer(s) express concern that
industry in recent years.170 A number of constrain fees and ‘‘barriers to entry volume-based exchange transaction
factors may be contributing to this based on necessary scale to be able to pricing that favors the high-volume
trend. According to an industry source, absorb the fixed costs of infrastructure, broker-dealers helps to erect significant
data and connectivity costs have been market data and connectivity.’’ 174 The barriers to entry for lower-volume
trending upwards,171 which increases number of registered broker-dealers broker-dealers.178
declined by over 20% between 2015 and Broker-dealers may be motivated to
Secretary, Commission, dated Nov. 13, 2018, at 5 2022, or by close to 1,000 from an initial offer lower commission fees or partially
(‘‘Healthy Markets 2018 Letter’’), available at value of 4,450 in 2022.175 The decline pass through their transaction price
https://www.sec.gov/comments/s7-03-20/s70320-
7235195-217095.pdf. in the number of broker-dealers is advantages, in part because certain
166 See, e.g., Chester Spatt, ‘‘Is Equity Market consistent with the Commission’s classes of investors are sensitive to
Exchange Structure Anti-Competitive?’’ at 7 (Dec. understanding that the broker-dealer changes in their trading costs or cum-
28, 2020) available at https://www.cmu.edu/tepper/ community has seen no salient growth rebate commission rates. Lower broker
faculty-and-research/assets/docs/anti-competitive- commission rates may provide
rebates.pdf and at 5 (describing rebate pricing tiers
of nascent firms in recent years.
based upon relative volume as ‘‘advantaging large Volume-based transaction pricing may incentives for sell-side institutional
vs. small brokers’’ and citing a letter from the further contribute to this trend of customers to place more orders through
Honorable Ted Budd, the Honorable Alex Mooney, increased concentration. Under volume- the broker-dealer providing liquidity, as
and the Honorable Ann Wagner, Congress, to
Chairman Jay Clayton, Commission, dated Jan. 31,
based exchange transaction pricing, the opposed to pursuing other strategies
2020 for its criticism of the role of pricing tiers in top volume broker-dealers’ lower such as taking liquidity, posting the
disadvantaging small brokers), and Healthy Markets trading costs give them an advantage same order on dark pools, or using
2018 Letter, supra note 165, at 5, observing that as when competing for customers against special order types. Likewise,
lower-volume and medium-sized exchange
members pay relatively higher transaction fees (and
smaller members.176 Specifically, proprietary trading firms are known to
receive relatively lower rebates), they may be cross- change their trading patterns with
subsidizing the exchange transaction pricing 172 See U.S. Institutional Equity Trading Study
benefits enjoyed by high-volume broker-dealers. (Feb. 2021), available at https://assets.bbhub.io/ transaction pricing advantages of high-volume
The sentiment that the only high-volume exchange professional/sites/10/2021_02-Market-Structure- broker-dealers. If exchange transaction pricing
member’s transaction prices are heavily subsidized Buyside-Survey-US.pdf. qualifications were based on absolute volume
is also expressed by IEX in ‘‘Why Exchange Rebate 173 See id.
thresholds, it could increase the number of lower-
Tiers are Anti-Competitive’’, available at https:// 174 Norges Bank comment letter ‘‘Re: Notice of volume members that benefit from rebates. In
www.iex.io/article/why-exchange-rebate-tiers-are- Proposed Rule on Market Data Infrastructure, contrast, relative volume qualifications effectively
anti-competitive. Securities Exchange Act Release No. 88216 (Feb. 14, put broker-dealers in a race against each other.
167 Chester Spatt, ‘‘Is Equity Market Exchange
2020) (File No. S7–03–20)’’, dated July 15, 2020, at 177 For example, hedge funds that trade large
Structure Anti-Competitive?’’, supra note 166, at 7. 3, available at https://www.sec.gov/comments/s7- volumes would be directly impacted by the size of
168 Remarks of Chris Concannon, supra note 3, 03-20/s70320-7422691-219826.pdf. exchange transaction rebates if they have negotiated
Transcript at 74–75. 175 See U.S. Securities and Exchange Commission pass-through arrangements with the sell-side
169 Healthy Markets 2018 Letter, supra note 165,
Fiscal Year 2024 Congressional Budget Justification, broker-dealers they use to access exchanges,
at 5. available at https://www.sec.gov/files/fy-2024- through which they pay on a ‘‘cost plus’’ basis.

170 Norges Bank comment letter ‘‘Re: Notice of congressional-budget-justification_final-3-10.pdf, Since the exchange transaction rebates would flow
Proposed Rule on Market Data Infrastructure, which reports there being 3,538 registered broker- back to these investors, higher exchange rebates
Securities Exchange Act Release No. 88216 (Feb. 14, dealers in 2022 which is down from the 4,450 incentivize hedge funds to direct order flow to the
2020) (File No. S7–03–20)’’, dated July 15, 2020, at registered broker-dealers in 2015. See U.S. top-tiered broker-dealers.
3, available at https://www.sec.gov/comments/s7- Securities and Exchange Commission Fiscal Year 178 One lower-volume broker-dealer’s expressed
03-20/s70320-7422691-219826.pdf. 2015 Congressional Budget Justification, available concerns to the Commission that the decrease in the
171 See Securities Industry & Financial Markets at https://www.sec.gov/about/reports/ number of brokers is reflective of the lower-volume
Association, An Analysis of Market Data Fees, secfy15congbudgjust.pdf. broker-dealers’ inability to qualify for better volume
available at https://www.sifma.org/resources/ 176 The use of relative volume thresholds based discounts. Healthy Markets 2018 Letter, supra note
general/an-analysis-of-market-data-fees/. on total consolidated volume reinforces the 165, at 5.
changes in broker commission rates. the 16 exchanges for the month of exchange transaction price tiers allow
One reason for their commission price January 2023. The coefficient of the lower-volume broker-dealers to
responsiveness, the Commission variation, applied to total dollar volume share in some or all of the volume-based
understands, is that some active defined as shares times trade price, tiers of high-volume broker-dealers if
proprietary trading firms may profit ranges from 1.48 to 3.11 across they receive pass-through exchange
from exchange transaction rebates on exchanges for the same month. For both transaction pricing, subject to the costs
some exchanges. Comparing the relative measures of dispersion, the ratios they pay to the sponsor for those
sizes of exchange transaction rebates suggest that the standard deviation of services. Thus, within these markets,
and broker commissions, average broker dollar volume is as large as the mean high-volume broker-dealers have certain
commissions tended to range from 0.65 across all firms. Moreover, the standard competitive advantages over lower-
to 2.67 cents per share in 2020.179 Since deviation of dollar volume across volume broker-dealers that helps to
the base tiers for exchange rebates tend members can be 3 times as large as account for their size. While a number
to be capped at roughly 0.3 cents per within-exchange average. of factors are involved, volume-based
share, exchange transaction rebates for Higher rebate earned enables the transaction pricing for agency-related
high-volume broker-dealers could be largest exchange members to attract a volume contributes to the competitive
more than 10 percent of average disproportionate share of order flow advantages of high-volume broker-
commissions. Considering that from non-members, further exacerbating dealers.
exchange transaction rebates from high- their competitive advantage over One reason that lower-volume broker-
volume members can be non-trivial smaller exchange members. Pricing dealers and proprietary traders that are
compared to the average broker arrangements for non-member’s not broker-dealers may rely on the
commissions, high-volume broker- exchange access services can be ‘‘cost broker-dealers that are exchange
dealers may effectively attract order plus’’, meaning that all or a portion of members to provide access and
flow by sharing portion of the rebates or the access fee and rebates get passed on connectivity to exchanges is the
offering lower commissions. While the to non-members, with an additional fee substantial fixed costs associated with
current trend of consolidation may be for connecting to an exchange. exchange connectivity and data. Market
concurrent with lower prices for Competition among direct market access data and connectivity fees, together with
investors and better service, increased (‘‘DMA’’) providers constrains the fee exchange membership, have increased
market power among the high-volume for non-members’ exchange access to a substantially in recent years and can be
broker-dealers could eventually lead to narrow band of 0.5 to 2 mils per share, significant enough to raise entry cost
increased costs for investors. When the and one source suggests that DMA concerns.182 While the cost to maintain
dominance of high-volume broker- providers may offer the service free.180 exchange membership tends to fall
dealers becomes sufficiently heightened, Considering that top tiers across between $5,000 and $10,000 on the
it is conceivable that dominant broker- exchanges lead to rebates exceeding 3 exchanges with the largest market share,
dealers may eventually choose to mils, the cost for direct market access proprietary exchange market data fees
exercise market power more may be modest compared to the highest and fees for the most closely-connected
aggressively. As a manifestation of the rebates and justifies non-members’ connectivity to the exchange’s matching
more general principle that a monopoly decisions to route through the largest engine can range from thousands to tens
(or players with market power) tends to exchange members. Large exchange of thousands or more per month.183 One
charge prices higher than what is members’ market power in DMA study reports that the fees for depth of
provision amplifies their competitive book data on some exchanges have
socially optimal, large broker-dealers
advantage over smaller exchange increased more than tenfold from 2010
may raise commission fees. Doing so
members, as the added liquidity accrued to 2018,184 while a commenter on a
may result in a decline of trading
from non-members helps the exchange
volume facilitated by broker-dealers and
members achieve even more favorable 182 Norges Bank comment letter ‘‘Re: Notice of
a shrinkage of total surplus across Proposed Rule on Market Data Infrastructure,
tiers.
investors. In addition to competing for order Securities Exchange Act Release No. 88216 (Feb. 14,
2020) (File No. S7–03–20)’’, dated July 15, 2020, at
b. The Market To Provide Exchange flow from investors, broker-dealers also 3, available at https://www.sec.gov/comments/s7-
Access to Non-Member Broker-Dealers compete to provide sponsored access to 03-20/s70320-7422691-219826.pdf.
exchanges for other entities, such as 183 Exchanges can extract more profits from data
Substantial differences in the sales by offering ‘‘low-latency’’ access to data feeds,
broker-dealers or proprietary traders.
exchange transaction pricing applicable such as additional monthly fees for the opportunity
Executing broker-dealers also compete to co-locate their computers in physical proximity
across members with different volume
to receive order flow from other brokers to the exchange’s own computer. This practice is
echoes in the dramatic difference in size who do not interact with the exchanges known as ‘‘co-location’’, and co-location fees alone
across those members. One measure of themselves. Through direct market and can cost traders tens of thousands per month. See
the dispersion of trading activities sponsored access services, investors and
New York Stock Exchange’s Connectivity Fee
across members on an exchange is the Schedule, available at https://www.nyse.com/
other lower-volume broker-dealers publicdocs/Wireless_Connectivity_Fees_and_
coefficient of variation, applied to choose to route orders through high- Charges.pdf. Co-location fees are separate from fees
shares executed or total dollar volume. volume broker-dealers. Among the for accessing individual exchange’s proprietary
The coefficient of variation for member- benefits from doing so,181 the current
data, which can amount to thousands per month.
level shares summarizes the standard See An Analysis of Market Data Fees (Aug. 2018),
available at https://www.sifma.org/wp-content/
deviation of firm’s total monthly shares 180 See Daniel Aisen, ‘‘Connecting to the Stock uploads/2019/01/Expand-and-SIFMA-An-Analysis-
relative to the average across members Market (Choosing a DMA Partner)’’ (Mar. 2021), of-Market-Data-Fees-08-2018.pdf. According to
on an exchange. The coefficient of available at https://medium.com/prooftrading/ IEX’s description of its market data fees, the
connecting-to-the-stock-market-choosing-a-dma- maximum monthly cost for ‘‘low-latency’’ (super-
variation, or ratio of standard deviation fast) data subscription is around $3,500. IEX’s
partner-9176ccd3ce84 (‘‘[i]t’s gotten to the point
to mean, ranges from 1.6 to 2.45 across where if you trade a fair amount of volume, you can report on its market data fees is available at https://
probably find a good DMA provider who will offer www.sec.gov/rules/sro/iex/2022/34-96331.pdf.
179 See U.S. Institutional Equity Trading Study you the service for free [. . .]’’). 184 See An Analysis of Market Data Fees (Aug.
(Feb. 2021), available at https://assets.bbhub.io/ 181 See supra section IV.B.4.b for a discussion of 2018), available at https://www.sifma.org/wp-
professional/sites/10/2021_02-Market-Structure- the benefits for small broker-dealers to send orders content/uploads/2019/01/Expand-and-SIFMA-An-
Buyside-Survey-US.pdf. via high-volume exchange members. Analysis-of-Market-Data-Fees-08-2018.pdf.
proposed exchange fee stated in 2016 providers constrains the fee for non- 1% of the shares from members at the
that fees for connectivity and co- member’s exchange access to a narrow 75th percentile on a single exchange.
location have also escalated during an band of 0.5 to 2 mils per share, and The proportion of exchange order flow
overlapping time period.185 some providers may offer the service for attributable to members between the
Moreover, high-volume exchange less.187 Considering that top tiers across 25th percentile and 75th percentile is no
members’ size and scale affords them exchanges lead to rebates exceeding 30 more than 12 percent on each exchange.
the resources that permit them to hire mils, nonmembers’ cost for direct Comparable ranges apply to trading
the expertise required to develop and market access may be modest compared activities measured by a member’s total
use the smart order routing technologies to the highest rebates and potential cost dollar volume defined as shares times
necessary to trade competitively in the savings achieved. As with the market to trade price. Comparing the ratios of the
NMS stock market. Lower-volume provide broker-dealer services to 25th percentile to 75th percentile across
market participants may lack the investors, these lower costs lead to more exchanges, dollar volume from the
economies of scale to operate their own volume from non-members. The broker- exchange member at the 25th percentile
smart order routers, and may need to dealer is more able to qualify for the is as small as less than 1% and no
purchase those services from the high- best tiers, further lowering costs and greater than 12% of dollar volume at the
volume broker-dealers that are exchange exacerbating its competitive advantage 75th percentile. When one restricts the
members. Some proprietary traders and over lower-volume exchange members. analysis of order flow to liquidity-
lower-volume broker-dealers, who may adding activities on maker-taker
otherwise be deterred from becoming c. The Dispersion of Member Broker-
Dealer Size exchanges, order flow is similarly
members of and trading directly on the concentrated. On several exchanges, the
exchanges, can benefit from the high- The fact that there are a range of member from the 25th percentile of the
volume exchange members’ access and different sizes by order volume for dollar volume (or shares) distribution
sophisticated systems, and may exchange members is an assumption executed trades that are less than 1% of
otherwise find it difficult to grow their that enters into the analysis that the the dollar volume (or shares) of the 75th
business or to compete on equal terms Commission is presenting on the percentile member on the same
with those members. economic effects of the proposed rule. exchange. Across exchanges, the ratio of
Another reason behind lower-volume In this section, the Commission presents the 25th to 75th percentile trading
broker-dealers’ and proprietary traders’ analysis showing the existence of such activities is no more than 10%. The
reliance on exchange members may be a dispersion in broker-dealer size. substantial differences in trading
that the smaller firms cannot One measure of the dispersion of
activities between high-volume and the
individually qualify for the fee and trading activities across members on an
tail of lower-volume exchange members
rebate levels that exchanges offer to exchange is the coefficient of variation,
applied to shares executed or total are consistent with an earlier
their high-volume exchange members.
dollar volume. The coefficient of observation that the broker-dealer space
Rather than becoming members of and
variation for member-level shares is highly concentrated.188
trading directly on exchanges, the
smaller firms can benefit from sending summarizes the standard deviation of 5. Lack of Tier Transparency
orders to exchanges via high-volume firm’s total monthly shares relative to
exchange members to share in a portion the average across members on an There is no public transparency about
of the larger members’ volume-based exchange. The coefficient of variation, the number of firms that qualify for the
pricing advantage, subject to any costs or ratio of standard deviation to mean, different tiers across exchange
or commissions.186 It is likely that ranges from 1.6 to 2.45 across the 16 transaction pricing schedules. This lack
volume-based transaction pricing exchanges for the month of January of transparency may limit the ability of
creates an advantage for the high- 2023. The coefficient of variation, members, other exchanges, and the
volume broker-dealers in attracting such applied to total dollar volume defined public to submit informed comment on
order flow. Because high-volume as shares times trade price, ranges from exchange pricing proposals and draw
broker-dealers tend to qualify for the 1.48 to 3.11 across exchanges for the conclusions about the effects of all
highest tiers, they effectively have lower same month. Both measures of exchange transaction pricing including
costs when offering sponsored access or dispersion suggest that the distribution volume-based transaction pricing tiers.
execution services to other brokers. of member’s trading level has Knowing how many exchange members
Competition among these sponsored considerable variability about its qualify for different pricing tiers would
access and direct market access exchange’s mean, with the standard provide interested parties with insight
deviation of dollar volume being as into how the costs and benefits afforded
185 See Letter from David L. Cavicke, Chief Legal large as the mean across all exchanges. by volume-based tiers are distributed
Officer, Wolverine Trading LLC, Wolverine Moreover, the standard deviation of across exchange members. This
Execution Services LLC, and Wolverine Trading knowledge would allow market
Technologies LLC to Mr. Brent J. Fields, Secretary, dollar volume across members can be 3
Commission, dated Dec. 23, 2016. times as large as within-exchange participants to submit more informed
186 For example, pricing arrangements between average. comments to the Commission by
members and non-members for sponsored and For further evidence of the large allowing them to better compare the
direct market access services can be ‘‘cost plus,’’ disparities in trading activities across pricing they receive to their competitors
meaning that the sponsoring broker-dealer passes and better ascertain if a pricing schedule
through to the non-member customer all or a broker-dealers, one can compare order
portion of the exchange transaction fees and rebates volume of exchange members at the disproportionately favors certain
for which it qualifies, with an additional fee 25th percentile and at the 75th participants.
charged for connecting to an exchange. A Exchanges are required to provide
sponsoring member whose total volume qualifies
percentile on each exchange. For trading
for a high tier would have more to offer through activities measured by shares executed information on their websites that detail
such arrangements than a lower-volume member. in the month of January 2023, shares the pricing schedules for trading on the
See Daniel Aisen, ‘‘Connecting to the Stock Market from exchange members at the 25th exchange.189 These documents include
(Choosing a DMA Partner)’’ (Mar. 2021), available
at https://medium.com/prooftrading/connecting-to-
percentile can be as little as less than
188 See supra section IV.B.4.a.
the-stock-market-choosing-a-dma-partner-
9176ccd3ce84. 187 See id. 189 See supra note 7 and accompanying text.
the various tiers that market participants of whether such limited qualification for and highest per unit fee.195 The context
might qualify for, along with the tiers occurs. of non-volume based pricing among
associated fee or rebate. exchanges is more complex, as
C. Economic Effects
The current transaction pricing exchanges can condition prices on other
practices of the exchanges in the market 1. Effect of the Proposed Ban on broker-dealer characteristics. However,
for NMS stocks is characterized by a Volume-Based Tiers for Non-Principal similar findings from the price
large number of different pricing Orders discrimination literature may prevail,
possibilities. These possibilities arise, in a. Benefits and price differentials across broker-
part, because fees and rebates for trades dealers may be diminished under a
i. Benefits To Lower Volume Exchange
are often contingent on multiple factors volume-based ban. The smallest and
Members
including, the order types used in the medium-sized members, who currently
trade, and whether the trade takes place We expect the proposal to yield some pay higher transaction fees, would
in opening or closing auctions with benefits to lower-volume exchange likely benefit from these ‘‘intermediate’’
additional discounts for volume-based members, some of which would be prices, or prices that are less extreme
tiers. The combination of the large passed on to investors who are their relative to a setting where exchanges
number of pricing contingencies on customers. In particular, to the extent target low net transaction fees to high-
many of the exchanges and the number that the differences in transaction fees volume broker-dealers and high fees to
of different exchanges in the market would be less extreme under the
lower-volume broker-dealers.196
creates a large number of different proposed prohibition on volume-based
pricing possibilities for market pricing for agency-related volume in The proposed prohibition on volume-
participants to consider when choosing proposed Rule 6b–1(a), the proposed based pricing may result in an increase
where to route orders.190 volume-based ban would result in in agency order flow to medium-sized
benefits to lower-volume exchange exchange members, due to their ability
The volume-based tiers 191 used in
members in the form of lower to divert business from direct market
many exchange pricing schedules are
generally based on a member’s trading transaction fees and higher rebates. In access customers. Under the current
volume relative to the market’s total response to the proposed prohibition of tiered pricing schemes, lower-volume
trading volume in the month in which volume-based pricing for agency-related broker-dealers with limited or no ability
the market participant’s trades take order flow, exchanges could set fees on to route directly to exchanges are most
place. This means that the member faces agency-related orders that are between likely to take advantage of the high-
the current highest fees charged in the volume members’ connectivity and
a degree of uncertainty during the
lowest volume tiers and the lowest fees tiers. In particular, because direct
month about the precise tier it will be
charged in the highest volume tiers paid market access (DMA) pricing tends to be
able to achieve on the exchange during
by the high-volume broker-dealers. Such ‘‘cost plus,’’ 197 lower transaction fees/
the month.
an outcome is supported by results from higher rebates for the high-volume
The complexity and number of the the price discrimination and mechanism
various tiers, along with the frequency exchange members may translate into
design literatures,194 applied to settings lower fees for sponsored broker-dealers.
with which they change,192 creates the where trading platforms (i.e., firms
possibility that for some tiers, only a The proposed ban on volume-based
making pricing decisions) face tiers, which would limit transaction fee
few market participants qualify in a heterogeneous customers and may offer
given month. It may even be the case differentials between the high-volume
different prices depending on broker-dealers and the remaining
that some tiers only have a single observable choices or observable
market participant that ultimately players, would also lessen the pricing
customer characteristics. For models
qualifies for them in a given month on advantage of high-volume members
where firms may potentially sort
a specific exchange.193 If only one or a when competing for DMA customers.
customers based on volume, when
small number of members regularly Hence one consequence of removing the
comparing firm’s optimal choices under
qualify for a particular pricing tier it price discrimination and restricting to a high-volume exchange members’ tiered
may suggest that an exchange’s pricing uniform price, prohibiting price pricing advantage is that agency flow
schedule is structured to reserve the tier discrimination oftentimes results in the from direct market access customers
for the benefit of particular members. new, flat per unit fee falling within the may shift from the high-volume
Pricing tiers of this manner could serve current range of the lowest per unit fee
to entrench the dominant position of 195 It is worth acknowledging that while charging
some members and contribute to the 194 ‘‘Price an ‘‘intermediate’’ price is a plausible outcome, it
discrimination’’ is a term of art in
is by no means the only outcome. The Commission
competitive imbalances between economics, meaning charging different prices to
believes an ‘‘intermediate’’ price to be a likely
exchange members. Because of the lack different segments of consumers, sometimes for
identical goods or services. Under price outcome given the wide range of order volume
of transparency with regards to ex-post discrimination, consumers could be segmented across broker-dealers, described in supra section
tier qualification, the public is unable to based on their choices of different goods or services. IV.B.4.c. See W. Kip Viscusi, Joseph E. Harrington,
and David M. Sappington, Economics of Regulation
assess whether there are tiers for which The practice of price discrimination is not
and Antitrust 365–70 (5th ed. 2018), for a simple
only one or a few market participants equivalent to unfair discrimination in the legal
sense. The welfare consequence of price setting with a numerical example. Alternatively,
qualify. The Commission believes that discrimination is ambiguous and can vary across when trading venues are optimally setting prices in
many market participants are not aware industry settings. However, a number of empirical standard screening settings with private ‘‘types’’
papers have found that when restricting to a across customers, optimal contracts for trading
constant price, customers previously enjoying the venues implies price discrimination. See Patrick
190 See RBC Letter, supra note 19, at 8 (‘‘Our
lower prices are worse off and those enjoying higher Bolton and Mathias Dewatripont, Contract Theory
analysis identifies at least 1,023 pricing paths prices are better off, relative to a world where firms 47–52 (2005), for a general reference.
across the exchanges.’’). can vary prices with the customers’ price- 196 This benefit may be, in part, a transfer from
191 See supra sections I.B and IV.B.1 (discussing
sensitivity. See, e.g., Igal Hendel, and Aviv Nevo, the large-volume broker-dealers, who would end up
volume-based pricing tiers). ‘‘Intertemporal Price Discrimination in Storable paying more under this pricing arrangement. See
192 See supra section I.B (discussing changes to, infra section IV.C.1.b.i (discussing costs to high-
Goods Markets’’, 103 Am. Econ. Rev. 2722 (2013);
and general complexity of, pricing schedules). Guillermo Marshall, ‘‘Hassel Costs and Price volume broker-dealers from this effect).
193 See Healthy Markets Letter, supra note 165, at Discrimination: An Empirical Welfare Analysis’’, 7 197 See Daniel Aisen, Connecting to the Stock
5. Am. Econ. J.: Applied Econ. 123 (2015). Market (Choosing a DMA Partner), supra note 180.
exchange members to the medium-sized support their functionalities. Consistent orders, including customer orders, to
exchange members. with that understanding, the average certain exchanges to qualify for better
exchange has 34 members who tiered pricing on those exchanges.200 A
ii. Benefits to Investors
contribute up to 99% of its dollar prohibition on volume-based
Proposed Rule 6b–1(a) may benefit volume, where the average is taken over transaction pricing would remove this
investors by increasing competition the 16 exchanges for the month of incentive. As a consequence of the
among exchange members. The January 2023.199 This observation aligns proposed rule, broker-dealers may focus
advantages afforded to high-volume with the fact that substantial economies on execution quality for their customers
broker-dealers through volume-based of scale are required to build expensive in making routing decisions without the
exchange transaction pricing may favor SORs with significant operational and influence of volume-based exchange
a more concentrated market structure in regulatory risks. Consequently, while transaction pricing, which may result in
the market for brokerage services in there is gradation in execution quality improved execution quality.
NMS stocks. The removal of volume- among exchange members, the Lower exchange transaction fees 201
based pricing tiers for agency-related difference in capability is more that could result from the proposed rule
order flow would reduce the pricing pronounced between the 30 or so large and that better facilitate the survival of
advantage afforded to higher volume or medium-sized exchange members smaller brokers may result in benefits to
exchange members for having more with both functional SORs and fast investors through increasing the variety
customer order flow. Having the same connectivity and the remaining small of broker-dealers available. Although
pricing for agency-related order flow players. Banning volume-based tiers for smaller broker-dealers may not have the
across differently sized members would agency-related order flow, which is scale economies of larger broker-dealers,
allow lower-volume members to more expected to level competition for direct they may have firm-specific expertise
effectively compete against higher- market access would benefit investors. valued by particular investors. A
volume members on the basis of passing The extent to which lower net brokerage’s strength may lie in good
on a higher proportion of collected transaction fees facilitate the survival of research in a niche area or personal
rebates. In contrast, the likely changes lower-volume broker-dealers a wider attention which contributes to a firm’s
in transaction fees and rebates, variety of broker-dealers may be perceived service quality. By preventing
previously discussed in section available to investors. Some lower- the loss of firm-specific advantages and
IV.C.1.a.i, suggest lower cum-rebate volume broker-dealers may specialize in increasing the overall variety of broker-
transaction fees for small and medium niche areas or be better positioned to dealers, lower exchange transaction fees
sized broker-dealers under the proposed provide personal attention to investors and higher rebates for small broker-
ban on volume-based tiers for agency and the proposed rule could help dealers may enhance investors’ overall
flow, which lead to higher profit prevent the loss of such firms, welfare under the proposed ban on
margins for such firms.198 Competition benefitting investor welfare. volume-based exchange rebates for
leading to a high proportion of rebates The proposed prohibition on volume-
agency-related volume.
being passed through may benefit based transaction pricing for agency-
investors even in the scenario in which related trades may also result in the iii. Benefits to Lower Volume Exchanges
the proposed rule reduces the total benefit of improved execution quality Based on analysis described in section
amount of price-savings (higher rebates/ for some customers of broker-dealers by IV.D.2 below, the Commission expects
lower fees) available to be passed removing an incentive to concentrate that the proposed rule may decrease the
through to investors. agency order flow. Reducing the level of order flow concentration for
The lower transaction fees for small incentive to concentrate agency order agency and riskless-principal orders and
and medium sized broker-dealers flow may result in improved execution
described in section IV.C.1.a.i might increase the concentration of principal
quality for the direct market access
lead to higher profit margins for such order flow, which would be likely to
customers of broker-dealers particularly
firms. This in turn would lead to a benefit some exchanges. In the analysis
if the broker-dealer had previously
lower propensity to exit the market for of the changes to competition among
routed customer orders in accordance
such firms, and a greater likelihood of exchanges, the Commission considered
with that incentive. How much the
new entrants. With more firms in the four separate scenarios: (1) agency order
customers of exchange members would
market for brokerage services in NMS flow concentration decreases by 100%,
tend to benefit from reducing the
stocks, competition to provide those (2) agency order flow concentration
conflict of interest is uncertain as it is
services could increase, benefiting decreases by 20%, (3) principal order
dependent on the preferences and
investors. flow concentration increases by 20%,
practices of each routing broker.
Following the proposed ban on Additionally, the proposed prohibition and (4) agency order flow concentration
volume-based tiers, medium-sized of volume-based pricing for agency- decreases by 20% and principal order
exchange members may be better related order flow will not resolve all flow concentration increases by 20%.202
positioned to gain DMA customers, potential conflicts of interest between Lower volume exchanges would be
compared to lower-volume exchange exchange members and their customers. most likely to benefit from a decrease in
members who are not well-equipped Currently, when exchanges offer the concentration of agency order flow.
with fast connectivity and trading volume-based transaction pricing to In the upper bound case where agency
infrastructure. Based on staff members in return for those members order flow was maximally dispersed
experience, the Commission executing more orders on the exchange, 200 See supra section IV.B.3 (discussing this
understands that roughly 30 broker- this creates a financial interest that conflict of interest in greater detail).
dealers across exchanges, including the could incentivize a member to route 201 See supra section IV.C.1.a.i discussing how
dozen or so largest exchange members, the proposed ban on volume-based tiers for agency
have functional smart order routers 199 This calculation was performed by first orders may reduce transaction fees paid by smaller
tabulating the number of members contributing up executing brokers.
(‘‘SORs’’), dedicated cabinets at data
to 99% of dollar volume for each exchange, and 202 See infra section IV.D.2.b and Table 9 (for
centers, and enough technical staff to then takes the mean across exchanges. The counts detailed discussion of the different scenarios
are based on data from the Consolidated Audit discussed here and the underlying assumptions
198 See supra note 194 and associated text. Trail, for the month of Jan. 2023. made).
(agency order flow concentration b. Costs technology, capital or service strengths

decreases by 100%), 11 of the 16 i. Cost to High-Volume Exchange arising from their scale economies.
exchanges that currently make up a Members Directing order flow to the high-volume
combined 19.58% of the on-exchange exchange members may better ensure
market would experience a 2.38 To the extent that average exchange that resources are utilized in a cost-
percentage point increase in market per unit trading fees become more effective manner. Conversely, under the
share on average. Assuming that both expensive than the lowest per unit (i.e., proposed ban on volume-based pricing,
volume and average net captures remain top tier) fees currently offered, the dispersing order flow across broker-
the same as those of January 2023, this proposed banning of volume-based dealers may reduce allocative efficiency.
would translate to a combined overall exchange transaction pricing for agency- An indirect, negative effect on the
increase of $26,382,403 in net related volume would result in costs for high-volume broker-dealers would arise
transaction fee revenue across the 11 the high-volume exchange members and from removing direct market access
venues.203 In the less extreme scenario possibly the smaller non-members services and sponsored access from the
in which concentration of agency order routing through them if they receive tier qualifications for the high-volume
flow decreases by 20%, the same pass-through exchange transaction members. If exchanges did not adjust
smaller exchanges would still benefit, pricing. This increase in costs may in their pricing levels in response to the
but with an average increase in market turn cause the commissions charged by proposed ban on volume-based
share of 0.47 percentage points and a such broker-dealers to increase, exchange transaction pricing for agency-
combined overall increase of resulting in costs for their customers as related volume, then removing the
well. sponsored customers’ order flow from
$5,276,481.
The proposed ban on volume-based the tiers calculation would weaken their
The Commission’s competition exchange transaction tiers might impose ability to obtain more favorable pricing
analysis 204 also considers the costs on a handful of the high-volume on principal orders compared to lower-
possibility of an increase in the members in the form of lower rebates/ volume members, thus eroding this
concentration of principal order flow. higher transaction fees for agency order competitive advantage.
That analysis concludes that the highest flow, along with loss of customer flow Exchange members with large
volume exchanges would be more likely due to the large members’ reduced price principal order flow also tend to have
to benefit from an increase in the advantage when competing for large agency order flow which is
concentration of principal order flow. customers. Various sources suggest that consistent with greater liquidity
Using January 2023 market shares, the 5 lower-volume exchange members may provision of either kind encouraging
largest exchanges would experience an be effectively subsidizing a handful of liquidity provision from the other order
average 0.50% percentage point increase the high-volume members receiving net type. The majority of exchange members
in market share given a 20% increase in payments.206 A ban on volume-based with principal order flow also route
principal order flow concentration. exchange transaction tiers that dampens agency orders to the same exchange.
Assuming that both volume and average the extent of cross-subsidization across There are over a thousand exchange-
net capture rates remain the same as broker-dealers may cost the large member firm pairs from January 2023
those of January 2023, the increase in members their forgone net payments. A across 16 exchanges, with a majority of
market share would translate to a second source of cost is the loss of exchange members engaged in principal
combined overall increase of $2,900,853 potential customer flow, order flow that trading. Among exchange members that
in net transaction fee revenue across the may have otherwise streamed to the top handle both principal and agency
5 venues. broker-dealers. Under volume-based trades, 79% of members with principal
pricing, the top broker-dealers’ lower trading also routed agency orders. One
The Commission also considered a
trading costs may give them a price can compare a firm’s position within the
case in its competition analysis 205
advantage when competing for distribution of principal volume against
where a 20% increase in principal order
customers against smaller members. As its rank among agency trading firms on
flow concentration is coupled with a
the high-volume broker-dealers can the same exchange. Conditional on
20% decrease in the concentration of
better afford lower commission fees, executing both agency and principal
agency order flow would result in
they attract greater order flow from orders on the same exchange, 83% of
increased market shares for the 12
investing customers and non-members, members whose principal trading was
smallest exchanges by trading volume,
which enhances their ability to attain above an exchange’s median dollar
with the exception of a single exchange,
more favorable pricing tiers. The volume also ranked in the top half of
which would lose market share. In this agency trading dollar volume. Again,
case, the eleven positively affected proposed ban on volume-based
discounts removes the competitive among members routing both types of
exchanges would experience an average orders, approximately 61% of members
percentage point increase in market advantage that the high-volume broker-
dealers otherwise gain through this self- that ranked in the top quarter in terms
share of 0.26% and a combined increase of principal dollar volume also qualified
in net transaction fee revenues of reinforcing cycle.
Tiered rebates that aid in the for the top quarter of agency dollar
$2,574,733. That exchanges could be volume on the same exchange. Thus,
negatively or positively affected when concentration of order flow among high-
volume exchange members may be high relative principal flow is
only one kind of order flow imperfectly associated with high
desirable from an allocative efficiency
concentration changes, indicates that relative agency flow. One plausible

exchanges have different sensitivities to perspective. Due to their scale
economies, the high-volume exchange underlying force is that top-tier
changes in order-flow concentration. exchange transaction pricing (notably,
members may be most efficient at
executing. Alternatively, the high- rebates) earned from large principal
203 See supra note 123 and the accompanying text
volume exchange members may have flow provide incentives for non-
(for a description of how net transaction fee revenue
is estimated and the assumed average net capture
members to direct their agency-related
rates). 206 See Healthy Markets 2018 Letter, supra note order flow through high-volume
204 See infra section IV.D.2.b.
165, at 5; Chester Spatt, ‘‘Is Equity Market Exchange members to take advantage of a portion
205 See infra section IV.D.2.b. Structure Anti-Competitive?’’, supra note 166, at 7. of that better exchange transaction
pricing that may not otherwise be high-volume broker-dealers engage in pricing for agency-related order flow
available to them. For these sponsoring both proprietary trading and in a would be for the exchanges to set
members that already are rewarded customer brokerage business. As intermediate transaction pricing for
preferred pricing for their principal discussed earlier in this section many agency-related orders that are between
flow, orders routed through them from firms with high levels of principal order the current highest fees charged in the
non-members further contributes to the flows also tend to achieve high levels of lowest volume tiers and the lowest fees
firm’s larger agency and overall agency order flow on the same charged in the top-tiers.210 To the extent
presence. exchange. In the scenario with a ban on that average exchange pricing on
While the direct effect of the proposed volume-based exchange transaction agency-related orders become more
banning of volume-based exchange pricing for agency-related flow, better
expensive than the previous top-tier
transaction fee tiers could raise pricing for principal order flow may
transaction costs on the high-volume pricing, investors and any
favor many of the same high-volume
broker-dealers’ agency orders, the members as are favored under current intermediating broker-dealers who
overall effect on the high-volume volume-based pricing schedules. If previously benefitted from the high-
broker-dealers’ trading activities and deeper discounts on principal order volume broker-dealers’ passing through
total welfare 207 depends on how flow for high-volume players helped to the volume-based exchange transaction
exchanges respond to the proposed ban, retain substantial principal order flow, pricing may be worse off.
especially through adjusting volume- then agency order flow may also tend to Another category of trading activity
based tiers for principal order flow. coalesce on the same exchange due to that would no longer benefit from the
Offering a steeper volume-based pricing the order flow externality. Changes in tiered pricing advantages of high-
discount, or lower per-unit prices for volume discount transaction rates for volume broker-dealers would be
greater utilization, has been principal order flow, combined with sponsored and direct market access.
documented as a means to attract possible fee cuts on agency order flow, Because proprietary traders using such
demand to platforms in other market may counter the profit losses from access trade through the exchange
settings.208 Likewise it is conceivable forgoing previous subsidies on agency- member’s connectivity to the exchange,
that while a ban on agency-related related order flow for the high-volume
volume discounts could weaken the orders directly routed to a trading center
broker-dealers.
incentive to extract increasing levels of through sponsored access are marked as
agency order flows if exchanges chose ii. Cost to Investors With Trades agency orders. These orders would no
not to offer their best transaction pricing Intermediated by High-Volume longer count towards volume-based tiers
to all members equally, exchanges might Exchange Members of the sponsoring member.
respond with an increased rate of Investors and other market Consequently, some sponsored traders
discounting for principal order flows. participants that send exchange orders may face higher net fees, compared to a
More generally, with the proposed ban through large exchange members, which setting where (1) the sponsored traders
on agency-related price tiers, the currently likely benefit from the benefit from being the customers of top-
exchanges might re-adjust pricing volume-based transaction tiers of their tiered broker-dealers and (2)
schedules within each family of sponsors, may experience costs in the incorporating orders from sponsored
affiliated exchanges. Enhancing form of higher fees from their executing traders reinforces the broker-dealers’
principal order flow enhances the broker-dealers under the proposed rule. ability to achieve higher rebates. The
liquidity externality across exchanges In the absence of the ability of proposed ban on volume-based tiers
within a family, thereby increasing the exchanges to use volume-based may have a particularly adverse effect
value of keeping agency order flow on transaction pricing for agency-related on the smaller traders that use these
exchanges. flow, investors which rely on high- arrangements. Without the ability to
For high-volume broker-dealers volume exchange members for market
tailor agency-related transaction fees to
trading in a principal capacity, the access may be left with relatively more
exchanges might re-adjust price trading volume, some exchanges may
expensive exchange transaction fee
schedules in a way that leaves the options. The transition from volume- not find it worthwhile to lower average
current high-volume firms with no based tiers to a flat fee that could result fees in order to retain the order flows of
substantial drop in profitability. While from the proposed rule is expected to the smallest traders.
the proposed ban on agency-related lead to fees and rebates that are between The Commission also believes that the
volume transaction pricing tiers would the current values for the highest and proposed banning of volume discounts,
weaken the competitive advantage of lowest tiers.209 This would lead to large- when considered in isolation, may have
high-volume broker-dealers over smaller volume broker-dealers who qualify for the effect of reducing efficiency if high-
ones, the exchanges may attempt to the best tiers to be worse off, and low- volume exchange members reduce the
offset the potential loss of agency order volume broker-dealers to be better off. amount of order flow which they
flow by either lowering the agency base Because the changes for these broker- execute on the exchanges, something
fee or offering even steeper volume- dealers would be to the marginal costs which could harm investor welfare.211
based discounts for principal order of their trading, the Commission expects As high-volume exchange members
flow. Deeper discounts for high this to impact the prices charged to their likely contribute substantially more to
principal volume may even enhance the investor customers in the same the depth of book on an exchange, a
profitability of these high-volume direction. That is, when considered in withdrawal of agency order flow on
members with high amounts of isolation, this effect would tend to make exchanges by these members may lower
principal trading. In addition, many customers of large broker-dealers worse the overall displayed liquidity provision
off and customers of small broker-
207 Here ‘‘total welfare’’ is defined as profitability
dealers better off. One potential 210 See supra section IV.C.1 for additional
summed across exchanges and broker-dealers with
trading activities facilitated by exchange members. response to limiting volume-based discussion on effect of the tiering ban on
208 Meghan Busse and Marc Rysman, transaction pricing.
‘‘Competition and Price Discrimination in Yellow 209 See supra section IV.C.1.a.i for discussion of 211 See section IV.C.1.b.iii for a discussion of the
Pages Advertising’’, 36 RAND J. Econs. 378 (2005). this point. costs to high-volume exchange members.
imposing a negative externality on other those of January 2023, the decrease in at which the customer order was
exchange members.212 market share would translate to a previously internalized at, then the
combined overall decrease of $3,356,751 internalize-then-offset process would
iii. Costs to Higher-Volume Exchanges
in net transaction fee revenue across the effectively transform what would have
Based on the analysis described in 11 venues. otherwise been an agency or riskless-
section IV.D.2 below, the Commission In the case where a 20% increase in principal order into principal order. The
expects that the proposed rule may principal order flow concentration is member broker-dealer would however
decrease the level of order flow coupled with a 20% decrease in the risk that the offsetting principal trade
concentration for agency and riskless- concentration of agency order flow, it would be executed at a worse price than
principal orders and increase the could result in decreased market shares what it had internalized the customer
concentration of principal order flow, for the four largest exchanges. In order at.
which would result in costs for some addition, one smaller exchange could Maintaining an inventory position is
exchanges. The Commission considers also lose market share in this case. In both costly and risky. Holding inventory
four separate scenarios: (1) agency order this case the five negatively affected involves the investment of capital,
flow concentration decreases by 100%, exchanges would experience an average broker-dealers have to purchase the
(2) agency order flow concentration percentage point drop in market share of shares needed to have a sufficient
decreases by 20%, (3) principal order 0.58% and a combined decrease in net supply of stock in order to fill
flow concentration increases by 20%, transaction fee revenues of $4,298,199. marketable buy orders as well as
and (4) agency order flow concentration sufficient cash to handle marketable sell
decreases by 20% and principal order iv. Increase in Principal Trades
orders. Exchange members looking to
flow concentration increases by 20%.213 The Commission recognizes that the transition to an inventory model may
Larger exchanges would be most proposed prohibition of volume-based also have to maintain specific net
likely to bear a cost in the form of lost pricing for only agency and riskless- capital levels as required by regulations
market share and net transaction cost principal orders would likely increase to maintain solvency.216 It is risky
revenue from an expected increase in the benefits of principal trading which because holding non-zero inventory
the dispersion of agency order flow may increase systemic risk across exposes the member broker-dealer to
across more competing exchanges. Per broker-dealers. Without being able to losses due to price fluctuation. This risk
Table 9, in the extreme case where count on agency order flow to help could lead to correlated trading among
broker-dealers decrease their agency qualify for a volume-based tier exchange inventory-holding broker-dealers if
order flow concentration by 100%, 5 of members may have to increase the price changes cause some to liquidate
the 16 exchanges that currently make up concentration of their principal order their inventory positions. This kind of
a combined 80.42% of the on-exchange flow in order to qualify for a preferred correlated trading can exacerbate
market would experience a 5.24 pricing tier. This effect likely would be systemic risk among broker-dealers, as
percentage point decrease in market exacerbated should exchanges adopt the liquidation of inventory by some can
share on average. Assuming that both pricing schedules with more attractive trigger further liquidations by others
volume and average net captures remain volume-based pricing tiers for principal forming a self-reinforcing cycle. In the
the same as those of January 2023, this orders.214 case that following this proposed rule
would translate to a combined overall One way market participants could exchanges would adopt pricing
decrease of $32,720,244 in net increase their principal order flow schedules that would make the
transaction fee revenue across the 5 would be to increase proprietary trading transition to an inventory model
venues. In the scenario under which operations. Proprietary trading can worthwhile, larger broker-dealers would
agency order flow concentration increase market instability if the likely have a competitive advantage in
decreases by 20%, these 5 exchanges positions of different traders are absorbing the costs and managing risk
would also be adversely affected, correlated as correlated trading can given their greater resources. The
though not as much as in the case of amplify price movements and quickly Commission expects the costs
even re-distribution of agency flow deplete available liquidity.215 associated with a shift in business
across exchanges, with an average Some exchange members might adopt model to limit the increase in principal
decrease in market share of 1.05 an inventory-based model to manage to trading due to broker-dealers taking on
percentage points and a combined effectively substitute what would have inventory for internalization.
overall decrease in trading revenues of been agency or riskless principal orders
with principal orders. Under an v. Migration to Off-Exchange Venues
$6,544,049.
Smaller exchanges may lose market inventory model the broker dealer The proposed prohibition of volume-
share from a given increase in the would aim to uphold a target inventory based pricing for agency-related order
concentration of principal order flow. level in its traded securities which they flow by exchanges would risk exchanges
Using January 2023 market shares, the could thereby use to internalize their losing market share to off-exchange
11 smallest exchanges by trading customer trades. After internalizing the venues. In addition to competing with
volume would experience an average customer trade the broker-dealer could other exchanges, exchanges also use
0.23% percentage point decrease in offset any changes in their inventory by volume-based pricing tiers as a means of
market share given a 20% increase in executing an identical order on an competition for order flow with off-
principal order flow concentration. exchange. The offsetting order, since it exchange market centers such as
Assuming that both volume and average would be to manage the broker-dealer’s wholesalers and ATSs. Lacking the
net capture rates remain the same as inventory, would be a principal order. If ability to offer volume discounts on
the off-setting principal order is agency-related order flow may make
212 See section IV.D.1 for additional discussion of executed on exchange at the same price exchanges less competitive. Not being
the effects of lower agency order flow on investor able to realize preferential pricing
welfare and of the effects on efficiency that the 214 See section IV.D.2.a.
costs to high-volume broker-dealers could have. 215 See
offered by the highest volume-based
Malceniece, Laura, Kārlis Malcenieks, and
213 See section IV.D.2.b and Table 9 (for detailed Tālis J. Putniņš. ‘‘High frequency trading and
tiers for the agency portion of their
discussion of the different scenarios discussed here comovement in financial markets.’’ Journal of
and the underlying assumptions made). Financial Economics 134.2 (2019): 381–399. 216 See 17 CFR 240.15c3–1.
order flow higher volume exchange exchanges, enhancing not only total on each exchange, as trades are easiest
members may instead face less attractive order flow and profit summed across the to arrange on good terms in liquid
pricing thereby making off-exchange exchanges but also total broker-dealers’ markets. Having more consolidated
venues relatively more attractive. welfare. Prohibiting tiered pricing may markets under volume-based price tiers
Freeing up agency flow from the shrink exchanges’ overall profitability, makes it easier for liquidity demand to
effects of volume-based tiers could to the detriment of broker-dealers as meet liquidity supply on the same
result in fewer agency orders routed to well. platform, lowering transaction costs.
exchanges. This view is manifested by Effectiveness of using price Conversely, loss of agency order flow
both standard screening games from the discrimination to increase total surplus, from shutting down volume-based
mechanism design literature and price relative to a world absent of volume- pricing could make the search for best
discrimination models, which suggest based discounts, depends on sufficient
price more costly for the remaining
that volume-based price discrimination, heterogeneity across exchange members.
participants (both agency and principal)
particularly those based on absolute Higher valuation, or greater gains from
execution, could originate from the on an exchange, who might in turn
pricing tiers, can increase total demand decide to redirect orders away from
for the platforms.217 On the other hand, lower cost of operating broker-dealer
businesses for high-volume exchange dominant exchanges. Order flow
shutting down quantity discount externality reinforces the initial loss of
schemes would remove a way for members. While the range of data
products and co-location services surplus from shutting down volume-
individual exchanges to better retain
offered by exchanges present substantial based price discrimination, resulting in
order flow from migrating to competing
fixed costs for exchange participants, further loss in efficiency, for dominant
venues. This may lead to both greater
dispersion of order flow across fees for proprietary data and exchanges and their participants alike.
exchanges and a decline in trade connectivity do not increase Finally, as off-exchange market centers
volume among exchanges. Either (1) proportionally with trading activity. As such as wholesalers often benchmark
total order flow across exchanges may the per-share cost falls with increases in trades (and price improvement) to the
decrease or (2) a portion of that flow the exchange’s trading volume, high- NBBO, the withdrawal of a portion of
moves off-exchange, which in turn volume broker-dealers may find the on-exchange order flow may potentially
would harm on-exchange liquidity and value of trading greater than lower- result in wider (NBBO) spreads thereby
increase trading costs. volume exchange members. Another harming execution quality in the market
Applying the insights from the price feature of standard screening models is as a whole.218
discrimination literature to the that the participant’s intrinsic value is
Following the proposed ban,
exchange setting suggests that the revealed by the exchange member’s self-
exchanges might adjust so as to
proposed ban on volume-based pricing selected quantity. The broad range of
trading quantities across agency broker- ameliorate the loss of order flow and
may decrease both overall order flow efficiency from reduced participation
across exchanges and overall efficiency, dealers suggests a large degree of
heterogeneity across agency broker- across exchange venues. In particular,
defined in terms of profit summed one predicted response of the proposed
across broker-dealers and the exchanges. dealers. Across the 16 exchanges in
January 2023, the coefficient of variation ban is that some exchanges might try to
Standard theoretic models suggest that retain agency order flows by offering
price discrimination can be a natural for dollar volume among exchange
members’ agency order flow ranges from steeper volume-based tiers for principal
consequence of the trading venues’ order flows. Deeper discounts that
1.3 to over 3.3. Fixing an exchange, the
profit-maximizing incentive schemes attract the largest proprietary traders
exchange member at the 25th percentile
(i.e., contracts with customers), in
has agency dollar volume that is as little and increase principal order flow on
setting with incomplete information
as less than 0.1% and no more than exchanges also benefit agency traders
present. Incomplete information could
12.5% of the dollar volume coming from due to liquidity externality. More
denote a setting with variation in
the 75th percentile exchange member. generally, exchanges might attempt to
valuation for execution/gains to trade One difference between the price discriminate along other
across broker-dealers. Because the conventional nonlinear pricing/
exchanges cannot perfectly ascertain dimensions not directly related to
screening framework and the exchanges’ agency trading volume. As one source
each broker-dealer’s intrinsic preference price tiering setting is the use of relative
for trades, exchanges cannot condition reports at least 3,762 separate pricing
volumes in the rebate formulae. Broker- variables across exchanges, fees charged
transaction fees on broker-dealers’ dealers have an incentive to commit
(private) valuations for order execution. and rebates offered are based on an
volume to an exchange so that their intricate array of other quality metrics,
Offering volume-based price discounts, accumulated liquidity outcompetes
compared to a regime prohibiting some of which are likely correlated with
rivals’ liquidity and satisfies the trading volume.219 It is conceivable that
pricing tiers, can encourage broker- threshold for higher rebates. The use of
dealers with the most to gain from trade exchanges might continue to ‘‘lock in’’
relative volumes in the rebate formulae order flow by offering discounts for
to better express their higher may further reinforce the exchanges’
willingness to participating on an broker-dealers’ percentage of time spent
ability to concentrate volume on their
exchange. Tiered pricing can heighten at the NBBO, among other measures of
venue.
the incentive to add liquidity to Market shrinkage and fragmentation trading activities.
of agency orders may have negative

217 See Hall R. Varian, ‘‘Price Discrimination and 218 This is assuming that volume-based rebates to
effects on transaction costs and
Social Welfare,’’ 75 Am. Econ. Rev. 870–75 (1985). liquidity providers contribute to narrowing the
See W. Kip Viscusi, Joseph E. Harrington, and
undercut the internalization of the NBBO, this particular increase in transaction costs
David M. Sappington, Economics of Regulation and liquidity externality, potentially may be limited to the extent to which such rebates
Antitrust 365–70 (5th ed. 2018), Chapter 8 resulting in further loss of both do not influence the NBBO.
‘‘Monopolization and Price Discrimination’’, pp principal and agency order flow. 219 See RBC Letter, supra note 19, at 1 (‘‘In total,
365–370 for a simple setting with a numerical we found at least 3,762 separate pricing variables
example. See also Hall R. Varian, ‘‘Price
Coalescence on the larger exchanges is across the exchanges—that is, 3,762 factors that
Discrimination and Social Welfare,’’ 75 Am. Econ. not only desirable for the exchanges but ultimately determine the fees charged and rebates
Rev. 870–75 (1985). also increases the value of participating offered by exchanges’’).
2. Effects of Proposed Requirement of that exchange members would attempt b. Costs

Rules and Policies and Procedures To to recover volume discounts for their
The requirements of proposed Rules
Prevent Evasion agency-based order flow by trying to 6b–1(b)(1) and 6b–1(b)(2) would result
a. Benefits obtain volume discounts offered for in costs for those national securities
principal-based order flow for their exchanges for NMS stocks that choose to
Proposed Rule 6b–1(b)(1) would
agency-based order flow. To the extent offer volume-based transaction pricing
require national securities exchanges
this happens, the benefits associated for a member’s proprietary order flow
offering volume-based transaction
pricing in connection with the with prohibiting volume discounts for after the implementation of the
execution of proprietary orders in NMS agency-based flow 220 would be less prohibition in proposed Rule 6b–1(a).
stocks for the account of a member to likely to materialize. Exchange rules Specifically, any national securities
impose rules to require members to requiring members to engage in exchanges for NMS stocks that offers
engage in practices that facilitate the practices that facilitate the exchange’s such volume-based transaction pricing
ability of the exchange to comply with ability to comply with proposed Rule would incur the legal and
the prohibition in proposed Rule 6b– 6b–1(a) and exchange policies and administrative costs to revise its rules to
1(a). Proposed Rule 6b–1(b)(2) would procedures reasonably designed to include the rules required by proposed
require national securities exchanges detect and deter members from Rule 6b–1(b)(1), and to develop and
offering such volume-based pricing for receiving volume-based transaction implement the policies and procedures
NMS stocks to establish, maintain, and pricing in connection with the required by proposed Rule 6b–1(b)(2), as
enforce written policies and procedures execution of agency-related orders well as the costs to maintain and
reasonably designed to detect and deter would reduce the likelihood that such enforce these rules and policies.
members from receiving volume-based attempts would happen, or would be Table 8 provides the Commission’s
transaction pricing in connection with successful if they did happen. The estimates of the PRA costs associated
the execution of agency or riskless Commission is unable to quantify the with developing the required written
principal orders in NMS stocks. These size of this benefit because it is not policies and procedures. The
requirements would increase the feasible to determine the propensity of Commission estimates that there would
likelihood that the benefits of Rule 6b– exchange members to attempt evasion be 13 221 exchanges that would incur
1(a) would materialize. It is possible without such measures in place. these costs.
TABLE 8—COMPLIANCE COSTS ESTIMATES

Initial Ongoing
Description (one-time) (annual)
Review & revise price schedule + supplement anti-evasion rules .............................................................. 222 $23,945.00 223 $8,949.00
Collect, compile, and submit required disclosures to the Commission ...................................................... 224 21,758.00 225 37,488.00
Total (per exchange) ............................................................................................................................ 45,703.00 46,437.00

× 13 Exchanges with volume-based pricing ................................................................................................ 594,139.00 603,681.00
The requirements of proposed Rules 3. Effects of the Transparency proprietary volume in NMS stocks,
6b–1(b)(1) and 6b–1(b)(2) to revise Provisions among other things.227
exchange rules and implement anti- a. Benefits Knowing the number of exchange
evasion policies and procedures would members that qualify for the different
also impose costs by increasing the i. Increased Transparency tiers will provide additional information
likelihood that the effects of Rule 6b– to exchange members who would be
Proposed Rule 6b–1(c) would require
1(a), the prohibition of volume-based concerned with which tiers they qualify
equities exchanges to make monthly
pricing to agency-related order flow, are for per their principal trading. While
submissions to the Commission
realized. The Commission believes the exchange members already know the
concerning how many members qualify
proposed prohibition on volume-based tier qualification criteria or many
for their volume-based pricing in
transaction pricing for agency-based volume-based tiers knowing the tier
connection with the execution of
order flow would result in costs.226 qualification criteria does not mean that
220 See supra section IV.C.1.a (discussing the note 84. The Commission derived the hourly rate Systems Analyst at 10 hours * $316 per hour) +
benefits associated with the prohibition on volume- figures from SIFMA’s Management & Professional (Compliance Manager at 10 hours * $344 per hour)
based transaction pricing in agency-related volume Earnings in the Securities Industry 2013, modified + (Director of Compliance at 5 hour * $542 per
for NMS stocks). to account for an 1,800-hour work-year and hour) + (Compliance Attorney at 8 hours * $406)
221 This estimate is based on the assumption that inflation, and multiplied by 5.35 to account for = $21,758 per exchange in initial costs. $21,758 per
the 13 national securities exchanges for NMS stocks bonuses, firm size, employee benefits, and exchange × 13 respondents = $282,854. See supra
currently offering volume-based tiers would overhead. notes 85, 106, and accompanying text.
225 The Commission derived the total estimated

continue to offer such tiers for principal related 223 The Commission derived the total estimated
order flow after the implementation of proposed burdens from the following estimates: (Compliance burdens from the following estimates: (Compliance
Rule 6b–1(a). See supra section III.D. Attorney at 12 hours * $406 per hour) + Attorney at 6 hours * $406 per hour) + (Compliance
222 The Commission derived the total estimated (Compliance Manager at 8 hours * $344 per hour) Manager at 2 hours * $344 per hour) = $3,124 per
burdens from the following estimates: (Attorney at + (Business analyst at 5 hours * $265 per hour) = monthly filing. $3,124 × 12 months = $37,488 per
30 hours * $462 per hour) + (Compliance Counsel $8,949 per exchange in ongoing annual costs. respondent. $37,488 per exchange × 13 respondents
at 10 hours * $406 per hour) + (Chief Compliance $8,949 per exchange × 13 respondents = $116,337. = $487,344. See supra note 89.
Officer at 5 hours * $542 per hour) + (General See supra note 85. 226 See supra section IV.C.2.b (discussing costs
Counsel at 5 hours * $663 per hour) = $23,945 per 224 The Commission derived the total estimated associated with proposed Rule 6b–1(a)).
exchange in initial costs. $23,945 per exchange × 13 burdens from the following estimates: (Sr. 227 See supra section II.D, discussing the full
respondents = $311,285 total initial costs. See supra Programmer at 25 hours * $368 per hour) + (Sr. requirements of proposed Rule 6b–1(c).
an exchange member can with certainty qualification criteria. While the qualify for each volume-based pricing
know which tier it would qualify for a Commission does not expect these other tier on their proprietary volume.
given absolute amount of trading items to provide new benefits, since Centralized filing of the proposed
volume. For example, many volume- total membership numbers and detailed disclosures would assist members, other
based pricing tiers set the volume pricing schedules are already publicly exchanges, and the public in analyzing
threshold needed for tier qualification accessible, the proposed rule would also and commenting on volume-based
as a percentage of aggregate measures require that these data be submitted to exchange transaction pricing schedules
such as the total consolidated trading EDGAR in Inline XBRL, which would be that apply to proprietary volume.
volume 228 which is dependent on the a benefit as we discuss below. Additionally, centralized filing of the
trading of other market participants and tiers disclosures with the Commission
ii. Benefits of EDGAR and Inline XBRL could, by making it easier for the
not just that of the member itself. The
Requirements Commission and the public to retrieve
disclosures of how many members
qualify for their volume-based pricing in Under proposed Rule 6b–1(c)(3), the exchange fee tiers disclosures over
connection with the execution of exchanges would provide the monthly time from a single source, facilitate
principal flow would help resolve disclosures in EDGAR in Inline XBRL. assessment of the level of competition
uncertainty regarding the distribution of Requiring equities exchanges to present and the impact of pricing tiers on
tier qualification. this information in a machine-readable, intermarket competition.231 The EDGAR
The Commission expects that the structured data language—namely, system also would enable technical
main benefit from the disclosure Inline XBRL—rather than an validations (i.e., programmatic data
provisions of the proposed rule would unstructured format (e.g., HTML, ASCII, error checks) on the disclosures, thus
be to improve the comments provided PDF) would further heighten potentially improving data quality by
by members and other interested parties transparency around exchange fee tier reducing the incidence of non-
by providing information on the structures by facilitating more efficient discretionary errors (e.g., including text
distribution of member tier retrieval, comparison, aggregation, and for a disclosure that should contain only
qualification. As previously other analysis of fee tiers data on numbers).
mentioned,229 the monthly disclosures specific exchanges as well as across iii. Impact on Exchange Price Schedules
would identify the different transaction different exchanges and time periods.
pricing tiers at each exchange and The use of Inline XBRL tags for The proposed transparency provisions
provide a breakdown of how many proprietary volume-based pricing would publicly reveal the number of
disclosures would thus make the exchange members which qualify for
members qualified for the various tiers
disclosures more easily accessible to, different pricing tiers on each exchange.
each month. The enhanced transparency
and usable by, the Commission, If publicized, this information could
would increase the ability of the
exchange members, and the public, prompt exchanges to reconsider their
exchange members, other exchanges,
which in turn should allow for more pricing structures, especially if they
and other interested parties to assess
efficient review of the impact of could give the appearance of
how many members qualify for specific
volume-based exchange transaction disproportionately favoring a small
transaction pricing on an exchange and
pricing. number of exchange members. A
better understand the effect of exchange
Inline XBRL is an open, possible effect of this kind of disclosure
fee tiers which may enable more
nonproprietary standard overseen by a could be for exchanges to voluntarily
detailed comment. The Commission adopt price schedules with fewer
expects that by helping interested not for profit consortium that includes
pricing tiers that end up applying to a
parties in providing more detailed a community of service providers and
few select exchange members in order to
comment on future fee filings the software tools.230 Exchange members
not give the appearance of
required disclosures would enhance the and market participants could leverage
disproportionately favoring a small
information available to the this existing infrastructure to readily
number of exchange members. If
Commission and improve regulatory compile, compare, and analyze the
exchanges adopt pricing schedules
efficiency. number of tiers at different exchanges,
which result in a more even distribution
Disclosure of the number broker- the number of members in various tiers
of tier qualification as opposed to
dealers qualifying for each tier across all at different exchanges, and the financial
pricing schedules where more members
NMS stock exchanges would enable benefits attributable to different tiers qualify for lower volume tiers and few
investors to learn the distribution of within and across exchanges. Thus, the qualify the top tiers it could result in a
transaction fee-related costs across Inline XBRL standard could help the benefit to the small to medium-sized
broker-dealers. public more efficiently assess the effects exchange members who, under the
The proposed rule would also require and application of exchanges’ volume- current price schedules, may struggle to
the exchanges to disclose the number of based pricing for NMS stocks for qualify for the best pricing tiers.
members that executed principal orders proprietary volume. Such a shift in pricing structure
in NMS stocks for each month as well In addition, requiring exchanges to would enable a broader range of
as provide a table enumerating each file the disclosures with the members to qualify for improved pricing
volume-based tier along with basic Commission would allow the terms which in turn could help level the
information regarding the tier and its Commission, the public, or exchange competitive field in the market between
members to access the disclosures exchange members to provide direct

228 For example, one exchange defines total directly from a central, publicly market access to non-member customers
consolidated volume as ‘‘the total consolidated accessible location, thus enabling
volume reported to all consolidated transaction insofar as members subsidize the terms
reporting plans by all exchanges and trade reporting
efficient access and retention of the
facilities during a month in equity securities, number of exchange members that 231 See supra section II.D (establishing the more
excluding executed orders with a size of less than effective assessment of whether pricing tier changes
one round lot.’’ See https://listingcenter. 230 See About, XBRL.org, available at https:// are reasonable, equitably allocated, not unfairly
nasdaq.com/rulebook/nasdaq/rules/nasdaq-equity- www.xbrl.org/the-consortium/about; Tools and discriminatory, and do not impose a burden on
7. Services, available at https://www.xbrl.org/the- competition as an objective of proposed Rule 6b–
229 See supra section II.D. standard/how/tools-and-services/. 1(c)).
offered to their agency customers with complying with Inline XBRL members which qualify for different
the savings realized from hitting higher requirements, the exchange’s pricing tiers with their principal order
pricing tiers with their principal order compliance costs could be partially flow has the potential to impose
flow. mitigated. reputational costs on the exchanges. As
The Commission believes the the proposed rule would prohibit the
b. Costs compliance costs associated with the application of volume-based tiers to
i. Implementation Costs proposed requirement to structure the agency-related order flow any
With respect to the Inline XBRL proposed fee tiers disclosures in Inline qualification to a volume-based tier
XBRL likely would decrease over time would have to be a function of non-
requirement for the proposed fee tiers
because equities exchanges likely would agency related volume and the pricing
disclosures, equities exchanges would
comply with structuring requirements of those tiers would only apply to non-
incur both initial Inline XBRL
more efficiently after gaining experience agency related orders. The fact that the
compliance costs, such as the cost of
over repeated filings, although such an disclosure would only apply to
training in-house staff to prepare filings
effect could be diminished for equities principal trades limits the extent to
in Inline XBRL, and the cost to license
exchanges affiliated with public which the information would be useful
Inline XBRL preparation software from
reporting companies that already have for market participants other than
vendors, and ongoing Inline XBRL
experience structuring filings in Inline proprietary traders.
compliance burdens that would result
XBRL. While exchanges currently are
from the proposed tagging requirements. Because national securities exchanges required to disclose their pricing
The proposed Inline XBRL requirements are not currently subject to EDGAR schedules by publishing them online,235
for the proposed fee tiers disclosures filing requirements,233 equities the number of members which qualify
would result in compliance costs for exchanges would incur a one-time for each tier is not known to the
equities exchanges relative to the compliance burden of submitting Form public.236 Some exchanges could suffer
current baseline, because equities ID to access EDGAR as a result of the reputational costs if the distribution of
exchanges would be newly required to proposed requirement to submit the fee members over the tiers for which they
apply Inline XBRL tags to the proposed tiers disclosure via EDGAR.234 While qualified for is perceived to be unfair.
disclosures before filing the fee tiers there are no fees associated with For instance, if only a few exchange
disclosures with the Commission (or registering as an EDGAR filer, the members qualify for the most
pay a third-party tagging service Commission recognizes that the advantageous pricing tiers, the potential
provider to do so). proposed requirement to submit the perception that these select few
Because Inline XBRL tagging proposed fee tiers disclosures in EDGAR members receive advantages not
compliance software has already been would impose compliance costs on available to a wider group could harm
developed and is already in use by equities exchanges in order to make the reputation of the relevant exchange,
public reporting companies to fulfill limited changes to their systems, especially if it appears as if the
Inline XBRL requirements, the policies, and procedures to comply with exchange is subsidizing the top pricing
Commission expects that vendors would the EDGAR filing requirement. These tiers at the expense of lower tiers.
update their tagging software to costs could be mitigated by the fact that The Commission believes that the risk
accommodate the proposed Inline XBRL many equities exchanges have affiliated of such reputational costs may induce
requirement for the proposed fee tiers entities that provide disclosures in exchanges to change their price
disclosures if such a requirement is EDGAR in Inline XBRL, and therefore schedules. Such changes would result
adopted. Equities exchanges currently employees of the equities exchanges in costs for those exchanges who
are not subject to Inline XBRL could leverage the knowledge and undertake them, in the form of costs to
requirements to comply with their legal experience about EDGAR and Inline alter existing price schedules, and
requirements as exchanges. That said, XBRL possessed by staff within those through the possibility that such
most equities exchanges are affiliated affiliates. changes in price may reduce the
with public reporting companies that incentive for their members to
are subject to existing Inline XBRL ii. Reputation Costs & Changes in
Exchange Price Schedules concentrate their principal order flow.
requirements. For example, 12 of the 16 Having to adopt a pricing schedule with
equities exchanges are affiliated with The proposed transparency provisions a more even distribution of tier
public companies that are required to which require the monthly public qualification, one where more members
file financial statements and other disclosure of the number of exchange qualify for the different tiers, may only
disclosures in EDGAR in Inline be possible by offering less attractive
233 The Commission recently proposed that
XBRL.232 To the extent that an equities pricing across the top tiers. Trading off
national securities exchanges and exempt
exchange shares compliance systems exchanges, including the equities exchanges that the pricing terms of high volume tiers in
with an affiliated entity that is required would be covered by proposed Rule 6b–1(c), file order to adopt a pricing schedule which
to submit Inline XBRL structured filings certain forms in EDGAR in structured data may be perceived as more equitable
in EDGAR, or could otherwise leverage languages. See Electronic Submission of Certain
Materials Under the Securities Exchange Act of could cause the exchange to lose trading
the affiliated entity’s processes, licenses, 1934; Amendments Regarding the FOCUS Report, volume or liquidity provided as high
service agreements, and expertise in Securities Act Release No. 11176; Exchange Act volume members may find other venues
Release No. 97182; Investment Company Release as more attractive following the change.
232 See, e.g., Cboe Global Holdings, Inc. 2022 No. 34864 (Mar. 22, 2023) 88 FR 23920 (Apr. 18,
Form 10–K, available at https://www.sec.gov/ 2023). As discussed in sections IV.D.2 and
ix?doc=/Archives/edgar/data/0001374310/ 234 Form ID must be completed and filed with the IV.D.1 the Commission cannot establish
000155837023008202/cboe-20230331x10q.htm; Commission by all individuals, companies, and a reliable estimated range for the extent
Intercontinental Exchange, Inc. 2022 Form 10–K, other organizations who seek access to file of these costs and which exchanges
available at https://www.sec.gov/ix?doc=/Archives/ electronically in EDGAR. See 17 CFR 232.10(b); 17
edgar/data/1571949/000157194923000006/ice- CFR 249.446. Accordingly, a filer that does not
would be affected given that exchanges
20221231.htm; NASDAQ, Inc. 2022 Form 10–K; already have access to EDGAR must submit a Form
235 See supra note 7 and accompanying text.
available at https://www.sec.gov/ix?doc=/Archives/ ID along with the notarized signature of an
edgar/data/0001120193/000112019323000014/ authorized individual to obtain an EDGAR central 236 See supra section IV.B.5 (discussing the
ndaq-20221231.htm. index key and access codes to file on EDGAR. current state of price tier transparency).
may modify their pricing schedules in intermediary before being able to reach this worry of missing out on preferential
response to many factors, including the one of the exchanges, which leaves pricing and allow broker-dealers to
proposed rule. agency traders with a latency route orders more readily to a variety of
disadvantage relative to principal exchanges on the basis of execution
D. Effect on Efficiency, Competition,
traders that can access the exchanges quality. While variation in rebates and
and Capital Formation
directly.238 If such a concentration of fees across exchanges would likely
1. Efficiency agency orders on certain exchanges continue to exist and be one factor that
The Commission anticipates that the occurs it would result in traders having influenced the routing decisions of
proposed rule would result in most a higher degree of certainty as to brokers, the lack of volume-based
exchanges that trade NMS stocks whether they are trading against an transaction tiering would mean that
significantly adjusting their transaction agency order or not based on which brokers could route agency orders to a
pricing schedules. By prohibiting one exchange the transaction is occurring. different exchange without jeopardizing
form of transaction pricing (volume- Understanding that their orders are the average net per-share costs of their
based) for trades of agency and riskless more likely to be routed to some overall trading.
principal, the proposed rule would exchanges over others and hence more While welfare for different customer
allow exchanges to apply different fees readily identified as an agency order, segments may increase or decrease
or rebates to principal trades. An agency traders could elect to provide under the proposed ban, the overall
example of one such case could entail liquidity at a wider spread as a means welfare effects of banning price
offering fixed transaction fees and of compensation for the increased risk discrimination are ambiguous and can
rebates to agency and riskless-principal of being adversely selected by a vary across market settings.239
trades but offering volume-based tiered principal trader. While the latency Nevertheless, standard intuition derived
prices to principal trades. While current disadvantage exists in current markets, from economic theory suggests that
pricing tiers may effectively exchanges that have a mix of agency and when heterogeneity across customers
differentiate between agency-related and principal orders may see less likely exists, price discrimination may
principal trades it is often as a by- adverse selection for agency orders increase total welfare (i.e., welfare
product of the tier categorization rather because principal orders face more summed across firm(s) and their
than an explicit condition of the uncertainty about the capacity of their customers who derive utility from the
application of the tier. An example of counterparty. The relative scarcity of purchased goods) if the quantity sold
such an instance would be pricing tiers agency order flow on exchanges that increases under discrimination.240 The
reserved for exchange members that are become dominated by principal trading analog of ‘‘customers’’ in the exchange
registered with the exchange as a following the implementation of the setting is a combination of broker-
market-maker and whose market- proposed rules could also result in dealers and their customers. Broker-
making orders would all be principal wider spreads on those exchanges. dealers and the end investors share in
trades. However, this pricing would not These dynamics could be even more gains from executing trades. As the
apply to other exchange members that pronounced in the presence of intermediaries, to the extent the broker-
exclusively trade in a principal capacity additional discrepancies between the dealers share the rebates with their
if they are not registered market makers; informativeness or adverse selection investors, the end investors benefit from
so while all orders in such a tier may risk of agency and principal orders. This both the fulfilled trades and rebate pass-
be of the same capacity categorization, phenomenon further underscores the through. To the extent that broker-
qualification to such a market-maker tier potential implications of distinct pricing dealers’ responsiveness to volume-based
does not universally apply to all mechanisms for different types of order discounts is driven by the end investors’
principal capacity trades. The proposed flow on market efficiency and responsiveness to cost savings, volume-
rule would not prohibit exchanges from transaction costs. based discounts may expand overall
proposing transaction pricing where The effects of the proposed liquidity across exchanges. Not only
qualification is predicated on the elimination of volume-based transaction might volume-based discounts help the
capacity of the order as long as they are pricing tiers for agency-related trades dominant exchange extract more order
could improve transaction quality and flow and revenue, but the pricing
not based on volume to any extent.
The potential for exchanges to offer market efficiency by alleviating an schemes could also increase broker-
distinct pricing to principal and agency- impediment to switching the routing of dealers’ and their customers’ total
related order flow introduces the orders from one exchange to another. As surplus.
previously discussed, volume-based Evaluation of price discrimination
possibility for greater market
transaction price tiering effectively from other market settings provides the
segmentation. This could arise if
makes it more difficult for market insight that volume-based pricing that
exchanges chose to tailor their
participants to justify partially attracts more agency business from
transaction pricing schedule to favor
switching trading venues by increasing high-volume exchange members may
one type of order flow over another.237
the opportunity costs of doing so, benefit both the high-volume exchange
Such segmentation could negatively members and the exchanges, possibly at
because switching the venue to which
impact overall transaction costs by the cost of lower-volume exchange
agency orders are routed to makes it less
resulting in wider spreads being quoted members. However, in the context of
likely that the market participant will
on the exchanges. By their very nature
end up qualifying for a preferential
agency orders have to be handled by an

pricing tier. The elimination of volume- 239 Igal Hendel and Aviv Nevo, ‘‘Intertemporal
based transaction price tiering for Price Discrimination in Storable Goods Markets,’’
237 A broker-dealer solely looking to minimize 103 Am. Econ. Rev. 2722 (2013); Guillermo
transaction fees and maximize transaction rebates agency-related trades would alleviate Marshall, ‘‘Hassel Costs and Price Discrimination:
would concentrate their principal order flow on the An Empirical Welfare Analysis,’’ 7 Am. Econ. J.:
exchange(s) with the most attractive principal 238 With the exception of sponsored access trades Applied Econ. 123 (2015); Sofia Berto Villas-Boas,
volume tiers and concentrate their agency flow on under which the exchange member’s sponsored ‘‘An empirical investigation of the welfare effects of
the exchange(s) with the best agency order pricing. customer can directly access the exchanges using banning wholesale price discrimination.’’ 40 RAND
Markets are more likely to fragment if the set of the member’s infrastructure, although sponsored J. Econ. 20 (2009).
exchanges with the best agency order pricing differ access trades comprise a small portion of total 240 See Hall R. Varian, ‘‘Price Discrimination and
from the set with the best principal order pricing. agency flow. Social Welfare,’’ 75 Am. Econ. Rev. 870–75 (1985).
trading platforms with liquidity discussed in sections IV.C.1.a.i and exchanges might adjust their pricing
externality, additional order flow from IV.C.2.b.i. schedules to confer greater rewards to
high-volume exchange members may the execution of principal trading
b. Changes in Order Flow Concentration
ultimately be beneficial to lower-volume volume as a means of competing for
broker-dealers. High-volume exchange The Commission expects that the principal trading flows. This effect
members likely contribute substantially proposed prohibition for volume-based would not be present if exchanges
more to the depth of book on an exchange transaction pricing on agency- instead offered their best transaction
exchange. When volume-based related order flow would be likely to pricing to all members equally.
discounts induce additional order flow increase the dispersion of agency flow
The extent to which the different
from high-volume broker-dealers to and increase the concentration of
order flows become more or less
convene on a dominant exchange, more principal order flow across exchanges.
The reason that agency-related dispersed under the proposed
liquidity reduces the cost of searching prohibition is uncertain as it depends
for the best execution and benefits the volume might be impacted in this way
is that volume-based transaction pricing on the changes of a multitude of other
lower-volume broker-dealers. This order factors and their interactions which are
flow externality, which is absent in incentivizes the concentration of order
flow and, all else being equal, the infeasible for the Commission to reliably
many traditional price discrimination forecast. For instance, many exchange
settings, provides a benefit that partially removal of this incentive should result
in less concentration of that flow. Under transaction pricing schedules would be
countervails the potential negative likely to significantly change as a result
impact of volume-based tiers on the the assumption that some variant of
volume-based transaction pricing of the proposed rule, which would
lower-volume broker-dealers. likely affect broker-dealer routing
remains in place for principal orders,
2. Competition the concentration of principal order decisions and could possibly increase
flow on exchanges that previously used principal trading.241 In light of these
a. Broker-Dealer Competition difficulties, rather than providing a
tiered transaction pricing would be
To the extent that such increased expected to increase since the absence single point estimate, the following
costs for investors caused them to send of agency volume counting towards tier analysis will present expected effects on
order flow to other, lower-volume qualification could lead to a higher the exchanges that a variety of
exchange members, allocative efficiency degree of concentration of principal hypothetical changes in order flow
in the market for NMS stock brokerage flow that would be needed to qualify for concentration are likely to have.
services might be reduced. The high- pricing similar to what they realized Table 9 reports the expected trading
volume exchange members might be prior to the proposed rule. As reported volumes and market shares for the 16
most efficient at executing trades due in Table 5 the members of exchanges exchanges under different changes in
technology, capital or service strength with more price tiering are more likely order flow concentration. The analysis
arising from their scale economies. to concentrate their order flow onto uses the January 2023 on-exchange
Directing more order flow to the lower- those exchanges as illustrated by higher trading volume as a baseline. Implicit in
volume exchange members might result average share of member trading volume the analysis is the assumption that the
in resources being inefficiently utilized. and a greater proportion of members various exchange members execute the
The effects of the proposed rule on the executing a plurality of their order flow same trading volume on-exchange as
competition among broker-dealers are on the exchange. This suggests that they did in January 2023 baseline.242
TABLE 9—EXCHANGE POSITIONS GIVEN CHANGES IN ORDER-FLOW CONCENTRATION
The following table reports the total amount of executed orders (panel A) and the changes in executed orders (panel B), measured in number of
shares, that were executed during regular trading hours across the 16 national stock exchanges under different scenarios using the total buy
and sell executed order flow from all exchange members using a sample of CAT data for the month of Jan. 2023 from Table 4 as a baseline.
Exchange members are identified as the set of unique CRD IDs in CAT which have directly routed orders to any of the national equities ex-
changes in the month. Exchange member CRDs are also verified in the CAT Industry Member Identifier List daily reference data. For each
exchange the number of shares executed under the CAT allowable trade capacities of Agency, Principal, and Riskless Principal are reported.
Trade capacity in CAT is defined by the exchange member for its side of a trade and represents the capacity in which the exchange member
acted at trade time. Trades with the sale-condition codes–M—Market Center Official Close, –Q—Market Center Official Open, –V—Contingent
Trade,–7—Qualified Contingent Trade (QCT), –8—Placeholder for 611 Exempt, and –9—Corrected Consolidated Close (per listing market)
were excluded. ‘‘Agency ¥100% Concentration’’ corresponds to the scenario under which every exchange member sends an equal propor-
tion of its agency-related order flow (orders of capacity code of agency or riskless principal) across all the exchanges they are a member of.
‘‘Agency ¥20% Concentration’’ corresponds to the case where the proportion of agency-related order flow executed by each exchange mem-
ber is adjusted to be 20% closer to the equal proportion levels. ‘‘Principal +20% Concentration’’ corresponds to the case where the proportion
principal order flow executed by each exchange member is adjusted to be 20% further from the equal proportion levels. ‘‘Agency ¥20% Con-
centration & Principal +20% Concentration’’ corresponds to the case where the proportion of principal order flow executed by each exchange
member is adjusted to be 20% further from the equal proportion levels and the proportion of agency-related order flow executed by each ex-
change member is adjusted to be 20% closer to the equal proportion levels. See note 243 and the associated text for a detailed description
of the calculations.
Panel A: Trading Volume and Market Share Levels. Below the total order flow, measured in number of shares, for each of the four scenarios
and the baseline for each exchange is reported. The percentage share of total trading volume between each of the four scenarios and the
baseline for each exchange are reported under the trading volume.
241 See supra section IV.C.2.b.iii (discussing how 242 See supra section IV.C.1.b.v (discussing how
the proposed rule is expected to increase the the proposed rule may increase the amount of
incentive to increase the concentration of principal trading which may migrate to off-exchange market
order flow). centers).
Agency ¥100% Agency ¥20% Principal +20% Agency ¥20% &

Exchange Baseline concentration concentration concentration principal +20%
NYSE American ..................................... 1,545,083,370 9,014,311,364 3,038,928,968 925,779,162 2,419,624,761

0.64% 3.74% 1.26% 0.38% 1.00%
NYSE Arca ............................................. 39,311,251,528 28,194,801,883 37,087,961,599 40,979,313,252 38,756,023,323
16.30% 11.69% 15.38% 16.99% 16.07%
BX .......................................................... 1,712,065,584 10,202,384,309 3,410,129,329 954,950,476 2,653,014,221
0.71% 4.23% 1.41% 0.40% 1.10%
Cboe BYX .............................................. 4,664,774,940 10,767,820,881 5,885,384,128 3,996,852,852 5,217,462,040
1.93% 4.47% 2.44% 1.66% 2.16%
Cboe BZX .............................................. 19,855,374,396 18,464,904,008 19,577,280,318 20,177,425,112 19,899,331,035
8.23% 7.66% 8.12% 8.37% 8.25%
NYSE Chicago ....................................... 432,565,797 6,732,028,311 1,692,458,299 271,874,586 1,531,767,089
0.18% 2.79% 0.70% 0.11% 0.64%
Cboe EDGA ........................................... 5,800,545,730 10,492,471,510 6,738,930,886 5,050,458,361 5,988,843,517
2.41% 4.35% 2.79% 2.09% 2.48%
Cboe EDGX ........................................... 26,669,251,824 21,126,143,742 25,560,630,207 27,337,564,263 26,228,942,646
11.06% 8.76% 10.60% 11.34% 10.88%
IEX ......................................................... 10,772,940,184 12,475,034,616 11,113,359,070 10,073,270,498 10,413,689,385
4.47% 5.17% 4.61% 4.18% 4.32%
LTSE ...................................................... 12,160,554 6,380,358,525 1,285,800,148 10,749,491 1,284,389,085
0.01% 2.65% 0.53% 0.00% 0.53%
MEMX .................................................... 13,241,685,902 14,925,744,644 13,578,497,650 12,975,451,264 13,312,263,013
5.49% 6.19% 5.63% 5.38% 5.52%
Nasdaq ................................................... 68,721,861,666 36,597,959,759 62,297,081,284 71,138,284,292 64,713,503,911
28.50% 15.18% 25.83% 29.50% 26.84%
NYSE National ....................................... 2,317,954,540 9,158,405,160 3,686,044,664 1,708,621,212 3,076,711,336
0.96% 3.80% 1.53% 0.71% 1.28%
NYSE ..................................................... 39,387,052,205 26,406,685,490 36,790,978,862 40,310,486,972 37,714,413,629
16.33% 10.95% 15.26% 16.72% 15.64%
MAX Pearl .............................................. 4,485,360,802 9,986,884,064 5,585,665,454 3,863,443,029 4,963,747,682
1.86% 4.14% 2.32% 1.60% 2.06%
Phlx (PSX) ............................................. 2,220,543,164 10,224,533,912 3,821,341,313 1,375,947,356 2,976,745,506
0.92% 4.24% 1.58% 0.57% 1.23%
Panel B: Changes in Trading Volume and Market Share. Below the difference in total order flow, measured in number of shares, across
each of the four scenarios and the baseline for each exchange is reported. Differences in the percentage share of total trading volume across
each of the four scenarios and the baseline for each exchange are reported under the trading volume. The number of tiers for each exchange
from Table 5 are also reported for each exchange.
NYSE American ..................................... 10 7,469,227,994 1,493,845,598 ¥619,304,208 874,541,391

3.10% 0.62% ¥0.26% 0.36%
NYSE Arca ............................................. 72 ¥11,116,449,645 ¥2,223,289,929 1,668,061,724 ¥555,228,205
¥4.61% ¥0.92% 0.69% ¥0.23%
BX .......................................................... 20 8,490,318,725 1,698,063,745 ¥757,115,108 940,948,637
3.52% 0.70% ¥0.31% 0.39%
Cboe BYX .............................................. 11 6,103,045,941 1,220,609,188 ¥667,922,088 552,687,100
2.54% 0.51% ¥0.27% 0.23%
Cboe BZX .............................................. 26 ¥1,390,470,388 ¥278,094,078 322,050,716 43,956,639
¥0.57% ¥0.11% 0.14% 0.02%
NYSE Chicago ....................................... 0 6,299,462,514 1,259,892,502 ¥160,691,211 1,099,201,292
2.61% 0.52% ¥0.07% 0.46%
Cboe EDGA ........................................... 8 4,691,925,780 938,385,156 ¥750,087,369 188,297,787
1.94% 0.38% ¥0.32% 0.07%
Cboe EDGX ........................................... 19 ¥5,543,108,082 ¥1,108,621,617 668,312,439 ¥440,309,178
¥2.30% ¥0.46% 0.28% ¥0.18%
IEX ......................................................... 0 1,702,094,432 340,418,886 ¥699,669,686 ¥359,250,799
0.70% 0.14% ¥0.29% ¥0.15%
LTSE ...................................................... 0 6,368,197,971 1,273,639,594 ¥1,411,063 1,272,228,531
2.64% 0.52% ¥0.01% 0.52%
MEMX .................................................... 13 1,684,058,742 336,811,748 ¥266,234,638 70,577,111
0.70% 0.14% ¥0.11% 0.03%
Nasdaq ................................................... 74 ¥32,123,901,907 ¥6,424,780,382 2,416,422,626 ¥4,008,357,755
¥13.32% ¥2.67% 1.00% ¥1.66%
NYSE National ....................................... 11 6,840,450,620 1,368,090,124 ¥609,333,328 758,756,796
2.84% 0.57% ¥0.25% 0.32%

NYSE ..................................................... 93 ¥12,980,366,715 ¥2,596,073,343 923,434,767 ¥1,672,638,576
¥5.38% ¥1.07% 0.39% ¥0.69%
MIAX Pearl ............................................. 8 5,501,523,262 1,100,304,652 ¥621,917,773 478,386,880
2.28% 0.46% ¥0.26% 0.20%
Phlx (PSX) ............................................. 4 8,003,990,748 1,600,798,149 ¥844,595,808 756,202,342
3.32% 0.66% ¥0.35% 0.31%
Changes in concentration are related order flow.246 The case of an the primary exchanges in order to
calculated by either increasing or even distribution of agency-related qualify for lower fees during the closing
decreasing the distance between the order flow across exchanges would auctions. The proposal would prohibit
proportions of order flow individual result in a more fragmented market with exchanges from offering volume-based
broker-dealers allocate to the different the overall pro-rata HHI falling from pricing in connection with the
exchanges and an even split. For a given 0.16 to 0.08.247 execution of agency-related order flow
percentage increase in concentration, Aside from the upper bound case of in NMS stocks. The proposal would
the distance between the relative share an even distribution of agency flow, a thus prohibit exchanges from offering
of a broker-dealer’s order flow sent to an case where there would be a 20% transaction pricing on any orders if that
exchange and 1/N, where N denotes the reduction in agency flow concentration, pricing is determined, in part, by the
number of exchanges it is a member of, a case where there would be a 20% execution of agency-related trading
is increased by that percentage increase in principal flow volume. Accordingly, the proposal
amount.243 The effect of this is to concentration, and a case with the would prohibit exchanges from tying
increase a member’s HHI measure by combination of the two are also reported transaction pricing on orders executed
reducing the share of order flow sent to Table 9. While the case of a 100% during closing or opening auctions to a
exchanges for which the exchange reduction in agency-related flow member’s agency-related trading volume
member allocated a smaller proportion concentration serves as an upper bound in NMS stocks during regular trading
of its original order flow and increase of the potential effects on order flow, hours. Limiting the listing exchanges’
the share sent to those exchanges for other scenarios serve as an exercise in ability to tie prices for the closing
which it was already allocating larger comparative statistics to illustrate the auctions to intraday agency-related
shares of its order flow. Similarly, a effects of more modest changes in trading volume may benefit smaller
percentage decrease in concentration concentration. For the cases of a 20% exchanges without listing capabilities.
would manifest in a lower HHI value.244 decrease in concentration of agency- A more level playing field for intraday
A 100% decrease in concentration related order flow and a 20% increase trading across exchanges will likely
corresponding to the case when an in principal order flow concentration, benefit broker-dealers for two reasons.
exchange member evenly splits its order the overall pro-rata HHI would be 0.14 First, the absence of tying that protects
flow and the member HHI is equal to the and 0.17, respectively. For the the primary listing exchanges may result
minimum achievable value.245 combined case of both a 20% decrease in more intense competition for order
The first non-baseline column of in agency-related flow concentration flow across exchanges during the
Table 9 shows what the on-exchange and 20% increase in principal flow regular hours. This may in turn result in
market would look like if all exchange concentration the resulting pro-rata HHI lower transaction fees/more generous
members evenly split their agency flow would be 0.15. Compared to the January terms for broker-dealers for order
across the exchanges they are member of 2023 HHI of 0.16, these changes suggest executed. Second, the primary
while not changing the distribution of that the distribution of trading volume exchanges’ closing auction pricing
principal order flow. This case serves as across the market is slightly more structure tends to partially foreclose
an upper limit of the potential effect of sensitive to decreases in agency-related broker-dealers’ order flow that may have
the proposed rule’s effect on agency- order flow concentration than to similar otherwise gone to whichever exchange
related order flow concentration. The increases in principal order flow offering the best execution quality or
reason why this case reflects an upper concentration. As a result, a reasonable more generous rebates. Broker-dealers’
bound is because while the Commission expectation for the likely effect of the welfare may be higher under
expects agency order flow concentration proposed rule would be to result in a ‘‘unbundling’’, if changes in choice sets
to decrease as a result of the proposed marginally more even distribution of result in broker-dealers choosing
rule, it believes that it is highly unlikely market share across stock exchanges, superior products.
that the resulting market landscape which may be representative of a more
would result in individual broker- competitive market.248 3. Capital Formation
dealers evenly distributing their agency- The Commission believes the
c. Tying Closing Auction Fees to
proposed rules would have a modest
243 Suppose that a broker-dealer allocates, for Consolidated Volume
impact on capital formation. The
each exchange i, a share si such that the sum of si’s As discussed in section IV.B.1.c, tying
across exchanges indexed by i (‘‘sum of shares’’)
proposed rules may lower transaction
equals one. Given a percentage change p in closing auction fees to broker-dealers’ costs for investors through their effect
concentration, the broker-dealer shares are overall volume helps the primary listing on exchange transaction pricing
transformed to an updated si*=max[si+p(si-1/N),0], exchanges extend their market power schedules,249 broker-dealer
where N denotes the count of exchanges over which and softens inter-exchange competition.
the broker-dealer allocates order flow. When p>0, competition,250 and the broker-dealer
member HHI increases, since the sum of the For listing companies and index funds conflict of interest.251 However, the net
updated (si*)2’s is greater than the sum of the (si)2’s. with strong interests in closing auctions, effect is difficult to determine. For
In cases where si+p(si-1/N) < 0, the updated sum of the current pricing structure heightens example, some broker-dealers’
shares would be greater than 1. In these cases the their incentive to divert order flow to
new shares are recalculated as the ratio of si* to the transaction costs may increase,252 which
updated sum of shares, in order to ensure that the could then increase the transaction costs
246 See section IV.B.2 (discussing non-tier factors
shares sum to one; whenever this occurs the of investors to the extent these increases
number of exchanges receiving non-zero order flow that may influence order routing decisions).
are passed through to them.
decreases. 247 Overall pro-rata HHI is calculated as the sum

244 To illustrate, if a broker-dealer distributed of squared market shares reported in Table 6. To the extent the proposed rules
their order flow 70%/30% across two exchanges a 248 It is important to note that the basis for the reduce transaction costs, they would
50% increase in concentration would result in a statement relies on the assumption that agency- increase the efficiency of trading, which
80%/20% split (0.8 = 0.7 + p(0.7–0.5), and 0.2 = related order flow concentration would decrease at may lead to better capital allocation.
0.3+p(0.3–0.5) for p = 50%). A 50% decrease in least as much as principal order flow concentration
concentration would result in a 60%/40% split (0.6 increases. More importantly the analysis assumes 249 See supra section IV.C.1.a.ii.
= 0.7—p(0.7–0.5), and 0.4 = 0.3¥p(0.3–0.5) fir p = that exchange membership and exchange pricing
250 See supra section IV.C.2.a.i.
50%). schedules do not change (outside of the prohibition
245 This is the case when p=¥1, and s =(1/N) for 251 See supra section IV.C.2.a.iii.
i of applying volume-based pricing on agency or
each exchange i. riskless principal order flow). 252 See supra section IV.C.2.b.ii.
E. Reasonable Alternatives High-volume exchange members’ volume firms which qualify for more
current tiered pricing advantage also preferential pricing tiers.257 Moreover,
1. Ban Volume-Based Pricing for All
helps them attract customer order flow conditional on the extent to which
Orders
from non-members and other members. volume-based pricing increases trading
As an alternative to the proposed The same pricing advantage applies to volumes, the prohibition of volume-
prohibition of volume-based transaction members engaged in both agency and based pricing under this alternative may
pricing for agency-related orders in principal trading because a member’s decrease the investment in faster
NMS stocks, the Commission might combined agency-related and principal connectivity and technological prowess
instead prohibit exchanges from offering activity is counted towards its total (e.g., trading algorithms) that contribute
volume-based transaction pricing for all volume to qualify it for higher tiers, to the competitive edge of principal
volume in NMS stocks. which benefits the member when traders by lowering the value of such
The Commission believes that much competing for customers in the market investments.
of the baseline regarding the effects of to provide exchange access to others. To A full ban on volume-based
volume-based transaction pricing on the extent that broker-dealers engage in transaction pricing would result in a
agency-related volume is relevant to principal bidding to fill customer number of differences in benefits and
principal-based volume. One difference orders,255 principal trading may still be costs.
in the baseline for principal order flow related to the market to provide Under a full ban on volume-based
from proprietary trading is that such exchange access to investors, albeit in transaction pricing, there would be no
order flow does not have the potential an indirect manner. In this case, the need, and therefore no requirement, for
for a conflict of interest between barriers to entry in the brokerage disclosures regarding the number of
members and customers with respect to business, including the contribution of exchange members qualifying for
routing. Because the member trades for volume-based transaction pricing, volume-based tiers, as there would be
its own account when routing in a would continue to apply to principal- no volume-based tiers left. Therefore,
principal capacity, only its own based trading. under this alternative there would be no
interests are at stake in the routing Whether or not exchange members need for the disclosures required under
decisions. Currently, the transaction compete for customer orders or proposed Rule 6b–1(c) nor would the
fees that a member pays and the rebates primarily trade in a principal capacity, anti-evasion provision in proposed Rule
that it receives apply to both the they face the same fixed costs described 6b–1(b) be needed because members
member’s agency-related volume and its in section IV.B.4 for data, hardware, would not be able to evade a broad
proprietary volume, as exchanges connectivity including co-location prohibition through activity such as
generally do not distinguish their services, and other inputs. While these mismarking orders to qualify for tiered
pricing tiers for orders solely on the fixed costs may create a substantial pricing because volume-based tiered
basis of whether the order was filled in barrier-to-entry, volume-based discounts transaction pricing would no longer be
a principal or agency capacity. that lower variable costs for trades may permitted. As described in sections
However, some tiers, such as those increase trading activities and variable IV.B.1 and IV.B.5 volume-based pricing
reserved for registered market makers, profits for the high-volume members. tiers contribute to a highly complex
effectively only apply to principal Higher variable profits for high-volume trading environment and by banning
orders. In addition, the incentives, in members help to offset the fixed costs of volume-based pricing for all orders, this
the form of lower transaction pricing, trading. Hence volume-based alternative may result in simpler
that volume-based exchange transaction transaction pricing that lowers trading markets. Volume-based pricing tiers
pricing create to attract members to costs for higher volume exchange allow for significant variation across
route their orders to particular members may amplify the market shares exchanges in the volume-based tiers
exchanges also apply to principal orders of those higher volume exchange offered to principal orders, and a
in the same way that they do for agency- members. Unlike the proposal which is prohibition of volume-based price
related orders.253 Further, the potential more likely to adversely affect exchange tiering would greatly limit the degree of
for burdens on competition between members with a high volume of agency- variation in pricing schedules across
members associated with volume-based related order flow, a ban on volume- exchanges. This lack of variation would
exchange transaction pricing exist for based pricing for all orders may also make the various trading venues look
proprietary volume in a similar manner affect exchange members with a high more similar in terms of the fees
as for agency-related volume. Even volume of principal order flow.256 charged facilitating the comparison of
though unlike for agency-related volume Prohibiting volume-based pricing for transaction pricing across exchanges
there are no third-party customers principal order flow could lead to a and could lead trading to increasingly
more level competitive environment congregate on a smaller number of
involved in or directly impacted by
between exchange members which exchanges, those with the highest
exchange transaction pricing for
primarily trade in a principal capacity, rebates and lowest fees. Relative to this
principal orders, volume-based pricing
including amongst market makers, as alternative, the proposal would still
tiers still present issues related to
differences in fees paid and rebates allow for a greater variation between
competition by granting those exchange
collected may meaningfully affect the exchange pricing schedules since it
members with a high degree of principal
competitive position of the higher would continue to allow the application
trading a competitive advantage in
of volume-based pricing tiers to
attracting customer order flow.254 tiers which in turn allows them to attract more principal order flow. On the other hand,
customer volume by offering more attractive terms contrary to the proposal, this alternative
253 See section IV.B.3 for a discussion of the
than lower volume competitors.
additional incentives introduced by volume-based 255 For example, a broker, instead of working a would be simpler for exchanges to
pricing tiers to order routing decisions. sell order as an agent for the customer, might just
254 Exchange members compete for the agency- offer the customer a price to buy the shares outright 257 See Letter from John Ramsay, Chief Market
related order flow of non-exchange member from the customer. Policy Officer, Investors Exchange LLC to Vanessa
customers. Volume-based pricing tiers present a 256 See section IV.C.1.b.i for a discussion of how Countryman, Secretary, Commission (Sept. 20,
network effect, or positive feed-back loop, in that the proposed rule could adversely affect exchange 2023) (‘‘IEX Letter’’) (comment letter on File No.
exchange members with large amount of trading members with a high volume of agency-related S7–30–22), available at https://www.sec.gov/
volume find it easier to qualify for higher volume order flow. comments/s7-30-22/s73022-262059-619382.pdf.
implement than a ban on only tiered rebates, which may be exacerbated remove the incentive to concentrate
transaction pricing for agency-related through the offer of large rebates, principal order flow on exchanges
volume in at least one sense: exchanges particularly amongst higher volume offering volume tiers.260 Unlike the
would not have to ascertain order exchange members.259 proposal, eliminating volume-based
capacity codes to separate agency- A broad ban would fully prohibit pricing for all orders would reduce the
related orders from proprietary orders volume-based discounts in the closing incentive to concentrate order flow for
when computing member transaction auctions, where the tiers are based on a all orders rather than potentially
invoices. member’s overall trading volume, which increase the concentration of principal
The Commission believes that the may benefit both high- and low-volume order flow as a means of offsetting the
benefits to lower-volume exchange exchange members if this unbundling effects of prohibiting volume-based
members described in section IV.C.1.a.i results in a more level playing field for pricing for agency-related order flow.261
could be increased and extended. In that intraday trading. As a consequence of Banning the tying of volume-based
section, the Commission describes how, unbundling, broker-dealers may be less tiering in the closing auctions for both
consistent with the relevant economic constrained by the incentive to direct agency-related and principal order flow
literature, exchanges could set new intraday order flow to a primary listing may further contribute to a dispersion of
prices that are between the current exchange so as to qualify for higher order flow across exchanges, to the
lowest and highest prices offered for discounts for their principal order flow benefit of the less dominant exchanges.
transactions, benefiting those broker- during the closing auctions. Instead, the Tying execution costs in the closing
dealers that currently pay the highest broker-dealer may place greater weight auction to the firm’s overall trading
prices. To the extent that these broker- on execution quality or rebates received, volume on the same platform can alter
dealers have principal order flow, the to the ultimate benefit of the broker- the level of competition for intraday
change in transaction pricing would dealer and the customer. Unbundling trading across exchanges.262 It provides
apply to that order flow as well, further that weakens primary listing exchanges’ a way for primary listing exchanges,
reducing these broker-dealers’ market power over intraday trading may which facilitate closing auctions with
transaction costs. also lead to lower average transaction large-scale liquidity, to extend their
Similarly, the costs to broker-dealers fees for intraday trading, further market power to intraday trading.
that currently qualify for the highest benefitting broker-dealers. Prohibiting tiers for both agency-related
tiers, described in section IV.C.1.b.ii Banning volume-based transaction and principal order flow in the closing
would be increased and extended. fees for both principal and agency- auctions may further contribute to a
Banning volume-based exchange related order flow may expand the range shift in order flow towards non-listing
transaction tiers would likely impose of profitable opportunities for new and exchanges.
costs on high-volume exchange smaller exchanges while limiting A ban on both principal and agency-
members in the form of lower rebates/ persistent concentration across the related flow would constrain the
higher transaction fees. The expanded largest exchanges. A ban on volume- exchanges’ ability to adjust their pricing
ban may also contribute to a loss in the based transaction pricing is likely to schedules for principal flow in a way
competitive advantage of the high- reduce the degree to which exchange that preserves their existing competitive
volume members in competing for members concentrate their order flow advantages. Shutting down volume-
customers, particularly if the member on exchanges by removing the incentive based tiers for both agency-related and
would have otherwise leveraged to concentrate order flow caused by principal order flow would limit the
discounts on principal volume to attract volume-based pricing which is potential for exchanges to employ
customers and qualify for higher volume discussed in section IV.B.3. As also strategic behavior under a ban on only
tiers. The number of broker-dealers discussed in section IV.B.3 it is likely agency-related order flow, since this
the case that principal order flow is behavior may otherwise serve to
affected would be greater under this
more responsive to changes in preserve the competitive advantage of
alternative relative to the proposal.258 If
transaction pricing and so extending the the largest exchanges.263 For example,
exchanges set transaction fees and
prohibition of volume-based pricing to to counter the potential loss of agency
rebates for all orders that are between
principal order flow would likely result volume, the higher-volume exchanges
those offered at the highest and lowest
in less order flow concentration. may re-adjust their pricing schedules for
volume tiers then exchange members,
Compared to the volume-based principal order flow. For instance,
including those which primarily trade
transaction pricing ban for agency- deeper discounts for increases in
with principal orders would be affected.
related volume under the proposal, a principal order flow may serve to both
If exchanges respond to the full ban by
full ban on volume-based transaction (1) further incentivize the submission of
offering a new price schedule in which inframarginal principal limit orders and
rebates of the lowest tier are increased pricing may result in greater dispersion
of order flow across the exchanges, (2) constrain the newer, smaller
or transaction fees are decreased, those
broker-dealers whose principal-related potentially leveling the playing field 260 Broker-dealers seeking to execute a proprietary
volume would have continued to among larger and smaller exchanges in order may choose to route it to an exchange for the
qualify for discounts would be subject this regard, since a full ban would also purpose of increasing the likelihood of qualifying
to higher trading costs for this principal for a volume tier even if, absent tier considerations,
259 Excessive intermediation here refers to they would choose to route to another exchange.
volume. Extending the prohibition of volume-based pricing
excessive quoting in sufficiently liquid securities in
A broad ban on the application of order to earn rebates, which crowds out investors to principal orders would remove this effect and
volume-based transaction pricing might from being able to supply liquidity. Large rebates could result in a greater dispersion in order flow
also reduce excessive intermediation, can increase quoting activity from high-frequency over exchanges, which might increase the
traders looking to earn rebates. Because rebates are competitiveness of less dominant exchanges. See
i.e., excessive quoting from high- section IV.C.1.a.iii for a discussion of how
paid when a quote is hit by a marketable order,
frequency traders looking to earn obtaining high priority in the queue at each tick is increased order flow dispersion might benefit
essential to such strategies. High-frequency, lower-volume exchanges.
258 Exchange members which currently qualify for 261 See section IV.D.2.b.
proprietary traders are generally better able to
262 See section IV.D.2.c.
the best volume-based pricing tiers may be worse obtain such priority, and consequently investors
off whilst those which fail to do so may be better may have less opportunity to profitably fill their 263 See section IV.D.1 for discussion of how
off. trades using limit orders. exchanges may adjust their price schedules.
exchanges’ ability to effectively compete exchange venues, as volume-based makers which award them with better
with the dominant exchanges. The transaction pricing may help exchanges rebates/fees.
dominant exchanges’ ability to compete with off-exchange venues.265 This alternative would allow
consolidate principal flow increases the The additional loss of such order flow exchanges to incentivize their registered
attractiveness of their exchange services, would increase the costs of the rule for market makers, through transaction
which in turn helps the exchanges those exchanges, but this change in pricing incentives, to maintain
better attract agency order flow. order flow would be a benefit to the off- displayed quotations. It would not
Exchanges may adapt to the proposal in exchange venues that receive it instead. permit volume-based exchange
a way that not only preserves their transaction pricing incentives for non-
dominance over the smaller exchanges 2. Ban Volume-Based Pricing for All displayed quoting activity, including
but also confers even more favorable Orders Except Registered Market Makers non-displayed orders, orders not in the
rebates for top-tiered principal order market maker’s assigned or registered
As an alternative to the proposed symbols (which would not be subject to
flow. As previously noted, aside from
prohibition of volume-based transaction the quantitative and qualitative market
high-frequency trading firms and
pricing for agency-related orders in making standards under an exchange’s
market-makers, exchange members with
NMS stocks, the Commission might rules). It also would not allow
the largest principal order flow also
tend to be high-volume players in terms instead prohibit exchanges from offering exchanges to determine volume-based
of their agency order flow. volume-based transaction pricing for all transaction fees based on total orders or
Consequently, increased discounts for volume in NMS stocks, but subject to a customer orders. Rather, the carve-out
principal trading activities may carve-out only for displayed liquidity would allow volume-based transaction
potentially offset some of their profit providing orders from exchange pricing only for the types of orders
loss from higher transaction fees on registered market makers in their specified above.
agency order flow. The possibility of registered or appointed symbols where Allowing exchanges to incentivize
cross-subsidization where transaction the registered market maker is subject to displayed quotations from their
fees on agency-related trading are used minimum continuous quotation and registered market makers allows
to subsidize better pricing for principal minimum quote width standards that exchanges to continue to reward
trading activities, along with the meet or exceed the highest such members for becoming, and remaining,
possibility that broker-dealers may standards in place among national registered market makers and for
effectively transform agency trades into securities exchanges.266 posting displayed quotations that are
principal trades if they switch from an visible to and accessible by all market
In the current trading environment, participants. Those displayed
agency model to a principal model, many stock exchanges also offer
means that the high-volume broker- quotations provide an important and
separate volume-based rebates to their central public source of price
dealers’ competitive advantage may registered market makers as a means of transparency that can directly benefit
persist even under a ban on pricing tiers incentivizing additional liquidity investors, as displayed quotations are
for agency flow. provision in the form of displayed
A by-product of the full ban on used for many purposes including
quotations. For example, one exchange informing trading decisions,
volume-based transaction pricing would has rebate tiers for its market makers
be to dampen the possibility that broker- establishing security valuations, and
with qualification based on the percent performing index calculations. Allowing
dealers transition to an inventory- of time the registered market maker
holding model, thereby reducing exchanges to continue to offer
quotes at the NBBO and the average size transaction pricing incentives to
systemic risk associated with holding of those quotes in addition to the encourage public displayed quotes,
inventory.264 A full volume-based ban volume of liquidity provided.267 Similar where those quotes are subject to
may not only lessen the high-volume
to the volume-based pricing tiers offered quantitative and qualitative standards
broker-dealers’ tier advantages from
to non-market-maker exchange members contained in exchange rules, could
principal trading but also limit the
these volume-based market maker benefit the public interest.
increase in inventory risk across these Because this alternative would
pricing tiers are designed to attract the
players that shift towards greater involve a prohibition on volume-based
order flow of high-volume market
reliance on principal trading. exchange transaction pricing for all
To the extent that volume-based makers who contribute significantly to
the overall liquidity on the exchange.268 NMS stocks, the discussion and analysis
transaction pricing helps exchanges above about extending the prohibition
better retain order flow, a ban on both As described in section IV.B.1.a,
exchanges compete to attract to also include proprietary volume,
agency-related and principal order flow including the baseline, the costs and
may increase cost to exchanges in the competitively priced liquidity and they
do so, in part, by offering variable benefits, and the effects, applies equally
form of forgone revenue and the cost to to this alternative and is hereby
broker-dealers in the form of forgone pricing terms to their registered market
incorporated by reference. This ban
surplus. Section IV.E.1 discusses how might also reduce excessive
265 Id.
volume-based pricing, viewed as a price intermediation, i.e., excessive quoting
266 See, e.g., NYSE Rule 104 (for an example of
discrimination mechanism or in a from high-frequency traders looking to
a rule that concerns quotation requirements). Such
mechanism-design (screening) context, exchange rules would typically impose, for earn rebates, which may be exacerbated
can be an effective way for exchanges to example, maximum quotation widths (i.e., the through the offer of large rebates,
extract increasing levels of order flow spread between the bid to buy and the offer to sell)
particularly amongst higher volume
and expand total surplus. Some of the as well as time at the inside requirements (i.e., time
where the market maker must be quoting at least as exchange members, though not from
forgone order flow loss under a full ban good as the national best bid and offer). registered market makers.
would be order flow streamed to off- 267 See NYSE pricing schedule, available at
A prohibition on volume-based
https://www.nyse.com/publicdocs/nyse/markets/ exchange transaction pricing for both
264 For a discussion concerning the incentive nyse/NYSE_Price_List.pdf.
broker-dealers may have to carry larger inventory 268 For additional discussion regarding the agency-related and principal order flow
position with which to internalize customer orders incentives introduced by volume-based pricing tiers that carves out displayed liquidity
see section IV.C.1.b.iv. see section IV.B.3. adding orders submitted by exchange
registered market makers in their and count that activity for compliance qualitative and quantitative quotation
registered or assigned symbols, where with the applicable exchange market standards that meet or exceed the
the registered market maker is subject to making requirements, including highest such standards in place among
minimum continuous quotation and quantitative quotation standards. Thus, national securities exchanges,
minimum quote width standards that the same activity that counts towards exchanges would be incentivized to
meet or exceed the highest such the registered market maker’s quotation adopt more rigorous quantitative and
standards in place among national would be eligible for tiered pricing qualitative market making requirements.
securities exchanges, would result in a under the carve out. Consequently, competition could
number of differences in benefits and For the same reason, under this increase for the provision of displayed
costs compared to the proposal. Those alternative, exchanges would not be quotes, which should promote price
differences are identical to the required to have policies and discovery and liquidity provision to the
differences discussed above for the procedures reasonably designed to benefit of investors and the public
alternative involving a prohibition on detect and deter members from engaging interest.
volume-based exchange transaction fees in practices that evade the prohibition For a ban with a limited carve-out for
for both agency-related and principal because the only type of activity that registered market maker quoting,
order flow without a carve out, except would be eligible for tiered pricing exchanges should readily be able to
where otherwise discussed directly would be the specially designated ascertain the applicable market-making
below. activity that counts towards the market activity because it is subject to existing
Under a ban on volume-based maker’s displayed quotation quantitative exchange quoting
exchange transaction pricing with a requirement. requirements. Exchanges would not
registered market maker displayed quote The Commission does not expect that need to ascertain the capacity of other
carve out, there would be less need for there would be a substantial increase in interest because those would be subject
disclosures regarding the number of the number of exchange registered to the broader prohibition. Accordingly,
exchange members qualifying for market makers under this alternative a prohibition with a limited carve-out
volume-based tiers, as fewer members even though the continued allowance of for registered market makers should also
would be eligible for volume-based tiers volume-based transaction pricing for be simpler for exchanges to implement
and it would only apply to displayed exchange registered market makers than a prohibition on tiered transaction
quotes. This alternative could be could make becoming one attractive. pricing for agency-related volume.
implemented with a transparency The requirements and obligations As discussed in the alternative for a
measure for those tiers eligible for the associated with being a registered prohibition on volume-based exchange
displayed quote carve-out, or with no market maker likely make the prospect transaction pricing for both agency-
additional disclosures. We request of becoming a registered market maker related and principal order flow, the
comment on these different possibilities for the purpose of receiving volume- prohibition with a limited carve out for
below. While this alternative would based pricing on liquidity providing registered market makers could also
allow some volume-based exchange orders not economically viable.269 provide benefits to lower-volume
transaction pricing for displayed Further, because the activity that would exchange members that currently pay
quoting activity of exchange registered be subject to the carve-out would be the highest prices if exchanges respond
market makers, that is only a subset of subject to those exchange market by offering lower fees and higher rebates
principal trading. Under this alternative, making requirement rules, any attempt for non-market making order flow. In
volume-based exchange transaction to evade the prohibition would result in turn, that could reduce these members’
pricing would not be available for members engaging in trading activity transaction costs. However, members
liquidity removing orders, non- that would become subject to those that receive the highest rebates and pay
displayed orders, or orders not in one of market making quoting requirements. the lowest fees may see their transaction
the registered market maker’s assigned Accordingly, an anti-evasion provision costs increase if exchanges reduce those
or registered symbols because those are would not serve a comparable purpose incentives when they discontinue
not liquidity-adding quotations for and would not be necessary with a offering volume-based transaction
which the registered market maker is broad ban that has a limited carve-out pricing. A ban with a limited carve-out
subject to the exchanges’ quotation for registered market makers. for registered market makers could
requirements. The significantly Similar to the alternative discussed in preserve some, or all, of the incentivized
narrowed scope of what would be section IV.E.1 featuring a prohibition on fee and rebate levels that a registered
subject to the disclosures under Rule volume-based exchange transaction market maker currently receives.
6b–1(c), and the limited subset of pricing for both agency-related and A ban with a limited carve-out for
members and trading activity to which principal order flow, this alternative registered market makers also would
they would apply, could significantly may result in less market fragmentation prohibit volume-based discounts for
limit the usefulness of the disclosures to and simplify markets and that both agency-related and principal order
a point where the benefits may not discussion applies equally to this flow in the closing auctions except for
justify the costs. Accordingly, this alternative. the registered market maker limited
alternative would not require the As exchanges would continue to be carve out. Similar to the first alternative,
proposed transparency disclosures. able to offer volume-based transaction members who are not market makers
Under this alternative, there would be pricing to market makers in their may be less constrained to direct
no anti-evasion provision because registered or appointed symbols where intraday order flow to a primary listing
members would not be able to evade a the registered market maker is subject to exchange so as to qualify for higher
broad prohibition through activity such discounts during the closing auctions.
as mismarking orders to qualify for 269 In particular, being a market maker involves Instead, the member may place greater
tiered pricing because volume-based regulatory, technology and operational burdens weight on execution quality or rebates
tiered transaction pricing would no such as having algorithmic trading strategies and received for just intraday order flow, to
servers in order to meet the quoting requirements,
longer be permitted except for orders and other affirmative obligations of a registered
the ultimate benefit of the broker-dealer
that exchanges closely track because market maker, while doing the fewest possible and the customer. Unbundling that
exchanges need to identify, monitor, unwanted trades. weakens primary listing exchanges’
market power over intraday trading may liquidity provision. Accordingly, a Commission would require exchanges to
also lead to lower average transaction limited carve-out for registered market disclose periodically certain
fees for intraday trading, further makers could allow exchanges to information if they offer volume-based
benefitting broker-dealers that are not continue to incentivize their members to transaction pricing for any NMS stocks,
market makers. become and remain registered market for both principal and agency-related
The distortions in intraday routing makers and quote and thereby confer a orders.271
decisions faced by principal traders, as broader benefit to the market generally Expanding the disclosure under
mentioned in section IV.B.3, do not compared to an incentive on non- proposed Rule 6b–1(c) to all volume in
apply in the same manner to registered market-making principal trading. NMS stocks, the added transparency
market makers, for whom market To the extent that volume-based would have benefits similar to those of
making requirements can provide transaction pricing helps exchanges Rule 6b–1(c) described in the
incentives to concentrate order flow on better retain order flow, a prohibition on proposal.272 It would allow interested
particular exchanges. volume-based exchange transaction fees persons greater access to information
Because registered market maker for both agency-related and principal about the eligibility of each exchange’s
quoting currently involves passive order flow with a limited carve out for members for its volume-based
displayed liquidity provision, registered registered market makers may, as is the transaction pricing tiers. It would
market makers cannot direct flow to an case for the first alternative, increase improve the information set for those
exchange intraday in the same manner costs to dominant exchanges in the form commenting during the SRO filing
that a non-market making member can, of forgone revenue and the cost to high-
process. These comments, in turn, might
though they can increase their quoting volume members in the form of forgone
assist the Commission in determining
activity in the expectation that they surplus. A ban with a limited carve-out
whether a filing is consistent with the
would receive more executions. Some for registered market makers would
types of exchange registered market Exchange Act. As the impact of their
mitigate these increased costs by
makers face more significant quoting transaction pricing schedules would
allowing exchanges to offer volume-
obligations and trading volume become evident to other members and
based pricing to their registered market
requirements than other types of the commenting public, greater
makers on their displayed liquidity-
exchange registered market makers. To transparency could perhaps place
adding volume in their registered or
meet stringent obligations, those types pressure on exchanges to adopt less
assigned symbols where applicable
of market makers might be more market making standards apply, thus ‘‘bespoke’’ volume-based transaction
reluctant to reroute orders to exchanges potentially retaining some of that pricing.273 It is possible that the
for which they are not designated transaction volume. appearance of a pricing scheme which
market makers. Compared to non- appears to disproportionately favor a
market making broker-dealers, tying 3. Proceed With Transparency small number of exchange members
discounts in the closing auction on Provisions for All Orders Without Tiers might make an exchange more likely to
intraday volume might not have as large Prohibition voluntarily adopt price schedules with
an effect at reducing market makers’ The proposal would prohibit volume- a more even distribution of tier
surplus. While a full ban could result in based transaction pricing for agency- qualification.
greater dispersion in trading activities related flow and would mandate One issue that is unlikely to be
across exchanges and a loss of order transparency for principal-flow. addressed by transparency alone would
flow to off-exchange venues, a limited Alternatives 1 and 2 would broaden the be the self-reinforcing competitive
carve-out for registered market makers volume-based transaction pricing advantage for high-volume exchange
could induce these members to prohibition, making transparency members, including high-volume firms
concentrate more quoting activities on irrelevant for Alternative 1, though that trade in a principal capacity.
certain exchanges. Under this possibly relevant for Alternative 2. Among lower-volume broker-dealers,
alternative, new and lower-volume Alternatively, the Commission could those who route some or all of their
exchanges could offer incentives to opt not to prohibit volume-based tiers orders through higher-volume exchange
attract registered market maker members for either agency or principal-related members serve to reinforce the
and could combine that with higher volume in NMS stocks, but rather competitive advantage of high-volume
market making standards. The expand the disclosures under proposed exchange members. Compared to
adjustments in market makers’ Rule 6b–1(c) to all orders.270 Alternatives 1 and 2, transparency alone
obligations and benefits might result in Specifically, under this alternative, the might not help level the playing field
the exchange more frequently setting the between exchanges that employ volume-
best prices and having more available 270 The SEC Investor Advisory Committee
based tiers and those that do not.274 In
liquidity, which would attract liquidity- previously recommended that the Commission
enhance disclosures to provide transparency about
removing order flow and increase the rebate tier practices at exchanges. Specifically, it
271 The Commission also could expand the
exchange’s market share. recommended that the Commission receive disclosures to all NMS securities, which would
Under the ban with a limited carve- monthly disclosures from exchanges concerning the include listed options in addition to NMS stocks.
272 See supra section IV.C.3.a.
out for registered market makers, volume of trades that receive a rebate and the rebate
273 See supra section IV.C.3.b.ii for additional
amounts broken down by volume ranges. In
competitive advantages for high-volume addition, it recommended public disclosure on an discussion of the possible effect that the proposed
broker-dealers might still exist, but the aggregated basis of rebate information broken down disclosures may have on exchange pricing.
advantage would be largely limited to by tiers. See Recommendation of the SEC Investor 274 As discussed in sections IV.B.1.b and IV.B.2,
registered market makers. Unlike Advisory Committee Regarding Exchange Rebate it would be more difficult for exchanges that do not
Tier Disclosure (Jan. 24, 2020), available at https:// employ volume-based pricing to effectively
ordinary principal trading that only www.sec.gov/spotlight/investor-advisory- compete against those that do, since without
involves the proprietary trading committee-2012/exchange-rebate-tier- volume-based pricing exchange members would not
member, displayed liquidity providing disclosure.pdf. See also supra Request for Comment be incentivized to concentrate their order flow on
orders from exchange registered market No. 24 (requesting comment on additional items for those exchanges. Additionally, lower volume
the monthly transparency disclosures, including the exchanges that are newer also face competitive
makers in their registered or appointed volume of shares qualifying for each tier, the dollar hurdles because it would be more costly for them
symbols benefits investors and markets amounts involved, and the average transaction fee to offer higher tier rebates similar to the higher
by contributing to price formation and paid and rebate received by members). Continued
addition, the transparency-only foreclose rival(s) from a portion of the removes an additional pricing advantage
alternative might not address the market or drive rivals out of the market for high-volume broker-dealers, who
incentive for members of more than one entirely.275 Similar intuition may apply may already be trading at dramatically
exchange to concentrate their trading, to an exchange context under the reduced prices because of their tier
particularly agency-related orders, on current baseline, where price discounts qualifications from intraday trading.
one particular exchange in order to for participation in the closing auctions Tiers applied to trading volume from
qualify for that exchange’s volume- are conditioned on consolidated broker-dealers’ continuous order book
based tiers, so as to achieve lower fees volume. Because conditional pricing for confers an outsized pricing advantage to
and higher rebates. Likewise, this closing auctions provides incentive for the high-volume broker-dealers. One
alternative would be unlikely to address broker-dealers to stream intraday concern is that the interaction of the
the related conflict of interest between volume to the same listing exchanges, high-volume broker-dealers’ tiered
members and customers that can arise tying provides a way for listing pricing advantage and high fixed market
when the member executes an agency- exchanges with market power over their data and connectivity costs creates
related order (i.e., the incentive for a closing auctions to partially expand significant disadvantage for lower-
member to route the order to one their dominance to intraday trading. A volume firms.276 Pricing tiers for the
particular exchange over others and ban on conditional pricing may provide closing auctions may accentuate the
retain the benefit for itself, assuming it a more level playing field for inter- barrier-to-entry for lower-volume firms,
does not pass through that better exchange competition and result in in an industry that has seen no salient
exchange transaction pricing to its lower transaction fees for the average growth of nascent firms in recent years.
customer). Finally, this alternative is broker-dealer participating during Prohibiting volume-based pricing for the
unlikely to address the incentive for a regular trading hours. closing auctions removes one potential
listing exchange to exploit demand for The ban would likely benefit small, source of barrier-to-entry for lower-
participating in the closing auction by non-listing exchanges at the cost of volume broker-dealers.
offering discounts on auction orders to primary listing exchanges. Tying Among incumbent exchange members
members who send volume, particularly provides a way for listing exchanges to participating in the closing auctions,
agency-related volume, into the intraday soften competition and potentially prohibiting ‘‘auction linked pricing’’
trading session—a practice that may charge higher transaction fees for may increase low-volume broker-
contribute to listing exchanges trading during regular hours, compared dealers’ profits derived from closing
preserving or extending their market to a regime where exchanges compete auctions while decreasing high-volume
power at the expense of non-listing for order flow for the ‘‘standalone’’ broker-dealers’ profits. Unlinking
exchanges and potentially exchange market for intraday trading. Un-tying transaction fees for closing auctions to
members. However, compared to the execution cost in the closing auction to member’s overall trading volume may
proposal, this alternative would not lead total volume reduces a broker-dealer’s induce exchanges to reduce the
to an advantage of principal brokerage incentive to route to a primary listing execution cost differentials between
models over agency ones. We request exchange during regular hours, in high- and low-volume participants in
comment below on the relative benefits anticipation of participating in the the closing auctions. Because the
of the proposed ban versus transparency closing auction on the same platform. execution cost for low-volume members
and mechanisms through which Unbundling the auction and continuous may be reduced, these members who
transparency would address the order book trading decisions could share their reduced input costs with
problems identified in the proposal. increase non-listing exchanges’ profits customers can better attract agency
at the expense of the listing exchanges’ order flow from investors and non-
4. Banning the Linking of Volume-Based profits.
Tiers for Closing Auctions to members. On the other hand,
Prohibiting tying auction fees to prohibiting ‘‘auction linked pricing’’
Consolidated Volume broker-dealers’ overall volume may alter may lessen high-volume members’
The Commission might ban consumers’ choices in a way that leads advantage in directing agency order
conditioning closing auctions’ to improvement of broker-dealers’ flow to the closing auctions.
transaction fees on consolidated welfare. To qualify for lower fees during Removing only the closing auctions’
volume. Under this alternative, current closing auctions, broker-dealers may volume criteria that are tied to overall
volume-based discounts for trading make intraday order routing decisions trading volume preserves the volume-
during regular hours would continue, that are suboptimal. Unbundling the based pricing schemes for intraday
but execution costs for the closing closing auction trading decisions and trading, a potential dimension along
auction would no longer be based on a order routing choices during regular which firms compete and a practice that
member’s continuous order book hours may ultimately be in the broker- may be welfare-enhancing. For a
volume. Offering discounts for closing dealers’ best interests, especially in different market setting where the
auction pricing linked to overall volume combination with the fact that authors examine pricing schedules that
is a practice known as ‘‘auction linked competition across exchanges may embody discounts for greater demand or
pricing.’’ lower average transaction fees during utilization, the authors find that firms
This ban would likely alter the level regular trading hours.
compete more aggressively to offer size
of inter-exchange competition, diverting Removing the conditioning of closing
discounts in response to increased
more intraday order flow to small, non- auction tiers on consolidated volume
competition from rivals.277 The paper
listing exchanges. Conditional pricing, highlights volume-based discount as a

275 Dennis W. Carlton and Michael Waldman,
or qualifications for price discounts on channel through which newspaper firms
‘‘The Strategic Use of Tying to Preserve and Create
one product depending on the purchase Market Power in Evolving Industries’’, 33 RAND J. compete with one another as means to
levels of other products, has been Econ. 194(Summer 2002). Michael D. Whinston, retain orders for advertising. This
shown to harm competition when ‘‘Tying, Foreclosure, and Exclusion’’, 80 Am. Econ.
Rev. 837 (Sept. 1990). See also a discussion of tying
firm(s) with market power are able to from W. Kip Viscusi, Joseph E. Harrington, and 276 Seesupra section IV.B.4.a.
David E. M. Sappington, Economics of Regulation 277 Meghan Busse and Marc Rysman,
volume exchanges due to their lower trading and Antitrust, Chapter 7 Vertical Mergers and ‘‘Competition and Price Discrimination in Yellow
volume. Vertical Restraints, pages 296–312 (5th ed. 2018). Pages Advertising’’, 36 Rand J. Econs. 378 (2005).
observation, along with the fact that place the structured fee tiers disclosures financial data aggregators and other
price discrimination schemes may only on exchange websites would market participants).282
enhance both the price-setting firms’ relieve exchanges of the need to apply Alternatively, the Commission could
and the customers’ overall welfare if for EDGAR filing access and adjust their require the disclosures to be submitted
they lead to greater demand,278 suggests compliance systems to submit the through another filing system,
that volume-based tiers may potentially disclosures in EDGAR, thus reducing specifically the Electronic Form Filing
be a welfare-enhancing outcome of costs on exchanges. However, a website System (‘‘EFFS’’) through which
competition across exchanges. Despite posting requirement would also exchanges presently file their proposed
the caveat that high-volume broker- decrease the ease of retrieving and pricing changes on Form 19b–4. Using
dealers may disproportionately benefit consolidating the new disclosures, EFFS would reduce the burdens on
from volume-based discounts, pricing exchanges by relieving them from the
because data users would need to visit
tiers for intraday trading may be worth need to apply for EDGAR filing access
each equities exchange’s website to
preserving because of their welfare- and adjust their compliance systems to
retrieve the disclosed information and submit the disclosures using EDGAR.
enhancing potentials. On the other manually incorporate those disclosures
hand, a number of studies have shed Use of EFFS would allow the
into datasets (or pay a third party to do Commission to centralize the collection
light on ways in which tying prices for so). In addition, the data quality
complementary goods (or markets) can of the disclosures and could still allow
associated with the disclosures could for the application of programmatic
be effectively used by firms to (1) extract
decrease under a website-only checks for nondiscretionary errors.
more surplus from customers 279 or (2)
requirement, because website postings However, EFFS would need to be
expand its market power from a
dominant market to complementary would not be subject to programmatic expanded to accept the disclosures in
markets.280 Without salient cost checks for nondiscretionary errors (such Inline XBRL format, and a mechanism
synergies from bundling (i.e., as text where there should only be would need to be implemented to make
concentrating limit book order flow and numbers). Such accessibility and data the disclosures available to the public.
participation in closing auction on the quality issues could impede the
6. Require a Different Structured Data
same listing exchange) or an objective of the proposal, which is to
Language for the Disclosures of Volume-
enhancement in overall demand for provide the Commission and the public
Based Pricing in Proprietary Volume in
broker-dealers, welfare-reducing tying with insight into the application of an
NMS Stocks
justifies a ban on linking tiers for exchange’s volume-based transaction
pricing schedule and to provide The Commission also considered
closing auctions to intraday trading
information that could facilitate requiring that exchanges make the
volumes.
assessment of the level of competition disclosures in a different machine-
5. Require Disclosures of Volume-Based among exchanges and the impact of readable structured data language than
Pricing in Proprietary Volume in NMS pricing tiers on intermarket Inline XBRL. The Commission
Stocks To Be Posted on Exchange competition. Requiring exchanges to considered requiring equities exchanges
Websites or Submitted Through a place the structured fee tiers disclosures to submit the proposed disclosures in an
Different System eXtensible Markup Language (‘‘XML’’)-
only on exchange websites would
The Commission considered requiring based data language specific to that form
relieve exchanges of the need to apply
equities exchanges post the fee and (‘‘custom XML’’ or, here, ‘‘Tiers-specific
for EDGAR filing access and adjust their
rebate tiers disclosures in Inline XBRL XML’’). Currently, certain registrants
compliance systems to submit the make filings in EDGAR in custom XML
on their websites, either in addition to, disclosures through EDGAR, thus
or instead of, filing the disclosures in data languages that are specific to
reducing burdens on exchanges. particular forms.283 For custom XML
EDGAR.281 Requiring exchanges to
Requiring exchanges to place the filings, filers typically are provided the
278 See supra section IV.D.1.
structured disclosures both on exchange option to either submit the filing
279 Gregory S. Crawford, ‘‘The Discriminatory websites and on EDGAR would not directly to the EDGAR system in the
Incentives to Bundle in the Cable Television relieve exchanges of the need to apply relevant custom XML data language, or
Industry’’, 6 Quantitative Mktg. & Econ. 41 (2008). for EDGAR filing access and adjust their to manually input the information into
280 See Katherine Ho, Justin Ho, & Julie Holland
compliance systems to submit the a fillable web-based form developed by
Mortimer, ‘‘The Use of Full-Line Forcing Contracts
in the Video Rental Industry’’, 102 Am. Econ. Rev. disclosures in EDGAR, and thus would the Commission that converts the
686 (2012), for an empirical analysis. See Dennis W. not reduce costs on exchanges. In
Carlton and Michael Waldman, ‘‘The Strategic Use addition, while adding a website 282 The Commission recently proposed rules to
of Tying to Preserve and Create Market Power in require certain registered entities, including
Evolving Industries’’, 33 Rand J. Econ. 194 (Summer
disclosure requirement may make it exchanges, to file new cybersecurity risk and
2002), for theoretic analysis. Michael D. Whinston, likelier that investors accustomed to incident history disclosures in EDGAR and post
‘‘Tying, Foreclosure, and Exclusion’’, 80 Am. Econ. accessing exchange websites for copies of those disclosures on their individual
Rev. 837 (Sept. 1990). See also a discussion of tying transaction pricing schedules would websites. See Cybersecurity Risk Management Rule
from W. Kip Viscusi, Joseph E. Harrington, and for Broker-Dealers, Clearing Agencies, Major
David E. M. Sappington, Economics of Regulation access those disclosures, the Security-Based Swap Participants, the Municipal
and Antitrust, Chapter 7 Vertical Mergers and Commission believes the fee and rebate Securities Rulemaking Board, National Securities
Vertical Restraints, 296–312 (5th ed. 2018). tiers information, when submitted Associations, National Securities Exchanges,
281 Certain Commission rules require registrants
electronically to the Commission, likely Security-Based Swap Data Repositories, Security-
to post structured disclosures on their individual Based Swap Dealers, and Transfer Agents,
websites. For example, market centers (including
would be equally accessible to the Securities Exchange Act Release No. 97142 (Mar.
equities exchanges) are required to post order parties most likely to access the 15, 2023), 88 FR 20212 (Apr. 5, 2023). In the
execution disclosures on their websites in pipe- information on a regular basis (e.g., proposing release, the Commission stated its belief
delimited ASCII. See 17 CFR 242.605(a)(1) and (2); that retail investors (as well as other market
broker-dealer exchange members, participants) would have an interest in accessing
Securities and Exchange Commission File No. 4–
518 (National Market System Plan Establishing the cybersecurity disclosures. See id. at 20308.
Procedures Under Rule 605 of Regulation NMS). disclosures. See 17 CFR 242.606. Nationally 283 For example, security-based swap entities file
Broker-dealers are required to post order routing recognized statistical rating organizations are Form SBSE in a custom XML language specific to
disclosures on their websites using a custom XML required to post credit rating history disclosures on that form. See section 8.2.19 of the EDGAR Filer
schema designed by the Commission for those their websites in XBRL. See 17 CFR 240.17g–7(b)(3). Manual (Volume II) version 66 (Jun. 2023).
completed form into a custom XML believes the use of a custom XML tier in a given month inhibit public
document. schema designed specifically for a comment on exchange fees?
As with the proposed Inline XBRL particular regulatory form, while an 32. The Commission discussed above
requirement, a custom XML improvement over unstructured forms, how the presence of volume-based
requirement would allow the would not provide the same level of transaction pricing on exchanges
Commission to download the proposed benefit as the use of a global, introduces a potential conflict of
information in a structured, machine- interoperable standard data language interest, because it gives broker-dealers
readable form, facilitating efficient such as Inline XBRL. an incentive to route agency-based
access, organization, and evaluation of volume in a way that minimizes
the disclosed information. Furthermore, 7. Remove Structured Data Language
Requirement for Disclosures of Volume- exchange fees for the broker-dealer. Is
if any filers were to use the fillable web- such a conflict of interest present? The
based form to provide their information Based Pricing in Proprietary Volume in
NMS Stocks Commission requests comment on the
under a custom XML requirement, those impact of such potential conflicts of
filers would forgo the compliance costs The Commission also considered not interest.
related to structuring their fee and tier- including the proposed requirement that 33. Does volume-based transaction
based disclosures. exchanges submit the disclosures in a pricing promote concentration in the
However, the Commission believes structured data language. Such an broker-dealer business? Specifically,
the use of Inline XBRL for the fee and alternative would result in an does it offer an advantage to larger
rebate tiers disclosures would provide incremental reduction in cost to equities broker-dealers that makes it harder for
advantages that the use of Tiers-specific exchanges associated with filing the fee small broker-dealers to compete? Does
XML would not. First, XBRL uses and tiers disclosures. However, the absence this make it more difficult for new
implements existing accounting and of any structured data language broker-dealers to enter the NMS equity
reporting standards,284 which facilitates requirement would significantly reduce brokerage business than it would be
the coordination and sharing of the benefits of the proposal because the
without volume-based transaction
financial information. Thus, Inline fee tiers data would be more difficult for
pricing?
XBRL would be well-suited to handle the Commission and market participants
34. Do commenters believe that there
data about proprietary volume-based to assemble, review, and analyze. The
are relevant factors which were not
pricing tiers on equities exchanges. use of HTML, ASCII, PDF, or another
discussed in the Commission’s
Second, the Commission believes unstructured format for the proposed
characterization of the relevant baseline
creating a custom XML schema for the disclosures would force user of the data,
for the proposed rule? Please describe
fee and rebate tiers disclosures would be including Commission staff and market
any additional baseline details that you
less efficient than leveraging the participants, to manually transcribe
believe are relevant for understanding
existing Inline XBRL architecture, information from the disclosures into
the impact of the proposed rule.
because doing so would involve re- datasets for aggregation, analysis, and
creating features that XBRL already comparison of the proprietary volume- 35. Is the Commission’s description of
offers through its taxonomies and based pricing data, or pay a third party current exchange pricing accurate,
related data elements within those to do so. This would impede data users including the practice of volume tiering
taxonomies.285 Lastly, the use of a such as financial analysts from and using auction linked pricing to
standard structured data language such producing reports and analyses about attract volume outside of the auction?
as Inline XBRL would allow equities equities exchange fee tiers practices and Are there additional details about these
exchanges and market participants to trends that market participants could practices which you believe are relevant
leverage an existing ecosystem of find useful. to understanding their impact?
software tools, service providers and 36. Do fees and rebates play a role in
F. Request for Comment attracting order flow to exchanges? How
related infrastructure that support XBRL
tagging.286 Thus, the Commission The Commission is sensitive to the sensitive are market participants to fees
potential economic effects, including and rebates when making decisions
284 See Donna Johaneman & Louis Matherne, costs and benefits, of the proposed rule. about where to route orders? Do
Harmonizing Accounting and Data Standards, The Commission has identified certain transaction fees and rebates significantly
XBRL.us, Dec. 23, 2019, available at https://xbrl.us/ costs and benefits associated with the influence an exchange’s market share?
harmonizing-accounting-data-standards/ (‘‘As a 37. What is the role of volume-based
data standard, [XBRL] is designed to support an proposal and requests comment on all
existing accounting standard by unambiguously aspects of its preliminary economic transaction pricing and its impact on
conveying details about that accounting standard analysis, including with respect to the what different market participants pay?
reporting requirement.’’). For example, the specific questions below. The 38. Does tying closing auction prices
Financial Accounting Standards Board assumed the
ongoing development of the Generally Accepted Commission encourages commenters to to intraday volume have an impact on
Accounting Principles (‘‘GAAP’’) Taxonomy from identify, discuss, analyze, and supply the market share exchanges are able to
the SEC in 2010 to keep it current with GAAP. relevant data, information, or statistics obtain for intraday volume?
XBRL: What Is it? Why the FASB? Who Uses It?, regarding any such costs or benefits. In 39. How does volume-based
FASB.org, available at https://www.fasb.org/page/
PageContent?pageId=/staticpages/what-is- addition, the Commission has the transaction pricing impact order routing
xbrl.html&isstaticpage=true; see also IFRS following specific requests: incentives for broker-dealers? Does the
Accounting Taxonomy 2023, XBRL.org, available at 31. Is there a lack of transparency for impact involve a potential conflict of
https://www.xbrl.org/news/ifrs-accounting- exchange price schedules? Does a lack interest?

taxonomy-2023/.
285 See, e.g., Standard Taxonomies, SEC.gov,
of information on how many exchange 40. Is the Commission’s
available at https://www.sec.gov/info/edgar/ members qualify for each volume-based characterization of the market to
edgartaxonomies; Taxonomies, XBRL.us, available provide access to exchanges to non-
at https://xbrl.us/home/filers/sec-reporting/ introduction-to-xbrl/. XBRL US is a jurisdiction of members through things like sponsored
taxonomies/. XBRL International. See also Membership access and direct market access
286 XBRL International is a global, nonprofit Organizations, XBRL.us, available at https://xbrl.us/
consortium that oversees the XBRL standard. join-us/membership/xusmembers/; Membership
accurate? Are there any relevant factors
Introduction to XBRL, XBRL.org, available at List, XBRL.org, available at https://www.xbrl.org/ which were not discussed in the
https://www.xbrl.org/the-standard/what/an- the-consortium/about/membership-list/. Commission’s characterization of the
baseline for the market to provide 51. Would prohibiting the application and policies and procedures to prevent
exchange access? of volume-based pricing for agency- evasion?
41. What is the current effect of related order flow and the proposed 61. Do commenters agree with the
volume-based tiering on broker-dealer disclosure provisions promote or Commission’s assessment of the impact
services? Does current volume-based impede competition between of the proposed rule on efficiency,
tiering create a barrier to entry in the exchanges? Does the Commission competition, and capital formation?
market for NMS equity brokerage adequately capture the costs and 62. The Commission requests
services? benefits resulting from the effect of the comment on the effects of an alternative
42. Is there substantial dispersion in proposed rule on competition among that implements a ban on volume-based
the size of broker-dealer exchange exchanges? transaction pricing for all exchange
members? What effect does such 52. What impact would an order types.
dispersion have on the market to elimination of volume-based pricing on 63. How important are the various
provide exchange access and the role of agency-related order flow have on the privileges afforded to registered market
volume-based transaction pricing in that NBBO, including the spread width and makers by the exchanges to their
market? depth of displayed interest at the willingness to participate and ability to
43. What is the current level of tier NBBO? function effectively? What is the effect
transparency? Does the lack of public 53. Would the prohibition of volume- of registered market makers on exchange
knowledge of the number of exchange based pricing for agency-related order liquidity?
members that qualify for each tier affect 64. Do commenters believe that
flow affect order-routing decisions by
the ability of the public to submit volume-based transaction pricing serves
reducing the conflict of interest between
informed comments on exchange fees? a unique role in the function of
members and customers in agency order
44. Are there any additional benefits registered market makers? In particular,
routing?
from increased transparency the do such tiers improve the participation
54. Would the execution quality of of registered market makers, or improve
Commission did not discuss? agency-related orders improve by
45. Is the Commission’s assessment of their performance on exchange as a
reducing the incentive to concentrate market maker? Do such tiers create a
the benefits of EDGAR and Inline XBRL
order flow on a small number of barrier to entry for smaller registered
requirements accurate?
46. What other benefits or costs to exchanges? market makers? What is the effect of
investors may arise from exchanges 55. Do commenters agree with the volume-based tiering on competition
voluntarily adopting different price Commission’s assessment of the costs among registered market makers to
schedules after the implementation of from the effect of the rule on provide liquidity in a given security?
the transparency provisions? competition among broker-dealers? Do 65. If the Commission prohibited the
47. Do commenters agree with the you agree that the rebates earned will application of volume-based pricing for
Commission’s assessment of the likely decrease and the fees paid will all order types with a carve-out for the
implementation costs associated with increase for the higher-volume broker- application of volume-based pricing
the transparency provision of the dealer members? Would these costs also only for registered market makers,
proposed rule? Are there any technical affect non-members that work with would requiring the monthly disclosure
aspects which were not discussed higher-volume exchange members to of the number of members which
which would affect any implementation trade? qualify for any tiers which fall within
costs? Do commenters agree with how 56. Do commenters agree with the the carve-out provide meaningful
the Commission has characterized the Commission’s description of the information? Could knowledge of the
costs associated with the requirement indirect costs and reduction in distribution of tier qualification across
for structured data, and the EDGAR efficiency which may result from a registered market makers influence
filing requirement? reduction of order-flow executed by order-routing decisions?
48. Will there be reputation costs and higher-volume exchange members on 66. How impactful would the
other monetary costs related to changes exchanges? proposed disclosure provisions,
exchanges may make to their tiered 57. How likely is the proposed expanded to apply to all volume-based
pricing in response to the transparency prohibition of volume-based pricing for tiers, without any prohibition on the
requirements, as the Commission agency-related order flow to result in application of volume-based pricing, be
describes above? broker-dealers moving to an inventory on addressing competitive imbalances
49. Are there any additional benefits model? Do commenters agree with the between broker-dealers? Do there exist
or costs of the transparency provisions Commission’s assessment of the costs of data to support conclusions on such
that the Commission did not discuss? the proposed rule resulting from impacts? Would the proposed
50. Do commenters agree with the increased principal trading? disclosure provisions influence order
Commission’s assessment of the benefits 58. Would the proposed rule affect the routing decisions by exchange
stemming from the effects of the ability of exchanges to compete with off- members?
volume-based prohibition on agency- exchange venues? Do commenters agree 67. Would the information revealed
related order pricing and competition with the Commission’s assessments of through the monthly disclosure of the
among broker-dealers? In particular, the costs from order flow potentially number of exchange members qualifying
would lower-volume exchange members moving to off-exchange venues? for each pricing tier, absent any
end up with lower fees and higher 59. Are there any additional benefits prohibition of the application of
rebates under such a ban? Would a flat or costs from the prohibition of volume- volume-based pricing, meaningfully
fee and rebate for agency-related volume based transaction pricing for agency- influence future exchange transaction
increase competition among broker- related volume that you believe the price schedules? Would the disclosures
dealers to provide exchange access? Commission did not discuss? promote exchange competition? Do
Would investors benefit from the lower 60. Do commenters agree with the there exist data to support conclusions
prices for lower-volume exchange Commission’s assessment of the benefits on such influence?
members and lower barriers to entry in and costs from the proposed rule’s 68. The Commission requests
the NMS equity brokerage business? requirements that exchanges adopt rules comment on all aspects of the costs of
the proposal to require equities proposed rule amendments, to must advise OMB whether a proposed
exchanges to provide the proposed tiers determine the impact of such regulation constitutes a ‘‘major’’ rule.
disclosures electronically on EDGAR in rulemaking on ‘‘small entities.’’ 290 Under SBREFA, a rule is considered
Inline XBRL. Are there costs that the Section 605(b) of the RFA states that ‘‘major’’ where, if adopted, it results in
Commission has over- or understated? this requirement shall not apply to any or is likely to result in (1) an annual
Are there additional costs that the proposed rule or proposed rule effect on the economy of $100 million
Commission has not mentioned? Please amendment which, if adopted, would or more; (2) a major increase in costs or
explain your answer. not have a significant economic impact prices for consumers or individual
69. Are the Commission’s assessment on a substantial number of small industries; or (3) significant adverse
of the costs of the requirements to entities.291 effects on competition, investment, or
provide the proposed disclosures in The proposed rule would apply only innovation. The Commission requests
Inline XBRL correct? Please explain to national securities exchanges comment on whether this proposal
why or why not. Would the use of a registered with the Commission that would be a ‘‘major rule’’ for purposes of
different structured data language trade NMS stocks. Rule 0–10(e) states the SBREFA. The Commission also
impact the cost of the structuring that the term ‘‘small business,’’ when requests comment on the potential effect
requirement? Please explain why or referring to an exchange, means any of proposed Rule 6b–1 on the U.S.
why not. exchange that has been exempted from economy on an annual basis; any
70. Is the Commission’s assessment of the reporting requirements of 17 CFR potential increase in costs or prices for
the costs of the requirements to provide 242.601 (Rule 601 of Regulation NMS), consumers or individual industries; and
the disclosures to the public using and is not affiliated with any person any potential effect on competition,
EDGAR correct? Please explain why or (other than a natural person) that is not investment, or innovation. Commenters
why not. How would the costs change a small business or small organization are requested to provide empirical data
if the Commission required exchanges as defined in Rule 0–10.292 The and other factual support for their views
to post the disclosures on their exchanges subject to this proposed to the extent possible.
individual websites rather than submit rulemaking do not satisfy this standard.
the disclosures using EDGAR? Statutory Authority
Therefore, none of the exchanges that
71. Should the proposed fee tiers would be subject to the proposed rule Pursuant to the Exchange Act (15
disclosures be provided in a structured are ‘‘small entities’’ for purposes of the U.S.C. 78a et seq.), and particularly
data language other than Inline XBRL? RFA.293 sections 2, 3(b), 5, 6, 11, 11A, 15, 15A,
For example, should exchanges For the above reasons, the 17, 19, 23(a), 24, and 36 thereof, 15
structure the proposed fee tiers Commission certifies that proposed Rule U.S.C. 78b, 78c(b), 78e, 78f, 78k, 78k–
disclosures using a custom XML schema 6b–1 would not have a significant 1, 78o, 78o–1, 78q, 78s, 78w(a), 78x, and
specific to those disclosures? Why or economic impact on a substantial 78mm, the Commission is proposing to
why not? Alternatively, should number of small entities for purposes of amend §§ 232.101 and 232.405 and is
exchanges structure the proposed fee the RFA. proposing new § 240.6b–1, as set forth
tiers disclosures using a pipe-delimited The Commission requests comment below.
ASCII format rather than Inline XBRL? regarding this certification. In
Why or why not? Should the particular, the Commission solicits List of Subjects
Commission instead require the comment on the following: 17 CFR Part 232
proposed fee tiers disclosures be 72. Do commenters agree with the
provided in an unstructured format? Are Commission’s certification? If not, Electronic filing, Reporting and
there other alternatives related to please describe the nature of any impact recordkeeping requirements, Securities.
structured data languages that would be on small entities and provide empirical
appropriate? How would the use of a 17 CFR Part 240
data to illustrate the extent of the
different language impact the usability impact. Fees, Reporting and recordkeeping
and accessibility of the tables for data requirements, Securities.
users? What time or expense is VI. Consideration of Impact on the
associated with the recommended Economy Text of the Proposed Rules
structured data language? Would a For purposes of the Small Business In accordance with the foregoing, the
particular structured data language Regulatory Enforcement Fairness Act of Securities and Exchange Commission
require any filers or users to license 1996, or ‘‘SBREFA,’’ 294 the Commission proposes to amend title 17, chapter II of
commercial software they otherwise
the Code of Federal Regulations as
would not, and, if so, at what expense? 290 The Commission has adopted definitions for
the term ‘‘small entity’’ for purposes of Commission follows:

V. Regulatory Flexibility Act rulemaking in accordance with the RFA. Those
Certification definitions, as relevant to this proposed rulemaking, PART 232—REGULATION S–T—
are set forth in 17 CFR 240.0–10 (Rule 0–10). See GENERAL RULES AND REGULATIONS
The Regulatory Flexibility Act Securities Exchange Act Release No. 18451 (Jan. 28, FOR ELECTRONIC FILINGS
(‘‘RFA’’) 287 requires Federal agencies, in 1982), 47 FR 5215 (Feb. 4, 1982) (File No. AS–305).
291 See 5 U.S.C. 605(b).
promulgating rules, to consider the
292 See 17 CFR 240.0–10(e). ■ 1.The general authority citation for
impact of those rules on small entities.
293 See also Securities Exchange Act Release Nos. part 232 continues to read as follows:
Section 603(a) 288 of the Administrative 82873 (Mar. 14, 2018), 83 FR 13008, 13074 (Mar.
Procedure Act,289 as amended by the Authority: 15 U.S.C. 77c, 77f, 77g, 77h,
26, 2018) (File No. S7–05–18) (Transaction Fee Pilot
RFA, generally requires the Commission for NMS Stocks Proposing Release); 55341 (May 8, 77j, 77s(a), 77z–3, 77sss(a), 78c(b), 78l, 78m,
to undertake a regulatory flexibility 2001), 72 FR 9412, 9419 (May 16, 2007) (File No. 78n, 78o(d), 78w(a), 78ll, 80a–6(c), 80a–8,
S7–06–07) (Proposed Rule Changes of Self- 80a–29, 80a–30, 80a–37, 80b–4, 80b–6a, 80b–
analysis of all proposed rules, or Regulatory Organizations proposing release); Access 10, 80b–11, 7201 et seq.; and 18 U.S.C. 1350,
Fee Proposal, supra note 17, at 87 FR at 80357. unless otherwise noted.
287 5 U.S.C. 601 et seq. 294 Public Law 104–121, Title II, 110 Stat. 857
288 5 U.S.C. 603(a). (1996) (codified in various sections of 5 U.S.C., 15
* * * * *
289 5 U.S.C. 551 et seq. U.S.C. and as a note to 5 U.S.C. 601). ■ 2. Amend § 232.101:
■ a. In paragraph (a)(1)(xxx), by C.4 of Form N–CSR (§§ 249.331 and Investment Company Act of 1940 (15
removing the word ‘‘and’’ from the end 274.128 of this chapter), and § 240.6b– U.S.C. 80a–2(a)(48)), a unit investment
of the paragraph; 1(c) of this chapter (Rule 6b–1(c) under trust as defined in Section 4(2) of the
■ b. In paragraph (a)(1)(xxxi), by the Exchange Act) specify when Investment Company Act of 1940 (15
removing the period and adding it its electronic filers are required or U.S.C. 80a–4), a national securities
place ‘‘; and’’; and permitted to submit an Interactive Data exchange as defined in 17 CFR
■ c. By adding paragraph (a)(1)(xxxii). File (§ 232.11), as further described in 242.600(b)(53) (Rule 600(b)(53) of
The addition reads as follows: note 1 to this section. This section Regulation NMS), or a clearing agency
imposes content, format, and that provides a central matching service,
§ 232.101 Mandated electronic
submissions and exceptions.
submission requirements for an and is not within one of the categories
Interactive Data File, but does not specified in paragraph (f)(1)(i) of this
(a) * * * change the substantive content section, as partly embedded into a filing
(1) * * * requirements for the financial and other
(i) * * * with the remainder simultaneously
disclosures in the Related Official Filing submitted as an exhibit to:
(xxxii) Disclosures provided pursuant
(§ 232.11). * * * * *
to § 240.6b–1(c) of this chapter. (a) * * *
* * * * * (ii) If the electronic filer is a
(2) Be submitted only by an electronic
■ 3. Amend § 232.405 by: management investment company
filer either required or permitted to
■ a. Revising the introductory text, and registered under the Investment
submit an Interactive Data File as
paragraphs (a)(2), (a)(3)(i) introductory Company Act of 1940 (15 U.S.C. 80a et
specified by Item 601(b)(101) of
text, (a)(3)(ii), (a)(4), and (b)(1) seq.), a separate account (as defined in
Regulation S–K, General Instruction F of
introductory text; section 2(a)(14) of the Securities Act (15
Form 11–K (§ 249.311 of this chapter);
■ b. Adding paragraph (b)(6); and paragraph (101) of Part II—Information U.S.C. 77b(a)(14)) registered under the
■ c. Revising Note 1 to § 232.405. Not Required to be Delivered to Offerees Investment Company Act of 1940, a
The revisions and addition read as or Purchasers of Form F–10 (§ 239.40 of business development company as
follows: this chapter), § 240.13a–21 of this defined in section 2(a)(48) of the
chapter (Rule 13a–21 under the Investment Company Act of 1940 (15
§ 232.405 Interactive Data File
Exchange Act), paragraph 101 of the U.S.C. 80a–2(a)(48)), a unit investment
submissions. trust as defined in Section 4(2) of the
Instructions as to Exhibits of Form 20–
This section applies to electronic F (§ 249.220f of this chapter), paragraph Investment Company Act of 1940 (15
filers that submit Interactive Data Files. B.(15) of the General Instructions to U.S.C. 80a–4), a national securities
Section 229.601(b)(101) of this chapter Form 40–F (§ 249.240f of this chapter), exchange as defined in 17 CFR
(Item 601(b)(101) of Regulation S–K), paragraph C.(6) of the General 242.600(b)(53) (Rule 600(b)(53) of
General Instruction F of Form 11–K Instructions to Form 6–K (§ 249.306 of Regulation NMS), or a clearing agency
(§ 249.311 of this chapter); paragraph this chapter), Rule 17Ad–27(d) under that provides a central matching service,
(101) of Part II—Information Not the Exchange Act, Note D.5 of Rule 14a– and is not within one of the categories
Required to be Delivered to Offerees or 101 under the Exchange Act, Item 1 of specified in paragraph (f)(1)(ii) of this
Purchasers of Form F–10 (§ 239.40 of Rule 14c–101 under the Exchange Act, section, as partly embedded into a filing
this chapter), § 240.13a–21 of this General Instruction I to Form F–SR with the remainder simultaneously
chapter (Rule 13a–21 under the (§ 249.333 of this chapter), General submitted as an exhibit to a filing that
Exchange Act), paragraph 101 of the Instruction C.3.(g) of Form N–1A contains the disclosure this section
Instructions as to Exhibits of Form 20– (§§ 239.15A and 274.11A of this requires to be tagged; and
F (§ 249.220f of this chapter), paragraph chapter), General Instruction I of Form (4) Be submitted in accordance with
B.(15) of the General Instructions to N–2 (§§ 239.14 and 274.11a–1 of this the EDGAR Filer Manual and, as
Form 40–F (§ 249.240f of this chapter), chapter), General Instruction C.3.(h) of applicable, Item 601(b)(101) of
paragraph C.(6) of the General Form N–3 (§§ 239.17a and 274.11b of Regulation S–K, General Instruction F of
Instructions to Form 6–K (§ 249.306 of this chapter), General Instruction C.3.(h) Form 11–K (§ 249.311 of this chapter),
this chapter), § 240.17Ad–27(d) of this of Form N–4 (§§ 239.17b and 274.11c of paragraph (101) of Part II—Information
chapter (Rule 17Ad–27(d) under the this chapter), General Instruction C.3.(h) Not Required to be Delivered to Offerees
Exchange Act), Note D.5 of § 240.14a– of Form N–6 (§§ 239.17c and 274.11d of or Purchasers of Form F–10 (§ 239.40 of
101 of this chapter (Rule 14a–101 under this chapter), General Instruction 2.(l) of this chapter), Rule 13a–21 under the
the Exchange Act), Item 1 of § 240.14c– § 274.12 of this chapter (Form N–8B–2), Exchange Act, paragraph 101 of the
101 of this chapter (Rule 14c–101 under General Instruction 5 of § 239.16 of this Instructions as to Exhibits of Form 20–
the Exchange Act), General Instruction I chapter (Form S–6), General Instruction F (§ 249.220f of this chapter), paragraph
of Form F–SR (§ 249.333 of this C.4 of Form N–CSR (§§ 249.331 and B.(15) of the General Instructions to
chapter), General Instruction C.3.(g) of 274.128 of this chapter), or Rule 6b–1(c) Form 40–F (§ 249.240f of this chapter),
Form N–1A (§§ 239.15A and 274.11A of under the Exchange Act (§ 240.6b–1(c) paragraph C.(6) of the General
this chapter), General Instruction I of of this chapter), as applicable; Instructions to Form 6–K (§ 249.306 of
Form N–2 (§§ 239.14 and 274.11a–1 of (3) * * * this chapter), Rule 17Ad–27(d) under
this chapter), General Instruction C.3.(h) (i) If the electronic filer is not a the Exchange Act, Note D.5 of Rule 14a–
of Form N–3 (§§ 239.17a and 274.11b of management investment company 101 under the Exchange Act, Item 1 of
this chapter), General Instruction C.3.(h) registered under the Investment Rule 14c–101 under the Exchange Act,
of Form N–4 (§§ 239.17b and 274.11c of Company Act of 1940 (15 U.S.C. 80a et General Instruction I to Form F–SR
this chapter), General Instruction C.3.(h) seq.), a separate account as defined in (§ 249.333 of this chapter), General
of Form N–6 (§§ 239.17c and 274.11d of section 2(a)(14) of the Securities Act (15 Instruction C.3.(g) of Form N–1A
this chapter), General Instruction 2.(l) of U.S.C. 77b(a)(14)) registered under the (§§ 239.15A and 274.11A of this
§ 274.12 of this chapter (Form N–8B–2), Investment Company Act of 1940, a chapter), General Instruction I of Form
General Instruction 5 of § 239.16 of this business development company as N–2 (§§ 239.14 and 274.11a–1 of this
chapter (Form S–6), General Instruction defined in section 2(a)(48) of the chapter), General Instruction C.3.(h) of
Form N–3 (§§ 239.17a and 274.11b of with respect to Form 11–K. Paragraph 4(2) of the Investment Company Act of
this chapter), General Instruction C.3.(h) (101) of Part II—Information not 1940 (15 U.S.C. 80a–4), General
of Form N–4 (§§ 239.17b and 274.11c of Required to be Delivered to Offerees or Instruction C.3.(g) of Form N–1A
this chapter), General Instruction C.3.(h) Purchasers of Form F–10 (§ 239.40 of (§§ 239.15A and 274.11A of this
of Form N–6 (§§ 239.17c and 274.11d of this chapter) specifies the circumstances chapter), General Instruction I of Form
this chapter); Instruction 2.(l) of under which an Interactive Data File N–2 (§§ 239.14 and 274.11a–1 of this
§ 274.12 of this chapter (Form N–8B–2); must be submitted and the chapter), General Instruction C.3.(h) of
General Instruction 5 of § 239.16 of this circumstances under which it is Form N–3 (§§ 239.17a and 274.11b of
chapter (Form S–6); General Instruction permitted to be submitted, with respect this chapter), General Instruction C.3.(h)
C.4 of Form N–CSR (§§ 249.331 and to Form F–10. Paragraph 101 of the of Form N–4 (§§ 239.17b and 274.11c of
274.128 of this chapter), or Rule 6b–1(c) Instructions as to Exhibits of Form 20– this chapter), General Instruction C.3.(h)
under the Exchange Act (§ 240.6b–1(c) F (§ 249.220f of this chapter) specifies of Form N–6 (§§ 239.17c and 274.11d of
of this chapter). the circumstances under which an this chapter), General Instruction 2.(l) of
(b) * * * Interactive Data File must be submitted Form N–8B–2 (§ 274.12 of this chapter),
(1) If the electronic filer is not a and the circumstances under which it is General Instruction 5 of Form S–6
management investment company permitted to be submitted, with respect (§ 239.16 of this chapter), and General
registered under the Investment to Form 20–F. Paragraph B.(15) of the Instruction C.4 of Form N–CSR
Company Act of 1940 (15 U.S.C. 80a et General Instructions to Form 40–F (§§ 249.331 and 274.128 of this chapter),
seq.), a separate account (as defined in (§ 249.240f of this chapter) and as applicable, specifies the
section 2(a)(14) of the Securities Act (15 Paragraph C.(6) of the General circumstances under which an
U.S.C. 77b(a)(14)) registered under the Instructions to Form 6–K (§ 249.306 of Interactive Data File must be submitted.
Investment Company Act of 1940, a this chapter) specify the circumstances For national securities exchanges as
business development company as under which an Interactive Data File defined in 17 CFR 242.600(b)(53) (Rule
defined in section 2(a)(48) of the must be submitted and the 600(b)(53) of Regulation NMS), Rule 6b–
Investment Company Act of 1940 (15 circumstances under which it is 1(c) under the Exchange Act (§ 240.6b–
U.S.C. 80a–2(a)(48)), a unit investment permitted to be submitted, with respect 1(c) of this chapter) specifies the
trust as defined in Section 4(2) of the to §§ 249.240f (Form 40–F) and 249.306 circumstances under which an
Investment Company Act of 1940 (15 of this chapter (Form 6–K). Rule 17Ad– Interactive Data File must be submitted.
U.S.C. 80a–4), a clearing agency that 27(d) under the Exchange Act specifies
provides a central matching service, or the circumstances under which an PART 240—GENERAL RULES AND
a national securities exchange as Interactive Data File must be submitted REGULATIONS, SECURITIES
defined in 17 CFR 242.600(b)(53) (Rule with respect the reports required under EXCHANGE ACT OF 1934
600(b)(53) of Regulation NMS), an Rule 17Ad–27. Note D.5 of § 240.14a– ■ 4. The general authority citation for
Interactive Data File must consist of 101 of this chapter (Schedule 14A) and part 240 continues to read as follows:
only a complete set of information for Item 1 of § 240.14c–101 of this chapter
all periods required to be presented in Authority: 15 U.S.C. 77c, 77d, 77g, 77j,
(Schedule 14C) specify the 77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn,
the corresponding data in the Related circumstances under which an 77sss, 77ttt, 78c, 78c–3, 78c–5, 78d, 78e, 78f,
Official Filing, as applicable, no more Interactive Data File must be submitted 78g, 78i, 78j, 78j–1, 78j–4, 78k, 78k–1, 78l,
and no less, from all of the following with respect to Schedules 14A and 14C. 78m, 78n, 78n–1, 78o, 78o–4, 78o–10, 78p,
categories: Rule 13a–21 under the Exchange Act 78q, 78q–1, 78s, 78u–5, 78w, 78x, 78dd, 78ll,
* * * * * and General Instruction I to Form F–SR 78mm, 80a–20, 80a–23, 80a–29, 80a–37, 80b–
(6) If the electronic filer is a national (§ 249.333 of this chapter) specify the 3, 80b–4, 80b–11, 7201 et seq., and 8302; 7
securities exchange as defined in 17 circumstances under which an U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 18
CFR 242.600(b)(53) (Rule 600(b)(53) of U.S.C. 1350; and Pub. L. 111–203, 939A, 124
Interactive Data File must be submitted, Stat. 1376 (2010); and Pub. L. 112–106, sec.
Regulation NMS), an Interactive Data with respect to Form F–SR. Item 503 and 602, 126 Stat. 326 (2012), unless
File must consist of the disclosure 601(b)(101) of Regulation S–K, otherwise noted.
provided pursuant to § 240.6b–1(c) of paragraph (101) of Part II—Information
this chapter (Rule 6b–1(c) under the * * * * *
not Required to be Delivered to Offerees ■ 5. Add § 240.6b–1 to read as follows:
Exchange Act). or Purchasers of Form F–10, paragraph
* * * * * 101 of the Instructions as to Exhibits of § 240.6b–1 Volume-Based Exchange
Note 1 to § 232.405: Form 20–F, paragraph B.(15) of the Transaction Pricing for NMS Stocks.
Item 601(b)(101) of Regulation S–K General Instructions to Form 40–F, and (a) A national securities exchange
specifies the circumstances under paragraph C.(6) of the General shall not offer volume-based transaction
which an Interactive Data File must be Instructions to Form 6–K all prohibit fees, rebates, or other incentives in
submitted and the circumstances under submission of an Interactive Data File connection with the execution of agency
which it is permitted to be submitted, by an issuer that prepares its financial or riskless principal orders in NMS
with respect to §§ 239.11 (Form S–1), statements in accordance with §§ 210.6– stocks, as defined in 17 CFR
239.13 (Form S–3), 239.25 (Form S–4), 01 through 210.6–10 of this chapter 242.600(b)(55) (Rule 600(b)(55) of
239.18 (Form S–11), 239.31 (Form F–1), (Article 6 of Regulation S–X). For an Regulation NMS). For purposes of this
239.33 (Form F–3), 239.34 (Form F–4), issuer that is a management investment section, the term riskless principal
249.310 (Form 10–K), 249.308a (Form company or separate account registered means a transaction in which, after
10–Q), and 249.308 (Form 8–K) of this under the Investment Company Act of having received an order to buy from a
chapter. General Instruction F of Form 1940 (15 U.S.C. 80a et seq.) or a customer, the broker or dealer
11–K (§ 249.311 of this chapter) business development company as purchased the security from another
specifies the circumstances under defined in section 2(a)(48) of the person to offset a contemporaneous sale
which an Interactive Data File must be Investment Company Act of 1940 (15 to such customer or, after having
submitted, and the circumstances under U.S.C. 80a–2(a)(48)), or a unit received an order to sell from a
which it is permitted to be submitted, investment trust as defined in Section customer, the broker or dealer sold the
security to another person to offset a (c) A national securities exchange that (ii) A label to identify each pricing
contemporaneous purchase from such offers volume-based transaction fees, tier that corresponds to the label used in
customer. rebates, or other incentives in the exchange’s pricing schedule;
(b) A national securities exchange that connection with the execution of (iii) The amount of the fee, rebate, or
offers volume-based transaction fees, proprietary orders in NMS stocks for the other incentive identified;
rebates, or other incentives in account of a member shall submit (iv) An explanation of the tier
connection with the execution of electronically to the Commission the requirements; and
proprietary orders in NMS stocks for the following information each calendar (v) The total number of members that
account of a member shall: month within five calendar days after qualified for the base fee, base rebate, or
the end of the month, which will be each tier during the month.
(1) Have rules to require members to made publicly available: (3) The disclosures required under
engage in practices that facilitate the
(1) The number of members that this paragraph (c) shall be provided in
exchange’s ability to comply with the
executed proprietary orders in NMS an Interactive Data File in accordance
prohibition in paragraph (a) of this
stocks for the member’s account on the with 17 CFR 232.405 (Rule 405 of
section; and
exchange during the month; and Regulation S–T).
(2) Establish, maintain, and enforce
(2) For each volume-based transaction By the Commission.
written policies and procedures
reasonably designed to detect and deter fee, rebate, and other incentive, a Dated: October 18, 2023.
members from receiving volume-based summary table that includes the J. Matthew DeLesDernier,
transaction pricing in connection with following information: Deputy Secretary.
the execution of agency or riskless (i) A label to identify the base fee or [FR Doc. 2023–23398 Filed 11–3–23; 8:45 am]
principal orders in NMS stocks. rebate; BILLING CODE 8011–01–P
FEDERAL REGISTER
Vol. 88 Monday,
Part III
Department of Health and Human Services

Centers for Medicare & Medicaid Services
42 CFR Parts 413 and 512
Medicare Program; End-Stage Renal Disease Prospective Payment
System, Payment for Renal Dialysis Services Furnished to Individuals With
Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program,
and End-Stage Renal Disease Treatment Choices Model; Final Rule
DEPARTMENT OF HEALTH AND Regulations (FAR) and Defense Federal I. Executive Summary
HUMAN SERVICES Acquisition Regulations (DFAR) apply.
A. Purpose
Centers for Medicare & Medicaid Table of Contents This rule finalizes changes related to
Services To assist readers in referencing sections the End-Stage Renal Disease (ESRD)
contained in this preamble, we are providing Prospective Payment System (PPS),
42 CFR Parts 413 and 512 a Table of Contents. payment for renal dialysis services
I. Executive Summary furnished to individuals with acute
[CMS–1782–F] A. Purpose kidney injury (AKI), the ESRD Quality
B. Summary of the Major Provisions Incentive Program (QIP), and the ESRD
RIN 0938–AV05
C. Summary of Cost and Benefits Treatment Choices (ETC) Model.
Medicare Program; End-Stage Renal II. Calendar Year (CY) 2024 End-Stage Renal Additionally, this rule finalizes policies
Disease Prospective Payment System, Disease (ESRD) Prospective Payment that reflect our commitment to
Payment for Renal Dialysis Services System (PPS) achieving equity in health care for our
Furnished to Individuals With Acute
A. Background beneficiaries by supporting our ability
B. Provisions of the Proposed Rule, Public to assess whether, and to what extent,
Kidney Injury, End-Stage Renal Comments, and Responses to the
Disease Quality Incentive Program, our programs and policies perpetuate or
Comments on the CY 2024 ESRD PPS exacerbate systemic barriers to
and End-Stage Renal Disease C. Transitional Add-On Payment
Treatment Choices Model opportunities and benefits for
Adjustment for New and Innovative underserved communities. Our policy
Equipment and Supplies (TPNIES) objectives include commitment to
AGENCY: Centers for Medicare &
Clarifications and Application for CY
Medicaid Services (CMS), Department advancing health equity, which stands
2024 Payment
of Health and Human Services (HHS). as the first pillar of the Centers for
D. Continuation of Approved Transitional
ACTION: Final rule. Add-On Payment Adjustments for New
Medicare & Medicaid Services (CMS)
and Innovative Equipment and Supplies Strategic Plan,1 and reflect the goals of
SUMMARY: This final rule updates and for CY 2024 the Administration, as stated in the
revises the End-Stage Renal Disease E. Continuation of Approved Transitional President’s Executive Order 13985.2 We
(ESRD) Prospective Payment System Drug Add-On Payment Adjustments for define health equity as the attainment of
(PPS) for calendar year (CY) 2024. This CY 2024 the highest level of health for all people,
rule also updates the payment rate for III. Calendar Year (CY) 2024 Payment for where everyone has a fair and just
renal dialysis services furnished by an Renal Dialysis Services Furnished to opportunity to attain their optimal
ESRD facility to individuals with acute Individuals With Acute Kidney Injury health regardless of race, ethnicity,
kidney injury (AKI). In addition, this (AKI) disability, sexual orientation, gender
final rule updates requirements for the A. Background identity, socioeconomic status,
ESRD Quality Incentive Program and B. Summary of the Proposed Provisions, geography, preferred language, or other
the ESRD Treatment Choices Model. Public Comments, and Responses to factors that affect access to care and
Comments on CY 2024 Payment for health outcomes.’’ 3 In the calendar year
DATES: These regulations are effective
Renal Dialysis Services Furnished to (CY) 2023 ESRD PPS final rule, we
on January 1, 2024. Individuals With AKI noted that, when compared with all
FOR FURTHER INFORMATION CONTACT: C. Annual Payment Rate Update for CY Medicare fee-for-service (FFS)
ESRDPayment@cms.hhs.gov, for 2024
beneficiaries, Medicare FFS
issues related to the ESRD PPS and IV. End-Stage Renal Disease Quality
beneficiaries receiving dialysis are
coverage and payment for renal dialysis Incentive Program (ESRD QIP)
A. Background
disproportionately young, male, African
services furnished to individuals with American, have disabilities and low
AKI. B. Updates to the Regulation Text for the
ESRD QIP income as measured by eligibility for
ESRDApplications@cms.hhs.gov, for both Medicare and Medicaid (dual
issues related to applications for the C. Updates to the Requirements Beginning
With the PY 2026 ESRD QIP eligible status), and reside in an urban
Transitional Drug Add-on Payment setting (87 FR 67183). In this final rule,
D. Updates to the Requirements Beginning
Adjustment (TDAPA) or Transitional we continue to address health equity for
With the PY 2027 ESRD QIP
Add-On Payment Adjustment for New V. End-Stage Renal Disease Treatment beneficiaries with ESRD who are
and Innovative Equipment and Supplies Choices (ETC) Model members of underserved communities,
(TPNIES). A. Background including but not limited to those living
ESRDQIP@cms.hhs.gov, for issues B. Summary of the Proposed Provisions, in rural communities, those who have
related to the ESRD Quality Incentive Public Comments, and Responses to disabilities, and racial and ethnic
Program (QIP). Comments on the ETC Model minorities. The term ‘underserved
ETC–CMMI@cms.hhs.gov, for issues VI. Collection of Information Requirements communities’ refers to populations
related to the ESRD Treatment Choices VII. Regulatory Impact Analysis sharing a particular characteristic,
(ETC) Model. A. Statement of Need including geographic communities, that
SUPPLEMENTARY INFORMATION: B. Overall Impact have been systematically denied a full
C. Impact Analysis
Current Procedural Terminology
D. Detailed Economic Analysis
(CPT) Copyright Notice: Throughout this 1 Centers for Medicare & Medicaid Services
E. Accounting Statement
final rule, we use CPT® codes and (2022). Health Equity. Available at: https://
F. Regulatory Flexibility Act Analysis www.cms.gov/pillar/health-equity.

descriptions to refer to a variety of (RFA) 2 86 FR 7009 (January 25, 2021). https://
services. We note that CPT® codes and G. Unfunded Mandates Reform Act www.federalregister.gov/documents/2021/01/25/
descriptions are copyright 2020 Analysis (UMRA) 2021-01753/advancing-racial-equity-and-support-
American Medical Association (AMA). for-underserved-communities-through-the-federal-
H. Federalism government.
All Rights Reserved. CPT® is a I. Congressional Review Act 3 Centers for Medicare & Medicaid Services
registered trademark of the AMA. VIII. Files Available to the Public via the (2022). Health Equity. Available at: https://
Applicable Federal Acquisition Internet www.cms.gov/pillar/health-equity.
opportunity to participate in aspects of Section 808(a) of the TPEA amended the CY 2022 ESRD PPS final rule (86 FR
economic, social, and civic life.4 section 1861(s)(2)(F) of the Act to 61874), and the CY 2023 ESRD PPS final
Specifically, in the CY 2024 ESRD PPS provide coverage for renal dialysis rule (87 FR 67136). In this final rule, we
proposed rule (88 FR 42431), we services furnished on or after January 1, are finalizing a modification to our
requested information regarding a 2017, by a renal dialysis facility or a regulations at 42 CFR 512.390 to
potential payment adjustment for provider of services paid under section acknowledge the availability of
geographically isolated and rural ESRD 1881(b)(14) of the Act to an individual administrative review of targeted review
facilities, proposed additional payment with AKI. Section 808(b) of the TPEA requests. This change will provide ETC
for the subgroup of Pediatric ESRD amended section 1834 of the Act by Participants with information about the
Patients (as defined in 42 CFR 413.171), adding a new subsection (r) that availability of administrative review if
and proposed policies to further our provides for payment for renal dialysis an ETC Participant wishes to seek
efforts to determine if payment to ESRD services furnished by renal dialysis additional review of its targeted review
facilities treating patients with co- facilities or providers of services paid request.
morbidities such as sickle cell anemia is under section 1881(b)(14) of the Act to
aligned with resource use by such ESRD individuals with AKI at the ESRD PPS B. Summary of the Major Provisions
facilities. As discussed in sections base rate beginning January 1, 2017. 1. ESRD PPS
II.B.1.g and II.B.1.j of this final rule, we This final rule updates the AKI payment
are now finalizing the proposed rate for CY 2024. • Update to the ESRD PPS base rate
payment adjustment for Pediatric ESRD for CY 2024: The final CY 2024 ESRD
3. End-Stage Renal Disease Quality PPS base rate is $271.02, an increase
Patients and policies to improve the
Incentive Program (ESRD QIP) from the CY 2023 ESRD PPS base rate
measurement of individual resource
use. Additionally, we are adding three The End-Stage Renal Disease Quality of $265.57. This amount reflects the
new measures to the ESRD QIP measure Incentive Program (ESRD QIP) is application of the combined wage index
set that are aimed at promoting health authorized by section 1881(h) of the and transitional pediatric ESRD add-on
equity for ESRD patients, including by Act. The Program establishes incentives payment adjustment (TPEAPA) budget-
enabling ESRD facilities to identify gaps for facilities to achieve high quality neutrality adjustment factor (0.999534)
experienced by their patient performance on measures with the goal and a productivity-adjusted market
populations. of improving outcomes for ESRD basket percentage increase of 2.1
beneficiaries. This final rule finalizes percent as required by section
1. End-Stage Renal Disease (ESRD) several updates for the ESRD QIP, 1881(b)(14)(F)(i)(I) of the Act, equaling
Prospective Payment System (PPS) including: (1) updates that will begin $271.02 (($265.57 × 0.999534) × 1.021 =
On January 1, 2011, we implemented with Payment Year (PY) 2026, including $271.02).
the ESRD PPS, a case-mix adjusted, one new quality measure, modifications • Annual update to the wage index:
bundled PPS for renal dialysis services to two current measures, and the We adjust wage indices on an annual
furnished by ESRD facilities as required removal of two measures; (2) the basis using the most current hospital
by section 1881(b)(14) of the Social addition of two new measures beginning
wage data and the latest core-based
Security Act (the Act), as added by with PY 2027; (3) a revision to the
statistical area (CBSA) delineations to
section 153(b) of the Medicare regulatory definition of ‘‘minimum total
account for differing wage levels in
Improvements for Patients and performance score’’ that more accurately
areas in which ESRD facilities are
Providers Act of 2008 (MIPPA) (Pub. L. captures how we calculate the median
located. For CY 2024, we are updating
110–275). Section 1881(b)(14)(F) of the of national ESRD facility performance
the wage index values based on the
Act, as added by section 153(b) of on reporting measures; and (4) the
latest available data.
MIPPA, and amended by section codification of our previously finalized
3401(h) of the Patient Protection and measure selection, retention, and • Annual update to the outlier policy:
Affordable Care Act (the Affordable Care removal policies. We are updating the outlier policy based
Act) (Pub. L. 111–148), established that on the most current data. Accordingly,
beginning CY 2012, and each 4. End-Stage Renal Disease Treatment we are updating the Medicare allowable
subsequent year, the Secretary of the Choices (ETC) Model payment (MAP) amounts for adult and
Department of Health and Human The ETC Model is a mandatory pediatric patients for CY 2024 using the
Services (the Secretary) shall annually Medicare payment model tested under latest available CY 2022 claims data. We
increase payment amounts by an ESRD section 1115A of the Act. The ETC are updating the ESRD outlier services
market basket percentage increase, Model is operated by the Center for fixed dollar loss (FDL) amount for
reduced by the productivity adjustment Medicare and Medicaid Innovation pediatric patients using the latest
described in section 1886(b)(3)(B)(xi)(II) (Innovation Center) and tests the use of available CY 2022 claims data and
of the Act. This final rule updates the payment adjustments to encourage updating the FDL amount for adult
ESRD PPS for CY 2024. greater utilization of home dialysis and patients using the latest available claims
kidney transplants, to preserve or data from CY 2020, CY 2021, and CY
2. Coverage and Payment for Renal 2022. For pediatric beneficiaries, the
enhance the quality of care furnished to
Dialysis Services Furnished to final FDL amount will decrease from
Medicare beneficiaries while reducing
Individuals With Acute Kidney Injury
Medicare expenditures. $23.29 to $11.32, and the MAP amount
(AKI)
The ETC Model was finalized as part will decrease from $25.59 to $23.36, as
On June 29, 2015, the President of a final rule published in the Federal compared to CY 2023 values. For adult
signed the Trade Preferences Extension Register on September 29, 2020, titled beneficiaries, the final FDL amount will
Act of 2015 (TPEA) (Pub. L. 114–27). ‘‘Medicare Program: Specialty Care decrease from $73.19 to $71.76, and the
Models to Improve Quality of Care and MAP amount will decrease from $39.62
4 86 FR 7009 (January 25, 2021). https://
Reduce Expenditures’’ (85 FR 61114), to $36.28. The 1.0 percent target for
www.federalregister.gov/documents/2021/01/25/
2021-01753/advancing-racial-equity-and-support-
referred to herein as the ‘‘Specialty Care outlier payments was not achieved in
for-underserved-communities-through-the-federal- Models final rule.’’ We revised and CY 2022. Outlier payments represented
government. updated certain ETC Model policies in approximately 0.8 percent of total
Medicare payments rather than 1.0 analysis of cost report data can be 4. ETC Model
percent. conducted. We are finalizing a modification to
• Update to the offset amount for the • Add-on payment adjustment
our regulations at § 512.390 to
transitional add-on payment adjustment following the end of the transitional
acknowledge the ability of the CMS
for new and innovative equipment and drug add-on payment adjustment
Administrator to review the results of
supplies (TPNIES) for CY 2024: The (TDAPA) period: We are finalizing a
ETC Participants’ targeted review
final CY 2024 average per treatment new add-on payment adjustment for
requests.
offset amount for the TPNIES for certain new renal dialysis drugs and
capital-related assets that are home biological products in existing ESRD C. Summary of Costs and Benefits
dialysis machines is $10.00. This offset PPS functional categories after the end
In section VII.D.5 of this final rule, we
amount reflects the application of the of the TDAPA period, which we call the
set forth a detailed analysis of the
ESRD Bundled (ESRDB) productivity- post-TDAPA add-on payment
impacts that the finalized changes will
adjusted market basket update of 2.1 adjustment. This payment adjustment
have on affected entities and
percent ($9.79 × 1.021 = $10.00). There will be case-mix adjusted and set at 65
beneficiaries. The impacts include the
are no capital-related assets set to percent of expenditure levels for the
following:
receive the TPNIES in CY 2024 for given renal dialysis drug or biological
which this offset will apply. product. The post-TDAPA add-on 1. Impacts of the Final ESRD PPS
• Clarifications to the TPNIES payment adjustment will be applied to The impact table in section VII.D.5.a
eligibility criteria: We are finalizing all ESRD PPS payments and paid for 3 of this final rule displays the estimated
certain clarifications regarding our years.
change in Medicare payments to ESRD
evaluation of the TPNIES eligibility • Reporting of discarded billing units
facilities in CY 2024 compared to
criteria under § 413.236(b). of certain renal dialysis drugs and
biological products paid for under the estimated Medicare payments in CY
• TPNIES application received for CY 2023. The overall impact of the CY 2024
ESRD PPS: We are finalizing a new
2024: In this final rule, we announce changes is projected to be a 2.1 percent
policy to require the use of the JW or JZ
our determination on the one TPNIES increase in Medicare payments.
modifier on claims to track discarded
application under consideration for the Hospital-based ESRD facilities have an
amounts of single-dose container and
TPNIES for CY 2024 payment. estimated 3.1 percent increase in
single-use package renal dialysis drugs
• Modifications to the administrative Medicare payments compared with
and biological products paid for under
process for the low-volume payment freestanding ESRD facilities with an
the ESRD PPS, effective January 1, 2025.
adjustment (LVPA): We are finalizing estimated 2.0 percent increase. We
exceptions to the current LVPA 2. Payment for Renal Dialysis Services estimate that the aggregate ESRD PPS
attestation process for ESRD facilities Furnished to Individuals With AKI expenditures will increase by
that are affected by disasters and other We are updating the AKI payment rate approximately $190 million in CY 2024
emergencies. These exceptions will for CY 2024. The final CY 2024 payment compared to CY 2023. This reflects an
allow ESRD facilities to close and rate is $271.02, which is the same as the increase of approximately $180 million
reopen in response to a disaster or other base rate finalized for the ESRD PPS for from the payment rate update and the
emergency and still receive the LVPA. CY 2024. final post-TDAPA add-on payment
Additionally, the exceptions will allow adjustment and approximately $10
an ESRD facility to receive the LVPA 3. ESRD QIP million in estimated TDAPA payment
even if it exceeds the LVPA treatment We are finalizing several updates for amounts for Korsuva® and Jesduvroq
volume threshold if its treatment counts the ESRD QIP. Beginning with PY 2026, (daprodustat), as further described in
increase due to treating additional we are adding the Facility Commitment the following paragraphs. Because of the
patients displaced by a disaster or to Health Equity reporting measure to projected 2.1 percent overall payment
emergency. the ESRD QIP measure set, modifying increase, we estimate there will be an
• Policy to measure patient-level the COVID–19 Vaccination Coverage increase in beneficiary coinsurance
utilization: We are finalizing a Among Healthcare Personnel (HCP) payments of 2.1 percent in CY 2024,
requirement for ESRD facilities to report reporting measure to align with updated which translates to approximately $40
the time on machine (that is, the amount measure specifications developed by the million.
of time that a beneficiary spends Centers for Disease Control and Section 1881(b)(14)(D)(iv) of the Act
receiving an in-center hemodialysis Prevention (CDC), removing the provides that the ESRD PPS may
treatment) on claims, effective January Ultrafiltration Rate reporting measure include such other payment
1, 2025. This will serve to provide more and the Standardized Fistula Rate adjustments as the Secretary determines
data to better inform CMS’s pursuit of clinical measure, and updating the appropriate. Under this authority, CMS
equitable payment policies in the future. Clinical Depression Screening and implemented § 413.234 to establish the
• Transitional Pediatric ESRD Add- Follow-Up measure’s scoring TDAPA, a transitional drug add-on
on Payment Adjustment (TPEAPA): We methodology and converting that payment adjustment for certain new
are finalizing the establishment of a new measure to a clinical measure. renal dialysis drugs and biological
budget neutral add-on payment Beginning with PY 2027, we are adding products and § 413.236 to establish the
adjustment of 30 percent of the per the Screening for Social Drivers of TPNIES, a transitional add-on payment
treatment payment amount for renal Health reporting measure and the adjustment for certain new and
dialysis services furnished to Pediatric Screen Positive Rate for Social Drivers innovative equipment and supplies. The
ESRD Patients effective January 1, 2024, of Health reporting measure to the ESRD TDAPA and the TPNIES are not budget
for CYs 2024, 2025, and 2026. This will QIP measure set. In addition, we are neutral.
serve to bring Medicare payments for revising the codified definition of As discussed in section II.D of this
renal dialysis services furnished to ‘‘minimum total performance score’’ final rule, the TPNIES payment period
pediatric patients more in line with and codifying our previously finalized for the Tablo® System ends on
their estimated relative costs for the measure selection, retention, and December 31, 2023. As discussed in
next 3 years until further collection and removal policies. section II.E of this final rule, the TDAPA
payment period for Korsuva® payment rate update and final CY 2024 110–275). Section 1881(b)(14)(F) of the
(difelikefalin) will continue through ESRD PPS wage index. We estimate that Act, as added by section 153(b) of
March 31, 2024, and for Jesduvroq, will the aggregate Medicare payments made MIPPA and amended by section 3401(h)
continue throughout 2024. As described to ESRD facilities for renal dialysis of the Patient Protection and Affordable
in section VII.D.5 of this final rule, we services furnished to individuals with Care Act (Affordable Care Act) (Pub. L.
estimate that the overall TDAPA AKI, at the final CY 2024 ESRD PPS 111–148), established that beginning
payment amounts in CY 2024 will be base rate, will increase by $1 million in with CY 2012, and each subsequent
approximately $13.3 million, of which, CY 2024 compared to CY 2023. year, the Secretary shall annually
approximately $2.7 million will be increase payment amounts by an ESRD
3. Impacts of the Final Changes to the
attributed to beneficiary coinsurance market basket percentage increase
ESRD QIP
amounts. We note that these reduced by the productivity adjustment
expenditures are estimated in addition We estimate that the overall economic described in section 1886(b)(3)(B)(xi)(II)
to the overall $180 million increase impact of the PY 2026 ESRD QIP will be of the Act.
described in the preceding paragraphs approximately $136.9 million. The Section 632 of the American Taxpayer
and are not fully represented in the $136.9 million estimate for PY 2026 Relief Act of 2012 (ATRA) (Pub. L. 112–
detailed impact analysis shown in Table includes $120.9 million in costs 240) included several provisions that
24. associated with the collection of apply to the ESRD PPS. Section 632(a)
Lastly as discussed in section II.B.1.i information requirements and of ATRA added section 1881(b)(14)(I) to
of this final rule, we are finalizing a approximately $16 million in payment the Act, which required the Secretary,
non-budget-neutral payment adjustment reductions across all facilities. We also by comparing per patient utilization
for certain new renal dialysis drugs and estimate that the overall economic data from 2007 with such data from
biological products after the TDAPA impact of the PY 2027 ESRD QIP will be 2012, to reduce the single payment for
period ends, starting in CY 2024. The approximately $144.3 million. The renal dialysis services furnished on or
structure of the post-TDAPA add-on $144.3 million estimate for PY 2027 after January 1, 2014, to reflect the
payment adjustment for a new renal includes $130.5 million in costs Secretary’s estimate of the change in the
dialysis drug or biological product will associated with the collection of utilization of ESRD-related drugs and
be based on the case-mix adjusted information requirements and biologicals (excluding oral-only ESRD-
average per-treatment expenditure for approximately $13.8 million in payment related drugs). Consistent with this
such drug or biological product. We will reductions across all facilities. requirement, in the CY 2014 ESRD PPS
apply a 65 percent risk-sharing final rule, we finalized $29.93 as the
4. Impacts of the Final Changes to the
adjustment to the calculated payment total drug utilization reduction and
ETC Model
amount for the post-TDAPA add-on finalized a policy to implement the
payment adjustment. We are finalizing a The impact estimate in section amount over a 3- to 4-year transition
3-year period following TDAPA during VII.D.5.d of this final rule describes the period (78 FR 72161 through 72170).
which the drug or biological product estimated change in anticipated Section 632(b) of ATRA prohibited
would be included in the post-TDAPA Medicare program savings arising from the Secretary from paying for oral-only
add-on payment adjustment. During this the ETC Model over the duration of the ESRD-related drugs and biologicals
period, the renal dialysis drug or ETC Model as a result of the changes in under the ESRD PPS prior to January 1,
biological product would be considered this final rule. We estimate that the ETC 2016. Section 632(c) of ATRA required
for outlier payments, if it meets the Model will result in $28 million in net the Secretary, by no later than January
definition of an ESRD outlier service. savings over the 6.5-year duration of the 1, 2016, to analyze the case-mix
The first drug that will meet these ETC Model. We also estimate that the payment adjustments under section
criteria in CY 2024 will be Korsuva®, changes in this final rule will produce 1881(b)(14)(D)(i) of the Act and make
which fits into the existing ESRD PPS no change in net savings for the ETC appropriate revisions to those
functional category for antipruritic Model. As the ETC Model targeted adjustments.
drugs and biological products. The post- review process has already been On April 1, 2014, the Protecting
TDAPA add-on payment adjustment finalized in the Specialty Care Models Access to Medicare Act of 2014 (PAMA)
calculated for Korsuva® will be $0.2493. final rule and ETC Participants are not (Pub. L. 113–93) was enacted. Section
required to seek administrative review 217 of PAMA included several
2. Impacts of the Final Payment Rate for provisions that apply to the ESRD PPS.
of targeted review determinations, we
Renal Dialysis Services Furnished to Specifically, sections 217(b)(1) and (2)
expect there will be minimal additional
Individuals With AKI of PAMA amended sections
burden associated with the
The impact table in section VII.D.5.c administrative review policy we are 1881(b)(14)(F) and (I) of the Act and
of this final rule displays the estimated finalizing. replaced the drug utilization adjustment
change in Medicare payments to ESRD that was finalized in the CY 2014 ESRD
facilities for renal dialysis services II. Calendar Year (CY) 2024 End Stage PPS final rule (78 FR 72161 through
furnished to individuals with AKI Renal Disease (ESRD) Prospective 72170) with specific provisions that
compared to estimated Medicare Payment System (PPS) dictated the market basket update for
payments for such services in CY 2023. A. Background CY 2015 (0.0 percent) and how the
The overall impact of the CY 2024 market basket percentage increase
changes is projected to be a 2.0 percent 1. Statutory Background should be reduced in CY 2016 through
increase in Medicare payments for On January 1, 2011, CMS
CY 2018.
individuals with AKI. Hospital-based implemented the ESRD PPS, a case-mix Section 217(a)(1) of PAMA amended
ESRD facilities have an estimated 2.1 adjusted bundled PPS for renal dialysis section 632(b)(1) of ATRA to provide
percent increase in Medicare payments services furnished by ESRD facilities, as that the Secretary may not pay for oral-
compared with freestanding ESRD required by section 1881(b)(14) of the only ESRD-related drugs under the
facilities that have an estimated 2.0 Act, as added by section 153(b) of the ESRD PPS prior to January 1, 2024.
percent increase. The overall impact Medicare Improvements for Patients and Section 217(a)(2) of PAMA further
reflects the effects of the final Medicare Providers Act of 2008 (MIPPA) (Pub. L. amended section 632(b)(1) of ATRA by
requiring that in establishing payment applicable, for: (1) a training add-on for herein as the ‘‘CY 2024 ESRD PPS
for oral-only drugs under the ESRD PPS, home and self-dialysis modalities proposed rule,’’ appeared in the Federal
the Secretary must use data from the (§ 413.235(c)); (2) an additional payment Register on June 30, 2023, with a
most recent year available. Section for high cost outliers due to unusual comment period that ended on August
217(c) of PAMA provided that as part of variations in the type or amount of 25, 2023. In that rule, we proposed to
the CY 2016 ESRD PPS rulemaking, the medically necessary care (§ 413.237); (3) make a number of annual updates for
Secretary shall establish a process for (1) a TDAPA for certain new renal dialysis CY 2024, including updates to the ESRD
determining when a product is no drugs and biological products PPS base rate, wage index, outlier
longer an oral-only drug; and (2) (§ 413.234(c)); and (4) a TPNIES for policy, and the offset amount for the
including new injectable and certain new and innovative renal TPNIES. We also proposed two new
intravenous products into the ESRD PPS dialysis equipment and supplies exceptions to the LVPA eligibility
bundled payment. (§ 413.236(d)). requirements for ESRD facilities
Section 204 of the Stephen Beck, Jr., impacted by a disaster or other
Achieving a Better Life Experience Act 3. Updates to the ESRD PPS
emergency, a new add-on payment
of 2014 (ABLE) (Pub. L. 113–295) Policy changes to the ESRD PPS are adjustment for pediatric ESRD patients,
amended section 632(b)(1) of ATRA, as proposed and finalized annually in the a new add-on payment adjustment for
amended by section 217(a)(1) of PAMA, Federal Register. The CY 2011 ESRD certain new drugs and biological
to provide that payment for oral-only PPS final rule was published on August products after the TDAPA period ends,
renal dialysis drugs and biological 12, 2010, in the Federal Register (75 FR a new reporting requirement for
products cannot be made under the 49030 through 49214). That rule discarded billing units of certain renal
ESRD PPS bundled payment prior to implemented the ESRD PPS beginning dialysis drugs or biological products,
January 1, 2025. on January 1, 2011, in accordance with and a new reporting requirement for
section 1881(b)(14) of the Act, as added time on machine data for in-center
2. System for Payment of Renal Dialysis by section 153(b) of MIPPA, over a 4-
Services hemodialysis treatments. We proposed
year transition period. Since the clarifications regarding our evaluation
Under the ESRD PPS, a single per- implementation of the ESRD PPS, we of the TPNIES eligibility criteria under
treatment payment is made to an ESRD have published annual rules to make § 413.236(b) and included a summary of
facility for all the renal dialysis services routine updates, policy changes, and the one CY 2024 TPNIES application
defined in section 1881(b)(14)(B) of the clarifications. that we received by the February 1, 2023
Act and furnished to individuals for the Most recently, we published a final deadline with our preliminary analysis
treatment of ESRD in the ESRD facility rule, which appeared in the November of the applicant’s claims related to
or in a patient’s home. We have codified 7, 2022, issue of the Federal Register, substantial clinical improvement and
our definition of renal dialysis services titled ‘‘Medicare Program; End-Stage other eligibility criteria for the TPNIES.
at § 413.171, which is in 42 CFR part Renal Disease Prospective Payment In addition, the proposed rule included
413, subpart H, along with other ESRD System, Payment for Renal Dialysis a request for information regarding
PPS payment policies. The ESRD PPS Services Furnished to Individuals With potential changes to the LVPA and a
base rate is adjusted for characteristics Acute Kidney Injury, and End-Stage potential new payment adjustment for
of both adult and pediatric patients and Renal Disease Quality Incentive geographic isolation.
accounts for patient case-mix Program, and End-Stage Renal Disease We received 344 public comments on
variability. The adult case-mix adjusters Treatment Choices Model,’’ referred to our ESRD PPS proposals, including
include five categories of age, body herein as the ‘‘CY 2023 ESRD PPS final comments from kidney and dialysis
surface area, low body mass index, rule.’’ In that rule, we updated the ESRD organizations, such as large and small
onset of dialysis, and four comorbidity PPS base rate, wage index, and outlier dialysis organizations; for-profit and
categories (that is, pericarditis, policy for CY 2023. We also finalized non-profit ESRD facilities; ESRD
gastrointestinal tract bleeding, changes that included rebasing and networks; and a dialysis coalition. We
hereditary hemolytic or sickle cell revising the ESRD Bundled (ESRDB) also received comments from patients;
anemia, myelodysplastic syndrome). A market basket to reflect a 2020 base healthcare providers for adult and
different set of case-mix adjusters are year, refining the methodology for pediatric ESRD beneficiaries; home
applied for the pediatric population. outlier calculations, implementing a renal dialysis services and advocacy
Pediatric patient-level adjusters include wage index floor of 0.600, implementing organizations; provider and legal
two age categories (under age 13, or age a permanent 5 percent cap on year-over- advocacy organizations; administrators
13 to 17) and two dialysis modalities year wage index decreases for ESRD and insurance groups; a non-profit
(that is, peritoneal or hemodialysis) facilities, and modifying the definition dialysis association, a professional
(§ 413.235(a) and (b)). of ‘‘oral-only drug.’’ For further detailed association, and alliances for kidney
The ESRD PPS provides for three information regarding these updates, see care and home dialysis stakeholders;
facility-level adjustments. The first 87 FR 67136. drug and device manufacturers; health
payment adjustment accounts for ESRD care systems; a health care consultant;
facilities furnishing a low volume of B. Provisions of the Proposed Rule,
and the Medicare Payment Advisory
dialysis treatments (§ 413.232). The Public Comments, and Response to the
Commission (MedPAC).
second payment adjustment reflects Comments on the CY 2024 ESRD PPS We received comments related to
differences in area wage levels The proposed rule, titled ‘‘Medicare issues that we either did not discuss in
Program; End-Stage Renal Disease
developed from core-based statistical the CY 2024 ESRD PPS proposed rule or
areas (CBSAs) (§ 413.231). The third Prospective Payment System, Payment that we discussed for the purpose of
payment adjustment accounts for ESRD for Renal Dialysis Services Furnished to background or context, but for which we
facilities furnishing renal dialysis Individuals With Acute Kidney Injury, did not propose changes in the rule.
services in a rural area (§ 413.233). End-Stage Renal Disease Quality These include, for example, concerns
There are four additional payment Incentive Program, and End-Stage Renal regarding staff training, education for
adjustments under the ESRD PPS. The Disease Treatment Choices Model’’ (88 kidney disease patients, access to
ESRD PPS provides adjustments, when FR 42430 through 42544), referred to innovation for Medicare Advantage
beneficiaries, transportation for ESRD take commenters’ insight, concerns, and 2016 base year. In the CY 2023 ESRD
patients, nutrition for ESRD patients, recommendations into consideration for PPS final rule (87 FR 67141 through
and telehealth. We also received several future rulemaking on this topic. 67154), we finalized a revised and
comments on Medicare coverage for Additionally, we received some rebased ESRDB input price index to
certain Humanitarian Use Devices. We comments from commenters including reflect a CY 2020 base year.
are not providing detailed responses to ESRD patients and caregivers which Although ‘‘market basket’’ technically
those comments in this final rule contained details of quality-of-care describes the mix of goods and services
because they are out of the scope of the concerns or adverse quality events for used for ESRD treatment, this term is
CY 2024 ESRD PPS proposed rule. We which the commenters had first-hand also commonly used to denote the input
thank the commenters for their input experience. We address these comments price index (that is, cost categories, their
and will consider the recommendations as they concern the proposals in the CY respective weights, and price proxies
in potential future rulemaking. 2024 ESRD PPS proposed rule, but we combined) derived from a market
We received numerous comments on wish to note that any serious adverse basket. Accordingly, the term ‘‘ESRDB
the potential inclusion of oral-only quality events can be reported to the market basket,’’ as used in this
drugs into the ESRD PPS bundled CMS ombudsman. Information on document, refers to the ESRDB input
payment beginning January 1, 2025. As beneficiary rights and how to report price index.
quality events can be found at https:// The ESRDB market basket is a fixed-
noted in the CY 2023 ESRD PPS final
www.cms.gov/center/special-topic/ weight, Laspeyres-type price index. A
rule (87 FR 67180), we expect that the
ombudsman/medicare-beneficiary- Laspeyres-type price index measures the
only oral-only drugs and biological
ombudsman-home. change in price, over time, of the same
products that would be included in the mix of goods and services purchased in
In this final rule, we provide a
ESRD bundled payment in CY 2025 are the base period. Any changes in the
summary of each proposed provision, a
phosphate binders. Commenters quantity or mix of goods and services
summary of the public comments
expressed concerns on potential access (that is, intensity) purchased over time
received and our responses to them, and
and health equity issues, which could are not measured.
the policies we are finalizing for the CY
result from including oral-only drugs
2024 ESRD PPS. (2) CY 2024 ESRD Market Basket Update
and biological products in the ESRD
PPS bundled payment. Some 1. CY 2024 ESRD PPS Update We proposed to use the 2020-based
commenters also expressed additional a. CY 2024 ESRD Bundled (ESRDB) ESRDB market basket as finalized in the
concerns associated with the potential Market Basket Percentage Increase; CY 2023 ESRD PPS final rule (87 FR
inclusion of oral-only drugs and Productivity Adjustment; and Labor- 67141 through 67154) to compute the
biological products in the ESRD PPS Related Share proposed CY 2024 ESRDB market basket
bundled payment, such as concerns percentage increase based on the best
about the following: the administrative (1) Background available data. Consistent with
burden of managing a patient’s dosage In accordance with section historical practice, we proposed to
and combination of phosphate lowering 1881(b)(14)(F)(i) of the Act, as added by estimate the ESRDB market basket
drugs; administration of the prescription section 153(b) of MIPPA and amended percentage increase based on IHS Global
insofar as patients think they must go to by section 3401(h) of the Affordable Inc.’s (IGI) forecast using the most
the ESRD facility to obtain the Care Act, beginning in 2012, the ESRD recently available data at the time of
phosphate binders; confusion for PPS payment amounts are required to be rulemaking. IGI is a nationally
patients, in that some patients think the annually increased by an ESRD market recognized economic and financial
phosphate lowering drugs would only basket percentage increase and reduced forecasting firm with which CMS
be dispensed at the ESRD facility, and by the productivity adjustment contracts to forecast the components of
since the drugs must be taken with food, described in section 1886(b)(3)(B)(xi)(II) the market baskets. As discussed in the
they would not be able to take the drugs of the Act. The application of the CY 2024 ESRD PPS proposed rule (88
because eating during dialysis is not productivity adjustment may result in FR 42435 through 42436), we proposed
allowed, or they must go to the ESRD the increase factor being less than 0.0 to calculate the market basket update for
facility to get the phosphate binders for a year and may result in payment CY 2024 based on the proposed market
even when they do not have a dialysis rates for a year being less than the basket percentage increase and the
treatment; innovation of new oral-only payment rates for the preceding year. proposed productivity adjustment,
drugs and biological products, such as Section 1881(b)(14)(F)(i) of the Act also following our longstanding
phosphate lowering therapies, would be provides that the market basket increase methodology.
unavailable because of the cost of the factor should reflect the changes over
new drugs or biological products; and time in the prices of an appropriate mix (a) CY 2024 Market Basket Percentage
the definition of oral-only drugs and of goods and services included in renal Increase
biological products for phosphate dialysis services. Based on IGI’s first quarter 2023
lowering agents until an intravenous or As required under section forecast of the 2020-based ESRDB
injectable equivalent of the drug is 1881(b)(14)(F)(i) of the Act, CMS market basket, the proposed CY 2024
available. We thank the commenters for developed an all-inclusive ESRD market basket percentage increase was
their insight regarding the potential Bundled (ESRDB) input price index 2.0 percent. We also proposed that if
inclusion of oral-only drugs and using CY 2008 as the base year (75 FR more recent data became available after
biological products in the ESRD PPS 49151 through 49162). We subsequently the publication of the CY 2024 ESRD
bundled payment beginning in CY 2025; revised and rebased the ESRDB input PPS proposed rule and before the
however, we did not make any price index to a base year of CY 2012 publication of the final rule (for
proposals related to the potential in the CY 2015 ESRD PPS final rule (79 example, a more recent estimate of the
inclusion of oral-only drugs and FR 66129 through 66136). In the CY market basket percentage increase), we
biological products in the ESRD PPS 2019 ESRD PPS final rule (83 FR 56951 would use such data, if appropriate, to
bundled payment in CY 2025 in the CY through 56964), we finalized a rebased determine the CY 2024 market basket
2024 ESRD PPS proposed rule. We will ESRDB input price index to reflect a CY percentage increase in this final rule.
(b) Productivity Adjustment moving average of TFP for the period in the March 2023 Report to the
Under section 1881(b)(14)(F)(i) of the ending CY 2024) was 0.3 percentage Congress: Medicare Payment Policy 6
Act, as amended by section 3401(h) of point. Furthermore, we proposed that if concluded that this increase is
the Affordable Care Act, for CY 2012 more recent data became available after warranted based on its analysis of
and each subsequent year, the ESRDB the publication of the CY 2024 ESRD payment adequacy (which includes an
market basket percentage increase shall PPS proposed rule and before the assessment of beneficiary access, supply
be reduced by the productivity publication of this final rule (for and capacity of facilities, facilities’
adjustment described in section example, a more recent estimate of the access to capital, quality, and financial
1886(b)(3)(B)(xi)(II) of the Act. The productivity adjustment), we would use indicators for the sector). Many
statute defines the productivity such data, if appropriate, to determine commenters expressed concern that the
adjustment to be equal to the 10-year the CY 2024 productivity adjustment in CY 2024 payment update does not
moving average of changes in annual this final rule. adequately factor in the effects of many
economy-wide, private nonfarm challenges faced by ESRD facilities,
(c) CY 2024 Market Basket Update
business multifactor productivity (MFP) such as the impact of the COVID–19
In accordance with section public health emergency (PHE),
(as projected by the Secretary for the 10-
1881(b)(14)(F)(i) of the Act, we inflationary pressure, higher patient
year period ending with the applicable
proposed to base the CY 2024 market acuity, Federal budget sequestration,
fiscal year (FY), year, cost reporting
basket percentage increase on IGI’s first increasing labor costs due to labor
period, or other annual period) (the
quarter 2023 forecast of the 2020-based shortages, and other increased costs,
‘‘productivity adjustment’’).
The Bureau of Labor Statistics (BLS) ESRDB market basket. We proposed to such as personal protective equipment
publishes the official measures of then reduce this percentage increase by (PPE), drugs, and supplies. Several
productivity for the United States the estimated productivity adjustment commenters also asserted that during
economy. As we noted in the CY 2023 for CY 2024 based on IGI’s first quarter the last two ESRD PPS rulemaking
ESRD PPS final rule (87 FR 67155), the 2023 forecast. Therefore, the proposed cycles the ESRDB market basket updates
productivity measure referenced in CY 2024 ESRDB market basket update have not kept pace with the market
section 1886(b)(3)(B)(xi)(II) of the Act was equal to 1.7 percent (2.0 percent basket increases for other Medicare
previously was published by BLS as market basket percentage increase providers, such as hospitals and Skilled
private nonfarm business MFP. reduced by a 0.3 percentage point Nursing Facilities (SNFs). Commenters
Beginning with the November 18, 2021, productivity adjustment). Furthermore, additionally noted that the proposed CY
release of productivity data, BLS as noted previously, we proposed that if 2024 ESRDB market basket increase was
replaced the term ‘‘multifactor more recent data became available after lower than certain other estimates of
productivity’’ with ‘‘total factor the publication of the CY 2024 ESRD overall inflation and healthcare-specific
productivity’’ (TFP). BLS noted that this PPS proposed rule and before the inflation. One commenter stated that
is a change in terminology only and will publication of the final rule (for since the ESRD PPS’ inception, the
not affect the data or methodology.5 As example, a more recent estimate of the annual updates in several years have
a result of the BLS name change, the market basket and/or productivity fallen far below other measures, such as
productivity measure referenced in adjustment), we would use such data, if general inflation or health care inflation
section 1886(b)(3)(B)(xi)(II) of the Act is appropriate, to determine the CY 2024 as measured by the Consumer Price
now published by BLS as private market basket percentage increase and Index (CPI).
nonfarm business TFP; however, as productivity adjustment in the final Response: We are required to update
mentioned previously, the data and rule. ESRD PPS payments annually by the
We invited public comment on our market basket update adjusted for
methods are unchanged. We referred
proposals for the CY 2024 ESRDB productivity, as directed by section
readers to https://www.bls.gov/
market basket update and productivity 1881(b)(14)(F)(i) of the Act. Specifically,
productivity/ for the BLS historical
adjustment. Approximately 150 section 1881(b)(14)(F)(i)(I) of the Act
published TFP data. A complete
commenters, including large dialysis states that the increase factor shall be
description of IGI’s TFP projection
organizations (LDOs); provider based on an ESRD market basket
methodology is available on CMS’s
advocacy organizations; nonprofit percentage increase for a bundled
website at https://www.cms.gov/
dialysis associations; a coalition of payment system for renal dialysis
Research-Statistics-Data-and-Systems/
dialysis organizations; a network of services that reflects changes over time
Statistics-Trends-and-Reports/Medicare
dialysis organizations; professional in the prices of an appropriate mix of
ProgramRatesStats/MarketBasket
organizations and several ESRD goods and services included in renal
Research. In addition, in the CY 2022
facilities, commented on the proposed dialysis services. We believe the
ESRD PPS final rule (86 FR 61879), we
CY 2024 ESRDB market basket update. increase in the 2020-based ESRDB
noted that effective for CY 2022 and
The following is a summary of the market basket adequately reflects the
future years, we will be changing the
public comments received on these average change in the price of goods and
name of this adjustment to refer to it as
proposals and our responses. services ESRD facilities purchase to
the productivity adjustment rather than
Comment: Commenters generally provide ESRD medical services and is
the MFP adjustment. We stated this was
supported increasing the ESRD PPS base technically appropriate to use as the
not a change in policy, as we will
rate and the utilization of the most ESRD payment update factor. The
continue to use the same methodology
recent data available (for example, a ESRDB market basket is a fixed-weight,
for deriving the adjustment and rely on
more recent estimate of the market
the same underlying data. Laspeyres-type index that measures

basket and/or productivity adjustment) price changes over time and would not
Based on IGI’s first quarter 2023
to determine the final CY 2024 ESRD reflect increases in costs associated with
forecast, the proposed productivity
PPS update. MedPAC recommended changes in the volume or intensity of
adjustment for CY 2024 (the 10-year
that the ESRD PPS base rate increase for
5 Total Factor Productivity in Major Industries— CY 2024 should be updated by the 6 https://www.medpac.gov/wp-content/uploads/
2020. Available at: https://www.bls.gov/ amount determined under current law, 2023/03/Mar23_MedPAC_Report_To_Congress_v2_
news.release/prod5.nr0.htm. and commented that analysis reported SEC.pdf.
input goods and services. As such, the inputs used to provide renal dialysis Comment: Several commenters
ESRDB market basket update would services is different from those used for indicated a belief that the ESRDB
reflect the prospective price pressures other services captured by other CMS market basket update would have an
described by the commenters (such as market baskets. For example, the ESRDB impact on quality of care provided by
wage growth or higher energy prices) market basket labor cost weights ESRD facilities. Other commenters
but would not inherently reflect other (reflecting those cost weights that use an indicated that they believe the current
factors that might increase the level of Employment Cost Index (ECI) as price quality of care that ESRD PPS
costs, such as the quantity of labor used proxy) are generally lower than the beneficiaries receive is too low, and
or any shifts between contract workers labor cost weights in other CMS PPS used this belief as justification for either
and staffed employees. We note that market baskets, and the pharmaceuticals supporting or opposing the ESRDB
cost changes (that is, the product of and medical supply cost weights in the market basket update.
price and quantities) would only be ESRDB market basket (which is based Response: We appreciate commenters’
reflected when a market basket is on the ESRD Medicare cost report (Form insight into the quality of care which
rebased, and the base year weights are CMS–265–11)) are higher than the Medicare beneficiaries receive at ESRD
updated to a more recent time period. pharmaceuticals and medical supply facilities. Medicare beneficiaries have a
We finalized the 2020-based ESRDB cost weights in other CMS PPS market right to safe, appropriate, and quality
market basket in the CY 2023 ESRD PPS baskets.7 The weighting together of health services. For ESRD facilities, the
final rule (87 FR 67141), and therefore, these different mixes of inputs can Federal health and safety requirements
any change in the cost structure for appropriately result in differential rates are codified at 42 CFR part 494. To
ESRD facilities that occurred between of increase for various market baskets. determine if a facility meets ESRD
2016 and 2020 is now reflected in the Additionally, we acknowledge that conditions for coverage, the State survey
cost weights for the 2020-based ESRDB many measures of inflation are higher agency (SA), or a CMS-approved
market basket, which was the most than both the proposed 1.7 percent and national accrediting organization (AO),
recent fully complete cost data available the final 2.1 percent productivity- performs an on-site survey of the
at the time of rulemaking. We will adjusted ESRDB market basket update facility. After the initial approval,
continue to monitor the cost share for CY 2024. We note that some of the dialysis facilities have routine onsite
weights and, if technically appropriate, surveys to monitor compliance with the
measures of inflation that commenters
consider rebasing the ESRDB market Federal requirements. If a dialysis
referenced in their comments are either
basket more frequently than usual facility is found to be deficient in one
measures of past inflation or measures
should the cost weights change or more of the standards in the
of current inflation. The ESRDB market
significantly. Any proposal to rebase the conditions for coverage, it may
basket update is based on a forecast for
ESRDB market basket would occur participate in, or be covered under, the
the changes in input prices as measured
through notice-and-comment Medicare program only if the dialysis
by the ESRDB market basket for CY
rulemaking. The final CY 2024 ESRDB facility has submitted an acceptable
2024, and not a measure of inflation
market basket update reflects the most plan of correction for achieving
during CY 2023. Under section
recent available data regarding prices of compliance within a reasonable period
1881(b)(14)(F)(i) of the Act, the annual
labor used to provide renal dialysis of time acceptable to CMS. In the case
market basket update reflects the of an immediate jeopardy situation (that
services. As set forth later in section changes over time in the prices of an
II.B.1.a.(2)(c) of this final rule, the final is, a situation in which the facility’s
appropriate mix of goods and services non-compliance with one or more
productivity-adjusted CY 2024 ESRDB included in renal dialysis services. We
market basket update is 2.1 percent, Medicare conditions for coverage has
believe that this is a more accurate caused, or is likely to cause, serious
representing a ESRDB market basket estimate of the changes in input prices
increase of 2.4 percent reduced by a injury, harm, impairment, or death to a
faced by ESRD facilities than less patient), we may require a shorter time
productivity adjustment of 0.3 percent. specific measures such as overall
We note that the final CY 2024 ESRDB period for achieving compliance.
inflation or inflation across the entire When poor quality or unsafe health
market basket update is 0.4 percentage healthcare sector. Additionally,
points higher than the proposed CY care is furnished by any type of
concerns raised by commenters that the Medicare-certified provider or supplier,
2024 ESRDB market basket update. We
ESRDB market basket updates have been a complaint may be filed by anyone,
recognize that this 2.1 percent
lower than general inflation or including patients, family members, or
productivity-adjusted ESRDB market
healthcare inflation measures are not staff. Dialysis facility complaints
basket update may still be lower than
relevant comparisons, because the law relating to improper care, unsafe
some commenters believe is
requires that the increase be based on an conditions, and quality of care may be
appropriate; however, it reflects the
index that measures input price filed with the State Health Department
most recent available data regarding
pressures for providing renal dialysis or the ESRD Network.8
expected price inflation for inputs
services. We acknowledge that many CMS has an established complaint
required to provide renal dialysis
patients, ESRD facilities, and other process to protect all patients from
services based on CMS’s longstanding
health care providers believe that rising abuse, neglect, exploitation, and
methodology.
prices are a major concern in providing inadequate care and supervision. The
We acknowledge commenters’ claims high quality care; however, we project goal of the complaints process is to
that the CY 2024 ESRD PPS proposed that growth in input prices for renal establish a system that will assist in
market basket increase is less than
dialysis services will slow in CY 2024 promoting and protecting the health and
increases for other Medicare payment relative to CY 2023, which is reflected safety of all patients receiving health
systems, including the Inpatient in the productivity-adjusted ESRDB services in a Medicare-certified facility.
Prospective Payment System (IPPS) and market basket update of 2.1 percent. The procedures for handling complaints
the Hospital Outpatient Prospective
Payment System (OPPS). In response to 7 Public data can be found at https://www.bls.gov/ 8 https://www.cms.gov/training-education/open-
these concerns, we note that one cause eci/home.htm and https://www.cms.gov/data- door-forums/end-stage-renal-disease-clinical-
of these differences is that the mix of research/statistics-trends-and-reports/cost-reports. laboratories-esrd/network.
are outlined in Chapter 5 of the State organizations, stated that ESRD facilities goods and services included in renal
Operations Manual,9 and they are face relatively small profit margins dialysis services. This update is not
followed when complaints and reported when caring for Medicare beneficiaries intended to account for or direct the
incidents, including referrals from the and indicated that they believe the business practices of other payors. We
public or other Federal entities, involve ESRDB market basket increase amount note that the final productivity-adjusted
Medicare-certified providers/suppliers. would lead to lower standards of care in CY 2024 ESRDB market basket update is
The evaluation, investigation, and CY 2024 and that to prevent this, CMS 2.1 percent, which represents an
resolution of complaints are critical should consider increasing payments by increase to the proposed productivity-
certification activities. CMS and the a larger amount. One ESRD patient adjusted CY 2024 ESRDB market basket
SAs, or AOs, are responsible for characterized the proposed CY 2024 update of 1.7 percent, and we anticipate
ensuring that participating providers/ ESRDB market basket update as being that the increase alleviates some of the
suppliers of healthcare services insufficient for the extent of the commenters’ concerns. We did not
continually meet Federal requirements. financial impact of recent inflationary propose to make any additional
This requires that the SA, or AO, events. Numerous commenters stated methodological changes to the market
promptly reviews complaints/incidents, that a larger payment rate increase basket update or ESRD PPS base rate to
conducts unannounced onsite would allow ESRD facilities to hire account for other payors and are not
investigations of reports alleged more staff and increase the quality of finalizing any additional
noncompliance, and informs the CMS care. Some commenters suggested that methodological changes on this topic.
locations any time a facility is found to CMS reevaluate the proposed market Comment: We received numerous
be out of compliance with the basket update and instead increase other comments on potential
applicable certification requirements. ESRD PPS payments by a larger amount. implications of the proposed CY 2024
We believe the resources provided by Response: We understand that ESRDB market basket update. Several
the ESRD PPS are appropriate to enable commenters are concerned about the commenters claimed the proposed CY
ESRD facilities to comply with the profit margins for ESRD facilities. As 2024 ESRD PPS base rate update would
requirements and procedures described stated previously, we believe that the have a negative impact on other factors
above. final CY 2024 ESRDB market basket including, but not limited to, wait times
Comment: One ESRD patient stated update reflects the most recent available for dialysis appointments, access to
that ESRD facilities were already being data regarding the input prices required innovative treatments for ESRD patients,
paid too much and that the quality of to provide renal dialysis services. We ESRD treatments for nursing home
care provided by ESRD facilities was did not propose any additional patients, ESRD treatments for the
insufficient given the payment amount. increases to the ESRD PPS base rate to elderly, Medicare Part A payments, and
Response: We appreciate the improve ESRD facility margins or hospitalizations for ESRD PPS patients.
comments on Medicare payment otherwise account for factors that Response: We recognize that
amounts to ESRD facilities. As stated commenters believe are not adequately commenters are concerned about the
previously, we are required to update represented in the market basket update impact that the magnitude of the CY
ESRD PPS bundled payments by the methodology, and we are not finalizing 2024 ESRDB market basket update has
market basket update adjusted for any such increases. We will continue to on ESRD facilities’ ability to provide
productivity under section monitor the adequacy of the ESRD PPS quality renal dialysis services. As stated
1881(b)(14)(F)(i) of the Act, which states payment amount and will consider previously, the final CY 2024 ESRDB
that the Secretary shall annually these comments in potential future market basket update reflects the most
increase payment amounts by an ESRD rulemaking. In addition, as described recent available data regarding prices for
market basket percentage increase that earlier in this section, CMS is actively inputs used to provide renal dialysis
reflects changes over time in the prices engaged in efforts to ensure Medicare services. We recognize that payment
of an appropriate mix of goods and ESRD beneficiaries receive quality care. policy within the ESRD PPS can affect
services included in renal dialysis Comment: Several commenters, the quality and accessibility of renal
services. As such, we believe that the including a provider advocacy dialysis services; however, the CY 2024
final CY 2024 ESRDB market basket organization, noted that the ESRD PPS ESRDB market basket update adequately
update is appropriate. We note that payment rate update would have reflects the average change in the price
MedPAC states that payment rates are implications for Medicare Advantage of goods and services ESRD facilities
adequate for the ESRD facilities. In payment rates. Many of these purchase to provide renal dialysis
addition, regarding the commenter’s commenters expressed that the services, so we do not agree with
belief that ESRD facilities are being paid proposed ESRDB market basket update commenters’ claims that the ESRDB
too much, and the concerns the of 1.7 percent would lead to lower market basket update would have a
commenter noted citing specific quality payments from Medicare Advantage. negative impact on these other factors.
Response: We understand that some We did not propose any changes to the
of care issues for ESRD patients, we note
commenters are concerned about the existing ESRDB market basket update
that, as described earlier in this section,
impact that the proposed CY 2024 methodology in the CY 2024 ESRD PPS
CMS is actively engaged in efforts to
ESRDB market basket update would proposed rule and are not finalizing any
ensure Medicare ESRD beneficiaries
have on rates for other payors, including such methodological changes in this
receive quality care. Additionally, the
Medicare Advantage. However, we are rule. We appreciate the insight of
ESRD QIP actively monitors and adjusts
required to update the ESRD PPS commenters into the implications of the
payments to facilities under the ESRD
bundled payment by the market basket
ESRDB market basket update and will

PPS based on their performance on
update adjusted for productivity under keep these implications in mind in
several quality measures.
section 1881(b)(14)(F)(i) of the Act, future rulemaking.
Comment: Several commenters,
which states that the Secretary shall Comment: Several commenters
including a coalition of dialysis
annually increase payment amounts by questioned CMS’s longstanding market
9 https://www.cms.gov/medicare/provider- an ESRD market basket percentage basket methodology. Commenters
enrollment-and-certification/surveycertification increase that reflects changes over time expressed concern over the accuracy of
geninfo/downloads/som107c05pdf.pdf. in the prices of an appropriate mix of the forecast underlying the proposed
market basket update for CY 2024, historical data and reflects a revised industry and associations, routinely
including that CMS’s use of the IGI outlook regarding the U.S. economy and throughout the year in our continuing
forecast for determining the market expected price inflation for CY 2024. efforts to align payment with resource
basket update does not capture the Based on IGI’s third quarter 2023 utilization. We welcome continuing
specialized nature of ESRD facility forecast with historical data through the dialogue on the topic of improving the
costs. A few commenters requested that second quarter of 2023, we are market basket update methodology, and
CMS reexamine the forecasting projecting a CY 2024 ESRDB market other topics pertinent to the ESRD PPS,
approach or consider other methods and basket update of 2.4 percent (reflecting toward the common goal of improving
data sources to calculate the final rule forecasted compensation price growth of care for ESRD patients.
market basket update that better reflect 4.1 percent) and a productivity Comment: Some commenters
the rapidly increasing input prices and adjustment of 0.3 percentage point. provided information on additional
costs facing ESRD facilities. Other Therefore, for CY 2024 a final ESRDB rising costs faced by ESRD facilities that
commenters indicated that they productivity-adjusted market basket the commenters believed were not
believed that it is inappropriate to update of 2.1 percent (2.4 percent less adequately captured in the proposed CY
continue to use the same mix of goods 0.3 percentage point) will be applicable, 2024 ESRDB market basket update.
and services that were used at the compared to the 1.7 percent These additional costs included the
inception of the ESRD PPS in the CY productivity-adjusted market basket following: costs associated with
2011 ESRD PPS final rule. One ESRD update that was proposed. We note that compliance with additional regulations
facility suggested that, because there has section 1881(b)(14)(F)(i) of the Act states regarding infection control; costs related
been significant variation between the to supply chain problems; rising costs
that the Secretary shall annually
forecasted and actual ESRDB market for certain supplies; and cost related to
increase payment amounts by an ESRD
basket price growth, CMS should changes in labor, such as additional pay
market basket percentage increase that
evaluate whether the market basket for traveling nurses or contract nurses.
reflects changes over time in the prices Response: We appreciate the insight
methodology is inherently flawed. of an appropriate mix of goods and
Several commenters believed that a into changing costs that ESRD facilities
services included in renal dialysis face. As stated previously, the final CY
retrospective adjustment to the base rate services. We believe that the current
to account for past differences between 2024 ESRDB market basket update
market basket update methodology as reflects the most recent available data
the ESRDB market basket update for a finalized in the CY 2011 ESRD PPS final
given year and what the ESRDB market regarding prices for inputs used to
rule (75 FR 49151 through 49162), and provide renal dialysis services. These
basket update would have been for that most recently updated in the CY 2023 costs which commenters listed are
year based on the actual changes in ESRD PPS final rule (87 FR 67141 included in the ESRDB and so the
prices, known as a forecast error through 67157) to reflect a 2020 base change in their prices would be
adjustment, could alleviate some of the year, fulfills this statutory requirement. included in the CY 2024 ESRDB market
perceived flaws in the market basket We support the continued use of the basket update. If the rising costs the
update methodology. current mix of goods and services to commenters’ mentioned are due to an
Response: We thank commenters for provide continuity to the financial increase in quantity of the good
providing these comments on the impacts of the ESRD PPS payment purchased, rather than an increase in
ESRDB market basket update policy, and we note that the weighting price, we note that such cost changes
methodology. In response to the for this mix of goods and services is would only be reflected when a market
commenters’ request that we reexamine updated periodically through rebasing. basket is rebased, and the base year
the current forecasting approach for However, we will consider the weights are updated to a more recent
determining the ESRDB market basket commenter’s suggestion regarding the time period. We finalized the 2020-
update, we provide the following use of different methods or other data based ESRDB market basket in the CY
information. IGI is a nationally sources for the ESRDB market basket for 2023 ESRD PPS final rule (87 FR 67141);
recognized economic and financial future rulemaking. We discuss the therefore, any change in the cost
forecasting firm with which CMS commenters’ request for a forecast error structure for ESRD facilities that
contracts to forecast the price proxies adjustment below. We did not propose occurred between 2016 and 2020 is now
used in the market baskets. At the time any methodological changes to the reflected in the cost weights for the
of the CY 2024 ESRD PPS proposed ESRDB market basket update 2020-based ESRDB market basket,
rule, based on the IGI first quarter 2023 methodology for CY 2024, and we are which was the most recent fully
forecast with historical data through the finalizing the continued use of the complete cost data available at the time
fourth quarter of 2022, the 2020-based ESRDB market basket methodology as of rulemaking. We believe that it is
ESRDB market basket update was finalized in the CY 2023 ESRD PPS final technically appropriate to use the 2020-
forecasted to be 2.0 percent for CY 2024, rule (87 FR 67141 through 67157). We based ESRDB market basket for the CY
reflecting forecasted compensation price do not believe that the ESRDB market 2024 ESRDB market basket update.
growth of 3.7 percent (by comparison, basket update is inherently flawed Comment: One commenter asserted
compensation price growth in the because the forecast errors for CYs 2021 that experience over the past few years
ESRDB market basket averaged 2.6 and 2022 were higher-than-normal due has indicated that the ESRD PPS
percent from 2013 to 2022). In the CY to the high inflation during the COVID– methodology is unable to reflect short-
2024 ESRD PPS proposed rule, we 19 PHE, which we discuss further in term and long-term impacts of an
proposed that if more recent data section II.B.1.a.(2)(d) of this final rule. economic shock, such as the COVID–19
became available, we would use such We will continue to monitor the PHE. The commenter noted that
data, if appropriate, to derive the final performance of the ESRDB market although CMS offers detailed
CY 2024 ESRDB market basket update basket update, and we will keep these explanations of the market basket’s
for the final rule. For this final rule, we comments on the market basket construction and issues data through its
now have an updated forecast of the methodology in mind for future website, the dialysis provider
price proxies underlying the market rulemaking. We note that CMS engages community still has little insight into
basket that incorporates more recent with the public, including the dialysis the factors contributing to annual
payment updates that the commenter supporting the adoption of certain new labor costs have increased over the past
believes consistently fail to reflect and innovative drugs, biological few years. Several commenters,
increases in the cost of care delivery. products, equipment and supplies by including an LDO and a non-profit
The commenter urged CMS to engage in ESRD facilities, by providing additional dialysis organization, referenced an
a formal dialogue with the kidney care payment to offset the additional cost of analysis that showed labor costs grew at
community outside of the annual those drugs, biological products, a compound average growth rate of 6.96
rulemaking process to better identify the equipment and supplies. We did not percent from 2018 to 2022, whereas the
methodology’s limitations and inform propose any changes to the ESRDB proxy for labor used in the ESRDB
development of improvements. The market basket update methodology to market basket update methodology grew
commenter also requested that IGI have account for innovation within the ESRD at a compound average growth rate of
representation and participation in this PPS and are not finalizing any such 3.15 percent from 2018 to Q1 2022. One
dialogue. changes in this final rule. We will provider advocacy organization
Response: We appreciate the consider these comments on supporting commented that its analysis found that
commenter’s concerns regarding the innovation and access to innovative direct patient care labor costs per
market basket methodology. Our products in potential future rulemaking. dialysis treatment increased by 18.9
longstanding ESRDB market basket Comment: We received approximately percent from 2017 to 2022.
update methodology sets rates 90 comments related to the nature of Commenters also stated that the
prospectively on an annual basis. We labor costs at ESRD facilities, including increasing labor costs were resulting in
acknowledge that over the course of a comments from large dialysis staffing concerns at ESRD facilities.
year, short term changes in economic organizations, advocacy organizations, Some of these comments highlighted
conditions can lead to uncertainty, ESRD facilities, providers, and a access issues arising from fewer
which may be exacerbated by economic coalition of dialysis organizations. available dialysis sessions. Some
shocks. Because the ESRD PPS base rate Commenters generally stated that labor comments referenced quality issues
is updated annually, the purpose of the costs at ESRD facilities are increasing, related to the burden placed on workers
ESRDB market basket update is to which is driving overall cost increases at ESRD facilities by low staffing and
account for the change in price of the at ESRD facilities, and that the proposed the limited training of staff at ESRD
ESRDB from year to year, not ESRDB market basket update was facilities due to high turnover. Many of
necessarily to capture the effect of insufficient to cover these increased these comments came from ESRD
shorter term fluctuations of prices. That labor costs. Many of the commenters patients, caretakers and patient
short term fluctuations are not cited that the growth in their labor costs advocates and included the
addressed by the ESRDB market basket has outpaced the ESRDB market basket commenters’ personal experience on the
update is a consequence of the annual updates or the growth of the market issues related to receiving care at ESRD
nature of the update as required by basket compensation cost category in facilities (for example, difficulty finding
section 1881(b)(14)(F) of the Act. We the ESRDB market basket. Additionally, appointments, having to travel
believe the ESRDB market basket update some commenters noted that labor costs significant distances to get care, and
appropriately captures the change in the were rising across the healthcare sector, how low staffing at ESRD facilities has
price of goods and services over time in which the commenters asserted was not impacted their care). Other commenters
the long term. Some commenters have appropriately reflected in the ESRDB conveyed their concern about
suggested a forecast error adjustment as market basket update. Commenters inadequate staffing and related many
a way to mitigate the impact of these described other barriers to hiring and incidents of significant adverse events
short-term uncertainties, which we maintaining staff including, but not and sub-standard quality care, which
discuss in further detail in section limited to, burnout, lack of resources, they attributed to low staffing. A kidney
II.B.1.a.(2)(d) of this final rule. CMS will inability to match competitive pay, and disease patient organization included
continue to engage with the public long travel times for staff. A coalition of multiple testimonials from ESRD
regarding ways to ensure the Medicare dialysis organizations commented that it patients regarding their issues in trying
ESRD PPS payments are appropriate was increasingly difficult for ESRD to locate dialysis treatments.
and that the market basket price proxies facilities to hire new staff while Some commenters highlighted the
and base year weights are accurate. competing with other health care impact that staffing shortages had on
Comment: We received several providers with more resources and non- home dialysis. Several patients
comments, including from a patient healthcare employers. They stated that expressed a willingness and desire for
organization, stating that the proposed this was leading to some ESRD facilities self-dialysis training, but stated they
ESRDB market basket update would not having to turn away patients or being were unable to receive self-dialysis
sufficiently support innovation. unable to continue operations. One LDO dialysis training due to staff shortages at
Response: We note that ESRD PPS noted that staffing concerns are leading their clinics.
policies to encourage the adaptation of to ESRD facilities using a higher Response: We thank commenters for
new innovations, such as the TDAPA percentage of more-expensive contract their insight into labor supply and labor
and TPNIES, are add-on payment labor and that contract labor wages and costs at ESRD facilities, and we
adjustments to the base rate, and benefits make up 1.9 percent and 0.5 recognize that labor costs are a driving
although there is only one ESRD PPS percent of the 2020-based ESRDB, factor in cost increases at ESRD
bundled payment, these adjustments are respectively. Some commenters facilities. We acknowledge that CY 2022
not a part of the ESRDB and therefore, highlighted the COVID–19 PHE as a price growth for the 2016-based ESRDB
are not included in the ESRD PPS base market basket was higher (5.1 percent)
significant factor in the workforce

rate or the ESRDB market basket update. shortage that ESRD facilities face; than was forecasted at the time of the
This is similarly true for the post- however, some commenters indicated CY 2022 ESRD PPS final rule (2.4
TDAPA add-on payment adjustment that they believe this workforce shortage percent). We note that the lower
that we are finalizing in this rule, which has been in progress for a long time. projected CY 2024 ESRDB market basket
is described in further detail in section Some ESRD facilities and LDOs percent increase (2.4 percent) relative to
II.B.1.i of this final rule. These add-on included various additional information the observed CY 2022 historical
payment adjustments are actively or data on the extent to which their increase, as well as the forecasted CY
2023 ESRDB market basket increase of facilities, it would be expected that the takes longer to update in response to
3.1 percent, reflect the expectation that labor percentage increase would be periods of large change.
wage and price pressures will lessen in greater than the overall ESRDB market We appreciate comments from ESRD
CY 2024 compared to recent years. As basket percentage increase. This is patients which highlighted their
described previously, the ESRDB market because the ESRDB market basket experiences at ESRD facilities. We are
basket measures price changes increase is a weighted average of the concerned by the comments which
(including changes in the prices for changes in prices for the ESRDB market indicate access and quality concerns at
wages and salaries and benefits) over basket. Labor is only one part of the ESRD facilities related to staffing issues.
time and would not reflect increases in ESRDB market basket, and commenters We note that § 494.180(b) requires that
costs associated with changes in the have indicated that other components of an ESRD facility have an adequate
volume or intensity of input goods and the ESRDB market basket have not number of qualified and trained staff;
services until the market basket is experienced the same growth in price as however, the governing body of the
rebased. An ESRD-specific labor. We believe the 2020-based ESRDB facility has a measure of discretion
compensation price index is when determining staffing. The ESRD
market basket increase adequately
unavailable; therefore, we use a PPS provides a bundled payment that
reflects the average change in the price
composite wage and benefit index of encompasses all renal dialysis services,
of goods and services ESRD facilities
various Employment Cost Indices (ECIs) including labor. We recognize that
purchase to provide renal dialysis staffing shortages can pose a difficulty
reflecting the occupational mix of full- services, including labor, and is to ESRD patients who desire training for
time equivalents (FTE) data from ESRD technically appropriate to use as the self-dialysis. We note that the ESRD PPS
Medicare Cost reports and ECIs from ESRD PPS payment update factor. The includes an add-on payment adjustment
BLS (87 FR 67147). Health-related ESRDB market basket update will reflect for self-dialysis training (42 CFR
occupations account for 79 percent of the expected prospective price pressures 413.235(c); 81 FR 77851 to 77856). We
the 2020-based ESRDB compensation described by the commenters as appreciate the comments regarding
cost weight and are proxied by the ECI increasing during a high inflation period these staffing issues and will consider
for All Civilian Workers in Hospitals, (such as faster wage growth or higher them for potential future rulemaking.
reflecting similar medical occupations energy prices) but inherently will not Comment: One commenter
used in ESRD facilities (particularly reflect other factors that might increase encouraged CMS to explore other
nurses) and their associated price the level of costs, such as the quantity changes to the composition of the
growth. As discussed in the CY 2023 of labor used. Therefore, the final CY market basket to better capture evolving
ESRD PPS final rule, we believe the 2024 ESRDB market basket update dynamics in the labor force. The
composite weighted index for wages reflects the most recent available data commenter provided as an example that
and salaries and benefits to be a regarding both prices and the items and the ECI may no longer accurately
reasonable proxy for the compensation services used to provide renal dialysis capture the changing composition and
component of the ESRDB market basket. services. cost structure of the hospital labor
We note that section 1881(b)(14)(F)(i) of market given the large increases in
the Act states that the Secretary shall We thank commenters for including
detailed information and data on the short-term contract labor use and its
annually increase payment amounts by growing costs.
an ESRD market basket percentage changes to labor costs that ESRD
Several commenters expressed
increase that reflects changes over time facilities face. We agree that during the
concern that not all the ESRDB market
in the prices of an appropriate mix of COVID–19 PHE, labor costs increased
basket price proxies, particularly the
goods and services included in renal more than normal. According to our labor-related price proxies, accurately
dialysis services. While labor is analysis, the ESRDB market basket reflect ESRD facilities’ faster than
included in the mix of goods and compensation price growth was expected cost growth. One commenter
services in the ESRD PPS bundled forecasted to increase a cumulative 18.9 noted that for healthcare providers
payment, the annual market basket percent from CY 2017 to CY 2022. This across all sectors, the impact of the tight
increase accounts for more than the is the same as the figure which one labor market (both in the healthcare
price change for labor. As such, it is commenter described as being the sector and general economy overall) has
possible for the market basket increase change in direct labor costs over that forced ESRD facilities to rely more
to be less than the increase in the price time. We recognize that some comments heavily on contracted labor. The
of labor if the other goods and services indicated that ESRD facilities commenter further pointed out that
included in the ESRDB do not experienced larger or smaller changes in under the 2020-based ESRDB market
experience as large of a price increase. labor costs than this over that time. We basket, contract labor wages and
Our analysis of the data used to note that the ESRDB market basket does benefits have 1.9 percent and 0.5
determine the ESRDB market basket not measure each individual ESRD percent weights, respectively; however,
forecast indicates that this dynamic is facility’s own experience, but instead the commenter expressed concern that
reflected in the market basket increases the ESRDB market basket cost weights these weights were derived by assuming
for the past few years. For example, in reflect the experience of the average that ESRD facilities use the same labor
2021 the overall market basket forecast ESRD facility. Therefore, if one area of amount and mix as they did more than
was an increase of 1.9 percent, but the the country experienced an increase in a decade ago, which does not reflect the
labor portion of the ESRDB market labor costs at a higher rate than other current environment in which dialysis
basket was forecasted to increase by 2.5 areas of the country, that would not be providers deliver care. They stated that
percent. We recognize commenters’ wholly captured in the annual update. use of the U.S. Census Bureau’s Services
view that the proposed ESRDB market Instead, the relative difference in labor Annual Survey (SAS) data may not
basket increase for CY 2024 was less cost growth should be captured in reflect staffing ratio or minimum wage
than ESRD facilities’ reported labor changes to the wage index for that ESRD requirements adopted by State and
increases. However, if, as commenters facility. However, we recognize that our municipal governments since 2012, the
have stated, labor is the driving factor wage index methodology uses historical recent years’ shift in labor mix,
for the increase in costs for ESRD data instead of a forecast and as such unanticipated increase in compensation
expenses, or the COVID–19 PHE’s its forecast for the ECI for All Civilian productivity-adjusted market basket
overall impact on the healthcare labor Workers in Hospitals, IGI considers increase factor is equal to 2.1 percent
force. overall labor market conditions (that is, the 2.4 percent market basket
A few commenters stated that certain (including rise in contract labor update reduced by the 0.3 percentage
market basket components rely, to some employment due to tight labor market point productivity adjustment).
extent, on severely lagged data, which conditions) as well as trends in contract
during times of unusual circumstances, (d) Requests for a Forecast Error
labor wages, which both have an impact
could limit a forecast model’s ability to Payment Adjustment
on wage pressures for workers
capture economic shocks and the employed directly by the hospital. We In the CY 2024 ESRD PPS proposed
subsequent impact on health care also acknowledge the commenters’ rule (88 FR 42435), we discussed that in
providers’ costs. The commenters concerns that the ECI only reflects the CY 2023 ESRD PPS final rule (87 FR
stated, for example, the BLS’s ECI price employed labor costs; however, we note 67157), many commenters requested
proxies generally hold the employment that the alternative publicly available that CMS apply a forecast error payment
mix constant for several years. They average hourly earnings series also does adjustment to the ESRD PPS base rate to
stated that the ECI’s weights reflected not include contract labor costs. support ESRD facilities during the
the 2012 occupational mix until Additionally, we analyzed the FTE data inflationary period occurring at that
recently (the December 2022 BLS reported on the Medicare cost reports time, particularly accounting for what
release updated the data to reflect 2021 and found that the share of contract commenters stated was an error in the
employment weights). The commenters labor FTEs is about 2 percent of all FTEs forecasted payment updates for CYs
noted that since ECI employment and has remained relatively constant in 2021 and 2022. In response to those
weights are held constant for a period 2021 and 2022. We will continue to comments, we reminded readers that
this would introduce inaccuracies into monitor the cost report data as it is ESRDB market basket updates are set
the market basket updates. They stated received to ensure that the ECI series prospectively, meaning the update relies
that since the ECI 2012 weights were used to proxy ESRD labor categories on a mix of both historical data for part
used for the price proxies in the ESRDB continues to offer the most appropriate of the period for which the update is
market basket through the CY 2022 price proxies for measuring calculated and forecasted data for the
rulemaking cycles it could have resulted compensation price growth in ESRD remainder. We explained that while
in errors in the ESRDB market basket facilities. there is no precedent to adjust for
update. Lastly, we acknowledge commenters’ market basket forecast error in the
Response: We appreciate the concern that the contract labor cost annual ESRD PPS update, the forecast
commenters’ concerns about the weight in the ESRDB market basket error for a market basket update is
composition of the ESRDB market relies on 2012 SAS data published by calculated as the actual market basket
basket and whether the price proxies the United States Census Bureau increase for a given year less the
used in the market basket are accurately inflated to 2020-dollar values as the forecasted market basket increase.10 We
capturing the price pressures basis for the contract labor cost weight. also explained that due to the
experienced by ESRD facilities. We proposed and finalized the uncertainty regarding future price
The commenters are correct that the methodology for deriving the trends, forecast errors can be both
ECI data are based on fixed occupational compensation cost share weights in the positive and negative. For example, the
weights; however, we believe these CY 2023 ESRD PPS rulemaking cycle CY 2017 ESRDB forecast error was ¥0.8
indexes continue to be technically (87 FR 67141 through 67157). Because percentage point, while the CY 2021
appropriate measures of pure the Medicare cost report data does not ESRDB forecast error was +1.2
compensation inflation to be used in the capture the specific costs for contract percentage points. At the time of the CY
ESRDB market basket. Because the labor, we therefore must rely on other 2023 ESRD PPS final rule, CY 2022
market baskets are intended to measure data sources to estimate the share of historical data was not yet available to
price changes over time, and not contract labor costs that are reported calculate a forecast error for CY 2022;
changes in costs that also reflect within Administrative and General costs however, based on the latest available
quantity and intensity changes, the on the cost reports. We have not historical data for CY 2022, we now
fixed occupational distribution of the identified any other data source that calculate that the CY 2022 ESRDB
ECI is appropriate. BLS periodically provides specific contract labor costs for forecast error was +2.7 percentage
updates these distributions (in the ESRD facilities. points.
January 2023 release of December 2022 Final Rule Action: After consideration We further noted that, in the CY 2023
ECI data they introduced updated 2021 of the comments received, we are ESRD PPS final rule (87 FR 67156), we
fixed employment weights, replacing finalizing a CY 2024 ESRDB recognized that recent higher
the 2012 weights used through productivity-adjusted market basket inflationary trends impacted the outlook
September 2022). Additionally, the increase of 2.1 percent based on the for price growth over the next several
observed ECI for Wages and Salaries for most recent data available. As noted quarters. For that CY 2023 ESRD PPS
All Civilian workers in Hospitals (which previously, based on the more recent final rule, we used an updated forecast
accounts for 29 percent of the 2020- data available for this CY 2024 ESRD of the price proxies underlying the
based ESRDB market basket) data has PPS final rule (that is, IGI’s third quarter market basket that incorporated more
reflected recent wage ‘‘price’’ pressures 2023 forecast of the 2020-based ESRDB recent historical data and reflected a
as growth in 2021 and 2022 accelerated market basket with historical data revised outlook regarding the U.S.
relative to 2020. The projection of the economy and expected price inflation
through the second quarter of 2023), the

ECI also considers anticipated wage CY 2024 ESRDB market basket update is for CY 2023 for ESRD facilities. We
pressures due to various economic and 2.4 percent. Based on the more recent explained that predictability in
industry-specific factors; the hospital data available from IGI’s third quarter
ECI is projected to grow faster in 2023 2023 forecast, the current estimate of the 10 FAQ—Market Basket Definitions and General
compared to the historical average productivity adjustment for CY 2024 is Information. Available at: https://www.cms.gov/
research-statistics-data-and-systems/statistics-
growth in the series, particularly prior 0.3 percentage point. Therefore, the trends-and-reports/medicareprogramratesstats/
to 2021. We note that when developing current estimate of the CY 2024 ESRD downloads/info.pdf.
Medicare payments is important to experienced similar forecast errors in base rate to account for the forecast error
enable ESRD facilities to budget and CY 2022 and CY 2023, the current in recent years, with commenters
plan their operations, and that forecast cumulative underpayment error for the suggesting it be applied to the ESRD
errors are unpredictable (87 FR 67517). ESRD PPS exceeds the errors in other PPS base rate in a non-budget neutral
Prior to the COVID–19 PHE period, the payment systems such as IPPS, home manner. Some commenters, including
positive differences between the actual health, and long-term care hospitals. an LDO, recognized that CMS’s view
and forecasted market basket increase in Some commenters acknowledged that that the market basket errors could
prior years have offset negative since the market basket updates are set balance out over time could be true for
differences over time. Therefore, we prospectively, they are inherently small variations; however, the
stated in the CY 2024 ESRD PPS imperfect, and forecast errors from year commenters stated that it would not
proposed rule that, in accordance with to year may occur in either a positive or hold true for periods of significant
our longstanding ESRDB market basket negative direction. However, several missed forecasts due to periods of rapid
update methodology, we would not commenters noted that in the case of the change, for example during the COVID–
propose to apply a forecast error ESRDB market basket these differences 19 PHE. Generally, commenters stated
adjustment to the ESRDB market basket have not offset one another over time. that they agreed with CMS on the
update for CY 2024. The commenters stated a belief that the importance of predictability for
Comment: We received approximately magnitude of the errors in 2021 and payments but stated that payment
30 comments related to CMS’s decision 2022, which they state resulted from a accuracy was more important, so a
not to propose a forecast error flawed methodology that failed to forecast error payment adjustment
adjustment for CY 2024. These accurately forecast higher than normal would be useful as it would improve
commenters, including a coalition of inflation, are highly unlikely to even out payment accuracy.
dialysis providers, several LDOs, and over time unless there is a similar, fast Some comments included additional
numerous provider and patient moving deflationary event resulting in information on what commenters stated
advocacy organizations, requested that the same magnitude in the forecast. could happen with or without a forecast
CMS reevaluate and implement a Many commenters requested CMS error adjustment. One LDO commented
payment adjustment to account for past establish a payment adjustment that their analysis indicated that the
forecast errors. Many commenters modeled after the forecast error under-forecast would lead to a total of
requested that CMS apply a forecast adjustment for payments to SNFs that $1.8 billion in underpayments between
error adjustment to the ESRD PPS was established in 2004 (68 FR 46057). CY 2021 to 2027. One patient-led
payment update for CY 2024. Some These commenters responded to CMS’s dialysis organization recommended an
specific suggestions for payment view that historical negative forecast ‘‘Essential Worker Safety Catch’’ to
adjustments included: a CY 2024 errors are offset by positive errors by revise past updates to ensure labor is
adjustment of 10 to 20 percent per noting that over the past few years the adequately compensated. A provider
discharge; an adjustment for the forecast errors have been predominantly advocacy organization questioned
‘‘underpayment’’ of ESRD facilities positive, at 1.2 percent and 2.7 percent CMS’s use of 2020-cost reports in
since 2020; and/or the adoption a in CYs 2021 and 2022 respectively. As determining payment for CY 2024,
forecast error adjustment like the one such, the ESRD PPS base rate is lower saying it was outdated and inaccurate.
used in the SNF PPS. Several than it would have been if the forecasts One ESRD facility commented that
commenters stated that absent a forecast had been accurate. Many of these given the size of recent errors, they
error adjustment they may be forced to commenters supported a forecast error believed it was likely that errors would
close some of their ESRD facilities, adjustment methodology that would, continue to increase and potentially
particularly those facilities located in like the SNF adjustment of 2004, only become larger in the future.
areas with vulnerable populations. be applied if the error is larger than a Response: While the projected ESRDB
The commenters stated that the certain threshold. Multiple commenters market basket updates for CY 2021 and
forecast error was driven mainly by supported a threshold of 0.5 percentage CY 2022 were under-forecast (that is,
unforeseen increased costs for labor point for this adjustment. Many actual increases were greater than
(including a higher reliance on contract commenters compared the state of SNF forecasted), as is the preliminary CY
labor staff), equipment, and medical payment in 2004 and of the ESRD PPS 2023 forecast error, this was largely due
supplies (including PPE and today, emphasizing the similarities in to unanticipated inflationary and labor
pharmaceuticals), which resulted in the amount by which the recent market market pressures as the economy
increased costs to provide care to ESRD basket updates had been incorrect, the emerged from the COVID–19 PHE. An
beneficiaries that were never properly source of the error mainly attributable to analysis of the forecast error of the
reimbursed under the Medicare ESRD unexpectedly large increases in the ESRDB market basket over a longer
PPS payments. Commenters stated that costs of labor, and certain similar period shows the forecast error has been
while the growth in these costs has statutory language describing the SNF both positive and negative. We
begun to stabilize somewhat in 2023, PPS and the ESRD PPS. A coalition of recognize that the COVID–19 PHE and
they continue to be substantially higher dialysis organizations suggested that for high inflationary environment have had
than pre-pandemic levels. Commenters the CY 2024 ESRD PPS final rule CMS an adverse impact on costs for ESRD
also pointed out that while high wage should adjust the ESRD PPS base rate by facilities. Due to ESRD payments being
inflation and labor shortages affect all the cumulative forecast error since 2019 set prospectively, we rely on a
health care providers, dialysis providers but added that they would also approve projection of the ESRDB market basket
are particularly vulnerable because of adjusting the ESRD PPS base rate by that reflects both historical and
there is not variation in types of services the cumulative forecast error since the forecasted trends. Due to the uncertainty
performed or billed and due to the less inception of the ESRD PPS in 2011. regarding future price trends, the
variable payer mix that relies more on Some commenters, including an LDO, difference between the projected and
Medicare and Medicaid payment than suggested in lieu of a permanent actual market basket increases can be
other health care provider types. forecast error adjustment policy for both positive and negative. We note that
One commenter noted that while ESRDs, CMS could apply a one-time from CY 2012 to CY 2020, the only year
other health care providers have positive adjustment to the ESRD PPS in which the forecast error of the ESRDB
market basket update exceeded the 0.5 forecast errors in CY 2021 and CY 2022 interpretation of the circumstances
percentage point threshold in absolute were largely due to unanticipated involved in the implementation of the
terms (which is applicable for the SNF inflationary and labor market pressures forecast error adjustment for SNF
PPS forecast error adjustment) was CY as the economy emerged from the payment; however, we disagree with the
2017. The forecasted CY 2017 ESRDB COVID–19 PHE, which we do not claim that the circumstance was
market basket update was 0.8 anticipate will continue in CY 2024. virtually identical to the ESRD PPS
percentage point higher than the actual Our preliminary estimates of the CY today. While the cumulative under-
CY 2017 percentage increase of the 2023 ESRD PPS forecast error indicate forecast of the SNF market basket
2012-based ESRDB market basket based that it was smaller than the forecast increases in 2004 was based on a rapid
on historical data. We also acknowledge errors in CY 2022 and CY 2021. increase in the price of labor, it was not
that the ESRDB market basket forecast For these reasons, after evaluating the due to a PHE as occurred with the ESRD
errors for CY 2021 (1.2 percentage historical performance of the ESRDB PPS’s under-forecast in recent years.
points) and CY 2022 (2.7 percentage market basket and the financial Additionally, it was an issue which only
points) exceeded the 0.5 percentage environment unique to ESRD facilities, SNFs were experiencing, unlike the
point threshold where the forecasted we do not believe it is appropriate to current ESRD PPS environment where
ESRDB market basket updates were include adjustments to the ESRDB multiple Medicare payment systems
lower than the actual percentage market basket update for future years have faced similar forecast errors. We
increases based on historical data. These based on the difference between the note that when CMS finalized a forecast
recent forecast errors were largely a actual and forecasted ESRDB market error adjustment for the SNF payment
function of uncertainty in the overall basket increase in prior years. However, system, we concluded that a forecast
economy and the health sector we will continue to monitor the overall error adjustment was appropriate for
specifically due to the nature of the performance of the ESRDB market payment accuracy for SNFs; not that it
COVID–19 PHE and the unforeseen basket update, including analyzing the was required under the statute (68 FR
rapidly accelerating inflationary change in the price of labor inputs for 46057). For these reasons, we do not
environment. Rapid increase in costs ESRD facilities over time. We will take agree with the commenter’s stated belief
during the COVID–19 PHE has led to a commenters’ concerns into that a forecast error adjustment would
positive forecast error for every consideration for potential future be required to fulfill the ESRD PPS
Medicare PPS. rulemaking. statutory requirements, and, at this time,
Comment: One LDO commented that for the reasons discussed previously, we
The data on which the final CY 2024 they believe that CMS has a statutory
ESRDB market basket update is based is do not believe that a forecast error
obligation to implement a forecast error payment adjustment would be
the most recent available data. We note adjustment under section
that the 2020 cost report data was used appropriate for the ESRD PPS.
1881(b)(14)(F)(i) of the Act, which states
for rebasing the market basket as that the Secretary shall annually Final Rule Action: After consideration
finalized in the CY 2023 ESRD PPS final increase payment amounts by an ESRD of the comments we received, we are
rule (87 FR 67141 through 67154), and market basket percentage increase for a finalizing a CY 2024 ESRDB
at the time of CY 2023 rulemaking the bundled payment system for renal productivity-adjusted market basket
2020 cost report data was the most dialysis services that reflects changes increase of 2.1 percent based on the
recent year of complete cost report data over time in the prices of an appropriate most recent data available. As noted
available to develop the ESRDB market mix of goods and services included in previously, based on the more recent
basket cost weights. The ESRDB market renal dialysis services. The commenter data available for this CY 2024 ESRD
basket cost weights do not change from acknowledged that forecasting prices is PPS final rule (that is, IGI’s third quarter
year to year since it is a fixed-weight inherent in a PPS but indicated that 2023 forecast of the 2020-based ESRDB
Laspeyres index; therefore, for CY 2024, they believe that the current market basket with historical data
we use the most recent available methodology fails to annually capture through the second quarter of 2023), the
forecast of the price proxies to estimate the changes over time in the price of CY 2024 ESRDB market basket update is
the growth in the input prices of this providing renal dialysis services. The 2.4 percent. Based on the more recent
mix of goods and services for providing commenter stated that correcting for data available from IGI’s third quarter
renal dialysis services for the coming prior and future forecast errors is a step 2023 forecast, the current estimate of the
year. The most recent forecast of the CMS can easily implement to ensure the productivity adjustment for CY 2024 is
price proxies in the ESRDB market ESRD PPS payment, and future market 0.3 percentage point. Therefore, the
basket for this final rule is the IGI third basket update factors, reflect the prices current estimate of the CY 2024 ESRD
quarter 2023 forecast with historical of delivering renal dialysis services. The productivity-adjusted market basket
data through the second quarter of 2023. commenter noted that in 2004 when increase factor is equal to 2.1 percent
This is the established methodology as CMS implemented a forecast error (2.4 percent market basket update
finalized in the CY 2011 ESRD PPS final adjustment in the payment system for reduced by 0.3 percentage point
rule (75 FR 49151 through 49162). SNFs it was based on very similar productivity adjustment). We are
Therefore, while the weighting of the statutory language and was finalizing our proposal to determine the
various goods and services that make up implemented under what the CY 2024 ESRDB market basket update
the ESRDB market basket did utilize commenter stated were ‘‘virtually for the final rule without an adjustment
2020 data for rebasing, it is inaccurate identical’’ circumstances to the ESRD to account for past forecast errors.
to characterize the CY 2024 market Additionally, we did not propose and
PPS today.
basket increase as being based on 2020 Response: We thank the commenter are not finalizing any methodology for
data generally. We do not agree with the for sharing their view on this issue; a forecast error payment adjustment. We
commenter that stated a belief that however, we do not agree that CMS’s will continue to monitor the
because forecast errors have been greater position regarding an ESRD PPS forecast performance of the ESRDB market
in recent years it is likely that forecast error payment adjustment conflicts with basket forecasts and will consider the
errors will be larger in the future. As we any statutory requirements for the ESRD information provided by commenters
have indicated, the larger-than-normal PPS. We appreciate the commenter’s for potential future rulemaking.
(e) Labor-Related Share the cost share weights and, if b. CY 2024 ESRD PPS Wage Indices
We define the labor-related share as technically appropriate, consider (1) Background
those expenses that are labor-intensive rebasing the ESRDB market basket more
frequently than usual should the cost Section 1881(b)(14)(D)(iv)(II) of the
and vary with, or are influenced by, the Act provides that the ESRD PPS may
local labor market. The labor-related weights change significantly. We
appreciate the suggestion to use a include a geographic wage index
share of a market basket is determined payment adjustment, such as the index
by identifying the national average different labor-related share for low
wage index ESRD facilities. We did not referred to in section 1881(b)(12)(D) of
proportion of operating costs that are the Act, as the Secretary determines to
related to, influenced by, or vary with propose any methodological changes to
the application of the labor-related be appropriate. In the CY 2011 ESRD
the local labor market. For the CY 2024 PPS final rule (75 FR 49200), we
ESRD PPS payment update, we share, such as using a different labor-
related share for different ESRD finalized an adjustment for wages at
proposed to continue using a labor- § 413.231. Specifically, CMS adjusts the
related share of 55.2 percent, which was facilities, but we will consider this
comment in potential future labor-related portion of the ESRD PPS
finalized in the CY 2023 ESRD PPS final base rate to account for geographic
rule (87 FR 67153 through 67154). rulemaking.
differences in the area wage levels using
Comment: We received three Comment: One commenter expressed
an appropriate wage index, which
comments which acknowledged our appreciation that the labor-related share
reflects the relative level of hospital
proposal to use the labor-related share of the ESRD PPS increased from 52.3
wages and wage-related costs in the
of 55.2 percent as finalized in the CY percent to 55.2 percent in CY 2023 and
geographic area in which the ESRD
2023 ESRD PPS final rule. Additionally, stated that they believe this is a
facility is located. We use the Office of
one LDO commented on the weights consistent trend with the ESRD PPS, for
Management and Budget’s (OMB’s)
attributed to contract labor and benefits which CMS has increased the labor-
CBSA-based geographic area
in the 2020-based ESRDB market basket, related share of the market basket over designations to define urban and rural
indicating that they thought that these the lifetime of the PPS. The commenter areas and their corresponding wage
areas were under-represented in the opined that increasing the labor-related index values (75 FR 49117). OMB
2020-based ESRDB market basket. This share of the market basket, while publishes bulletins regarding CBSA
LDO recognized that CMS did not positive, does not fully address the changes, including changes to CBSA
propose any changes to the labor-related steep rising costs of labor needed to numbers and titles. The bulletins are
share from CY 2023. One provider deliver care to Medicare beneficiaries available online at https://
advocacy organization suggested CMS with ESRD, since it only alters the www.whitehouse.gov/omb/information-
utilize a different labor-related share for percentage of ESRD PPS payments for-agencies/bulletins/.
ESRD facilities with low wage index allocated to labor as compared with We have also adopted methodologies
values, noting that for facilities with low other inputs required for renal dialysis for calculating wage index values for
wage index values, labor likely relates to services but does not deliver more ESRD facilities that are in urban and
a smaller share of total costs. resources through the ESRD PPS to rural areas where there is no hospital
Response: We thank commenters for cover the rising costs of care associated data. For a full discussion, see the CY
reviewing the proposed labor-related with the increases in the cost of labor. 2011 and CY 2012 ESRD PPS final rules
share. We appreciate the comment on Response: The purpose of the labor- at 75 FR 49116 through 49117 and 76
the weights of contract labor in the related share is to reflect the proportion FR 70239 through 70241, respectively.
2020-based ESRDB market basket. As of the national ESRD PPS base payment For urban areas with no hospital data,
stated in section II.B.1.a.(2)(c) of this rate that is adjusted by the wage index. we compute the average wage index
final rule, changes in both the cost and CMS adjusts the labor-related portion of value of all urban areas within the State
quantity of an input are reflected when the base rate to account for geographic to serve as a reasonable proxy for the
the ESRDB market basket is rebased, differences in the area wage levels using wage index of that urban CBSA, that is,
and the base year weights are updated an appropriate wage index, which we use that value as the wage index. For
to a more recent time period. We reflects the relative level of hospital rural areas with no hospital data, we
finalized the 2020-based ESRDB market wages and wage-related costs in the compute the wage index using the
basket in the CY 2023 ESRD PPS final geographic area in which the ESRD average wage index values from all
rule (87 FR 67141), and, therefore, any facility is located. Therefore, we include contiguous CBSAs to represent a
change in the cost structure for ESRD a cost category in the labor-related share reasonable proxy for that rural area. We
facilities that occurred between 2016 if the costs are labor intensive and vary applied the statewide urban average
and 2020 is now reflected in the cost with the local labor market. We note based on the average of all urban areas
weights for the 2020-based ESRDB that the historical increase to the labor- within the State to Hinesville-Fort
market basket, which was the most related share is based on the increase to Stewart, Georgia (78 FR 72173), and we
recent fully complete cost data available the labor-related cost-weights in the applied the wage index for Guam to
at the time of rulemaking. Our ESRDB market basket. American Samoa and the Northern
monitoring indicates that the 2020- As acknowledged by the commenter, Mariana Islands (78 FR 72172).
based ESRDB market basket is still the purpose of the labor-related share is Under § 413.231(d), a wage index
appropriate for determining the cost to allocate ESRD payment between floor value of 0.6000 is applied under
weights for inputs for providing renal labor-related costs and non-labor costs. the ESRD PPS as a substitute wage
dialysis services. Therefore, following The labor-related share is not meant to index for areas with very low wage
the methodology finalized in the CY increase payments overall for the rising index values, as finalized in the CY
2011 ESRD PPS final rule (75 FR 49116), cost of labor. 2023 ESRD PPS final rule (87 FR 67161).
we consider the labor related Final Rule Action: We are finalizing Currently, all areas with wage index
components of the ESRDB market basket our proposal to use the labor-related values that fall below the floor are in
to be an appropriate basis for the labor- share of 55.2 percent, as finalized in the Puerto Rico and the U.S. Virgin Islands.
related share for the CY 2024 ESRD PPS CY 2023 ESRD PPS final rule, for CY However, the wage index floor value is
payments. We will continue to monitor 2024 ESRD PPS payments. applicable for any area that may fall
below the floor. A further description of if appropriate, to determine the CY 2024 expected price inflation for CY 2024 for
the history of the wage index floor ESRD PPS wage index in the final rule. ESRD facilities. We believe the final
under the ESRD PPS can be found in the We received several comments on our productivity-adjusted market basket
CY 2019 ESRD PPS final rule (83 FR proposal to update the ESRD PPS wage update will address some of the
56964 through 56967) and the CY 2023 index. The comments and our responses commenter’s concerns regarding rising
ESRD PPS final rule (87 FR 67161). are set forth below. wages due to inflation.
An ESRD facility’s wage index is Comment: We received several Comment: Several commenters,
applied to the labor-related share of the comments on CMS’s proposal to use the including MedPAC, a coalition of
ESRD PPS base rate. In the CY 2023 most recent wage index data in the CY dialysis organizations and an LDO,
ESRD PPS final rule (87 FR 67153), we 2024 ESRD PPS final rule. Commenters suggested that CMS reevaluate the wage
finalized a labor-related share of 55.2 were generally supportive of the use of index methodology for the ESRD PPS.
percent. In the CY 2021 ESRD PPS final more recent data. Additionally, several MedPAC recommended we establish an
rule (85 FR 71436), we updated the commenters reiterated support for the 5 ESRD PPS wage index for all ESRD
OMB delineations as described in the percent cap on wage index decreases facilities using wage data that represents
September 14, 2018, OMB Bulletin No. that we finalized in the CY 2023 ESRD all employers and industry-specific
18–04, beginning with the CY 2021 PPS final rule (87 FR 67161). occupational weights, rather than the
Response: We thank the commenters hospital wage data currently used. Two
ESRD PPS wage index. In that same
for their support on the use of more ESRD facilities and a provider advocacy
rule, we finalized the application of a 5
recent data and for the policy to cap organization requested CMS use the
percent cap on any decrease in an ESRD
wage index decreases. floors and reclassifications that IPPS
facility’s wage index from the ESRD Comment: One ESRD facility
facility’s wage index from the prior CY. uses for their wage index. Some of these
expressed concerns that the ESRD PPS commenters additionally indicated a
We finalized that the transition would wage index does not reflect the realities
be phased in over 2 years, such that the belief that this change would help ESRD
that it faces and, specifically, does not facilities compete with hospitals for
reduction in an ESRD facility’s wage accurately reflect the increase in its cost
index would be capped at 5 percent in labor.
of labor over the past few years. Response: We appreciate the
CY 2021, and no cap would be applied Response: We appreciate the concerns suggestions from commenters on how to
to the reduction in the wage index for that the commenter raised; however, we improve the ESRD PPS wage index
the second year, CY 2022. In the CY did not propose to change the wage methodology. The use of hospital wage
2023 ESRD PPS final rule (87 FR 67161), index methodology for CY 2024 and are data for the ESRD PPS wage index is set
we finalized a permanent policy under not finalizing any changes to that forth in §§ 413.196(d)(2) and 413.231(a).
§ 413.231(c) to apply a 5 percent cap on methodology in this final rule. The wage As we previously discussed in the CY
any decrease in an ESRD facility’s wage data used to construct the ESRD PPS 2011 ESRD PPS proposed rule (74 FR
index from the ESRD facility’s wage wage index are updated annually, based 49968), the ESRD PPS wage index uses
index from the prior CY. For CY 2024, on the most current data available, and the same wage index values used in the
as discussed in section II.B.1.a.(2)(e) of are based on OMB’s CBSA delineations basic case-mix adjusted composite
this final rule, the labor-related share to when applying the rural definitions and payment system, which are calculated
which the wage index will be applied is corresponding wage index values. As without regard to geographic
55.2 percent. discussed in CY 2011 ESRD PPS final reclassifications authorized under
(2) CY 2024 ESRD PPS Wage Index rule (75 FR 49200), the wage index sections 1886(d)(8) and (d)(10) of the
reflects the relative level of hospital Act and utilize pre-floor hospital data
For CY 2024, we proposed to update wages and wage-related costs in the that are unadjusted for occupational
the wage indices to account for updated geographic area in which the ESRD mix. The application of the pre-floor,
wage levels in areas in which ESRD facility is located. Because the wage pre-reclassification hospital wage index
facilities are located using our existing index is scaled relative to the national for the ESRD case-mix adjusted
methodology. We proposed to use the average, it does not reflect changes over composite payment system is further
most recent pre-floor, pre-reclassified time to the cost of labor. Rather, the discussed in the CY 2009 Physician Fee
hospital wage data collected annually market basket increase accounts for Schedule (PFS) final rule (73 FR 69726,
under the inpatient PPS. The ESRD PPS national trends, including inflation. As 69758) and the CY 2007 PFS final rule
wage index values are calculated discussed in the CY 2024 ESRD PPS (71 FR 69624, 69685). We did not
without regard to geographic proposed rule (88 FR 42435), we propose changes to the ESRD PPS wage
reclassifications authorized under proposed to increase the ESRD PPS base index methodology for CY 2024, and we
sections 1886(d)(8) and (d)(10) of the rate for CY 2024 by the market basket are not finalizing any changes to that
Act and utilize pre-floor hospital data increase factor in accordance with methodology in this final rule.
that are unadjusted for occupational section 1881(b)(14)(F)(i) of the Act, As discussed in the CY 2023 ESRD
mix. For CY 2024, the updated wage which provides that the market basket PPS final rule (87 FR 67160), the wage
data are for hospital cost reporting increase factor should reflect the index is intended to be a relative
periods beginning on or after October 1, changes over time in the prices of an measure of the value of labor in
2019, and before October 1, 2020 (FY appropriate mix of goods and services prescribed labor market areas. There is
2020 cost report data). that reflect the costs of furnishing renal a variety of reasons why our
For CY 2024, we proposed to update dialysis services. As discussed in longstanding ESRD PPS wage index
the ESRD PPS wage index to use the section II.B.1.a.(2).(c) of this final rule, policy has not applied the same floors
most recent hospital wage data. We the final productivity-adjusted market or reclassifications as applied under the
proposed that if more recent data basket update for CY 2024 is 2.1 percent IPPS, which we note, are not applied to
become available after the publication of based on the latest available data. We the ESRD PPS wage index by statute
the proposed rule and before the note that this final update is 0.4 (sections 1881(b)(12)(D) &
publication of the final rule (for percentage point higher than the (b)(14)(D)(iv)(II) of the Act). For
example, a more recent estimate of the proposed update and reflects a revised example, applying reclassifications to
wage index), we would use such data, outlook regarding the U.S. economy and the ESRD PPS wage index would
significantly increase administrative potential future rulemaking. We did not have been, prior to January 1, 2011,
burden, both for ESRD facilities and for propose any change to the current wage covered under Medicare Part D,
CMS, that would be associated with index floor of 0.6000 specified in including renal dialysis oral-only drugs
ESRD facilities reclassifying from one § 413.231(d) and are not finalizing any effective January 1, 2025; and (v) renal
CBSA to another, and it would changes to that floor in this final rule. dialysis equipment and supplies, except
significantly increase the complexity of Final Rule Action: We are finalizing for capital-related assets that are home
the methodology. our proposal to update the ESRD PPS dialysis machines (as defined in
Furthermore, because floors and wage index for CY 2024 to use the most § 413.236(a)(2)), that receive the
reclassifications would be applied recent hospital wage data, as proposed. transitional add-on payment adjustment
budget-neutrally under the wage index, The final CY 2024 ESRD PPS wage as specified in § 413.236 after the
these policies would increase the wage index is set forth in Addendum A and payment period has ended.11
index for some ESRD facilities while is available on CMS’s website at https:// In the CY 2011 ESRD PPS final rule
reducing ESRD PPS payments for all www.cms.gov/Medicare/Medicare-Fee- (75 FR 49142), CMS stated that for
other ESRD facilities, which would for-Service-Payment/ESRDpayment/ purposes of determining whether an
upset the long-settled expectations with End-Stage-Renal-Disease-ESRD- ESRD facility would be eligible for an
which ESRD facilities across the country Payment-Regulations-and-Notices. outlier payment, it would be necessary
have been operating. For example, Addendum A provides a crosswalk for the ESRD facility to identify the
under the IPPS rural floor policy, between the CY 2023 wage index and actual ESRD outlier services furnished
section 4410(a) of the Balanced Budget the CY 2024 wage index. Addendum B to the patient by line item (that is, date
Act of 1997 (Pub. L. 105–33) provides provides an ESRD facility level impact of service) on the monthly claim. Renal
that, for discharges on or after October analysis. Addendum B is available on dialysis drugs, laboratory tests, and
1, 1997, the area wage index applicable CMS’s website at https://www.cms.gov/ medical/surgical supplies that are
to any hospital that is located in an Medicare/Medicare-Fee-for-Service- recognized as ESRD outlier services
urban area of a State may not be less Payment/ESRDpayment/End-Stage- were specified in Transmittal 2134,
than the area wage index applicable to Renal-Disease-ESRD-Payment- dated January 14, 2011.12 We use
hospitals located in rural areas in that Regulations-and-Notices. administrative issuances and guidance
State. Applying the IPPS rural floor to to continually update the renal dialysis
the ESRD PPS wage index would result c. CY 2024 Update to the Outlier Policy service items available for outlier
in increasing the wage index for any (1) Background payment via our quarterly update CMS
ESRD facilities located in an urban area Change Requests, when applicable. For
whose wage index is less than the rural Section 1881(b)(14)(D)(ii) of the Act
requires that the ESRD PPS include a example, we use these issuances to
wage index for that State. As we identify renal dialysis oral drugs that
discussed in the CY 2023 ESRD PPS payment adjustment for high-cost
outliers due to unusual variations in the were or would have been covered under
final rule (87 FR 67164 through 67165) Medicare Part D prior to 2011 to provide
with respect to the increase to the ESRD type or amount of medically necessary
care, including variability in the amount unit prices for determining the imputed
PPS wage index floor in that year, a MAP amounts. In addition, we use these
higher wage index floor will slightly of erythropoiesis stimulating agents
(ESAs) necessary for anemia issuances to update the list of ESRD
decrease the ESRD PPS base rate for all outlier services by adding or removing
ESRD facilities due to the application of management. Some examples of the
patient conditions that may be reflective items and services that we determined,
the budget neutrality factor. Given that based our monitoring efforts, are either
increasing the wage index floor results of higher facility costs when furnishing
dialysis care are frailty and obesity. A incorrectly included or missing from the
in a proportional decrease in the base list.
rate for all ESRD facilities, we patient’s specific medical condition,
Under § 413.237, an ESRD facility is
established a wage index floor value such as secondary hyperparathyroidism,
eligible for an outlier payment if its
that strikes a balance between providing may result in higher per treatment costs.
imputed (that is, calculated) MAP
increased payment to areas for which The ESRD PPS recognizes that some
amount per treatment for ESRD outlier
labor costs are higher than the current patients require high-cost care, and we
services exceeds a threshold. The MAP
wage index for the relevant CBSAs have codified the outlier policy and our
amount represents the average estimated
indicates, while maintaining the methodology for calculating outlier
expenditure per treatment for services
accuracy of payments under the ESRD payments at § 413.237.
Section 413.237(a)(1) enumerates the that were or would have been
PPS and minimizing the overall impact considered separately billable services
to all ESRD facilities. following items and services that are
eligible for outlier payments as ESRD prior to January 1, 2011. The threshold
For these reasons, we believe that the is equal to the ESRD facility’s predicted
ESRD PPS wage index is the most outlier services: (i) Renal dialysis drugs
and biological products that were or MAP amount per treatment plus the
appropriate data to use for estimating FDL amount. As described in the
the variation in wage levels across the would have been, prior to January 1,
2011, separately billable under following paragraphs, the ESRD
country. However, we will take these
comments into consideration to Medicare Part B; (ii) renal dialysis 11 Under § 413.237(a)(1)(vi), as of January 1, 2012,
potentially inform future rulemaking. laboratory tests that were or would have the laboratory tests that comprise the Automated
Comment: A non-profit health been, prior to January 1, 2011, Multi-Channel Chemistry panel are excluded from
insurance organization commented that separately billable under Medicare Part the definition of outlier services.
12 Transmittal 2033 issued August 20, 2010, was
B; (iii) renal dialysis medical/surgical
they believed a wage index floor of

rescinded, and replaced by Transmittal 2094, dated
0.7000 was justified and suggested CMS supplies, including syringes, used to November 17, 2010. Transmittal 2094 identified
reevaluate the current wage index floor administer renal dialysis drugs and additional drugs and laboratory tests that may also
of 0.6000. The commenter indicated that biological products that were or would be eligible for ESRD outlier payment. Transmittal
CMS would find it appropriate to raise have been, prior to January 1, 2011, 2094 was rescinded and replaced by Transmittal
2134, dated January 14, 2011, which included one
the wage index floor to 0.7000. separately billable under Medicare Part technical correction. https://www.cms.gov/
Response: We appreciate the B; (iv) renal dialysis drugs and Regulations-and-Guidance/Guidance/Transmittals/
suggestion and will consider it for biological products that were or would downloads/R2134CP.pdf.
facility’s predicted MAP amount is the payments, at 1.0 percent of total (2) CY 2024 Update to the Outlier
national adjusted average ESRD outlier payments (75 FR 49142 through 49143). Services MAP Amounts and FDL
services MAP amount per treatment, We also established the FDL amounts Amounts
further adjusted for case-mix and that are added to the predicted outlier
facility characteristics applicable to the services MAP amounts. The outlier For CY 2024, we proposed to update
claim. We use the term ‘‘national services MAP amounts and FDL the MAP amounts for adult and
adjusted average’’ in this section of this amounts are different for adult and pediatric patients using the latest
final rule for clarity, to distinguish the pediatric patients due to differences in available CY 2022 claims data. We
calculation of the average ESRD outlier the utilization of separately billable proposed to update the ESRD outlier
services MAP amount per treatment services among adult and pediatric services FDL amount for pediatric
from the calculation of the predicted patients (75 FR 49140). As we explained patients using the latest available CY
MAP amount for a claim. The average in the CY 2011 ESRD PPS final rule (75 2022 claims data, and to update the
ESRD outlier services MAP amount per FR 49138 through 49139), the predicted ESRD outlier services FDL amount for
treatment is based on utilization from outlier services MAP amounts for a adult patients using the latest available
all ESRD facilities, whereas the patient are determined by multiplying claims data from CY 2020, CY 2021, and
calculation of the predicted MAP the adjusted average outlier services CY 2022, in accordance with the
amount for a claim is based on the MAP amount by the product of the methodology finalized in the CY 2023
individual ESRD facility and patient patient-specific case-mix adjusters
ESRD PPS final rule (87 FR 67170
characteristics of the monthly claim. In applicable using the outlier services
through 67174). CY 2022 claims data
accordance with § 413.237(c), ESRD payment multipliers developed from the
facilities are paid 80 percent of the per regression analysis used to compute the showed outlier payments represented
treatment amount by which the imputed payment adjustments. In the CY 2023 approximately 0.8 percent of total
MAP amount for outlier services (that is, ESRD PPS final rule, we finalized an Medicare payments (88 FR 42432 and
the actual incurred amount) exceeds update to the outlier methodology to 42438).
this threshold. ESRD facilities are better target 1.0 percent of total The impact of this final update is
eligible to receive outlier payments for Medicare payments (87 FR 67170 shown in Table 1, which compares the
treating both adult and pediatric through 67177). We finalized that we outlier services MAP amounts and FDL
dialysis patients. would continue to follow our amounts used for the outlier policy in
In the CY 2011 ESRD PPS final rule established methodology for the CY 2023 with the updated estimates for
and codified in § 413.220(b)(4), using calculation of the adult and pediatric this final rule. The estimates for the CY
2007 data, we established the outlier MAP amounts, but we would 2024 MAP amounts, which are included
percentage, which is used to reduce the prospectively calculate the adult FDL in Column II of Table 1, were inflation
per treatment ESRD PPS base rate to amounts based on the historical trend in adjusted to reflect projected 2024 prices
account for the proportion of the FDL amounts that would have achieved
for ESRD outlier services.
estimated total Medicare payments the 1.0 percent outlier target in the 3
under the ESRD PPS that are outlier most recent available data years.
TABLE 1: Outlier Policy: Impact of Using Updated Data for the Outlier Policy
Column I Column II
Final outlier policy for CY 2023 Final outlier policy for CY 2024
(based on 2021 data, price inflated (based on 2022 data, price inflated
to 2023) * to 2024) **
Age< 18 Age>= 18 Age< 18 Age>= 18

verage outlier services MAP amount $24.13 $41.36 $22.30 $37.92
er treatment
Standardization for outlier 1.0819 0.9774 1.0691 0.9763

services
MIPPA reduction 0.98 0.98 0.98 0.98
Adjusted average outlier services $25.59 $39.62 $23.36 $36.28
MAP amount
Fixed-dollar loss amount fuat is added $23.29 $73.19 $11.32 $71.76
o tile predicted MAP to determine the
outlier tlrreshold
Patient-monfu-facilities qualifying for 12.90% 5.90% 20.86% 4.87%
outlier payment
*Column I was obtained from Column II of Table 11 from the CY 2023 ESRD PPS final rule (87 FR 67176).
**The FDL amount for adults incorporates retrospective adult FDL amounts calculated using data from CYs 2020,
2021, and 2022.
As demonstrated in Table 1, the treatment base rate by 1 percent to utilization rates. We also noted that the
estimated FDL per treatment that account for the proportion of the proposed recalibration of the FDL
determines the CY 2024 outlier estimated total payments under the amounts would result in no change in
threshold amount for adults (Column II; ESRD PPS that are outlier payments as payments to ESRD facilities for
$71.76) is lower than that used for the described in § 413.237. In the 2023 beneficiaries with renal dialysis items
CY 2023 outlier policy (Column I; ESRD PPS final rule, we finalized a and services that are not eligible for
$73.19). The lower threshold is change to the outlier methodology to outlier payments.
accompanied by a decrease in the better achieve this 1 percent target (87 The comments and our responses to
adjusted average MAP for outlier FR 67170 through 67174). We stated in the comments on our proposed updates
services from $39.62 to $36.28. For the CY 2024 ESRD PPS proposed rule to the outlier policy are set forth below.
pediatric patients, there is a decrease in that, based on the CY 2022 claims, Comment: We received several
the FDL amount from $23.29 to $11.32. outlier payments represented comments on CMS’s proposals to
There is a corresponding decrease in the approximately 0.9 percent of total update the FDL and MAP amounts for
adjusted average MAP for outlier payments. Based on more complete CY CY 2024. Commenters were generally
services among pediatric patients, from 2022 claims data, this figure has been supportive of the use of more recent
$25.59 to $23.36. updated to 0.8 percent for this final rule, data to determine the CY 2024 ESRD
We estimate that the percentage of which is below the 1 percent target due PPS final MAP and FDL amounts.
patient months qualifying for outlier to declines in the use of outlier services. Several commenters stated that they
payments in CY 2024 would be 4.87 However, this is significantly closer to appreciated that the methodological
percent for adult patients and 20.86 the 1 percent target than the outlier changes CMS made to the outlier policy
percent for pediatric patients, based on payments based on CY 2021 claims, in the CY 2023 ESRD PPS final rule
the 2022 claims data and methodology which represented approximately 0.5 resulted in the total percentage of
finalized in the CY 2023 ESRD PPS final percent of total payments. In the CY payments for outliers being closer to the
rule. The outlier MAP and FDL amounts 2024 ESRD PPS proposed rule, we noted 1 percent target than ever before.
continue to be lower for pediatric that we believe the update to the outlier However, some commenters noted that
patients than adults due to the MAP and FDL amounts for CY 2024 the ESRD PPS base rate is reduced on
continued lower use of outlier services would increase payments for ESRD the assumption that 1 percent of total
(primarily reflecting lower use of ESAs beneficiaries requiring higher resource payments will be attributable to outlier
and other injectable drugs). utilization. This would move us even payments, and if the actual percentage
closer to meeting our 1 percent outlier is less than 1 percent it means that total
(3) Outlier Percentage
policy goal, because we would be using payments to ESRD facilities are less
In the CY 2011 ESRD PPS final rule more current data for computing the than they should be. Commenters
(75 FR 49081) and under MAP and FDL amounts, which is more suggested that CMS should implement a
ER06NO23.003</GPH>
§ 413.220(b)(4), we reduced the per reflective of current outlier services policy to recompense ESRD facilities for
underpayment when total outlier 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) 2024 estimated payments, aggregate
payments are less than 1 percent of total of the Act, respectively. Specifically, the Medicare payments to ESRD facilities
ESRD PPS payments. One commenter ESRD PPS base rate was developed from would remain budget neutral when
recommended CMS reduce the outlier CY 2007 claims (that is, the lowest per compared to the target amount of
target to 0.5 percent of total payments. patient utilization year as required by expenditures. That is, the wage index
Response: We appreciate the support section 1881(b)(14)(A)(ii) of the Act), budget neutrality adjustment factor
for the proposed use of more recent data updated to CY 2011, and represented ensures that wage index adjustments do
to update the MAP and FDL amounts for the average per treatment MAP for not increase or decrease aggregate
the outlier policy and the thoughtful composite rate and separately billable Medicare payments with respect to
suggestions provided by commenters. services. In accordance with section changes in wage index updates. The
We acknowledge that, even with 1881(b)(14)(D) of the Act and our final CY 2024 wage index budget-
annually adjusting the MAP and FDL regulation at § 413.230, the per- neutrality adjustment factor is 1.000031.
amounts to reflect the most recent treatment payment amount is the sum of This CY 2024 wage index budget-
utilization and costs of ESRD PPS the ESRD PPS base rate, adjusted for the neutrality adjustment factor reflects the
eligible outlier services according to the patient specific case-mix adjustments, impact of all wage index policy changes,
updated outlier methodology finalized applicable facility adjustments, including the final CY 2024 ESRD PPS
in the CY 2023 ESRD PPS final rule, geographic differences in area wage wage index and labor-related share.
total outlier payments have not yet levels using an area wage index, and TPEAPA Budget-Neutrality
reached the 1 percent target. However, any applicable outlier payment, training Adjustment Factor: As explained in
the performance of the outlier payments adjustment add-on, TDAPA, and section II.B.1.g.(7) of this final rule, we
has improved significantly due to the TPNIES. are finalizing a new, budget-neutral
modification to the outlier methodology transitional add-on payment adjustment
(2) Annual Payment Rate Update for CY for pediatric ESRD renal dialysis
finalized in CY 2023 ESRD PPS final 2024
rule, as outlier payments represented services, which we call the TPEAPA.
0.8 percent of the total payments in CY In the CY 2024 ESRD PPS proposed The final CY 2024 budget-neutrality
2022. We appreciate the comments rule, we proposed an ESRD PPS base adjustment factor for the TPEAPA is
suggesting solutions for refining the rate for CY 2024 of $269.99 (88 FR 0.999503. The budget-neutrality
outlier policy methodology, for 42432). We are finalizing an ESRD PPS adjustment factor for the TPEAPA is
example, reducing the outlier base rate for CY 2024 of $271.02. This discussed in section II.B.1.g of this final
percentage, as defined at § 413.220(b)(4), update reflects several factors, described rule.
to less than 1 percent or establishing a in more detail as follows: Combined Wage Index and TPEAPA
Wage Index Budget-Neutrality Budget-Neutrality Adjustment Factor:
mechanism that pays back ESRD
Adjustment Factor: We compute a wage For purposes of calculating the ESRD
facilities those allocated outlier amounts
index budget-neutrality adjustment PPS base rate for CY 2024, we are using
that were not paid out in the projected
factor that is applied to the ESRD PPS one combined budget-neutrality
year. We did not propose any base rate. For CY 2024, we did not adjustment factor includes both the
modifications to the ESRD PPS outlier propose and are not finalizing any wage index budget-neutrality
policy for CY 2024 codified at § 413.220, changes to the methodology used to adjustment factor and the TPEAPA
and we are not finalizing any changes to calculate this factor, which is described budget-neutrality adjustment factor. The
the methodology in this final rule. We in detail in the CY 2014 ESRD PPS final CY 2024 combined wage index and
will consider the commenters’ rule (78 FR 72174). We computed the TPEAPA budget neutrality factor is
suggestions regarding changes in final CY 2024 wage index budget- 0.999534 (1.000031 × 0.999503). This
methodology in potential future neutrality adjustment factor using application would yield a CY 2024
rulemaking. treatment counts from the 2022 claims ESRD PPS base rate of $265.48 prior to
Final Rule Action: After considering and facility-specific CY 2023 payment the application of the CY 2024 market
the public comments, we are finalizing rates to estimate the total dollar amount basket update percentage ($265.57 ×
the updated outlier thresholds for CY that each ESRD facility would have 0.999534 = $265.45).
2024 displayed in Column II of Table 1 received in CY 2023. The total of these Market Basket Update: Section
of this final rule based on the most payments became the target amount of 1881(b)(14)(F)(i)(I) of the Act provides
current data. expenditures for all ESRD facilities for that, beginning in 2012, the ESRD PPS
d. Impacts to the CY 2024 ESRD PPS CY 2024. Next, we computed the payment amounts are required to be
Base Rate estimated dollar amount that would annually increased by an ESRD market
have been paid for the same ESRD basket percentage increase. As
(1) ESRD PPS Base Rate facilities using the final CY 2024 ESRD discussed previously in section
In the CY 2011 ESRD PPS final rule PPS wage index and final labor-related II.B.1.a.(2)(a) of this final rule, the latest
(75 FR 49071 through 49083), CMS share for CY 2024. As discussed in CY 2024 projection of the ESRDB
established the methodology for section II.B.1.b of this final rule, the market basket percentage increase is 2.4
calculating the ESRD PPS per-treatment ESRD PPS wage index for CY 2024 percent. In CY 2024, this amount must
base rate, that is, the ESRD PPS base includes an update to the most recent be reduced by the productivity
rate, and calculating the per-treatment hospital wage data and continued use of adjustment described in section
payment amount, which are codified at the 2018 OMB delineations. The total of 1886(b)(3)(B)(xi)(II) of the Act, as
§§ 413.220 and 413.230. The CY 2011 these payments becomes the new CY required by section 1881(b)(14)(F)(i)(II)
ESRD PPS final rule also provides a 2024 amount of wage-adjusted of the Act. As discussed previously in
detailed discussion of the methodology expenditures for all ESRD facilities. The section II.B.1.a.(2)(b) of this final rule,
used to calculate the ESRD PPS base wage index budget-neutrality factor is the latest CY 2024 projection of the
rate and the computation of factors used calculated as the target amount divided productivity adjustment is 0.3
to adjust the ESRD PPS base rate for by the new CY 2024 amount. When we percentage point, thus yielding a CY
projected outlier payments and budget multiplied the wage index budget 2024 productivity-adjusted ESRDB
neutrality in accordance with sections neutrality factor by the applicable CY market basket update of 2.1 percent for
CY 2024. Therefore, the final CY 2024 that are home dialysis machines when amount for capital related assets that are
ESRD PPS base rate is $271.02 (($265.57 used in the home for a single patient. To home dialysis machines, including
× 0.999534) × 1.021 = $271.02). establish the TPNIES basis of payment comments from an LDO and a device
The comments and our responses to for these items, we finalized the manufacturer. The comments and our
the comments on our proposed updates additional steps that the Medicare responses to the comments on the
to the ESRD PPS base rate are set forth Administrative Contractors (MACs) proposed update to the TPNIES offset
below. must follow to calculate a pre-adjusted amount are set forth below.
Comment: We received several per treatment amount, using the prices Comment: A device manufacturer
comments which characterized the they establish under § 413.236(e) for a requested that CMS remove the TPNIES
proposed CY 2024 ESRD PPS base rate capital-related asset that is a home offset for capital-related assets that are
as too low. Some of these commenters dialysis machine, as well as the home dialysis machines. The
requested that CMS increase the base methodology that CMS uses to calculate commenter and two others indicated
rate. The reasoning for this requested the average per treatment offset amount that they believe that the TPNIES offset,
increase varied by commenter. Some for home dialysis machines that is used combined with the 65 percent reduction
commenters wanted an increase to in the MACs’ calculation, to account for for risk sharing, are leading to capital-
account for recent under-forecasts, the cost of the home dialysis machine related assets that are home dialysis
whereas other commenters wanted an that is already in the ESRD PPS base machines being undervalued. An LDO
increase to allow facilities to provide an rate. For purposes of this final rule, we agreed that the TPNIES for capital-
increased quality of care. refer to this as the ‘‘TPNIES offset related assets that are home dialysis
Response: The CY 2024 ESRD PPS amount.’’ machines should be offset by an amount
base rate is derived from the CY 2023 The methodology for calculating the currently in the base rate.
ESRD PPS base rate, the CY 2024 TPNIES offset amount is set forth in Response: We appreciate the
ESRDB market basket update, and the § 413.236(f)(3). Section 413.236(f)(3)(v) commenters’ insight into the impacts of
CY 2024 combined wage index-TPEAPA states that effective January 1, 2022, the TPNIES offset for capital-related
budget neutrality factor. In accordance CMS annually updates the amount assets that are home dialysis machines.
with section 1881(b)(14)(F) of the Act, determined in § 413.236(f)(3)(iv) by the We did not propose any methodological
the primary factor in determining the ESRD bundled market basket percentage changes for this TPNIES offset amount
ESRD PPS base rate increase from one increase factor minus the productivity set forth at § 413.236(f), and we are not
year to the next is the ESRDB market adjustment factor. The TPNIES for finalizing any changes. We will consider
basket update. We believe the final CY capital-related assets that are home the commenters’ concerns for potential
2024 ESRDB market basket update dialysis machines is based on 65 future rulemaking.
reflects the most recent available data percent of the MAC-determined pre- Final Rule Action: We are finalizing
regarding the forecasted prices of labor adjusted per treatment amount, reduced our proposal to calculate the CY 2024
used to provide renal dialysis services. by the TPNIES offset amount, and is TPNIES offset amount using the most
We discuss the CY 2024 ESRDB market paid for 2 CYs. recent data available. The CY 2023
basket update in more detail in section As we discussed in the CY 2024 ESRD TPNIES offset amount for capital-related
II.B.1.a of this final rule, with detailed PPS proposed rule (88 FR 42432), there equipment that are home dialysis
responses to comments on the are currently no capital-related assets machines used in the home is $9.79. As
magnitude of the productivity-adjusted that are home dialysis machines set to discussed previously in section
ESRDB market basket increase in receive TPNIES for CY2024, as the II.B.1.a.(2)(c) of this final rule, the final
section II.B.1.a.(2)(c) of this final rule TPNIES payment period for the Tablo®
CY 2024 ESRDB productivity-adjusted
and detailed responses to comments on System ends on December 31, 2023, and
market basket update is 2.1 percent (2.4
previous forecast errors for the ESRDB the only TPNIES application for CY
percent market basket percentage
market basket update in section 2024 is not for a home dialysis machine.
increase reduced by 0.3 percent
II.B.1.a.(2)(d) of this final rule. We However, as required by
productivity adjustment). Applying the
appreciate the concerns of the § 413.236(f)(3)(v), we proposed to
update factor of 1.021 to the CY 2023
commenters, but we did not propose update the TPNIES offset amount
TPNIES offset amount results in a final
any new payment adjustments to the annually according to the methodology
CY 2024 TPNIES offset amount of
base rate based on those concerns. We described previously.
We proposed a CY 2024 TPNIES offset $10.00 ($9.79 × 1.021).
will continue to monitor the adequacy
of the ESRD PPS payment and will amount for capital-related assets that are f. Refinement of the Low-Volume
consider these commenters’ insights for home dialysis machines of $9.96, based Payment Adjustment (LVPA)
future rulemaking. on the proposed CY 2024 ESRDB
(1) Background
Final Rule Action: We are finalizing a productivity-adjusted market basket
CY 2024 ESRD PPS base rate of $271.02. update of 1.7 percent (2.0 percent Section 1881(b)(14)(D)(iii) of the Act
This amount reflects the combined CY market basket percentage increase provides that the ESRD PPS shall
2024 wage index-TPEAPA budget- reduced by 0.3 percentage point include a payment adjustment that
neutrality adjustment factor of 0.999534, productivity adjustment). We explained reflects the extent to which costs
and the CY 2024 ESRD PPS in the CY 2024 ESRD PPS proposed rule incurred by low-volume facilities (as
productivity-adjusted market basket that applying the proposed update defined by the Secretary) in furnishing
update of 2.1 percent. factor of 1.017 to the CY 2023 offset renal dialysis services exceed the costs
incurred by other facilities in furnishing
amount resulted in the proposed CY

e. Update to the Average per Treatment 2024 offset amount of $9.96 ($9.79 × such services, and for payment for renal
Offset Amount for Home Dialysis 1.017 = $9.96). We proposed to update dialysis services furnished on or after
Machines this calculation to use the most recent January 1, 2011, and before January 1,
In the CY 2021 ESRD PPS final rule data available in the CY 2024 ESRD PPS 2014, such payment adjustment shall
(85 FR 71427), we expanded eligibility final rule. not be less than 10 percent. Therefore,
for the TPNIES under § 413.236 to We received three comments on this the ESRD PPS provides a facility-level
include certain capital-related assets proposal to update the TPNIES offset payment adjustment to ESRD facilities
that meet the definition of a low-volume facility equals the aggregate number of (b) Current Issues and Concerns From
facility. In this section of the final rule, treatments furnished by the ESRD Interested Parties
we discuss the low volume-payment facility and the number of treatments Interested parties, including MedPAC
adjustment (LVPA) under the ESRD furnished by other ESRD facilities that and the Government Accountability
PPS. are both under common ownership with Office (GAO),13 have recommended that
The current amount of the LVPA is and 5 road miles or less from the ESRD we make refinements to the LVPA to
23.9 percent. In the CY 2011 ESRD PPS facility in question. To receive the better target ESRD facilities that are
final rule (75 FR 49118 through 49125), LVPA, an ESRD facility must submit a critical to beneficiary access to dialysis
we finalized the methodology used to written attestation statement to its care in remote or isolated areas.14 These
target the appropriate population of Medicare Administrative Contractor groups and other interested parties have
ESRD facilities that were low-volume
(MAC) confirming that it meets all the also have expressed concern that the
and to determine the treatment
requirements specified in § 413.232 and strict treatment count introduces a
threshold for those ESRD facilities
identified. After consideration of public qualifies as a low-volume ESRD facility. ‘‘cliff-effect’’ that may incentivize ESRD
comments, we established an 18.9 For purposes of determining eligibility facilities to restrict their patient
percent adjustment for ESRD facilities for the LVPA, ‘‘treatments’’ mean total caseload to remain below 4,000
that furnish less than 4,000 treatments hemodialysis equivalent treatments treatments per year to meet the LVPA
annually and indicated that this (Medicare and non-Medicare). For threshold.15
increase to the ESRD PPS base rate peritoneal dialysis patients, one week is (2) Requests for Information on
would encourage small ESRD facilities considered equivalent to three Modification of LVPA Methodology and
to continue providing access to care. hemodialysis treatments (80 FR 68994). Development of a New Payment
In the CY 2016 ESRD PPS proposed Section 413.232(e) generally imposes a Adjustment Based on Geographic
rule (80 FR 37819), we analyzed ESRD yearly November 1st deadline for Isolation
facilities that met the definition of a attestation submissions unless
low-volume facility under § 413.232(b) In the CY 2024 ESRD PPS proposed
extraordinary circumstances justify an
as part of the updated regression rule (88 FR 42440 through 42441), we
exception and specifies exceptions for
analysis and found that these ESRD explained that we recognize the
certain years where the deadline is in
facilities still had higher costs compared importance of revising the ESRD PPS
December or January. The November 1st
to other ESRD facilities. A regression LVPA adjustment methodology to
attestation timeframe provides 60 days ensure that payments accurately reflect
analysis of CYs 2012 and 2013 low- for a MAC to verify that an ESRD facility
volume facility claims and cost report differences in cost and adequately target
meets the LVPA eligibility criteria (76 low-volume facilities, and to strive for
data indicated a multiplier of 1.239 FR 70236). The ESRD facility would
percent; therefore, we proposed an healthcare equity for ESRD
then receive the LVPA payment for all beneficiaries. The LVPA and rural
updated LVPA adjustment factor of 23.9 the Medicare-eligible treatments in the
percent in the CY 2016 ESRD PPS adjusters currently result in increased
payment year. Once an ESRD facility is payments to some geographically
proposed rule (80 FR 37819) and
determined to be eligible for the LVPA, isolated ESRD facilities, but these
finalized this policy in the CY 2016
a 23.9 percent increase is applied to the adjusters do not specifically target
ESRD PPS final rule (80 FR 69001). In
CY 2021, 366 ESRD facilities received ESRD PPS base rate for all treatments geographically isolated ESRD facilities.
the LVPA. Using the most recent furnished by the ESRD facility (80 FR We noted several points of concern that
available data for CY 2022, the number 69001). interested parties have raised in the
of ESRD facilities receiving the LVPA In the CY 2021 ESRD PPS final rule past, as well as certain statutory
was 353. (85 FR 71443), we finalized a policy to limitations that could apply to some of
allow ESRD facilities flexibility for the methodological approaches
(a) Current LVPA Methodology suggested in the past. We solicited
LVPA eligibility due to the COVID–19
Under § 413.232(b), a low-volume PHE. Under § 413.232(g)(4), for information from the public about
facility is an ESRD facility that, based purposes of determining ESRD facilities’ potential approaches to refine the ESRD
on the submitted documentation: (1) eligibility for payment years 2021, 2022, PPS methodology, which we would take
furnished less than 4,000 treatments in and 2023, we will only consider total into consideration for any potential
each of the 3 cost-reporting years (based changes to the LVPA in the future.
dialysis treatments for any 6 months of
on as-filed or final settled 12- This section addresses several RFIs
their cost-reporting period ending in
consecutive month costs reports, regarding the LVPA and a potential new
2020. ESRD facilities that would not adjustment for geographically isolated
whichever is most recent, except as
otherwise meet the number of ESRD facilities.
specified in paragraph (g)(4)) preceding
treatments criterion because of the
the payment year; and (2) has not (a) Comment Solicitation for
COVID–19 PHE may attest that their
opened, closed, or received a new Modifications to LVPA Methodology
provider number due to a change in total dialysis treatments for those 6
ownership (except where the change in months of their cost reporting period In the CY 2024 ESRD PPS proposed
ownership results in a change in facility ending in 2020 are less than 2,000. The rule, we solicited comments on
type) in the 3 cost-reporting years (based attestation must further include that
on as-filed or final settled 12- although the total number of treatments 13 https://www.medpac.gov/wp-content/uploads/
furnished in the entire year otherwise import_data/scrape_files/docs/default-source/

consectuive month cost reports, reports/jun20_ch7_reporttocongress_sec.pdf.

whichever is most recent) preceding the exceeded the LVPA threshold, the 14 https://www.cms.gov/files/document/end-
payment year. excess treatments furnished were due to stage-renal-disease-prospective-payment-system-

In addition, under § 413.232(c), for temporary patient shifting resulting technical-expert-panel-summary-report-april-
purposes of determining the number of from the COVID–19 PHE. MACs will 2021.pdf.
15 https://www.cms.gov/files/document/end-
treatments furnished by the ESRD annualize the total dialysis treatments
stage-renal-disease-prospective-payment-system-
facility, the number of treatments for the total treatments reported in those technical-expert-panel-summary-report-april-
considered furnished by the ESRD 6 months by multiplying by 2. 2021.pdf.
potential changes to the LVPA (i) Maintain a Single LVPA Threshold percentage amount using the latest
methodology (88 FR 42441 through available claims and cost report data
42444), including maintaining a single As discussions about modifying the and the methodology established in the
threshold, establishing LVPA tiers, and/ existing treatment threshold or payment CY 2011 and CY 2016 ESRD PPS final
or utilizing a continuous function. Any adjustment percentage have been rules (75 FR 49118 through 49125 and
potential refinements to the LVPA ongoing since the beginning of the 80 FR 69001), the current treatment
methodology that may result from our multi-year LVPA reform efforts, we threshold of 4,000 treatments per year
solicited comments on maintaining a would correspond to a 17.6 percent
consideration of these comments would
single threshold for the LVPA. ESRD payment adjustment. The 4,000-
be proposed through notice-and-
facilities that fall below the treatment treatment threshold could be
comment rulemaking in the future. We
threshold would continue to receive maintained, or the treatment threshold
requested that commenters keep in
payment, and payments would not be could be recalibrated to maintain the
mind that section 1881(b)(14)(D)(iii) of
adjusted for those ESRD facilities above 23.9 percent payment adjustment.
the Act requires the LVPA to reflect the
the threshold. We stated that we were Maintaining a single threshold would
extent to which costs incurred by low- engaged in continuing monitoring not address concerns regarding the
volume facilities in furnishing renal efforts to align resource use with potential for gaming or remove what
dialysis services exceed the costs payment. As noted in the CY 2024 ESRD commenters call the payment cliff.
incurred by other facilities in furnishing PPS proposed rule (88 FR 42442), if we Potential approaches for a single LVPA
such services. were to re-compute the LVPA threshold are outlined in Table 2.
TABLE 2: Potential Approaches for a Single LVPA Threshold
Option Description
(ii) Establishment of Multiple LVPA facilities under each threshold level, ESRD PPS base rate. As illustrated
Tiers would reduce the potential for gaming below, scaling the adjusters while
through reduction of the magnitude of maintaining budget neutrality within
We solicited comments on creating a the payment cliff. Additionally, LVPA the LVPA results in lower LVPA
tiered payment adjustment that would eligibility would be expanded to more adjusters. For example, Tier 1 (less than
include multiple thresholds, with ESRD facilities. We solicited comments 5,000 treatments) in the Four-Tiered
separate payment adjustments regarding the establishment of multiple Model varies based on the approach to
calibrated so that ESRD facilities in tiers thresholds, including up to an eight- maintaining budget neutrality, as the
with the lowest treatment volume tiered structure for the LVPA. Tables 3 LVPA adjuster is 13.7 percent where
would receive the highest payment through 6 outline various budget neutrality is maintained within
adjustment, and vice versa. MedPAC methodological options. Tables 3 and 4 the ESRD PPS (Table 3) and 5.8 percent
has previously recommended setting would establish larger adjustment where budget neutrality is maintained
LVPA treatment thresholds at fewer factors on average than the current within the LVPA (Table 5). For
than 4,000 treatments, between 4,000 methodology but would require comparison, the Eight-Tiered Model
and 4,999 treatments, and between reductions to the ESRD PPS base rate to shows that for Tier 1 (less than 1,000
5,000 and 6,000 treatments, with maintain budget neutrality. Tables 5 and treatments), ESRD facilities would
payment adjustments calibrated so that 6 show adjustment factors which are receive a 123 percent LVPA adjuster
ESRD facilities in tiers with the lowest scaled to maintain budget neutrality where budget neutrality is maintained
volume would receive the highest within the LVPA, keeping the LVPA’s within the ESRD PPS (Table 4) and 40.5
payment adjustment, and vice versa.16 budget at the same amount that would percent LVPA adjuster where budget
Establishing multiple thresholds, with a occur under the current methodology neutrality is maintained within the
separate payment adjustment for ESRD without requiring reductions to the LVPA (Table 6).
ER06NO23.004</GPH>
16 https://www.medpac.gov/wp-content/uploads/
import_data/scrape_files/docs/default-source/
reports/jun20_ch7_reporttocongress_sec.pdf.
TABLE 3: L VP A Adjustment with Four Tiers ($1.20 reduction to the ESRD PPS Base
Rate to Maintain Budget Neutrality)
Tier (by treatment count) LVPA Adjusters
Tier 4 (7,000 - 7,999) 1.9%
TABLE 4: LVPA Adjustment with Eight Tiers ($1.80 reduction to the ESRD PPS Base
Rate to Maintain Budget Neutrality)
Tier (by treatment count) L VPA Adjusters
Tier 8 (7,000 - 7,999) 1.9%
TABLE 5: LVPA Adjustment with Four Tiers (Adjusters scaled to maintain total LVPA
payments at current levels)
Tier 4 (7,000 - 7,999) 0.8% 318

ER06NO23.006</GPH> ER06NO23.007</GPH>
ER06NO23.005</GPH>
TABLE 6: L VP A Adjustment with Eight Tiers (Adjusters scaled to maintain total LVP A
payments at current levels)
Tier 8 (7,000 - 7,999) 0.6% 318
(iii) Continuous Function CMS welcomed input and responses • Interested parties have voiced
to the following considerations, concern regarding the administrative
We also solicited comments on requests, and questions: burden involved in the current LVPA
potentially establishing a continuous • Regarding concerns about a attestation process. As such, we are
function to adjust LVPA payments. payment cliff in the existing LVPA, we considering potentially decreasing the
Under this approach, ESRD facilities are considering implementing payment number of years of attestation data
with the lowest treatment volume tiers or a continuous adjustment, based needed to determine LVPA eligibility.
would receive the highest payment on treatment volume, in place of the ++ Comment on the extent to which
adjustment, and the payment current single tiered adjustment. this change would alleviate burden, and
adjustment would decrease ++ Comment on which payment if there are other administrative changes
continuously as volume increases. This structure would be more appropriate: that could be made to simplify this
could include calibration of the point at single threshold as currently employed, process.
which the payment adjustment becomes tiered structure, or continuous function, ++ Describe any anticipated effects of
zero to correspond with the existing and provide the reasoning behind your decreasing the amount of treatment
4,000 treatment upper bound, or recommendation. volume data used to determine LVPA
establishment of a new upper bound eligibility.
++ Comment on which option would
based on a regression analysis. ++ Describe the ways that simplifying
be most effective in removing gaming
the attestation process could help ESRD
Establishment of a continuous function incentives and which option would
facilities with fewer resources to
has the potential to significantly reduce bring greater congruency between cost
promote health equity by improving
the potential for gaming by eliminating of providing renal dialysis services and
their ability to serve vulnerable and
payment cliffs entirely. Additionally, payment.
underserved communities.
this would increase payment for ESRD • Using the alternative methodology
facilities with the lowest volume, described previously, under a tiered or (b) Comment Solicitation on the
therefore better aligning payment with continuous payment adjustment, the Development of a New Payment
resource use. Furthermore, a continuous treatment threshold for eligibility would Adjustment Based on Geographic
function would potentially expand be determined based on the median Isolation
LVPA eligibility to the most ESRD treatment count among all ESRD CMS is striving to promote health
facilities. facilities (approximately eight thousand equity by ensuring that ESRD facilities,
treatments per year). The resulting tiers including both rural and low-volume
In the CY 2024 ESRD PPS proposed and incremental payment adjustments
rule, we noted that we are considering facilities, are being paid equitably for
between tiers could follow several serving populations that are currently
several approaches to modifying the different configurations. underserved. Therefore, in the CY 2024
LVPA to address concerns about its ++ What factors should be evaluated ESRD PPS proposed rule (88 FR 42444
incentive structure, treatment threshold, to best determine the treatment count through 42445), we solicited comments
and administrative burden, as expressed threshold, as well as the tiering on potentially assisting geographically
by interested parties (including the structure? Specifically, comment on the isolated ESRD facilities and promoting
GAO, MedPAC, and industry treatment volume beneath which per-
access in these areas, including labor

representatives). We issued this RFI to treatment costs begin to increase. force hiring and retention. We stated
seek feedback on the suggested changes ++ Enumerate any concerns you that we considered establishing a new
to the LVPA, as described previously, might have should the implementation payment adjustment that accounts for
and to solicit further input from of a tiered or continuous adjustment isolation, rurality, and other
interested parties to inform future result in an expanded set of eligible geographical factors. We also requested
modifications to the methodology used ESRD facilities, and payment information on geographic isolation to
ER06NO23.008</GPH>
to determine the LVPA. redistribution. determine if ESRD facilities that are
currently considered rural would Please provide any data that could MedPAC. A high-level description of
benefit from a geographic isolation further inform CMS’s understanding of these comments is included in the
adjustment. The new geographically the relationship between geographic following subsections of this CY 2024
based payment adjustment may isolation and cost for low volume ESRD PPS final rule.
consider local dialysis need (LDN), as facilities. We thank the commenters for their
explained later in this section, instead ++ Comment on the appropriateness
of utilizing driving time between detailed and thoughtful comments.
of basing payment strictly upon a rural
current beneficiary address and While we will not respond to these
designation, as set forth in § 413.233
and 413.231(b)(2). We considered treatment location as the appropriate comments in this CY 2024 ESRD PPS
changes to the eligibility criteria to metric for travel time. final rule, we intend to take them into
address the concerns that GAO and ++ Are there ways in which the consideration for future rulemaking and
MedPAC raised about targeting LVPA suggested methodology for this potential future policy development. We will
payments to ESRD facilities that are not payment adjustment could fail in provide more detailed information
located near other ESRD facilities that targeting isolated ESRD facilities, or about the commenters’
are necessary to protect access to care. ESRD facilities in areas with low LDN? recommendations in a future posting on
As noted previously, under section ++ Are there ways in which the CMS’s website located at the following
1881(b)(14)(D)(iii) of the Act, the LVPA determination of LDN might be subject link: https://www.cms.gov/Medicare/
must reflect the extent to which costs to gaming? Medicare-Fee-for-Service-Payment/
incurred by low-volume facilities (as ++ Would a payment adjustment for ESRDpayment/Educational_Resources.
defined by the Secretary) in furnishing ESRD facilities in areas with low LDN
improve health equity? Are there (i) Responses on Criteria for Receiving
renal dialysis services exceed the costs
incurred by other facilities in furnishing specific recommendations to change the LVPA Status
such services. We explained that our LDN methodology described above to We received a wide range of
preliminary analysis found that, in promote quality access to care for all responses to the RFI. Many commenters
general, low-volume facilities that are ESRD beneficiaries?
supported MedPAC’s proposal of
rural, isolated, or located in low- ++ Comment on the favorability of
CMS’s implementation of a new implementing a two-tier low-volume
demand areas did not have higher costs and isolated (LVI) adjustment in place
than low-volume ESRD facilities overall. payment adjustment for ESRD facilities
in areas with low LDN as described of the LVPA so that facilities can
Therefore, certain changes that
above. expand services to meet patient needs
interested parties have suggested would
++ Are there any other considerations without substantial payment decreases
not comport with the statutory
we should keep in mind when while limiting administrative burden.
requirements and limitations for the
LVPA. We solicited comments on considering proposing a new payment Some commenters supported
potential methodologies for creating a adjustment based on an LDN maintaining a single threshold with
separate payment adjustment that could methodology? varying recommendations for adjusted
potentially address GAO and MedPAC’s treatment counts. Other commenters
(c) Summary of Request for Information supported establishing varying numbers
concerns, relying upon the authority on Potential Modification to LVPA
under section 1881(b)(14)(D)(iv) of the of tiers at varying treatment counts.
Methodology and Information Received Some commenters also supported
Act, which states that the ESRD PPS From Commenters
may include such other payment establishing a continuous function as
adjustments as the Secretary determines As discussed above, in the CY 2024 described in the CY 2024 ESRD PPS
appropriate. ESRD PPS proposed rule (88 FR 42430), proposed rule. Many comments
We solicited responses to the we sought comment on several included general concerns regarding the
following questions. approaches to modifying the LVPA to administrative burden and transparency
++ What factors should be considered address concerns about its incentive of the various methodologies described.
in formulating a payment adjustment for structure, treatment threshold, and While we are not providing a detailed
ESRD facilities in isolated geographical administrative burden. We issued an response to these comments in this final
areas or areas for which there is a low RFI to seek feedback from the public on rule, we thank the commenters for their
need for renal dialysis services? potential changes to the LVPA input and will consider the
++ What are the best ways to methodology, including maintaining a recommendations in potential future
incentivize renal dialysis service single threshold, establishing LVPA rulemaking.
provision in isolated geographic areas? tiers, and/or utilizing a continuous
++ Our analysis of the LDN function to ensure that payments (ii) Responses on the Local Dialysis
methodology has shown that low LDN accurately reflect differences in cost and Need (LDN) Methodology
census tracts intersect with areas adequately target low-volume facilities.
designated as Health Professional We also solicited comments on the Commenters generally believed that
Shortage Areas. What impact would a establishment of an add-on payment the LDN methodology was overly
payment adjustment based on adjustment for geographic isolation of complicated and lacked transparency.
geographic isolation have on the ability ESRD facilities. We asked commenters Several commenters expressed renewed
of ESRD facilities in isolated areas to whether a payment adjustment for support for incorporating geographic
recruit and retain health care geographic isolation of ESRD facilities isolation directly into the LVPA
formula, using a methodology such as
professionals? in areas with low local dialysis need

++ Comment on the appropriateness would improve health equity. the LVI adjustment that MedPAC
of maintaining the rural facility We received 23 public comments in suggested. While we are not providing
adjustment under § 413.233 if we were response to our RFI, including from a detailed response to these comments
to establish an LDN payment adjustment large, small, and non-profit dialysis in this final rule, we thank the
in conjunction with a modified LVPA. organizations; an advocacy organization; commenters for their input and will
++ Comment on the relationship a coalition of dialysis organizations; a consider the recommendations in
between geographic isolation and cost. large non-profit health system; and potential future rulemaking.
(3) Exception to the Current LVPA parties have expressed support for promote our commitment to ensuring
Attestation Process for Disasters and CMS’s swift response to the COVID–19 access to care for ESRD patients.
Other Emergencies PHE’s impact on ESRD facilities, with (a) Changes to the LVPA
Under our current regulations at an association of dialysis providers
stating that holding harmless LVPA We proposed to make two changes to
§ 413.232(b), a low-volume facility is an
status for these ESRD facilities will the LVPA regulation at § 413.232 to
ESRD facility that, based on the
better ensure that ESRD patients can allow for more administrative
submitted documentation (1) furnished
continue to access the life-sustaining flexibilities during disasters or other
less than 4,000 treatments in each of the emergencies. First, we proposed to
3 cost reporting years (based on as-filed dialysis treatment they need,
create a new exception to the attestation
or final settled 12-consecutive month particularly in rural and underserved
process for disasters and other
cost reports, whichever is most recent, areas where low-volume facilities
emergencies. Second, we proposed to
except as specified in § 413.232(g)(4)) heavily depend on the LVPA to remain
establish a process that would allow
preceding the payment year; and (2) has open and provide treatment for patients. low-volume facilities to close and
not opened, closed, or received a new In the CY 2024 ESRD PPS proposed reopen in response to a disaster or other
provider number due to a change in rule, we stated that we recognize there emergency and still receive the LVPA.
ownership (except where the change in could be future circumstances, CMS would assess whether a particular
ownership results in a change in facility potentially like the circumstances of the situation is a disaster or other
type) in the 3 cost reporting years (based COVID–19 PHE, in which it would be emergency based on the totality of the
on as-filed or final settled 12 appropriate to provide flexibilities with circumstances that could result in
consecutive month cost reports, respect to certain LVPA requirements disruption of or inability to furnish
whichever is most recent) preceding the (88 FR 42446). Commenters have renal dialysis services at one or more
payment year. When we first established previously expressed concerns about the ESRD facilities, thus affecting the ESRD
these requirements in the CY 2011 strict attestation requirements for ESRD facility or facilities’ ability to qualify for
ESRD PPS final rule, we explained that the LVPA. For purposes of the proposal,
facilities to remain eligible for the
looking across data for three years disasters or other emergencies would
LVPA, particularly when faced with a
provided us with sufficient information include, but not be limited to, the below
disaster or other emergency, such as a
to view consistency in business examples:
local or national emergency, natural
operations (79 FR 49123). In the CY • A public health emergency declared
disaster, catastrophic event, or public
2019 ESRD PPS final rule (83 FR 56949) by the Secretary due to a significant
health emergency. We noted that during
and the CY 2021 ESRD PPS proposed outbreak of infectious disease or
disasters or other emergencies, low-
rule (85 FR 42165), we acknowledged bioterrorist attacks.
volume facilities could be forced to
commenters’ concerns that the
close, or could experience increases in • Natural disasters including winter
eligibility criteria in the LVPA storms, floods, tornados, hurricanes,
regulations are very explicit and leave their treatment counts if they treat
patients who are displaced from a wildfires, earthquakes, or any
little room for flexibility during combination thereof.17
nearby ESRD facility that is impacted by
disasters or other emergency situations • Catastrophic events outside of an
like the COVID–19 PHE. Commenters such an event. For example, in August
ESRD facility’s control that disrupt
have emphasized that low-volume of 2021, an ESRD facility in Louisiana
operations and result in an ESRD
facilities rely on the LVPA, and that loss sustained significant damage because of
facility’s closure, for example, loss of
of the payment adjustment could result Hurricane Ida, which required the ESRD
operations or patient shifting due to a
in beneficiary access issues. facility to close for repairs and
local emergency such as fire, floods,
As discussed in the CY 2021 ESRD temporarily stop furnishing renal
earthquakes, or tornadoes.
PPS proposed rule (85 FR 42165), the dialysis services. The ESRD facility • Other disasters or emergency
COVID–19 PHE caused ESRD facilities served a rural community and for over conditions under which a waiver could
to have to shift patients among ESRD 10 years received the LVPA due to the be granted pursuant to section 1135 of
facilities to provide uninterrupted care low number of dialysis treatments it the Act.
to their Medicare ESRD population. In furnished each year. This ESRD facility We stated that these policy changes
some cases, this patient shifting sought recourse to maintain its could help displaced ESRD patients
increased dialysis treatments at some eligibility for the LVPA when it maintain access to renal dialysis
low-volume ESRD facilities, putting the resumed operations following the services by preventing ESRD facilities
ESRD facility temporarily over the required repairs to the ESRD facility, from permanently closing due to the
LVPA treatment threshold. This however, recourse was unavailable due loss of their LVPA. It is important that
increase in dialysis treatments, resulting to the limitations set forth in ESRD facilities that are receiving the
from the COVID–19 PHE, disqualified § 413.232(b). We explained that when LVPA can maintain LVPA eligibility
some ESRD facilities that would have we established the LVPA in the CY 2011 despite the impacts caused by a disaster
otherwise received the LVPA of 23.9 ESRD PPS final rule, we stated that we or other emergency. This policy could
percent per treatment. In the CY 2021 believed the LVPA should encourage potentially protect other ESRD facilities
ESRD PPS final rule (85 FR 71485), we small ESRD facilities to continue to that need to maintain the LVPA to
established a policy that ESRD facilities provide access to care to an ESRD remain open from potentially losing
would be held harmless from increases patient population where providing that their LVPA by exceeding the treatment
in treatment counts due to temporary care would otherwise be problematic
threshold because they accepted

patient shifting because of the COVID– (75 FR 49118). Given that these displaced patients. We noted that we do
19 PHE. To be held harmless, ESRD requirements for low-volume facilities not want the fear of losing the LVPA
facilities must follow the attestation were created to protect access to care for due to increased treatments exceeding
process for the exception set forth in the vulnerable patient population that the threshold to disincentivize ESRD
§ 413.232(g)(4) and are expected to these ESRD facilities serve, we noted, facilities from accepting patients from
provide supporting documentation to adding certain flexibilities during
the MACs upon request. Interested disasters or other emergencies would 17 https://www.dhs.gov/natural-disasters.
other ESRD facilities experiencing a LVPA for Medicare beneficiaries for up the proposed provision in
disaster or other emergency. It is also to the first 4,000 dialysis treatments in § 413.232(g)(5), CMS would determine
important that ESRD facilities that are the payment year in which the that ESRD facility Y furnished
forced to close due to a disaster or other temporary patient-shifting occurred. treatments equal to or more than 4,000
emergency can maintain their LVPA Under this exception, the ESRD facility in the cost reporting year due to
eligibility upon reopening to ensure would be held harmless for meeting or temporary patient-shifting because of
continued access in areas that otherwise exceeding the 4,000-treatment threshold the closure or operational disruption of
may lack sufficient ESRD facilities. This during one or more cost reporting years ESRD facility X resulting from a disaster
policy could also help those ESRD within the 3-year lookback for LVPA or other emergency. Should the
facilities affected by the disaster or other eligibility as long as their 4,000- exception be approved by CMS, ESRD
emergency potentially resume treatment threshold was exceeded as a facility Y would receive the LVPA for
operations and avoid permanent closure result of temporary patient-shifting from up to the first 4,000 treatments it
if they would be allowed to receive the the ESRD facility that experienced the furnished in 2024. Additionally, ESRD
LVPA upon reopening despite the disaster or other emergency. If CMS facility Y would not be disqualified
closure or disruption of operations. does not approve the request, CMS from receiving the LVPA for payment
(i) Exception to the LVPA Treatment would notify the ESRD facility and the years (PYs) 2025 and 2026 due to
Threshold for ESRD Facilities That MAC, and the ESRD facility would be exceeding the treatment volume
Accept Patients From an ESRD Facility disqualified from receiving the LVPA threshold in cost reporting year 2024,
Affected by a Disaster or Other until it meets all the LVPA criteria assuming the temporary patient-shifting
Emergency (including the 3-year lookback). The from ESRD facility X occurred only in
ESRD facility receiving this exception cost reporting year 2024. For PY 2025
We proposed in the CY 2024 ESRD must maintain documentation of the
PPS proposed rule to create an and PY 2026, ESRD facility Y would
number of displaced patients treated have to attest that it meets all the
exception to the LVPA treatment and information about the ESRD facility
threshold requirements set forth in criteria for the LVPA because it
or facilities that previously treated those furnished treatments equal to or more
§ 413.232(b)(1) under a new provision in patients and closed or experienced an
§ 413.232(g)(5), which would allow an than 4,000 in the cost reporting year due
operational disruption due to a disaster to temporary patient-shifting as a result
ESRD facility to receive the LVPA even or other emergency and must provide
if it exceeds the LVPA threshold if its of the closure or operational disruption
such documentation to CMS and the of an ESRD facility resulting from a
treatment counts increase due to
MAC upon request. The ESRD facility disaster or other emergency and
treating additional patients displaced by
requesting this exception would have to received an exception for cost reporting
a disaster or other emergency.
repeat the process for requesting an year 2024. This would be the same
Qualification for the exception would
exception for each cost reporting year in attestation process as if ESRD facility Y
require an ESRD facility to absorb those
which its treatment volume meets or did not furnish any excess treatments
displaced patients from an outside or
exceeds 4,000 due to temporary patient- and was attesting that it continued to
adjacent ESRD facility that experienced
shifting from the ESRD facility that meet the criteria for the LVPA for those
a temporary closure or operational
experienced the disaster or other payment years. If the closure or
disruption (such as a water shut off). If
emergency. Additionally, the ESRD operational disruption of ESRD facility
an ESRD facility accepts the patients of
the ESRD facility affected by the disaster facility requesting this exception would X causes the treatment volume for ESRD
or other emergency, causing that ESRD have to follow the attestation process as facility Y to meet or exceed the 4,000-
facility to meet or exceed the 4,000- described at § 413.232(e) for the two dialysis treatment threshold in cost
treatment count for all dialysis patients, payment years following the last cost reporting year 2025, ESRD facility Y
it would attest to its MAC that it reporting year in which its treatment would have to submit another request
furnished treatments equal to or in volume meets or exceeds 4,000 due to for an exception by November 1, 2025.
excess of 4,000 in the cost reporting year treating displaced patients from the Should this exception be approved,
due to temporary patient-shifting as a ESRD facility that experienced the ESRD facility Y would receive the LVPA
result of the closure or operational disaster or other emergency and attest for up to the first 4,000 treatments it
disruption of an ESRD facility due to a that the ESRD facility meets the criteria furnished in cost reporting year 2025
disaster or other emergency. We established at § 413.232. and would not be disqualified from
proposed to define temporary patient- We provided the following example: receiving the LVPA for PYs 2026 and
shifting in the context of the LVPA in if a disaster occurs on June 1, 2024, 2027 due to exceeding the treatment
the ESRD PPS as providing renal which results in ESRD facility X’s volume threshold in cost reporting year
dialysis services to one or more closure or operational disruption 2024 and cost reporting year 2025. If
patient(s) at any time through the end of resulting in ESRD facility Y (an existing ESRD facility Y continued to treat
the CY following the 12-month period low-volume facility) treating additional displaced patients from ESRD facility X
beginning when an ESRD facility first patients from ESRD facility X that puts in cost reporting year CY 2026, it would
begins providing renal dialysis services ESRD facility Y’s total renal dialysis only be considered temporary patient-
to the displaced patient(s). The ESRD treatments for cost reporting year 2024 shifting if ESRD facility Y treated those
facility would be required to request over the 4,000 treatment threshold, patients before January 1, 2026, and if
this exception from CMS by writing to ESRD facility Y would be required to patients treated after January 1, 2026
request an exception to § 413.232(b)(1) cause ESRD facility Y to exceed the
the ESRD Payment Mailbox

(ESRDPAYMENT@cms.hhs.gov) no later from CMS by November 1, 2024 to 4,000-treatment volume threshold in
than the annual attestation deadline of continue receiving the LVPA. Since cost reporting year 2026 then the ESRD
November 1st. CMS would review the ESRD facility Y began treating the facility would be disqualified from
exception request within 30 days to displaced patients in CY 2024, the receiving the LVPA under
determine if the ESRD facility qualifies window for temporary patient shifting § 413.232(b)(1). Under this example,
for the exception. If approved by CMS, would extend until December 31, 2025. ESRD facility Y would still have to meet
the ESRD facility would be paid the To be approved for the exception under the other eligibility requirements to
receive the LVPA in any PY in which such supporting documentation to CMS or other emergency. We note that
the ESRD facility would receive the and/or the MAC upon request. § 413.232(e) currently states that ‘‘to
LVPA. We provided the following example: receive the low-volume adjustment an
If a disaster occurs on June 1, 2024, ESRD facility must provide an
(ii) Exception to the LVPA Closure which results in an ESRD facility
Provision for ESRD Facilities Affected attestation statement, by November 1st
experiencing a closure, the ESRD of each year preceding the payment
by a Disaster or Other Emergency facility would request an exception to year, to its Medicare Administrative
In addition to the proposed exception § 413.232(b)(2) from CMS within 60 Contractor (MAC) that the facility meets
to the treatment threshold requirement days of June 1, 2024 (that is, on or all the criteria established in this
under § 413.232(b)(1) and (g)(5), we before July 31, 2024). CMS would section,’’ except as otherwise specified.
proposed an exception under review the request and notify the ESRD We did not propose to change the
§ 413.232(g)(6) that would allow an facility and the MAC within 30 days if attestation deadline for ESRD facilities
ESRD facility to still receive the LVPA the exception is approved or denied. If impacted by a disaster or other
if it temporarily closes. That is, if an the ESRD facility then reopens on
emergency. In the CY 2012 ESRD PPS
ESRD facility temporarily ceases to September 1, 2024, the ESRD facility
final rule (76 FR 70236), we finalized a
operate and the patients must go to would notify CMS and the MAC in
yearly November 1st deadline for
another ESRD facility to receive renal writing within 30 days of reopening
(that is, on or before October 1, 2024). attestation submission, and noted that
dialysis services due to a disaster or this timeframe provides 60 days for a
other emergency, and the ESRD facility CMS would notify the ESRD facility and
the MAC of its receipt of the reopening MAC to verify that an ESRD facility
subsequently reopens, we proposed to meets the LVPA eligibility criteria. It is
create an exception to the requirement notification within 30 days. If the
exception was approved by CMS, the important that all ESRD facilities have
in § 413.232(b)(2) that an ESRD facility the same attestation deadline for the
‘‘has not opened, closed, or received a ESRD facility would remain eligible for
the LVPA for the rest of payment year LVPA to allow adequate verification
new provider number’’ in the 3 cost time for the MACs and so that those
reporting years preceding the payment 2024 and for the entirety of payment
year 2025 and payment year 2026, ESRD facilities eligible for LVPA are
year. If an ESRD facility is affected by able to receive it timely. In the past
a disaster or other emergency and the provided the ESRD facility continues to
meet the other eligibility requirements when we have extended the LVPA
ESRD facility is forced to close and re-
for the LVPA. attestation deadline, we have done so
open later, the ESRD facility would
We received 10 public comments on for all ESRD facilities (85 FR 71442).
need to request an exception from CMS
our proposals to modify the LVPA However, we believe that a November
in writing at the ESRD Payment Mailbox
regulation at § 413.232 to allow for more 1st deadline is necessary so that the
at ESRDPAYMENT@cms.hhs.gov within
administrative flexibilities during LVPA attestations can be properly
60 days of the closure and inform the
disasters or other emergencies. These processed, and payments can begin on
MAC of the request. CMS would review
comments came from three LDOs, a January 1st of the next CY. In response
the request within 30 days of receipt
non-profit dialysis organization, a to the concern for ESRD facilities which
and either approve the request based on
coalition of dialysis organizations, a are impacted by a disaster late in the
a determination that the ESRD facility
non-profit advocacy organization, and a year, we are modifying the proposed
closed due to a disaster or other
non-profit kidney organization. The regulation language at § 413.232(g)(5) to
emergency, or deny the request, and
comments on our proposals and our allow an ESRD facility to request the
would inform both the ESRD facility
responses are set forth below. exception to the 4,000-treatment volume
and the MAC of its decision. Comment: All of the comments
Under the proposal, upon reopening threshold requirement up to 30 days
supported CMS’s proposal to establish after the end of the cost reporting year
and providing renal dialysis services, exceptions to the LVPA requirements
the ESRD facility would be required for which they are attesting. Although
for ESRD facilities impacted by a the ESRD facility would still have to
notify CMS and the MAC in writing disaster or other emergency.
within 30 days of its reopening. CMS submit an attestation by the November
Response: We appreciate the support
would acknowledge receipt of the 1st deadline, this will allow additional
for our proposed exceptions to the
written notification within 30 days. If flexibility for ESRD facilities that
LVPA requirements for ESRD facilities
the exception is approved and CMS is that are impacted by a disaster or other experience temporary patient shifting
duly informed of the ESRD facility’s emergency. late in the year if their cost-reporting
reopening, the ESRD facility would Comment: One LDO requested that year ends within 30 days of the
remain eligible for the LVPA and the CMS reevaluate the attestation deadline attestation deadline. We clarify that
MAC would process payment for ESRD facilities that exceed the LVPA under this exception, an ESRD facility
accordingly. To continue receiving the treatment volume threshold due to would have to submit the exception
LVPA the ESRD facility would still have accepting displaced patients from an request by either the attestation
to meet all the other eligibility ESRD facility that closes or experiences deadline or 30 days after the end of the
requirements for the LVPA. The an operational disruption due to a ESRD facility’s cost reporting year,
exception to § 413.232(b)(2) would be disaster or other emergency. This LDO whichever is later, but would not be
applicable for a period of 2 cost noted that if the disaster were to occur required to have received the exception
reporting years following the date of late in the year, it might be difficult for by the attestation deadline. Then, in the
closure of the ESRD facility. After a event that the ESRD facility does not
an ESRD facility to meet the November

period of 2-cost reporting years the 1st attestation deadline. receive approval for the exception from
ESRD facility would follow the normal Response: We thank the commenter CMS, the MAC would follow the current
attestation process for the LVPA for the thoughtful suggestion on how to process. Specifically, as noted in
specified in paragraphs (e) and (g) of improve the proposed exception for § 413.232(h)(2), if the MAC determines
§ 413.232. The ESRD facility would be ESRD facilities that exceed the 4,000- an ESRD facility does not meet the
required to maintain documentation treatment volume threshold due to definition of a low-volume facility, the
regarding its closure, and to provide treating patients displaced by a disaster MAC reprocesses claims and recoups
low-volume adjustments paid during § 413.232(g)(5) which states that if an displaced by a disaster or emergency.
the payment year. ESRD facility exceeds the 4,000- Furthermore, we considered that low-
Comment: A coalition of dialysis treatment volume threshold due to volume ESRD facilities generally receive
organizations requested that the temporary patient shifting from an the LVPA on fewer than 4,000
exception to the attestation process for ESRD facility that experiences a closure treatments per year, since the 4,000
ESRD facilities that treat displaced or operational disruption due to a treatment threshold includes all
patients be extended to ESRD facilities disaster or other emergency, the treatments that the facility provides. We
that treat displaced patients from ESRD accepting ESRD facility would be able to therefore do not believe it is necessary
facilities that closed for reasons not apply for an exception to the to apply the proposed limit, since ESRD
related to a disaster or other emergency. requirement at 413.232(b)(1) and, if the facilities operating under an exception
This commenter noted that between exception is approved, the ESRD facility would be unlikely to exceed 4,000
2020 and 2023, 383 ESRD facilities would not be disqualified from treatments paid under the ESRD PPS.
closed, which impacted an estimated receiving the LVPA on the basis of We intend to monitor the use of these
21,000 patients. 413.232(b)(1) due to exceeding the new exceptions to ensure that they are
Response: At this time, we do not 4,000-treatment volume threshold in being applied appropriately and do not
agree that it is appropriate to allow that cost reporting year. The deadline create opportunities for gaming.
ESRD facilities to exceed the LVPA Additionally, we are finalizing
for requesting this exception would be
treatment volume threshold due to § 413.232(g)(6), which states that if an
either the attestation deadline or 30
treating displaced patients from ESRD ESRD facility has closed and reopened
days after the end of the cost reporting
facilities that close for reasons unrelated in response to a disaster or other
year for which the ESRD facility is
to disasters or other emergencies. If an emergency, it would be able to apply for
attesting, whichever is later. We are
ESRD facility closes due to a disaster or an exception to the requirement at
other emergency, the ESRD facility finalizing a definition of temporary
patient shifting in the context of the 413.232(b)(2) and, if the exception is
could re-open or another ESRD facility approved, the ESRD facility would not
could open in its place, which would ESRD PPS LVPA as providing renal
dialysis services to one or more be disqualified from receiving the LVPA
lead to the accepting ESRD facility on the basis of 413.232(b)(2) due to
returning to a lower treatment volume. patient(s) at any time through the end of
the CY following the 12-month period closing in that year. The deadline for
However, if an ESRD facility closes for requesting this exception is 60 days
reasons unrelated to a disaster or other beginning when an ESRD facility first
begins providing renal dialysis services after ESRD facility’s closure.
emergency, such as lack of demand or
profitability, it is less likely that the to the displaced patient(s). We are (4) Technical Correction to § 413.232(g)
ESRD facility would re-open or that a finalizing a second modification of the
proposed regulation text at We proposed a technical correction at
new ESRD facility would replace it. § 413.232(g) to replace ‘‘their’’ with
Additionally, implementing this § 413.232(g)(5)(iv) to indicate that we
will not limit the LVPA payment to ‘‘its,’’ to clarify the regulation language.
commenter’s suggestion could lead to Final Rule Action: We did not receive
perverse incentives. For example, an 4,000 treatments for the payment year in
which the temporary patient-shifting comments regarding the technical
ESRD facility that does not receive the correction to the regulations text for the
LVPA and closes temporarily has its occurred due to a disaster or other
emergency. We proposed that if an LVPA, and we are finalizing this
patients receive treatment at another revision as proposed.
affiliated ESRD facility, which usually exception is approved under
receives the LVPA (and therefore, a § 413.232(g)(5), the ESRD facility would g. Transitional Pediatric ESRD Add-On
higher payment rate). If the commenter’s be paid the low-volume adjustment on Payment Adjustment for Pediatric
suggestion were to be implemented, claims for Medicare beneficiaries for up Patients With ESRD Receiving Renal
with the influx of new patients, the to the first 4,000 dialysis treatments Dialysis Services
‘‘accepting’’ ESRD facility could during the payment year in which the
temporary patient-shifting occurred, so (1) Background
strategically surpass the 4,000-treatment
level and still receive the LVPA. long as all other requirements for the Section 1881(b)(14)(D)(iv)(I) of the Act
Final Rule Action: We are finalizing low-volume adjustment are met. The provides that the ESRD PPS may
our proposals to establish an exception intent of this proposed limit was to include such payment adjustments as
process to allow a facility to close and support stability of payments for ESRD the Secretary determines appropriate,
reopen in response to a disaster or facilities experiencing temporary including a payment adjustment for
emergency and still receive the LVPA, patient-shifting due to an emergency at pediatric providers of services and renal
and to allow a facility to receive the a level commensurate with their dialysis facilities. Determining such a
LVPA even if it exceeds the LVPA historical treatment volumes, while payment adjustment has been
threshold if its treatment counts protecting the Medicare program against historically difficult due to the
increase due to treating additional the risk of paying the LVPA for a large consistent lack of data. The Medicare
patients displaced by a closure or number of treatments. After further pediatric ESRD patient population
operational disruption caused by a consideration of the operational and receiving dialysis is small compared to
disaster or other emergency, as payment implications of this policy, we the adult ESRD population, representing
proposed, with two modifications. First, are making this change to be consistent approximately 0.14 percent of the total
as noted above, we are finalizing one with our historical practice of not ESRD patient population in 2022. In the
modification to § 413.232(g)(5)(ii) to limiting payment of the LVPA in the past, CMS has considered various
change the deadline by which the ESRD year in which the LVPA threshold is payment adjustments for pediatric
facility must request the exception to exceeded. We are concerned that patients with ESRD, including different
§ 413.232(b)(1) to be the later of the limiting LVPA payment to 4,000 Medicare payments by sex or
attestation deadline or 30 days after the treatments for facilities would create comorbidities (74 FR 49984 through
end of the cost reporting year for which operational confusion for facilities and 49986). However, many of these
the ESRD facility is attesting. could limit the ability of these ESRD considered adjustments were not used
Specifically, we are finalizing facilities to take on patients who are as we were unable to get acceptable
precision due to the small sample size services to pediatric patients with through 49987). The CY 2011 ESRD PPS
of pediatric patients with ESRD. ESRD. This factor was derived from the proposed rule then calculated an
Prior to the establishment of the ESRD average exception amounts for 20 ESRD ‘‘expanded bundle’’ modifier, which
PPS, payment for pediatric ESRD renal facilities that had received exceptions combined the composite rate and
dialysis services was generally the same for pediatric patients. This was intended separately billable modifiers for each of
rate as adult ESRD renal dialysis to be a temporary measure, which the eight groups (74 FR 44987). These
services, unless the ESRD facility would be eliminated once we developed expanded bundle modifiers were the
qualified for an exception to the the case-mix methodology that would proposed pediatric patient-specific case-
composite rate. Section 1881(b)(7) of the apply for the ESRD PPS bundled mix adjustment factors that would be
Act stated that, subject to section payment. The use of this methodology applied to the base rate under the ESRD
422(a)(2) of the Medicare, Medicaid, and allowed CMS to provide additional PPS. These modifiers were based on a
SCHIP Benefits Improvement and payment for the pediatric ESRD regression of costs for all renal dialysis
Protection Act of 2000 (Pub. L. 106–554) population under the composite rate in services furnished to Pediatric ESRD
(BIPA), the Secretary shall provide for a data-driven manner to account for the Patients. Comments on this proposed
exceptions as may be warranted by higher costs pediatric patients faced (69 rule indicated that many interested
unusual circumstances (including the FR 66327). parties believe the expanded bundle
special circumstances of sole facilities modifier was insufficient (75 FR 49128).
located in isolated, rural areas and of Section 153(b) of MIPPA added
section 1881(b)(14) of the Act, which In the CY 2011 ESRD PPS final rule, we
pediatric facilities). During this time, responded to those comments by
CMS received many comments and required CMS to implement an ESRD
bundled PPS beginning January 1, 2011, implementing the first iteration of the
concerns regarding the payment rate for current four-group system for both the
renal dialysis services furnished to under which a single payment for renal
dialysis services is made in lieu of any expanded bundle and the separately
pediatric patients with ESRD. Section billable services. This methodology was
623(b) of the Medicare Prescription other payment. Renal dialysis services
generally include items and services data driven, but unlike the simple
Drug, Improvement, and Modernization regression for composite rate costs,
Act of 2003 (Pub. L. 108–173) later included in the composite rate for renal
dialysis services as of December 31, allowed for different Medicare payment
amended section 422(a)(2) of BIPA to amounts based on two sets of two
provide that any pediatric ESRD facility 2010, and services furnished to
individuals for treatment of ESRD, characteristics: age of the patient (under
would be eligible for an exception to the 13 or 13 to 17) and modality of the
composite rate, effective October 1, which were formerly separately billable,
including drugs and biological products treatment (hemodialysis or peritoneal
2002. This statute defined pediatric
and laboratory tests. In the CY 2011 dialysis). Additionally, this
ESRD facilities as facilities with at least
ESRD PPS proposed rule, we proposed methodology used the same groups for
50 percent patients under the age of 18.
a single composite rate modifier of 1.199 the expanded bundle and separately
This enabled pediatric ESRD facilities to
for all Pediatric ESRD Patients receiving billable modifiers (75 FR 49134).
obtain payments that specifically
recognized the higher cost associated dialysis (74 FR 49982 through 49983). A We codified the Pediatric ESRD
with treating these patients (69 FR ‘‘Pediatric ESRD Patient’’ is defined as Patient payment adjustment in
47530). an individual less than 18 years of age § 413.235(b), which states that CMS
We finalized a basic case-mix who is receiving renal dialysis services adjusts the per treatment base rate for
adjustment to the composite payment (§ 413.171). We also proposed an eight- pediatric patients in accordance with
rate in the CY 2005 Physician Fee group system for separately billable section 1881(b)(14)(D)(iv)(I) of the Act,
Schedule (PFS) final rule published on renal dialysis services furnished to to account for patient age and treatment
November 15, 2004 (69 FR 66327). This Pediatric ESRD Patients with two modality. These multipliers were
included a 62 percent pediatric payment subdivisions for each of the following updated in the CY 2016 ESRD PPS final
increase (that is, an adjustment factor of factors: age (under 13, 13 to 17), rule using the same methodology (80 FR
1.62) applied to the composite payment modality (hemodialysis, peritoneal 69001 through 69002). The current
rate per treatment for any facility when dialysis) and number of comorbidities expanded bundle case mix adjusters are
furnishing outpatient renal dialysis (none, one or more) (74 FR 49983 presented in Table 7.
TABLE 7: Current Pediatric ESRDB Payment Modifiers
Current Pediatric ESRD Expanded Bundled Payment Modifiers by Age and Modality
(Effective 1/1/2016)
Age <13 13-17
Hemodialvsis 1.306 1.327
Peritoneal Dialysis 1.063 1.102
As we discussed in the CY 2024 ESRD renal dialysis services furnished to improve payment for pediatric dialysis
PPS proposed rule (88 FR 42449), Pediatric ESRD Patients are too low. In care under the ESRD PPS. Panelists 18
despite these changes intended to addition to comments received through generally preferred creating more
improve payment accuracy for renal the annual ESRD PPS rulemaking, we refined case-mix adjusters over creating
dialysis services furnished to Pediatric have also solicited comments from
ESRD Patients, we continue to receive interested parties on several occasions. 18 https://www.cms.gov/files/document/end-
comments and concerns from interested During the December 2020 TEP, we stage-renal-disease-prospective-payment-system-
technical-expert-panel-summary-report-april-
parties that the payment amounts for queried a panel of experts on how to
ER06NO23.009</GPH>
2021.pdf.
an entirely new pediatric ESRD PPS, furnishing renal dialysis services to Patients based on the variation in costs
citing the costs of creating an entirely Pediatric ESRD Patients. However, we across the ESRD facilities. To achieve
new system both on CMS and the ESRD estimated it would take approximately 3 this, we would use propensity score
facilities and the need for new years to obtain and analyze the granular matching (PSM).
legislation to be able to increase data provided by the stratified cost PSM is a technique that uses
payment through a separate pediatric reports data from these changes that we regression analysis to account for
ESRD PPS. Panelists also pointed to need to consider proposing a more systematic differences between two
labor costs as a major reason for higher finely tuned payment adjustment. populations to isolate the effects of a
costs among pediatric dialysis clinics single variable, in this case percentage
(2) Alternative Methodology for
because these patients need more of Pediatric ESRD Patients. The PSM
Estimating Relative Costs for Furnishing
nursing attention and specialized regression includes a wide range of
Renal Dialysis Services to Pediatric
pediatric nutritionists. ESRD facility-level characteristics
We noted that, in the CY 2023 ESRD ESRD Patients
including facility type, size, geographic
PPS proposed rule (87 FR 38529), we As discussed in the CY 2024 ESRD
location, and the pediatric ESRD
issued a request for information PPS proposed rule, payment accuracy
dialysis population nearby the ESRD
regarding health equity for pediatric has been historically difficult for
pediatric ESRD dialysis because of the facility to make a propensity score. This
patients with ESRD. Many commenters
small sample size of Pediatric ESRD propensity score represents the
asserted that Medicare payments for
Patients receiving renal dialysis services probability that a given ESRD facility
Pediatric ESRD Patients are too low and
paid for under the ESRD PPS. Pediatric treats a high volume of Pediatric ESRD
that the ESRD PPS bundled payment
ESRD dialysis treatments are also Patients given its facility-level
does not target the unique issues facing
furnished differently from adult ESRD characteristics.
ESRD facilities furnishing renal dialysis
services to Pediatric ESRD Patients. dialysis treatments in several crucial Once the propensity score for each
As we explained in the CY 2024 ESRD ways. For example, pediatric ESRD ESRD facility is determined, each ESRD
PPS proposed rule, we are committed to facilities are more likely to be hospital- facility with a significant percentage of
improving health equity for Pediatric based and, on average, have lower Pediatric ESRD Patients (high-pediatric)
ESRD Patients receiving renal dialysis treatment volume and are in higher is matched with the ESRD facility
services by improving payment equity wage index areas. These systematic without a significant percentage of
through more efficient Medicare differences in treatment, when Pediatric ESRD Patients (low-pediatric)
payments. Ensuring Medicare payments combined with the small sample size, with the most similar propensity score.
are appropriate and reflect costs for make it very difficult to obtain low We can then compare the relative per-
renal dialysis services furnished to variance estimates of the differences in treatment costs of those ESRD facilities
Pediatric ESRD Patients would allow costs between pediatric and adult ESRD to estimate the additional costs an ESRD
more ESRD facilities to provide quality dialysis patients. Even if simple cost facility faces when it furnishes renal
care to this vulnerable population. The models show statistically significant dialysis services to a higher proportion
main barrier to payment equity is the estimates, it is possible that the of Pediatric ESRD Patients, controlling
lack of sufficient data to determine the systematic differences between pediatric for some important facility-level
relative costs associated with furnishing and adult ESRD facilities can bias these characteristics. The dependent variable
renal dialysis services to Pediatric ESRD estimates. Obtaining a reliable estimate of this regression is the log of the cost
Patients. To improve payment rate of the additional costs that Pediatric per treatment for the ESRD facility. The
accuracy for Pediatric ESRD Patients, ESRD Patients incur would allow us to independent variables are the percent of
CMS has issued changes to the cost create a payment adjustment to bring dialysis treatments that are furnished to
reports for both freestanding ESRD relative Medicare payments more in line Pediatric ESRD Patients, the log of the
facilities and hospital-based ESRD with relative costs. facility size, the type of ESRD facility
facilities effective January 1, 2023.19 20 21 One can account for this bias by (hospital-based, children’s hospital-
These changes include separate selecting a specific sample of ESRD based or freestanding), the log of the
categories for labor and supplies used in facilities that have similar wage index for the ESRD facility and the
furnishing renal dialysis services to characteristics except for proportion of year for the cost report data. The
Pediatric ESRD Patients. These updates dialysis treatments furnished to regression equation for cost per
are intended to provide data for CMS to Pediatric ESRD Patients. This would treatment given a certain percentage of
more comprehensively estimate the help to show the additional costs of dialysis treatments furnished to
additional costs associated with furnishing dialysis to Pediatric ESRD Pediatric ESRD Patients is:
Cost )
Log ( - - - -
Treatment
= Pediatric Share+ log(Facility Size) + Hospital Type + log(wage Index) + Year Indicator
This cost regression should be that could be matched using PSM. This estimates. The result of this regression
unbiased due to the use of PSM. smaller sample size inherently results in is that ESRD facilities that solely serve
However, PSM also requires a reduction an increase in margin of error. We stated Pediatric ESRD Patients incur costs that
in sample size, because there are that we believe this is a necessary are 40 percent higher per patient for
relatively few ESRD facilities with a tradeoff because a biased estimate furnishing renal dialysis services than
significant number of treatments cannot be relied upon, but we must be similar ESRD facilities that serve no
furnished to Pediatric ESRD Patients cautious while using high-error Pediatric ESRD Patients. The confidence
19 https://www.cms.gov/Regulations-and- 20 https://www.cms.gov/Regulations-and- 21 87 FR 26760 (May 5, 2022). https://www.federal
Guidance/Guidance/Transmittals/Transmittals/ Guidance/Guidance/Transmittals/Transmittals/ register.gov/documents/2022/05/05/2022-09581/

r7p242. r18p240i. agency-information-collection-activities-
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interval of this estimate is 20 percent to ESRD facilities furnishing renal dialysis after accounting for the current payment
60 percent. Therefore, on average, services to Pediatric ESRD Patients. rate. This option would still represent a
furnishing renal dialysis services to a significant increase in Medicare
(4) Transitional Pediatric ESRD Add-On
Pediatric ESRD Patient costs 40 percent payments to ESRD facilities for Pediatric
Payment Adjustment
more than furnishing renal dialysis ESRD Patients without much risk of
services to an adult patient with ESRD. As we stated in the CY 2024 ESRD making payments higher than
PPS proposed rule, despite the high appropriate. However, this alternative
(3) Current Medicare Payments for margin of error of the cost regression
Renal Dialysis Services Furnished to option may lead to underpayment to
using PSM, we believe that 30 percent ESRD facilities serving Pediatric ESRD
Pediatric ESRD Patients cost is the most reasonable estimate of Patients, which is contrary to our goal
As discussed in the CY 2024 ESRD the unaccounted-for costs incurred in of aligning resource use with payment.
PPS proposed rule, the ESRD PPS treating Pediatric ESRD Patients We invited comments on the most
already accounts for some of the higher compared to adult ESRD patients. appropriate amount for the proposed
costs that ESRD facilities incur while Creating a new add-on payment transitional add-on payment
furnishing renal dialysis services to adjustment using this figure would adjustment.
Pediatric ESRD Patients through the provide pediatric ESRD facilities with
case-mix adjusters. Because the analysis Medicare payments proportional to their We proposed in the CY 2024 ESRD
described previously uses cost report estimated costs for a temporary period PPS proposed rule a new transitional
data, it does not incorporate either the while we collect additional data. add-on payment adjustment of 30
current case-mix adjusters or payment However, due to the high margin of percent (adjustment factor of 1.3) for
rates for Pediatric ESRD Patients error of the model, increasing Medicare dialysis treatments furnished to
receiving renal dialysis services. We payments to ESRD facilities such that Pediatric ESRD Patients for 3 CYs,
noted that our most recent estimates payments are 40 percent higher for effective January 1, 2024. We stated that
showed that payments for dialysis Pediatric ESRD Patients compared to all based on the time lag for cost report
treatments furnished to Pediatric ESRD patients would risk making payments data, 3 years should allow for enough
Patients were approximately 10 percent higher than appropriate. We noted that time for CMS to get more detailed data
higher than for adult patients with when we conduct the analysis with the from the changes to the cost reports
ESRD in CY 2022. more comprehensive cost report data described previously. After that period,
We explained that we are striving for provided by the cost report changes we would evaluate the more
payment accuracy, which is achieved implemented for CY 2023, we might comprehensive cost report data from the
when relative Medicare payments are find that our analysis overestimated the first year of cost reporting periods
proportional to relative costs. There are cost of furnishing renal dialysis services beginning on or after January 1, 2023, to
several ways we could adjust ESRD PPS to Pediatric ESRD Patients (that is, that refine our methodology for determining
payments to achieve payment accuracy, the additional 30 percent payment the payment rate for pediatric ESRD
including calculating the unaccounted- adjustment was too large). We further dialysis. As proposed, this would be a
for cost differential, which is the stated that if we finalized the separate, additional add-on payment
amount by which ESRD PPS payments transitional add-on payment adjustment adjustment of 30 percent of the per
for pediatric ESRD renal dialysis for Pediatric ESRD Patients as proposed, treatment payment amount under
services must be increased to achieve pediatric ESRD facilities should be § 413.230, which reflects the other
payment accuracy. We could do this by prepared for the possibility that the patient and facility level adjustments.
reducing the cost differential estimate of payment rate for Pediatric ESRD This adjustment would not be part of
40 percent by a factor 1.1 to account for Patients could decrease in the future, the case-mix adjusters. This payment
the current payment differential of 10 should that be indicated by future data adjustment would only apply to the
percent. This would yield an analysis and finalized through notice- ESRD bundled payment and not to any
unaccounted-for cost differential of and-comment rulemaking. We discussed outlier adjustments. Due to the
approximately 30 percent (1.4 divided the alternative to propose a smaller, multiplicative nature of the case-mix
by 1.1 is 1.27 which we are rounding to more cautious add-on payment adjusters it would function similarly to
1.3). This is a reasonable estimate of the adjustment based on the 20 percent a 30 percent increase to the expanded
additional labor and supply costs, lower bound of the confidence interval, bundle case-mix adjusters. For
which are not accounted for by the leading to an additional 10 percent comparison, the effective case-mix
current case-mix adjusters, incurred by transitional add-on payment adjustment adjusters are presented in Table 8.
TABLE 8: Pediatric ESRDB Effective Payment Modifiers
Pediatric ESRDB Effective Payment Modifiers by Age and Modality
Age Modality Current Case- Mix 30% Increase Alternative 10%

Adjuster Effective Case- Mix Increase Effective Case-
(Effective 1/1/2016) Ad_justers Mix Adjusters
<13 PD 1.063 1.382 1.169

<13 HD 1.306 1.698 1.437
13-17 PD 1.102 1.433 1.212
13-17 HD 1.327 1.725 1.460
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We noted that the exact magnitude of analysis, and when updating the case- furnished to Pediatric ESRD Patients
the increase in payment would vary mix adjusters, attributed pediatric ESRD would improve payment equity for
based on the age of the patient and the renal dialysis services costs to the these patients by increasing payments to
wage index of a given area; we general population. Therefore, we align with the estimated costs of
estimated approximately $80 for explained, it would be appropriate to treatment more closely. A 30 percent
(hemodialysis-equivalent) peritoneal reduce the ESRD PPS base rate to increase in ESRD PPS payments for
dialysis treatments and $100 for account for the new allocation of costs. pediatric ESRD renal dialysis services
hemodialysis treatments. This would Furthermore, we stated that any changes would represent approximately $80 to
represent a substantial increase in to the case-mix adjustments are required $100 per pediatric ESRD dialysis
payment for renal dialysis services by section 1881(b)(14)(A)(ii) of the Act treatment, although the exact magnitude
furnished to Pediatric ESRD Patients to be budget neutral, which means that of the increase would depend on age,
and would account for the extra costs any future modifications to the pediatric modality, and the wage index of the
that this population incurs temporarily case-mix adjusters would be budget area. This payment increase would have
until additional cost data is available. neutral. The proposed budget neutrality beneficial health equity impacts on this
This payment adjustment would apply adjustment factor for the proposed population by improving access to care
for all dialysis treatments furnished to TPEAPA consisting of 30 percent of the and quality of care. Some ESRD
ESRD patients under the age of 18, not per treatment payment amount was facilities may not be able to absorb the
solely treatments furnished in pediatric 0.999532. We explained that applying additional expense of the Pediatric
ESRD facilities. This is warranted this budget neutrality factor to the ESRD Patient population. Patients may
because many of the additional costs proposed ESRD PPS base rate would need to travel to a limited number of
related to the treatment of Pediatric reduce the ESRD PPS base rate by an primarily hospital-based ESRD facilities
ESRD Patients are not specific to estimated $0.12. We stated that under where pediatric ESRD dialysis is
treatments furnished in pediatric ESRD the alternative 10 percent TPEAPA performed. As a result, this population
facilities. discussed in the proposed rule (88 FR may be underserved and disadvantaged
We proposed to call this the 42464), the budget neutrality factor with respect to access to ESRD care. We
adjustment would be 0.999847. We stated that additional payment to those
Transitional Pediatric ESRD Add-on
explained that applying this budget ESRD facilities treating Pediatric ESRD
Payment Adjustment (TPEAPA) and
neutrality factor to the proposed ESRD Patients would thereby benefit this
make this adjustment budget neutral.
PPS base rate would reduce the ESRD potentially underserved and
We explained that, in general, add-on
PPS base rate by an estimated $0.04. disadvantaged population of Pediatric
payment adjustments under section To establish this new TPEAPA, we
1881(b)(14)(D)(iv) of the Act are not ESRD patients. Additionally, this would
proposed to amend § 413.235 by have a beneficial financial impact on the
statutorily required to be budget neutral splitting current paragraph (b) into
under the ESRD PPS, but we stated that ESRD facilities, both pediatric and non-
paragraphs (b)(1) and (2). Paragraph pediatric, that serve this pediatric
we believed in this instance that budget (b)(1) would set forth the established age
neutrality is appropriate, due to the way population.
and modality of treatment case mix
this adjustment is derived. We noted adjustment methodology as currently We proposed that this payment
that other non-budget neutral add-on stated in paragraph (b). Paragraph (b)(2) adjustment be budget neutral, which
payment adjustments that we have would state that beginning January 1, would lead to an estimated decrease of
established under this authority 2024, we will provide a per-treatment $0.12 to the ESRD PPS base rate,
generally account for costs that were not transitional add-on payment adjustment corresponding to a budget neutrality
used for the construction of the ESRD of 30 percent of the per treatment factor of 0.99954. This relatively small
PPS bundled payment, such as the payment amount under § 413.230 for adjustment would represent less than a
TDAPA for calcimimetics (80 FR 69013 renal dialysis services furnished to twentieth of a percent of the total ESRD
through 69027). We explained that we Pediatric ESRD Patients during CYs PPS base rate. However, we recognized
have also established certain non-budget 2024, 2025, and 2026. We also proposed that any decrease in the ESRD PPS base
neutral add-on payment adjustments for to revise the current language of rate would represent a monetary loss to
items or services that were not § 413.235(b) to use the term ‘‘Pediatric ESRD facilities. As stated previously,
commonplace, and therefore not ESRD Patients,’’ which is defined at our analysis indicated that this transfer
adequately represented in cost reports, § 413.171, to improve clarity for this would be reasonable given the
such as home dialysis training (75 FR section. likelihood that the methodology used in
49063). However, we noted that we have the case-mix adjusters attributed some
implemented other payment (5) Costs and Benefits for a Transitional pediatric costs to the general
adjustments under this authority in a Pediatric ESRD Add-On Payment population. However, we noted, should
budget neutral manner; for example, the Adjustment (TPEAPA) future analysis of the stratified pediatric
changes to the wage index in the CY As we explained in the CY 2024 ESRD cost data indicate that pediatric ESRD
2023 ESRD PPS final rule were PPS proposed rule, we believe CMS renal dialysis services costs are less than
implemented in a budget neutral could better align the resource use of 40 percent higher than adult costs, this
manner as they represented a shifting of pediatric ESRD renal dialysis services budget neutral decrease would mean
cost allocations, rather than new costs with payment. Our analysis using the that the treatments for adult patients
not originally included in the ESRD PPS methodology outlined previously found with ESRD were slightly underpaid
bundled payment (87 FR 67157). We that costs for Pediatric ESRD Patients during this 3-year period. In either case
stated that this TPEAPA is primarily for receiving renal dialysis services are there would be a risk of underpayment
costs that would have been included in estimated to be 40 percent higher than for one group of patients. We stated that
the cost reports used in the analysis for adult patients and that the current we believe using the mean estimate of
conducted when we created the ESRD payment adjusters account for 10 the analysis will provide us with the
PPS bundled payment in the CY 2011 percent higher costs. Implementing a best approach for achieving payment
ESRD PPS final rule. We explained that transitional 30 percent add-on payment accuracy while we collect additional
the methodology used both in that adjustment for renal dialysis services data. Additionally, the health equity
implications of potentially underpaying a faster path towards transplantation, for service provided to adult patients,
for Pediatric ESRD Patients receiving ultimately yielding both cost savings whose population is comprised of a
dialysis by 20 percent would be and healthier adults. significant percentage of patients from
significantly higher than the Response: We thank the commenters racial or ethnic minority groups, of low-
implications of potentially underpaying for their support and dedication to socioeconomic status, and living in
for adult patients by less than 0.1 improving access and equity for the medically underserved areas. A health
percent. We noted that in CY 2021 there pediatric patient population with ESRD system expressed concerns that the add-
were 116 ESRD facilities that furnished receiving renal dialysis services. on payment adjustment would shift
more than 2 percent of their dialysis Comment: We received several funding away from ESRD facilities
treatments to Pediatric ESRD Patients, comments regarding the proposed exclusively providing adult services. An
out of 7882 total ESRD facilities. These TPEAPA payment amount, calculation, LDO expressed that applying the add-on
ESRD facilities are a relatively small and length of payment period. Most in a budget-neutral manner would
group, but they are critical for the care commenters supported the effectively penalize all ESRD facilities
of Pediatric ESRD Patients. For these implementation of the 30 percent add- for the inability of existing cost report
reasons, we stated that we believe the on payment adjustment as a reasonable data to improve payment accuracy. A
expected benefits for the TPEAPA estimate of the unaccounted-for costs nephrology society expressed concerns
would outweigh the costs. incurred in treating pediatric ESRD that while younger patients require
We explained that we believe patients. An LDO expressed concern more support, that does not mean that
providing this 30 percent TPEAPA for that PSM does not provide for an adults requiring dialysis require less
CYs 2024, 2025, and 2026 would be the accurate computation of the costs support than they are already receiving.
best approach for improving payment incurred in providing specialized A non-profit dialysis association
accuracy until more precise data is pediatric care; while a pediatric expressed that the budget neutral
available. However, we acknowledged nephrology society agreed that in the application of the adjustment is contrary
that in any case there is a risk of making absence of accurate pediatric cost data, to the Administration’s stated health
payments which are higher or lower the PSM methodology seems reasonable. equity goals, because it would cut
than appropriate. Therefore, in the CY A pediatric nephrology society reported payments for one medically vulnerable
2024 ESRD PPS proposed rule we the 30 percent add-on to be consistent group to increase payments for another
requested comments on our proposal, with anecdotal cost data collected by medically vulnerable group.
including on (1) the alternative the society from around the country. An
adjustment amount; and (2) the budget LDO urged CMS to implement a three- Response: We examined the potential
neutrality of the proposal. year period of analysis after the impact of the proposed TPEAPA as a
We received 30 comments in response proposed 30 percent adjustment. budget neutral adjustment. As we noted
to our proposed Transitional Pediatric Another LDO requested more in the CY 2024 ESRD PPS proposed
ESRD Add-on Payment Adjustment transparency on the data and rule, add-on payment adjustments
(TPEAPA) for pediatric ESRD patients assumptions used to calculate the under section 1881(b)(14)(D)(iv) of the
receiving renal dialysis services. pediatric adjustment. Act are not statutorily required to be
Respondents included large and small Response: We thank the commenters budget neutral under the ESRD PPS, but
dialysis organizations, non-profit for their support and suggestions. we believe in this instance that budget
organizations, an advocacy organization, Payment accuracy has been historically neutrality is appropriate due to the way
a coalition of dialysis organizations, a difficult for pediatric ESRD dialysis this adjustment is derived. As explained
large non-profit health system, and because of the small sample size of in section II.B.1.g.(4) of this final rule,
individual providers. The comments on pediatric patients receiving renal this TPEAPA is primarily for costs that
our proposal and our responses are set dialysis services paid for under the would have been included in the cost
forth below. ESRD PPS. Obtaining reliable data on reports used in the analysis conducted
Comment: We received several the additional costs that pediatric when we created the ESRD PPS bundled
comments that supported CMS patients with ESRD incur would payment in the CY 2011 ESRD PPS final
establishing an add-on payment facilitate the creation of a permanent rule. We explained that the
adjustment for pediatric ESRD patients. payment adjustment based on resource methodology used both in that analysis,
Most commenters expressed their belief use to bring relative Medicare payments and when updating the case-mix
that an add-on payment adjustment of more in line with relative costs. We adjusters, attributed pediatric ESRD
this nature is necessary to support the recognize that while our use of PSM renal dialysis services costs to the
higher costs associated with providing unavoidably leads to larger variance in general population. CMS has therefore
for the unique care needs and parameter estimates because only a determined it to be appropriate to
specialized support required for renal small subset of the broader provider reduce the ESRD PPS base rate to
dialysis services in the ESRD PPS population is utilized in the estimation, account for the new allocation of costs.
pediatric population. Physician this approach is useful because it We note that the adjustment would
commenters cited the unique challenges provides a means of comparison with decrease the ESRD PPS base rate by a
in caring for this population that are not less biased estimates and as suggested budget neutrality factor of 0.999503, a
reflected in the current ESRD PPS by commenters the 30 percent estimate sum total of $0.14, due to the
payment models. Numerous is in line with anecdotal data. We plan application of the budget neutrality
commenters expressed their support for to share data and assumptions through factor. We further note that the
using an ESRD PPS add-on payment adjustment does not rely on any
notice-and-comment rulemaking for

adjustment to improve patient access potential future pediatric payment assumption that resource use by adult
and equity among this vulnerable adjustments to ESRD facilities. patients has decreased over time; rather
subpopulation of patients with ESRD. A Comment: Most commenters urged it assumes that the ESRD PPS payment
pediatric ESRD facility noted that CMS to reconsider implementing the rate as applied to adults has since its
money invested in this population payment adjustment as a budget neutral inception incorporated some amount of
lowers avoidable adverse outcomes and add-on. An LDO expressed that it would costs that were more properly
complications from ESRD and facilitates be inappropriate to cut payment rates attributable to treatment of pediatric
ESRD patients. The TPEAPA therefore inclusion (we assume in cost reports) of improve clarity. As such we are
makes the ESRD PPS payment more pediatric nurse practitioners. The finalizing this change as proposed. In
reflective of relative costs by association also recommended CMS addition, after consideration of the
reallocating payments associated with consider direct patient labor categories comments received and for reasons
those costs from the payment amounts when determining costs for pediatrics, outlined in the CY 2024 ESRD PPS
for adults to pediatric ESRD patients. as there are additional training and proposed rule and previously in this
Comment: An ESRD facility urged requirements necessary for the pediatric section of the final rule, we are
CMS to extend the add-on payment population. As an extension of labor finalizing our proposal to establish this
adjustment to pediatric AKI patients to categories, the association noted the new TPEAPA on a budget-neutral basis.
ensure these patients receive the same shortage of pediatric nephrologists and Under our authority at section
additional support. suggested that CMS include pediatric 1881(b)(14)(D)(iv) of the Act, we will
Response: We appreciate the nurse practitioners who can assist in adjust the per treatment base rate for
suggestion to apply the TPEAPA to meeting the needs of the youngest and Pediatric ESRD Patients to provide a
pediatric AKI patients. As we discussed most vulnerable individuals on dialysis. per-treatment transitional add-on
in the CY 2017 ESRD PPS final rule, we These commenters did not specify how payment adjustment of 30 percent of the
have determined that treatment for AKI CMS should include pediatric nurse per treatment payment amount under
is substantially different from treatment practitioners or how such inclusion § 413.230 for renal dialysis services
for ESRD and the case-mix adjustments would relate to the ESRD PPS bundled furnished to Pediatric ESRD Patients
applied to ESRD patients may not be payment. during CYs 2024, 2025, and 2026. CMS
applicable to AKI patients. Therefore, Response: We thank the commenters is codifying this payment adjustment in
we have not historically applied these for their input. As the TPEAPA is a the regulations at § 413.235(b)(2). The
ESRD PPS adjustments and policies to temporary adjustment until we can fully budget-neutrality factor for the CY 2024
AKI payments (81 FR 77959). We did analyze the costs associated with TPEAPA is 0.999503. This change will
not propose to apply the TPEAPA to pediatric dialysis, we did not include be effective January 1, 2024, as
pediatric AKI patients for the same any proposals regarding shifts to home- proposed.
reason. based settings, or the inclusion of a
Comment: We received several pediatric nurse practitioner in the CY h. Reporting Policy for Discarded
additional comments regarding the 2024 ESRD PPS proposed rule. Amounts of Renal Dialysis Drugs and
TPEAPA implementation. Commenters However, as we continue to analyze Biological Products Paid for Under the
suggested that CMS create and how best to collect pediatric specific ESRD PPS
implement pediatric ESRD-specific metrics and the payment for Pediatric (1) Background
metrics for the pediatric ESRD ESRD Patients to facilitate future
programs. A pediatric nephrology refinements, we will consider these As discussed in the CY 2023 PFS final
society requested CMS utilize means of comments for potential future ESRD rule (87 FR 69710), many drugs and
communication such as the Medicare PPS payment policies. We appreciate biological products that are payable
Learning Network to educate children’s the suggestion about using Medicare under Medicare Part B are dosed in a
hospitals on completing costs reports. A Learning Networks to educate children’s variable manner such that the entire
professional nursing association urged hospitals on completing costs report. amount identified on the vial or package
CMS to promote a shift towards CMS is considering a number of options is not administered to the patient. For
pediatric ESRD dialysis care moving on how best to provide educational example, many drugs are dosed based
towards home-based settings. The outreach on this topic. on the patient’s body weight or body
association also urged investment into Final Rule Action: We did not receive surface area (BSA). Often, these drugs
the field of pediatric nephrology, as any comments on our proposal to revise are available only in single-dose
there are limited qualified health care the language of § 413.235(b) to use the containers. As stated in U.S. Food and
providers and recommended the term ‘‘Pediatric ESRD Patients’’ to Drug Administration (FDA) guidance for
industry,22 a single-dose container is single-use packages payable under Part payment from the discarded drug refund
designed for use with a single patient as B, in order to more effectively identify policy. One commenter expressed
a single injection or infusion. The and monitor billing and payment for concern regarding how implementation
labeling for a drug packaged in a single- discarded amounts of drugs.23 24 The of the discarded drug refund might
dose container typically includes policy does not apply to drugs that are inadvertently impact ESRD products,
statements instructing users to discard not separately payable, such as including those used by home dialysis
unused portions. When the labeling packaged hospital outpatient patients. In response to those comments,
instructs a health care provider to prospective payment system (OPPS) we clarified that units for drugs that are
discard the amount of drug that was drugs or those administered in federally packaged under the Medicare ESRD PPS
unused (that is, the discarded amount) qualified health centers (FQHCs) or were not subject to the JW modifier
from a single-dose container or other rural health clinics (RHCs). policy or the discarded drug refund.
single-use package of a drug after In the CY 2023 PFS final rule (87 FR
administering a dose to a Medicare 69718 through 69719), we codified our In the same CY 2023 PFS final rule,
beneficiary, the program provides existing policy as discussed in the prior CMS also finalized a proposal to require
payment for the unused and discarded paragraph in Chapter 17 of the Medicare billing providers to report the JZ
amount, as well as the dose Claims Processing Manual,25 and modifier for all such drugs with no
administered, up to the amount of the required that billing providers report the discarded drug amounts, beginning no
drug indicated on the vial or package JW modifier for all separately payable later than July 1, 2023. Specifically, as
labeling. On a Medicare Part B claim, drugs with discarded drug amounts discussed in the CY 2023 PFS proposed
the JW modifier (drug amount from single-dose containers or single- rule (87 FR 46058), we proposed to
discarded/not administered to any use packages payable under Part B, require the use of a separate modifier,
patient) is a Healthcare Common beginning January 1, 2023. These the JZ modifier, to attest that there were
Procedure Coding System (HCPCS) changes were promulgated in no discarded amounts. We stated that to
Level II modifier used to report the connection with the implementation of align with the JW modifier policy, the
amount of a drug that is discarded and the discarded drug refund program JZ modifier would be required when
eligible for payment. under section 90004 of the there are no discarded amounts from
Beginning on January 1, 2017, CMS Infrastructure Investment and Jobs Act single-dose containers or single-use
revised the Medicare Part B JW modifier (Pub. L. 117–9, November 15, 2021). In packages payable under Part B for
policy to require the uniform use of the that same CY 2023 PFS final rule (87 FR which the JW modifier would be
modifier for all claims for separately 69722), we responded to commenters required if there were discarded
payable drugs with discarded drug who requested we exempt drugs paid amounts. Table 9 provides additional
amounts from single-dose containers or for under the ESRD PPS bundled information about these modifiers.
TABLE 9 - JW and JZ Short and Long Descriptors
SHORT DESCRIPTOR LONG DESCRIPTOR

MODIFIER (28-character limit)
JW Discarded drug not Drug amount discarded/not administered to any
administered patient
JZ Zero drug wasted Zero drug amount discarded/not administered to any
patient
We explained that on all claims for package, record discarded amounts in (2) Current Reporting of the JW Modifier
single-dose containers or single-use the patient medical record, and specify Under the ESRD PPS
packages payable under Part B, either administered and discarded amounts on
As we discussed in the CY 2024 ESRD
the JW modifier would be used (on a the claim form. We finalized the JZ PPS proposed rule, the Medicare Part B
separate line) to identify any discarded modifier requirement in the CY 2023 JW modifier policy generally does not
amounts or the JZ modifier (on the PFS final rule. Lastly, we noted in the apply to drugs that are not separately
claim line with the administered CY 2023 PFS final rule that we would payable. The ESRD PPS statute
amount) would be present to attest that begin claims edits for both the JW and generally requires a single bundled
there were no discarded amounts. We JZ modifier beginning October 1, 2023 payment for renal dialysis services.
noted that we believed the JZ modifier (87 FR 69179). Additional details can be Specifically, section 1881(b)(14)(A)(i)
requirement would not increase burden found in Chapter 17 of the Medicare requires the Secretary to implement a
on the provider, because under the Claims Processing Manual and the JW/ payment system under which a single
current JW modifier policy, the provider JZ modifier frequently asked questions payment is made to a provider of
already needs to determine whether (FAQ) document.26 services or a renal dialysis facility for
there are any discarded units from a renal dialysis services in lieu of any
single-dose container or single-use other payment. The only exception is
22 https://www.fda.gov/media/117883/download. 24 MLN Matters® Number MM9603: https:// 26 https://www.cms.gov/Medicare/Medicare-Fee-
23 CR6603:
https://www.cms.gov/Regulations- www.hhs.gov/guidance/sites/default/files/hhs- for-Service-Payment/HospitalOutpatientPPS/
and-Guidance/Guidance/Transmittals/Downloads/ guidance-documents/mm96033.pdf. Downloads/JW-Modifier-FAQs.pdf.
25 https://www.cms.gov/regulations-and-
R3538CP.pdf.
guidance/guidance/manuals/downloads/
ER06NO23.012</GPH>
clm104c17.pdf.
for oral-only drugs, as defined at Current guidance in Chapter 17, section Additionally, we have previously
§ 413.234(a), which are currently paid 40.1 of the Medicare Claims Processing established in the CY 2012 ESRD PPS
separately under Medicare Part D. Manual states that the ESRD facility final rule (76 FR 70243 through 70244)
Section 204 of ABLE amended section must bill the program using the JW that ESRD facilities may only report
632(b)(1) of ATRA, as amended by modifier for the amount of ESAs units and charges for drugs and
section 217(a)(1) of PAMA, to provide appropriately discarded if the home biological products purchased and may
that payment for oral-only renal dialysis dialysis patient must discard a portion not bill for overfill units of drugs and
drugs and biological products cannot be of the ESA supply due to expiration of biological products which exceed the
made under the ESRD PPS bundled a vial, because of interruption in the amount indicated on the vial or package
payment prior to January 1, 2025. We patient’s plan of care, or unused ESAs labeling.31 Additionally, we explained
noted that although the ESRD PPS on hand after a patient’s death. We that consistent with prior rulemaking,
includes certain add-on payment noted that separate payment is not made under our authority in section
adjustments such as the TDAPA and for ESAs under the ESRD PPS; however, 1881(b)(14)(D)(ii) of the Act, we were
TPNIES, these are adjustments to the ESAs are eligible for outlier payments adopting the average sales price (ASP)
ESRD PPS base rate and therefore part when the criteria in § 413.237 are met. policy on overfill for purposes of
of the single payment made under the Most recently, the March 15, 2022, calculating the outlier payment. That is,
ESRD PPS; these payment adjustments Change Request 30 that established the we adopted a policy to exclude overfill
are not separate payments. For example, TDAPA for Korsuva® (difelikefalin) units of drugs and biological products
as described in our TDAPA instructs facilities to use the JW which exceed the amount indicated on
implementation guidance issued August modifier to report the amount of the vial or package labeling from
4, 2017, and updated January 10, 2018, difelikefalin that is discarded and consideration for the purposes of
available on the CMS website at https:// eligible for payment under the ESRD calculating outlier payments. We stated
www.cms.gov/Regulations-and- PPS. We noted that based on the latest we believe the use of the ASP policy for
Guidance/Guidance/Transmittals/ available data at the time of the CY 2024 purposes of calculating the outlier
2018Downloads/R1999OTN.pdf, the ESRD PPS proposed rule, nearly 40 payment is appropriate because we
methodology used to calculate the per percent of the TDAPA expenditures for believe overfill does not represent a cost
treatment payment amount incorporates those drugs that were reported in 2022 to the ESRD facility; thus, overfill
the cost of the drugs that are paid for represented discarded amounts reported should not factor into our determination
using the TDAPA. using the JW modifier, which of outlier payments.
Although renal dialysis drugs and represented approximately $1.3 million In summary, our longstanding policy
biological products paid for under the in TDAPA expenditures for discarded for payment under the ESRD PPS,
ESRD PPS are not considered amounts of difelikefalin. Overall, our including the calculation of the TDAPA
‘‘separately billable’’ and are not subject analysis of Medicare claims data from and outlier payment adjustments,
to the general Part B JW modifier policy 2017 to 2021 found that approximately includes payment for units of renal
discussed in the prior paragraph, CMS 2 percent of ESRD PPS claims indicate dialysis drugs and biological products
has previously issued guidance on the discarded or unused portions of drugs billed with the JW modifier, but does
use of the JW modifier on ESRD PPS or biological products through use of the not allow payment for overfill units.
claims for certain circumstances. JW modifier. We estimated that the total That is, the current ESRD PPS payment
Chapter 8, section 60.4.5.1 of the amount of unused product billed from policy is consistent with the broader
Medicare Claims Processing Manual 2017 to 2021 and paid for under the Medicare Part B policy to pay for the
pertains to self-administered supplies of ESRD PPS is approximately $22 million. unused and discarded amount, as well
ESAs.27 Under current guidance, when We explained in the CY 2024 ESRD as the dose administered, up to the
billing for discarded amounts of drugs PPS proposed rule that, under our amount of the drug indicated on the vial
in accordance with the policy in chapter current policy, we do not reduce the or package labeling.
17 of this manual, section 40.1, the single payment under the ESRD PPS for
provider must bill for discarded any discarded amounts of renal dialysis (3) ESRD PPS Policy for Reporting of
amounts on a separate line item with drugs or biological products that are Discarded Amounts of Renal Dialysis
the modifier JW. The line-item date of reported with the JW modifier. Drugs and Biological Products
service should be the date of the last Furthermore, when calculating any As discussed in the CY 2024 ESRD
covered administration according to the adjustments to the ESRD PPS base rate PPS proposed rule (88 FR 42464) and in
plan of care or, if the patient dies, use for the TDAPA or outlier payments, we section II.B.1.j of this final rule, we are
the date of death. More specifically, in include all units of renal dialysis drugs undertaking analysis of ESRD PPS
Chapter 17, section 40.1 of the Medicare and biological products billed on the claims and cost report data to better
Claims Processing Manual,28 we state claim for which an adjustment is made, understand the patient-specific costs
that multi-use vials are not subject to including any discarded amounts of associated with furnishing renal dialysis
payment for discarded amounts of drug such drugs and biological products. services to Medicare beneficiaries. We
or biological products, with the
exception of self-administered ESAs by equipment and supplies from a supplier that was 31 We explained in the CY 2011 PFS final rule (75
Method I home dialysis patients, for not a Medicare approved dialysis facility. This was FR 73466) that we had become aware of situations
whom an ESRD facility furnishes and referred to as Method II home dialysis. In the CY where manufacturers intentionally included a small
2011 ESRD PPS final rule (75 FR 49061), we stated amount of overfill in drug containers, and that this
bills for renal dialysis services.29 that all costs associated with home dialysis services overfill is provided at no extra charge to the
(both Method I and Method II) are included in the provider. We also noted that we understood the
27 https://www.cms.gov/Regulations-and-
composite portion of the two equation model, and intent of the intentional overfill was to compensate
Guidance/Guidance/Manuals/Downloads/ we stated that effective January 1, 2011, all home for product loss during the proper preparation and
clm104c08.pdf. ESRD patients would be considered Method I home administration of a drug. We explained that ASP
28 https://www.cms.gov/regulations-and- patients and all Medicare payments for home calculations are based on data reported by
guidance/guidance/manuals/downloads/ dialysis services would be made to the ESRD manufacturers, including ‘‘volume per item’’.
clm104c17.pdf. facility. Therefore, providers may only bill for the amount
29 Prior to the ESRD PPS, a Medicare ESRD 30 https://www.cms.gov/files/document/ of drug product actually purchased and the cost
beneficiary could elect to obtain home dialysis r11295CP.pdf. that the product represents (75 FR 73467).
stated in the proposed rule that in under the ESRD PPS bundled payment are properly resubmitted.33 We also
considering potential refinements to the for discarded amounts of renal dialysis stated that if this proposal is finalized,
ESRD PPS case-mix adjustments in the drugs and biological products, and such CMS would publish information about
future, it is important to understand and discarded amounts are included in the which HCPCS codes would be
have consistent data about the costs calculation of the ESRD PPS base rate identified as single-dose containers or
associated with the quantities of the and any applicable adjustments, such as single-use package renal dialysis drugs
renal dialysis drugs and biological the TDAPA and the outlier adjustment. and biological products subject to
products that are used by ESRD Therefore, consistent with the current required reporting of the JW or JZ
beneficiaries. This is consistent with our JW and JZ reporting requirements that modifier. We also stated that we would
longstanding policy principles, which were finalized in the CY 2023 PFS final plan to issue guidance regarding
are reflected by our policy for billing for rule for separately payable Part B drugs, additional operational considerations
unused amounts of renal dialysis drugs we proposed to require that beginning and billing instructions specific to the
and biological products under the ESRD reporting requirements for these
no later than January 1, 2024, ESRD
PPS. In the CY 2016 ESRD PPS final products.
facilities must report information on We further clarified that, under our
rule (80 FR 69033), we discussed our
existing policy since the inception of ESRD PPS claims about the total proposal, ESRD facilities would not be
the ESRD PPS that all renal dialysis number of billing units of any discarded required to document in the
service drugs and biological products amount of a renal dialysis drug or beneficiary’s medical record when there
prescribed for ESRD patients, including biological product from a single-dose are no discarded amounts. We reiterated
the oral forms of renal dialysis container or single-use package that is in the CY 2024 ESRD PPS proposed rule
injectable drugs, must be reported by paid for under the ESRD PPS, using the that, as discussed in the CY 2023 PFS
ESRD facilities, and the units reported JW modifier (or any successor modifier final rule (87 FR 69722), units for renal
on the monthly claim must reflect the that includes the same data). We also dialysis drugs and biological products
amount expected to be taken during that proposed that ESRD facilities must that are bundled under the Medicare
month. We stated that ESRD facilities document any discarded amounts in the ESRD PPS would not be subject to the
should use the best information they beneficiary’s medical record. Medicare Part B discarded drug refund
have in determining the amount Additionally, we proposed to require program and would continue to be
expected to be taken in a given month, ESRD facilities to report the JZ modifier exempted from the Medicare Part B
including fill information from the for all such renal dialysis drugs and discarded drug refund. We also clarified
pharmacy and the patient’s plan of care. biological products with no discarded that for any oral-only drugs, as defined
We noted that any billing system amounts, beginning no later than in § 413.234(a), to the extent that any
changes to effectuate this change needed January 1, 2024. We proposed to codify such drugs are produced in single-dose
to be made as soon as possible, as this these reporting requirements in containers or single-use packaging, this
requirement had been in effect since the regulation at § 413.198(b)(5) and (6). proposed reporting requirement would
ESRD PPS began in 2011. This policy is not apply until such drugs are paid for
We proposed the amount of a renal
also discussed in the Medicare Benefits under the ESRD PPS.
dialysis drug or biological product from We stated that we believe this
Policy Manual, Pub. 100–02, Chapter
a single-dose container or single-use reporting requirement would enable
11, section 20.3.C.32
Consistent with our longstanding package that is administered would be CMS to obtain more reliable information
billing policies for unused amounts of billed on one line (reflected as billing about the extent to which the costs of
drugs and biological products and units in the unit field) and any providing renal dialysis drugs and
consistent with the requirements for the discarded amounts would be billed on biological products represent amounts
uniform use of the JW modifier for all a separate line with the JW modifier that beneficiaries use as well as amounts
claims for separately payable drugs (reflected as billing units in the unit that are discarded. We explained that
under Part B since 2017, to more field). If a renal dialysis drug or we believe this is particularly important
effectively identify and monitor billing biological product from a single-dose because under Medicare Part B,
and payment for discarded amounts of container or single-use package is beneficiaries are responsible for paying
drugs, in the CY 2024 ESRD PPS administered and there are no discarded a 20 percent coinsurance. As noted
proposed rule, we proposed to require amounts, then we proposed that a single previously, nearly 40 percent of TDAPA
ESRD facilities to report accurate and line would be billed on the claim form expenditures in CY 2022 represented
consistent data about discarded with the JZ modifier and the billing discarded amounts of renal dialysis
amounts of single-dose renal dialysis units in the unit field. Therefore, on all drugs and biological products. Medicare
drugs and biological products paid claims for renal dialysis drugs and beneficiaries, therefore, paid
under the ESRD PPS. Further, section biological products from single-dose approximately $260,000 in copayments
1881(b)(2)(B) of the Act requires the containers or single-use packages for these discarded amounts. While this
Secretary to prescribe in regulations any payable under the ESRD PPS, we currently represents a small amount of
methods and procedures to determine proposed that either the JW modifier payments overall, the cost for discarded
the costs incurred by ESRD facilities in would be used (on a separate line) to renal dialysis drugs and biological
furnishing renal dialysis services to identify any discarded amounts or the products is borne by a very small
beneficiaries with ESRD, and to JZ modifier (on the claim line with the population of beneficiaries. We stated
determine payment amounts for Part B administered amount) would be present that it is important for CMS to
services furnished by such ESRD to attest that there were no discarded

facilities. amounts. We proposed that claims for
33 Under the basic requirements for all claims at
We noted that, under our § 424.32(a)(1), a claim must be filed with the
renal dialysis drugs and biological appropriate intermediary or carrier on a form
longstanding policy, payment is made products from single-dose containers or prescribed by CMS in accordance with CMS
single-use packages that do not report instructions. Chapter 1 of the Medicare Claims
32 https://www.cms.gov/regulations-and- Processing Manual, section 70.2.3.1 states that
guidance/guidance/manuals/downloads/
either the JW or JZ modifier may be submissions that are found to be incomplete or
bp102c11.pdf. returned as un-processable until claims invalid are returned to the provider (RTP).
understand the full scope of biological products as well. We invited regarding this requirement no later than
expenditures, including expenditures comments on this assumption and on January 1, 2024.
that may be incurred by beneficiaries, the proposed JW and JZ reporting Comment: Many commenters stated
for discarded amounts of renal dialysis requirements for the ESRD PPS. that although they understand and agree
drugs and biological products in the We received public comments on our with CMS’s need to better understand
future, which may be more expensive or proposal to require the reporting of the patient-specific costs associated with
more widely used than the current drug JW and JZ modifiers on ESRD PPS furnishing renal dialysis services to
that is being paid for using the TDAPA claims. The comments on our proposal Medicare beneficiaries, they did not
under the ESRD PPS. Thus, we did not and our responses are set forth below. agree that the proposed collection of
propose in the CY 2024 ESRD PPS Comment: Several commenters raised information about the JW and JZ
proposed rule to alter payments to ESRD concerns about the lead time needed to modifiers on claims was appropriate or
facilities based on the amounts of operationalize the proposed changes to relevant. Several commenters expressed
discarded renal dialysis drugs and report the JW and JZ modifiers on ESRD their belief that Medicare beneficiaries
biological products reported, but noted PPS claims. Commenters expressed that do not incur additional coinsurance for
that data collected through adoption of a minimum of six months after the renal dialysis drugs and biological
the JW and JZ modifier reporting publication of detailed guidance would products that are paid under the ESRD
requirements discussed in that section be needed to reprogram systems and PPS bundled payment, and therefore
of the proposed rule may inform future train staff to comply with the proposed information about discarded amounts
payment policies, which would be requirements. Other commenters noted would not be relevant to ESRD PPS
proposed through future notice and that, especially for independent ESRD payment. Several commenters
comment rulemaking if appropriate. facilities, a longer lead time of one year encouraged CMS to withdraw the
may be appropriate. Specifically, proposed reporting requirement.
Based on our analysis of ESRD PPS commenters expressed that ESRD Response: We appreciate the concerns
claims, as well as the billing guidance facilities would need to implement raised by commenters. We are not
in sections 8 and 17 of the Medicare extensive changes to their policies and withdrawing the proposed reporting
Claims Processing Manual, we stated procedures, including aligning requirement. We do not agree with the
that we believe the JW modifier information from numerous commenters’ assertion that discarded
requirement reflects current practices independent medical record systems, amounts of renal dialysis drugs and
for ESRD facilities and would not and that such activities could not begin biological products paid under the
significantly increase burden for ESRD in earnest until detailed guidance about ESRD PPS have no impact on payment,
facilities. Additionally, we stated that these reporting requirements is or that Medicare beneficiaries do not
we believe the JZ modifier requirement available. Several commenters urged incur additional coinsurance for such
would not increase burden on ESRD CMS to commit to publishing guidance discarded amounts. As we discussed in
facilities, because under the current by January 1, 2024, and to modify the the CY 2024 ESRD PPS proposed rule,
guidance provided regarding use of the effective date of the proposed JW and JZ certain ESRD PPS payment adjustments,
JW modifier, the ESRD facility should modifier reporting requirement to begin specifically the outlier adjustment and
already have processes in place to no earlier than January 1, 2025. the TDAPA, are dependent upon the
determine, in the case of certain drugs Response: We thank commenters for amount of renal dialysis drugs and
and biological products, whether or not their detailed comments regarding the biological products billed on an ESRD
there are any discarded units from a operational changes needed to comply PPS claim. For renal dialysis drugs and
single-dose container or single-use with the proposed reporting biological products from single-dose
package, record discarded amounts in requirement. As commenters pointed containers or single-use packaging
the patient medical record, and specify out, although ESRD facilities may have which are eligible for such payment
administered and discarded amounts on processes in place to track amounts of adjustments, discarded amounts
the claim form. Furthermore, we noted discarded drugs, these processes may contribute directly to increased ESRD
that while renal dialysis drugs and not be uniformly applied to all drugs. PPS payment as well as increased
biological products that are paid under We recognize the importance of beneficiary copays. Furthermore,
the ESRD PPS are not considered providing ESRD facilities the because the ESRD PPS base rate
separately payable, ESRD facilities are appropriate amount of time to adjust includes payment for renal dialysis
permitted to bill and receive separate systems and train staff to expand the drugs and biological products,
payment using the AY modifier for scope of drugs to which existing discarded amounts of renal dialysis
drugs and biological products that are processes are applied. In light of the drugs and biological products from
not related to the treatment of ESRD. operational needs that commenters single-dose containers and single-use
Although we noted that renal dialysis described, we are modifying the packaging contribute to overall
drugs and biological products paid effective date of this reporting increases in the ESRD PPS base rate and
under the ESRD PPS are not subject to requirement to begin January 1, 2025, the amount of beneficiary coinsurance.
the Medicare Part B drug refund instead of January 1, 2024. Commenters Comment: Several commenters
program or the current JW or JZ indicated that for certain independent expressed concerns about the
reporting requirements, any separately facilities, 1 year would provide application of the proposed reporting
payable drugs, or biological products sufficient time to train staff and update requirements for home dialysis patients
that ESRD facilities bill for using the AY systems as needed to comply with the and for any oral-only drugs from single-
modifier would be subject to such reporting requirements we are finalizing dose containers or single-use packaging
policies under Medicare Part B. in this final rule. We believe extending that may, after January 1, 2025, be paid
Therefore, we explained that we believe the effective date of the requirement by under the ESRD PPS. Commenters
most ESRD facilities should already be 1 year strikes an appropriate balance expressed concern about ESRD
reporting the JW and JZ modifiers in between the need to collect this data facilities’ ability to accurately document
such circumstances and would and ESRD facilities’ need to make the discarded amounts of such drugs
reasonably be able to report these operational changes. We intend to and biological products that are not
modifiers for renal dialysis drugs and publish detailed operational guidance administered at the ESRD facility. One
commenter noted that CMS’s current drugs and biological products from refunds from manufacturers for
policy applies to a very limited number multi-use vials should not be billed on discarded amounts of drugs, apply only
of patients and ESAs, but the proposed ESRD PPS claims. to separately payable drugs and
expansion of this policy could apply to Comment: Many commenters biological products and do not apply to
a broader range of ESAs, calcimimetics, requested that CMS provide additional drugs and biological products paid for
intravenous iron, and more products. clarity about how information about under the ESRD PPS. We believe that
The same commenter noted that most discarded drug amounts may be used in collecting more complete information
home dialysis patients use multi-use the future to inform payment policy. about discarded amounts of renal
vials, to which the current JW Commenters pointed out that packaging dialysis drugs and biological products
requirement does not apply. for drugs and biological products is from single-dose containers and single-
Commenters urged CMS to exempt oral- controlled by manufacturers and FDA, use packaging will help CMS to more
only drugs and renal dialysis drugs and rather than by ESRD facilities, and fully evaluate the impact that such
biological products used by home expressed concern that data collected discarded amounts have on both
dialysis patients from the proposed under this proposed reporting policy Medicare payments and beneficiary
reporting requirements or clarify that would be used in the future to reduce copayments.
ESRD facilities can report the amount of ESRD PPS payments. Commenters Lastly, we are reiterating that we are
such drugs in good faith. stated that ESRD facilities are already not applying any penalties for
Response: We thank commenters for incentivized, by the nature of the ESRD noncompliance with this reporting
PPS, to minimize the amount of requirement for discarded amounts;
their detailed comments regarding the
discarded renal dialysis drugs and however, as we noted in the CY 2024
applicability of the proposed reporting
biological products to the extent ESRD PPS proposed rule (88 FR 42455),
requirement for renal dialysis drugs and
possible. One commenter stated that the claims for renal dialysis drugs and
biological products paid under the
underlying issue of waste can only be biological products from single-dose
ESRD PPS that are administered outside
solved by holding the manufacturers containers or single-use packages that
of an ESRD facility. Consistent with our
responsible. Some commenters do not report either the JW or JZ
longstanding policy discussed in the CY
requested clarification on whether CMS modifier may be returned as un-
2016 ESRD PPS final rule (80 FR 69033),
intends to apply penalties for non- processable until the claims are
all renal dialysis service drugs and
compliance with the JW and JZ modifier properly resubmitted.
biological products prescribed for ESRD reporting requirements. Final Rule Action: We are finalizing
patients, including the oral forms of Response: As we noted in the CY the proposed reporting requirement for
renal dialysis injectable drugs, must be 2024 ESRD PPS proposed rule, we did discarded amounts of renal dialysis
reported by ESRD facilities, and the not propose any reduction to ESRD PPS drugs and biological products from
units reported on the monthly claim payments based on the amounts of single-dose containers and single-use
must reflect the amount expected to be discarded renal dialysis drugs and packaging, with a modified effective
taken during that month. Accordingly, biological products reported using the date of January 1, 2025. Therefore,
with respect to reporting discarded JW modifier. As we noted in the CY consistent with the current JW and JZ
amounts of renal dialysis drugs and 2024 ESRD PPS proposed rule, we reporting requirements that were
biological products that are intend to analyze information about finalized in the CY 2023 PFS final rule
administered to home dialysis patients discarded amounts in the broader for separately payable Part B drugs, we
and oral forms of renal dialysis drugs context of changes to the ESRD PPS are finalizing that beginning no later
and biological products, ESRD facilities case-mix adjustments and may propose than January 1, 2025, ESRD facilities
should use the best information they changes in future rulemaking if must report information on ESRD PPS
have in determining the amount appropriate. We appreciate and agree claims about the total number of billing
expected to be discarded in a given with commenters’ assertions that ESRD units of any discarded amount of a renal
month, including fill information from facilities have limited control over the dialysis drug or biological product from
the pharmacy and the patient’s plan of amount of discarded renal dialysis a single-dose container or single-use
care. Consistent with current guidance drugs and biological products, and that package that is paid for under the ESRD
in Chapter 17, section 40.1 of the ESRD facilities are required to discard PPS, using the JW modifier (or any
Medicare Claims Processing Manual, any remaining amounts from a single- successor modifier that includes the
ESRD facilities must bill the program dose container or single-use packaging same data). We are also finalizing that
using the JW modifier for the amount of that are not used by the patient. As we ESRD facilities must document any
ESAs appropriately discarded if the discussed in the CY 2024 ESRD PPS discarded amounts in the beneficiary’s
home dialysis patient must discard a proposed rule, we have previously medical record. Additionally, we are
portion of the ESA supply due to established in the CY 2012 ESRD PPS finalizing that ESRD facilities must
expiration of a vial, because of final rule (76 FR 70243 through 70244) report the JZ modifier for all such renal
interruption in the patient’s plan of that ESRD facilities may only report dialysis drugs and biological products
care, or unused ESAs on hand after a units and charges for drugs and with no discarded amounts, beginning
patient’s death. In response to the biological products purchased and may no later than January 1, 2025. We are
commenter’s statement about the use of not bill for overfill units of drugs and finalizing a modification to the
multi-use vials by home dialysis biological products which exceed the proposed regulation text to clarify that
patients, we are reiterating that amount indicated on the vial or package for renal dialysis drugs and biological
discarded amounts should only be
labeling. We recognize that products from single-dose containers

reported for drugs and biological manufacturers of renal dialysis drugs and single-use packaging that are
products from single-dose containers or and biological products are ultimately administered to home dialysis patients
single-use packaging. ESRD facilities responsible for decisions about or that are oral forms of renal dialysis
should not report discarded amounts of packaging, which drive the magnitude injectable drugs, the ESRD facility
renal dialysis drugs or biological of discarded amounts. As some should report the amount of such drugs
products from multi-use vials. commenters noted, current provisions at and biological products expected to be
Discarded amounts of renal dialysis §§ 414.902 and 414.940, which require discarded. We are finalizing our
proposal to codify these reporting product is considered included in the Type 5 in combination with Type 2, or
requirements in regulation at ESRD PPS bundled payment and no Type 9 when the ‘‘parent NDA’’ is a
§ 413.198(b)(5) and (6), with changes to separate payment is available. The new Type 3, 5, 7, or 8, effective January 1,
indicate that the January 1, 2025, injectable or IV product qualifies as an 2020.
effective date applies to each of these outlier service. We noted in that rule Under our current TDAPA policy at
requirements. that the productivity-adjusted ESRDB § 413.234(c), a new renal dialysis drug
market basket update is used to increase or biological product that falls within an
i. New Add-On Payment Adjustment for the ESRD PPS base rate annually and existing ESRD PPS functional category
Certain New Renal Dialysis Drugs and accounts for price changes of the drugs is considered included in the ESRD PPS
Biological Products After the TDAPA and biological products. We also base rate and is paid the TDAPA for 2
Period Ends finalized in the CY 2016 ESRD PPS final years. After the TDAPA period, the
(1) Background on the TDAPA rule that, if the new renal dialysis ESRD PPS base rate will not be
Section 217(c) of PAMA required the injectable or IV product does not fall modified. If the new renal dialysis drug
within an existing functional category, or biological product does not fall
Secretary to establish a process for
the new injectable or IV product is not within an existing ESRD PPS functional
including new injectable and
considered included in the ESRD PPS category, it is not considered included
intravenous (IV) products into the ESRD
bundled payment and the following in the ESRD PPS base rate, and it will
PPS bundled payment as part of the CY
steps occur. First, an existing ESRD PPS be paid the TDAPA until sufficient
2016 ESRD PPS rulemaking. Therefore,
functional category is revised or a new claims data for rate setting analysis is
in the CY 2016 ESRD PPS final rule (80
ESRD PPS functional category is added available, but not for less than 2 years.
FR 69013 through 69027), we finalized
for the condition that the new injectable After the TDAPA period, the ESRD PPS
a process based on our longstanding
or IV product is used to treat or manage. base rate will be modified, if
drug designation process that allowed
Next, the new injectable or IV product appropriate, to account for the new
us to include new injectable and renal dialysis drug or biological product
is paid for using the TDAPA codified in
intravenous products into the ESRD PPS in the ESRD PPS bundled payment.
§ 413.234(c). Finally, the new injectable
bundled payment and, when As discussed in the CY 2019 and CY
or IV product is added to the ESRD PPS
appropriate, modify the ESRD PPS 2020 ESRD PPS final rules, for new
bundled payment following payment of
payment amount. We codified this renal dialysis drugs and biological
the TDAPA.
process in our regulations at § 413.234. In the CY 2016 ESRD PPS final rule, products that fall into an existing ESRD
We finalized that the process is we finalized a policy in § 413.234(c) to PPS functional category, the TDAPA
dependent upon the ESRD PPS pay the TDAPA until sufficient claims helps ESRD facilities to incorporate new
functional categories, consistent with data for rate setting analysis for the new drugs and biological products and make
the drug designation process we have injectable or IV product are available, appropriate changes in their businesses
followed since the implementation of but not for less than 2 years. The new to adopt such products, provides
the ESRD PPS in 2011. As we explained injectable or IV product is not eligible additional payments for such associated
in the CY 2016 ESRD PPS final rule (80 as an outlier service during the TDAPA costs, and promotes competition among
FR 69014), when we implemented the period. We established that following the products within the ESRD PPS
ESRD PPS, drugs and biological the TDAPA period, the ESRD PPS base functional categories, while focusing
products were grouped into functional rate will be modified, if appropriate, to Medicare resources on products that are
categories based on their action. This account for the new injectable or IV innovative (83 FR 56935; 84 FR 60654).
was done to add new drugs or biological product in the ESRD PPS bundled For new renal dialysis drugs and
products with the same functions to the payment. biological products that do not fall
ESRD PPS bundled payment as In the CYs 2019 and 2020 ESRD PPS within an existing ESRD PPS functional
expeditiously as possible after the drugs final rules (83 FR 56927 through 56949 category, the TDAPA is a potential
are commercially available, so and 84 FR 60653 through 60677, pathway toward a potential ESRD PPS
beneficiaries have access to them. As we respectively), we made several revisions base rate modification (83 FR 56935).
stated in the CY 2011 ESRD PPS final to the drug designation process For the complete history of the TDAPA
rule, we did not specify all the drugs regulations at § 413.234. In the CY 2019 policy, including the pricing
and biological products within these ESRD PPS final rule, we revised the methodology, see the CY 2016 ESRD
categories, because we did not want to regulations at § 413.234(a), (b), and (c) to PPS final rule (80 FR 69023 through
inadvertently exclude drugs that may be reflect that the process applies for all 69024), CY 2019 ESRD PPS final rule
substitutes for drugs we identified, and new renal dialysis drugs and biological (83 FR 56932 through 56948), and CY
we wanted the ability to reflect new products that are FDA approved 2020 ESRD PPS final rule (84 FR 60653
drugs and biological products regardless of the form or route of through 60681).
developed or changes in standards of administration. In addition, we revised
practice (75 FR 49052). § 413.234(b) and (c) to expand the (2) Request for Information in the CY
In the CY 2016 ESRD PPS final rule, TDAPA to all new renal dialysis drugs 2023 ESRD PPS Proposed Rule
we finalized the definition of an ESRD and biological products, rather than just In the CY 2023 ESRD PPS proposed
PPS functional category in § 413.234(a) those in new ESRD PPS functional rule (87 FR 38522 through 38523), we
as a distinct grouping of drugs or categories. In the CY 2020 ESRD PPS summarized the concerns of interested
biologicals, as determined by CMS, final rule, we revised § 413.234(b) and parties and issued a request for
whose end action effect is the treatment information about methods that could
added paragraph (e) to exclude from

or management of a condition or TDAPA eligibility generic drugs be used to develop an add-on payment
conditions associated with ESRD (80 FR approved by FDA under section 505(j) adjustment for certain new renal
69077). We finalized a policy in the CY of the Federal Food, Drug, and Cosmetic dialysis drugs and biological products
2016 ESRD PPS final rule that if a new Act and drugs for which the new drug after the end of the TDAPA. We
renal dialysis injectable or IV product application (NDA) is classified by FDA explained that since 2019, dialysis
falls within an existing functional as Type 3, 5, 7, or 8, Type 3 in associations and pharmaceutical
category, the new injectable drug or IV combination with Type 2 or Type 4, or representatives have expressed concerns
to CMS about payment following the and of prospective payment systems in Following the discussion in the CY
TDAPA period for new renal dialysis general is for ESRD facilities to be 2023 ESRD PPS proposed rule about
drugs and biological products that are efficient in their resource use. these potential methodologies, we
paid for using the TDAPA. We noted We also noted that price changes to issued a request for information within
that these interested parties have the ESRD PPS bundled payment are that proposed rule (87 FR 38523) to seek
asserted that unless money is added to updated annually by the productivity- feedback from the public on the need for
the ESRD PPS base rate for these drugs adjusted ESRDB market basket update, an add-on payment adjustment of this
and biological products, like what which includes a pharmaceutical cost kind and the potential methodologies
occurred with calcimimetics (85 FR category weight. In addition, we for calculating such an add-on payment
71406 through 71410), then it is explained that our analysis of renal adjustment. We noted that while we
unlikely that ESRD facilities would be dialysis drugs and biological products would not be responding to specific
able to sustain the expense of these paid for under the ESRD PPS has found comments submitted in response to this
drugs and biological products when the costs and utilization to have decreased RFI, we intended to use this input to
TDAPA period ends. Further, these over time for some high volume inform future policy development. We
interested parties cautioned that formerly separately billable renal stated that any potential payment
uncertainty about payment could affect dialysis drugs, relative to overall ESRDB policies related to this RFI would be
ESRD facility adoption of these drugs market basket growth. Therefore, we proposed through a separate notice and
and biological products during the stated that we believe that any potential comment rulemaking.
TDAPA period. We noted that to date, methodology for an add-on payment We provided a high-level summary of
calcimimetics are the only renal dialysis adjustment in these circumstances responses to this RFI in the CY 2023
drugs or biological products that have should adapt to changes in price and ESRD PPS final rule (87 FR 67219
been paid for using the TDAPA and utilization over time. through 67220) and noted that we
incorporated into the ESRD PPS We noted that section would publish more detailed
bundled payment following the TDAPA 1881(b)(14)(D)(iv) of the Act provides information about the commenters’
payment period. We stated that there recommendations in a future posting on
that the ESRD PPS may include such
have been no other renal dialysis drugs the CMS website located at the
other payment adjustments as the
or biological products that have following link: https://www.cms.gov/
Secretary determines appropriate, such
completed their TDAPA payment Medicare/Medicare-Fee-for-Service-
as a payment adjustment—(1) for
period, and as a result, CMS does not Payment/ESRDpayment/Educational_
pediatric providers of services and renal
yet have data on other drugs or Resources. We noted that we received
dialysis facilities; (2) by a geographic
biological products to evaluate the 27 public comments regarding our RFI,
index, such as the index referred to in
specific risks and access challenges that including from large, small, and non-
section 1881(b)(12)(D), as the Secretary
interested parties have raised. profit dialysis organizations; an
determines to be appropriate; and (3) for
advocacy organization; a coalition of
We also discussed that, as mentioned providers of services or renal dialysis dialysis organizations; a large, non-
in the CY 2019 (83 FR 56941) and CY facilities located in rural areas. profit health system; and MedPAC.
2020 (84 FR 60672 and 60693) ESRD Regarding the patient access concerns In the CY 2023 ESRD PPS final rule,
PPS final rules, many commenters have that we discussed in the CY 2023 ESRD we stated that most commenters
suggested a rate-setting exercise at the PPS proposed rule, we stated that we expressed their belief that an add-on
end of the TDAPA period for all new were considering whether it would be payment adjustment of this nature is
renal dialysis drugs and biological appropriate to establish an add-on necessary to support the adoption of
products. We responded to those payment adjustment for certain renal new renal dialysis drugs and biological
comments by noting that we do not dialysis drugs and biological products products, and that most commenters
believe adding dollars to the ESRD PPS in existing ESRD PPS functional stated that they supported CMS
base rate would be appropriate for new categories after their TDAPA period allowing all new renal dialysis drugs
drugs that fall into the ESRD PPS ends. We noted that any add-on and biological products to be eligible to
functional categories, given that the payment adjustment would be subject to receive an add-on payment adjustment
purpose of the TDAPA for these drugs the Medicare Part B beneficiary after the TDAPA period ends. However,
is to help ESRD facilities incorporate coinsurance payment under ESRD PPS. we noted that MedPAC opposed this
new drugs and biological products and In the CY 2023 ESRD PPS proposed type of add-on payment adjustment by
make appropriate changes in their rule, we presented four potential stating that it would undermine
businesses to adopt such products, methods that we were considering, competition with existing drugs in the
provide additional payments for such which we noted could be used to ESRD PPS bundled payment and
associated costs, and promote develop an add-on payment adjustment encourage higher launch prices. We also
competition among the products within for these drugs and biological products. noted that MedPAC recommended that
the ESRD PPS functional categories. In We noted that the methods presented CMS limit the add-on payment
addition, we explained that the ESRD differed in terms of which formerly adjustment to new renal dialysis drugs
PPS base rate already includes money separately billable renal dialysis drugs and biological products that show a
for renal dialysis drugs and biological and biological products would be substantial clinical improvement
products that fall within an existing considered for methodological inclusion compared with existing products
ESRD PPS functional category. We in a potential add-on payment reflected in the ESRD PPS bundled
stated that under a PPS, Medicare makes adjustment. We further noted that under
payment.
payments based on a predetermined, the potential options presented, we We further noted in the CY 2023
fixed amount that reflects the average would apply a reconciliation ESRD PPS final rule that several
patient, and that there would be patients methodology only when an add-on commenters stated they supported
whose treatment costs at an ESRD payment adjustment would align reconciling the expenditure of the new
facility would be more or less than the resource use with payment for a renal renal dialysis drug or biological product
ESRD PPS payment amount. We noted dialysis drug or biological product in an with any reduction in expenditures for
that a central objective of the ESRD PPS existing ESRD PPS functional category. other formerly separately billable renal
dialysis drugs that are clinically or outlier policy, the threshold to qualify planning and budgeting. We also
statistically related to the introduction for outlier payments would increase recognized the importance of providing
of the new renal dialysis drug in the dramatically, thus adversely affecting an appropriate pathway for ESRD
bundle. Several commenters expressed access to products traditionally eligible facilities to incorporate new renal
their belief that the FDA-approved label for the outlier payment adjustment. We dialysis drugs and biological products
should be used to determine the described comments which expressed into their business operations. We noted
primary indication and clinical that this increase in the outlier that in the CY 2019 ESRD PPS final rule
association, rather than end-action threshold may also raise health equity in which we first established the 2-year
effect. MedPAC expressed opposition to concerns because, as we noted in the CY TDAPA period for new renal dialysis
calculating any add-on payment 2023 ESRD PPS final rule (87 FR 67170 drugs and biological products in an
adjustment for new renal dialysis drugs through 67171), the outlier adjustment existing ESRD PPS functional category
and biological products in existing protects access for beneficiaries whose (83 FR 56934), we acknowledged that
ESRD PPS functional categories after the care is unusually costly. We stated that ESRD facilities have unique
TDAPA period ends but noted that if an we recognize that if the outlier circumstances regarding incorporation
add-on payment adjustment were threshold were to increase significantly of new drugs and biological products
applied, it would be appropriate to use due to significant use of a new renal into their standards of care. For
an offset, like the approach used with dialysis drug or biological product after example, we stated that when new
the TPNIES, to avoid duplicative the end of the TDAPA, then ESRD drugs are introduced to the market,
payment for renal dialysis services facilities might be incentivized to avoid ESRD facilities need to analyze their
already included in the ESRD PPS base treating costlier beneficiaries. budget and engage in contractual
rate. Additionally, we described several agreements to accommodate the new
comments that raised concerns about therapies in their care plans. We noted
(3) Add-On Payment Adjustment for the ability of the ESRDB market basket
Certain New Renal Dialysis Drugs and that newly launched drugs and
update to account for the cost of new biological products can be
Biological Products After the TDAPA renal dialysis drugs and biological
Period Ends unpredictable regarding their uptake
products. These commenters referred to and pricing, which makes these
As discussed previously, section a Moran study 35 suggesting that the
decisions challenging for ESRD
1881(b)(14)(D)(iv) of the Act provides drug price proxies used in the ESRDB
facilities. Furthermore, we stated that
that the ESRD PPS may include such market basket have not adequately
practitioners should have the ability to
other payment adjustments as the accounted for the costs of non-ESA
evaluate the appropriate use of a new
Secretary determines appropriate. Based drugs under existing functional
product and its effect on patient
on the public comments received categories. We explained that while we
outcomes. We noted that we agreed this
regarding the RFI in the CY 2023 ESRD continue to believe that the market
uptake period would be best supported
PPS proposed rule,34 we stated in the basket price proxies are the best
by the TDAPA pathway because it
CY 2024 ESRD PPS proposed rule (88 available information for projecting the
would help ESRD facilities transition or
FR 42458) that we believe it is future price growth of renal dialysis
drugs and biological products, and that test new drugs and biological products
appropriate to propose, beginning
they provide an adequate mechanism in their businesses under the ESRD PPS.
January 1, 2024, an add-on payment
for projecting future ESRD PPS price In the CY 2024 proposed rule, we stated
adjustment for new renal dialysis drugs
growth, we recognize that there is that we continue to believe the 2-year
and biological products in existing
additional uncertainty about future TDAPA period is appropriate and
ESRD PPS functional categories after the
trends in the expenditures for new renal achieves its stated goals. However, we
end of the TDAPA period. We noted
dialysis drugs and biological products, also recognized that continuity and
that this proposed payment adjustment
including trends in pricing and predictability is an integral part of ESRD
would not apply to new renal dialysis
utilization of such drugs and any facilities’ ongoing business operations.
drug or biological products used to treat
functionally equivalent substitutes such We stated that we agree with
or manage a condition for which there
as generic drugs.36 We stated that we commenters’ concerns that a sudden
is not an ESRD PPS functional category,
believe these trends could be more decrease in payments after the end of
because we have already established a
effectively analyzed by collecting the TDAPA for these products could
policy to modify the ESRD PPS base rate
additional ESRD facility cost data result in a decrease in access for these
for such products, if appropriate, after
following the 2-year TDAPA period. We new renal dialysis drugs and biological
the TDAPA period ends, to account for
stated that we recognize that although products. We therefore proposed to
the products in the ESRD PPS bundled
the TDAPA for drugs and biological establish a new transitional add-on
payment (§ 413.234(c)(2)(i)).
products in existing ESRD PPS payment adjustment that would provide
We stated that we agreed with
functional categories enables ESRD an appropriate transition of the level of
commenters who expressed concerns
facilities to incorporate new renal payment following the TDAPA period
that the ESRD PPS’ current mechanisms
dialysis drugs and biological products for these drugs. For ease of reference, we
may not fully account for the costs of
into their businesses, additional support proposed to refer to this add-on
these new drugs. We noted that several
may be needed to assure continued payment adjustment as the post-TDAPA
commenters asserted that the outlier
access to such drugs and biological add-on payment adjustment. We stated
adjustment and the ESRDB market
products for Medicare beneficiaries and that our goals for the post-TDAPA add-
basket updates cannot adequately
on payment adjustment are to support
account for these costs, and several to support ESRD facilities’ long-term
Medicare beneficiaries’ access to new
organizations noted that if renal dialysis
35 Kidney Care Partners. August 4, 2022. renal dialysis drugs or biological
drugs and biological products with
Comment Letter. https://kidneycarepartners.org/ products that are used to treat or
significant costs were adopted under the wp-content/uploads/2022/08/KCP-PPS-Comment- manage a condition for which there is
Letter-Part-1-Final.pdf. Accessed May 16, 2023.
34 https://www.cms.gov/files/document/cy-2023- 36 https://www.fda.gov/drugs/frequently-asked- an ESRD PPS functional category and
esrd-pps-payment-after-tdapa-rfi-summary- questions-popular-topics/generic-drugs-questions- that are therefore considered included
comments.pdf. answers. in the ESRD PPS bundled payment. We
also stated that we want to support allowing CMS to incorporate data patients, expressed support for
ESRD facilities’ long-term planning with showing trends in use over an adequate establishing a post-TDAPA add-on
respect to continuing to budget and plan period of time. Additionally, we stated payment adjustment. Commenters
for new renal dialysis drugs and that we believe a 3-year period for the expressed that adequate payment is
biological products that ESRD facilities post-TDAPA add-on payment necessary to support Medicare
have incorporated into their businesses adjustment would be appropriate and beneficiaries’ access to both current and
during the TDAPA period. In addition, consistent with the transition period future new and innovative renal dialysis
we explained that in accordance with that we finalized at the beginning of the drugs and biological products.
the goals of prospective payment under ESRD PPS, when ESRD facilities were Response: We appreciate the support
the ESRD PPS, our goal for the post- transitioned from receiving payments for the proposed post-TDAPA add-on
TDAPA add-on payment adjustment is under the composite rate payment payment adjustment. We agree with
to incentivize ESRD facilities to be system to receiving payments under the commenters about the importance of
efficient in the use of resources. ESRD PPS (79 FR 49162). We finalized adequate payment. As we discussed in
We proposed to calculate the post- the transition period for CY 2011 the CY 2024 ESRD PPS proposed rule
TDAPA add-on payment adjustment through CY 2013 to comply with the and in the following section of this final
following the methodology described in requirement of section 1881(b)(14)(E)(i) rule, we believe the proposed payment
the following subsections for any new of the Act to provide a 4-year phase-in methodology provides a significant level
renal dialysis drug or biological product of the payment amount under the ESRD of payment that adequately supports
that is paid for using the TDAPA under PPS, where full implementation of the beneficiaries’ access to drugs and
ESRD PPS payment would occur biological products after the TDAPA
§ 413.234(c)(1). We proposed that the
beginning in the fourth year, CY 2014. period ends, while sharing a significant
post-TDAPA add-on payment
We proposed a similar timeline to portion of the cost with ESRD facilities,
adjustment would be applied for a
provide an appropriate transition for thereby incentivizing ESRD facilities to
period of 3 years following the end of
new renal dialysis drugs and biological allocate resources efficiently.
the TDAPA period for those products. Comment: MedPAC reiterated several
We stated that we believe a 3-year products in existing ESRD PPS
functional categories, which are not concerns that it previously raised in
payment period would provide response to the RFI on this topic in the
eligible for a modification to the ESRD
sufficient time for CMS to analyze cost CY 2023 ESRD PPS proposed rule. First,
PPS base rate. Based on the experience
reports that include costs for the new MedPAC reiterated its strong opposition
of ESRD facilities during the 4-year
renal dialysis drug or biological product to the establishment of a post-TDAPA
phase-in from CY 2011 to CY 2014,
paid for using the TDAPA under the add-on payment adjustment as
ESRD facilities would be familiar with
ESRD PPS, to incorporate changes as proposed, stating that such a payment
this timeline for phasing in major
appropriate to the ESRDB market basket adjustment would be duplicative of
changes that impact their long-term
price proxies. The ESRDB market basket payment under the ESRD PPS base rate.
planning and budgeting. Lastly, in the
is a fixed-weight, Laspeyres-type price MedPAC specifically identified that
interest of transparency, we noted that
index. A Laspeyres-type price index this 3-year period would provide time when Mircera® (an ESA) became
measures the change in price, over time, for analysis of utilization data for public available in 2015, beneficiary access to
of the same mix of goods and services awareness about the potential need for the new drug was not impeded when
purchased in the base period. We stated refinements to the ESRD PPS. Therefore, the agency included it in the ESRD PPS
that the proposed 3-year payment we proposed to calculate and apply the bundled payment (in a budget-neutral
period for the post-TDAPA add-on post-TDAPA add-on payment manner). Between 2015 and 2020, use of
payment adjustment would allow CMS adjustment for a period of 3 years Mircera® significantly and steadily
to evaluate how the new drug or following the end of the TDAPA period, increased. MedPAC further noted that,
biological product affects the overall with no post-TDAPA add-on payment with respect to Mircera®, one LDO
mix of renal dialysis drugs and adjustment calculated beginning in the announced its intent to have more than
biological products in the ESRDB 4th year. 70 percent of the company’s ESA
market basket and to determine the We proposed that this post-TDAPA patients (110,000 patients) switched to
appropriate price proxies for such new add-on payment adjustment would not Mircera® (from epoetin alfa) by the end
drug or biological product. We noted be budget neutral, as discussed later in of the first quarter of 2016, and sources
that for new renal dialysis drugs and this section of the final rule. We noted suggest that this LDO reduced its total
biological products that are not that this post-TDAPA add-on payment ESA costs. In addition, MedPAC also
considered included in the ESRD PPS adjustment, if finalized, would be reiterated its concerns that CMS would
base rate, the TDAPA is paid until calculated for Korsuva®, the only renal not apply a clinical superiority standard
sufficient claims data for rate setting dialysis drug currently receiving the when implementing the post-TDAPA
analysis for the new renal dialysis drug TDAPA, and that payment of this post- payment adjustment policy and stated
or biological product is available, but TDAPA add-on payment adjustment, if that beneficiaries and taxpayers would
not for less than 2 years. Similarly, as finalized, would begin April 1, 2024, at pay for a new drug without evidence
described earlier in this paragraph, we the end of the TDAPA period for that the new product is an advance in
proposed a 3-year payment period for Korsuva®. medical technology that substantially
the post-TDAPA add-on payment We received several public comments improves beneficiaries’ outcomes
adjustment, which would enable the on our proposal to establish a post- relative to technologies in the ESRD
collection and analysis of sufficient
TDAPA add-on payment adjustment PPS.

Medicare cost report information and beginning in CY 2024. The comments Response: We thank MedPAC for its
would address the concerns that on our proposal and our responses are comments. We recognize and agree with
commenters raised about the set forth below. MedPAC about the importance of
effectiveness of the ESRDB market Comment: Many commenters, avoiding making payments under a
basket price proxies to reflect the prices including LDOs, drug manufacturers, post-TDAPA add-on payment
of new renal dialysis drugs and patient advocacy organizations, adjustment that would be duplicative of
biological products going forward by coalitions of dialysis organizations, and payment under the ESRD PPS base rate
or that would undermine competition agree with commenters’ concerns that a the amount of the post-TDAPA add-on
between new and existing renal dialysis sudden decrease in payments after the payment adjustment will decline
services. We anticipate that the post- end of the TDAPA for these products accordingly.
TDAPA add-on payment adjustment could result in a decrease in access for In addition, we stated in the CY 2024
will provide appropriate payment that these new renal dialysis drugs and ESRD PPS proposed rule that we
supports Medicare beneficiaries’ access biological products. We therefore recognize that continuity and
to new renal dialysis drugs and proposed to establish a new transitional predictability is integral to ESRD
biological products, create stability in add-on payment adjustment that would facilities’ operations, and we do not
payments to ESRD facilities after the provide an appropriate transition of the think that this principle applies only to
end of the TDAPA, and appropriately level of payment following the TDAPA renal dialysis drugs and biological
align incentives to promote competition period for these drugs. products that show a substantial clinical
between new and existing renal dialysis Importantly, we note that under improvement. As we previously
services. The proposed post-TDAPA current regulations at § 413.234, explained in the CY 2023 ESRD PPS
add-on payment adjustment would not Mircera® would not have been eligible final rule (87 FR 67189), the intent of
be duplicative of payment under the for payment under the TDAPA, because the ESRD PPS functional category
ESRD PPS base rate, because it would it was approved under an NDA type that framework is to be broad and to
specifically support access to new renal is excluded from TDAPA eligibility facilitate adding new drugs to the
dialysis services at the level observed under § 413.234(e). In contrast to renal therapeutic armamentarium of the
during the most recent 12 months, dialysis drugs and biological products treating physician. As we further
providing a glidepath for new renal that are paid for using the TDAPA, explained in the CY 2023 ESRD PPS
dialysis drugs and biological products Mircera® was seen as a direct and less final rule, the functional category
in existing functional categories expensive substitute for existing renal structure helps to ensure the ESRD
following the TDAPA, since under dialysis drugs included in the ESRD patient has broad access to all renal
§ 413.234(c)(1), there is no modification PPS, specifically Amgen’s anemia dialysis service drugs, which is a
to the ESRD PPS base rate. As further management drug Epogen®.37 distinct benefit to the patient. In
discussed below, the proposed Accordingly, as MedPAC noted in its addition, the structure of the functional
application of a risk-sharing comment letter, ESRD facilities broadly categories helps to ensure the treating
methodology would account for existing adopted Mircera® into their business physician has a broad array of drugs to
substitute drugs and biological products practices without the need for meet the specific, individual needs of
included in the ESRD PPS. additional payment. However, as each ESRD patient, including differing
explained earlier, we do not consider pharmaceutical profiles, comorbidities,
There are several important Mircera® to be an appropriate contra-indications with other drugs the
distinctions between the historical comparison to new renal dialysis drugs patient may be taking, and personal
inclusion of Mircera® into the ESRD and biological products for which we patient preference (87 FR 67189). We do
PPS bundled payment and the inclusion propose to calculate the post-TDAPA not think that limiting the post-TDAPA
of renal dialysis drugs and biological add-on payment adjustment, because add-on payment adjustment based on
products in existing ESRD PPS under current regulation Mircera® CMS’s determination of substantial
functional categories that receive would not be eligible to receive either clinical improvement would align with
TDAPA payment, for which we have the TDAPA or a post-TDAPA add-on this stated intent of the ESRD PPS
proposed to calculate the post-TDAPA payment adjustment. functional category framework to
add-on payment adjustment beginning As we stated in the CY 2024 ESRD support broad access to all renal dialysis
in CY 2024. First, when Mircera® was PPS proposed rule, we anticipate that service drugs. We further note that the
incorporated into the ESRD PPS the structure of the proposed post- current TDAPA exclusion criteria under
bundled payment, CMS had not yet TDAPA payment methodology will § 413.234(e) consider FDA’s
established any TDAPA policies, which serve to incentivize the use of drugs that determination of the drug’s NDA type or
are integral to the current ESRD PPS represent a substantial improvement approval under section 505(j) of the
drug designation process. As we over existing drugs, which will promote Federal Food, Drug, and Cosmetic Act,
previously stated, section 217(c) of competition between new and existing which is less subjective than a
PAMA required the Secretary to renal dialysis drugs and biological determination of substantial clinical
establish a process for including new products and drive down prices of such improvement. Therefore, we continue to
injectable and intravenous products into new renal dialysis drugs and biological be of the view that the proposed
the ESRD PPS bundled payment, which products over time. We expect that our methodology most appropriately
CMS finalized in the CY 2016 ESRD PPS methodology for the post-TDAPA add- balances the need to provide adequate
final rule (80 FR 69013 through 69027) on payment adjustment will incentivize payment with the concerns that
and codified in our regulations at ESRD facilities’ efficient use of MedPAC raised regarding duplicative
§ 413.234. Under current law, new renal resources, because payment for an payment and clinical superiority or
dialysis drugs and biological products individual claim will not be dependent substantial clinical improvement.
in existing functional categories which on individual utilization of the new Comment: Many commenters
qualify for TDAPA payment are renal dialysis drug or biological expressed concerns about the proposed
generally paid for using the TDAPA for product. Accordingly, we anticipate that 3-year duration for the post-TDAPA
a period of 2 years, after which such under our methodology, for new renal add-on payment adjustment. Several
drugs and biological products are
dialysis drugs and biological products commenters stated that the 3-year
considered included in the ESRD PPS that are not a substantial clinical period would create a new payment cliff
base rate with no modification to the improvement over existing renal at the end of the 3-year post-TDAPA
base rate. As we stated in the CY 2024 dialysis drugs and biological products, period and advocated for a permanent,
ESRD PPS proposed rule, we recognize utilization will diminish over time and non-budget neutral payment
continuity and predictability are adjustment.
integral parts of ESRD facilities’ ongoing 37 https://www.ncbi.nlm.nih.gov/pmc/articles/ Response: We appreciate the concerns
business operations. We stated that we PMC4090042/. that commenters raised about the
proposed 3-year period for the post- products in existing functional proposed post-TDAPA add-on payment
TDAPA add-on payment adjustment. categories. MedPAC stated that a post- adjustment would provide appropriate
We recognize that the policy would not TDAPA period is not needed to collect payment stability for ESRD PPS
permanently maintain increased and analyze cost report data, and that if payments to ESRD facilities during the
payments for new renal dialysis drugs CMS has concerns about the price intervening years, which would support
and biological products that receive the proxies for ESRD drugs used in the beneficiaries’ continued access to new
TDAPA, and we do not believe that ESRDB market basket, CMS can conduct renal dialysis drugs and biological
such a permanent increase in payments the necessary analyses, without creating products.
would be appropriate. The TDAPA for the post-TDAPA add-on payment With respect to the question of the
renal dialysis drugs and biological adjustment policy. In addition, MedPAC utility of Medicare cost report data, we
products in existing functional questioned the utility of current cost think that more recent cost reports,
categories is inherently transitional in reports to evaluate whether the ESRDB which would include information about
nature and therefore not permanent. As market basket accounts for price total drug spending across categories,
we discussed in the CY 2019 and CY changes of new ESRD drugs, since would provide meaningful information
2020 ESRD PPS final rules (83 FR Medicare cost reports do not require about how new renal dialysis drugs and
56935; 84 FR 60654), for new renal providers to report the cost of each new biological products affect ESRD
dialysis drugs and biological products item or product paid under a TDAPA or facilities’ costs. Although TDAPA and
that fall into an existing ESRD PPS a TPNIES. TPNIES costs are not reported
functional category, the TDAPA helps Response: As we previously separately, if spending for new renal
ESRD facilities to incorporate the new discussed, we proposed to pay the post- dialysis drugs and biological products is
drugs and biological products and make TDAPA add-on payment adjustment for driving significant increases in ESRD
appropriate changes in their businesses a period of 3 years following the facilities’ costs, more recent Medicare
to adopt such products. We also payment of TDAPA for 2 years, to allow cost report data will inform CMS’s
explained that the TDAPA provides more complete cost reporting understanding of how such spending
additional payments for such associated information to become available. CMS affects the ESRDB market basket
costs and promotes competition among routinely rebases and revises the ESRDB composition. We would also evaluate
the products within the ESRD PPS market basket and price proxies, usually Part B spending data to determine the
functional categories, while focusing every four to five years, incorporating mix of the types of drugs and the
Medicare resources on products that are more recent cost report information. We appropriate price proxy based on
innovative. Accordingly, we proposed a agree with MedPAC that a post-TDAPA changes to the relative mix of drugs
post-TDAPA add-on payment period is not strictly necessary to collect used in the ESRD facility setting.
adjustment beginning in CY 2024 that is more recent cost report information. Nevertheless, we recognize the
similarly transitional in nature and However, as we stated in the CY 2024 limitations of the current Medicare cost
which provides a glidepath for ESRD PPS proposed rule, we think that reports that MedPAC identified, and we
inclusion of such new renal dialysis providing a post-TDAPA add-on may consider changes in the future to
drugs and biological products into the payment adjustment during this period improve the data that we collect through
ESRD PPS. In the CY 2024 ESRD PPS would provide stability in ESRD PPS the Medicare cost report.
payments while CMS analyzes such Final Rule Action: After consideration
proposed rule, we stated that a 3-year
information. of the comments, we are finalizing as
period for the post-TDAPA add-on
The existing 2-year TDAPA period proposed to establish, beginning for CY
payment adjustment would be
provides useful information about ESRD 2024, a post-TDAPA add-on payment
consistent with the transition period facilities’ spending on drugs and adjustment for any new renal dialysis
that was finalized at the beginning of biological products paid for using the drug or biological product that is
the ESRD PPS, when ESRD facilities TDAPA, but due to lags in the timing of considered included in the ESRD PPS
were transitioned from receiving when ESRD facilities submit their cost base rate that is paid for using the
payments under the composite rate reports, such data would not become TDAPA under § 413.234(c)(1). This
payment system to receiving payments available in ESRD facilities’ cost report post-TDAPA add-on payment
under the ESRD PPS (79 FR 49162). We information until after the end of the adjustment will be applied for a period
finalized the transition period for CY TDAPA period. For example, CMS of 3 years following the end of the
2011 through CY 2013, with full generally uses Medicare cost report data TDAPA period for those products.
implementation in CY 2014, to comply that lags by approximately 3 to 4 years
with the requirement of section (a) Calculation of the Post-TDAPA Add-
prior to the rulemaking year. Therefore,
1881(b)(14)(E)(i) of the Act to provide a On Payment Adjustment
complete Medicare cost report data for
4-year phase-in of the payment amount CY 2023 or CY 2024 could be used to As discussed earlier in this section of
under the ESRD PPS. We proposed a consider changes to market basket cost the final rule, we proposed to establish
similar timeline for the post-TDAPA categories, cost weights, and price a new add-on payment adjustment for
add-on payment adjustment to provide proxies for the CY 2026 or CY 2027 certain new renal dialysis drugs and
an appropriate transition for new renal rulemaking cycle. As proposed, the biological products in existing ESRD
dialysis drugs and biological products post-TDAPA add-on payment PPS functional categories after the end
in existing ESRD PPS functional adjustment would begin to be paid on of the TDAPA period. In the CY 2024
categories, which are not eligible for a April 1, 2024, based on utilization of ESRD PPS proposed rule, we proposed
modification to the ESRD PPS base rate. Korsuva®, the only renal dialysis drug to apply the post-TDAPA add-on
Comment: MedPAC encouraged CMS currently receiving the TDAPA, and payment adjustment to all ESRD PPS
to clarify why an additional period of 3 would end no later than March 31, payments beginning at the end of a new
years is appropriate for the proposed 2027. CMS would be able to analyze renal dialysis drug or biological
post-TDAPA add-on payment Medicare cost report data for CY 2023 product’s TDAPA period. Specifically,
adjustment, as compared to the and CY 2024 to consider changes to the we proposed that the post-TDAPA add-
established 2-year TDAPA period for ESRDB market basket for CY 2027 on payment adjustment would begin 8
new renal dialysis drugs and biological rulemaking, if appropriate. The calendar quarters after the beginning of
the first calendar quarter in which fixed amount that reflects the average 56935; 84 FR 60654), for new renal
TDAPA payment is made for the new patient, and CMS acknowledges there dialysis drugs and biological products
renal dialysis drug or biological product will be patients whose treatment costs at that fall into an existing ESRD PPS
in an existing ESRD PPS functional an ESRD facility will be more or less functional category, the TDAPA helps
category and would end no later than than the ESRD PPS payment amount. ESRD facilities to incorporate the new
the 12th calendar quarter after the last Additionally, we were concerned that drugs and biological products and make
calendar quarter in which TDAPA such an approach would result in a appropriate changes in their businesses
payment is made. We stated that we substantial cost burden for beneficiaries to adopt such products, provides
believe our calculation of the post- who use the new renal dialysis drug or additional payments for such associated
TDAPA add-on payment adjustment biological product, because they incur a costs, and promotes competition among
would be the most appropriate to 20 percent coinsurance under Part B for the products within the ESRD PPS
address the patient access concerns we renal dialysis services. We stated that functional categories, while focusing
discussed in the CY 2023 ESRD PPS we do not believe this approach would Medicare resources on products that are
proposed rule and in this section of the align with our priorities to reduce drug innovative. We stated that we believe
final rule, and the most consistent with costs for Medicare beneficiaries. In after the end of the TDAPA period,
the principles of prospective payment. contrast, our proposed methodology ESRD facilities will have made
We stated that this proposal would would apply the post-TDAPA add-on appropriate changes in their business
apply the patient-level adjustment payment adjustment to all ESRD PPS models to adopt such products, and
factors to the post-TDAPA add-on payments, which would result in a therefore any approach to a post-TDAPA
payment adjustment amount paid on minimal increase in per-treatment add-on payment adjustment should
each claim, which would ensure that coinsurance amounts for all apply equally to all ESRD PPS
ESRD PPS payment would support beneficiaries. As discussed later in this treatments, in order to apply the
access to new renal dialysis drugs and section, we proposed to apply the ESRD appropriate incentive structures for
biological products for beneficiaries PPS patient-level adjustments to the ESRD facilities’ utilization of renal
with conditions that are costlier to treat, post-TDAPA add-on payment dialysis drugs and biological products
in alignment with our goals as stated adjustment for each treatment. and to continue to promote competition
earlier in this final rule. We proposed to among the products within the ESRD
Next, we considered applying the
codify the payment of the post-TDAPA PPS functional categories, including the
post-TDAPA add-on payment
add-on payment adjustment as part of new renal dialysis drug or biological
adjustment based only on claims from
the per treatment payment amount at product that was previously paid for
ESRD facilities that used the new renal
§ 413.230(f). We proposed to codify the using the TDAPA under the ESRD PPS.
dialysis drug or biological product
methodology for calculating the post- Furthermore, we stated that we believe
during the TDAPA period. However,
TDAPA add-on payment adjustment at that such an approach would help to
like the previous option, we stated that
§ 413.234(g). We proposed to make support access to new renal dialysis
we believe limiting application of this
additional changes under § 413.234(b) drugs and biological products to the
add-on payment adjustment to claims widest scope of beneficiaries. This is in
and (c) to address payment of the post-
TDAPA payment adjustment. from ESRD facilities that include the line with CMS’s commitment to
In determining the calculation of the new renal dialysis drug or biological advance health equity by supporting
post-TDAPA add-on payment product would be inconsistent with the access to renal dialysis services.
adjustment, we considered the principles of prospective payment. As Accordingly, we proposed to apply
comments that we received regarding we discussed in the CY 2011 ESRD PPS the post-TDAPA add-on payment
the RFI in the CY 2023 ESRD PPS final rule, there are patients whose adjustment to each ESRD PPS treatment,
proposed rule. Some commenters medical treatment results in more costly and to adjust it for patient
expressed that new and innovative care as well as those with less costly characteristics. In other words, the post-
drugs may only be used by a small care, and the ESRD PPS bundled base TDAPA add-on payment adjustment
percentage of the dialysis population rate reflects Medicare payment for the would be multiplied by the ESRD PPS
and suggested that an add-on payment average ESRD patient (75 FR 49045). patient-level adjustments under
adjustment should address patient- Further, we were concerned that § 413.235. We stated that we believe this
specific needs to support access. limiting the post-TDAPA add-on approach would appropriately adjust
First, we considered calculating the payment adjustment to claims from aggregate ESRD PPS payment to account
post-TDAPA add-on payment ESRD facilities that use the new renal for the new renal dialysis drugs and
adjustment as the average cost for dialysis drug or biological product biological products in a way that is
patients that used the new renal dialysis could result in substantial consistent with the principles of
drug or biological product that was overestimation of the post-TDAPA add- prospective payment and would support
previously paid for using the TDAPA on payment adjustment, if more ESRD beneficiary access to new renal dialysis
under the ESRD PPS and applying the facilities begin using the new renal drugs and biological products by
post-TDAPA add-on payment dialysis drug or biological product. As recognizing the additional patient-
adjustment only to claims that include we discuss later in this final rule, we specific needs associated with the
the new renal dialysis drug or biological proposed to apply this post-TDAPA existing ESRD PPS case-mix adjusters.
product. However, we were concerned add-on payment adjustment in a non- We noted that to calculate an
that such an approach would not align budget neutral manner. Therefore, we appropriate post-TDAPA add-on
stated in the CY 2024 ESRD PPS
with the principles of prospective payment adjustment, we would apply a

payment under the ESRD PPS. As we proposed rule that we were concerned case-mix standardization factor to the
noted previously, a central objective of that an overestimation of the post- post-TDAPA add-on payment
the ESRD PPS (and of prospective TDAPA add-on payment adjustment adjustment amount as discussed in the
payment systems in general) is for ESRD could result in an inappropriate following paragraphs.
facilities to be efficient in their resource increase in Medicare expenditures. As In addition, we explained that we
use. Under a PPS, Medicare makes we discussed in the CY 2019 and CY considered the public comments
payments based on a predetermined, 2020 ESRD PPS final rules (83 FR regarding the need to reconcile
estimated expenditures for a new renal an alternative, we explained that we add-on payment adjustment; however,
dialysis drug or biological product with considered MedPAC’s suggestion to we believe that considerations based on
the declines in expenditures for related align the methodology closer to that of specific population needs could be less
drugs. We noted that commenters the ESRD PPS TPNIES, wherein CMS transparent than applying a simple 65-
expressed support for establishing a pays a reduced percentage of the percent risk-sharing percentage.
methodology that would consider the estimated incremental cost of a new Additionally, we noted that in the
decline in estimated expenditures for product as a risk-sharing mechanism future, there could be multiple new
drugs that are clinically or empirically with ESRD facilities and to provide a renal dialysis drugs or biological
related to the new renal dialysis drug or disincentive for significant increases in products for which we would be
biological product. We explained that drug prices. Under the TPNIES, CMS calculating multiple offset adjustments,
such a methodology would be highly calculates the TPNIES amount as 65 which would further increase
complex and less transparent than other percent of the MAC-determined price complexity and reduce transparency.
potential options that commenters for certain new and innovative We solicited comments on whether
suggested. We also explained that equipment and supplies (§ 413.236(f)). there are other ways CMS could
commenters in the past noted various We stated that we believe this approach consider calculating an offset amount
ideas that CMS would need to consider would have the same general effect of for the post-TDAPA payment
when attempting to establish the accounting for declines in other drug adjustment. Alternatively, we sought
offsetting financial effects of drugs and expenditures, while being significantly comment on if there are other ways
biological products that are either less complex and more transparent. In CMS could ensure any growth in post-
clinically or empirically related to the the CY 2020 ESRD PPS final rule that TDAPA add-on payment adjustment
new renal dialysis drug or biological established the 65 percent cost-sharing amounts is reasonable, such as not
product. For example, most commenters proportion for the TPNIES, we stated allowing increases to exceed inflation or
suggested that CMS use drugs with the that the goal of the TPNIES was to other relevant metrics.
We proposed to calculate the post-
same FDA clinical indication to offset support ESRD facility use of new and
TDAPA add-on payment adjustment
the payment adjustment, in the interest innovative renal dialysis equipment and
annually, based on the latest available
of transparency and objectivity. supplies (84 FR 60692). In that same CY
full calendar quarter of average sales
However, some commenters, including 2020 ESRD PPS final rule, we further
price (ASP) data, which would be
MedPAC, noted that they do not believe stated in response to comments that we consistent with the current policy for
that FDA determinations or ESRD PPS believe that we need to balance this goal determining the basis of payment for the
functional categories should be the basis with sharing risk for the new product TDAPA. We stated that under current
of eligibility for the post-TDAPA (84 FR 60697). We noted that one goal policy, finalized in the CY 2020 ESRD
payment adjustment, as CMS should of the post-TDAPA add-on payment PPS final rule (84 FR 60679), we pay the
make these determinations based on the adjustment is to support continued TDAPA based on 100 percent of ASP. If
specific needs of the Medicare access to new renal dialysis drugs and ASP is not available, we base the
population. We stated that we believe biological products and to support TDAPA payment adjustment on
such considerations based on specific ESRD facilities’ long-term planning and wholesale acquisition cost (WAC), and
population needs could be less budgeting for such drugs after the if WAC is not available, then we base
transparent than alternative approaches, TDAPA period. Additionally, we stated payment on invoice pricing. As we
especially in situations when there that our goal is also to incentivize stated in the CY 2020 ESRD PPS final
could, in the future, be multiple new efficient use of resources, consistent rule, we continue to believe that after
renal dialysis drugs or biological with the principles of prospective the TDAPA period, calculating the post-
products for which we would be payment under the ESRD PPS. We TDAPA add-on payment adjustment for
calculating multiple offset adjustments. explained that we believe applying a new renal dialysis drugs based on ASP,
We stated that we anticipate it would be cost-sharing proportion of 65 percent to as compared to WAC or invoice pricing,
challenging for CMS to determine, the post-TDAPA add-on payment would be the most appropriate choice
within the annual rulemaking adjustment would effectively achieve for the ESRD PPS, and would strike the
timeframes, the extent to which changes these goals, because it would provide a right balance in supporting ESRD
in the utilization of existing renal significant level of payment that facilities in their uptake of innovative,
dialysis drugs and biological products supports access for beneficiaries and new renal dialysis drugs and biological
are clinically or empirically related to long-term planning for ESRD facilities, products and limiting increases to
utilization of a new renal dialysis drug while incentivizing ESRD facilities to Medicare expenditures. We proposed to
or biological product paid for using the efficiently allocate resources by sharing address the annual calculation of the
TDAPA. We noted that the latest a significant portion of the cost with post-TDAPA add-on payment
available data at the time of the ESRD facilities. Furthermore, we stated adjustment in the annual proposed and
proposed rulemaking included less than that this 65 percent cost-sharing factor final ESRD PPS rules for future years.
a full year of TDAPA utilization. We would serve to further reduce the As discussed in the CY 2024 ESRD
explained that we anticipate that as minimal cost-sharing burden of new PPS proposed rule (88 FR 42472), under
additional data are collected, CMS will renal dialysis drugs and biological current TDAPA policy, if CMS stops
be able to analyze trends and may be products for beneficiaries, under the receiving ASP during the TDAPA
able to retrospectively determine the post-TDAPA add-on payment period, then CMS will stop paying the
extent of any substitution effects methodology. Lastly, we noted that for
TDAPA after 2 calendar quarters.

between new and existing renal dialysis home dialysis machines that are capital- Similarly, we explained that if drug
drugs and biological products. related assets that qualify for the manufacturers were to stop submitting
Furthermore, we noted that the TPNIES, our policy is to apply an offset ASP data for products that are included
calculation of these offsets could to account for such capital-related assets in the calculation of the post-TDAPA
involve multiple overlapping periods of in the ESRD PPS base rate. As we add-on payment adjustment, and we
time, which would further increase discussed previously, we considered had to revert to basing calculation of the
complexity and reduce transparency. As applying an offset to the post-TDAPA post-TDAPA add-on payment
adjustment on WAC or invoice pricing, Comment: Many commenters, that are aligned with the principles of
we believe we would be overpaying for including LDOs, drug manufacturers, prospective payment. We anticipate that
the add-on payment adjustment. and patient advocacy organizations, the post-TDAPA payment methodology
Therefore, we proposed to make expressed concerns that the proposed that we are finalizing will provide an
payment of the post-TDAPA add-on methodology would not support access appropriate level of funding to support
payment adjustment conditional on to new and innovative renal dialysis access to new renal dialysis drugs and
receiving ASP data. Because the post drugs and biological products. biological products after the end of the
TDAPA add-on payment adjustment Commenters stated that the proposed TDAPA, without providing a direct
would be calculated annually rather amount would provide a level of incentive to use any particular new drug
than quarterly, we proposed that if CMS funding that supports the provision of or biological product, which we
does not receive the latest full calendar drugs and biological products currently anticipate could result in
quarter of ASP data for a drug that paid for using the TDAPA to only a overutilization.
would be included in the calculation of small proportion of patients and would Comment: MedPAC stated that
the post-TDAPA add-on payment not support expanded access to such although it strongly disagrees with the
adjustment, then CMS would not drugs. One commenter stated that CMS implementation of a post-TDAPA add-
include that drug in the calculation of policy must recognize that practice on payment adjustment, it recognizes
the post-TDAPA add-on payment follows payment and provided an that CMS’s proposed per claim add-on
adjustment for any future years. We also example of certain payment policy payment approach provides better
proposed that if CMS stops paying the changes in the SNF PPS, specifically the incentives for more judicious use of a
TDAPA for a drug or biological product recent transition from the SNF Resource new renal dialysis drug rather than a per
because CMS stops receiving the latest Utilization Group payment system to use add-on payment approach. MedPAC
full calendar quarter of ASP data, then the Patient-Driven Payment Model (83 reiterated that paying on a per unit basis
we would not include that drug or FR 39162), which the commenter stated for a drug incentivizes its use (to the
biological product in the calculation of drove subsequent utilization patterns in extent clinically possible) and
the post-TDAPA add-on payment that system by reducing incentives for recommended that if CMS finalizes the
adjustment for the next CY or any future overutilization of certain rehabilitative post-TDAPA add-on payment
CY. Consistent with our policy for therapies. adjustment, the agency should proceed
calculating the TDAPA, as discussed in Response: We disagree with with a per claim add-on payment.
section II.B.1.k of the proposed rule, we commenters who stated that the amount MedPAC also expressed support for the
proposed that in situations when a of the proposed post-TDAPA add-on proposed 65 percent risk-sharing
manufacturer reports zero or negative payment adjustment would not support percentage as an incentive for price
sales, we would consider CMS to have access to new and innovative renal competition.
received the latest full calendar quarter dialysis drugs and biological products. Response: We appreciate MedPAC’s
of ASP data, but we would calculate the Because the proposed methodology is qualified support for the proposed
post-TDAPA payment adjustment based based on the latest available price and methodology. We agree with MedPAC
on WAC, or if WAC is not available, on utilization information, we believe it that the proposed per-treatment
invoice pricing, in such circumstances. provides an adequate level of funding to methodology would appropriately align
Finally, we proposed that for each of maintain access to new renal dialysis incentives for ESRD facilities to be
the 3 years for which this post-TDAPA drugs and biological products after the efficient with their resources, and as a
add-on payment adjustment would be end of the TDAPA period. We note that result it would foster competition
paid, we would update the amount of the proposed amount of the post- between new and existing renal dialysis
the post-TDAPA add-on payment TDAPA add-on payment adjustment for drugs and biological products. We also
adjustment by the productivity-adjusted CY 2024 reflects utilization of current agree that the proposed application of a
ESRDB market basket update to account TDAPA drugs by a small proportion of risk-sharing percentage would provide a
for estimated future input price changes ESRD beneficiaries, amounting to less further incentive for price competition
faced by ESRD facilities. We solicited than 1 percent of all treatments. between drugs within an ESRD PPS
comment on whether it would be more Although the payment per treatment is functional category. As we discussed in
appropriate to consider using the a relatively small amount, an ESRD the CY 2024 ESRD PPS proposed rule
growth in the price proxy for the facility’s aggregate payments under the (88 FR 42462), we anticipate that the
pharmaceuticals cost category in the proposed post-TDAPA add-on payment proposed risk sharing percentage of 65
ESRDB market basket, rather than the adjustment methodology would percent would be appropriate, as it
productivity-adjusted ESRDB market nonetheless help to support the would provide a significant level of
basket update. We also provided a utilization for new renal dialysis drugs payment that supports access for
detailed set of steps for calculating the and biological products at the level of beneficiaries and long-term planning for
amount of the proposed post-TDAPA utilization observed during the TDAPA ESRD facilities, while incentivizing
add-on payment adjustment for CY period. We note that, as discussed later ESRD facilities to allocate resources
2024, which we calculated at $0.0961 in this final rule, we are calculating the efficiently.
for the proposed rule. We solicited final amount of the post-TDAPA add-on Comment: Several commenters
comments on this proposed payment adjustment for CY 2024 to be advocated for an alternative
methodology for a post-TDAPA add-on significantly higher than the CY 2024 methodology that would calculate an
payment adjustment and its ESRD PPS proposed rule, based on the add-on payment adjustment based on
the average cost for patients that use the
appropriateness for CY 2024 and future latest available price and utilization
years. data. new renal dialysis drug or biological
We received public comments on our Lastly, we appreciate the concerns product. Commenters stated that the
proposed methodology for calculating that the commenter raised regarding proposed methodology for the post-
the post-TDAPA add-on payment utilization patterns as the result of TDAPA add-on payment adjustment,
adjustment. The comments on our payment policies, and we are acutely and the structure of the ESRD PPS
proposal and our responses are set forth aware of the importance of establishing overall, do not address the needs of the
below. payment adjustments in the ESRD PPS non-average patient. Several
commenters drew parallels to the patients. The ESRD PPS includes post-TDAPA add-on payment
comprehensive ambulatory payment patient-level and facility-level adjustment annually.
classification (C–APC) complexity adjustments that better align payment Response: We thank commenters for
adjustment in the Hospital OPPS as an with resource use for facilities that incur their comments regarding the proposed
example of a payment policy that higher costs due to their patient update methodology for the post-
adjusts payment based on patient population or geographic location. TDAPA add-on payment adjustment.
characteristics. We do not believe that the OPPS C– We proposed to use the most recent
Response: We appreciate the APC complexity adjustment is an available price and utilization
suggested methodology for which these appropriate comparison to the proposed information to determine a per-
commenters advocated but do not agree post-TDAPA payment amount, which as treatment amount for each of the three
that such a methodology would be we previously noted will be applied in years during which a post-TDAPA add-
appropriate, because it would directly a non-budget-neutral manner and is on payment adjustment would apply.
incentivize utilization of a particular intended to provide a transitional level We are clarifying in this rule that we
drug or biological product, which can of payment that supports ESRD would annually recalculate the post-
result in overutilization. As we facilities’ long-term planning and TDAPA add-on payment adjustment,
discussed earlier in this final rule, we budgeting and supports beneficiaries’ based on the most recent available price
believe that the proposed methodology access to new renal dialysis drugs and and utilization information at the time
provides the most appropriate biological products. In contrast, the of rulemaking. Accordingly, the post-
incentives for ESRD facilities to be OPPS C–APC complexity adjustment is TDAPA add-on payment adjustment
efficient with resources, while budget neutral under the OPPS and is amount could increase or decrease from
providing an appropriate level of intended to provide increased payment year to year, depending on changes in
payment that supports access to new when certain service combinations pricing and utilization. We note that
renal dialysis drugs and biological represent a complex, costly, or more although we proposed to apply the
products. resource-intensive version of the productivity-adjusted ESRDB market
Additionally, we disagree with basket update, we proposed to do so
primary service. As an example, we
several of the premises that commenters only for the purpose of updating the
believe a more appropriate payment
offered with respect to the proposed post-TDAPA add-on payment
mechanism to recognize the additional
methodology for calculating the post- adjustment to reflect anticipated prices
costs of treating ESRD patients with
TDAPA add-on payment adjustment. in the target year. We did not propose,
pruritus may be a patient-level
Specifically, commenters stated that and are not finalizing, the application of
adjustment under the ESRD PPS. As we
both the proposed post-TDAPA an update factor to update the amount
discuss in section II.B.1.j of this final
methodology and the ESRD PPS are of the post-TDAPA add-on payment
designed to meet the needs of the rule, we are collecting additional
adjustment from one payment year to
average patient and do not meet the information on dialysis duration and
the next.
needs of the non-average patient. In fact, may consider future revisions to the We appreciate the comments
the ESRD PPS base rate is not ESRD PPS case-mix adjustments, if recommending the use of the
constructed to address the needs of the appropriate. pharmaceutical price proxy rather than
average patient, but rather to provide a Comment: Several commenters the productivity-adjusted market basket
level of payment that reflects the responded to our comment solicitation update. We agree with commenters that
average per-treatment costs of renal on the methodology for applying the a pharmaceutical price proxy would
dialysis services. As we discussed in the productivity-adjusted ESRDB market more effectively track the change in
CY 2011 ESRD PPS final rule (75 FR basket update, or an alternative update prices for new renal dialysis drugs and
49037), in response to concerns that factor, to the proposed post-TDAPA biological products than would the
bundling payment for drugs like EPO add-on payment adjustment. market basket update. We are finalizing
and oral medications would limit Commenters generally advocated for that for each year that we calculate a
nephrologists from prescribing what is applying a pharmaceutical price proxy, post-TDAPA add-on payment
necessary, we stated that the ESRD PPS rather than the productivity-adjusted adjustment, we will apply the projected
would establish a bundled payment ESRDB market basket update, stating growth in the ESRDB market basket
system based on the average cost of care that a pharmaceutical price proxy price growth for pharmaceuticals, which
with adjustments that target more would be more representative of reflects the weighted blend of the ESA
payment to more resource intensive anticipated future price growth for new and non-ESA price proxies in the 2020-
ESRD patients. We further explained renal dialysis drugs and biological based ESRDB market basket, to reflect
that in situations where costs for products. Commenters requested anticipated pricing for the target year.
treating patients exceed an established clarification about whether CMS would We refer readers to the CY 2023 ESRD
threshold, the outlier policy would recalculate the post-TDAPA add-on PPS final rule (87 FR 67149) for a
apply. Later in the same CY 2011 ESRD payment adjustment annually for each detailed discussion of the construction
PPS final rule (75 FR 49047) we of the three years, in addition to of this price proxy.
explained that the ESRD PPS provides applying an update factor as proposed. Comment: Several commenters
an opportunity for ESRD facilities to Several commenters requested that CMS opposed the application of a 65 percent
make financially sound decisions while calculate the post-TDAPA add-on risk sharing percentage and urged CMS
providing necessary care, recognizing payment adjustment at the end of the to instead calculate and apply an offset
TDAPA period, and then annually based on actual utilization of related
that some patients may utilize less renal

dialysis items and services while others update that amount based on an update drugs. Many commenters suggested that
may use more. In other words, while factor such as a pharmaceutical price CMS limit the calculation of an offset to
some patients cost more than average proxy. MedPAC expressed concern the post-TDAPA add-on payment
and others cost less, an ESRD facility’s about a payment methodology in which adjustment that accounts for the actual
aggregate payments under the ESRD PPS the payment amount would only spending for products that are in the
are reflective of the overall cost of increase and suggested alternative same ESRD PPS functional category as
providing renal dialysis services to its approaches to update the amount of the the new renal dialysis drug or biological
product and are directly impacted by proposed the methodology to calculate • Step 5, apply the reduction factor
the drug or biological product. the amount of the post-TDAPA add-on from Step 4 to the post-TDAPA add-on
Response: As we discussed in the CY payment adjustment, except that, as payment adjustment amount from Step
2024 ESRD PPS proposed rule, we did noted previously, we will apply the 2.
not propose to calculate an offset based price growth of the pharmaceutical cost • Step 6, apply the 65 percent risk-
on utilization, because we are category, reflecting a weighted blend of sharing factor to the amount from Step
concerned that this approach would be the ESA and non-ESA price proxies in 5 to calculate the case-mix adjusted
more burdensome and less transparent the 2020-based ESRDB market basket, to post-TDAPA add-on payment
than the proposed 65 percent risk- adjust the amount of the post-TDAPA adjustment amount.
sharing percentage. We do not believe it add-on payment adjustment to reflect • Step 7, multiply the case-mix
would be appropriate to limit the anticipated pricing for the target year adjusted post-TDAPA add-on payment
calculation of an offset to just drugs and rather than using the productivity- adjustment amount by the growth in the
biological products in the same adjusted ESRDB market basket update. ESRDB market basket price proxy for
functional category, because we Therefore, we will use the following pharmaceuticals to account for
recognize that utilization of drugs in one calculation to determine the amount of anticipated price growth to the target
functional category can affect the the post-TDAPA add-on payment year.
utilization of drugs in other functional adjustment to be applied to each ESRD We are amending § 413.234 by
categories. For example, utilization of PPS treatment. revising § 413.234(c)(1)(i) and adding
drugs in the bone and mineral • Step 1, using the most recent regulations at § 413.234(b)(1)(iii),
metabolism functional category can (c)(1)(ii), (c)(3), and (g) that describe the
available 12 months of claims data,
indirectly affect the incidence of itching post-TDAPA add-on payment
calculate the total expenditure of the
among dialysis patients. However, if we adjustment and the calculation we will
new renal dialysis drug or biological
were to apply a per-treatment offset use to determine the post-TDAPA add-
product being paid for using the TDAPA
based on changes in spending for all on payment adjustment amount, as
under the ESRD PPS. Total expenditure
formerly separately billable drugs and described previously. In addition, we
is calculated by multiplying the latest
biological products, it would be difficult are amending § 413.230 by adding
available full calendar quarter of ASP
to determine definitively which reference to the post-TDAPA add-on
data for the new renal dialysis drug or
reductions in spending were related to payment adjustment in the calculation
biological product by the quantity of
a new renal dialysis drug or biological of the ESRD PPS per treatment payment
units billed. If CMS does not receive the amount.
product. latest available calendar quarter of ASP
Comment: One commenter pointed We will follow these steps to calculate
data for a drug or biological product, the case-mix adjusted post-TDAPA add-
out that the CY 2024 ESRD PPS
then CMS would not apply the post- on payment adjustment amount for CY
proposed rule does not indicate whether
TDAPA add-on payment adjustment for 2024 and future years, when
the ESRD PPS outlier adjustment would
that drug or biological product. As we appropriate. We will include in the
apply to products for which a post-
noted earlier, if the latest available full calculation of the case-mix adjusted
TDAPA add-on payment adjustment is
calendar quarter of ASP data reflects post-TDAPA add-on payment
calculated.
Response: We appreciate the request zero or negative sales, CMS will adjustment amount any new renal
for clarification regarding outlier calculate the post-TDAPA add-on dialysis drugs and biological products
eligibility for drugs and biological payment adjustment based on WAC, or in existing ESRD PPS functional
products during the post-TDAPA if WAC is not available, invoice pricing. categories that are eligible for payment
period. Under current policy, after the • Step 2, divide the total expenditure using the TDAPA described in
end of the TDAPA period, a drug or of the new renal dialysis drug or § 413.234(c). We will begin making
biological product is considered an biological product from Step 1 by the payment under this new post-TDAPA
eligible outlier service only if it meets total number of ESRD PPS treatments add-on payment adjustment 8 calendar
the requirements of § 413.237(a)(1). We furnished during the same 12-month quarters after the beginning of the
are clarifying that any renal dialysis period as used in Step 1. The resulting TDAPA payment period for the new
drug or biological product included in quotient from Step 2 is the post-TDAPA renal dialysis drug or biological
the calculation of the post-TDAPA add- add-on payment adjustment amount for product. Payment of the post-TDAPA
on payment adjustment would be each treatment, before applying the add-on payment adjustment will end no
considered an eligible ESRD outlier reduction factor to account for case-mix later than 12 calendar quarters after the
service only if it meets the requirements standardization, as described in Step 4. end of the TDAPA payment period for
of § 413.237(a)(1). However, we are • Step 3, calculate the dollar amount the new renal dialysis drug or biological
further clarifying that under current of the total aggregate case-mix adjusted product.
policy, Korsuva®, the only renal dialysis post-TDAPA add-on payment
drug whose TDAPA period will end in adjustment amount by multiplying the (b) Example of the Final Post-TDAPA
CY 2024, will not be considered an post-TDAPA add-on payment Add-On Payment Adjustment
eligible outlier ESRD service after the adjustment amount from Step 2 by the Calculation for CY 2024
end of its TDAPA period, because it is applicable patient-level adjustments for Following the methodology finalized
a substitute for diphenhydramine each ESRD PPS treatment furnished in the previous section, we will apply
hydrochloride, which was included in during the 12-month period. a post-TDAPA add-on payment
• Step 4, divide the aggregate case- adjustment to all ESRD PPS treatments
the composite rate prior to 2011, and

therefore does not meet the mix adjusted add-on payment beginning April 1, 2024, when the
requirements of § 413.237(a)(1) (that is, adjustment amount from Step 3 by total TDAPA payment period for Korsuva®
it would not have been, prior to January expenditure from Step 1. The resulting ends. We will calculate the amount of
1, 2011, separately billable under quotient is the reduction factor applied this post-TDAPA add-on payment
Medicare Part B). to the post-TDAPA add-on payment adjustment based on the most recent
Final Rule Action: After considering adjustment amount to account for case- available 12 months of utilization data
the comments, we are finalizing as mix standardization. for Korsuva® and the most recent
available 12 months of ESRD PPS claims new renal dialysis drug or biological budget neutral. We invited comments
data for this final rule. As we proposed, product to all beneficiaries for whom it on the budget neutrality aspect of this
we will use updated data for this ESRD is reasonable and medically necessary. proposal.
PPS final rule. We will apply the ESRD We noted that we believe it is also Comment: Several commenters
PPS patient-level adjustment factors for important to support access to new expressed support for applying the post-
determining the amount of the post- renal dialysis drugs and biological TDAPA add-on payment adjustment in
TDAPA add-on payment adjustment for products while minimizing the financial a non-budget neutral way. These
each ESRD PPS claim. impact to beneficiaries, who incur a 20 commenters agreed with CMS that
Based on the latest available data, percent coinsurance for renal dialysis calculating the post-TDAPA add-on
which includes utilization of Korsuva® services under the ESRD PPS. payment budget neutrally would be
from July 2022 through June 2023, we As discussed previously, we counterproductive, as it would
estimate that total expenditure for considered and proposed this new post- effectively undo the impact of the
Korsuva® is $11,948,389 and that TDAPA add-on payment adjustment in proposed adjustment.
28,450,178 total ESRD PPS treatments Response: We agree, and we thank the
response to concerns that a sudden
were furnished during the same time commenters for their support.
decrease in payment for certain new Final Rule Action: After considering
period. In addition, as discussed earlier renal dialysis drugs and biological
in this final rule, we are finalizing the the comments we received, we are
products after the end of the TDAPA finalizing the application of the post-
application of the growth in the ESRDB period could negatively affect Medicare
market basket price proxy for TDAPA add-on payment adjustment as
beneficiaries’ access to such new renal a non-budget neutral payment
pharmaceuticals to adjust the amount of
dialysis drugs and biological products. adjustment, beginning for CY 2024.
the post-TDAPA add-on payment
Although we have noted that the ESRD
adjustment to reflect anticipated pricing j. Requirement of ‘‘Time on Machine’’
PPS base rate already includes money
for CY 2024. The ESRDB Hemodialysis Treatment Data as a
for renal dialysis drugs and biological
pharmaceutical price proxy used for this Recordkeeping and Cost Reporting
products that fall within an existing
CY 2024 ESRD PPS final rule is 1.3 Requirement for Outpatient
ESRD PPS functional category, we
percent. Accounting for the existing Maintenance Dialysis
stated that proposing a budget neutral
ESRD PPS patient-level adjustment
payment adjustment would not be We proposed certain new
factors and the TPEAPA as discussed in
appropriate for the post-TDAPA add-on recordkeeping and cost reporting
section II.B.1.g of this final rule, the
reduction to the post-TDAPA add on payment adjustment. Because we requirements for outpatient
payment adjustment to account for case- proposed to apply the post-TDAPA add- maintenance dialysis at proposed
mix standardization for this time period on payment adjustment to every ESRD § 413.198(b)(5). Specifically, we
is 0.901653. Accordingly, we will PPS treatment, budget neutralizing this proposed to require patient-level
calculate a case-mix adjusted post- final add-on payment adjustment would reporting on resource use involved in
TDAPA add-on payment adjustment for effectively undo the adjustment and furnishing hemodialysis treatment in-
CY 2024 equal to (($11,948,389)/ leave aggregate payments at the same center in ESRD facilities that would
(28,450,178)) × (0.901653) × (0.65) × level they would have been without an serve to apportion composite rate costs
(1.013) = $0.2493. Estimates for the adjustment, which as we previously for use in the case-mix adjustment.
impact of this post-TDAPA add-on noted could negatively affect Importantly, this new data would be
payment adjustment for CY 2024 are beneficiaries’ access to such drugs and used to disaggregate facility-level
included in section VII.D.5 of this final biological products. In contrast, composite rate costs (as obtained from
rule. applying this add-on payment the cost reports) and assign them to the
adjustment in a non-budget neutral patient-month level, which would
(c) Considerations Related to Budget manner would increase aggregate ESRD enable a refined single-equation
Neutrality for the Post-TDAPA Add-On PPS expenditures to a level that reflects estimation methodology. The integrity
Payment Adjustment the most recent 12 months’ utilization of of the ESRD PPS is dependent on our
As discussed in the CY 2024 ESRD the new renal dialysis drug or biological ability to monitor payment accuracy and
PPS proposed rule and earlier in this product, which we believe would make refinements to the payment
final rule, the ESRD PPS includes other support beneficiary access. By applying system, as needed. Under this proposal,
add-on payment adjustments based on the post-TDAPA add-on payment CMS would require ESRD facilities to
the authority in section adjustment in a non-budget neutral way, report information on ESRD PPS claims
1881(b)(14)(D)(iv) of the Act, which are we would effectively maintain for renal dialysis services about the
not statutorily required to be budget expenditures for these new renal duration of time in minutes that ESRD
neutral. In the case of existing add-on dialysis drugs and biological products at beneficiaries spend in center receiving
payment adjustments under the ESRD 65 percent of the level of expenditures hemodialysis treatment (hereafter
PPS, these generally account for costs paid during the TDAPA period. We referred to in this section as ‘‘time on
that were not included in cost reports stated that we believe this approach machine’’). We would use time on
used for the construction of the ESRD would provide consistency and machine data to help us evaluate and
PPS bundled payment. These include predictability in a way that would monitor the accuracy of our payments
items that either did not exist at the support beneficiaries’ continued access for patient-level adjustment factors.
time of the construction of the ESRD to new renal dialysis drugs and CMS would also evaluate whether the
PPS bundled payment, like new drugs biological products, while appropriately data could be used to inform future
and equipment, or services that were reducing expenditures for such drugs refinements to the existing patient-level
not commonplace that the add-on after the TDAPA period ends both for adjustment factors set forth at
payment adjustment is meant to the Medicare program and for § 413.235(a), which include patient age,
encourage, like home dialysis training. individual beneficiaries, as discussed body mass index (BMI), body surface
In the proposed rule, we stated that we earlier in this section. Accordingly, we area (BSA), and co-morbidities such as
expect this increased payment would proposed that this post-TDAPA add-on sickle cell anemia. Finally, CMS would
support ESRD facilities in providing the payment adjustment would not be review the data for its potential to
identify any disparities from a health dialysis, age, race, ethnicity, and other In the CY 2024 ESRD PPS proposed
equity perspective that may support appropriate factors. We implemented rule (88 FR 42464 through 42472), we
proposing in future rulemaking new this statutory requirement in § 413.235, noted that, if the proposed requirement
patient-level adjustment factors, which sets forth certain patient to collect time on machine data were to
including potential social determinants characteristics for which the per be finalized, we would issue
of health (SDOH) factors. As described treatment ESRD PPS base rate may be corresponding guidelines. We stated
in section II.B.1.h of this final rule, we adjusted, specifically where those that such guidance would provide
proposed the addition of § 413.198(b)(5), patient characteristics result in higher instructions regarding the applicable
which states that ESRD facilities must costs for ESRD facilities. The patient administrative requirements for
submit data and information in the characteristics at § 413.235(a) include: reporting a value code on an electronic
formats established by CMS for the patient age, BSA, low BMI, onset of claim, here value code D6, connected to
purpose of estimating patient-level and renal dialysis (new patient), and co- the number of minutes of hemodialysis
facility level variation in resource use. morbidities. The Secretary is also treatment provided in-center in an
Under this paragraph, we proposed to authorized, under section ESRD facility. We further noted that the
require ESRD facilities to report ‘‘time 1881(b)(14)(D)(iv) of the Act, to apply National Uniform Billing Committee
on machine’’ as when a patient the such other payment adjustments under (NUBC) has approved and is prepared
begins dialysis treatment and ends the ESRD PPS as the Secretary for ESRD facilities’ use of value code D6
dialysis treatment. We proposed to determines appropriate. Per § 413.196, on claim form CMS–1450 (UB–04)
require ESRD facilities to report this we publish notice of any proposed (OMB–0938–0997) to report the total
information using the D6 value code on changes to payment adjustments, number of minutes of hemodialysis
ESRD PPS claims. including adjustments to the composite provided during the billing period.
rate,40 in the Federal Register. We last
(1) Background (b) Case-Mix Adjustments Background
updated the payment multipliers for the
(a) Statutory Authorities for and the Two-Equation ESRD PPS Model
ESRD PPS patient-level adjustment
Recordkeeping, Cost Reporting, and factors in the CY 2016 ESRD PPS final The ESRD PPS includes patient-level
Case-Mix Adjustments Under the ESRD rule (80 FR 68968, at 68973 through adjustments that adjust the ESRD PPS
PPS 68984), for age, BSA, low BMI, sex, four base rate for certain patient
Section 1881(b)(2)(B) of the Act co-morbidity categories (that is, characteristics. The current ESRD PPS
generally directs the Secretary to pericarditis; gastrointestinal tract case-mix adjustments are derived from a
prescribe in regulations any methods bleeding with hemorrhage; hereditary case-mix adjustment model involving
and procedures to determine the costs hemolytic or sickle cell anemias; and two equations. In the CY 2011 ESRD
incurred by providers of services and myelodysplastic syndrome), and the PPS final rule (75 FR 49083), we
renal dialysis facilities in furnishing onset of renal dialysis. We also discussed the two-equation
covered services to individuals with established payment adjustments for methodology used to develop the
ESRD, and to determine, on a cost- pediatric patients and for facilities adjustment factors that would be
related or other economical and treating a low volume of patients with applied to the ESRD PPS base rate to
equitable basis, payment amounts for ESRD. calculate each patient’s case-mix
Medicare part B services furnished by Finally, the collection of data from adjusted payment per treatment. The
such providers and facilities to ESRD claims, cost reports and record two-equation approach used to develop
individuals with ESRD. To that end, keeping, has been instrumental in the ESRD PPS included a facility-based
CMS promulgated § 413.198,38 which identifying underserved populations regression model for services
specifies certain recordkeeping and cost and establishing that ESRD historically paid for under the
reporting requirements for ESRD disproportionately affects African composite rate as indicated in ESRD
facilities that meet the conditions for American/Black men relative to their facility cost reports, and a patient-
coverage under 42 CFR part 494.39 The share of the total population. The month-level regression model for
recordkeeping and cost reporting proposal to collect and evaluate time on services historically billed separately.
requirements at § 413.198 enable CMS machine data would provide additional One significant limitation, which in
to determine the costs incurred in information concerning resource use to large part drove the development of the
furnishing outpatient maintenance enable CMS to identify, assess, and two-equation model, was that there was
dialysis and support the two-equation address potential health disparities. no way to reliably identify, using claims
payment model that is currently used as This proposal therefore may support the data, the costs for composite rate
the basis for the ESRD PPS. Secretary’s efforts to evaluate race and services—that is, items and services
Section 1881(b)(14)(D)(i) of the Act ethnicity data and provide such as staff labor, dialysate, capital-
requires that the ESRD PPS include a recommendations for improving the related assets such as renal dialysis
payment adjustment based on case-mix quality of the data, as required under machines, and certain drugs and
that may consider patient weight, BMI, section 1809 of the Act, previously laboratory tests that are used in the
comorbidities, length of time on discussed in the CY 2011 ESRD PPS provision of outpatient maintenance
final rule (75 FR 49030 at 49108 through dialysis for the treatment of ESRD and
38 We note that § 413.198 was promulgated prior 49113). that were included in the composite
to the establishment of the ESRD PPS. It was payment system established under
initially set forth in 1983 at 42 CFR 405.441 (48 FR 40 As explained in the CY 2011 ESRD PPS final section 1881(b)(7) of the Act and the
21254), to implement section 2145 of the Omnibus
rule (75 FR 49030 at 49032), the composite rate is basic case-mix adjusted composite
Budget Reconciliation Act of 1981 (Pub. L. 97–35). the method by which CMS determines
Section 405.441 was later redesignated in 1986 as prospectively the amounts of payments for renal
payment system established under
42 CFR 413.174 (51 FR 34790–01), and the dialysis services furnished by providers of services section 1881(b)(12) of the Act.
requirements were moved again, from § 413.174 to and by renal dialysis facilities to individuals in a In the CY 2016 ESRD PPS final rule,
§ 413.198, in a reorganization of subpart H of part facility and to such individuals at home. The we updated the payment multipliers for
413 (62 FR 43657). composite rate is a single composite weighted
39 Likewise, under section 1881 of the Act, CMS formula that is combined with separately billable
the ESRD PPS patient-level adjustment
established related data and information services under a single payment, adjusted to reflect factors for age, BSA, low BMI, sex, four
requirements at 42 CFR 494.180(h). patient differences in resource needs or case-mix. co-morbidity categories (that is,
pericarditis; gastrointestinal tract Technical Expert Panel (TEP) held on June 2019.42 The 2018 TEP report
bleeding with hemorrhage; hereditary December 6, 2018, a Request for provided examples of ways that
hemolytic or sickle cell anemias; and Information (RFI) published in the extended treatment duration could
myelodysplastic syndrome), and the ESRD PPS CY 2020 ESRD PPS proposed affect cost components. First, an
onset of renal dialysis. We also rule (84 FR 38399), and more recently, imputed cost per treatment was
established payment adjustments for an RFI published in the ESRD PPS CY calculated using a combination of
pediatric patients and for ESRD 2022 proposed rule (86 FR 36322, 36399 treatment duration data from
facilities treating a low-volume of ESRD through 36400). In addition, CMS issued CROWNWeb43 (now the ESRD Quality
patients (80 FR 68968 at 68973 through sub-regulatory guidance in Transmittal Reporting System, or EQRS) and facility
68984). In that CY 2016 ESRD PPS final 10368, from September 24, 2020, to cost per-minute data from cost reports to
rule, we discussed and responded to begin collecting time on machine data, infer differences in costs reported across
several public comments in which but it later rescinded that guidance. patient-months. An average interquartile
commenters expressed concerns about range of 34.6 minutes was observed
the continued use of the two-equation (i) Technical Expert Panel (TEP) from CROWNWeb duration data,
model (80 FR 68974 through 68976). December 2018 indicating significant within-facility
One comment from MedPAC suggested As we discussed in the CY 2020 ESRD variation in dialysis treatment time.
that CMS develop a one-equation model PPS proposed rule (84 FR 38396 Significant variation in average imputed
for the ESRD PPS. In response, we noted through 38400), a TEP was held on cost per hemodialysis sessions also was
that the ESRD PPS is not currently able December 6, 2018, to discuss options for observed, with an across-facility
to utilize a one-equation method, improving data collection to refine the interquartile range of $62.62. Overall, it
because ESRD facilities do not report ESRD PPS case-mix adjustment model. was found that costs increased with
charges associated with the components In that CY 2020 ESRD PPS proposed longer treatment times, and this pattern
of renal dialysis treatment costs that rule, we discussed the purpose of the was consistent for the individual cost
vary across patients such as time on TEP and the topics that were discussed, report components as well. Facilities
machine. In other words, patient-level including several data collection with a higher proportion of beneficiaries
claims provide line-item detail on the options.41 receiving treatments ≥ 4.5 hours
use of the formerly separately billable duration were found to have higher
services but do not provide any In the CY 2020 ESRD PPS proposed average costs for each cost component,
information regarding variation across rule, we noted that CMS’s data except for cost report drugs.44
patients in the use of the formerly contractor’s pre-TEP analysis of CY CMS presented further discussion
composite rate services. In addition, we 2016 cost report data showed that into collection of time on machine data
stated that we believed that capturing composite rate costs comprise nearly 90 for each dialysis session in the CY 2020
the resource cost for furnishing renal percent of average total treatment costs, ESRD PPS proposed rule (84 FR 38396
dialysis services is complex since with capital, direct patient care labor, through 38400), where we further
Medicare has historically paid an ESRD and administrative costs representing identified this potential data set as a
PPS base rate (that is, composite rate approximately 88 percent of total singular option that would provide
payment) to account for those costs that average composite rate cost per sufficient data to develop a refined case-
were never itemized on a claim but were treatment. The data contractor provided mix adjustment model. If renal dialysis
reported through the cost report (80 FR examples of ways that longer duration session time were reported for each
68975 through 68976). of renal dialysis time might be renal dialysis treatment, cost report and
associated with increased treatment treatment-level data could be integrated
(c) Background on CMS Efforts To costs, including utility costs, accelerated
Explore the Use of ‘‘Time on Machine’’ to infer differences in composite rate
depreciation on equipment, and lower costs across patients. In this paradigm,
Data To Refine the Case-Mix daily census counts, which, among
Adjustment Model patient-level differences in composite
other things, would result in increased rate costs could be attributed to two
Interested parties, including MedPAC, per-treatment capital costs. The analysis discrete categories: differences due to
have long expressed concerns about the suggested that additional labor hours for renal dialysis treatment duration
complexity of the two-equation model a patient with longer treatments on (measured in units of time); and
underpinning the ESRD PPS and have average could increase per-treatment differences unrelated to treatment
questioned the validity of assuming that labor costs, and that patients with duration. To alleviate concerns from
the composite rate costs for all patients increased use of dialysate and water interested parties, we noted that time on
at an ESRD facility are the same. treatment supplies or equipment likely machine data would not be used to
Interested parties have encouraged CMS have higher average per-treatment
to develop a patient cost model that is supply costs. We noted that, under 42 The final TEP report from December 2018 is
based on a single patient-level cost current reporting practices, there are no found directly at: https://www.cms.gov/medicare/
variable that accounts for all composite data on the patient-and treatment-level medicare-fee-for-service-payment/esrdpayment/
rate and formerly separately billable downloads/esrd-pps-tep-summary-report-june-
variation in the cost of composite rate 2019.pdf.
services. Additionally, interested parties items and services. We explained that 43 In 2008, CMS introduced an electronic Web-
have expressed concerns that the these findings underscore the based data collection system, Consolidated Renal
existing case-mix adjustors might not importance of identifying variation in Operations in a Web-enabled Network
correlate well with the current cost of these costs to inform the development of (CROWNWeb) which was designed to collect
clinical performance measures data from dialysis
renal dialysis treatment and have a refined case-mix adjustment model. facilities (73 FR 20370, at 20372). CrownWeb is
encouraged CMS to explore a CMS published the findings from the now ‘‘EQRS’’—that is, the ESRD Quality Reporting
refinement. December 2018 TEP in a report dated System (OMB Control Number 0938–1289).
In response, CMS has explored the 44 Acumen LLC. ESRD PPS Case-Mix Adjustment
feasibility of collecting time on machine Technical Expert Panel (TEP). Slide Presentation
41 The final TEP report from December 2018 and Slide 42. December 2018. See https://www.cms.gov/
data on patient claims from ESRD other materials can be found at: https:// Medicare/Medicare-Fee-for-Service-Payment/
facilities and the potential for using www.cms.gov/Medicare/Medicare-Fee-for-Service- ESRDpayment/Downloads/ESRD-PPS-TEP-
such data. These efforts include: a Payment/ESRDpayment/Educational_Resources. Presentation.pdf.
directly adjust ESRD PPS payment, facilities. However, we stated that we New Value Code for Time on Machine),
rather, it would be used to apportion believed that, for ESRD facilities with effective January 1, 2021. At the same
composite rate costs (currently only EHRs, the burden associated with the time, CMS announced a new
observable at the facility level to the collection of renal dialysis treatment requirement for ESRD facilities to report
patient or treatment level) for use in the time is expected to be small and value code D6 on ESRD claims, for in-
case-mix adjustment. Time on machine temporary, because the information is facility or home hemodialysis
data would allow for a higher already being collected. We noted that maintenance, training, or retraining
proportion of composite rate costs to be collecting time on machine data could treatments. Shortly after making these
allocated to patients with longer renal be difficult to accomplish for ESRD contractor directions public, CMS
dialysis treatment times, and ultimately facilities that do not use EHRs. Lastly,
issued a Medicare Learning Network
inform CMS refinements to existing we stated that some participants
(MLN) Matters guidance document
patient-level adjusters, including age maintained that certain factors related to
and comorbidities. patient complexity—such as (MLN Matters No. MM11871) advising
We further explained that, in the comorbidities and mental health ESRD facilities of the new requirement
December 2018 TEP, the data contractor status—that are associated with to include treatment time on claims.
proposed two approaches to collect time treatment costs are unrelated to However, after a large dialysis
on machine data: (1) Use existing data treatment duration. organization submitted a petition 46
from Consolidated Renal Operations in pursuant to the HHS Good Guidance
a Web-Enabled Network (CROWNWeb) (ii) Request for Information (RFI) in the Practices Regulation,47 HHS issued a
(now EQRS) on delivered renal dialysis CY 2020 ESRD PPS Proposed Rule finding that notice-and-comment
minutes during the monthly session In addition to presenting the findings rulemaking was required for CMS to
when a laboratory specimen is drawn to from the December 2018 TEP, we impose such a requirement.
measure blood urea nitrogen (BUN); or solicited comments in the CY 2020 Consequently, CMS rescinded
(2) have ESRD facilities report time on ESRD PPS proposed rule (84 FR 38399) Transmittal 10368 and replaced it with
machine data on Medicare claims. For on the option of collecting time on Transmittal 10576, dated January 20,
the latter, we suggested that time on machine data. As discussed in the CY 2021, withdrawing the requirement for
machine data could be reported by 2020 ESRD PPS final rule (84 FR 60648, reporting time on the dialysis machine
using a new HCPCS or revenue center 60782), commenters responding to the
with value code D6. Although the
code to indicate units of treatment time RFI opposed the use of time on machine
guidance to report time on machine data
for each renal dialysis treatment or by data, maintaining that other factors were
more directly related to cost of was rescinded, the value code D6 for the
updating the definition of the existing
treatment. Commenters claimed that time on machine in minutes remains
revenue center code for renal dialysis
treatments so that the units correspond many subgroups of patients are approved by the NUBC and remains on
to treatment time instead of the number challenged to stay on renal dialysis for CMS’s claim form CMS–1450 (UB–04)
of treatments. We noted that ESRD the prescribed treatment time because of (OMB–0938–0997), in a deactivated
facilities already reported to CMS a their physical status or other status.
single monthly treatment time in limitations, leading to more frequent (iv) Request for Information (RFI) in the
CROWNWeb for in-facility treatments, treatment and/or higher costs related to
CY 2022 ESRD PPS Proposed Rule
indicating that ESRD facilities currently patients’ special circumstances and
collect time on machine data.45 comorbidities and not to treatment CMS revisited the topic of time on
Moreover, we stated that we were aware duration. Regarding patient-level factors machine in the 2020 TEP and discussed
that many ESRD facilities’ electronic contributing to high costs of care, the case-mix adjusters.48 Interested
health records (EHR) systems commenters expressed that patient-level parties continued expressing concerns
automatically collect this information adjusters should be based on sound, that the existing case-mix adjustors
for every renal dialysis treatment, empirical evidence of their contribution
might not align with resource-intensive
minimizing additional burden of to cost of care and opposed the use of
patient-level services such as isolation
reporting this metric on claims. time on machine data as a single,
rooms, behavioral issues, or
The December 2018 TEP participants patient-level factor to estimate variation
in composite rate costs. Some neurocognitive issues. We sought
preferred that the data be collected on
Medicare claims (84 FR 38398). They commenters expressed the objection additional public input in the ESRD PPS
did not support using the then-existing that use of this measure would not be CY 2022 proposed rule, requesting
CROWNWeb data for time on machine productive because there was great information on the methodology used to
data, as there were too many questions homogeneity in treatment times across calculate the case-mix adjustment (86
about its completeness and timeliness. patients. FR 36322, 36399 through 36400) and the
They agreed that if time on machine methodology to collect data to reflect
(iii) CMS Sub-Regulatory Guidance in patient-level differences in composite
data is collected on claims that it should Transmittal 10368 (September 24, 2020)
be reported in actual minutes dialyzed rate costs, including the use of a value
(Now Rescinded)
and not, for example, in 15-minute
increments. We explained that the TEP In Transmittal 10368, published 46 The petition (dated December 23, 2020) is
participants cautioned that reporting September 24, 2020, CMS instructed the attached as Exhibit A to HHS’s petition response
MACs to implement a new value code (January 8, 2021) which can be found at https://
time on renal dialysis on the claims www.hhs.gov/sites/default/files/davita-petition-
D6, which reflects the total number of
would place additional burden on ESRD response-and-exhibit.pdf.

minutes of dialysis provided during the 47 The HHS ‘‘Good Guidance Practices’’ final rule
45 Centers for Medicare & Medicaid Services billing period. See Transmittal 10368, appeared in the Federal Register on December 7,
(CMS) End-Stage Renal Disease Quality Incentive CR 11871 (Changes to the End Stage 2020 (85 FR 78770) and was later rescinded July 25,
Program (ESRD QIP) Payment Year (PY) 2021 Renal Disease (ESRD) PRICER to Accept 2022 (87 FR 44002).
Measure Technical Specifications. Page 23. 48 https://www.cms.gov/files/document/end-
Available at: https://www.cms.gov/files/document/

the New Outpatient Provider Specific stage-renal-disease-prospective-payment-system-
cy-2021-final-technical-specifications- File Supplemental Wage Index Fields, technical-expert-panel-summary-report-april-
20201130.pdf. the Network Reduction Calculation and 2021.pdf.
code to collect time on machine on the hours compared to 5 hours, the remaining comorbid case mix adjusters;
claim.49 composite rate costs for those treatments revise the weight adjusters to maintain
We received similar comments on this will be very similar. The only difference a low-BMI adjuster; create a high-BMI
RFI to those expressed in response to in cost between those two treatments adjuster; eliminate the BSA adjuster;
the CY 2020 ESRD PPS proposed rule. would be 1.5 hours more use of utilities, retire the age adjuster (which they
As discussed in the CY 2022 ESRD PPS dialysate and bicarbonate solution, believe is not methodologically sound
final rule, commenters cited concerns machine depreciation, and a small and does not resonate with clinician or
that apportioned composite rate costs amount of labor to check on the patient. renal dialysis facility experience of
(such as labor and capital related costs) Most of the labor for renal dialysis care); maintain the adjuster for low
from the cost reports, used in the case- treatments is putting the patient on and volume facilities; consider expanding
mix adjustments, were currently only taking the patient off dialysis. Therefore, the adjuster to a second tier of facilities
observable at the facility-level and did in both previously described scenarios, providing fewer than 6,000 treatments
not include patient or treatment-level the commenter asserted that cost would per year; eliminate the rural adjuster;
variations. remain the same. Further, they pointed and maintain the onset of renal dialysis
Like previously mentioned concerns out that some patients will not remain adjuster to support the resource
regarding the collection of time on for their full renal dialysis treatment, intensive needs of patients starting
machine data, commenters suggested and they generally cannot force a dialysis. Other commenters stated it
this data element would be burdensome patient to remain for their full would be too preliminary to eliminate
and complex (especially for those prescribed treatment time. Therefore, in the case-mix adjusters entirely, and
dialyzing at home) and would not their view, using actual treatment time instead they recommended that CMS
identify high-cost patients. They stated for cost allocation is not realistic. initiate a discussion of the adjusters that
that what little variation might be A small renal dialysis organization
are true drivers of high costs and how
identified would not be worth the within a large non-profit health system
the use of adjusters can be
burden of collecting the information. In commented that reporting treatment
operationalized for practical purposes.
addition, these commenters stated that times would be difficult and confusing
and identified many factors that would One payment adjustment that was
ESRD facilities’ staffing is based on
need to be addressed by CMS, universally supported by commenters
prescribed time, not on the actual time
including: identifying renal dialysis was the onset adjustment.
a patient is on the machine. They stated
that the prescription approach is the start time, early removal from renal MedPAC recommended that CMS
most rational way to determine staffing dialysis, inadvertent lack of time on develop a one-equation regression
levels, because ESRD facilities do not machine information, data inclusion on model in place of the two-equation
have time on machine in advance. a claim form, and staff training. They model currently used as the basis for the
According to these commenters, ESRD also expressed concern about the ESRD PPS. MedPAC also recommended
facilities would only have the reporting of time on machine creating that CMS consider removing the
prescribing physician’s prescription to opportunities for ESRD facilities to comorbidity adjustments and revise the
use. game the system by having the renal body size adjustment. MedPAC further
A provider advocacy organization dialysis run a few extra minutes to move recommended that CMS address the
opposed the use of time on machine into the next highest level. inherent correlation between BSA and
data for purposes of ESRD PPS Several commenters recommended BMI by jointly estimating the
primarily because certain patients changes or removal of the case-mix association of BSA and BMI with
benefit from shorter, more frequent adjusters, including refinement of the treatment cost. Both BSA and BMI are
dialysis, such as patients with catheter- age and weight (BSA and BMI) calculated based on patient height and
related access issues, non-compliant adjustments and removal of the weight. MedPAC’s analyses found that
patients, patients with chronic pain or comorbidity adjustments, based on BSA and BMI values are correlated such
diarrhea, and patients suffering from declining frequency of claims that patients with low BMI also tend to
certain comorbidities. They expressed containing comorbidities. Some have low BSA, and that these variables
significant concern that use of time on comments recommended removal of the have a joint effect on treatment costs
machine data for differentiating comorbidity adjustments, because they that is different from the sum of
treatment cost variability creates report the adjustments are not utilized. independent effects as currently
inappropriate incentives for certain They recommended CMS refine the age implemented. We reiterated in the CY
ESRD facilities to ‘‘game the system’’ by: and weight (BSA and BMI) adjusters to 2022 ESRD PPS final rule our current
(1) putting patients on renal dialysis better capture and designate higher cost inability to implement such a model
longer than necessary; or (2) placing patients. Many commenters expressed given the absence of data on the charges
patients on the cheapest dialyzer and the belief that the comorbidity associated with the components of renal
keeping them on it for all five possible categories no longer protect beneficiary dialysis treatment costs that vary across
hours of dialysis. Another small renal access and no longer correlate with patients in the use of the formerly
dialysis organization agreed, pointing increased costs. A non-profit renal composite rate services. A non-profit
out that most renal dialysis treatments, dialysis association recommended that renal dialysis association agreed with
regardless of time, will have similar CMS minimize resources devoted to MedPAC.
composite rate costs. In other words, adjusters. The commenters suggested
they asserted that if a treatment is 3.5 including only the minimum needed to (2) Health Equity Considerations
deliver quality patient care, restore Supporting the Proposed Collection of

49 We published a summary of the responses to significant funding to the ESRD PPS Time on Machine Data
the CY 2022 ESRD PPS RFI (86 FR 36322, 36399 base rate for the benefit and care of all
through 36400) for the current case-mix beneficiaries, and focus retained In the CY 2024 ESRD PPS proposed
methodology in the ESRD PPS CY 2022 final rule adjusters only on those that are clearly rule (88 FR 42468), we stated that CMS
(86 FR 61874, 61997) and provided greater detail on prioritizes expansion of the collection,
CMS’s website at https://www.cms.gov/files/
linked to patient cost of care or clear
document/cy-2022-esrd-pps-rfi-summary- barriers to access. Specifically, they reporting, and analysis of standardized
comments.pdf. recommended that CMS: retire the data as a key means to advance health
equity.50 We explained that by monitoring activities have involved an attack, known as a vaso-occlusive
increasing our understanding of the analysis of ESRD facility cost reports pain crisis, precipitates a series of
needs of those we serve, CMS aims to and patient claims to determine the medical interventions involving
ensure all individuals have access to most accurate adjustments and intravenous fluids, analgesia, as well as
equitable care and coverage. We noted methodologies as well as to identify the treatment of any precipitant and/or
that CMS’s proposal to collect time on trends in beneficiary health outcomes. acute comorbid state.53 CMS would be
machine data supports these priorities. Similarly, we noted that the proposal in able to use time on machine data for
We stated that we believe the proposed the CY 2024 ESRD PPS proposed rule to patients with sickle cell anemia to
data reporting requirements would collect more-detailed standardized data evaluate its alignment with the patient-
support our ability to assess whether, (that is, the proposed time on machine level adjuster for the corresponding co-
and to what extent, our programs and reporting) than is presently available for morbidity.
policies may perpetuate or exacerbate analysis supports our ability to evaluate In addition to re-evaluating and
systemic barriers to opportunities and potential disparities in health care potentially updating the payment
benefits for underserved communities. provided to our beneficiaries. multiplier for the patient-level adjuster
As noted previously, as part of CMS’s Presently, CMS adjusts the per- for the co-morbidity of sickle cell
December 2018 TEP and in the ESRD treatment ESRD PPS base rates to anemia, we noted that we anticipate that
PPS CY 2020 final rule, CMS’s EQRS account for variation in the case mix, as there could be other instances where
data (formerly collected under set forth in § 413.235. These patients need more time on renal
CROWNWeb) is reported once per adjustments account for patient age, dialysis to avoid uncomfortable post-
patient-month. CMS’s proposal to BSA, low BMI, onset of renal dialysis dialytic sequela, such as profound post-
collect time on machine data, which (new patient), and comorbidities (for dialytic exhaustion. In instances of
would require duration of treatment example, sickle cell anemia), as profound post-dialytic exhaustion, for
data reported for every renal dialysis specified by CMS. We explained in the example, CMS would evaluate the
treatment, would provide a more CY 2024 ESRD PPS proposed rule that forthcoming time on machine data for
granular set of standardized data for the data and information that inform the potential correlations between
analyzing (and potentially apportioning) these adjustments are derived from cost additional hemodialysis treatment time
composite rate costs for use in the case- reports, which are submitted to CMS on and decreased incidence of profound
mix adjustment. We noted that we the facility level. However, we noted post-dialytic exhaustions, which may
would also look to time on machine that time on machine data would be have cost implications. We stated that
data as a source to monitor claims data provided to CMS at the patient level on we are aware there may be a need for
and identify disparities in care that patient claims. This change would shift a future patient-level payment adjuster
could be mitigated by potential future CMS’s focus to a more patient-centered associated with post-dialysis fatigue.
adjustments that would incentivize paradigm. We stated that we believe (3) Requirement for Reporting Time on
equitable care within the framework of time on machine data would provide Machine Data To Evaluate Accuracy of
the ESRD PPS. the insights we need to develop (and
As we noted in the CY 2024 ESRD Current Payment Adjusters Aligned
propose) potential amendments to the With Resource Use
PPS proposed rule, ESRD PPS reform is payment multipliers for the current, and
an ongoing multi-year effort to refine In the CY 2024 ESRD PPS proposed
potential future, patient-level
payment adjustments and rule (88 FR 42469), we proposed to
adjustments, including new SDOH
methodologies under the ESRD PPS. require patient-level reporting on
factors or health conditions (such as resource use involved (time on
Section 1881(b)(2)(B) of the Act
profound post-dialytic exhaustion) as machine) in furnishing in-center
provides that the Secretary shall
patient-level adjustments. More hemodialysis treatment in ESRD
prescribe in regulations any methods
immediately, however, time on machine facilities, which would serve as a proxy
and procedures to determine the
data would significantly enhance CMS’s to apportion composite rate costs
amounts of payments to be made for
insight into whether our current (capital, labor, and administrative costs,
part B services (which include renal
payment adjusters are appropriately as well as drugs, laboratory tests, and
dialysis services), on a cost-related basis
aligning with actual resource use for supplies necessary to administer the
or other economical and equitable basis.
individuals and communities who are dialysis treatment) for use in the case-
Section 1881(b)(14)(D) of the Act
underserved or disadvantaged and who mix adjustment. This would allow us to
requires the ESRD PPS to include a
payment adjustment based on case mix may have multiple patient-level more precisely estimate the average
that may consider various patient characteristics that necessitate longer costs of the various earlier-mentioned
characteristics and other appropriate renal dialysis times. components of a renal dialysis treatment
For example, CMS is aware of that cannot currently be captured
factors.
Since the establishment of the ESRD anecdotal evidence and published because payment for these items is
PPS in the CY 2011 ESRD PPS final rule studies showing that patients with the bundled, and claims data do not contain
(75 FR 49030), CMS has been engaged comorbidity of sickle cell anemia may detail on the use of these items and
in ongoing monitoring and analysis of need a longer renal dialysis treatment services. We stated that CMS would
the ESRD PPS. CMS publishes these time as well as additional resources review the patient-level resource use
monitoring results regularly.51 CMS’s from medical staff to attend to the data, including time on machine data, to
manifestations of sickle cell that occur evaluate and monitor the accuracy of
during dialysis. In fact, renal dialysis the methods and procedures, including
50 https://www.cms.gov/about-cms/agency-
information/omh/health-equity-programs/cms- patients with sickle cell anemia may the payment methodology for the
framework-for-health-equity. have frequent pain attacks during the
51 Since the implementation of the ESRD PPS in patient-level adjustment factors,
January 2011, CMS has monitored outcomes,
actual renal dialysis treatment.52 Such
through a claims-based monitoring program, for 53 Derebail VK, Lacson EK Jr, Kshirsagar AV, Key
52 Benjamin Jacob et al. Management of the
Medicare beneficiaries receiving outpatient NS, Hogan SL, Hakim RM, et al.: Sickle trait in
maintenance dialysis. See https://www.cms.gov/ Dialysis Patient with Sickle Cell Disease (Seminars African American hemodialysis patients and higher
medicare/medicare-fee-for-service-payment/ in Dialysis 14 July 2015, https://doi.org/10.1111/ erythropoiesis-stimulating agent dose. J Am Soc
esrdpayment/esrd-claims-based-monitoring. sdi.12403). Nephrol 25: 819–826, 2014.
enhancing the integrity of the ESRD hemodialysis treatment on patient longer treatment times, and that this
PPS. In addition, we stated that CMS claims. With this background in mind, pattern was consistent for the individual
would evaluate whether the data could we further refined our proposed cost report components.
be used to inform future refinements to requirements at § 413.198(b)(5) in a way We stated in the CY 2024 ESRD PPS
the existing patient-level adjustment that would result in the reporting of the proposed rule that we anticipate that the
factors set forth at § 413.235(a), which most useful, high value data. data that would become available under
may include age, BMI, BSA, and co- Considering past comments the proposed requirement, if finalized,
morbidities such as sickle cell anemia. questioning the feasibility and accuracy for reporting time on machine data
Finally, we stated that CMS would of time on machine reporting for home would provide insight into meaningful,
review the data for its potential to dialysis patients, we proposed a measurable variabilities in certain costs
identify any disparities from a health reporting requirement that would only associated with patient-level
equity perspective and to support the apply to patients receiving an in-center characteristics.
future proposal of any new patient-level hemodialysis treatment. We explained We stated that the significance of the
adjustment factors, including potential that we believe this approach would time on machine data is dependent
SDOH factors. We noted that such data ensure greater uniformity to the upon the collection of data from a
may also be used to inform potential recording process and thus greater preponderance of patient claims for in-
future refinements to the facility-level consistency in the data reported. facility hemodialysis. We further noted
adjustment factors, if appropriate. We CMS also considered past comments that while most patient claims may
stated that per § 413.196, we would responding to its RFI in the CY 2020 come from patients with similar profiles
publish notice of any proposed changes ESRD PPS final rule (84 FR 60648, and treatment plans, the needs of the
to payment adjustments, including 60782) regarding patient-level factors more complex and resource-intensive
adjustments to the composite rate, in the that contribute to high costs of care. We patients can only be identified by CMS
Federal Register. stated that we agree with commenters through the collection of patient-level
that expressed that patient-level data from across the ESRD PPS patient
(a) Changes to 42 § 413.198 adjusters should be based on sound, population. We stated that complex and
We proposed to amend § 413.198 by empirical evidence of their contribution resource-intensive patients are
adding language at § 413.198(b)(5) that to cost of care. frequently encountered in the ESRD
would require each ESRD facility to We noted in the CY 2024 ESRD PPS dialysis treatment setting, but it is not
submit data and information, under proposed rule that we agree that the possible to obtain precise estimates of
existing paragraph § 413.198(b)(3) payment multipliers for patient-level the higher costs of these patients’
describing allowable costs, of the types adjusters should be grounded in strong hemodialysis treatments from currently
and in the formats established by CMS, evidence, and we recognize that each reported data. We identified that cost
for the purpose of estimating patient- patient will have unique needs, with reports and claims are the two data
level and facility-level variation in some being more costly to treat and sources from which per treatment costs
resource use, such as data and others with fewer costs, given their can be estimated. Since cost reports
information on the duration of medical backgrounds. We emphasized aggregate data at the facility level, we
hemodialysis treatment (that is, time on and again clarified that time on machine explained that patient-level differences
machine data) involved in furnishing data would not be directly used to in resource use are not detectable as
hemodialysis treatment in center in an determine payment for renal dialysis higher medical needs, and related costs
ESRD facility. For additional context, services, nor would higher payments be are masked by averages. Further,
we noted that, under § 413.198(b)(3), made for longer treatments. analysis of claims data from 2016 found
allowable cost is the reasonable cost We also considered comments that roughly 99 percent of ESRD
related to renal dialysis treatments. suggesting that a ‘‘time on machine’’ facilities reported 10 or fewer distinct
Reasonable cost includes all necessary data element would not identify high- charge values across all patients and
and proper expenses incurred by the cost patients and comments suggesting treatment modalities.55 Routinely
ESRD facility in furnishing the renal such a data element would not be collected, ESRD patient population-
dialysis treatments, such as productive as described earlier in this based data on time on machine for each
administrative costs, maintenance costs, section. We stated that we agree with in-facility hemodialysis treatment
and premium payments for employee commenters that treatment times and would enable CMS to assess variation in
health and pension plans. Reasonable costs may be similar across most the use of composite rate items and
cost includes both direct and indirect patients based on our analysis and the services at the patient level and to
costs and normal standby costs. comments of TEP participants. identify high-need and high-cost
We also proposed to update However, we would not expect to find patients. In addition, the time on
§ 413.198(a) by adding a reference to that ESRD facilities are treating ESRD machine data set would enable CMS to
section 1881(b)(14) of the Act to patients in a homogeneous fashion, but further determine what trends or causal
acknowledge the statutory provisions on a case-by-case basis determined by relationships may exist between certain
for the ESRD PPS. patient-centered plans of care. We noted patient-level characteristics and the
(b) Additional Background that a review of CY 2016 cost report
Considerations for, and Comments and data, conducted as part of the December 55 See page 9 of the December 2018 TEP Report
2018 TEP,54 showed that overall costs of at https://www.cms.gov/Medicare/Medicare-Fee-for-

Responses Thereto on, the Proposed Service-Payment/ESRDpayment/Downloads/ESRD-
Reporting of Time on Machine Data renal dialysis services (within the ESRD PPS-TEP-Summary-Report-June-2019.pdf. See also
facility cost reports) increased with Slide 27 from the December 2018 TEP Presentation
As we noted in the CY 2024 ESRD at https://www.cms.gov/Medicare/Medicare-Fee-for-
PPS proposed rule, CMS reviewed past 54 As presented on Slide 42 from the December Service-Payment/ESRDpayment/Downloads/ESRD-
comments from its TEPs and RFIs and 2018 TEP, overall costs of renal dialysis services PPS-TEP-Presentation.pdf.
considered the approach of our now- (within the ESRD facility cost reports) increased And see Slide 30 from the December 2019 TEP
with longer treatment times. See https:// Presentation at https://www.cms.gov/files/
rescinded sub-regulatory guidance in www.cms.gov/Medicare/Medicare-Fee-for-Service- document/end-stage-renal-disease-prospective-
Transmittal 10368 and the complexities Payment/ESRDpayment/Downloads/ESRD-PPS- payment-system-technical-expert-panel-
of reporting the number of minutes of TEP-Presentation.pdf. presentation-december-2019.pdf.
number of minutes of hemodialysis payment multipliers with resource use with CMS that these data could be used
treatment received by such patients. within the ESRD PPS. in the future to apportion composite rate
CMS would evaluate whether specific We stated that we anticipate that our costs (including labor and capital-
patient characteristics are associated proposed requirement would generate related costs) that are currently only
with increased length of dialysis the data we would need to evaluate a observable at the facility-level to the
treatment, which contribute to cost. potential adjustment of the payment patient- or treatment- level for use in
multipliers for patient level case-mix adjustment. One large dialysis
We also considered comments that
adjustments, thereby allowing us to organization expressed appreciation for
the costs to ESRD facilities for providing
counteract possible financial CMS’s acknowledgement that the
dialysis treatment could be better disincentives to serving those patients.
measured by looking at costs based on current two-equation payment model
We noted that we expect that such has intricacies that can be mitigated by
prescribed time, and not on the actual adjustments may thereby enhance
time a patient is on the dialysis moving toward a single patient-level
access to renal dialysis services for such cost variable. This commenter asserted
machine. The commenters stated their resource-intensive patients. We also
view that looking to prescribed time(s) that using a patient-level cost variable
believe that collecting time on machine would more accurately align treatment
would be the most rational way to data is preferable to collecting cost to payment. Further, the
determine staffing levels (and costs), prescribed times, since we recognize commenter urged transparency and
because ESRD facilities plan for dialysis that patients’ actual experiences do not inclusion of the dialysis community in
session length based on the prescribed always align with their doctors’ orders. moving forward with the development
time. Although CMS recognizes ESRD We recognized that a new reporting of a patient-level cost variable.
facilities’ labor practices to align staffing requirement would require uniformity
with the stated prescription times, CMS Response: CMS appreciates the
in its implementation across ESRD support expressed by MedPAC and
is concerned that, for some patients, facilities. We noted that the proposed
their prescription times are not aligning other commenters for moving toward a
‘‘time on machine’’ requirement is for
with actual usage and thus may not be patient cost model. As we discussed in
the reporting of the number of minutes
the CY 2024 ESRD PPS proposed rule
the best predictor of ESRD facilities’ of hemodialysis treatment a beneficiary
and reiterate in this final rule, the
costs. For example, we noted that we are receives, and it refers to only the
proposed requirement for reporting time
aware that patients who experience minutes (reported in whole minutes)
on machine data is the first step toward
severe itching or have certain spent dialyzing, while the patient is
creating the kind of patient cost model
psychological disorders may be less connected to the dialysis machine. We
that commenters acknowledged would
likely to receive dialysis for the full stated that we would address such
have advantages over the current cost
prescribed time. For such patients, only details in operational guidance.
We received numerous public model. As we discuss later in this final
the collection of time on machine data
comments on our proposal in the CY rule, we intend to analyze time on
for the number of minutes of
2024 ESRD PPS proposed rule to require machine data for the purposes of
hemodialysis treatment received would
reporting of time on machine data from creating a patient-level cost variable for
facilitate CMS’s understanding of their potential future refinement to the ESRD
complex needs and the implications for a broad array of interested parties.
Commenters included professional PPS case mix adjusters. We intend to
the ESRD PPS. For such patients, a undertake further rulemaking in
pattern of shorter treatment times may associations, advocacy organizations,
large dialysis organizations, subsequent years to address various
ultimately result in worse patient considerations, including the
outcomes and higher patient costs to the independent and regional dialysis
providers, individual physicians, other methodology for allocating composite
ESRD facility as well as to Medicare. We rate costs to patients for the
stated that CMS is also aware that healthcare providers, and patients.
The majority of the commenters development of a patient-level cost
patients with certain characteristics, variable. Interested parties would have
generally opposed the requirement, but
such as higher BSA quartiles, may be the opportunity to comment on the
some commenters expressed support.
more likely to need longer dialysis methodology used in CMS’s analysis to
Many commenters were supportive of
times.56 Additionally, CMS has been support such development at that time.
CMS’s effort to develop a patient cost
made aware of instances in which ESRD We look forward to actively engaging
model and to pursue future refinements
facilities may avoid treating complex with the public throughout that process
that would advance health equity in the
patients or patients with higher costs in the future.
ESRD PPS. However, commenters
generally (thereby favoring average or Comment: Several commenters,
questioned the utility of time on
lower cost patients). We noted that including a network of dialysis
machine data and expressed concern for
prescribed dialysis times would not organizations, State regional offices, a
the additional administrative burden
provide insight into costs for dialysis collecting and reporting the data would non-profit organization of ESRD
sessions for patients whose individual entail. Commenters expressed concerns networks, an individual commenter, a
needs or circumstances might about the adverse effects on specific national organization of patients and
necessitate a dialysis treatment time that populations. The comments on our kidney health care professionals,
differs in practice from the prescribed proposal and our responses are set forth MedPAC, an ESRD facility, and patients
dialysis time. Therefore, identifying below. advocated for evaluating disparities in
actual resource usage, as correlated with Comment: Some commenters the ESRD PPS, to refine case-mix
the needs, health outcomes, and patient- expressed support for establishing a adjusters in a way that would improve
level characteristics of complex patients patient cost model that is based on a payment accuracy, promote health
would enable CMS to better align the single patient-level cost variable. equity, and ensure quality of patient
MedPAC reiterated its support for care. A national organization of patients
56 See slide 31 from the 2020 ESRD TEP
collection of time on machine data, and kidney health care professionals
presentation, which can be found here: https://
www.cms.gov/files/document/end-stage-renal-
which the commission previously noted voiced support for aligning patient
disease-prospective-payment-system-technical- in their comments on the CY 2022 ESRD characteristics and co-morbidities more
expert-panel-presentation-december-2020.pdf. PPS proposed rule. MedPAC agreed accurately to case-mix adjusters to
establish that patients are receiving collection of data related to services Furthermore, several commenters
patient-centered care. provided to beneficiaries enrolled in expressed their concern that
One commenter explained that his MA is outside the scope of this final underserved or disadvantaged
research has demonstrated that slower, rule. populations would be allocated fewer
longer dialysis sessions have a positive Comment: Several commenters, resources because of inaccuracies in
impact on patient health and mortality. including a coalition of dialysis time on machine data. Specifically,
In addition, several commenters organizations, a non-profit kidney care commenters noted that pediatric
described serious issues with shortened alliance, and a non-profit dialysis patients require highly individualized
dialysis treatments contributing to organization, raised various concerns prescription time due to patient size and
reduced quality of care. One patient about the validity and sufficiency of blood volume, which would not be
reported an incident in which they lost time on machine data for the purpose of indicative of health disparities. Lastly,
consciousness during treatment and no measuring patient resource use. One one large dialysis organization
staff member responded. Several large dialysis organization requested requested that CMS track disasters and
patients indicated they did not receive details about how CMS would validate remove any data related to shortened
education regarding home modalities for the time on machine data it proposes to treatments from the data.
years after beginning dialysis treatment. collect. Several commenters claimed Response: We appreciate the concerns
Two patients reported disregard and that shorter time on machine does not that commenters raised regarding the
lack of education by physicians. Several correlate with lower costs, and that time validity and sufficiency of the data.
patients reported additional quality of on machine data is not an accurate Many of the concerns that commenters
care issues, including starting dialysis predictor of facility-level composite rate raised about potential issues of data
treatment late or being removed from costs, since time on machine does not quality can be addressed through CMS’s
dialysis treatment early, being requested capture the full scope of services analysis of the data. We note that
to move their treatment time frequently, rendered. Specifically, commenters methodological considerations related
being moved to another ESRD facility noted that time on machine fails to to allocating costs based on time on
for treatment, and even being requested capture services provided before and machine data or any other data would
to skip dialysis treatment. after the actual dialyzing time, such as be addressed in future notice and
Response: We appreciate the support time spent working with social workers. comment rulemaking.
for advancing health equity and quality Commenters expressed concern that use First, regarding the question about
of care through refinements to the ESRD of such data would misinform payment how CMS intends to validate the data,
PPS case mix adjusters. We believe that model refinements. it is not clear whether the commenter is
time on machine data, which we Commenters also noted that patient referring to validating that ESRD
proposed to collect beginning January 1, characteristics such as pain, co- facilities are reporting accurate and
2025, would support CMS’s analysis of morbidities, or an inability to adhere to complete information, or ensuring the
disparities and support potential future the prescribed length of dialysis time, statistical validity of aggregated data
refinements to advance health equity. all contribute to variation in time on CMS uses for analysis. In the former
Time on machine data can help inform machine. A coalition of dialysis case, as we noted in the CY 2024 ESRD
CMS’s understanding of the relationship organizations asserted that the costs of PPS proposed rule, requiring reporting
between resource use and many of the all these patients would remain the of time on machine data on a claim, by
issues reported by patients related to same regardless of their time on definition, would involve an attestation
lack of staff time to address education machine. Several commenters expressed that the information submitted is correct
or side effects of dialysis treatments. concern regarding the accuracy of data and that the items represent expenses
Monitoring time on machine data will for patients that require the dialysis for medically necessary services. CMS
enable CMS to address patient concerns treatment to be suspended or for reserves the right to request
about the possibility of being removed dialysis treatment to be ended early due documentation from the provider
from treatment early or started late and to medical or other needs. One non- validating the time on machine data,
receiving shortened treatments. Any profit treatment and research center and to recoup payment if this
potential new case-mix adjusters or expressed that some patients may have documentation is not provided or
changes to the case-mix adjusters would personal needs that require working supportable, as well as to take other
be the subject of separate rulemaking, with staff while they are not connected administrative actions, as appropriate.
and as we noted earlier in this final rule, to a dialysis machine, that some patients We note that prescription data and
interested parties would have the may need to have dialysis treatment historically reported monthly time on
opportunity to comment on the interrupted for a variety of needs, such machine data is available in EQRS and
methodology used in CMS’s analysis to as mechanical issues, bathroom breaks, can be used for the purposes of
support such development at that time. and blood pressure issues; therefore, comparison. In the case of ensuring the
Comment: MedPAC recommended some patients do not complete the full statistical validity of data used for future
that CMS consider the collection of time dialysis treatment ordered by the analysis, we note that CMS has
on machine data for Medicare physician. historically applied statistical trims to
Advantage (MA) dialysis beneficiaries, Various commenters, including a remove outlier values and erroneous
as the share of dialysis beneficiaries professional organization of data and could employ similar methods
enrolled in MA plans now exceeds 40 nephrologists, a non-profit dialysis for future analyses.
percent. Doing so, MedPAC explained, association, and a large dialysis As commenters rightly pointed out,
organization, suggested that CMS time on machine data does not account
would enable the agency to identify,

assess, and address potential health exclude certain types of dialysis from for costs that ESRD facilities incur
disparities among both FFS and MA the proposed reporting requirement before and after the time spent
beneficiaries. because of concerns about data quality. dialyzing. As we previously discussed
Response: We appreciate the Commenters suggested excluding time in the CY 2020 ESRD PPS proposed rule
recommendation from MedPAC to on machine data collection for home (84 FR 38396 through 38400), patient-
collect time on machine data for MA dialysis patients, AKI patients, and level differences in composite rate costs
beneficiaries, but we note that the nocturnal dialysis patients. could be attributed to two discrete
categories: differences due to renal for each cost component, except for cost burden associated with the proposed
dialysis treatment duration (measured report drugs.59 collection of time on machine on
in units of time); and differences Lastly, we recognize that the unique claims. Some commenters suggested
unrelated to treatment duration. The needs of particular subpopulations such that existing CrownWeb (now EQRS)
collection of time on machine data for as pediatric patients, AKI patients, clinical data on time on machine,
each dialysis session would support the nocturnal patients, and patients with collected once monthly in conjunction
development of a patient-level cost social needs may affect time on machine with blood urea nitrogen (BUN)
model, with respect to the portion of data. We intend to consider such patient laboratory testing, could be used
composite rate costs that are attributable characteristics when proposing a instead, reducing the burden on
to dialysis duration. We would consider methodology for allocating composite providers to collect data for each
additional data and information to rate costs in the future. We do not treatment. A non-profit kidney care
inform our allocation of costs that are believe it would be appropriate to alliance indicated while time on
not related to dialysis duration, such as exclude these subpopulations from the machine data may be interesting, there
analysis entirely, because doing so may be superior alternatives as a proxy
time spent with social workers.
would result in refinements to the ESRD to apportion composite rate costs;
Importantly, however, without a
PPS that in no way account for the however, they did not provide any
measure of dialysis duration, which we
unique needs of these subpopulations. alternatives to time on machine as a
have proposed to collect as time on Rather, we intend to look for ways to proxy. Some commenters encouraged
machine data reported on claims, it analyze and understand the impacts of the use of physician prescribed time,
would not be possible to develop a such patient characteristics on treatment rather than actual time on machine, as
comprehensive patient-level cost model duration. For example, because it reflects how ESRD facilities are
in the future. commenters have indicated time on staffed. One commenter suggested
We disagree with the commenter that machine may be shortened due to social defining time on machine as blood
the cost to care for patients is factors, we would encourage ESRD volume processed >0, as this would
unchanged regardless of pain, co- facilities to use Z codes when enable CMS to capture resources
morbidities, or adherence to prescribed submitting ESRD PPS claims as expended on sequential ultrafiltration.
dialysis treatment schedule based on appropriate to note when social factors Several other commenters suggested
time on machine. CMS published the affect treatment time or other aspects of limiting the scope of the proposed data
findings from the December 2018 TEP in treatment. For instance, if a patient has collection to reduce burden. Some
a report dated June 2019.57 The 2018 transportation issues necessitating commenters suggested limiting time on
TEP report provides clear evidence that removal from treatment early, the ESRD machine data collection to a subset of
in general, longer treatment duration is facility could include Z59.82 dialysis facilities or treatments.
associated with higher costs. First, as (Transportation insecurity), or if the MedPAC urged CMS to be mindful of
discussed in the 2018 TEP report, an patient has difficulty in understanding the potential for increased
imputed cost per treatment was the education provided related to the administrative burden on ESRD
calculated using a combination of importance of completing treatments the facilities and consider collecting these
treatment duration data from ESRD facility could use Z55 (Problems data for a finite period of time, only as
related to education and literacy) to long as needed to explore refining the
CROWNWeb 58 (now EQRS) and facility
indicate the psychosocial need to be payment adjustment factors.
cost per-minute data from cost reports to Response: We acknowledge that
addressed. The coding of this type of
infer differences in costs across patient- collecting time on machine data will
information, when clinically
months. An average interquartile range appropriate, would support CMS’s increase administrative burden for
of 34.6 minutes was observed from efforts to understand the impact of ESRD facilities, especially those for
CROWNWeb duration data, indicating social determinants of health, and other whom the collection of such data will
significant within-facility variation in factors, on treatment duration and have to be done manually. However, we
dialysis treatment time. Significant patient-level cost. do not agree that the proposed reporting
variation in average imputed cost per Comment: Many commenters stated requirement will substantially impact
hemodialysis sessions also was that collecting time on machine data time available for patient care, as some
observed, with an across-facility would place a significant administrative commenters suggested. We anticipate
interquartile range of $62.62. Overall, it burden on ESRD facilities, including for that ESRD facilities will employ medical
was found that costs increased with facilities that utilize EHR systems, but records technicians or similar non-
longer treatment times, and this pattern especially for smaller facilities and direct-care staff to aggregate time on
was consistent for the individual cost facilities that lack EHR capabilities. machine data and report it on claims.
report components as well. Facilities Commenters expressed that the time- Furthermore, as we stated in the CY
with a higher proportion of beneficiaries consuming task of reporting time on 2024 ESRD PPS proposed rule (88 FR
receiving treatments ≥4.5 hours duration machine would add to ESRD facilities’ 42466), for facilities that have already
were found to have higher average costs costs and would have a negative impact automated the collection of machine-
on time available for patient care during generated data directly into the patient
57 The final TEP report from December 2018 is a prolonged period of workforce electronic medical record, this burden
found directly at: https://www.cms.gov/medicare/ shortage. should be minimal. CMS will work to
medicare-fee-for-service-payment/esrdpayment/ Several commenters suggested provide timely operational guidance
downloads/esrd-pps-tep-summary-report-june-
2019.pdf.
alternative data sources that CMS could about the reporting requirement for time
58 In 2008, CMS introduced an electronic Web- consider using in order to avoid the on machine information so that facilities
based data collection system, Consolidated Renal may prepare their information
Operations in a Web-enabled Network 59 Acumen LLC. ESRD PPS Case-Mix Adjustment technology (IT) or EHR systems or other
(CROWNWeb) which was designed to collect Technical Expert Panel (TEP). Slide Presentation processes to collect and report complete
clinical performance measures data from dialysis Slide 42. December 2018. See https://www.cms.gov/
facilities (73 FR 20370, at 20372). CROWNweb is Medicare/Medicare-Fee-for-Service-Payment/
time on machine data by January 1,
now ‘‘EQRS’’—that is, the ESRD Quality Reporting ESRDpayment/Downloads/ESRD-PPS-TEP- 2025. We have revised our burden
System (OMB Control Number 0938–1289). Presentation.pdf. estimate in the regulatory impact
analysis in section VII.D.2.a of this final This approach would address long- Comment: Several commenters,
rule to reflect the additional burden standing concerns, including such including a non-profit kidney care
associated with aggregating time on concerns raised by MedPAC and other alliance, a coalition of dialysis
machine data from the patient record interested parties, that CMS should providers, and large dialysis
and reporting it on the claim. move to a one-equation model. We organizations requested clarification
We appreciate commenters’ stated that we agree with interested about the scope and specifications of the
suggestions regarding alternative parties that a single-equation model, to proposed reporting requirement.
sources of data. As we discuss earlier in be constructed at the patient level, Commenters requested CMS to clarify
this final rule, we believe time on would reduce the complexity of the its proposed definition of time on
machine is the most appropriate source current model, and would better align machine and how ESRD facilities would
of data for our proposed purpose. In payment with costs. The current two- be expected to collect and report such
contrast to the sources that commenters equation model’s payment adjusters are data under the proposed requirement. A
suggested, time on machine data would derived using weighted averages of the coalition of dialysis providers stated
provide more comprehensive coefficients from the facility-level and that there are inconsistencies in the
information about the actual quantity of patient-level equations. Because the methodology used across health care
dialysis that a patient receives each composite rate items currently comprise providers for the collection of time on
month. As we have previously noted, roughly 90 percent of the payment, we machine data and that CMS will need to
past analysis has demonstrated a stated that we are seeking a more provide guidance to ensure data is
statistically significant relationship detailed understanding of patients’ accurately provided. Two large dialysis
between a patient’s total time on utilization of such treatment resources. organizations recommended CMS define
machine and resource utilization. We noted that we anticipate that the time on machine data collection using
In addition, we appreciate the time on machine data would provide a an approach like that used in the ESRD
suggestion to limit time on machine useful proxy for these composite rate Measures Specification Manual
data collection to a subset of dialysis items. associated with the ESRD QIP.61 One
facilities to drive the revision of case- Furthermore, we noted that the large dialysis organization
mix adjusters. However, we believe this proposal to collect time on machine recommended using ‘‘clock time’’ to
would be counterproductive, because data on patient claims would address measure time on machine. We note that
analysis of a subset of facilities could past comments on whether such a the commenter did not specify a
skew the data and impact the accuracy reporting requirement could create meaning for the term ‘‘clock time’’;
of case-mix adjusters for the ESRD PPS perverse incentives for ESRD facilities however, we interpret this to mean the
in its entirety. We also appreciate the to amend actual reported time on total number of minutes between the
recommendation from MedPAC to limit machine. Another past commenter beginning of dialysis and the end of
the duration of data collection to the expressed concern about whether an dialysis, without accounting for any
length of time necessary to develop ESRD facility might have the renal interruptions. Clock time, the
methodology to use for case-mix dialysis run a few extra minutes to commenter suggested, could be utilized
adjustment. Without collection, review, increase the payment. However, we by all ESRD facilities, since it would not
and assessment of the time on machine noted that requiring the reporting of require networked electronic medical
data, we cannot provide an estimate of records. Another large dialysis
time on machine data on a claim, by
the length of time CMS will need to organization requested confirmation
definition, would involve an attestation
collect the data. We will consider the that ESRD facilities would be required
that the information submitted is correct
recommendation from MedPAC and the to report time on machine for all in-
and that the items presented represent
level of burden that reporting places on center dialysis treatments, including
medically necessary expenses. The
ESRD facilities in the future. We intend those provided under special
False Claims Act (31 U.S.C. 3729 to
to monitor and potentially propose circumstances for patients who
3733) establishes civil liability for
modifications to this policy, as normally perform dialysis treatments at
knowingly presenting a false or
appropriate, through future notice and home.
fraudulent claim to the government for
comment rulemaking. Response: We appreciate these
payment.
(c) Using a Medicare Claims Data Field We noted that if the requirement to requests for clarification from the
To Report Time on Machine Data report time on machine information on commenters. Although we intend to
claims is finalized, we would issue publish detailed operational guidance,
In the CY 2024 ESRD PPS proposed we are taking the opportunity in this
rule (88 FR 42471), we proposed that operational guidance in support of the
requirement. We stated that such final rule to respond directly to the
ESRD facilities report the number of questions that commenters posed. First,
minutes of hemodialysis treatment guidance would describe the applicable
instructions for reporting a value code while we appreciate the
received in center in an ESRD facility recommendation that we use the ESRD
using the D6 value code on the (in this case, the D6 60 value code)
Measures Specification Manual as a
Medicare 72X type of bill (TOB) that is connected to the number of minutes of
guide to define data collection, we note
part of CMS’s claim form CMS–1450 hemodialysis treatment provided to a
that the manual does not define time on
(UB–04) (OMB–0938–0997). While our patient in center.
The majority of the commenters machine in a way that is useful for our
proposal limited the time on machine purposes. Rather, for the purposes of
reporting requirement to in-center expressed concerns about the need for
specific operational guidance and about this reporting requirement, we are
claims, to address the concerns
exclusions and missing data. The clarifying that we generally define time
previously raised by interested parties on machine as the total number of
about the burden and complexity of comments on our proposal and our
responses are set forth below. minutes between the beginning of
home dialysis reporting, we noted that dialysis and the end of dialysis, without
time on machine for home dialysis data 60 Value code D6 on claim form CMS–1450 (UB– accounting for any interruptions, which
could nonetheless be voluntarily 04) (OMB–0938–0997), for reporting the total
reported using the D6 value code on number of minutes of dialysis provided during the 61 https://www.cms.gov/files/document/cy-2023-
claims. billing period. final-technical-specifications-20230613.pdf.
we believe one commenter referred to as exceptional circumstances. We for patient-level case-mix flags that are
‘‘clock time’’, as noted earlier. We do recognize that circumstances such as associated with higher costs. We wrote
not intend for ESRD facilities to track power outages, network failures, that final payment adjustments would
minutes for interruption during dialysis mechanical issues or failures, still only depend on existing patient-
due to frequent alarms or when a patient emergency circumstances, and human level case-mix adjustors, rather than a
is removed from dialysis treatment to go error can result in disruptions to factor directly derived from time on
to the bathroom, nor do we expect standard workflows and consequently, machine data.
facilities to subtract those minutes of missing time on machine data for Several of the commenters expressed
interruption from the time on machine individual dialysis treatments. We are concerns about how the resultant time
that is reported. We expect these clarifying that since data for time on on machine data would be used in the
episodes to be infrequent and time- machine is reported as an aggregate model refinement process to potentially
limited, and generally not a significant value for all dialysis treatment sessions determine payment. The comments on
driver of aggregate variation in total in one month, we will not return claims our proposal and our responses are set
time on machine between patients. that lack reporting of individual forth below.
Thus, time on machine for each dialysis sessions. We will only return claims Comment: Several commenters
treatment can be calculated by that have nothing reported in the D6 requested further clarification about
subtracting the time the dialysis value code. Therefore, although we how CMS intends to use the time on
treatment started from the time the appreciate the suggestion to allow a ten machine data. A not-for-profit dialysis
treatment ended. For each ESRD PPS percent error rate, we believe it is organization expressed concern that
claim, the ESRD facility should report in neither necessary nor appropriate to do reporting time on machine data would
the D6 value code the total number of so. lead to a payment methodology based
minutes across all treatments provided At this time, we have not established on minutes of dialysis provided.
to the patient during the billing period, any specific indicators to differentiate Response: In the proposed rule and
which is typically a month. Lastly, between time on machine that is this final rule, we have clearly stated
regarding the comment about in-center collected manually versus how data collected from time on
dialysis treatments provided under electronically. Nor have we established machine will be used. We will use time
special circumstances for patients who any identifiers for circumstances when on machine data to help us evaluate and
normally perform dialysis treatments at a patient needs to end his or her dialysis monitor the accuracy of our payments
home, we are clarifying that time on session earlier than the prescribed time; for patient-level adjustment factors.
machine data must be reported for all however, as we discussed earlier in this CMS will also evaluate whether the data
dialysis treatments that are provided in- final rule, we believe additional could be used to inform future
center, even if the patient usually uses information already reported on claims, refinements to the existing patient-level
a home modality. In such such as ICD–10 codes, could provide adjustment factors set forth at
circumstances, the ESRD facility should relevant context for such circumstances. § 413.235(a), which include patient age,
be billing for in-center dialysis We may consider developing additional BMI, BSA, and co-morbidities such as
treatments on a separate claim from any indicators to identify circumstances like sickle cell anemia. Finally, CMS will
home dialysis treatments, with the the ones that commenters described, review the data for its potential to
appropriate indicators to reflect that the and we would discuss any such changes identify any disparities from a health
treatment is being provided in-center. in future notice and comment equity perspective that may support
Comment: Several commenters rulemaking. proposing, in future rulemaking, new
requested clarification about how to patient-level adjustment factors,
(d) Use of Time on Machine Data for the including potential SDOH factors.
report time on machine in various
ESRD PPS
exceptional circumstances. One large (e) Request for Information About
dialysis organization stated that CMS In our CY 2024 ESRD PPS proposed
rule (88 FR 42470), we emphasized and Effective Date
should provide guidance regarding how
to report time on machine during again clarified that time on machine In the CY 2024 ESRD PPS proposed
certain infrequent anomalous data would not be directly used to rule, we proposed a January 1, 2025,
circumstances such as power outages, determine payment for renal dialysis effective date for this new reporting
network failures, mechanical issues or services, nor would higher payments be requirement. We stated that we are
failures, or emergency circumstances made for longer treatments. Rather, we aware that all ESRD facilities record the
when treatments must be shortened. stated that time on machine data would time a patient has received
One large dialysis organization allow for patient-specific calculation of hemodialysis treatment into a patient’s
requested CMS to differentiate between costs for composite rate services, medical record, and that, for most ESRD
when time on machine data is captured including labor costs, costs for the use facilities, this time is automatically
manually and when it is captured of renal dialysis machines and related recorded into the patient’s EHR. We
electronically. Commenters also equipment, and costs for such items as noted that we further understand that
expressed concern about whether ESRD dialysate and other essential supplies. ESRD facilities can transfer data from
facilities would be paid for treatments We noted that, in this way, time on EHRs into the patient-specific claims
for which time on machine was missing machine data would be used to that are submitted to Medicare for
and requested that payment should not disaggregate facility-level composite rate payment. However, we recognized that
be withheld for missing time on costs (as obtained from the cost reports) some ESRD facilities with limited
and assign them to the patient-month resources may need to make
machine data (that is, claims with no D6

value). One large dialysis organization level, which would enable a refined, modifications to their record keeping
requested CMS consider allowing an single-equation estimation and reporting systems to facilitate the
error rate of ten percent of total methodology. The refined, single- transfer of a patient’s recorded
treatments to allow for unforeseen equation regression analysis (currently hemodialysis treatment time in the
circumstances. under development) would still be used patient’s medical record to the Medicare
Response: We appreciate the concerns to determine the inclusion/exclusion claim. Although we did receive a past
that commenters raised about and magnitude of payment multipliers comment indicating that a facility’s
implementation time would involve collect and report accurate and period in center in an ESRD facility. We
training staff on how to count and track complete time on machine data. As we are finalizing our proposal to require
time, we stated that we do not expect noted in the CY 2024 ESRD PPS ESRD facilities to report this
that the manual recording of a patient’s proposed rule, we have proposed an information using the D6 value code on
hemodialysis treatment time into their implementation date of January 1, 2025, ESRD PPS claims. We are codifying this
health record is widespread. Finally, we for this reporting requirement to provide requirement in regulation at
noted that ESRD facilities are already what we believe will be sufficient lead § 413.198(b)(5)(i). As discussed in
reporting extensive information from time for ESRD facilities to make these section II.B.1.h of this final rule, we are
patient EHRs into Medicare institutional necessary changes to their systems and finalizing the addition of
claim form CMS–1450 (UB–04) (OMB– operations. Commenters indicated that § 413.198(b)(5), which states that ESRD
0938–0997), and we would not expect it would take 1 year for ESRD facilities facilities must submit data and
implementation to be overly to update their systems after the information in the formats established
burdensome to ESRD facilities. We provision of operational guidance due to by CMS for the purpose of estimating
stated that we recognize that some ESRD systems updates and staff education. We patient-level and facility level variation
facilities would need to establish a new believe that the 1 year implementation in resource use.
pathway from patient EHRs to the timeline strikes a balance between the
(4) Technical Change to § 413.198
Medicare claim form, in addition to need to collect this data and ESRD
making simpler programming updates to facilities’ need to make operational We proposed to fix a typographical
add a field for the total number of changes. error in § 413.198(b)(3)(iii), which
minutes of dialysis provided during the We also appreciate the concerns of currently refers to ‘‘luxury items or
billing period. Based on our findings in commenters who requested specific servicess’’. We proposed to change this
the TEP from December 2018, we noted operational guidance, and the to ‘‘luxury items or services’’. CMS did
that we anticipate that the opportunity to comment on such not receive any comments regarding
implementation challenges that ESRD guidance, before the effective date of the correcting this typographical error in
facilities might experience would be proposed reporting requirement. In this § 413.198(b)(3)(iii). We are finalizing our
small and temporary, as a patient’s time final rule, we have addressed many of proposal to revise the typographical
receiving dialysis treatment is already the operational questions that error in § 413.198(b)(3)(iii), which
collected for the patient’s medical commenters posed. Additionally, as we currently refers to ‘‘luxury items or
record. We solicited comment on noted earlier in this final rule, we servicess’’ to ‘‘luxury items or services’’.
whether an earlier effective date, such intend to issue detailed operational k. Clarification to TDAPA Average Sales
as January 1, 2024, would be feasible guidance no later than January 1, 2024. Price (ASP) Policy
and would provide ESRD facilities with This operational guidance will address
adequate time to implement this new topics such as instructions for the In the CY 2020 ESRD PPS final rule,
reporting requirement. collection and reporting of time on we finalized a conditional policy for
The majority of the commenters machine data, detailed billing TDAPA payment based on the
expressed concerns about the ability to requirements, including the types of availability of ASP data (84 FR 60679).
make the necessary changes to internal ESRD PPS claims subject to required In that final rule, we explained that if
IT systems by a January 1, 2024, reporting of the D6 value code, and drug manufacturers were to stop
reporting requirement. The comments guidance on how to proceed when time submitting full quarters of ASP data for
on our proposal and our responses are on machine for a qualifying treatment is products that are eligible for the
set forth below. missing or otherwise unavailable. The TDAPA, and we had to revert to basing
Comment: Commenters expressed proposed 1-year lead time between the the TDAPA on the wholesale
strong opposition to any start date issuance of detailed operational acquisition cost (WAC) or invoice
earlier than January 1, 2025. A large guidance and the effective date of the pricing, we believed we would be
dialysis organization expressed that proposed reporting requirement will overpaying for the TDAPA for those
making the necessary operational afford CMS the opportunity to engage in products. We stated that we would no
changes to report time on machine data further dialogue with interested parties longer apply the TDAPA for a new renal
would require considerable effort and about such guidance during the CY 2025 dialysis drug or biological product if a
would not be possible prior to January rulemaking cycle. CMS has responded drug manufacturer submits a full
1, 2025. Several commenters called for to specific concerns about operational calendar quarter of ASP data into CMS
CMS to allow for at least one year before guidance earlier in this section of this within 30 days after the last day of the
implementation for ESRD facilities, final rule. Further guidance will be 3rd calendar quarter after the TDAPA is
including large dialysis organizations, to provided by the MACs. Additionally, initiated for the product, but at a later
program the new requirements into their interested parties may reach out to CMS point during the applicable TDAPA
IT and EHR systems, and to provide to request meetings to discuss and period specified in § 413.234(c)(1) or (2),
comprehensive guidance before resolve specific concerns. stops submitting a full calendar quarter
finalizing this policy. A few Final Rule Action: We are finalizing of ASP data into CMS. We explained
commenters also suggested that our proposal to require the reporting of that once we determine that the latest
operational guidance be issued in in-center hemodialysis duration on full calendar quarter of ASP is not
conjunction with the CY 2024 ESRD ESRD PPS claims, beginning January 1, available, we would stop applying the
PPS final rule, and that implementation 2025. Specifically, we are finalizing our TDAPA for the new renal dialysis drug
or biological product within the next 2-
of the proposed time on machine proposal to require ESRD facilities to

reporting requirement be delayed until report ‘‘time on machine,’’ with certain calendar quarters. For example, we
interested parties have an opportunity changes to clarify that ESRD facilities stated that if we began paying the
to comment on such guidance. are required to report the number of TDAPA on January 1, 2021 for an
Response: CMS understands the minutes between the start and end of eligible new renal dialysis drug or
concerns that commenters raised hemodialysis treatment, without biological product, and a full calendar
regarding lead time needed to develop accounting for interruptions, a quarter of ASP data is made available to
IT systems and processes in order to beneficiary receives during the billing CMS by October 30, 2021 (30 days after
the close of the 3rd quarter of paying the of the published average wholesale conditional policy in § 413.234(c).
TDAPA), but a full calendar quarter of price (AWP)). In determining the Consistent with the pricing
ASP data is not made available to CMS payment limit based on WAC, the methodologies for separately payable
as of January 30, 2022 (30 days after the contractors follow the methodology Medicare Part B drugs, in such
close of the 4th quarter of paying the specified in Publication 100–04, circumstances, we will set the TDAPA
TDAPA), we would stop applying the Chapter 17, section 20.4 Drugs and payment amount based on WAC, or if
TDAPA for the product no later than Biologicals, for calculating the AWP, but WAC is not available, invoice pricing,
June 30, 2022 (2 quarters after the 4th substitute WAC for AWP. The payment for the quarter in which zero or negative
quarter of paying the TDAPA). limit is 106 percent of the lesser of the sales were reported.
We adopted this conditional policy to lowest-priced brand or median generic
avoid overpaying for the TDAPA on an WAC.63 Therefore, for purposes of the C. Transitional Add-On Payment
ongoing basis and to ensure that TDAPA TDAPA conditional policy, in Adjustment for New and Innovative
payment is based on the most circumstances where a manufacturer Equipment and Supplies (TPNIES)
appropriate data, that is, ASP. submitted ASP data reflecting zero or Clarifications and Application for CY
Specifically, we explained in the CY negative sales during the TDAPA 2024 Payment
2020 ESRD PPS proposed rule (84 FR period, we clarified that we consider 1. Background
38349) and final rule (84 FR 60680) that CMS to have received the latest full
we were concerned about (1) increases calendar quarter of ASP data, and we In the CY 2020 ESRD PPS final rule
to Medicare expenditures due to the would not discontinue TDAPA payment (84 FR 60681 through 60698), CMS
TDAPA for calcimimetics; (2) drug under the conditional policy in established the transitional add-on
manufacturers not reporting ASP data § 413.234(c). Consistent with the pricing payment adjustment for new and
for products eligible for TDAPA; and (3) methodologies for separately payable innovative equipment and supplies
our TDAPA policy potentially Medicare Part B drugs, we would set the (TPNIES) under the ESRD PPS, under
incentivizing drug manufacturers to TDAPA payment amount based on the authority of section
withhold ASP data from CMS. WAC, or if WAC is not available, 1881(b)(14)(D)(iv) of the Act, to support
In the CY 2024 ESRD PPS proposed invoice pricing, for the quarter in which ESRD facility use and beneficiary access
rule (88 FR 42472), we discussed that zero or negative sales were reported. to these new technologies. We
our existing regulation at § 413.234(c) Comment: We received two comments established this add-on payment
does not specifically address the on our proposal to clarify the ASP data adjustment to help address the unique
application of the TDAPA conditional submission requirement. Both circumstances experienced by ESRD
policy in situations in which the commenters, a coalition of dialysis facilities when incorporating new and
manufacturer of the new renal dialysis organizations and a drug manufacturer, innovative equipment and supplies into
drug or biological product submitted agreed with CMS that a submission their businesses and to support ESRD
ASP data to CMS and reported zero or reflecting zero or negative sales should facilities transitioning or testing these
negative sales. Zero or negative sales not lead to a discontinuation of TDAPA products during the period when they
may occur for a variety of reasons, payment. Both commenters supported are new to market. We added § 413.236
including no sales, recalls of a product, this clarification. The comment from the to establish the eligibility criteria and
or repurchases of sold products. In the coalition of dialysis organizations stated payment policies for the TPNIES.
CY 2012 PFS final rule (76 FR 73296), that this policy would support In the CY 2020 ESRD PPS final rule
CMS clarified that zero or negative continued patient access to a drug or (84 FR 60650), we established in
values are valid for ASP, ASP units, and biological product that is in the TDAPA § 413.236(b) that for dates of service
WAC. Therefore, when such a scenario period. The comment from the drug occurring on or after January 1, 2020, we
occurs for separately payable Medicare manufacturer expressed further support would provide the TPNIES to an ESRD
Part B drugs, we consider the for the use of WAC, or if WAC is not facility for furnishing a covered
submission of zero or negative sales to available, invoice pricing, when ASP equipment or supply only if the item:
fulfill the reporting requirements of data is not usable for the purposes of (1) has been designated by CMS as a
manufacturer ASP data to CMS as set determining the TDAPA payment renal dialysis service under § 413.171;
forth in sections 1927(b)(3)(A)(iii) and amount and post-TDAPA payment (2) is new, meaning granted marketing
1847A(f) of the Act. We noted that in amount. authorization by the FDA on or after
situations when zero sales are Response: We thank commenters for January 1, 2020; (3) is commercially
submitted, CMS guidance 62 instructs their support and for their insight into available by January 1 of the particular
the manufacturer to report ‘‘0.000’’ for the importance and impact of this CY, meaning the year in which the
the ASP and the number of ASP units. policy. payment adjustment would take effect;
The payment allowance limits for drugs Final Rule Action: We are finalizing (4) has a Healthcare Common Procedure
and biologicals that are not included in the clarification to the TDAPA ASP Coding System (HCPCS) application
the ASP Medicare Part B Drug Pricing payment policy as proposed; for submitted in accordance with the
File or Not Otherwise Classified Pricing purposes of the TDAPA conditional official Level II HCPCS coding
File, other than new drugs that are policy, in circumstances where a procedures by September 1 of the
produced or distributed under a new manufacturer submitted ASP data particular CY; (5) is innovative, meaning
drug application (or other application) reflecting zero or negative sales during it meets the substantial clinical
approved by the U.S. FDA, are based the TDAPA period, we consider CMS to improvement criteria specified in the
either on the published WAC or invoice have received the latest full calendar Inpatient Prospective Payment System
pricing (except under OPPS, where the quarter of ASP data, and we will not (IPPS) regulations at § 412.87(b)(1) and
payment allowance limit is 95 percent discontinue TDAPA payment under the related guidance; and (6) is not a
62 https://www.cms.gov/Medicare/Medicare-Fee- 63 Medicare Claims Processing Manual Chapter
capital-related asset that an ESRD
for-Service-Part-B-Drugs/McrPartBDrugAvgSales 17, section 20.1.3 https://www.cms.gov/
facility has an economic interest in
Price/Downloads/ASP_Data_Collection_Validation_ Regulations-and-Guidance/Guidance/Manuals/ through ownership (regardless of the
Macro_User_Guide.pdf. Downloads/clm104c17.pdf. manner in which it was acquired).
Regarding the innovation requirement demonstrated greater medication consideration of public comments, we
in § 413.236(b)(5), in the CY 2020 ESRD adherence or compliance; or, would announce the results in the
PPS final rule (84 FR 60690), we stated • The totality of the circumstances Federal Register as part of our annual
that we would use the following criteria otherwise demonstrates that the new updates and changes to the ESRD PPS
to evaluate substantial clinical renal dialysis equipment or supply in the ESRD PPS final rule. In the CY
improvement for purposes of the substantially improves, relative to renal 2020 ESRD PPS final rule, we also
TPNIES under the ESRD PPS based on dialysis services previously available, specified certain deadlines for the
the IPPS substantial clinical the diagnosis or treatment of Medicare application requirements. We noted that
improvement criteria in § 412.87(b)(1) beneficiaries. we would only consider a complete
and related guidance: Third, evidence from the following application received by February 1 prior
A new technology represents an published or unpublished information to the particular CY. In addition, we
advance that substantially improves, sources from within the United States or required that FDA marketing
relative to renal dialysis services elsewhere may be sufficient to establish authorization for the equipment or
previously available, the diagnosis or that a new renal dialysis equipment or supply must occur by September 1 prior
treatment of Medicare beneficiaries. supply represents an advance that to the particular CY. We also stated in
First, CMS considers the totality of the substantially improves, relative to renal the CY 2020 ESRD PPS final rule (84 FR
circumstances when making a dialysis services previously available, 60690 through 60691) that we would
determination that a new renal dialysis the diagnosis or treatment of Medicare establish a workgroup of CMS medical
equipment or supply represents an beneficiaries: Clinical trials, peer and other staff to review the materials
advance that substantially improves, reviewed journal articles; study results; submitted as part of the TPNIES
relative to renal dialysis services meta-analyses; consensus statements; application, public comments, FDA
previously available, the diagnosis or white papers; patient surveys; case marketing authorization, and HCPCS
treatment of Medicare beneficiaries. studies; reports; systematic literature application information and assess the
Second, a determination that a new reviews; letters from major healthcare extent to which the product provides
renal dialysis equipment or supply associations; editorials and letters to the substantial clinical improvement over
represents an advance that substantially editor; and public comments. Other current technologies.
appropriate information sources may be In the CY 2020 ESRD PPS final rule,
improves, relative to renal dialysis
considered. we established § 413.236(d) to provide a
services previously available, the
Fourth, the medical condition payment adjustment for certain new and
diagnosis or treatment of Medicare diagnosed or treated by the new renal
beneficiaries means one of the innovative renal dialysis equipment or
dialysis equipment or supply may have supplies. We stated that the TPNIES is
following: a low prevalence among Medicare paid for two CYs. Following payment of
• The new renal dialysis equipment beneficiaries. the TPNIES, the ESRD PPS base rate
or supply offers a treatment option for Fifth, the new renal dialysis will not be modified, and the new and
a patient population unresponsive to, or equipment or supply may represent an innovative renal dialysis equipment or
ineligible for, currently available advance that substantially improves, supply will become an eligible outlier
treatments; or relative to services or technologies service as provided in § 413.237.
• The new renal dialysis equipment previously available, the diagnosis or Regarding the basis of payment for the
or supply offers the ability to diagnose treatment of a subpopulation of patients TPNIES, in the CY 2020 ESRD PPS final
a medical condition in a patient with the medical condition diagnosed or rule, we finalized at § 413.236 that the
population where that medical treated by the new renal dialysis TPNIES is based on 65 percent of the
condition is currently undetectable, or equipment or supply. price established by the MACs, using
offers the ability to diagnose a medical In the CY 2020 ESRD PPS final rule the information from the invoice and
condition earlier in a patient population (84 FR 60681 through 60698), we also other specified sources of information.
than allowed by currently available established a process modeled after In the CY 2021 ESRD PPS final rule
methods, and there must also be IPPS’s process of determining if a new (85 FR 71410 through 71464), we made
evidence that use of the new renal medical service or technology meets the several changes to the TPNIES eligibility
dialysis service to make a diagnosis substantial clinical improvement criteria at § 413.236. First, we revised
affects the management of the patient; or criteria specified in § 412.87(b)(1). As the definition of new at § 413.236(b)(2)
• The use of the new renal dialysis we discussed in the CY 2020 ESRD PPS as within 3 years beginning on the date
equipment or supply significantly final rule (84 FR 60682), we believe it of the FDA marketing authorization.
improves clinical outcomes relative to is appropriate to facilitate access to new Second, we changed the deadline for
renal dialysis services previously and innovative equipment and supplies TPNIES applicants’ HCPCS Level II
available as demonstrated by one or through add-on payment adjustments code application submission from
more of the following: (1) a reduction in similar to the IPPS New Technology September 1 of the particular CY to the
at least one clinically significant adverse Add-On Payment and to provide HCPCS Level II code application
event, including a reduction in stakeholders with standard criteria for deadline for biannual Coding Cycle 2 for
mortality or a clinically significant both inpatient and ESRD facility durable medical equipment, orthotics,
complication; (2) a decreased rate of at settings. In § 413.236(c), we established prosthetics, and supplies (DMEPOS)
least one subsequent diagnostic or a process for our announcement of items and services as specified in the
therapeutic intervention; (3) a decreased TPNIES determinations and a deadline HCPCS Level II coding guidance on the
number of future hospitalizations or for consideration of new renal dialysis CMS website prior to the CY. In
physician visits; (4) a more rapid equipment or supply applications under addition, a copy of the applicable FDA
beneficial resolution of the disease the ESRD PPS. We would consider marketing authorization must be
process treatment including, but not whether a new renal dialysis equipment submitted to CMS by the HCPCS Level
limited to, a reduced length of stay or or supply meets the eligibility criteria II code application deadline for
recovery time; (5) an improvement in specified in § 413.236(b) and summarize biannual Coding Cycle 2 for DMEPOS
one or more activities of daily living; an the applications received in the annual items and services as specified in the
improved quality of life; or (6) a ESRD PPS proposed rules. Then, after HCPCS Level II coding guidance on the
CMS website in order for the equipment criteria specified in § 413.236(b) and accordance with the HCPCS Level II
or supply to be eligible for the TPNIES announce the results in the Federal coding procedures on the CMS website,
the following year. Third, we revised Register as part of our annual updates by the HCPCS Level II code application
§ 413.236(b)(5) to remove a reference to and changes to the ESRD PPS. In deadline for biannual Coding Cycle 2 for
related guidance on the substantial accordance with § 413.236(c), we will DMEPOS items and services as specified
clinical improvement criteria, as the only consider, for additional payment in the HCPCS Level II coding guidance
guidance had already been codified. using the TPNIES for a particular CY, an on the CMS website prior to the CY; (5)
Finally, in the CY 2021 ESRD PPS application for a capital-related asset is innovative, meaning it meets the
final rule, we expanded the TPNIES that is a home dialysis machine received criteria specified in § 412.87(b)(1); and
policy to include certain capital-related by February 1 prior to the particular CY. (6) is not a capital-related asset, except
assets that are home dialysis machines If the application is not received by for capital-related assets that are home
when used in the home for a single February 1, the application will be dialysis machines.
patient. We explained that capital- denied and the applicant is able to
related assets are defined in the 2. Clarifications Regarding CMS’s
reapply within 3 years beginning on the Evaluation of the TPNIES Eligibility
Provider Reimbursement Manual date of FDA marketing authorization to
(chapter 1, section 104.1) as assets that Criteria
be considered for the TPNIES, in
a provider has an economic interest in accordance with § 413.236(b)(2). This section of the final rule discusses
through ownership (regardless of the In the CY 2021 ESRD PPS final rule, clarifications to our policies for
manner in which they were acquired). at § 413.236(f), we finalized a pricing evaluating the TPNIES eligibility criteria
We noted that examples of capital- methodology for capital-related assets under § 413.236(b).
related assets for ESRD facilities are that are home dialysis machines when a. Sequential Order of CMS Review of
dialysis machines and water used in the home for a single patient, the TPNIES Eligibility Criteria
purification systems. We explained that, which requires the MACs to calculate (§ 413.236(b))
although we stated in the CY 2020 ESRD the annual allowance and the
PPS proposed rule (84 FR 38354) that As stated previously, we consider
preadjusted per treatment amount. The
we did not believe capital-related assets whether a new renal dialysis supply or
pre-adjusted per treatment amount is equipment meets the TPNIES eligibility
should be eligible for additional reduced by an estimated average per
payment through the TPNIES because criteria as part of the annual ESRD PPS
treatment offset amount to account for rulemaking and announce the results in
the cost of these items is captured in the costs already paid through the ESRD
cost reports, they depreciate over time, ESRD PPS final rule. To qualify for the
PPS base rate.64 We finalized that this TPNIES, an applicant must meet each of
and are generally used for multiple amount would be updated on an annual
patients, there were a number of other the TPNIES eligibility criteria set forth
basis so that it is consistent with how in § 413.236(b)(1) through (6). An
factors we considered that led us to the ESRD PPS base rate is updated.
consider expanding eligibility for these applicant that fails to demonstrate that
We revised § 413.236(d) to reflect that it meets each of the six eligibility
technologies in the CY 2021 ESRD PPS we would pay 65 percent of the pre-
rulemaking. We explained that, criteria is not eligible for the TPNIES.
adjusted per treatment amount minus In the CY 2021 ESRD PPS final rule,
following publication of the CY 2020 the offset for capital-related assets that
ESRD PPS final rule, we continued to we focused our analysis of the TPNIES
are home dialysis machines when used eligibility criteria on those that were not
study the issue of payment for capital- in the home for a single patient.
related assets under the ESRD PPS, met. That is, for the Theranova Dialyzer,
We revised § 413.236(d)(2) to reflect we included our analysis of how the
taking into account information from a that following payment of the TPNIES,
wide variety of stakeholders and recent applicant did not meet the innovation
the ESRD PPS base rate will not be criterion under § 413.236(b)(5), and for
developments and initiatives regarding modified, and the new and innovative
kidney care. For example, we the Tablo® cartridge, we included our
renal dialysis equipment or supply will analysis of how the applicant did not
considered various HHS home dialysis be an eligible outlier service as provided
initiatives, Executive Orders to meet the newness criterion under
in § 413.237, except a capital-related § 413.236(b)(2) and innovation criterion
transform kidney care, and how the risk asset that is a home dialysis machine
of COVID–19 for particularly vulnerable under § 413.236(b)(5) (85 FR 71444
will not be an eligible outlier service as through 71464). In the CY 2022 and CY
ESRD beneficiaries could be mitigated provided in § 413.237.
by encouraging home dialysis. 2023 ESRD PPS final rules, we
In summary, under the current expanded our analysis to include our
After closely considering these issues,
eligibility requirements in § 413.236(b), determination as to whether the
we proposed a revision to
CMS provides for a TPNIES to an ESRD applicants met each of the six criteria.
§ 413.236(b)(6) in the CY 2021 ESRD
facility for furnishing a covered In doing so, we analyzed the TPNIES
PPS proposed rule to provide an
equipment or supply only if the item: eligibility criteria in the sequence that is
exception to the general exclusion for
(1) has been designated by CMS as a provided in § 413.236(b)(1) through (6)
capital-related assets from eligibility for
renal dialysis service under § 413.171; (86 FR 61889 through 61906 and 87 FR
the TPNIES for capital-related assets
that are home dialysis machines when (2) is new, meaning within 3 years 67193 through 67216).
used in the home for a single patient beginning on the date of the FDA In the CY 2024 ESRD PPS proposed
and that meet the other eligibility marketing authorization; (3) is rule (88 FR 42475 through 42476), we
criteria in § 413.235(b), and finalized the commercially available by January 1 of stated that we are clarifying that our
the particular CY, meaning the year in analysis of the TPNIES eligibility
exception as proposed in the CY 2021

ESRD PPS final rule. We finalized the which the payment adjustment would criteria would continue to proceed in
same determination process for TPNIES take effect; (4) has a complete HCPCS sequential order. Specifically, in the
applications for capital-related assets Level II code application submitted in annual ESRD PPS proposed rule, we
that are home dialysis machines as for 64 The CY 2023 TPNIES offset amount was $9.79.
would continue to summarize the
all other TPNIES applications; that we CMS finalized a CY 2024 TPNIES offset amount of
information from the application
will consider whether the new home $10.00, as discussed in section II.B.1.e of this final regarding each of the six eligibility
dialysis machine meets the eligibility rule. criteria and include any questions or
concerns that we identify during our rule (73 FR 48561 through 48563) § 413.236(b)(6), as well as each of the
analysis of the application. discussed the way in which CMS five preceding criteria in § 413.236(b)(1)
Based on information provided by the evaluates the NTAP eligibility criteria through (5) as discussed previously
applicant and from public comments for new medical service or technology have been met, the equipment or supply
during the annual ESRD PPS add-on payment applications. That is, would qualify for and would be paid for
rulemaking cycle, we would continue to we first determine whether a medical under the ESRD PPS using the TPNIES
analyze the TPNIES eligibility criteria in service or technology meets the newness per § 413.236(d) beginning in the year
sequential order in the annual ESRD criterion, and only if so, do we then that is the subject of the rulemaking.
PPS final rule. However, the change that make a determination as to whether the In summary, we proposed to clarify
we proposed is that once it has been technology meets the cost threshold and that as CMS proceeds through the
established that one criterion has not represents a substantial clinical sequential analysis of the six TPNIES
been met, we would not discuss or make improvement over existing medical eligibility criteria in the ESRD PPS final
specific determinations on the services or technologies. The NTAP cost rule for a particular equipment or
subsequent criteria for that item in the criterion is not applicable in analyzing supply, once we determine that the item
annual ESRD PPS final rule. We noted TPNIES eligibility. However, consistent has failed to demonstrate having met
that the criteria set forth in § 413.236(b) with our approach under NTAP, we one of the eligibility criteria, the item
are intentionally listed in the order in stated that we believe that the most would be ineligible for the TPNIES. We
which they appear. The first criterion is prudent use of CMS resources would be would limit our analysis in the final
foundational in that an equipment or to reserve our analysis and rule to the TPNIES criterion that is not
supply that is not a renal dialysis determination regarding whether a new met and any preceding criteria that have
service would not be paid for under the equipment or supply meets the TPNIES been determined to have been met. We
ESRD PPS and therefore would not fit innovation criterion by representing a would not include the analysis of the
within the TPNIES payment pathway. substantial clinical improvement over remaining criteria in the final rule. This
As such, it would not be pertinent to existing technologies until after we policy would be effective January 1,
evaluate the remaining TPNIES criteria determine the new equipment or supply 2024 and would apply to our analysis of
for that item. TPNIES criteria two meets the earlier criteria. TPNIES applications for CY 2025
through four are objective and not payment.
Under this proposal, we would first We received six comments regarding
subject to interpretation in that they
determine whether an equipment or our proposed clarification of the
each require date evidence to
demonstrate newness, commercial supply meets the renal dialysis service sequential order of CMS review of the
availability, and the submission of a criterion in § 413.236(b)(1) and present TPNIES eligibility criteria at
HCPCS application, respectively. The our analysis of this first criterion in the § 413.236(b). These comments and
TPNIES innovation criterion under final rule. In instances where CMS CMS’s responses are set forth below.
§ 413.236(b)(5) requires the most determines that § 413.236(b)(1) has been Comment: One commenter supported
significant CMS evaluation. We met, we would proceed in assessing the our proposal with the understanding
explained that, under our TPNIES newness criterion in § 413.236(b)(2) and that all criteria would be discussed in
policy and § 412.87(b)(1)(i), CMS is present our analysis of this second full in the annual ESRD PPS proposed
required to consider the totality of the criterion in the final rule. In instances rule. Other commenters requested CMS
circumstances when making a where CMS determines that confirmation that we would continue to
determination that a new renal dialysis § 413.236(b)(2) has been met, we would summarize the information from each
equipment or supply represents an proceed in assessing whether the TPNIES application, including any
advance that substantially improves, commercial availability criterion in questions and concerns regarding each
relative to renal dialysis services § 413.236(b)(3) has either been met or of the six eligibility criteria, in the
previously available, the diagnosis or the applicant expects that it will be met annual CY ESRD PPS proposed rule.
treatment of Medicare beneficiaries. In by January 1 of the particular CY and Commenters also requested clarification
doing so, we consider various non- present our analysis of this third that in the annual CY ESRD PPS final
objective circumstances in our review of criterion in the final rule. In instances rule, CMS would limit its analysis to the
the TPNIES applications, including the where CMS determines that criterion not met as well as any
state of the ESRD landscape and the § 413.236(b)(3) has been met or the preceding criteria that are met. Several
particular challenges and vulnerabilities applicant expects that it will be met by other commenters expressed concern
of patients with ESRD (86 FR 61905). January 1 of the particular CY, we that our proposal would deny
We noted that we believe it is prudent would proceed in assessing the HCPCS applicants CMS’s analysis of each
to reserve our in-depth analysis of the Level II code application criterion in criterion, eliminating the opportunity
TPNIES innovation criterion only for § 413.236(b)(4) and present our analysis for the public to review the latter
applications that provide the necessary of this fourth criterion in the final rule. eligibility criteria and limiting
evidence to demonstrate that they meet In instances where CMS determines that applicants’ ability to correct deficiencies
the earlier foundational and objective § 413.236(b)(4) has been met, we would prior to the next TPNIES application
TPNIES criteria. proceed in assessing the innovation cycle.
As described previously in the criteria in §§ 413.236(b)(5) and Response: We thank the commenters
background section of this final rule, the 412.87(b)(1) and present our analysis of for their input and confirm that we will
TPNIES innovation criterion in this fifth criterion in the final rule. In continue to include our analysis of each
instances where CMS determines that TPNIES eligibility criterion in
§ 413.236(b)(5) incorporates the

substantial clinical improvement § 413.236(b)(5) has been met, we would sequential order in the annual CY ESRD
criteria in the IPPS regulations at proceed in assessing the non-capital- PPS proposed rule. We believe that
§ 412.87(b)(1) for the new technology related asset (except home dialysis identifying our comments or concerns
add-on payment (NTAP). This machines) criterion in § 413.236(b)(6) with each of the eligibility criteria in the
sequential approach for reviewing and present our analysis of this sixth proposed rule provides the public with
eligibility criteria is also in place for the criterion in the final rule. In instances sufficient information and ample
NTAP pathway. The FY 2009 IPPS final where CMS determines that opportunity to review and respond to
our analysis and provides the applicant consistent with our current TPNIES II devices, as noted on FDA’s website,
with the opportunity to correct policies and would not represent any are exempt from premarket notification
deficiencies, as needed. changes to the eligibility criteria: (1) the (510(k)) requirements, subject to certain
If a TPNIES applicant who is denied 3-year newness period and (2) FDA limitations.66 As we stated in the CY
reapplies in a later application cycle, we marketing authorization. 2023 ESRD PPS final rule (87 FR 67202
will continue to provide a full analysis First, with respect to the 3-year through 67023), devices that receive
of all the eligibility criteria once again newness period, we stated in the CY FDA marketing authorization have met
in the annual ESRD PPS proposed rule 2021 ESRD PPS final rule that by regulatory standards that provide a
to allow the applicant an opportunity to defining new as within 3 years reasonable assurance of safety and
correct any additional deficiencies for beginning on the date of the FDA effectiveness for the devices. For exempt
all the eligibility criteria, as needed. marketing authorization, we limit devices, FDA has determined that a
As stated in the CY 2024 ESRD PPS eligibility for the TPNIES to new premarket notification is not required to
proposed rule (88 FR 42475), an technologies but allow prospective provide a reasonable assurance of safety
applicant that fails to demonstrate that TPNIES applicants 3 years beginning on and effectiveness for the devices.
it meets each of the six eligibility the date of FDA marketing authorization However, generally a Class I or Class II
criteria is not eligible for the TPNIES. in which to submit their applications device that is exempt from 510(k)
Therefore, we believe that reviewing the (85 FR 71410 through 71464). requirements still must comply with
TPNIES eligibility criteria in sequential To further clarify the timeframe certain regulatory controls (known as
order allows CMS to reserve our in- during which a prospective TPNIES ‘‘general controls’’) to provide a
depth analysis of the TPNIES applicant is eligible to apply, in the CY reasonable assurance of safety and
innovation criterion only for 2024 ESRD PPS proposed rule (88 FR effectiveness for such devices. In
applications that provide the necessary 42476), we proposed to modify our limiting the TPNIES policy to items that
evidence to demonstrate that they meet regulation to specify that the applicant have received FDA marketing
the earlier foundational and objective would have 3 years from the date of authorization, we intended to exclude
TPNIES criteria. This approach is FDA marketing authorization to apply devices that lack FDA marketing
consistent with the way that NTAP for the TPNIES, based on the date the authorization (87 FR 38511). In the
applications are assessed in the annual application is submitted. We noted that absence of evidence that the renal
IPPS rule. this modification is consistent with dialysis equipment or supply is new,
Final Rule Action: After consideration current policy, and while it is not a meaning a complete application has
of the public comments received, we are change in policy, we believe that been submitted to CMS under
finalizing our clarification regarding the clarifying the regulation text would help § 413.236(c) within 3 years of the date
sequential order of CMS review of the to eliminate any confusion about the 3- of the FDA marketing authorization, the
TPNIES eligibility criteria as proposed. year newness period. As indicated in equipment or supply would not meet
In the annual ESRD PPS proposed rule, § 413.236(c), February 1 prior to the the TPNIES newness criterion under
we will continue to summarize the particular CY is the annual TPNIES § 413.236(b)(2).
information from the application application submission deadline. We We received 11 comments on our
regarding each of the six eligibility proposed to clarify that the 3-year proposed clarifications regarding the
criteria and include any questions or newness period is only for submission TPNIES newness criterion at
concerns that we identify during our of the complete application. An § 413.236(b)(2). These comments and
analysis of the application. As CMS applicant does not have to ensure that CMS’s responses are set forth below.
proceeds through the sequential CMS renders its determination through Comment: In general, commenters
analysis of the six TPNIES eligibility notice and comment rulemaking within supported both TPNIES clarifications.
criteria in the ESRD PPS final rule for the 3-year newness period. Specifically, Commenters supported our proposal to
a particular equipment or supply, once we proposed to revise § 413.236(b)(2) to revise § 413.236(b)(2) to clarify that the
we determine that the item has failed to clarify that the equipment or supply is equipment or supply is new if a
demonstrate having met one of the new if a complete application has been complete application has been
eligibility criteria, the item will be submitted to CMS under § 413.236(c) submitted to CMS under § 413.236(c)
ineligible for the TPNIES. We will limit within 3 years of the date of the FDA within 3 years of the date of the FDA
our analysis in the final rule to the marketing authorization. marketing authorization and stated that
TPNIES criterion that is not met and any Second, with respect to the basing the three-year newness period on
preceding criteria and will not include requirement in § 413.236(b)(2) that the the date of the TPNIES application
the analysis of the remaining criteria in equipment or supply must have FDA submission, and not the date of CMS’s
the final rule. This policy will be marketing authorization, we proposed to determination through notice and
effective January 1, 2024 and will apply clarify that an equipment or supply with comment rulemaking would ensure that
to our analysis of TPNIES applications FDA Exempt status would not meet the months of eligibility are not taken up by
for CY 2025 payment. newness criterion and therefore would the determination process.
b. Clarifications Regarding the TPNIES not be eligible for the TPNIES. As With respect to our proposal that an
Newness Criterion (§ 413.236(b)(2)) described on the FDA website, the equipment or supply with FDA Exempt
Medical Device Amendments of 1976 to status would not meet the newness
As stated previously, applicants must the Federal Food, Drug, and Cosmetic criterion and therefore would not be
meet the newness criterion in Act established three regulatory classes
§ 413.236(b)(2) to qualify for the
for medical devices: Class I, Class II, and Available at: https://www.fda.gov/medical-devices/
TPNIES. CMS defines the TPNIES Class III. The three classes are based on consumers-medical-devices/learn-if-medical-
newness criterion at § 413.236(b)(2) as the degree of control necessary to assure device-has-been-cleared-fda-marketing. Accessed
within 3 years beginning on the date of the various types of devices are safe and on March 14, 2023.
66 Food & Drug Administration. Class I and Class
the FDA marketing authorization. In the effective.65 Most Class 1 and some Class II Device Exemptions. Available at: https://
CY 2024 ESRD PPS proposed rule (88 www.fda.gov/medical-devices/classify-your-
FR 42476), we clarified two distinct 65 Food & Drug Administration. Learn if a Medical medical-device/class-i-and-class-ii-device-
aspects of the criterion that are Device Has Been Cleared by FDA for Marketing. exemptions. Accessed on May 30, 2023.
eligible for the TPNIES, one commenter 3. CY 2024 TPNIES Application for marketing authorization, the applicant
stated that this policy would limit Buzzy® Pro stated that it is seeking 510(k) marketing
access to the TPNIES. The commenter Pain Care LabsTM submitted an authorization from the FDA for a new
stated that because exempt devices must application for the TPNIES for Buzzy® utility and design of Buzzy® created for
still comply with general controls to Pro for CY 2024. Buzzy® Pro is one of dialysis fistulae sites, patented in 2022
provide a reasonable assurance of safety several models of the Buzzy® device. under the name Buzzy® Pro. To be
and effectiveness, these devices have no The Buzzy® device is intended to eligible for the TPNIES, the applicant
need to apply for FDA marketing control pain associated with needle must apply within 3 years of the FDA
authorization, and an FDA procedures and for temporary relief of marketing authorization date and
determination should not exclude these minor injuries. Buzzy® Pro is a palm- receive FDA marketing authorization by
devices from the TPNIES. This sized external use vibration device used the HCPCS Level II deadline of July 3,
commenter asserted that CMS should with unique ice packs and is intended 2023.
incentivize innovation in the ESRD to temporarily desensitize and The applicant submitted the
space by allowing all relevant and physiologically block pain associated indications for use portion of its FDA
appropriate technologies an opportunity with dialysis cannulation. The applicant 510(k) application that identifies
to apply for the TPNIES. stated that dialysis cannulation pain Buzzy® as all Buzzy® models: Mini
Response: We appreciate the Healthcare, XL Healthcare, Mini
affects 12 to 80 percent of dialysis
commenters’ overall support for our Personal, XL Personal and Pro to control
patients and is a substantial contributor
clarifications regarding the TPNIES pain associated with needle procedures
to reduced quality of life.67 68 The
newness criterion. Regarding our including dialysis and the temporary
applicant further stated that cannulation
proposed clarification that an relief of minor injuries. The applicant
pain is associated with fear of the
equipment or supply with FDA Exempt provided supplemental information in a
cannulation process, the decision to
status would not meet the newness document titled ‘‘510(k) Summary’’ that
undergo hemodialysis and sometimes
criterion, we emphasize that for the included a comparison table of the
the hemodialysis itself.
purposes of the TPNIES, we rely on Predicate Device (K130631) to the
The applicant described the steps for
Subject Device (K202993). The
FDA marketing authorization to ensure using Buzzy® Pro during dialysis: (1)
that devices have met regulatory document indicated that only the
thread the hands free strap or regular
standards that provide a reasonable Buzzy® Pro model is recommended for
tourniquet through the ice pack and the
assurance of safety and effectiveness. dialysis. The document also indicated
device so that the ice pack is on the
While a Class I or Class II device that that Buzzy® Pro is identical to the
concave side of the device; (2) attach the
is exempt from 510(k) requirements still predicate device in terms of materials,
device and the ice directly over the site;
must comply with certain regulatory vibration motor, circuitry, functionality,
(3) activate the vibration toggle switch
and intended use; differs only in shape
controls (known as ‘‘general controls’’) and leave in place 30 to 120 seconds; (4)
but is comparable in size to the
to provide reasonable assurance of during cannulation, move the device predicate device; and Buzzy® Pro is
safety and effectiveness for such proximally so the dot on the side distinguished by its rectangular shape to
devices, we do not believe devices with opposite the switch is 2 to 3 cm offer users a more professional looking
Exempt status offer the level of proximal to the cannulation site; (5) alternative to the bee-shape of the other
assurance that is provided with FDA clean the site per cannulation protocol; device. In the CY 2024 ESRD PPS
marketing authorization. As such, we and (6) remove the device after the proposed rule, we stated that we would
maintain that our original intent was to painful part of procedure is completed. be interested in better understanding the
exclude devices that lack FDA
a. Renal Dialysis Service Criterion way in which the Buzzy® Pro, that is the
marketing authorization (87 FR 38511). subject of this TPNIES application,
(§ 413.236(b)(1))
Final Rule Action: After considering differs from the other Buzzy® models
public comments, we are finalizing as Regarding the first TPNIES eligibility
and whether Buzzy® Pro is indicated for
proposed our proposal to revise criterion in § 413.236(b)(1), that the item
adult versus pediatric patients, or both.
§ 413.236(b)(2) to clarify that the has been designated by CMS as a renal
We noted that to satisfy the newness
equipment or supply is new if a dialysis service under § 413.171, pain
criterion, the FDA 510(k) marketing
complete application has been management associated with dialysis
authorization must have been issued
submitted to CMS under § 413.236(c) cannulation is a service that is furnished
within 3 years covering the specific
within 3 years of the date of the FDA to individuals for the treatment of ESRD
device and model that is the subject of
marketing authorization. We are also and is essential for the delivery of
the TPNIES application. We invited
finalizing as proposed our proposed maintenance dialysis. We consider
public comment on this issue in the
clarification that an equipment or Buzzy® Pro a renal dialysis service
proposed rule.
supply with FDA Exempt status would under § 413.171. Comment: The applicant submitted a
not meet the newness criterion and b. Newness Criterion (§ 413.236(b)(2)) comment to demonstrate that the device
therefore would not be eligible for the meets the newness criterion. With
TPNIES. In the absence of evidence that With respect to the second TPNIES
respect to our question regarding the
eligibility criterion in § 413.236(b)(2),
the renal dialysis equipment or supply way in which the Buzzy® Pro, which is
is new, meaning a complete application that the item is new, meaning within 3
the subject of this TPNIES application,
years beginning on the date of the FDA
has been submitted to CMS under differs from the other Buzzy® models,
§ 413.236(c) within 3 years of the date
67 Kosmadakis G, Amara I, Costel G. Pain on

the applicant provided a table
of the FDA marketing authorization, the arteriovenous fistula cannulation: A narrative comparing Buzzy® Pro and predicate
equipment or supply would not meet review. Semin Dial 2021;34(4):275–84 doi: 10.1111/ Buzzy® devices and stated that Buzzy®
the TPNIES newness criterion under sdi.12979 [published Online First: 20210507]. Pro is identical to the predicate devices
§ 413.236(b)(2). 68 Kosmadakis G, Amara B, Costel G, Lescure C.
in terms of materials, vibration motor,
Pain associated with arteriovenous fistula
We received one application for the cannulation: Still a problem. Nephrol Ther
circuitry, functionality, curvature to fit
TPNIES for CY 2024. A discussion of 2022;18(1):59–62 doi: 10.1016/j.nephro.2021.05.002 the angle of the arm, and the mnemonic
the application is presented below. [published Online First: 20210618]. design with a ‘‘dot’’ to put near the
‘‘shot.’’ The applicant stated that e. Innovation Criteria (§§ 413.236(b)(5) effective for reducing dialysis pain for
Buzzy® Pro is thinner, lighter, and has and 412.87(b)(1)) both adults and children, it is messy
dual arms to attach to the cannulation (1) Substantial Clinical Improvement and inferior. The applicant further
site compared to the predicate device; Claims and Sources stated that a Buzzy® device cannulation
and Buzzy® Pro offers users a more study in adults found that ice is only 10
professional looking alternative to the With regard to the fifth TPNIES percent of the effect, with the
bee-shape of the other device. eligibility criterion under mechanical gate control
With respect to FDA marketing § 413.236(b)(5), that the item is neuromodulation (vibration) providing
authorization, the applicant indicated innovative, meaning it meets the 90 percent of the pain relief.74
that Buzzy® Pro received FDA 510(k) substantial clinical improvement With respect to the claim that Buzzy®
approval on May 15, 2023, to control criteria specified in § 412.87(b)(1), the Pro reduces needle fear, the applicant
pain associated with needle procedures applicant presented two substantial stated that 25 to 47 percent of chronic
(for example, injections, vascular access, clinical improvement claims. First, the kidney patients have needle fear.75 The
applicant stated that Buzzy® Pro applicant further stated that CDC
cannulation, lab draws, blood donation,
controls needle pain for dialysis. recommends vibrating cold devices for
dialysis, cosmetic and dental
Specifically, per the applicant, Buzzy® needle fear in children, and cold
injections).
Pro makes cannulation pain relief devices with a buzzer for adults.76 The
Response: We appreciate the
available to dialysis patients, which applicant also stated that meta-analyses
applicant’s clarification regarding
significantly improves clinical outcomes demonstrate significant fear reduction
Buzzy® Pro’s similarity to its predicate related to depression and
devices and confirmation of FDA with Buzzy® device,77 and a New
discontinuation of dialysis due to Zealand study demonstrated improved
marketing authorization. Based on the needle pain. Second, the applicant
information provided by the applicant, adherence to Bicillin injections with
stated that Buzzy® Pro reduces needle fear reduced 50 percent after three uses
we agree that Buzzy® Pro meets the fear.
newness criterion. of Buzzy® device.78 The applicant also
With respect to the claim that Buzzy® stated that Buzzy® device is indicated
c. Commercial Availability Criterion Pro controls needle pain for dialysis, the by Health Canada to ‘‘control pain and
(§ 413.236(b)(3)) applicant stated that currently, the most fear from needles’’ and is used for
effective options for dialysis fearful dialysis patients in the
Regarding the third TPNIES eligibility cannulation pain are the topical
criterion in § 413.236(b)(3), that the item Netherlands.
anesthetic, EMLA® and vapocoolant The applicant submitted 33 unique
is commercially available by January 1 spray.69 Per the applicant, systematic
of the particular CY, meaning the year sources of evidence with its application
reviews recommend against vapocoolant in support of its claims of substantial
in which the payment adjustment use due to lack of efficacy70 and EMLA®
would take effect, the applicant stated clinical improvement. Thirty of the
incurs $15 cost per use and takes 1 hour sources that were submitted examined
that it expects Buzzy® Pro would be to become effective. The applicant
commercially available immediately the effect of external cold and vibration
asserted that the Buzzy® device has devices, including the Buzzy® device,
after receiving FDA marketing been shown to be superior to
authorization. though not Buzzy® Pro, during needle
vapocoolant spray71 and equivalent to
Comment: The applicant submitted a procedures other than dialysis
topical anesthetics EMLA® and LMX® at
comment indicating that as of May 15, cannulation. One article examined the
a fraction of the cost and time.72 73 The
2023, Buzzy® Pro is commercially effect of cryotherapy on pediatric pain
applicant stated that while ice is
available. management at the arteriovenous fistula
Response: Based on the information 69 Çelik G, Özbek O, Y(lmaz M, Duman I, Özbek
site during hemodialysis.79 Because the
provided by the applicant, Buzzy® Pro S, Apiliogullari S. Vapocoolant spray vs lidocaine/
74 Abidin NH. Assessing The Effectiveness Of A
prilocaine cream for reducing the pain of
meets the commercial availability venipuncture in hemodialysis patients: a Thermomechanical Device (Buzzy®) In Reducing
criterion. randomized, placebo-controlled, crossover study. Venous Cannulation Pain In Adult Patients. Middle
Int J Med Sci 2011;8(7):623–7 doi: 10.7150/ East Journal of Anesthesiology 2018;25(1):61–67.
d. HCPCS Level II Application Criterion ijms.8.623 [published Online First: 20111012]. 75 Duncanson E, Le Leu RK, Shanahan L, et al.
(§ 413.236(b)(4)) 70 Hogan ME, Smart S, Shah V, Taddio A. A The prevalence and evidence-based management of
systematic review of vapocoolants for reducing pain needle fear in adults with chronic disease: A
Regarding the fourth TPNIES from venipuncture and venous cannulation in scoping review. PLoS One 2021;16(6):e0253048 doi:
eligibility criterion in § 413.236(b)(4) children and adults. J Emerg Med 2014;47(6):736– 10.1371/journal.pone.0253048 [published Online
requiring that the applicant submit a 49 doi: 10.1016/j.jemermed.2014.06.028 [published First: 20210610].
complete HCPCS Level II code Online First: 20140829]. 76 Easy to Read: Needle Phobia. Available at:
71 Baxter AL, Leong T, Mathew B. External https://www.cdc.gov/ncbddd/humandevelopment/
application by the HCPCS Level II covid-19/needle-phobia/index.html. Accessed
thermomechanical stimulation versus vapocoolant
application deadline of July 3, 2023, the for adult venipuncture pain: pilot data on a novel March 9, 2023.
applicant stated that it intends to apply device. Clin J Pain 2009;25(8):705–10 doi: 10.1097/ 77 Ballard A, Khadra C, Adler S, Trottier ED, Le
by the deadline. AJP.0b013e3181af1236 [published Online First: May S. Efficacy of the Buzzy® Device for Pain
2009/11/19]. Management during Needle-Related Procedures: A
Comment: The applicant submitted a 72 Lescop K, Joret I, Delbos P, et al. The Systematic Review and Meta-analysis. Clin J Pain
comment indicating that the HCPCS effectiveness of the Buzzy® device to reduce or 2019 doi: 10.1097/ajp.0000000000000690
Level II code application was submitted prevent pain in children undergoing needle-related [published Online First: 2019/03/05].
to CMS on July 1, 2023. procedures: The results from a prospective, open- 78 Russell K, Nicholson R, Naidu R. Reducing the
Response: We appreciate the label, randomised, non-inferiority study. Int J Nurs pain of intramuscular benzathine penicillin
Stud 2021;113:103803 doi: 10.1016/ injections in the rheumatic fever population of

applicant’s confirmation of having j.ijnurstu.2020.103803 [published Online First: Counties Manukau District Health Board. J Paediatr
submitted the HCPCS Level II code 20201019]. Child Health 2014;50(2):112–7 doi: 10.1111/
application and confirm that CMS 73 Potts DA, Davis KF, Elci OU, Fein JA. A jpc.12400 [published Online First: 2013/10/19].
received the application by the Vibrating Cold Device to Reduce Pain in the 79 Attia, A., Hassan, A. Effect of cryotherapy on
Pediatric Emergency Department: A Randomized pain management at the puncture site of

deadline. Therefore, we agree the Clinical Trial. Pediatr Emerg Care 2017 doi: arteriovenous fistula among children undergoing
applicant has met the HCPCS Level II 10.1097/pec.0000000000001041 [published Online hemodialysis. International Journal of Nursing
application criterion. First: 2017/01/26]. Sciences 2017; (4) 46–51.
study did not examine the effect of improvement claims. One document examined the effect of external cold and
external cold and vibration devices such labeled as Dutch guidelines was vibration devices, including the Buzzy®
as the Buzzy® device or more submitted in non-English text and thus, device, though not Buzzy® Pro, during
specifically the device that is the subject was not readily accessible to our review needle procedures other than dialysis
of this TPNIES application, Buzzy® Pro, team. cannulation. The document identified
in managing dialysis related pain or The applicant also submitted a list of several additional sources that were not
fear, it was not directly applicable to the references, referred to as a literature submitted by the applicant. Finally, the
applicant’s substantial clinical review, that pertained to the applicant’s applicant submitted a document titled
improvement claims. One article products, among which, the Buzzy®
‘‘Buzzy Fear reduction rationale and
evaluated the effectiveness of device was listed as relieving or
table’’ that duplicated information
distraction cards, in pediatrics in reducing needle pain and fear and for
needle procedures and for already captured in the ‘‘Summary of
reducing pain and anxiety during Clinical Evidence—relief of needle pain
intramuscular injection.80 Because the musculoskeletal pain.
In a document titled ‘‘Summary of and fear’’ document. Table 10 lists the
study did not examine the effect of
Clinical Evidence—relief of needle pain 29 sources that were both identified by
external cold and vibration devices such
as the Buzzy® device or the Buzzy® Pro and fear,’’ the applicant presented the the applicant in the ‘‘Summary of
device in managing dialysis-related pain study objectives and key features of Clinical Evidence—relief of needle pain
or fear, it was not directly applicable to 29 81 of the 30 submitted sources that and fear’’ document and that were
the applicant’s substantial clinical submitted. We have not included
81 The following source was not included in the
sources that were mentioned by the
summary table: Redfern RE, Chen JT, Sibrel S,
80 Sahiner, N., Turkmen, A. The Effect of
Effects of Thermomechanical Stimulation during
applicant, but not submitted to us.
Distraction Cards on Reducing Pain and Anxiety Vaccination on Anxiety, Pain, and Satisfaction in BILLING CODE 4120–01–P
During Intramuscular Injection in Children. Pediatric Patients: A Randomized Controlled Trial.
Worldviews on Evidence-Based Nursing 2019; 1–6. J Pediatr Nurs.2018.38: 1–7.
TABLE 10: Applicant's Substantial Clinical Improvement Sources
(1) 0: Pain relief and anxiety Buzzy ( 1) Self-Reported pain reduction - Ballard A Khadra C, Adler S,
reduction for pediatric needle 1.11; 95% [CI]: -1.52 to -0.70; Doyon- Trottier E, Le May S.
procedures P<0.0001) Of 4 studies only Efficacy of the Buzzy Device for
F: Systematic review and meta- assessing lab draws, IV Pain Management during
analysis catheter/venipuncture procedures Needle-Related Procedures: A
N=ll38 (SMD: -1.30; 95% CI: -1.84 to Systematic Review and Meta-
P: 3 -18 y/o -0.76 P<0.00001) analysis. Clin J Pain. 2019 June;
35(6):532-543.
(2) 0: Anxiety reduction (2) (Pain reduction -1.11; 95%
F: Systematic Review and Meta- confidence interval [CI]: -1.52 to -
analysis 0.70; P<0.0001), anxiety reduction
N=l138 (SMD -1.37; 95% CI: -1.77 to -
P: 2-17 0.96; P<0.00001
0: Pain relief and anxiety reduction Multiple Meta-regression demonstrated a Su HC, Hsieh CW, Lai NM,
for pediatric needle procedures devices significant negative correlation of Chou PY, Lin PH, Chen KH.
F: Systematic review and meta- pain score with age. For children Using vibrating and cold device
analysis at 8.5 years, cold vibration reduced for pain relievers in children: a
N=l479 the pain score by 0.13 averagely systematic review and meta-
P: 2-18 y/o for every increment in year analysis ofrandomized
compared with controls (MD -0.13; controlled trials. J Pediatr Nurs.
95% CI: -0.25, -0.01 2021 Mar 15; 61:23-33.
0: Pain relief for cannulation in Buzzy There were no statistically Bahorski JS, Hauber RP, Hanks
pediatrics M-stim significant differences among C, Johnson M, Mundy K, Ranner
F: RCT: Buzzy compared to LMX only treatment groups based on the D, Stoutamire B, Gordon G.
topical anesthetic observational measures of pain or Mitigating procedural pain
N=l73 the self-report measures of pain. during venipuncture in a
P: 18 months - 17 y/o Findings support the use of both pediatric population: A
mechanical vibration and topical randomized factorial study. Int J
anesthetic as effective in children Nurs Stud. 2015
Oct;52 10 :1553-64.
0: Pain relief and first stick Buzzy Vascular access success more Baxter AL, Cohen LL, McElvery
vascular access success in pediatric likely w/ Buzzy: (odds ratio, 3.05; HL, Lawson ML, von Baeyer
emergency 95% CI, 1.03- 9.02), p=.040); CL. An integration ofvibration
F: RCT: Buzzy v. Vapocoolant Self-reported pain scores lower and cold relieves venipuncture
N=81 with Buzzy: (-2; 95% CI, -4 to 0) pain in a pediatric emergency
P: 4-18 y/o than with vapocoolant (p=.029). department. Pediatr Emerg Care.
Parent reported pain scores lower 2011 Dec;27(12):1151-6.
with Buzzy (-2; 95% CI -4 to -2)
than va ocoolant =.005.
ER06NO23.013</GPH>
(1) 0: Pain relief in adult vascular Buzzy (1) In a crossover trial, Buzzy Baxter AL, Leong T, Mathew B.
access reduced angiocath placement pain External thermomechanical
F: RCT: Buzzy v. Vapocoolant (mean 9.9 mm, 95% [CI] 0.82-19, stimulation versus vapocoolant
N=31 P=0.035, SD 16) compared to for adult venipuncture pain: pilot
P: 18+ Years Hospital employees vapocoolant (mean 7.9 mm, 95% data on a novel device. Clin J
[CI]-1.8-17.7, P=0.1, SD 16.9) Pain. 2009 Oct;25(8):705-10.
(2) 0: Pain relief with cannulation
on the dorsum of hand (2) Each 20mm of pre-procedural
F: Crossover trial rated with VAS fear increased the likelihood of a
N=31 successful intervention pain relief
P: Adult healthcare workers (odds ratio 2, P=0.043).
(1) 0: Pain and anxiety relief in Buzzy (1) Pain: "Buzzy was highly Bergomi P, Scudeller L, Pintaldi
vascular access procedures in effective in children younger than 9 S, Dal Molin A. Efficacy ofNon-
children (p=0.04). Also, a significant pharmacological methods of
F: RCT: Buzzy, Buzzy + Cartoons, efficacy was recorded in the Buzzy pain management in children
Cartoons alone, Control/nothing. and Cartoon group (p=0.04) for the undergoing venipuncture in a
N=150 nurse's perception of the child's pediatric outpatient clinic: A
P: Mean age 9.4 years pain, and in the Buzzy group for randomized controlled trial of
the mother's perception of the audio-visual distraction and
(2) 0: Fear reduction using Buzzy child's pain (p=0.002)." External Cold and Vibration. J
v. Cartoons v. Nothing v. Buzzy+ Anxiety: "Particularly, the Pediatr Nurs. 2018 Sep-Oct; 42:
Cartoons difference was statistically e66-e72.
F: RCT significant in the Buzzy (p=0.03)
N=150 and the Buzzy and animated
P: Pediatric 5-12 years Cartoon groups (p=0.02) for nurses'
perception of the child's anxiety,
and in the Buzzy group for
mothers' perception of anxiety
(p=0.03)."
(2) (Children's Emotional

Manifestation Scale for anxiety:
per nursing and mother evaluation)
Nothing -0.26 v. Buzzy-0.86
P=.03.
Nothing -0.26 v. Buzzy+ Cartoons
-0.89 P=.02
Nothing -0.26 v. Cartoons alone -
.073 P=.09).
0: Pain reduction comparison in Buzzy Pain scores were lower in the Binay S, Bilsin E, Gen;eker GO,
children during vascular access groups of Buzzy and blowing soap Kahraman A, Bal-Y1lmaz H.
F: RCT: Buzzy, Bubbles, and bubbles than the control group. Comparison ofthe Effectiveness
Control There was no statistical difference of Two Different Methods of
N=96 between Self Report, Parent Decreasing Pain During
P: 3 -6 y/o Report, Nurse Report, or Phlebotomy in Children: A
Researcher Report between Buzzy Randomized Controlled Trial. J
and Bubbles. The differences Perianesth Nurs. 2019 Feb 20
between Buzzy or Bubbles and S 1089-9472(18)30414-3.

Control was significant for all
P=.0000.
ER06NO23.014</GPH>
0: Superiority trial of pain relief Buzzy No significant difference between a Cozzi G, Crevatin F, Dri V,
during vascular access handheld computer distraction and Bertossa G, Rizzitelli P, Matassi
F: RCT: Buzzy, Handheld computer Buzzy, median (IQR) = 3.0 (1.0- D, Minute M, Ronfani L, Barbi
distraction 4.8) and 2.0 (1.0--4.8), respectively, E. Distraction Using Buzzy or
N=200 P = 0.72. Handheld Computers During
P: 4-12 y/o Venipuncture. Pediatr Emerg
Care. 2018 Dec 27.
0: Pain relief during pediatric Buzzy Buzzy resulted in lower pain than Gen;eker GO, Binay S, Bilsin E,
vascular access VR and significantly better than Kahraman A, Yilmaz HB.
F: RCT: Virtual Reality (VR) versus control, P = 000). Buzzy n=40; 1.5 Effects of Virtual Reality and
Buzzy +/- .2SD versus VR n=41; 2 +/- External Cold and Vibration on
N=121 .2SD, p<.0001). Pain in 7- to 12-year- old
P: 7 - 12 y/o Children During Phlebotomy: A
Randomized Controlled trial. J
Perianesth Nurs. 2018 Mar 17.
0: Pain Relief for vascular access Buzzy All groups using Buzzy had Inal S., Kelleci M. The Effect of
with Buzzy, Buzzy + Distraction, significantly reduced pain (P < External Thermomechanical
Distraction, and Control 0.001) compared to the control Stimulation and Distraction on
F: RCT: 4 arm trial group. Lowest pain measured Reducing Pain Experienced by
N=218 w/Buzzy in combination Children During Blood Drawing.
P: 6 - 12 y/o w/DistrAction Cards. Pediatr Emerg Care. 2020
Feb;36 2 :66-69.
( 1) 0: Pain relief during vascular Buzzy (1) Lower pain (p < .001) and Inal S, Kelleci M. Relief ofpain
access in pediatric patients anxiety (p < .001 w/ Buzzy) during blood specimen collection
F: RCT: [Buzzy v. control] compared to the control group. in pediatric patients. MCN Am J
N=120 Matern Child Nurs. 2012
P: 6 - 12 y/o Sep;37(5):339-45. PMID:
22895207.
(2) 0: Pain and anxiety relief with (2) (Lower pain (p < .001) and
lab draws anxiety with Buzzy. CAPS Parent
F: RCT using Child Pain Scale reported 1.61(Buzzy) v. 3.36
N=120 (Control) (p < .001))
P: 6-12 Jo
(1) 0: Pain, stress cortisol level, and Buzzy "A significant difference was found Kii<;iik Alemdar D, Yaman Akta~
fear relief during vascular access between the intervention and Y. The use of the Buzzy, Jet
comparing Buzzy, Jet Lidocaine, control groups in terms of levels of lidocaine, bubble-blowing and
Bubbles and aromatherapy pain during and after phlebotomy aromatherapy for reducing
F: RCT in favor of the Buzzy group pediatric pain, stress and fear
N=195, 39 x 5 groups (p<0.05)." associated with phlebotomy. J
P: 5 -10 y/o PediatrNurs. 2019 Jan 30
S0882-5963(18)30352- X.
(2) 0: Pain, stress cortisol level, and (2) ("children in the Buzzy group
fear relief during vascular access were less frightened during
comparing Buzzy, Jet Lidocaine, phlebotomy (CFS 1.33 v. 2.66 p <
Bubbles and aromatherapy 0.05)." "There was a significant
F: RCT difference between intervention
N=195, 39 x 5 groups and control groups fear levels in
P: 5 -10 y/o favor of the Buzzy group during
hlebotom < 0.05 ."
ER06NO23.015</GPH>
0: Pain and anxiety in adults during Buzzy Pain was less than expected in Pald~ <;::etin S, <;::evik K. Effects
cannulation using Buzzy or control. 44/50 Buzzy patients and 0/50 of Vibration and Cold
F: RCT control, and more than expected in Application on Pain and Anxiety
N=lO0 no Buzzy patients and 6/50 control During Intravenous
P: Mean age: 49.6 +/- 13.8y (P<.000), with overall less pain Catheterization. J Perianesth
(1.04 v 5.32) and greater Nurs. 2019 Aug:34(4):701-709.
satisfaction. (95.3 v 2.12) P<.001.
There was no difference in pulse,
state, or trait anxiety before or after
cannulation.
0: Pain relief during vascular access Buzzy "Reported no or mild procedural Schreiber S, Cozzi G, Rutigliano
in children with cognitive pain in 32 cases (91.4%) in the R, Assandro P, Tubaro M,
impairment Buzzy group and in 22 cases Cortellazzo Wiel L, Ronfani L,
F: RCT: Buzzy v. Control (61.1 %) in the no-intervention Barbi E. Analgesia by cooling
N=70 group (p = 0.003)." vibration during venipuncture in
P: Median age - 9 y/o children with cognitive
difficulties. Acta Paediatr. 2016
Jan;105 1 : el2-6.
0: Efficacy of Buzzy for pain Buzzy Buzzy pain 3.65 vs Magic Glove Susam V. Friedel M, Basile P,
reduction in children 4.67 (p=.039). Ferri P, Bonetti L. Efficacy of the
F: RCT Buzzy System for pain relief
N=72 during venipuncture in children:
P: 3 -10 y/o a randomized controlled trial.
Acta Biomed. 2018 Jul 18;89(6-
S :6-16.
(1) 0: Effect of Buzzy, distraction Buzzy (1) Lowest pain scores with Buzzy Tork HM Comparison of the
cards, and balloons in reducing pain (1.90±1.34) vs Distracting cards Effectiveness ofBuzzy,
and anxiety in children receiving (3.17±2.13) vs Balloon inflating Distracting Cards and Balloon
procedure requiring vascular access (2.83±1.41) vs control (4.15±1.29), Inflating on Mitigating Pain and
F:RCT (p=0.012) Anxiety During Venipuncture in
N=180 a Pediatric Emergency
P: 7 -12 y/o Department. Am J Nursing
Science 2017 Feb;6(2):26- 32.
(2) 0: Fear reduction with (2) (Fear with Children's Fear
venipuncture Scale lowest with Buzzy (0.61)
F: RCT with CFS versus control (3 .17), one way
N=180 ANOVA with 4 arms p=.13
P: pediatrics 9.3 +/- 1.9 years "clinically significant rather than
statistically significant." - p <.0001
if Buzzy compared to control,
p=.003 if compared to Balloon
inflatin CFS 1.19.
0: Effect of vibration on outpatient Buzzy "21 of the 26 [phlebotomists'] Whelan HM, Kunselman AR,
vascular access in children (80.8%) responses provided Thomas NJ, Moore J, Tamburro
F: Retrospective review indicated that the device made the RF. The impact of a locally
N=64 procedure easier; the other 5 applied vibrating device on
P: 4-18 y/o claimed that it had no effect." outpatient venipuncture in
children. Clin Pediatr (Phila).
2014Oct;53 12 :1189-95.
ER06NO23.016</GPH>
(1) 0: Effect of vibration in reducing Buzzy ( 1) "The effect size for the Buzzy Ueki S, Yamagami Y, Makimoto
needle pain in children tended to be higher than that for the K. Effectiveness of vibratory
F: Systematic review other devices." "Buzzy self-rated stimulation on needle-related
N=264 pain (n=): -0.94, [95% CI]: -1.54, - procedural pain in children: a
P: 0 - 18 y/o 0.35) p<.00001. [With Buzzy] the systematic review. JBI Database
effect on the child's anxiety (SMD: System Rev Implement Rep.
-1.03, 95% CI: -1.85 to - 0.20 2019 Jul; 17(7): 1428-1463.
p<.00001) was significant."
(2) 0: Identify, evaluate and (2) Comparison devices

synthesize evidence of the DentalVibe and Vibrational
effectiveness of vibratory Anesthesia Device used primarily
stimulation to reduce needle-related or exclusively for Dental
procedural pain in children aged 18 procedures. "The effect size for the
years and younger. Buzzy tended to be higher than that
F: Systematic Review for the other devices. Overall,
N=n/a vibratory stimulation was
P: 0-18 y/o significantly effective: self-rated
pain: -0.55, 95% confidence
interval [95% CI]: -0.92 to -0.18)
observer-rated pain outcomes
(SMD: -0.47, 95% CI: -0.76 to -
0.18 ."
0: Effect of the Use of Buzzy during Buzzy "Results indicate that the use of the Yilmaz D., Reper Y., Gozler.
Phlebotomy on Pain and Individual Buzzy device was an effective Effect of the Use ofBuzzy during
Satisfaction in Blood Donors method of reducing the pain of Phlebotomy on Pain and
F: Abstract phlebotomy and increasing Individual Satisfaction in Blood
N=90 phlebotomy satisfaction in healthy Donors. Pain Management
P: Adult men adult male blood donors." [N=90, Nursing. 2017 Aug;18(4):260-
Pain 20.93 +/- 15.1 versus 35.23 267.PMID:28601479.
+/- 19.3, p=.004, satisfaction
Buzzy 76.0 +/- 23.7 v. 55.26 +/-
34.8 control, =.031
(1) 0: Pain relief during intraoral Buzzy (1) Conclusion: "Buzzy® can Suohu T, Sharma S, Marwah N,
injections using FLACC reduce pain and anxiety during et al. A Comparative Evaluation
F: RCT local anesthetic delivery for various of Pain Perception and Comfort
N=50 dental procedures". 1.4 Buzzy, of a Patient Using Conventional
P: 5-10 y/o 3.96 Conventional using FLACC, Syringe and Buzzy System. Int J
p<.05 Clin Pediatr Dent 2020;13(1):27-
(2) 0: Oral dental injections 30.
F: RCTFLACC (2) "Buzzy® can reduce pain and
N=50 anxiety during local anesthetic
P: 5-10 years delivery for various dental
procedures." FLACC 1.4 Buzzy,
3 .96 Conventional, <.05
0: Pain and anxiety relief for Buzzy (WBFS pain Buzzy 2.75, Control Canbulat N, Ayhan F, Inal S.
cannulation 5.7 p=0.000, VAS pain Buzzy 1.66, Effectiveness of external cold
F: RCT VAS anxiety VAS pain Control 4.09 p=.000; VAS anxiety and vibration for procedural
N=176 Buzzy 0.94, Control 2.09 p=.000; pain relief during peripheral
P: 7-12 y/o VAS observer anxiety Buzzy 0.92, intravenous cannulation in

Control 2.14 p=.000.). pediatric patients. Pain Manag
Nurs. 2015 Feb;16 1 :33-9.
ER06NO23.017</GPH>
0: Pain and anxiety relief for Buzzy "According to all raters, the Erdogan B, Ozdemir AA. The
vascular access with Child Fear Buzzy® group had the lowest mean Effect of Three Different
Score CFS score, followed by the VR, Methods on Venipuncture Pain
F: RCT Virtual Reality v. DC, and control groups (p < 0.05)." and Anxiety in Children:
Distraction cards v. Buzzy v control Distraction Cards, Virtual
N=l42 Reality and Buzzy (Randomized
P: 7-12 y/o Controlled Trial). J Pediatr Nurs.
Ma -Jun 2021;58:e54-e62.
0: Pain, fear and anxiety from Buzzy "This review found consistent Lee VY, Caillaud C, Fong J,
vaccination evidence for reduction in pain, Edwards KM. Improving
F: Systematic Review 27 articles distress and/or fear with vaccine-related pain, distress or
N=n/a interventions that combined fear in healthy children and
P: 4 - 15 years cooling and vibrating together ... " adolescents-a systematic search
[pooled data not reported]. ofpatient-focused interventions.
Hum Vaccin Immunother.
2018;14 11 :2737-2747.
0: Anxiety and pain reduction with Buzzy (In subjects who reported higher Redfern RE, Micham J, Sievert
cannulation pre procedure anxiety, the D, Chen JT. Effects of
F: RCT Buzzy v control experimental [Buzzy] group Thermomechanical Stimulation
N=105 reported lower pain (0.84 ± 0.50) During Intravenous Catheter
P: Elective Surgical Adults than the control group (3.92± 0.58). Insertion in Adults: A
Prospective Randomized Study. J
lnfus Nurs. 2018
Se t/Oct;41 5 :294-300.
0: Pain relief with flu vaccination Buzzy (pain 0.87 v 1.12 p=.035, better Redfern RE, Micham J, Seegert
F: RCT VAS, IO-point satisfaction than previous experiences 62% S, Chen JT. Influencing
scale Buzzy 23.9% control p<.0001.) Vaccinations: A Buzzy
N=497 "Buzzy can be used in adult Approach to Ease the Discomfort
P: Adult employees influenza patients to reduce pain during of a Needle Stick - a prospective,
vaccine clinic immunization and is especially Randomized Controlled Trial.
effective in those with high levels Pain Management Nursing, 2019
ofanxie " A r;20 2 :164-169.
0: Reduction in fear and pain with Buzzy (Nonadherent group offered Buzzy, Russell K, Nicholson R, Naidu
Bicillin injections LA bicillin, or both; overall pain R. Reducing the pain of
F: Observational prospective and fear reduced 50%, Special intramuscular benzathine
interventional trial needle phobia clinic able to be penicillin iryections in the
N=118 disbanded.) rheumatic fever population of
P: Teens and Adults Counties Manukau District
Health Board. J Paediatr Child
Health. 2014 Feb;50 2 :112-7.
0: To investigate the effect of the Buzzy (Pain 74% reduced, satisfaction 95 Sahin M. Effect ofBuzzy®
Buzzy application on pain and v. 84. P<.001 both favor Buzzy). application on pain and iryection
satisfaction during injections. satisfaction in adult patients
F: RCT receiving intramuscular
N=65 injections. Pain Management
P: Average age 52 Nurs2018 Dec:19(6):645.
ER06NO23.018</GPH>
0: Immunization pain and fear Buzzy Buzzy: 0.58 +/- 0.63 v. 1.96 +/- Sahiner NC, Inal S, Akbay AS.
reduction Buzzy v. control with 1.13 p=.001 The effect of combined
TdAP Finding: The experimental group stimulation of external cold and
F: RCT Children Fear Scale showed significantly lower pain vibration during immunization
N=104 and anxiety levels than the control on pain and anxiety levels in
P: 7-year-olds group during immunization. children. J Perianesth Nurs. 2015
Conclusions/implications for Jun;30(3 ):228-35.
practice: The combined
stimulation of skin with external
cold and vibration can be used to
reduce pain and anxiety during
pediatric immunization.
0: Buzzy Bubbles Shotblocker or Buzzy Results: A significant difference Yilmaz G, Almdar DK Using
nothing for IM injections was found between the intervention Buzzy, Shotblocker, and Bubble
F: RCT4 arm and control groups in terms of Blowing in a Pediatric
N=l60 levels of pain and fear during IM Emergency Department to
P: 5-10 years injection. Pain and fear were Reduce the Pain and Fear
notably less in the group of Caused by Intramuscular
children receiving the Buzzy lryection: A Randomized
intervention. Discussion: The Controlled Trial. J Emerg Nurs.
Buzzy intervention should be used 2019 Sep;45(5):502-51 l.
when children are undergoing IM
injections to reduce their levels of
ain and fear.
BILLING CODE 4120–01–C

ER06NO23.019</GPH>
(2) CMS Assessment of Substantial design created for dialysis fistulae sites, not an eligibility criterion for the
Clinical Improvement Claims and patented in 2022. However, the sources TPNIES.
Sources submitted were dated prior to the 2022 We also noted that it was unclear
As discussed in the CY 2024 ESRD new design patent date for dialysis whether a single Buzzy® Pro device and
PPS proposed rule (88 FR 42484 fistulae sites. As such, we stated that it its components (for example, tourniquet
through 42485), we summarized our appeared that the sources submitted and ice pack) are intended for single
specific concerns regarding application reflected the use of a predecessor versus multiple patient use in the ESRD
of the substantial clinical improvement Buzzy® device. In addition, while the facility setting. To the extent that the
criteria under §§ 413.236(b)(5) and applicant’s ‘‘Summary of Clinical device or its components are intended
412.87(b)(1) in connection with the Evidence’’ document presented sources for use among multiple patients, we
submission. as evaluating Buzzy® Pro’s efficacy in noted that we would be interested in
As stated previously, the applicant managing vascular access pain or fear, data that examines the risk of infection
must demonstrate that the equipment or we noted that none of these sources associated with the use of Buzzy® Pro
supply meets at least one of the appear to evaluate vascular access in the in the dialysis patient population.
following three substantial clinical context of dialysis cannulation. The Additionally, we noted that we were not
improvement criteria in order to be studies evaluated pain and fear in the aware of any data that examines the risk
eligible for the TPNIES: (1) the item context of other types of needle of harm to the dialysis access site or any
offers a treatment option for a patient procedures, including vaccine or other adverse events associated with use
population unresponsive to, or medication injections, blood specimen of the Buzzy® Pro in the dialysis patient
ineligible for, currently available collection, and intravenous catheter population, including access and
treatment; (2) the item offers the ability insertion. bloodstream infections and thromboses
to diagnose a medical condition in the We noted that it was unclear whether but would be interested in the results of
patient population where that medical findings of pain or fear reduction from such data.
condition is currently undetectable or the use of the Buzzy® device in non- In addition, the applicant stated that
offers the ability to diagnose a medical dialysis needle procedures could be currently, the most effective options for
condition earlier in a patient population extrapolated to dialysis cannulation dialysis cannulation pain are topical
than allowed by currently available pain or fear. There are several unique anesthetics and vapocoolant spray. We
methods; or (3) the item significantly features to dialysis cannulation that may noted that we would be interested in
improves clinical outcomes relative to limit generalizability. These include the studies comparing the use of Buzzy®
services or technologies previously need for regular punctures several times Pro to topical anesthetics or vapocoolant
available. The applicant stated that per week, the maintenance of and that demonstrate that Buzzy® Pro
Buzzy® Pro makes dialysis cannulation cannulation for several hours during significantly improves clinical outcomes
pain relief available to dialysis patients, dialysis treatments, the use of of dialysis patients relative to existing
which significantly improves clinical substantially larger needle sizes in available treatments.
outcomes related to depression and dialysis, and complications that are We invited public comments on
discontinuation of dialysis due to associated with frequent vascular access whether the Buzzy® Pro meets the
needle pain. Therefore, in the proposed cannulation, such as infections and substantial clinical improvement
rule, we noted our belief that the thrombosis. As such, we questioned criteria for the TPNIES.
applicant was targeting the clinical whether outcomes could reasonably be Comment: We received a comment
outcomes criterion (previously noted extrapolated as applicable to patients from the applicant in support of a
number (3)). The applicant also stated undergoing dialysis cannulation. TPNIES approval for Buzzy® Pro. The
that Buzzy® Pro reduces needle fear. In applicant stated that there are seven
the proposed rule, we also noted that we As identified in the table, most of the literature-supported parameters by
did not identify evidence within the studies provided in support of the which Buzzy® Pro meets the substantial
application or the submitted materials applicant’s claims reflect pediatric clinical improvement criteria, any one
documenting improved clinical patient experiences. We noted that of which independently would satisfy
outcomes related to depression or pediatric patients comprise a small the standard. The applicant presented
dialysis adherence but would be proportion, just 0.14 percent, of the total the following table highlighting the
interested in reviewing such evidence. Medicare ESRD patient population (87 ways in which Buzzy® significantly
With respect to the submitted FR 67222). As such, we noted that the improves clinical outcomes relative to
evidence, we noted that it did not data that was heavily weighted towards renal dialysis services previously
appear that the studies reflected the use the pediatric population may have available.
of (1) Buzzy® Pro, the device that is the limited generalizability to the non-
subject of the TPNIES application, nor pediatric majority of the ESRD patient 82 Russell K, Nicholson R, Naidu R. Reducing the
(2) Buzzy® Pro in the context of dialysis population. pain of intramuscular Benzathine penicillin
injections in the rheumatic fever populations of
cannulation. Specifically, the applicant While the applicant stated that the Counties Manukau District Health Board. J Paediatr
submitted an application for Buzzy® Buzzy® devices are less expensive than Child Health 2014;50(2):112–7 doi: 10.1111/
Pro, indicating that Buzzy® Pro is a new topical anesthetic, we noted that cost is jpc.12400 [published Online First: 2013/10/19].
Buzzy® Pro Areas of Substantial Clinical Improvement

Criterion + Source Specific Improvement
Peer-reviewed publications of Buzzy
1. A more rapid beneficial resolution of the disease 5 minutes for pain management compared to lh 10
process treatment (412.87(b)(l)(ii)(C)(4)) minutes with EMLA saves 169 hours/year
2. Improved quality oflife (412.87(b)(l)(ii)(C)(6)) a. Decreased pain compared to vapocoolant spray
b. Faster equivalent pain relief with EMLA
c. Decreased fear compared to other interventions
d. Pain relief access for patients with buttonholes
3. Reduction in at least one clinically significant a. 25% reduction in severe vasovagal symptoms
adverse event (412.87(b)(l)(ii)(C)(l)) b. Vasodilation with potential reduction of vessel wall
trauma.
Publications of impact of pain and depression addressed by improved availability+ pain control
4. Decrease in the number of future hospitalizations Adherence to regular cannulation reduces
(412.87(b)(1 )(ii)(C)(3)) hospitalization - Buzzv improves adherence. 82
5. Improved quality oflife (412.87(b)(l)(ii)(C)(6)) Increased feelings of control are correlated with reduced
depression.
With respect to the more rapid The applicant stated that Buzzy® for adult needle fear on the CDC
beneficial resolution of the disease decreases fear as compared to other website.93
process treatment, the applicant stated interventions, citing multiple meta- The applicant stated that 43 percent
that chronic patients consider a analyses indicating that Buzzy® reduces of dialysis patients experienced pain
reduction in their procedural time a fear and anxiety in pediatric despite EMLA use 94 and that Buzzy®
clinically significant improvement. venipuncture 89 90 and that Buzzy® was patients like the sense of control of
With respect to improved quality of also effective in adult venipuncture being able to hold the device in the right
life, the applicant stated that Buzzy® patients with needle fear or anxiety.91 92 spot for the best pain relief.
devices have been shown to be In support of the claim that Buzzy®
The applicant referred to a generic reduces at least one clinically
clinically superior to vapocoolant spray
recommendation for ‘‘buzzing devices’’ significant adverse event, the applicant
for pain relief in adults and
children,83 84 and that vapocoolant spray stated that vibration over 150Hz results
Stud 2021;113:103803 doi: 10.1016/ in vasodilation, which can reduce the
lacks efficacy and is associated with
j.ijnurstu.2020.103803 [published Online First:
potential risks of frostbite or triggering 20201019].
likelihood of a needle side-walling a
a sickle cell crisis. The applicant stated 87 Potts DA, Davis KF, Elci OU, Fein JA. A vein, causing pain or vasovagal
that EMLA is effective for cannulation Vibrating Cold Device to Reduce Pain in the stimulation.95 The applicant referred to
pain but requires 60 minutes to become Pediatric Emergency Department: A Randomized a recent study presented in 2023, which
effective and is associated with Clinical Trial. Pediatr Emerg Care 2019;35(6):419– found that in 360 teenagers who
potential risks, including petechiae and 25 doi: 10.1097/pec.0000000000001041 [published received vaccination,96 Buzzy® reduced
Online First: 2017/01/26].
skin breakdown from the occlusive 88 Baxter AL, Cohen LL, Tsze D. Buzzy versus
severe vasovagal symptoms 25 percent
dressing used after applying the cream. EMLA: Abstract omits clinical noninferiority and
and improved vasodilation, potentially
The applicant stated that Buzzy® is time and cost savings: A commentary on Lescop et reducing vessel wall trauma.
equivalent to the topical anesthetics al. (2021). Int J Nurs Stud 2021;121:104011 doi: The applicant also provided
EMLA and LMX by patient and parent 10.1016/j.ijnurstu.2021.104011 [published Online responses to CMS’s concerns identified
First: 20210626]. in the CY 2024 proposed rule. In
report and at a fraction of the 89 Ballard A, Khadra C, Adler S, Trottier ED, Le
time.85 86 87 88 response to the CMS concern regarding
May S. Efficacy of the Buzzy Device for Pain
Management during Needle-Related Procedures: A
a lack of evidence documenting
83 Baxter AL, Cohen LL, McElvery HL, Lawson
Systematic Review and Meta-analysis. Clin J Pain improved clinical outcomes related to
ML, von Baeyer CL. An integration of vibration and 2019 doi: 10.1097/ajp.0000000000000690 depression or dialysis adherence, the
cold relieves venipuncture pain in a pediatric [published Online First: 2019/03/05]. applicant stated that increased feelings
emergency department. Pediatr Emerg Care
2011;27(12):1151–6 doi: 10.1097/
90 Su HC, Hsieh CW, Lai NM, Chou PY, Lin PH,
of control are correlated with reduced
Chen KH. Using Vibrating and Cold Device for Pain depression. The applicant specified that
PEC.0b013e318237ace4.
84 Baxter AL, Leong T, Mathew B. External
Relieves in Children: A Systematic Review and
Meta-analysis of Randomized Controlled Trials. J
thermomechanical stimulation versus vapocoolant 93 https://www.cdc.gov/ncbddd/
Pediatr Nurs 2021;61:23–33 doi: 10.1016/
for adult venipuncture pain: pilot data on a novel humandevelopment/covid-19/needle-phobia/
j.pedn.2021.02.027 [published Online First:
device. Clin J Pain 2009;25(8):705–10 doi: 10.1097/ healthcare-providers.html Accessed September 8,
20210316].
AJP.0b013e3181af1236 [published Online First: 2023.
91 Baxter AL, Leong T, Mathew B. External
2009/11/19]. 94 https://www.youtube.com/
85 Bahorski JS, Hauber RP, Hanks C, et al. thermomechanical stimulation versus vapocoolant watch?v=1moJgluvS7c&t=350s Accessed September
Mitigating procedural pain during venipuncture in for adult venipuncture pain: pilot data on a novel 8, 2023.
a pediatric population: A randomized factorial device. Clin J Pain 2009;25(8):705–10 doi: 10.1097/ 95 Skoglund CR. Vasodilatation in human skin
study. Int J Nurs Stud 2015;52(10):1553–64 doi: AJP.0b013e3181af1236 [published Online First: induced by low-amplitude high-frequency
10.1016/j.ijnurstu.2015.05.014 [published Online 2009/11/19]. vibration. Clin Physiol 1989;9(4):361–72.
92 Redfern RE, Micham J, Sievert D, Chen JT.
First: 20150610]. 96 Smith MJ, Broder KR, Chung RJ, et al.
86 Lescop K, Joret I, Delbos P, et al. The Effects of Thermomechanical Stimulation During Preventing Post-Vaccination Presyncope and
effectiveness of the Buzzy(®) device to reduce or Intravenous Catheter Insertion in Adults: A Syncope in Adolescents Using Simple Clinic-Based
prevent pain in children undergoing needle-related Prospective Randomized Study. J Infus Nurs Interventions: a Randomized-Controlled Trial.
procedures: The results from a prospective, open- 2018;41(5):294–300 doi: 10.1097/ Pediatric Academic Societies Meeting. Washington,
ER06NO23.020</GPH>
label, randomised, non-inferiority study. Int J Nurs nan.0000000000000294. DC, 2023.
because studies of patients with chronic applicant stated that because Buzzy® In response to the CMS interest in
pain with or without depression have Pro received FDA 510(k) approval on studies comparing the use of Buzzy®
identified self-efficacy as a primary May 15, 2023, there are no studies Pro to topical anesthetics or vapocoolant
component of effective interventions 97 specific to Buzzy® Pro. and that demonstrate that Buzzy® Pro
and because chronic pain and In response to the CMS concern that significantly improves clinical outcomes
depression are common in dialysis it is unclear whether findings of pain or of dialysis patients relative to existing
patients,98 99 a fast intervention that fear reduction from the use of the available treatments, the applicant
allows self-adjustment and relief Buzzy® device in non-dialysis needle provided the following two summary
optimization should be more procedures could be extrapolated to
tables and stated that the numbers given
appropriate and effective among dialysis cannulation pain or fear, the
in the tables allow relative comparison
patients receiving dialysis than among applicant asserted that because
emergency department venipuncture between interventions and the pain
patients undergoing single, small gauge,
and less risky cannulations. The studies typically involve anxiety, they reported with dialysis cannulation and
applicant stated that adherence to are appropriate comparators for dialysis, adult emergency department trials of
regular cannulation reduces where anxiety is common. The Buzzy®. The first table summarizes
hospitalization.100 The applicant also applicant further noted that many studies of pain or anxiety relief specific
stated that needle fatigue can lead to dialysis studies do not find a benefit the to dialysis cannulation and identifies
nonadherence to a treatment plan and first time an intervention is attempted. the significant differences in bold text.
that nonadherence increases healthcare The applicant also stated that adult The second table summarizes Buzzy®
costs, emergency department visits, dialysis cannulation studies that use outcomes including pain, anxiety, and
disease complications, and in extreme vapocoolant and topical anesthetic do vasovagal symptom relief in various
cases, the likelihood of death.101 not evaluate anxiety, and the only types of cannulations and identifies the
In response to the CMS concern that studies evaluating anxiety and dialysis significant differences in bold text.
the sources submitted reflected the use cannulation used lavender oil as a BILLING CODE 4120–01–P
of a predecessor Buzzy® device, the comparator.
0: Dialysis pain Vapocoolant Vapocoolant -2.29 (95%CI -4.17 Khosravi BMC Anesthesiol
Randomized crossover trial or Lidocaine to -0.43) 2023(1):69[14]
N= 41 Scale: NRS (0-10) spray or Lidocaine Spray NS
Placebo
0: Dialysis: Vapocoolant EMLA-18.1 (10.7 +/- 10.6 <;elik G. Int J Med Sci
Randomized crossover trial orEMLAor vc -14.4 14+/-12.4 2011;8(7):623-7[15]
N= 41 Scale: VAS (0-100) Placebo Control 28.8+/17.9
0: Dialysis: Vapocoolant Vapocoolant 2.98+/-1.53 Lee 2023 Appl Nurs Res

Open crossover design Or Placebo Placebo 4.04+/-1.82 June;71: 151674[16]
N=38 Orno No treatment 4.45+/-1.31
treatment
0: Dialysis: EMLAor EMLA-4.13(-5.44 - (-2.82)) Babamohamadi H, Ev Based
Randomized controlled Valsalva or VM -2.9(-4.2-(-1.59)) Complem med 2022:8383021
N=90 NRS 0-10 Control e. 17
0: Dialysis: EMLAor "Significant reduction in pain in Kortobi L. Saudi J Kidney Dis
Prospective crossover Ice Cubes x favor of [ice cubes]." Trans 202;31(3):597-603[18]
N=32 5 minutes
0: Dialysis: Lavender Lavender 2.91+/-1.69 Ghods A. Comp Tuer Med
Open Crossover Trial Oil or No intervention 4.59 2015;23(3):325-330[19]
N=34NRS Placebo or Placebo 4.18+/-1.66
Control
0: Dialysis Lavender No difference first time Sahin s. Pain Mgmt Nursing
Randomized Crossover trial Oil or Lavender -2.68 (p=.002) 2021;22(4):519-515[20]
N= 74 NRS STAI anxie Placebo Anxie correlated w/ ain
97 Borsbo B, Gerdle B, Peolsson M. Impact of the Pain Symptom Manage 2005;30(5):465–73 doi: injections in the rheumatic fever population of
interaction between self-efficacy, symptoms and 10.1016/j.jpainsymman.2005.05.013. Counties Manukau District Health Board. J Paediatr
catastrophising on disability, quality of life and 99 Masià-Plana A, Juvinyà-Canal D, Suñer-Soler R, Child Health 2014;50(2):112–7 doi: 10.1111/
health in with chronic pain patients. Disability and Sitjar-Suñer M, Casals-Alonso C, Mantas-Jiménez S. jpc.12400 [published Online First: 2013/10/19].
rehabilitation 2010;32(17):1387–96 doi: 10.3109/ Pain, Anxiety, and Depression in Patients 101 Lee K, Kim D, Lee H, Lee E. The effect of using
09638280903419269 [published Online First: 2010/ Undergoing Chronic Hemodialysis Treatment: A vapocoolant spray for pain reduction in
Multicentre Cohort Study. Pain Manag Nurs arteriovenous fistula cannulation among patients
06/02].
2022;23(5):632–39 doi: 10.1016/j.pmn.2022.03.005 undergoing hemodialysis: A randomized control
98 Davison SN, Jhangri GS. The impact of chronic
[published Online First: 20220422]. trial. Appl Nurs Res 2023;71:151674 doi: 10.1016/
pain on depression, sleep, and the desire to 100 Russell K, Nicholson R, Naidu R. Reducing the j.apnr.2023.151674 [published Online First:
ER06NO23.021</GPH>
withdraw from dialysis in hemodialysis patients. J pain of intramuscular benzathine penicillin 20230317].
0: Pain relieffor cannulation 4-arm Buzzy v. + cold: 33.92 Abadin N. M East J

F: Vibration v cold v sham v both Buzzy trial Buzzy alone: 34.18 Anesthesiology 2018 25(1)
N: 184 18-65 years of age pain relief Sham+ cold: 39.16 Sham no
vibration v. cold: 43.21
cold v. P=.016 overall v. sham
combination
0: Pain relief for cannulation BuzzyM- Findings support the use of both Bahorski JS, Hauber RP, et al.
F: RCT: Buzzy compared to LMX stim only mechanical vibration and Int J Nurs Stud. 2015
topical anesthetic NOICEv. topical anesthetic as effective Oct;52(10): 1553-64[21]
N=l 73 18 months - 17 lo LMX4
0: Pain relief and first stick Buzzy v. Self-report (-2; 95% CI, -4 to 0) Baxter AL, Cohen LL,
vascular access success in Vapocoolant (p=.029) Parent report (-2; 95% McElvery HL, Lawson ML,
pediatric emergency CI -4 to -2 (p=.005) Favor von Baeyer CL. Pediatr Emerg
F: RCT: Buzzy v. Vapocoolant BUZZY Care. 2011 Dec;27(12):1151-
N=81 4 - 18 y/o Vascular access success more 6[22]
likely w/ Buzzy: (odds ratio,
3.05; 95% CI, 1.03- 9.02),
=.040
0: Pain relief and cannulation Buzzy Buzzy -9.9 mm, 95% [CI] 0.82- Baxter AL, Leong T, Mathew
success in vascular access Vapocoolant 19, P=0.035, SD 16) 100% first B. Clin J Pain. 2009
F: Crossover trial stick success Oct;25(8):705-10[23]
N=30 Vapocoolant: NS pain reduction,
P: adults 95% [CI]-1.8-17.7, P=0.1, SD
16.9)
7.14% cannulation failure
va ocoolant
0: Pain relief during vascular Buzzy Lower pain (p < .001) and Inal S, Kelleci M. MCN Am J
access in pediatric patients Control anxiety (p < .001 w/ Buzzy) Matern Child Nurs. 2012
F: RCT: [Buzzy v. control] compared to the control group. Sep;37(5):339-45.[24]
N=120 P: 6 - 12 lo
0: Pain and anxiety in adults Buzzy Pain: BUZZY 1.04 c:5.32 Paki~ <;etin S, <;evik K. J
during cannulation using Buzzy or Control Pain less than expected: Perianesth Nurs. 2019
control. BUZZY 44/50 C 0/50 Aug:34(4):701-709[25 26]
F:RCT Pain more than expected:
N=IO0 BUZZY 0/50 C 6/50 (P<.000)
P: Mean age: 49.6 +/- 13.8y Satisfaction BUZZY (95.3 v
2.12 P<.001.
0: Venipuncture pain with Buzzy v Pain with high needle anxiety: Redfern RE J infusion nursing
anxious adults Control Buzzy: 0.84+/- .5 2018 41(5):295[26]
F:RCT Control: 3.92+/- 0.58
N=105 P: adults mean 63Y
0: Pain and Individual Satisfaction Buzzy BUZZY 20.93 +/- 15.1 Control Yilmaz D., Reper Y., Gozler.
in Blood Donation phlebotomy Control 35.23 +/- 19.3, p=.004 Pain Management Nursing.
F: Abstract Satisfaction (p =.031)] 2017 Aug;18(4):260- 267.[27]
N=90 P: Adult men Buzzy 76.0 +/- 23.7
Control 55.26 +/- 34.8
Vasovagal symptoms with Buzzy+ BUZZY 36% presyncope Smith M. PAS 2023 (A)
vaccination Video v. Control 48% presyncope NCT04772755[28]
F:RCT Standard 25% reduction (p=.02)
N=340 10-14 care
BILLING CODE 4120–01–C population, the applicant referred to vapocoolant, and equivalency to topical
In response to the CMS concern that materials submitted with its application anesthetics but in a shorter period of
the data heavily weighted towards the and asserted that these demonstrate time. The applicant stated that five
pediatric population may have limited significant pain and fear reduction with independent peer reviewed studies on
generalizability to the non-pediatric the Buzzy® device, superiority to adult venipuncture using Buzzy®
ER06NO23.022</GPH>
majority of the ESRD patient
demonstrate the following: vibration is the cannulation site when it is being applicant also stated that the pain from
the primary active ingredient; improved cleaned and accessed, there is never a the mechanical pressure of the dialysis
efficacy in patients with needle fear; time when Buzzy® is placed on the area needle inside the vessel cannot be
superiority to vapocoolant spray; and of recent cannulation. The applicant treated with EMLA or vapocoolant
pain reduction and improved also stated that Buzzy® has been used spray. The applicant stated that because
satisfaction. for dialysis in the Netherlands for four Buzzy® Pro works proximally to the
In response to our clarification that years with only positive reports of pain, it is effective for patients who
cost is not a TPNIES eligibility criterion, efficacy, efficiency, and safety. otherwise are unable to access pain
the applicant acknowledged our The applicant also provided control.
clarification but stated that cost is a additional information explaining the We also received several comments
barrier to the use of EMLA. The pain transmission process and its belief from patient advocates supporting the
applicant compared the cost of EMLA at that that Buzzy® Pro’s mechanical applicant’s two substantial clinical
$6.48 per cannulation to the cost of stimulation is an innovative approach in improvement claims that Buzzy® Pro
Buzzy® at $0.375 per cannulation. The pain management. Specifically, the reduces pain and anxiety associated
applicant concluded that increased applicant stated that pain is transmitted with dialysis. A few commenters offered
access to pain relief is a substantial to the spine on fast pain nerves and that anecdotal experience regarding the use
clinical benefit that is not currently local mechanisms to reduce pain of Buzzy® Pro in the context of dialysis
available due to cost. transmission from skin to spine include cannulation and stated that Buzzy®
In response to the CMS question as to lidocaine, cold spray or ice. Per the Pro’s benefits are supported by peer-
whether a single Buzzy® Pro device and applicant, as cold travels to the brain on reviewed scientific literature.
its components (for example, tourniquet slow C-fibers it activates pain Commenters stated that Buzzy® Pro
and ice pack) are intended for single inhibition, which is most effective when would promote patient choice by
versus multiple patient use in the ESRD applied at temperatures ranging from 0– providing fast onset dialysis
facility setting, the applicant stated that 4C, for a duration of 30 seconds or more, cannulation pain relief without the
Buzzy® and Buzzy® Pro are made of and when applied proximal or distant to hassles and expense of topical
medical grade plastic in accordance the area of pain. The applicant also anesthetics. One commenter suggested
with ISO–13485 and MDSAP standards identified the mechanical stimulation of that the In-Center Hemodialysis
and can be disinfected with the fibers which transmit touch Consumer Assessment of Healthcare
chlorhexidine, alcohol swabs, or any sensations as a mechanism for reducing Providers and Systems (CAHPS) Survey
hospital grade cleanser in accordance pain, noting that optimal stimulation should be updated to capture patient
with the requirements applied to a occurs between 180 and 250Hz. Per the experience with dialysis cannulation
stethoscope or blood pressure cuff. The applicant, Buzzy® units provide pain.
applicant further noted that the ice mechanical stimulation using a 200 Hz Response: We appreciate the
packs are medical grade, intended for a vibration motor. applicant and other commenters’ input
single patient, but can be reused The applicant also presented a new regarding whether Buzzy® Pro meets the
hundreds of times. Per the applicant, substantial clinical improvement claim, TPNIES innovation criterion at
the straps are also intended for single- asserting that Buzzy® Pro offers a § 413.236(b)(5) and substantial clinical
patient use but can be used multiple treatment option for a patient improvement criteria at § 412.87(b)(1).
times in a home setting. population unresponsive to, or While the applicant stated that there are
The applicant stated that infection ineligible for currently available seven literature-supported parameters
control varies widely based on regional treatment options. Specifically, the by which Buzzy® Pro meets the
idiosyncrasies and may involve the use applicant stated that cost and time are substantial clinical improvement
of an infection control bag around the barriers to patients accessing the criteria, it was not clear to us to which
ice pack; not using the ice pack; using currently available treatment options for parameters or sources of literature the
an infection control bag around both the dialysis cannulation pain control and applicant was referring.
device and the ice pack; having patients asserted that Buzzy® Pro addresses In response to our request for
bring their own ice pack; giving the ice these barriers. As stated previously, the evidence of improved clinical outcomes
pack to the patient following the applicant compared the cost of EMLA at related to depression or dialysis
procedure; or discarding the ice pack. $6.48 per cannulation to the cost of adherence, the applicant stated that
In response to the CMS interest in Buzzy® at $0.375 per cannulation and because increased feelings of control are
data that examines the risk of infection concluded that Buzzy® addresses the correlated with reduced depression, an
associated with the use of Buzzy® Pro cost barrier to patients accessing intervention that allows for self-
in the dialysis patient population and dialysis cannulation pain relief. The adjustment and relief should be more
the CMS interest in data that examines applicant also asserted that the time effective among patients receiving
the risk of harm to the dialysis access requirement for using EMLA reduces dialysis than patients undergoing other
site or any other adverse events the likelihood of its use in busy dialysis types of needle cannulations. However,
associated with use of the Buzzy® Pro clinics or if the patient comes in late. the applicant did not provide direct
in the dialysis patient population, The applicant stated that because evidence that interventions to reduce
including access and bloodstream patients prescribed EMLA for home pain in dialysis populations would
infections and thromboses, the application prior to treatment at the subsequently reduce depression or that
applicant stated that to date, with dialysis clinic often misuse the product, Buzzy® Pro specifically reduces
conservatively over 114,000,000 needle
they are unresponsive to EMLA. Per the depression. In addition, while the
procedures, there are no reported applicant, Buzzy® works on contact and applicant stated that adherence to
instances of Buzzy® being associated can easily be applied by the patient. The regular cannulation reduces
with a vascular access mishap. Per the applicant stated that given the short, 30 hospitalization, the evidence cited by
applicant, the standard risks of vascular to 60 second duration of pain relief the applicant does not pertain to
damage may be reduced because of the obtained from vapocoolant spray, improved dialysis adherence or
vasodilation. The applicant also stated needle pain is a barrier to receiving reductions in hospitalizations. We are
that because the device goes proximal to treatment in the home setting. The not aware of evidence demonstrating
that the use of Buzzy® Pro is associated In response to our request for studies of Buzzy® Pro in the renal dialysis
with the clinical outcome of improved comparing Buzzy® Pro to topical patient population has not been
dialysis adherence. Therefore, our anesthetics or vapocoolant spray and sufficiently addressed.
request for evidence of improved that demonstrate that Buzzy® Pro For the reasons noted previously, we
clinical outcomes related to depression significantly improves clinical outcomes do not believe that there is sufficient
or dialysis adherence associated with of dialysis patients relative to existing evidence to demonstrate that Buzzy®
the use of Buzzy® Pro in the dialysis available treatments, the applicant’s first Pro significantly improves clinical
patient population has not been summary table reflects outcomes outcomes relative to renal dialysis
sufficiently addressed. specific to dialysis but does not reflect services previously available.
We appreciate the applicant’s experiences with Buzzy® Pro. While the With respect to the applicant’s new
confirmation that the evidence second table reflects outcomes specific substantial clinical improvement claim
submitted pertained to studies of the to Buzzy®, it does not capture that Buzzy® Pro offers a treatment
predicate device, Buzzy® and that there experience in the dialysis setting. Not option for a patient population
are no studies specific to Buzzy® Pro. all studies included in the summary unresponsive to, or ineligible for,
We also appreciate the applicant’s tables shown previously in this rule currently available treatments, we
responses to our concern about the were provided with the application or acknowledge that patients may
absence of evidence that evaluates public comment. However, none of the appreciate the option of a rapid acting
Buzzy® Pro’s efficacy in managing pain studies appear to specifically examine form of dialysis cannulation pain relief.
or fear in the context of dialysis Buzzy® Pro’s efficacy in improving While the applicant stated that Buzzy®
cannulation rather than in the context of clinical outcomes of dialysis patients as offers a more rapid beneficial resolution
non-dialysis needle procedures. The compared to topical anesthetics or of the disease process treatment than
applicant asserted that emergency vapocoolant spray. currently available options, the
department venipuncture studies Regarding our concern that data in applicant did not provide additional
typically involve anxiety and are support of the applicant’s claims may evidence demonstrating the clinical
therefore appropriate comparators for have limited generalizability to the non- superiority of Buzzy® Pro over topical
dialysis, where anxiety is common. We pediatric majority of the ESRD patient lidocaine in the context of dialysis
do not believe that the presence of population, the applicant reiterated cannulation. Although the applicant
anxiety renders emergency department references from its application to stated that lidocaine requires an hour to
venipuncture a suitable proxy for independent peer reviewed studies on take full effect, it did not provide
dialysis cannulation. In addition, the adult venipuncture using Buzzy®. These evidence that Buzzy® Pro is superior to
applicant did not address the unique studies compared Buzzy® to no lidocaine after shorter time frames in
features of dialysis or the differences intervention and Buzzy® to vapocoolant the dialysis setting, that shorter
between venipuncture and dialysis or cold interventions. We also note that timeframes do not provide adequate
cannulation that may limit the applicant referred to a source pain control with topical lidocaine, or
generalizability, including the use of labeled ‘‘Abedin et. al.,’’ but we did not that patients are unable to apply
substantially larger needle sizes in receive the study or the complete lidocaine an hour before their scheduled
dialysis, repeated cannulations thrice citation for this source. Because the dialysis treatment. With respect to the
weekly, continued cannulation studies did not compare Buzzy® to applicant’s assertion that the higher cost
throughout a dialysis session, and lidocaine and did not take place in the of EMLA as compared to Buzzy® is a
complications associated with frequent dialysis setting, the applicant has not barrier to pain relief, we note that
vascular access cannulation such as sufficiently addressed our concern because topical lidocaine is included in
infections and thrombosis. As such, we about the generalizability of these the pain management category of drugs/
do not believe it is possible to studies. biological products included in the
extrapolate outcomes achieved with Regarding the applicant’s additional ESRD PPS, dialysis facilities would be
Buzzy® Pro in the context of non- evidence since the application expected to provide it when determined
dialysis needle procedures to dialysis submission, we acknowledge the necessary for the treatment of graft site
cannulation. reference to the 1989 study pertaining to pain. While cost may be a practical
We also appreciate the comments vasodilation in human skin and the barrier to access for some patients, we
from patient advocates offering 2023 study pertaining to the prevention do not equate this barrier with either
anecdotal experience with Buzzy® Pro of post-vaccine syncope. While these unresponsiveness or ineligibility. In
in the context of dialysis cannulation studies were not submitted to us, summary, based on the information
but would be especially interested in similarly to the evidence previously provided, we are not able to conclude
additional detail, including the numbers submitted, it does not appear that they that there is sufficient evidence to
of patients involved and the specific assessed the efficacy of Buzzy® Pro in demonstrate that Buzzy® Pro offers a
outcomes that they experienced from the context of dialysis cannulation. treatment option for a patient
Buzzy® Pro. While some commenters We appreciate the applicant’s population unresponsive to, or
asserted that Buzzy® Pro’s benefits for clarification regarding use among single ineligible for, currently available
the renal dialysis patient population are vs. multiple patients in the ESRD treatments.
supported by peer-reviewed scientific facility setting and confirmation that to Finally, we note that the comment
literature, because such sources were date, there are no reported instances of suggesting that the CAHPS Survey
not provided by the commenters, we Buzzy® being associated with a vascular should be updated to capture patient
were unable to verify these assertions. access mishap. However, because the experience with dialysis cannulation
While Buzzy® Pro may demonstrate applicant did not specify the percentage pain is beyond the scope of this
similar results to that of its predicate of the 114,000,000 needle procedures proposed rule.
devices, our primary concern regarding performed with Buzzy® that pertained In accordance with TPNIES policy
the lack of direct evidence that Buzzy® to dialysis cannulation, our concern and § 412.87(b)(1)(i), we consider the
results in pain or fear reduction in the about the lack of data examining the risk totality of the circumstances when
context of dialysis cannulation pain or of harm to the access site or any other making a determination that a new renal
fear has not been sufficiently addressed. adverse events associated with the use dialysis equipment or supply represents
an advance that substantially improves, applications for the TPNIES. Based on is continuing for CY 2024. As described
relative to renal dialysis services the Buzzy® Pro FDA marketing in the CY 2023 ESRD PPS final rule,
previously available, the diagnosis or authorization date of May 15, 2023, the payment for the one item approved for
treatment of Medicare beneficiaries. In applicant may be eligible to apply for the TPNIES, the Tablo® Hemodialysis
addition, per § 412.87(b)(1)(iii), CMS the TPNIES for CYs 2025, 2026, or 2027, System, as described by HCPCS code
considers a range of evidence from and CMS would review any new E1629, expires on December 31, 2023
published or unpublished information information provided for the applicable (87 FR 67216). As such there are no
sources, including other appropriate rulemaking cycle. items previously approved for the
information sources not otherwise listed TPNIES for which payment is
4. Other Public Comments on the
under § 412.87(b)(1)(iii). continuing in CY 2024.
After carefully reviewing the TPNIES Comment: Several commenters
application, the information submitted We received several comments requested that CMS extend the TPNIES
by the applicant addressing our regarding the TPNIES policies, payment period for the Tablo®
concerns raised in the CY 2024 ESRD including the length of the TPNIES Hemodialysis System beyond the
PPS proposed rule, and comments payment period and suggestions for new December 31, 2023, end date to
submitted by the public, we have payment adjustments. Commenters December 31, 2024. Commenters stated
determined that Buzzy® Pro has not urged CMS to extend the TPNIES that implementation difficulties with
shown that it represents an advance that payment period to at least three years to the first CMS-approved TPNIES
substantially improves, relative to renal allow for two full years of data application resulted in lower than
dialysis services previously available, collection, and then increase the ESRD anticipated uptake of the Tablo®
the treatment of Medicare beneficiaries. PPS base rate to account for the new System. Commenters stated that MACs
For the reasons discussed previously, technology. Commenters suggested that demonstrated variable levels of
we conclude that Buzzy® Pro does not CMS issue an RFI seeking public understanding about the Capital Related
meet the TPNIES innovation criteria feedback on a post-TPNIES add-on Assets (CRA) for the TPNIES and that
under § 413.236(b)(5) and § 412.87(b)(1). payment adjustment and adopt a post- providers lacked clear guidance on what
TPNIES payment adjustment in future information ESRD facilities were to
f. Capital-Related Assets Criterion
rulemaking. include on their claims. The
(§ 413.236(b)(6))
Commenters suggested revisions to commenters stated that these challenges
With respect to the sixth TPNIES existing TPNIES policies, such as contributed to claim denials and an
eligibility criterion under extending the TPNIES to all capital- administrative burden on ESRD
§ 413.236(b)(6), limiting capital-related related assets, expanding the TPNIES for facilities.
assets from being eligible for the home dialysis devices that are acquired Response: CMS did not propose to
TPNIES, except those that are home through operating leases, removing the extend the 2–CY TPNIES payment
dialysis machines, we note that Buzzy® TPNIES offset amount, and developing period as established in § 413.236(d)(1)
Pro does not meet the definition of a further guidance explaining the way in in the CY 2024 ESRD PPS proposed
capital-related asset under which CMS evaluates TPNIES rule, and we are not finalizing any such
§ 413.236(a)(2), because it is not an asset applicants’ substantial clinical change in this final rule. However, we
that the ESRD facility has an economic improvement data. acknowledge the commenters’ concerns
interest in through ownership that is Commenters suggested that we clarify pertaining to TPNIES claims processing
subject to depreciation.102 the way in which MACs determine and related matters and have issued Change
Comment: The applicant submitted a provide payment rates for items Request 12347 to the MACs outlining
comment indicating that Buzzy® Pro is approved for the TPNIES. Commenters the way in which the CRA for the
not an asset that the ESRD facility has suggested that these rates should be TPNIES is calculated for claims
an economic interest in through provided no later than March 31 of the processing purposes.103 In addition, in
ownership that is subject to first year of TPNIES eligibility and that August 2022, CMS instructed MACs to
depreciation. MACs should provide clear and timely adjust ESRD claims following CMS
Response: We agree that Buzzy® Pro TPNIES claims processing guidance to deployment of a corrected ESRD Pricer
does not meet the definition of a capital- the dialysis facilities. and to ensure that their systems were
related asset under § 413.236(a)(2). Finally, we received comments properly set up to suspend the claim for
Final Rule Action: After a suggesting that CMS develop a manual pricing. CMS provided a
consideration of all the public Transitional Laboratory Add-on Medicare Learning Network (MLN)
comments received, we have Payment Adjustment (TLAPA) to article instructing providers on how to
determined that the evidence and public incentivize innovation in laboratory submit Tablo® Systems claims.104 This
comments submitted are not sufficient services for beneficiaries with ESRD. article was supplemented with an MLN
to demonstrate that Buzzy® Pro meets While we are not providing detailed Connects newsletter reminding
all eligibility criteria to qualify for the responses to these comments in this
TPNIES for CY 2024. As a result, final rule because they are out of scope 103 Change Request 12347. Implementation of the
Buzzy® Pro will not be paid for using of the proposed rule, we thank the Capital Related Assets Adjustment (CRA) for the
the TPNIES per § 413.236(d). We note Transitional Add-on Payment Adjustment for New
commenters for their input and will and Innovative Equipment and Supplies (TPNIES)
that in the CY 2021 ESRD PPS final rule potentially consider the Under the End Stage Renal Disease Prospective
(85 FR 71412), CMS indicated that recommendations for future rulemaking. Payment System (ESRD PPS). https://www.cms.gov/
entities would have 3 years beginning files/document/r11533otn.pdf.
on the date of FDA marketing D. Continuation of Approved 104 MLN Matters Article. Implementation of the
Transitional Add-On Payment Capital Related Assets (CRA) Adjustment for the
authorization in which to submit their Transitional Add-on Payment Adjustment for New
Adjustments for New and Innovative and Innovative Equipment and Supplies (TPNIES)
102 See also CMS Provider Reimbursement Equipment and Supplies for CY 2024 Under the End Stage Renal Disease Prospective
Manual, Chapter 1, section 104.1. Available at: Payment System (ESRD PPS). https://www.cms.gov/
https://www.cms.gov/Regulations-and-Guidance/
In this section of the final rule, we files/document/mm12347-implementation-capital-
Guidance/Manuals/Paper-Based-Manuals-Items/ identify any items previously approved related-assets-cra-adjustment-transitional-add-
CMS021929. for the TPNIES and for which payment payment-adjustment-new.pdf.
providers to submit the invoice for the base rate is paid the TDAPA for 2 years. specified in CMS Transmittal 12157,
CRA for the TPNIES to their MAC and In December 2021, CMS approved dated July 27, 2023, and available at:
report the appropriate revenue code and Korsuva® (difelikefalin) for the TDAPA https://www.cms.gov/files/document/
HCPCS code with modifier on the claim under the ESRD PPS, effective April 1, r12157cp.pdf.
for treatments in which the CRA for the 2022. Implementation instructions are Table 11 identifies the two new renal
TPNIES was used. Providers were also specified in CMS Transmittal 11295,106 dialysis drugs for which the TDAPA
reminded to address any issues returned dated March 15, 2022, and available at: payment period as specified in
to them by their MAC and resubmit the https://www.cms.gov/files/document/ § 413.234(c)(1) will continue in CY
effected claims.105 r11295CP.pdf. 2024: Korsuva® (difelikefalin) that was
In July 2023, after the CY 2024 ESRD approved for the TDAPA effective in CY
E. Continuation of Approved
PPS proposed rule appeared in the 2022, and Jesduvroq (daprodustat) that
Transitional Drug Add-On Payment
Federal Register on June 30, 2023, CMS was approved for the TDAPA effective
Adjustments for CY 2024
approved Jesduvroq (daprodustat) for in CY 2023. Table 11 also identifies the
Under § 413.234(c)(1), a new renal the TDAPA under the ESRD PPS, products’ HCPCS coding information as
dialysis drug or biological product that effective October 1, 2023. well as the payment adjustment
is considered included in the ESRD PPS Implementation instructions are effective dates and end dates.
TABLE 11: Continuation of Approved Transitional Drug Add-On Payment

Adjustments
HCPCSCode Long Descriptor Payment Payment Adjustment End Date

Adjustment
Effective Date
J0879 Injection, difelikefalin, 0.1 4/1/2022 3/31/2024
microgram, (for ESRD on dialysis)
J0889 Daprodustat, oral, 1 mg, (for ESRD 10/1/2023 9/30/2025
on dialysis)
III. Calendar Year (CY) 2024 Payment Act) by any other adjustment factor B. Summary of the Proposed Provisions,
for Renal Dialysis Services Furnished under section 1881(b)(14)(D) of the Act Public Comments, and Responses to
to Individuals With Acute Kidney that the Secretary elects. Comments on the CY 2024 Payment for
Injury (AKI) In the CY 2017 ESRD PPS final rule, Renal Dialysis Services Furnished to
A. Background we finalized several coverage and Individuals With AKI
payment policies to implement The CY 2024 ESRD PPS proposed
The Trade Preferences Extension Act
subsection (r) of section 1834 of the Act rule, titled ‘‘Medicare Program; End-
of 2015 (TPEA) (Pub. L. 114–27) was
and the amendments to section Stage Renal Disease Prospective
enacted on June 29, 2015, and amended
the Act to provide coverage and 1861(s)(2)(F) of the Act, including the Payment System, Payment for Renal
payment for dialysis furnished by an payment rate for AKI dialysis (81 FR Dialysis Services Furnished to
ESRD facility to an individual with AKI. 77866 through 77872 and 77965). We Individuals with Acute Kidney Injury,
Specifically, section 808(a) of the TPEA interpret section 1834(r)(1) of the Act as End-Stage Renal Disease Quality
amended section 1861(s)(2)(F) of the Act requiring the amount of payment for Incentive Program, and End-Stage Renal
to provide coverage for renal dialysis AKI dialysis services to be the base rate Disease Treatment Choices Model’’ (88
services furnished on or after January 1, for renal dialysis services determined FR 42430–42544), referred to as the ‘‘CY
2017, by a renal dialysis facility or a for a year under the ESRD PPS base rate 2024 ESRD PPS proposed rule,’’
provider of services paid under section as set forth in § 413.220, updated by the appeared in the June 30, 2023 version of
1881(b)(14) of the Act to an individual ESRD bundled market basket percentage the Federal Register, with a comment
with AKI. Section 808(b) of the TPEA increase factor minus a productivity period that ended on August 25, 2023.
amended section 1834 of the Act by adjustment as set forth in In that proposed rule, we proposed to
adding a subsection (r) to provide § 413.196(d)(1), adjusted for wages as set update the AKI dialysis payment rate for
payment, beginning January 1, 2017, for forth in § 413.231, and adjusted by any CY 2024. We received 10 public
renal dialysis services furnished by other amounts deemed appropriate by comments on our proposal. In this final
renal dialysis facilities or providers of the Secretary under § 413.373. We
services paid under section 1881(b)(14) rule, we provide a summary of each
codified this policy in § 413.372 (81 FR proposed provision, a summary of
of the Act to individuals with AKI at the 77965).
ESRD PPS base rate, as adjusted by any public comments received and our
applicable geographic adjustment responses to them, and the policies we
applied under section are finalizing for CY 2024 payment for

1881(b)(14)(D)(iv)(II) of the Act and renal dialysis services furnished to
adjusted (on a budget neutral basis for individuals with AKI.
payments under section 1834(r) of the
105 MLN Connects Newsletter. ESRD: Submitting training-education/medicare-learning-network/ 106 CMS Transmittal 11295 rescinded and
Dialysis Claims the Include Capital Related Assets newsletter/2023-09-14-mlnc#_Toc145581414. replaced CMS Transmittal 11278, dated February
ER06NO23.023</GPH>
Eligible for the TPNIES https://www.cms.gov/ 24, 2022.
C. Annual Payment Rate Update for CY to AKI dialysis payments to ESRD 2020-based ESRDB adequately reflects
2024 facilities. the average change in the price of goods
We received 10 public comments on and services ESRD facilities purchase to
1. CY 2024 AKI Dialysis Payment Rate our proposal to update the payment rate provide renal dialysis services and is
The payment rate for AKI dialysis is for renal dialysis services furnished to technically appropriate to use as the
the ESRD PPS base rate determined for individuals with AKI. Commenters ESRD PPS payment update factor,
a year under section 1881(b)(14) of the included a coalition of dialysis which determines the payment rate for
Act, which is the finalized ESRD PPS organizations, a non-profit dialysis renal dialysis services furnished to
base rate, including the applicable organization, a trade association, a renal patients with AKI at ESRD facilities. We
annual market basket update, product development company, and appreciate the commenter’s suggestion
geographic wage adjustments, and any multiple large dialysis organizations. that any forecast error adjustment
other discretionary adjustments, for The comments on our proposal and our applied to payments under the ESRD
such year. We note that ESRD facilities responses are set forth below. PPS should also be applied to payments
can bill Medicare for non-renal dialysis Comment: Some commenters for AKI patients. As discussed in section
items and services and receive separate expressed support for the CY 2024 II.B.1.a.(2)(e) of this final rule, we are
payment in addition to the payment rate proposed payment rate for individuals not finalizing a forecast error adjustment
for AKI dialysis. with AKI, which is to say the for the ESRD PPS for several reasons,
commenters supported increasing but we will consider this suggestion for
As discussed in section II.B.1.d of this
payments for AKI by the proposed potential future rulemaking.
final rule, the ESRD PPS base rate is
productivity-adjusted ESRDB market Final Rule Action: We are finalizing
$271.02, which reflects the application
basket update of 1.7 percent. Many our proposal to base the AKI payment
of the CY 2024 wage index budget-
commenters requested that CMS allow rate on the finalized ESRD PPS base
neutrality adjustment factor of 0.999534
for AKI patients to select home dialysis rate, adjusted by the ESRD facility’s
and the CY 2024 ESRDB market basket
modalities by eliminating the current wage index. Specifically, the final CY
percentage increase of 2.4 percent prohibition. Some commenters also 2024 ESRD PPS base rate is $271.02 as
reduced by the productivity adjustment expressed concerns that the proposed finalized in section II.B.1.d of this final
of 0.3 percentage point, that is, 2.1 market basket increase is insufficient to rule. Accordingly, we are finalizing a
percent. Accordingly, we are finalizing account for inflation. One commenter CY 2024 per treatment payment rate of
a CY 2024 per treatment payment rate suggested that any forecast error $271.02 for renal dialysis services
of $271.02 (($265.57 × 0.999534) × 1.021 adjustment applied to the ESRD PPS furnished by ESRD facilities to
= $271.02) for renal dialysis services should also be applied to payments for individuals with AKI. Additionally, we
furnished by ESRD facilities to AKI patients. are finalizing our proposal to apply the
individuals with AKI. This final Response: We appreciate the updated the ESRD PPS wage index for
payment rate is further adjusted by the commenters’ support for the proposed CY 2024 payments for renal dialysis
wage index, as discussed in the next CY 2024 productivity-adjusted ESRDB services furnished by ESRD facilities to
section of this final rule. market basket update of 1.7 percent. We individuals with AKI as finalized in
2. Geographic Adjustment Factor acknowledge the request for AKI section II.B.1.b of this final rule.
patients to select home dialysis
Under section 1834(r)(1) of the Act modalities, and we thank commenters IV. End-Stage Renal Disease Quality
and regulations at § 413.372, the amount for their input. We note that currently, Incentive Program (ESRD QIP)
of payment for AKI renal dialysis CMS will only pay for renal dialysis A. Background
services is the base rate for renal services at an ESRD facility for patients
dialysis services determined for a year with AKI, and we did not propose to For a detailed discussion of the ESRD
under section 1881(b)(14) of the Act change this policy in the CY 2024 ESRD QIP’s background and history, including
(updated by the ESRDB market basket PPS proposed rule. Current AKI dialysis a description of the Program’s
percentage increase and reduced by the payment policy was implemented under authorizing statute and the policies that
productivity adjustment), as adjusted by the CY 2017 ESRD PPS final rule (81 FR we have adopted in previous final rules,
any applicable geographic adjustment 77866 through 77872, and 77965). Over we refer readers to previous ESRD QIP
factor applied under section the years, we have received several rules at: 75 FR 49030; 76 FR 628; 76 FR
1881(b)(14)(D)(iv)(II) of the Act. comments regarding the site of renal 70228; 77 FR 67450; 78 FR 72156; 79 FR
Accordingly, we apply the same wage dialysis services for Medicare 66120; 80 FR 68968; 81 FR 77834; 82 FR
index under § 413.231 that is used beneficiaries with AKI. We have 50738; 83 FR 56922; 84 FR 60648; 85 FR
under the ESRD PPS and discussed in solicited comments in the recent past, 71398; 86 FR 61874; and 87 FR 67136.
section II.B.1.b of this final rule. The including in the CY 2022 ESRD PPS We have also codified many of our
AKI dialysis payment rate is adjusted by proposed rule (86 FR 36322, 36408), policies for the ESRD QIP at §§ 413.177
the wage index for a particular ESRD when we requested information and 413.178.
facility in the same way that the ESRD regarding potentially modifying the site B. Updates to the Regulation Text for
PPS base rate is adjusted by the wage of renal dialysis services for patients the ESRD QIP
index for that ESRD facility (81 FR with AKI and payment for AKI in the
77868). Specifically, we apply the wage home setting. CMS continues to believe 1. Revision to the Definition of
index to the labor-related share of the that this population requires close ‘‘Minimum Total Performance Score
ESRD PPS base rate that we utilize for medical supervision by qualified staff (mTPS)’’ at § 413.178(a)(8)
AKI dialysis to compute the wage- during their dialysis treatment. We In the CY 2019 ESRD PPS final rule,
adjusted, per-treatment-AKI dialysis recognize commenters’ concerns that we codified a number of key terms used
payment rate. We also apply the wage the proposed ESRDB market basket in the ESRD QIP at § 413.178(a) of our
index policies regarding the 0.600 wage update is insufficient given inflation. As regulations (83 FR 56980 through
index floor (87 FR 67161 through 67166) discussed in section II.B.1.a.(2)(c) of this 56982). One of these terms is ‘‘minimum
and the 5 percent cap on wage index final rule, we believe the final CY 2024 total performance score’’ (mTPS), which
decreases (87 FR 67159 through 67161) ESRDB market basket update using the we defined at § 413.178(a)(8) ‘‘with
respect to a payment year’’ 107 as ‘‘the will provide facilities with additional also finalized a policy to retain a
total performance score that an ESRD predictability and transparency measure for certain specified reasons,
facility would receive if, during the regarding our calculation of the mTPS such as when a particular measure
baseline period, it performed at the 50th for a payment year. We noted that, addresses a gap in quality so significant
percentile of national ESRD facility although many facilities score much that removing the measure could result
performance on all clinical measures higher than zero during the initial in poor quality or when a measure
and the median of national ESRD performance periods of a new reporting addresses a statutorily-required topic,
facility performance on all reporting measure, we believe that setting the even if one or more of the measure
measures.’’ proxy median at zero where we do not removal factors applies. In the CY 2013
In the CY 2024 ESRD PPS proposed have sufficient data available will ESRD PPS final rule (77 FR 67475), we
rule, we stated that we have recently account for the possibility that new also finalized that we would generally
reevaluated this definition and reporting measures may have different remove an ESRD QIP measure using
determined that it should be revised to reporting requirements. For example, a notice and comment rulemaking unless
more accurately capture how we new reporting measure may require a we determined that the continued
calculate the median of national ESRD facility to report new or additional data collection of data on the measure raised
facility performance on reporting in CMS’s ESRD Quality Reporting patient safety concerns. In that case, we
measures (88 FR 42487). We noted that, System (EQRS) to be eligible for scoring stated that we would promptly remove
although we use data prior to the on the reporting measure. Additionally, the measure, immediately notify ESRD
performance period to calculate these a new reporting measure may require facilities and the public through the
medians, the data may not be from the that a facility reconsider its internal usual communication channels
same time period, or ‘‘baseline period’’ processes to comply with the reporting (including listening sessions, memos,
(see § 413.178(a)(2)) used to calculate requirements and be eligible for scoring. email notification, and website
the 50th percentile of national ESRD In the proposed rule, we stated that we postings), and publish the justification
facility performance on the clinical believe that using a median of zero for for the removal in the Federal Register
measures. Instead, our policy has been new reporting measures would ensure during the next rulemaking cycle.
to calculate the median of national that the mTPS is calculated based on the In the CY 2024 ESRD PPS proposed
ESRD facility performance on the ESRD worst-case scenario, rather than rule, we proposed to revise § 413.178(c)
QIP reporting measures using the most assuming a median higher than what such that it incorporates these measure
recently available data prior to the may be observed once data are available. adoption, retention, and removal
applicable performance period for the We noted that setting the proxy median policies (88 FR 42487). We proposed
payment year. If there were no data at zero until we have sufficient data that existing § 413.178(c)(1) through (5)
available prior to the first performance available to calculate the median would would be consolidated and renumbered
period of a new reporting measure, as allow the timely inclusion of a new as § 413.178(c)(1)(i) through (v), and we
was the case for the Clinical Depression reporting measure in the ESRD QIP would add a new § 413.178(c)(1)(vi),
Screening and Follow-Up reporting measure set, as well as our calculation which would codify our policy to adopt
measure, we would use a proxy median of the mTPS, while also encouraging measures for the ESRD QIP beyond
for purposes of including the reporting facilities to report the new or additional those that address the topics described
measure in our calculation of the mTPS. data that may be specified by that at § 413.178(c)(1)(i) through (v). We also
We stated that we selected the values for reporting measure so that they are able proposed to codify at § 413.178(c)(2) our
these proxy medians based on the to receive credit for reporting. policies regarding the use of endorsed
availability of previous measure data, a We welcomed public comment on measures. We proposed to codify at
facility’s familiarity with similar this proposal. The comments we § 413.178(c)(3) our policy regarding the
measures or requirements, and received and our responses are set forth updating of measure specifications.
considerations regarding a facility’s below. Additionally, we proposed to codify at
ability to comply with new reporting Comment: A few commenters § 413.178(c)(4) our policy regarding
measure requirements during the initial expressed support for the proposed measure retention. Finally, we proposed
performance periods for a new reporting update to the definition of mTPS, as it to codify at § 413.178(c)(5) our policies
measure. will allow for timely inclusion of new regarding measure removal. We stated
In the CY 2024 ESRD PPS proposed reporting measures and encourage our belief that these proposals will make
rule, we proposed to update the facilities to report data. it easier for interested parties to find
definition of ‘‘minimum total Response: We thank commenters for these policies and will further align the
performance score’’ at § 413.178(a)(8) so their support. ESRD QIP regulations with the
that it accurately captures these policies Final Rule Action: After considering regulations we have codified for other
(88 FR 42487). We also proposed that, public comments, we are finalizing our quality reporting programs.
with respect to the adoption of future proposal as proposed. We welcomed public comment on
reporting measures, including the 2. Codification of the ESRD QIP these proposals. The comments we
reporting measures proposed in the CY Measure Adoption, Retention, and received and our responses are set forth
2024 ESRD PPS proposed rule, if there Removal Policies below.
is an insufficient quantity of data Comment: A few commenters
In the CY 2013 ESRD PPS final rule expressed support for the proposals to
available prior to the first performance
(77 FR 67475), we finalized a policy to codify existing measure adoption,
period of a new reporting measure, we
retain measures from prior program
will set a proxy median of zero for the retention, and removal policies, noting
years for each successive program year, that these updates will provide
reporting measure until we have
unless otherwise proposed and transparency for evaluating measures.
sufficient data to calculate the median.
finalized. In the CY 2019 ESRD PPS Response: We thank the commenters
We stated our belief that this proposal
final rule (83 FR 56983 through 56985), for their support.
107 In the CY 2023 ESRD PPS final rule, we we finalized eight measure removal Final Rule Action: After considering
revised § 413.178(a)(8) to exempt PY 2023 (87 FR factors for the ESRD QIP, and we refer public comments, we are finalizing our
67229). readers to that final rule for details. We proposals as proposed.
C. Updates to Requirements Beginning Commitment to Health Equity reporting these measures can be found in the CMS
With the PY 2026 ESRD QIP measure to the ESRD QIP measure set ESRD Measures Manual for the 2023
beginning with PY 2026 (88 FR 42489 Performance Period.108
1. PY 2026 ESRD QIP Measure Set
through 42494). The previously BILLING CODE 4120–01–P
In the CY 2024 ESRD PPS proposed finalized and proposed new measures
rule, we proposed to remove the are summarized in Table 12 of the
Ultrafiltration Rate reporting measure proposed rule (88 FR 42488). We 108 https://www.cms.gov/files/document/esrd-
and the Standardized Fistula Rate describe the previously finalized measures-manual-v80.pdf.
109 In previous years, we referred to the
clinical measure beginning with PY measures and the measures we are consensus-based entity by corporate name. We have
2026 (88 FR 42499 through 42500). We finalizing in this final rule in Table 12. updated this language to refer to the consensus-
also proposed to add the Facility The technical specifications for each of based entity more generally.
TABLE 12: Previously Finalized and Newly Finalized Measures for the PY 2026 ESRD
QIP Measure Set
Consensus- Measure Title and Description

Based
Entity109
(CBE) #
0258 In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CARPS) Survey
Administration, a clinical measure
Measure assesses patients' self-reported experience of care through percentage of patient responses to
multiple survey questions.
2496 Standardized Readmission Ratio (SRR), a clinical measure
Ratio of the number of observed unplanned 30-day hospital readmissions to the number of expected
unplanned 30-day readmissions.
Based on Standardized Transfusion Ratio (STrR), a clinical measure
CBE#2979 Ratio of the number of observed eligible red blood cell transfusion events occurring in patients dialyzing at
a facility to the number of eligible transfusions that would be expected.
NIA (Kt/V) Dialysis Adequacy Comprehensive, a clinical measure
A measure of dialysis adequacy where K is dialyzer clearance, t is dialysis time, and V is total body water
volume. Percentage of all patient months for patients whose delivered dose of dialysis (either hemodialysis
or peritoneal dialysis) met the specified threshold during the reporting period.
2978 Hemodialysis Vascular Access: Long-Term Catheter Rate clinical measure
Measures the use of a catheter continuously for 3 months or longer as of the last hemodialysis treatment
session of the month.
1454 Hypercalcemia, a reporting measure
Proportion of patient-months with 3-month rolling average of total uncorrected serum or plasma calcium
greater than 10.2 mg/dL.
1463 Standardized Hospitalization Ratio (SHR), a clinical measure
Risk-adjusted SHR of the number of observed hospitalizations to the number of expected hospitalizations.
Based on Clinical Depression Screening and Follow-Up, a clinical measure*
CBE#0418 Facility reports in ESRD Quality Reporting System (EQRS) one of four conditions for each qualifying
patient treated during performance period.
Based on National Healthcare Safety Network (NHSN) Bloodstream Infection (BSI) in Hemodialysis Patients, a
CBE#1460 clinical measure
The Standardized Infection Ratio (SIR) ofBSis will be calculated among patients receiving hemodialysis at
outpatient hemodialysis centers.
NIA NHSN Dialysis Event reporting measure
Number of months for which facility reports NHSN Dialysis Event data to the CDC.
NIA Percentage of Prevalent Patients Waitlisted (PPPW), a clinical measure
Percentage of patients at each facility who were on the kidney or kidney-pancreas transplant waitlist
averaged across patients prevalent on the last day of each month during the performance period.
2988 Medication Reconciliation for Patients Receiving Care at Dialysis Facilities (MedRec ), a reporting measure
Percentage of patient-months for which medication reconciliation was performed and documented by an
eligible professional.
3636 COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP), a reporting measure**
Percentage of HCP who are up to date on their COVID-19 vaccination course.
NIA Facility Commitment to Health Equity, a reporting measure***
Facilities will receive two points each for attesting to five different domains of commitment to advancing
health equity for a total often points.
*We are finalizing our proposal to update the Clinical Depression Screening and Follow-Up measure beginning with
PY 2026, as discussed in section IV.C.4 of this fmal rule.
**We are fmalizing our proposal to update the COVID-19 Vaccination Coverage Among HCP reporting measure
beginning with PY 2026, as discussed in section IV.C.3 of this fmal rule.
***Weare fmalizing our proposal to add the Facility Commitment to Health Equity reporting measure beginning
with PY 2026, as discussed in section IV.C.2 of this final rule.
ER06NO23.024</GPH>
2. Adoption of the Facility Commitment hospital care, report lower experiences quality of care received by people from
to Health Equity Reporting Measure of care, and experience more frequent racial and ethnic minority groups show
Beginning With the PY 2026 ESRD QIP hospital readmissions and procedural worse health outcomes, including a
a. Background complications.120 121 122 123 124 125 higher incidence of diabetes
Readmission rates in the Hospital complications such as retinopathy.132
In the CY 2024 ESRD PPS proposed Readmissions Reduction Program have Additionally, inequities in the drivers of
rule, we stated that significant and shown to be higher among Black and health affecting these groups, such as
persistent disparities in healthcare Hispanic Medicare beneficiaries with poverty and healthcare access, are
outcomes exist in the U.S. (88 FR common conditions, including interrelated and influence a wide range
42489). For example, belonging to a congestive heart failure and acute of health and quality-of-life outcomes
racial or ethnic minority group, being a myocardial infarction.126 127 128 129 130 and risks.133
member of the lesbian, gay, bisexual, Data indicate that, even after accounting In the CY 2022 ESRD PPS proposed
transgender, and queer (LGBTQ+) for factors such as socioeconomic rule (86 FR 36362 through 36369), we
community, being a member of a conditions, members of racial and requested information on our Equity
religious minority, living in a rural area, ethnic minority groups reported Plan for Improving Quality in Medicare
being a person with a disability or experiencing lower quality (also referred to as the CMS Framework
disabilities, or being near or below the healthcare.131 Evidence of differences in for Health Equity),134 which outlines
poverty level, is often associated with our commitment to close health equity
worse health 120 CMS Office of Minority Health. (2020). Racial, gaps through improved data collection,
outcomes.110 111 112 113 114 115 116 117 118 119 Ethnic, and Gender Disparities in Healthcare in measurement, and analysis of
Medicare Advantage. Baltimore, MD: Centers for
Numerous studies have shown that Medicare & Medicaid Services. Available at: .
disparities across programs and policies.
among Medicare beneficiaries, 121 CMS Office of Minority Health. (Updated The request for information requested
individuals who are racial and ethnic August 2018). Guide to Reducing Disparities in public comment regarding the potential
minorities often receive lower quality Readmissions. Baltimore, MD: Centers for Medicare stratification of quality measure results
& Medicaid Services. Available at: https:// by race and ethnicity and the potential
www.cms.gov/About-CMS/Agency-Information/
110 Joynt KE, Orav E, Jha AK. (2011). Thirty-Day
OMH/Downloads/OMH_Readmissions_Guide.pdf. creation of a hospital or facility equity
Readmission Rates for Medicare Beneficiaries by 122 Singh JA, Lu X, Rosenthal GE, Ibrahim S, score in CMS quality reporting and
Race and Site of Care. JAMA, 305(7), 675–681.
Available at: doi:10.1001/jama.2011.123.
Cram P. (2014). Racial Disparities in Knee and Hip value-based purchasing programs,
111 Lindenauer PK, Lagu T, Rothberg MB, et al.
Total Joint Arthroplasty: An 18-year analysis of including the ESRD QIP. In the CY 2024
national Medicare data. Ann Rheum Dis., 73(12),
(2013). Income Inequality and thirty-Day Outcomes 2107–15. Available at: doi:10.1136/annrheumdis-
ESRD PPS proposed rule, we stated that
After Acute Myocardial Infarction, Heart Failure, 2013–203494. we received many responses to that
and Pneumonia: Retrospective Cohort Study. BMJ, 123 Rivera-Hernandez M, Rahman M, Mor V, request for public comment (88 FR
346. Available at: https://doi.org/10.1136/bmj.f521.
112 Trivedi AN, Nsa W, Hausmann LRM, et al.
Trivedi AN. (2019). Racial Disparities in 42489), and we referred readers to the
Readmission Rates among Patients Discharged to CY 2022 ESRD PPS final rule for
(2014). Quality and Equity of Care in U.S. Hospitals. Skilled Nursing Facilities. J Am Geriatr Soc., 67(8),
N Engl J Med, 371(24), 2298–2308. Available at: doi: 1672–1679. Available at: https://doi.org/10.1111/ summaries of those comments (86 FR
10.1056/NEJMsa1405003. jgs.15960. 61934 through 61937). We noted in the
113 Polyakova, M, Udalova V, Kocks, G, Genadek 124 Joynt KE, Orav E, Jha AK. (2011). Thirty-Day CY 2022 ESRD PPS final rule the value
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into account for future development and Studies demonstrate that hospital care at dialysis facilities is accessible to
expansion of our health equity quality leadership can positively influence all. Based on this well-developed body
measurement efforts. culture for better quality, patient of evidence, in the proposed rule we
The Agency for Healthcare Research outcomes, and experience of proposed to adopt an attestation-based
and Quality (AHRQ) and The Joint care.140 141 142 A systematic review of 122 structural reporting measure, Facility
Commission have independently published studies showed that strong Commitment to Health Equity, for the
concluded that facility leadership plays leadership that prioritized safety, ESRD QIP beginning with PY 2026 (88
an important role in promoting a culture quality, and the setting of clear guidance FR 42490).
of quality and safety.135 136 137 AHRQ with measurable goals for improvement The first pillar of our strategic
research shows that facility boards can resulted in a high-performing hospital priorities 146 reflects our deep
influence quality and safety in a variety with better patient outcomes.143 We commitment to improvements in health
of ways; not only through strategic believe this conclusion also applies to equity by addressing the health
initiatives, but also through more direct dialysis facilities, and that the disparities that underly our health
interactions with frontline workers.138 commitment of dialysis facility system. In line with this strategic pillar,
The Joint Commission found that a leadership to health equity would result we developed this structural measure to
leader who is committed to prioritizing in a reduction of health disparities in assess facility commitment to health
and making patient safety visible the ESRD population. equity across five domains (see Table
through every day actions is a critical Our belief that a leadership 13) using a suite of organizational
part of creating a true culture of safety, commitment to health equity can lead to competencies aimed at achieving health
which in turn fosters an organizational a reduction of health disparities is also equity for all patients, including but not
culture in which patients are treated supported by research conducted by the limited to patients who belong to racial
with dignity and respect.139 Because Institute for Healthcare Improvement and ethnic minority groups, people with
CMS is also working toward the goal of (IHI), which studied 23 health systems disabilities, members of the LGBTQ+
all patients receiving high-quality throughout the U.S. and Canada. The community, individuals with limited
healthcare, regardless of individual IHI’s research showed that health equity English proficiency, rural populations,
characteristics, we are also committed to must be a priority championed by religious minorities, and people facing
supporting healthcare organizations in leadership teams to improve both socioeconomic challenges. We believe
building a culture of safety and equity patient access to needed healthcare these elements are actionable focus
that focuses on educating and services and outcomes among areas, and assessment of dialysis facility
empowering their workforce to populations that have been leadership commitment to them is
recognize and eliminate health disadvantaged by the healthcare foundational.
disparities. This includes patients system.144 This IHI study specifically We proposed to adopt the measure
receiving the right care, at the right identified concrete actions to make under section 1881(h)(2)(A)(iv) of the
time, in the right setting for their advancing health equity a core strategy, Act, which gives the Secretary broad
condition(s), regardless of those including establishing this goal as a authority to specify measures for the
characteristics. leader-driven priority alongside ESRD QIP (88 FR 42490). We noted that
We believe that strong and committed organizational development structures disparities in health equity are tied to
leadership from dialysis facility and processes.145 Based upon these worse patient outcomes in the ESRD
executives and board members is findings, we believe that dialysis facility community. For example, individuals
essential and can play a role in shifting leadership can be instrumental in from racial and ethnic minority groups
organizational culture and advancing setting specific, measurable, attainable, and with lower incomes are less likely
equity goals for dialysis facilities. realistic, and time-based (SMART) goals to receive recommended care for CKD
to assess progress towards achieving risk factors and are also less likely to
135 Agency for Healthcare Research and Quality.
equity goals and ensuring high-quality reduce CKD risk through recommended
Leadership Role in Improving Patient Safety. treatment goals.147 148 149 150
Patient Safety Primer, September 2019. Available at: 140 Bradley EH, Brewster AL, McNatt Z, et al.
https://psnet.ahrq.gov/primer/leadership-role-
improving-safety. (2018) How Guiding Coalitions Promote Positive 146 Brooks-LaSure, C. (2021). My First 100 Days
136 Joint Commission on Accreditation of Culture Change in Hospitals: A Longitudinal Mixed and Where We Go From Here: A Strategic Vision
Methods Interventional Study. BMJ Qual Saf., 27(3), for CMS. Centers for Medicare & Medicaid.
Healthcare Organizations, USA. The essential role
of leadership in developing a safety culture. 218–225. doi:10.1136/bmjqs-2017–006574. Available at: https://www.cms.gov/blog/my-first-
141 Smith SA, Yount N, Sorra J. (2017). Exploring 100-days-and-where-we-go-here-strategic-vision-
Sentinel Event Alert. 2017 (Revised June 2021).
Available at: https://www.jointcommission.org/-/ Relationships Between Hospital Patient Safety cms.
media/tjc/documents/resources/patient-safety- Culture and Consumer Reports Safety Scores. BMC 147 United States Renal Data System. 2021 USRDS
topics/sentinel-event/sea-57-safety-culture-and- Health Services Research, 17(1), 143. doi:10.1186/ Annual Data Report: Epidemiology of kidney
leadership-final2.pdf. s12913–017–2078–6. disease in the United States. National Institutes of
142 Keroack MA, Youngberg BJ, Cerese JL, Krsek Health, National Institute of Diabetes and Digestive
137 See information on launch of new ‘‘Health
Care Equity Certification’’ in July 2023 from Joint C, Prellwitz LW, Trevelyan EW. (2007). and Kidney Diseases, Bethesda, MD, 2021. We note
Commission on Accreditation of Healthcare Organizational Factors Associated with High that, following publication of the CY 2024 ESRD
Organizations, USA, available at: https:// Performance in Quality and Safety in Academic PPS proposed rule, the USRDS has published its
www.jointcommission.org/our-priorities/health- Medical Centers. Acad Med., 82(12), 1178–86. doi: 2022 annual report, which is available at: https://
care-equity/health-care-equity-prepublication/. 10.1097/ACM.0b013e318159e1ff. usrds-adr.niddk.nih.gov/2022.
138 Agency for Healthcare Research and Quality. 143 Millar R, Mannion R, Freeman T, et al. (2013). 148 Benjamin O, Lappin SL. End-Stage Renal
Leadership Role in Improving Patient Safety. Hospital Board Oversight of Quality and Patient Disease. [Updated 2021 Sep 16]. In: Stat Pearls
Patient Safety Primer, September 2019: Available at: Safety: A Narrative Review and Synthesis of Recent [internet]. Treasure Island (FL): StatPearls
https://psnet.ahrq.gov/primer/leadership-role- Empirical Research. The Milbank quarterly, 91(4), Publishing; 2022. Available from: https://www.ncbi.
improving-safety. 738–70. doi:10.1111/1468–0009.12032. nlm.nih.gov/books/NBK499861/.

139 Joint Commission on Accreditation of 144 Mate KS and Wyatt R. (2017). Health Equity 149 Norris, K.C., Williams, S.F., Rhee, C.M.,
Healthcare Organizations, USA. The essential role Must Be a Strategic Priority. NEJM Catalyst. Nicholas, S.B., Kovesdy, C.P., et al. (2017).
of leadership in developing a safety culture. Available at: https://catalyst.nejm.org/doi/full/ Hemodialysis Disparities in African Americans: The
Sentinel Event Alert. 2017 (Revised June 2021). 10.1056/CAT.17.0556. Deeply Integrated Concept of Race in the Social
Available at: https://www.jointcommission.org/-/ 145 Mate KS and Wyatt R. (2017). Health Equity Fabric of Our Society. Seminars in Dialysis
media/tjc/documents/resources/patient-safety- Must Be a Strategic Priority. NEJM Catalyst. 30(3):213–223. doi:10.1111/sdi.12589.
topics/sentinel-event/sea-57-safety-culture-and- Available at: https://catalyst.nejm.org/doi/full/ 150 CMS (2021). Chronic Kidney Disease
leadership-final2.pdf. 10.1056/CAT.17.0556. Disparities: Educational Guide for Primary Care.
Consequently, some groups are more their patient populations and, in turn, is aligned with the Meaningful
likely to progress from CKD to ESRD develop appropriate solutions to Measures Area of ‘‘Equity of Care’’ and
and less likely to be under the care of improve access and outcomes. Thus, the the Meaningful Measures 2.0 goal to
a nephrologist before starting measure aims to support facilities in ‘‘Leverage Quality Measures to Promote
dialysis.151 Individuals from racial and leveraging available data, pursuing Equity and Close Gaps in Care’’ because
ethnic minority groups with ESRD are focused quality improvement activities, it seeks to assess structural health equity
more likely to have 30-day hospital and promoting efficient and effective issues that could inform facility
readmissions when compared to non- use of their resources. While the practices such that their patients attain
Hispanic White patients.152 We stated measure does not require facilities to better outcomes. This measure also
that we believe that this measure is an take specific actions, we expect that any supports the Meaningful Measures 2.0
appropriate measure of ESRD quality of solution a facility might develop to objective to ‘‘[c]ommit to a patient-
care because it would improve facilities’ address a gap it identifies would comply centered approach in quality measure
awareness of the tie between their with all applicable Federal non- and value-based incentives programs to
structural practices and their patient discrimination laws. We also note that ensure that quality and safety measures
outcomes by reporting these data, thus the measure is intended to promote address healthcare equity’’ because the
informing facility practices such that health equity for all patients and is not measure would incentivize facilities to
their patients attain better outcomes. We intended to create a conflict between a identify their own healthcare equity
also stated our belief that the proposed CMS requirement and a State’s civil gaps from a structural perspective.
measure would incentivize facilities to rights laws.
b. Overview of Measure
collect and utilize their data to identify The five questions of the structural
their own critical equity gaps, measure are adapted from the CMS The Facility Commitment to Health
implement plans to address said gaps, Office of Minority Health’s Building an Equity reporting measure assesses
and ensure that they dedicate resources Organizational Response to Health dialysis facility commitment to health
to addressing those gaps. Facilities Disparities framework, which focuses equity using a suite of equity-focused
could analyze data to understand, for on data collection, data analysis, culture organizational competencies aimed at
example, whether there are any of equity, and quality improvement.153 achieving health equity for all
demographic factors (such as race, We have already adopted this measure populations, including those that have
national origin, primary language, and for the Hospital Inpatient Quality been disadvantaged, marginalized, and
ethnicity), or social drivers of health Reporting (IQR) Program, and we refer underserved by the healthcare system.
(such as housing status and food readers to the FY 2023 IPPS/LTCH PPS As previously noted, this includes, but
security) that may be affecting access to final rule (87 FR 49191 through 49201) is not limited to: racial and ethnic
care or contributing to poor outcomes in for a discussion of the measure in that minority groups, people with
program. In the proposed rule, we stated disabilities, members of the LGBTQ+
Available at: https://www.cms.gov/files/document/ that, other than replacing the term community, individuals with limited
chronic-kidney-disease-disparities-educational- ‘‘hospital’’ with the term ‘‘facility,’’ the English proficiency, rural populations,
guide-primary-care.pdf. measure is identical to the Hospital IQR religious minorities, and people facing
151 Norton, J. M., Moxey-Mims, M. M., Eggers, P.
Program measure. The Facility socioeconomic challenges. Table 13
W., Narva, A. S., Star, R. A., Kimmel, P. L., &
Rodgers, G. P. (2016). Social Determinants of Racial Commitment to Health Equity measure includes the five attestation domains
Disparities in CKD. Journal of the American Society and the elements within each of those
of Nephrology: JASN, 27(9), 2576–2595. https:// 153 Centers for Medicare & Medicaid Services. domains for which we had proposed a
doi.org/10.1681/ASN.2016010027. (2021). Building an Organizational Response to facility would report an affirmative
152 CMS (2014). Health Disparities Among Aged Health Disparities [Fact Sheet]. U.S. Department of attestation in order for the facility to
ESRD Beneficiaries, 2014. Available at: https:// Health and Human Services. Available at: https://
www.cms.gov/About-CMS/Agency-Information/ www.cms.gov/About-CMS/Agency-Information/ receive points for that domain.
OMH/Downloads/ESRD-Infographic.pdf. OMH/Downloads/Health-Disparities-Guide.pdf. BILLING CODE 4120–01–P
TABLE 13: Proposed Facility Commitment to Health Equity Measure's Five Attestations
Attestation Elements: Select all that apply
(Note: Affirmative attestation of all elements within a domain

would be required for the facility to receive a point for the
domain in the numerator)
Domain 1: Equity is a Strategic Priority
Facility commitment to reducing healthcare disparities is strengthened (A) Our facility strategic plan identifies priority populations
when equity is a key organizational priority. Please attest that your who currently experience health disparities.
facility has a strategic plan for advancing health equity and that it
includes all the following elements. (B) Our facility strategic plan identifies health equity goals and
discrete action steps to achieving these goals.
(C) Our facility strategic plan outlines specific resources which

have been dedicated to achieving our equity goals.
(D) Our facility strategic plan describes our approach for

engaging key stakeholders, such as community-based
organizations.
Domain 2: Data Collection
Collecting valid and reliable demographic and social determinant of (A) Our facility collects demographic information (such as
health data on patients served in a facility is an important step in self-reported race, national origin, primary language, and
identifying and eliminating health disparities. Please attest that your ethnicity data) and/or social determinant of health information
facility engages in the following activities. on the majority of our patients.
(B) Our facility has training for staff in culturally sensitive

collection of demographic and/or social determinant of health
information.
(C) Our facility inputs demographic and/or social determinant

of health information collected from patients into structured,
interoperable data elements using certified EHR technology.
Domain 3: Data Analysis
Effective data analysis can provide insights into which factors (A) Our facility stratifies key performance indicators by
contribute to health disparities and how to respond. Please attest that demographic and/or social determinants of health variables to
your facility engages in the following activities. identify equity gaps and includes this information on facility
performance dashboards.
Domain 4: Quality Improvement
Health disparities are evidence that high-quality care has not been (A) Our facility participates in local, regional, or national
delivered equitably to all patients.* Engagement in quality quality improvement activities focused on reducing health
improvement activities can improve quality of care for all patients. disparities.
Domain 5: Leadership Engagement
Leaders and staff can improve their capacity to address disparities by (A) Our facility senior leadership, including chief executives
demonstrating routine and thorough attention to equity and setting an and the entire facility** board of trustees, annually reviews our
organizational culture of equity. Please attest that your facility engages strategic plan for achieving health equity.
in the following activities.
(B) Our facility senior leadership, including chief executives
and the entire facility board of trustees, annually reviews key
performance indicators stratified by demographic and/or social
factors.
* After publication of the 2022 MUC List, we clarified the language in Domain 4: "Health disparities are evidence
that high quality care has not been delivered equitably to all patients."
** After publication of the 2022 MUC List, we identified that Domain 5 incorrectly referred to the "hospital board
of trustees" instead of the "facility board of trustees," and therefore updated the language in Domain 5 to be more
applicable to the ESRD QIP.
ER06NO23.025</GPH>
BILLING CODE 4120–01–C based questions. For example, a facility e. Review by the Measure Applications
c. Measure Calculation that responds ‘‘yes’’ to all five Partnership
The Facility Commitment to Health attestation-based questions would The Facility Commitment to Health
Equity measure consists of five receive the maximum 10 points (two Equity measure was included as a
attestation-based questions, each points for each of the five ‘‘yes’’ measure under consideration for the
representing a separate domain of responses). A facility that responds ESRD QIP on the publicly available
commitment. For a facility to ‘‘yes’’ to three of the attestation-based ‘‘List of Measures Under Consideration
affirmatively attest ‘‘yes’’ to a domain, questions would receive six points. for December 1, 2022’’ (MUC List), a list
and receive points for that domain, the We proposed that the Facility of measures under consideration for use
facility would need to determine that it Commitment to Health Equity reporting in various Medicare quality
engages in all of the activities that are measure would be added to the programs.154 The CBE-convened
included as elements under the domain. Reporting Measure Domain (88 FR Measure Applications Partnership
A facility that engages in all of the 42493). We noted that technical (MAP) Health Equity Advisory Group
activities for a domain would report an specifications for the measure can be reviewed the MUC List and the Facility
affirmative attestation by answering Commitment to Health Equity measure
found in the ESRD QIP CY 2024
‘‘yes’’ to the attestation-based question (MUC2022–027) in detail on December
Technical Measure Specifications,
for that domain. There is no option for 6–7, 2022.155 The Health Equity
a facility to answer ‘‘yes’’ in response to which are available at: https://
Advisory Group expressed concern that
an attestation-based question for a www.cms.gov/medicare/quality- this is more of a ‘‘checklist’’ measure
domain if the facility engages in some, initiatives-patient-assessment- that may not directly address health
but not all, of the activities included as instruments/esrdqip/061_technical inequities at a systemic level, but the
domain elements, and there is also no specifications. Consistent with case advisory group generally agreed that a
option for a facility to answer ‘‘no’’ in minimums we have adopted for our structural measure such as this one
response to any attestation-based other ESRD QIP reporting measures, we represents progress toward improving
question for a domain. The measure proposed that facilities must have 11 equitable care.156 In addition, on
would be expressed as a fraction, and a qualifying patients and a CCN open date December 8 through 9, 2022, the MAP
facility can score either 0, 2, 4, 6, 8, or before September 1 of the performance Rural Health Advisory Group reviewed
10 for the performance period, period that applies to the program year the 2022 MUC List, and the MAP
depending on the number of domains to in order to be eligible for scoring on the Hospital Workgroup reviewed the 2022
which a facility positively attests. In the Facility Commitment to Health Equity MUC List on December 13 through 14,
proposed rule, we proposed that the reporting measure. 2022.157 The MAP Hospital Workgroup
measure denominator would be ‘‘ten,’’ recognized that reducing health care
with each domain being represented as d. Data Submission and Reporting disparities would represent a substantial
two points out of that total ten points, In the proposed rule, we proposed to benefit to overall quality of care, but
and that the numerator would be require facilities to submit data needed expressed reservations about the
calculated as two points for each ‘‘yes’’ measure’s link to clinical outcomes; the
to calculate the Facility Commitment to
answer the facility reports which are MAP Hospital Workgroup members
Health Equity measure once on an
then summed together (88 FR 42493). voted to conditionally support the
annual basis using CMS’s ESRD Quality
We stated that we chose to award measure for rulemaking pending: (1)
facilities two points for each affirmative Reporting System (EQRS) beginning
endorsement by a consensus-based
response to an attestation-based with PY 2026 (88 FR 42494). We entity (CBE); (2) committing to look at
question so that the maximum number proposed that the deadline for outcomes in the future; (3) providing
of points a facility could receive for the submission would be the end of the more clarity on the measure and
measure is ten, which is the same EQRS December data reporting month supplementing interpretations with
maximum number of points that a for the applicable performance period,
facility can receive on other ESRD QIP which is consistent with current 154 Centers for Medicare & Medicaid Services.
measures. reporting deadlines for other ESRD QIP 2022. List of Measures Under Consideration for
December 1, 2022. We note that the link provided
For example, for Domain 1 (‘‘Facility measures. For example, for the PY 2026 in the CY 2024 ESRD PPS proposed rule has been
commitment to reducing healthcare ESRD QIP, facilities would need to updated, and is now available at: https://
disparities is strengthened when equity report data on the measure by the end mmshub.cms.gov/measure-lifecycle/measure-
is a key organizational priority’’), a of the December data reporting month in implementation/pre-rulemaking/lists-and-reports.
155 Centers for Medicare & Medicaid Services.
facility would evaluate and determine CY 2024. As described in Table 17 of 2023. 2022–2023 MAP Final Recommendations. We
whether its strategic plan satisfies all of the proposed rule (88 FR 42504) and note that the link provided in the CY 2024 ESRD
the elements described in (A) through reproduced in Table 18 of this final rule, PPS proposed rule has been updated, and is now
(D) (see Table 13). If the facility’s plan we proposed performance standards for available at: https://mmshub.cms.gov/measure-
satisfies all four of these elements, the lifecycle/measure-implementation/pre-rulemaking/
the Facility Commitment to Health lists-and-reports.
facility would respond ‘‘yes’’ to the Equity reporting measure. We also 156 Centers for Medicare & Medicaid Services.
attestation-based question for Domain 1 proposed a 12-month performance 2023. 2022–2023 MAP Final Recommendations. We
and receive two (2) points for that period for the measure, and note that we note that the link provided in the CY 2024 ESRD
response. If the facility determined that PPS proposed rule has been updated, and is now
did not receive any comments on this available at: https://mmshub.cms.gov/measure-
its strategic plan satisfies elements (A)

aspect of the measure proposal. We lifecycle/measure-implementation/pre-rulemaking/
and (B) but not (C) and (D), the facility lists-and-reports.
would not be able to respond ‘‘yes’’ to further proposed that facilities would be 157 Centers for Medicare & Medicaid Services.
Domain 1 and would not receive any required to follow the submission and 2023. 2022–2023 MAP Final Recommendations.
points for that domain. reporting requirements for web-based Rural Health Advisory Group. We note that the link
measures for the ESRD QIP posted on provided in the CY 2024 ESRD PPS proposed rule
The numerator is calculated as the has been updated, and is now available at: https://
sum of the points the facility earns for the QualityNet website: https:// mmshub.cms.gov/measure-lifecycle/measure-
responding ‘‘yes’’ to the attestation- qualitynet.cms.gov/esrd/esrdqip. implementation/pre-rulemaking/lists-and-reports.
results; and (4) verifying attestation noted that the measure will help Response: We appreciate the
provided by the accountable entities.158 facilities assess commitment to health commenter’s support and will monitor
Thereafter, the MAP Coordinating equity by focusing on relevant this measure, as we do all ESRD QIP
Committee deliberated on January 24 organizational competencies. One measures, for any unintended or adverse
through 25, 2023 and ultimately voted commenter, emphasizing the outcomes associated with
to conditionally support the Facility importance of strong, diverse, and implementation.
Commitment to Health Equity measure committed leadership in advancing Comment: Several commenters stated
for rulemaking with the same health equity goals at the facility level, that it was unclear how the Facility
conditions.159 stated that the measure would Commitment to Health Equity measure
incentivize facilities to identify and would result in a reduction of social
f. Consensus-Based Entity Endorsement address equity gaps. One commenter inequities. A few commenters expressed
Although section 1881(h)(2)(B)(i) of noted that the measure is a low burden concern that the measure lacks follow-
the Act generally requires that measures first step to address inequity, supports up and does not require facilities to take
specified by the Secretary for the ESRD Meaningful Measures 2.0, and focuses specific action upon identifying health
QIP be endorsed by the entity with a on SMART goals which are the basis for equity gaps. A few commenters
contract under section 1890(a) of the measuring improvement in health expressed concern that, without
Act, section 1881(h)(2)(B)(ii) of the Act outcomes. additional requirements for facilities to
states that in the case of a specified area Response: We thank commenters for make changes based on identified health
or medical topic determined appropriate their support of our proposal to adopt equity gaps, the Facility Commitment to
by the Secretary for which a feasible and the Facility Commitment to Health Health Equity measure may only serve
practical measure has not been endorsed Equity reporting measure. We agree that as a checklist measure rather than
by the entity with a contract under the measure assesses a facility’s incentivizing change at the systemic
section 1890(a) of the Act, the Secretary commitment to health equity and is level. One commenter expressed
may specify a measure that is not so intended to encourage facilities to concern that the Facility Commitment to
endorsed as long as due consideration is understand their own health equity gaps Health Equity measure is not relevant to
given to measures that have been so they can improve patient outcomes. the ESRD QIP because the measure was
endorsed or adopted by a consensus Comment: A few commenters developed for the hospital setting. One
organization identified by the Secretary. expressed support for public reporting commenter expressed concern that the
We reviewed CBE-endorsed measures of the measure. measure would not promote meaningful
and were unable to identify any other Response: We thank the commenters action in patient care because it is not
CBE-endorsed measures on this topic, for their support. clinical.
Comment: A few commenters who Response: We believe this measure is
and therefore we believe the exception
supported the adoption of the Facility an important foundational measure for
in section 1881(h)(2)(B)(ii) of the Act
Commitment to Health Equity measure improving health equity for the facility’s
applies.
also offered suggestions for possible entire patient population, which may
g. Public Display expansion of the measure. A few include patients that have been
In the proposed rule, we proposed to commenters recommended expanding underserved by the healthcare system.
publicly display the facility-specific the scope of the measure to specifically As we discussed in section IV.C.2.a. of
results for the Facility Commitment to ensure that facilities identify and the proposed rule, there is substantial
Health Equity reporting measure on an address equity in access to home research showing differences in care
annual basis through our Care Compare dialysis. One commenter recommended and experiences among underserved
website at: https://www.medicare.gov/ that the measure eventually be populations (88 FR 42489 through
care-compare/. We stated that we expanded to capture a greater depth of 42491). The measure is intended to
anticipate making the first public report information that would provide more encourage facilities to analyze their own
available in January 2026. meaningful data to CMS and patients. data to understand whether there are
We invited public comment on this The commenter also recommended that demographic factors or other social
proposal. The comments we received CMS include health equity requirements drivers of health that may be
and our responses are set forth below. as part of the Conditions for Coverage contributing to the health outcomes
Comment: Several commenters for the Medicare program, which could experienced by their patients so they
expressed support for the Facility potentially be used to require that can develop solutions to improve those
Commitment to Health Equity measure. facilities collect and stratify data on outcomes for all of their patients. We
certain demographic elements. One believe that adopting the measure for
A few of these commenters appreciated
commenter encouraged CMS take dialysis facilities will help improve
the Facility Commitment to Health
actions to further enable nurses to access to care and outcomes for the
Equity measure as a step towards
support health equity efforts, noting ESRD population by making facilities
requiring demonstration of equitable
their critical role in patient engagement more aware of certain potential
policies and practices. One commenter
while balancing administrative burden. opportunities for improvement. We also
158 Centers for Medicare & Medicaid Services.
Response: We thank commenters for believe that a commitment to health
2023. 2022–2023 MAP Final Recommendations. We their suggestions, which we will equity by dialysis facility leadership can
note that the link provided in the CY 2024 ESRD consider as we continue to develop foster organizational competencies
PPS proposed rule has been updated, and is now potential future policies on this topic. aimed at achieving health equity for the
available at: https://mmshub.cms.gov/measure- Comment: One commenter expressed
lifecycle/measure-implementation/pre-rulemaking/
facility’s patients. Although the Facility
lists-and-reports. support for the Facility Commitment to Commitment to Health Equity reporting
159 Centers for Medicare & Medicaid Services. Health Equity measure but measure is not a clinical measure, the
2023. 2022–2023 MAP Final Recommendations. We recommended that CMS ensure that measure could improve facility
note that the link provided in the CY 2024 ESRD there are no unintended consequences, awareness of the tie between its
PPS proposed rule has been updated, and is now
available at: https://mmshub.cms.gov/measure-
such as disincentivizing facilities from structural practices and its patient
lifecycle/measure-implementation/pre-rulemaking/ operating in areas that may have greater outcomes, which we believe will lead to
lists-and-reports. health disparities. improved clinical outcomes for patients.
Comment: Although commenters of the Act the Secretary may specify a year if it cannot affirmatively attest to
appreciated the importance of a measure that is not endorsed by a CBE all five domains. We believe that the
commitment to health equity and as long as due consideration is given to proposed scoring methodology is
expressed support for CMS’s efforts to measures that have been endorsed or consistent with the scoring methodology
address health equity, a few adopted by a consensus organization we have adopted for the MedRec
commenters expressed concern that the identified by the Secretary. We reporting measure, which requires that
Facility Commitment to Health Equity reviewed CBE-endorsed measures and facilities report that medication
measure needs to be developed further were unable to identify any other CBE- reconciliation was performed and
prior to inclusion in the ESRD QIP so endorsed measures on this topic, and documented by an eligible professional
that it is more meaningful to the ESRD therefore, we believe the exception in during the reporting period in order to
population and care setting. One section 1881(h)(2)(B)(ii) of the Act be awarded the maximum number of
commenter requested that CMS engage applies. We believe the Facility points for the measure (83 FR 57009 and
with stakeholders in the ESRD Commitment to Health Equity measure 57011).
community to improve the measure so establishes an important foundation to Comment: One commenter
that it is more applicable to the dialysis prioritize the achievement of health recommended removing the term
facility setting. equity among facilities. ‘‘priority’’ from Domain 1 to avoid
Response: The Facility Commitment Comment: A few commenters implying that there are populations who
to Health Equity measure is a structural expressed concern regarding the are not priorities.
measure that is designed to apply across reporting burden associated with the Response: We agree with the
multiple healthcare settings. The five proposed measure requirements and commenter that a facility’s entire patient
measure domains (that is, equity is a recommended that CMS weigh the population should have access to high
strategic priority, data collection, data potential impact on patient health quality ESRD care. However, we
analysis, quality improvement, and outcomes against this new disagree with commenter that the term
leadership engagement) apply to administrative burden. A few ‘‘priority’’ should be removed, as we
dialysis facilities. Specifically, dialysis commenters stated that certain types of believe the element focuses on
facilities collect data and analyze data facilities, such as rural and small populations that the facility may
for quality improvement purposes. facilities, may lack the resources to identify as having experienced health
Facilities also establish organizational implement this measure and, as a result, disparities at that particular facility. A
plans that define practices and policies could be unfairly penalized. One facility has discretion to identify its own
that impact health equity. We believe commenter stated that compliance with priority populations and develop its
strong and committed leadership from the new measure will require own solutions to support its equity
dialysis facility leadership is essential substantial training and additional staff goals. Therefore, we are finalizing the
and can play a role in advancing equity support. One commenter expressed reference to ‘‘priority populations’’ in
goals for facilities. Although we concern that the reporting requirements Domain 1 as proposed.
appreciate commenters’ desire that the associated with the proposed measure Comment: Several commenters
measure be tailored further to the ESRD would take resources away from patient recommended that CMS update the
population and setting, we believe that care. measure specifications in Domain 2 so
the measure sufficiently addresses a Response: We recognize the that facilities without certified EHR
facility’s leadership and its commitment commenters’ concerns about burden of technology are able to positively attest
to health equity in a way that new measure requirements in the ESRD to all domains, noting that dialysis
encompasses the needs of that QIP and believe that our data facilities are not required to use certified
population and setting. The measure is submission requirements pose minimal EHR technology and may not have it
intended to provide information to burden on facilities given that facilities available. These commenters expressed
facilities on the level of unmet need will have 14 months to report the concern that public reporting of
among their patients by encouraging measure with respect to each measure results for facilities that do not
facilities to identify and address performance period. We believe this positively attest to all domains because
potential health equity gaps. We believe measure reporting timeline will provide they are without access to certified EHR
this measure is an important step facilities with ample time to submit data technology could lead the public to
toward assessing facility leadership in a timely manner. We also believe the misinterpret the results as a lack of
commitment and a fundamental step benefits of this measure outweigh the commitment to health equity. A few
toward closing the gap in equitable care burden of reporting it. commenters recommended that CMS
for the facility’s patients. We will Comment: One commenter requested revise the language to remove the
continue to monitor the measure as it is that facilities receive full credit for reference to certified EHR technology to
implemented to ensure that it is attestation, regardless of whether the provide flexibility regarding the type of
meaningful to the ESRD community. facility negatively or positively attests to data technology used while retaining
Comment: A few commenters each given domain. The commenter the requirement to input the data into
recommended that CMS submit the noted that this would be consistent with structured fields. One commenter
measure to the CBE for review and other reporting measures in the ESRD requested clarification regarding
endorsement to ensure that it is useful QIP measure set, which award points for whether it will accept Electronic Data
and meaningful for the ESRD reporting the data, rather than the Interchange (EDI) in the EQRS for this
population and care setting. results of the reported data. measure.
Response: While we recognize the Response: We believe this measure is Response: We thank commenters for
value of CBE endorsement review, and an important step towards assessing their feedback. Although the majority of
plan to submit this measure for CBE leadership commitment to health equity dialysis facilities use some type of EHR
endorsement in the future, measures of and a fundamental step towards technology, we acknowledge that
health equity are a priority for CMS, and identifying and closing gaps in quality dialysis facilities are not currently
we believe it is important to implement outcomes. We also believe that a facility required to use EHR technology certified
this measure as soon as possible. We should not receive the maximum 10 by the Office of the National
note that under section 1881(h)(2)(B)(ii) points on the measure for a performance Coordinator for Health Information
Technology (ONC) to comply with the in EQRS. In addition, a facility can Response: We thank commenters for
requirements of the ESRD QIP. We agree report an affirmative attestation for a their feedback and are finalizing a
with commenters that the proposed domain as long as it satisfies the modified version of the Domain 5
language in Domain 2 may prevent elements of the domain at any time elements. Whereas the originally
facilities from affirmatively attesting to during the applicable performance proposed language for Domain 5
Domain 2 if they can only affirmatively period. required that facilities attest to
attest to the elements in (A) and (B). Comment: One commenter stated that leadership engagement at the facility
Therefore, we are finalizing a revision to all facilities participating in the ESRD level only, we agree that facilities
the elements of Domain 2 so that Network Program should meet the should be able to attest to leadership
facilities can affirmatively attest to that Domain 4 requirement that facilities engagement under Domain 5 if their
domain if they use EHR technology that engage in quality activities and senior leadership engages in the Domain
is not certified by ONC. This updated recommended that all dialysis facilities 5 elements and that engagement applies
language is provided in Table 14 below receive automatic credit for this domain. to the facility, regardless of whether
and states, ‘‘(C) Our facility inputs Response: We believe it is necessary
those senior leaders operate at only the
demographic and/or social determinant for each dialysis facility to review its
facility or at a larger organization that
of health information collected from health equity practices under each
includes the facility. Accordingly, we
patients into structured, interoperable domain and attest to each domain
separately, including Domain 4. If a are finalizing that the referenced facility
data elements using EHR technology.’’ senior leadership could be, but are not
Although we encourage facilities to use facility participates in quality
improvement activities focused on required to be, the facility’s own chief
certified health IT to promote
reducing health disparities as part of a executives or its board of trustees.
interoperability and health information
exchange across the healthcare system, facility’s participation in an ESRD Regarding commenters’ requests for
we are not requiring dialysis facilities to Network, then a facility may clarification as to whether the measure
use certified EHR technology for affirmatively attest under Domain 4. requirements would apply to each
purposes of reporting this measure. We Comment: A few commenters individual dialysis facility separately, or
note that EHR technology may include observed that the language in Domain 5 whether they would apply to the larger
EDI, and therefore EDI may be accepted does not apply to many individual organization which includes the
as part of the EHR technology dialysis facilities, as they are part of individual dialysis facility, we note that
requirements included under Domain 2. national groups and therefore do not we proposed for the Facility
Comment: One commenter noted the have facility-level CEOs or boards of Commitment to Health Equity reporting
relatively short timeframe for trustees. A few commenters also measure to apply to individual facilities.
implementation and potential for error requested clarification as to whether the For all five measure domains, an
in data collection and reporting due to Facility Commitment to Health Equity individual facility may attest to both
the complexity of the new data measure requirements would apply to facility-level efforts as well as activities
collection and reporting requirements. each individual dialysis facility that are implemented by the individual
One commenter expressed concern separately, or whether they would apply facility as part of a larger organization’s
regarding the element under Domain 3 to the larger organization which policies. For individual facilities that
that the facility have facility includes the individual dialysis facility. are part of larger organizations, we note
performance dashboards to affirmatively One commenter expressed concern that this may include leadership
attest to that domain beginning with PY regarding the potential burden imposed engagement at the larger organizational
2024, noting that such dashboards on small facilities if compliance with level as well as leadership engagement
require thoughtful development to the Facility Commitment to Health at the individual facility level.
ensure that they are appropriately Equity measure would be required at the Specifically, the reporting measure
designed for lower patient volumes and facility level and recommended that would require facilities to review their
account for potential clinically-related small facilities be exempt from Facility
own activities in relation to the five
factors. Commitment to Health Equity reporting
measure domains to identify ways to
Response: We believe that facilities requirements, or that CMS allow such
address disparities within the patient
should have sufficient time to facilities that are part of a larger
population they serve. We believe this
implement any structural processes they organization to use the organization’s
revision will apply more broadly to
need to report the measure. However, to strategic plan to satisfy measure
accommodate the unique organization
the extent a facility may need to requirements. One commenter
structures across facilities.
implement new data collections or expressed concern that facility-level
update its systems to enable it to analysis of disparities may be The elements of the Facility
affirmatively attest to Domain 3 or any insufficient to identify and address gaps Commitment to Health Equity Measure,
other domain, a facility will have until in the dialysis setting as these facilities including the revised language for
two months after the end of each 12- serve more geographically homogenous Domains 2 and 5, are provided in Table
month performance period to submit its populations than other types of 14.
attestations for that performance period healthcare facilities, such as hospitals. BILLING CODE 4120–01–P
TABLE 14: Facility Commitment to Health Equity Measure's Finalized Five Attestations
Attestation Elements: Select all that apply
(Note: Affmnative attestation of all elements within a

domain would be required for the facility to receive a
point for the domain in the numerator)
Domain 1: Equity is a Strategic Priority
Facility commitment to reducing healthcare disparities is (A) Our facility strategic plan identifies priority
strengthened when equity is a key organizational priority. Please populations who currently experience health disparities.
attest that your facility has a strategic plan for advancing health
equity and that it includes all the following elements. (B) Our facility strategic plan identifies health equity
goals and discrete action steps to achieving these goals.
(C) Our facility strategic plan outlines specific resources

which have been dedicated to achieving our equity goals.
(D) Our facility strategic plan describes our approach for

engaging key stakeholders, such as community-based
organizations.
Domain 2: Data Collection
Collecting valid and reliable demographic and social determinant (A) Our facility collects demographic information (such
of health data on patients served in a facility is an important step as self-reported race, national origin, primary language,
in identifying and eliminating health disparities. Please attest that and ethnicity data) and/or social determinant of health
your facility engages in the following activities. information on the majority of our patients.
(B) Our facility has training for staff in culturally

sensitive collection of demographic and/or social
determinant of health information.
(C) Our facility inputs demographic and/or social

determinant of health information collected from patients
into structured, interoperable data elements using EHR
technology.*
Domain 3: Data Analysis
Effective data analysis can provide insights into which factors (A) Our facility stratifies key performance indicators by
contribute to health disparities and how to respond. Please attest demographic and/or social determinants of health
that your facility engages in the following activities. variables to identify equity gaps and includes this
information on facility performance dashboards.
Domain 4: Quality Improvement
Health disparities are evidence that high-quality care has not been (A) Our facility participates in local, regional, or national
delivered equitably to all patients. Engagement in quality quality improvement activities focused on reducing
improvement activities can improve quality of care for all health disparities.
patients.
Domain 5: Leadership Engagement
Leaders and staff can improve their capacity to address (A) Our facility senior leadership, such as, but not limited
disparities by demonstrating routine and thorough attention to to, chief executives and the entire facility board of
equity and setting an organizational culture of equity. Please trustees, annually reviews our strategic plan for achieving
attest that your facility engages in the following activities. health equity.**
(B) Our facility senior leadership, such as, but not limited
to, chief executives and the entire facility board of
trustees, annually reviews key performance indicators
stratified by demographic and/or social factors.
* After consideration of public comments, we are refining the language in Domain 2 to remove the requirement
that EHR technology must be "certified" to affmnatively attest to the elements of that domain.
** After consideration of public comments, we are refining the language in Domain 5 to provide flexibility
regarding the type of leadership that may be engaged in these efforts.
BILLING CODE 4120–01–C Comment: One commenter expressed Commitment to Health Equity measure,
concern regarding the Facility stating that the measure essentially
ER06NO23.026</GPH>
served as a back-door mandate to Reporting Program (86 FR 63875 approved or issued emergency use
require that facilities perform a specific through 63883), the Long-Term Care authorizations (EUAs) for COVID–19
activity and did not provide facilities Hospital Quality Reporting Program (86 vaccines for adults manufactured by
with flexibility to achieve the ultimate FR 45438 through 45446), the Skilled Pfizer-BioNTech,165 Moderna,166 and
goal of the measure. Nursing Facility Quality Reporting Janssen.167 The populations for which
Response: We disagree with the Program (86 FR 42480 through 42489), all three vaccines were authorized at
commenter. We believe this measure is and the Inpatient Rehabilitation Facility that time included individuals 18 years
an important foundation for improving Quality Reporting Program (86 FR 42385 of age and older, and the Pfizer-
health equity in the provision of ESRD through 42396). COVID–19 has BioNTech vaccine was authorized for
care. We believe that each of the continued to spread domestically and ages 12 and older. The FDA issued an
domains provides flexibility for around the world with more than 103.9 approval for the Pfizer-BioNTech
facilities to affirmatively attest without million cases and 1.13 million deaths in vaccine, now marketed as Comirnaty, on
imposing overly narrow or prescriptive the United States as of June 19, 2023.161 August 23, 2021.168 Additionally, the
requirements. Although facilities will be In recognition of the ongoing FDA issued approval for the Moderna
required to affirmatively attest to each of significance and complexity of COVID– vaccine, marketed as Spikevax, on
the elements for a domain to receive 19, the Secretary renewed the PHE on January 31, 2022169 and an EUA for the
points for that domain, a facility has the April 21, 2020, July 23, 2020, October 2, Novavax adjuvanted vaccine on July 13,
discretion to determine what activities 2020, January 7, 2021, April 15, 2021, 2022.170 The FDA also issued EUAs for
will satisfy each element. We encourage July 19, 2021, October 15, 2021, January single booster doses of the then-
facilities to analyze their own data to 14, 2022, April 12, 2022, July 15, 2022, authorized COVID–19 vaccines. As of
improve their awareness of whether October 13, 2022, January 11, 2023, and November 19, 2021,171 172 173 a single
there is a tie between their structural February 9, 2023.162 While the PHE
165 Food and Drug Administration. (December
practices and the outcomes experienced expired on May 11, 2023, HHS has
2020). FDA Takes Key Action in Fight Against
by their patients, with the goal of stated that the public health response to COVID–19 By Issuing Emergency Use Authorization
attaining better outcomes for all of their COVID–19 remains a public health for First COVID–19 Vaccine. Available at: https://
patients. priority with a whole of government www.fda.gov/news-events/press-announcements/
Final Rule Action: After considering approach to combatting the virus, fda-takes-key-action-fight-against-covid-19-issuing-
emergency-use-authorization-first-covid-19.
public comments, we are finalizing the including through vaccination efforts.163 166 Food and Drug Administration. (December
adoption of the Facility Commitment to As we stated in the CY 2023 ESRD 2020). FDA Takes Additional Action in Fight
Health Equity reporting measure with PPS final rule (87 FR 67244) and in our Against COVID–19 By Issuing Emergency Use
language refinements to the elements in Revised Guidance for Staff Vaccination Authorization for Second COVID–19 Vaccine.
Domains 2 and 5 as described in Table Available at: https://www.fda.gov/news-events/
Requirements,164 vaccination is a press-announcements/fda-takes-additional-action-
14 of this final rule, beginning with PY critical part of the nation’s strategy to fight-against-covid-19-issuing-emergency-use-
2026. effectively counter the spread of authorization-second-covid.
167 Food and Drug Administration. (February
3. Modification of the COVID–19 COVID–19. We continue to believe it is
2021). FDA Issues Emergency Use Authorization for
Vaccination Coverage Among important to incentivize and track HCP Third COVID–19 Vaccine. Available at: https://
Healthcare Personnel (HCP) Measure vaccination through quality www.fda.gov/news-events/press-announcements/
Beginning With PY 2026 measurement across care settings, fda-issues-emergency-use-authorization-third-
including dialysis facilities, to protect covid-19-vaccine.
a. Background health care workers, patients, and
168 Food and Drug Administration. (August 2021).
FDA Approves First COVID–19 Vaccine. Available

On January 31, 2020, the Secretary of caregivers, and to help sustain the at: https://www.fda.gov/news-events/press-
the Department of Health and Human ability of HCP in each of these care announcements/fda-approves-first-covid-19-
Services declared a public health settings to continue serving their vaccine.
169 Food and Drug Administration. (January
emergency (PHE) for the United States communities. Prior to the publication of
2022). Coronavirus (COVID–19) Update: FDA Takes
in response to the global outbreak of the CY 2023 ESRD PPS final rule on Key Action by Approving Second COVID–19
SARS–COV–2, a novel (new) November 7, 2022, the FDA had Vaccine. Available at: https://www.fda.gov/news-
coronavirus that causes a disease named events/press-announcements/coronavirus-covid-19-
‘‘coronavirus disease 2019’’ (COVID– 161 CDC. COVID Data Tracker. Accessed June 19, update-fda-takes-key-action-approving-second-
2023. Available at: https://covid.cdc.gov/covid- covid-19-vaccine.
19).160 Subsequently, the COVID–19 data-tracker/#datatracker-home. We note that we 170 Food and Drug Administration. (July 2022).
Vaccination Coverage Among have updated in this final rule the number of cases Coronavirus (COVID–19) Update: FDA Authorizes
Healthcare Personnel (HCP) measure and deaths provided in the proposed rule, which Emergency Use of Novavax COVID–19 Vaccine,
was adopted across multiple quality stated that ‘‘COVID–19 has continued to spread Adjuvanted. Available at: https://www.fda.gov/
domestically and around the world with more than news-events/press-announcements/coronavirus-
reporting programs including the ESRD 103.9 million cases and 1.1 million deaths in the covid-19-update-fda-authorizes-emergency-use-
QIP (87 FR 67244 through 67248), the United States as of March 27, 2023.’’ (88 FR 42494). novavax-covid-19-vaccine-adjuvanted.
Hospital IQR Program (86 FR 45374), 162 U.S. Dept. of Health and Human Services. 171 Food and Drug Administration. (September
the Inpatient Psychiatric Facility Office of the Assistant Secretary for Preparedness 2021). FDA Authorizes Booster Dose of Pfizer-
Quality Reporting Program (86 FR 42633 and Response. (2023). Renewal of Determination BioNTech COVID–19 Vaccine for Certain
that a Public Health Emergency Exists. Available at: Populations. Available at: https://www.fda.gov/
through 42640), the Hospital Outpatient https://aspr.hhs.gov/legal/PHE/Pages/COVID19- news-events/press-announcements/fda-authorizes-
Quality Reporting Program (86 FR 63824 9Feb2023.aspx. booster-dose-pfizer-biontech-covid-19-vaccine-
through 63833), the PPS-Exempt Cancer 163 U.S. Dept. of Health and Human Services. Fact certain-populations.
Hospital Quality Reporting Program (86 Sheet: COVID–19 Public Health Emergency 172 Food and Drug Administration. (October
Transition Roadmap. February 9, 2023. Available at: 2021). Coronavirus (COVID–19) Update: FDA Takes
FR 45428 through 45434), the https://www.hhs.gov/about/news/2023/02/09/fact- Additional Actions on the Use of a Booster Dose for
Ambulatory Surgical Center Quality sheet-covid-19-public-health-emergency-transition- COVID–19 Vaccines. Available at: https://
roadmap.html. www.fda.gov/news-events/press-announcements/
160 U.S. Dept of Health and Human Services, 164 Centers for Medicare & Medicaid Services. coronavirus-covid-19-update-fda-takes-additional-
Office of the Assistant Secretary for Preparedness Revised Guidance for Staff Vaccination actions-use-booster-dose-covid-19-vaccines.
and Response. (2020). Determination that a Public Requirements QSO–23–02–ALL. October 26, 2022. 173 Food and Drug Administration. (November
Health Emergency Exists. Available at: https:// Available at: https://www.cms.gov/files/document/ 2021). Coronavirus (COVID–19) Update: FDA
aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx. qs0-23-02-all.pdf. Expands Eligibility for COVID–19 Vaccine Boosters.
booster dose of each COVID–19 vaccine and 93 percent effective against As SARS–COV–2 persists and
was authorized for all eligible hospitalization for COVID–19, evolves, our COVID–19 vaccination
individuals 18 years of age and older. respectively, over 6 months for adults strategy must remain responsive. When
EUAs were subsequently issued for a over age 18 without we finalized adoption of the COVID–19
second booster dose of the Pfizer- immunocompromising conditions.177 Vaccination Coverage Among HCP
BioNTech and Moderna vaccines in During a SARS–COV–2 surge in the measure in the CY 2023 ESRD PPS final
certain populations in in March 2022.174 spring and summer of 2021, 92 percent rule, we stated that HCP should be
FDA first authorized the use of a booster of COVID–19 hospitalizations and 91 counted as vaccinated if they received
dose of bivalent or ‘‘updated’’ COVID– percent of COVID–19-associated deaths COVID–19 vaccination any time from
19 vaccines from Pfizer-BioNTech and were reported among persons not fully when it first became available in
Moderna in August 2022.175 Since the vaccinated.178 Real-world studies of December 2020 (87 FR 67247). We noted
publication of the CY 2024 ESRD PPS population-level vaccine effectiveness that a completed vaccination course,
proposed rule, the 2023–2024 updated indicated similarly high rates of defined for purposes of the measure as
Pfizer-BioNTech, Moderna, and effectiveness in preventing SARS–COV– the primary vaccination series, may
Novavax COVID–19 vaccines were 2 infection among frontline workers in require one or more doses depending on
recommended by CDC for use in the multiple industries, with a 90 percent the specific vaccine used, and that the
United States.176 The 2023–2024 effectiveness in preventing symptomatic NHSN application automatically
updated COVID–19 vaccine more calculates the total value for ‘‘Any
and asymptomatic infection from
closely targets the XBB lineage of the completed COVID–19 vaccine series.’’
December 2020 through August 2021.179
Omicron variant and could restore We also stated that, as vaccination
Vaccines have also been highly effective
protection against severe COVID–19 that protocols continue to evolve, we would
in real-world conditions preventing
may have decreased over time. continue to work with the CDC to
We stated in the CY 2023 ESRD PPS COVID–19 in HCP with up to 96 percent
effectiveness for fully vaccinated HCP, update relevant measure specifications
final rule that HCP are at risk of carrying as necessary. Since we finalized the
COVID–19 infection to patients, including those at risk for severe
infection and those in racial and ethnic COVID–19 Vaccination Coverage
experiencing illness or death themselves Among HCP measure in the CY 2023
as a result of contracting COVID–19, and groups disproportionately affected by
COVID–19.180 In the presence of high ESRD PPS final rule, new variants of
transmitting COVID–19 to their families, SARS–COV–2 have emerged around the
friends, and the general public (87 FR community prevalence of COVID–19,
residents of nursing homes with low world and within the United States.
67244). While the impact of COVID–19 Specifically, the Omicron variant (and
vaccines on asymptomatic infection and staff vaccination coverage had higher
rates of COVID–19 cases and COVID–19 its related subvariants) is listed as a
transmission is not yet fully known, variant of concern by the CDC because
there is now robust data available on related deaths than those among
it spreads more easily than earlier
COVID–19 vaccine effectiveness across residents of nursing homes with high
variants.182 Vaccine manufacturers
multiple populations against staff vaccination coverage.181 Overall,
initially responded to the Omicron
symptomatic infection, hospitalization, data demonstrate that COVID–19
variant by developing bivalent COVID–
and death. Two-dose COVID–19 vaccines are effective and prevent
19 vaccines, which included a
vaccines from Pfizer-BioNTech and severe disease, including hospitalization
component of the original virus strain to
Moderna were found to be 88 percent and death.
provide broad protection against
177 CDC. (September 24, 2021). Morbidity and
COVID–19 and a component of the
Available at: https://www.fda.gov/news-events/ Omicron variant to provide better
press-announcements/coronavirus-covid-19- Mortality Weekly Report (MMWR). Comparative
update-fda-expands-eligibility-covid-19-vaccine- Effectiveness of Moderna, Pfizer-BioNTech, and protection against COVID–19 caused by
boosters. Janssen (Johnson & Johnson) Vaccines in Preventing the Omicron variant.183 These booster
174 Food and Drug Administration. (March 2022). COVID–19 Hospitalizations Among Adults Without doses of the bivalent COVID–19
Coronavirus (COVID–19) Update: FDA Authorizes Immunocompromising Conditions—United States,
March–August 2021. Available at: https://cdc.gov/
vaccines were shown to increase
Second Booster Dose of Two COVID–19 Vaccines
for Older and Immunocompromised Individuals. mmwr/volumes/70/wr/mm7038e1.htm?s_ immune response to SARS–COV–2
Available at: https://www.fda.gov/news-events/ cid=mm7038e1_w. variants, including Omicron,
press-announcements/coronavirus-covid-19- 178 CDC. (September 10, 2021). Morbidity and
particularly in individuals who are
update-fda-authorizes-second-booster-dose-two- Mortality Weekly Report (MMWR). Monitoring more than 6 months removed from
covid-19-vaccines-older-and. Incidence of COVID–19 Cases, Hospitalizations, and
175 Food and Drug Administration. (August 2022). Deaths, by Vaccination Status—13 U.S. receipt of their primary series.184 We
Coronavirus (COVID–19) Update: FDA Authorizes Jurisdictions, April 4–July 17, 2021. Available at: noted in the proposed rule that the FDA
Moderna, Pfizer-BioNTech Bivalent COVID–19 https://www.cdc.gov/mmwr/volumes/70/wr/ issued EUAs for booster doses of two
Vaccines for Use as a Booster Dose. Available at: mm7037e1.htm. bivalent COVID–19 vaccines, one from
179 CDC. (August 27, 2021). Morbidity and
https://www.fda.gov/news-events/press- Pfizer-BioNTech185 and one from
announcements/coronavirus-covid-19-update-fda- Mortality Weekly Report (MMWR). Effectiveness of
authorizes-moderna-pfizer-biontech-bivalent-covid- COVID–19 Vaccines in Preventing SARS–COV–2
182 Food and Drug Administration. (August 2021).
19-vaccines-use. We note that, as of September 12, Infection Among Frontline Workers Before and
2023, the bivalent COVID–19 vaccines are no longer During B.1.617.2 (Delta) Variant Predominance— Variants of the Virus. Available at: https://
FDA authorized. FDA. (September 11, 2023). FDA Eight U.S. Locations, December 2020–August 2021. www.cdc.gov/coronavirus/2019-ncov/variants/
Takes Action on Updated mRNA COVID–19 Available at: https://www.cdc.gov/mmwr/volumes/ index.html.
Vaccines to Better Protect Against Currently 70/wr/mm7034e4.htm. 183 Food and Drug Administration. (November
Circulating Variants. Available at: https:// 180 Pilishivi, T. et al. (December 2022). 2022). COVID–19 Bivalent Vaccine Boosters.
www.fda.gov/news-events/press-announcements/ Effectiveness of mRNA Covid–19 Vaccine among 184 Oster Y et al. (May 2022). The effect of a third
fda-takes-action-updated-mrna-covid-19-vaccines- U.S. Health Care Personnel. New England Journal BNT162b2 vaccine on breakthrough infections in
better-protect-against-currently-circulating. The of Medicine. 2021 Dec 16;385(25):e90. Available health care workers: a cohort analysis. Clin
bivalent COVID–19 vaccines have been replaced online at: https://pubmed.ncbi.nlm.nih.gov/ Microbiol Infect. 2022 May;28(5):735.e1–735.e3.
with the updated 2023–2024 (XBB-variant) COVID– 34551224/. Available online at: https://pubmed.ncbi.nlm.
19 vaccines. 181 McGarry BE et al. (January 2022). Nursing nih.gov/35143997/.
176 CDC. (October 4, 2023). Stay Up to Date with Home Staff Vaccination and Covid-19 Outcomes. 185 Food and Drug Administration. (November
COVID–19 Vaccines. Available at: https:// New England Journal of Medicine. 2022 Jan 2022). Pfizer-BioNTech COVID–19 Vaccines.
www.cdc.gov/coronavirus/2019-ncov/vaccines/stay- 27;386(4):397–398. Available online at: https:// Available at: https://www.fda.gov/emergency-
up-to-date.html. pubmed.ncbi.nlm.nih.gov/34879189/. Continued
Moderna,186 and strongly encouraged rates of updated vaccinations, it is During review, the Health Equity
anyone who is eligible to consider important to modify the COVID–19 Advisory Group highlighted the
receiving a booster dose with a bivalent Vaccination Coverage Among HCP importance of COVID–19 measures and
COVID–19 vaccine to provide better measure to reflect recent updates that questioned whether the measure
protection against currently circulating explicitly specify for HCP to receive excludes individuals with
variants.187 Since the publication of the primary series and updated vaccine contraindications to FDA authorized or
CY 2024 ESRD PPS proposed rule, an doses in a timely manner. As the approved COVID–19 vaccines, and
updated 2023–2024 formulation of COVID–19 pandemic persists, we whether the measure will be stratified
COVID–19 vaccine has been approved continue to believe that monitoring and by demographic factors. The measure
that more closely targets the XBB surveillance is important and provides developer confirmed that HCP with
lineage of the Omicron variant and patients, beneficiaries, and their contraindications to the vaccines are
could restore protection against severe caregivers with information to support excluded from the measure
COVID–19 that may have decreased informed decision making. In the CY denominator, but the measure would
over time.188 Updated COVID–19 2024 ESRD PPS proposed rule, we not be stratified since the data are
vaccine doses are associated with a proposed to modify the COVID–19 submitted at an aggregate rather than an
greater reduction in infections among Vaccination Coverage Among HCP individual level. The Rural Health
HCP and their patients relative to those measure to replace the term ‘‘complete Advisory Group expressed concerns
who only received primary series vaccination course’’ with the term ‘‘up about data collection burden, citing that
vaccination,189 190 with a rate of to date’’ in the HCP vaccination collection is performed manually and
breakthrough infections among HCP definition (88 FR 42496). We also that small rural facilities may not have
who received only a two-dose regimen proposed to update the numerator to employee health software.193 The
of 21.4 percent compared to a rate of 0.7 specify the time frames within which an measure developer acknowledged the
percent among boosted HCP.191 Data HCP is considered up to date with challenge of getting adequate
from the existing COVID–19 recommended COVID–19 vaccines, documentation and emphasized the goal
Vaccination Coverage Among HCP including updated vaccine doses, to ensure the measure does not present
measure demonstrate clinically beginning with PY 2026. As we stated a burden on the provider. The developer
significant variation in booster dose in the CY 2023 ESRD PPS final rule (87 also noted that the model used for this
vaccination rates across facilities. FR 67245), the COVID–19 Vaccination measure is based on the Influenza
We believe that vaccination remains Coverage Among HCP measure is a Vaccination Coverage Among HCP
the most effective means to prevent the process measure that assesses HCP measure (CBE #0431), and it intends to
worst consequences of COVID–19, vaccination coverage rates. Unlike utilize a similar approach to the
including severe illness, hospitalization, outcome measures, process measures do modified COVID–19 Vaccination
and death. Given the availability of not assess a particular outcome. Coverage Among HCP measure if the
vaccine efficacy data, EUAs and COVID–19 vaccination strategy becomes
Biologics License Application approvals b. Overview of Updated Measure seasonal. The revised measure received
issued by the FDA for updated 2023– The COVID–19 Vaccination Coverage conditional support for rulemaking from
2024 formulations of the vaccine, the Among HCP measure is a process both the MAP workgroups pending
continued presence of SARS–COV–2 in measure developed by the CDC to track testing indicating the measure is reliable
the United States, and variance among COVID–19 vaccination coverage among and valid, and endorsement by the
HCP in settings such as dialysis consensus-based entity (CBE).194 The
preparedness-and-response/coronavirus-disease-
facilities, and the measure is reported MAP noted that the previous version of
2019-covid-19/pfizer-biontech-covid-19-vaccines. the measure received endorsement from
186 Food and Drug Administration. (November via the CDC’s NHSN.
2022). Moderna COVID–19 Vaccines. Available at: We refer readers to the CY 2023 ESRD the CBE (CBE #3636) 195 and that the
https://www.fda.gov/emergency-preparedness-and- PPS final rule (87 FR 67245 through CDC intends to submit the updated
response/coronavirus-disease-2019-covid-19/
67246) for more information on the measure for endorsement.
moderna-covid-19-vaccines.
187 Food and Drug Administration. (August 2022). initial review of the measure by the (1) Measure Specifications
Coronavirus (COVID–19) Update: FDA Authorizes Measure Applications Partnership
This reporting measure includes at
Moderna, Pfizer-BioNTech Bivalent COVID–19 (MAP). We included an updated version
Vaccines for Use as a Booster Dose. Available at: least one week of data collection a
of the measure on the Measures Under month for each of the three months in
https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-fda- Consideration (MUC) list for the 2022–
authorizes-moderna-pfizer-biontech-bivalent-covid- 2023 pre-rulemaking cycle for now available at: https://mmshub.cms.gov/sites/
19-vaccines-use. consideration by the MAP. In December default/files/map-preliminary-recommendations-
188 CDC. (October 4, 2023). Stay Up to Date with
2022, the MAP’s Hospital Workgroup 2022-2023.xlsx.
COVID–19 Vaccines. Available at: https://
www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-
discussed the modified measure. The 193 Centers for Medicare & Medicaid Services.
MAP 2022–2023 Final Recommendations. We note

up-to-date.html. Hospital Workgroup stated that the that the link provided in the CY 2024 ESRD PPS
189 Prasad N et al. (May 2022). Effectiveness of a revision of the current measure captures proposed rule has been updated, and is now
COVID–19 Additional Primary or Booster Vaccine up-to-date vaccination information in available at: https://mmshub.cms.gov/measure-
Dose in Preventing SARS-CoV–2 Infection Among accordance with CDC recommendations lifecycle/measure-implementation/pre-rulemaking/
Nursing Home Residents During Widespread lists-and-reports.
Circulation of the Omicron Variant—United States, updated since its initial development. 194 In previous years, we referred to the
February 14–March 27, 2022. Morbidity and Additionally, the Hospital Workgroup consensus-based entity by corporate name. We have
Mortality Weekly Report (MMWR). 2022 May appreciated that the respecified updated this language to refer to the consensus-
6;71(18):633–637. Available online at: https:// proposed measure of the target based entity more generally.
pubmed.ncbi.nlm.nih.gov/35511708/. 195 We note that the reference provided in the CY
190 Oster Y et al. (May 2022). The effect of a third population is broader and simplified
2024 ESRD PPS proposed rule has been updated,
BNT162b2 vaccine on breakthrough infections in from seven categories of HCP to four.192 and is now as follows: Centers for Medicare &
health care workers: a cohort analysis. Clin Medicaid Services. Measure Specifications for
Microbiol Infect. 2022 May;28(5):735.e1–735.e3. 192 Centers for Medicare & Medicaid Services. Hospital Workgroup for the 2022 MUC List.
Available online at: https://pubmed.ncbi.nlm. MAP 2022–2023 Preliminary Analysis Worksheet. Available at: https://mmshub.cms.gov/sites/default/
nih.gov/35143997/. 2022. We note that the link provided in the CY 2024 files/map-hospital-measure-specifications-manual-
191 Ibid. ESRD PPS proposed rule has been updated, and is 2022.pdf.
a quarter. The denominator is the recommended COVID–19 vaccines. UpToDateGuidance-508.pdf for more
number of HCP eligible to work in the Facilities would refer to the definition details on the measure specifications.
facility for at least one day during the of up to date as of the first day of the We noted in the proposed rule that
reporting period, excluding persons applicable reporting quarter, which can the updated COVID–19 Vaccination
with contraindications to COVID–19 be found at https://www.cdc.gov/nhsn/ Coverage Among HCP measure would
vaccination that are described by the pdfs/hps/covidvax/UpToDateGuidance- remain a reporting measure. The
CDC. Facilities report the following four 508.pdf. In the proposed rule, we updates to measure weighting for PY
categories of HCP to NHSN: provided the example that HCP would 2026 and PY 2027 are discussed further
1. Employees: includes all persons be considered up to date during the in sections IV.C.6 and IV.D.7 of this
who receive a direct paycheck from the applicable performance period for the final rule.
reporting facility (that is, on the ESRD QIP if they met one of the (2) Consensus-Based Entity
facility’s payroll), regardless of clinical following criteria: Endorsement
responsibility or patient contact. 1. Individuals who received an
2. Licensed independent practitioners updated bivalent 198 booster dose, or The current version of the measure in
(LIPs): This includes physicians (MD, 2a. Individuals who received their last the ESRD QIP received CBE
DO), advanced practice nurses, and booster dose less than 2 months ago, or endorsement (CBE #3636, ‘‘Quarterly
physician assistants only who are 2b. Individuals who completed their Reporting of COVID–19 Vaccination
affiliated with the reporting facility but primary series 199 less than 2 months Coverage among Healthcare Personnel’’)
are not directly employed by it (that is, ago. on July 26, 2022. Although section
they do not receive a direct paycheck We note that since publication of the 1881(h)(2)(B)(i) of the Act generally
from the reporting facility), regardless of proposed rule, the CDC’s definition for requires that measures specified by the
clinical responsibility or patient contact. up to date vaccination has evolved. HCP Secretary for the ESRD QIP be endorsed
Post-residency fellows are also included would be considered up to date during by the entity with a contract under
in this category if they are not on the the applicable performance period for section 1890(a) of the Act, section
facility’s payroll. the ESRD QIP if they met the following 1881(h)(2)(B)(ii) of the Act states that in
3. Adult students/trainees and criteria: the case of a specified area or medical
volunteers: This includes all medical, 1. Individuals who received an topic determined appropriate by the
nursing, or other health professional updated 200 vaccine dose. Secretary for which a feasible and
students, interns, medical residents, and We refer readers to https:// practical measure has not been endorsed
volunteers aged 18 or over who are www.cdc.gov/nhsn/pdfs/hps/covidvax/ by the entity with a contract under
affiliated with the healthcare facility, section 1890(a) of the Act, the Secretary
but are not directly employed by it (that 198 In the CY 2024 ESRD PPS proposed rule, we
may specify a measure that is not so
is, they do not receive a direct paycheck noted that the updated (bivalent) Moderna and endorsed as long as due consideration is
from the facility), regardless of clinical Pfizer-BioNTech boosters targeted the most recent given to measures that have been
Omicron subvariants. The updated (bivalent) endorsed or adopted by a consensus
responsibility or patient contact. boosters were recommended by the CDC on
4. Other contract personnel: Contract September 2, 2022. As of the CY 2024 ESRD PPS
organization identified by the Secretary.
personnel are defined as persons proposed rule, we also noted that the original, In developing the CY 2024 ESRD PPS
providing care, treatment, or services at monovalent mRNA vaccines are no longer proposed rule, we reviewed CBE-
authorized as a booster dose for people ages 12 endorsed measures and were unable to
the facility through a contract who do years and older. Since the proposed rule was
not fall into any of the previously published, the bivalent COVID–19 vaccines are no
identify any other CBE-endorsed
discussed denominator categories. This longer FDA authorized. FDA. (September 11, 2023). measures on this topic; therefore, we
also includes vendors providing care, FDA Takes Action on Updated mRNA COVID–19 believe the exception for non-CBE-
Vaccines to Better Protect Against Currently endorsed measures applies. The CDC, as
treatment, or services at the facility who Circulating Variants. Available at: https://
may or may not be paid through a www.fda.gov/news-events/press-announcements/
the measure developer, is pursuing
contract. Facilities are required to enter fda-takes-action-updated-mrna-covid-19-vaccines- endorsement for the modified version of
data on other contract personnel for better-protect-against-currently-circulating. The the measure.
bivalent COVID–19 vaccines have been replaced
submission in the NHSN application, with the updated 2023–2024 (XBB-variant) COVID– c. Data Submission and Reporting
but data for this category are not 19 vaccines.
We refer readers to the CY 2023 ESRD
included in the COVID–19 Vaccination 199 Although in the CY 2024 ESRD PPS proposed
PPS final rule (87 FR 67246) for
Coverage Among HCP measure.196 The rule we indicated that completing a primary series
means receiving a two-dose series of a COVID–19 information on data submission and
denominator excludes denominator- vaccine or a single dose of Janssen/J&J COVID–19 reporting for the measure. We did not
eligible individuals with vaccine (88 FR 42496), we note that the Janssen/J&J propose any changes to the existing data
contraindications as defined by the COVID–19 vaccine is no longer being used in the
submission requirements.
CDC.197 There are no changes to the United States. For further information, please see
CDC. (2023). Janssen (Johnson & Johnson) COVID– We invited public comment on this
denominator exclusions. 19 Vaccine. Available at: https://www.cdc.gov/ proposal. The comments we received
The numerator of the modified vaccines/covid-19/info-by-product/janssen/ and our responses are set forth below.
measure is the cumulative number of index.html. Comment: Several commenters
200 The 2023–2024 updated Pfizer-BioNTech,
HCP in the denominator population expressed support for the proposal to
Moderna, and Novavax COVID–19 vaccines were
who are considered up to date with recommended by CDC for use in the United States. modify the COVID–19 Vaccination
The 2023–2024 updated COVID–19 vaccine more Coverage Among HCP reporting
196 For more details on the reporting of other
closely targets the XBB lineage of the Omicron measure. Several of these commenters
contract personnel, we refer readers to the NHSN variant and could restore protection against severe
COVID–19 Vaccination Protocol, Weekly COVID–19 COVID–19 that may have decreased over time.
noted that vaccination is a critical tool
Vaccination Module for Healthcare Personnel Individuals are also considered up to date if they to protect the health of HCP and
available at: https://www.cdc.gov/nhsn/pdfs/hps/ received a bivalent vaccine or a Novavax vaccine patients. One commenter expressed
covidvax/protocol-hcp-508.pdf. within the last 2 months, or if they received a support for the proposed modification,
197 CDC. (2022). Contraindications and Novavax vaccine after completing a primary series.
precautions. Available at: https://www.cdc.gov/ For further details, please see: https://www.cdc.gov/
noting that continued tracking of up-to-
vaccines/covid-19/clinical-considerations/interim- coronavirus/2019-ncov/vaccines/stay-up-to- date vaccination status is important to
considerations-us.html#contraindications. date.html. help facilities prepare for infectious
threats. One commenter expressed patient and provider burden (83 FR submitted the modified measure to the
support for the proposed update 56995 through 56996). CBE for endorsement and it is currently
because it will align the requirements Comment: One commenter also under review.
between agencies. supported aligning reporting with that
Comment: A few commenters
Response: We thank the commenters for Influenza Vaccination Coverage
expressed concern regarding the
for their support. We agree that Among HCP if the COVID–19
vaccination plays a critical part of vaccination strategy becomes seasonal. COVID–19 Vaccination Coverage
HHS’s strategy to effectively counter the One commenter recommended requiring Among HCP reporting measure, stating
spread of COVID–19. We continue to annual reporting at the end of the that facilities should not be held
believe it is important to incentivize and respiratory season. responsible for a HCP’s decision to get
track rates of vaccination among HCP Response: We thank the commenter vaccinated because those decisions are
through quality measurement across for this suggestion. As we stated in the beyond the facility’s control.
care settings, including the dialysis CY 2024 ESRD PPS proposed rule (88 Response: We understand the
facility setting, to protect healthcare FR 42497), the model used for this commenters’ concern that there are
workers, patients, and caregivers, and to measure is based on the Influenza many factors outside of a facility’s
help sustain the ability of HCP in each Vaccination Coverage Among HCP control that could affect vaccination
of these care settings to continue serving measure (CBE #0431), and the measure coverage among a facility’s HCP;
their communities. developer intends to utilize a similar however, we believe that all facilities
Comment: Several commenters approach with respect to the modified face such concerns and that public
expressed concern regarding the version of the measure if the COVID–19 reporting of these data can help patients
reporting burden associated with the vaccination strategy becomes seasonal.
and their caregivers identify which
proposed changes, recommending that For that reason, we may consider
facilities have better vaccination
CMS weigh the potential impact on aligning reporting for the COVID–19
patient health outcomes against Vaccination Coverage Among HCP coverage among their HCP. We wish to
potential administrative burden for reporting measure with the Influenza emphasize that the measure does not
facilities. A few commenters Vaccination Coverage Among HCP require that HCP actually receive the
recommended that the measure exclude measure in the future. We continue to COVID–19 vaccine. The COVID–19
staff who are not directly employed by monitor COVID–19 as part of our public Vaccination Coverage Among HCP
the facility to reduce tracking burden. health response and will consider measure only requires reporting of
One commenter noted that the reporting information we collect to inform any vaccination rates.
burden associated with the measure was potential action that may address Comment: A few commenters
disproportionate to its weight as part of seasonality in future rulemaking. recommended removing the COVID–19
the ESRD QIP measure set. Comment: One commenter Vaccination Coverage Among HCP
Response: We acknowledge recommended that the measure get CBE reporting measure from the ESRD QIP
commenters’ concerns regarding review and endorsement prior to measure set. One commenter believed
reporting burden associated with the inclusion in the ESRD QIP. that the measure should be removed
specifications of this measure Response: The current version of the
because the PHE has ended and CMS
specifically around the definition of measure received CBE endorsement
(CBE #3636, ‘‘Quarterly Reporting of has also ended staff vaccination
HCP. We note that given the highly
COVID–19 Vaccination Coverage among requirements related to COVID–19
infectious nature of the virus that causes
COVID–19, we believe it is important to Healthcare Personnel’’) on July 26, 2022. vaccination. One commenter stated that
encourage all eligible personnel within As we stated in the CY 2024 ESRD PPS the measure should be removed because
the facility, regardless of patient contact, proposed rule (88 FR 42497 through it is outside the scope of the ESRD QIP.
role, or employment type, to receive the 42498), in the case of a specified area or Response: As commenters noted, the
COVID–19 vaccination to prevent medical topic determined appropriate PHE for COVID–19 expired on May 11,
outbreaks within the facility which may by the Secretary for which a feasible and 2023.201 However, the expiration of the
affect resource availability and have a practical measure has not been endorsed PHE for COVID–19 has no bearing on
negative impact on patient access to by the entity with a contract under this measure because vaccination
care. We note that the proposed updates section 1890(a) of the Act, the Secretary continues to be an essential tool in
to the COVID–19 Vaccination Coverage may specify a measure that is not so preventing COVID–19 transmission, and
Among HCP reporting measure do not endorsed as long as due consideration is we believe that monitoring and
include a change to the definition of given to measures that have been surveillance of vaccination rates
HCP, and that facilities have been endorsed or adopted by a consensus through measure performance is
reporting the COVID–19 Vaccination organization identified by the Secretary. important and provides patients,
Coverage among HCP measure since For this CY 2024 ESRD PPS rule cycle,
beneficiaries, and their caregivers with
January 1, 2022. With regard to the we reviewed CBE-endorsed measures.
information to support informed
commenter’s concern about the While the current, CBE-endorsed
decision making.
proportionality of the measure’s version of the measure is available, the
reporting burden to its measure weight modified version of the measure more Final Rule Action: After considering
within the ESRD QIP, we note that the completely accounts for the availability public comments, we are finalizing our
burden associated with a given measure of booster and bivalent doses which proposal to modify the COVID–19
is only one of several factors taken into were not yet developed when the Vaccination Coverage Among
consideration when determining the current version of the measure was Healthcare Personnel (HCP) Measure.
weight of the measure within the ESRD adopted. Having given due
QIP. We take numerous factors into consideration to CBE-endorsed 201 U.S. Dept. of Health and Human Services. Fact
account when determining appropriate measures, we believe the exception for Sheet: COVID–19 Public Health Emergency
Transition Roadmap. February 9, 2023. Available at:
domain and measure weights, including non-CBE-endorsed measures under https://www.hhs.gov/about/news/2023/02/09/fact-
clinical evidence, opportunity for section 1881(h)(2)(B)(ii) of the Act sheet-covid-19-public-health-emergency-transition-
improvement, clinical significance, and applies. The measure steward, CDC, has roadmap.html.
4. Conversion of the Clinical Depression Depression Screening and Follow-Up report the reason for either not
Screening and Follow-Up Reporting reporting measure, facilities are required documenting that they screened for
Measure to a Clinical Measure to report one of six conditions with clinical depression, or why they do not
Beginning With the PY 2026 ESRD QIP respect to each eligible patient, and we possess documentation of a follow-up
In the CY 2015 ESRD PPS final rule, calculate the measure rate for the plan. We believe that the performance
we finalized the adoption of the Clinical facility as the percentage of eligible score calculation methodology changes
Depression Screening and Follow-Up patients for which the facility reports we proposed to the Clinical Depression
reporting measure, beginning in PY one of those six conditions. The six Screening and Follow-Up reporting
2018 (79 FR 66200 through 66203). As conditions are as follows: measure would have a greater impact on
we noted in the CY 2015 ESRD PPS • Screening for clinical depression is fostering care coordination among
documented as being positive, and a providers and improving patient
final rule, depression is a highly
follow-up plan is documented. outcomes by incentivizing the
prevalent condition in patients with
• Screening for clinical depression is documentation of depression screenings
ESRD, which impacts many aspects of a
documented as positive, and a follow- and follow-up plans, or alternatively
patient’s life and is associated with
up plan is not documented, and the requiring facilities to provide a reason
higher rates of mortality in the ESRD
facility possesses documentation stating why no screening or follow-up plan was
population. Adoption of a measure that
the patient is not eligible. documented. This measure update
assesses whether facilities screen • Screening for clinical depression is would also align with our efforts under
patients for depression, and develop documented as positive, the facility the Meaningful Measures Framework,
follow-up plans when appropriate, was possesses no documentation of a follow- which identifies high-priority areas for
and still is an opportunity to improve up plan, and no reason is given. quality measurement and improvement
the health of patients with ESRD. • Screening for clinical depression is to assess core issues most critical to
In the CY 2024 ESRD PPS proposed documented as negative, and a follow- high-quality healthcare and improving
rule, we proposed to convert the up plan is not required. patient outcomes.205 In 2021, we
Clinical Depression Screening and • Screening for clinical depression is launched Meaningful Measures 2.0 to
Follow-Up reporting measure to a not documented, but the facility promote innovation and modernization
clinical measure and to adopt a new possesses documentation stating the of all aspects of quality, and to address
methodology for scoring that measure as patient is not eligible. a wide variety of settings, stakeholders,
a clinical measure (88 FR 42498). We • Screening for clinical depression is and measure requirements.206 We are
stated our belief that this proposed not documented, and no reason is given. addressing healthcare priorities and
update would help to ensure that the In the proposed rule, we did not gaps with Meaningful Measures 2.0 by
measure is scored in a manner that more propose to revise any of these leveraging quality measures to increase
closely aligns with current clinical conditions. However, we proposed that efficiency, reduce burden, and close
guidelines for depression screening and we would convert the measure to a gaps in care. In the CY 2024 ESRD PPS
follow-up because it

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FEDERAL REGISTER

OFFICE OF THE FEDERAL REGISTER

the last issue received.

Contents Federal Register

Monday, November 6, 2023

Agricultural Marketing Service Defense Department

Federal Aviation Administration Food and Drug Administration

Phosphate Fertilizers from the Russian Federation, NOTICES

International Trade Commission Pipeline and Hazardous Materials Safety Administration

Transportation Statistics Bureau Part III

U.S. International Development Finance Corporation

CFR PARTS AFFECTED IN THIS ISSUE

Rules and Regulations Federal Register

Monday, November 6, 2023

Government and Indian Tribes.

remaining nine comments, AMS

all individuals without regard based on

TABLE 1 TO PARAGRAPH (a)—CATTLE AND CALVES 1

1. Alabama ............................................................................................................................................................... 1,285 1

3. Arkansas .............................................................................................................................................................. 1,733 2

2 https://www.nass.usda.gov/AgCensus/ 4 https://data.census.gov/profile/424470__Meat_ 5 https://data.census.gov/profile/311612_-Meat_

index.php. and_meat_product_merchant_wholesalers?g= and_meat_product_merchant_wholesalers?g=

TABLE 1 TO PARAGRAPH (a)—CATTLE AND CALVES 1—Continued

6. Georgia ................................................................................................................................................................ 1,077 1

Total ........................................................................................................................................................... 1,316

Total ........................................................................................................................................................... 658 1

Total ........................................................................................................................................................... 707 1

Total ........................................................................................................................................................... 5,632 6

§ 1260.315 [Amended] No. FAA–2023–1410; or in person at 211(524)–7RR, and that these

11, 2023. products. Except for minor editorial

(c) Applicability (4) This AD does not require compliance

each oil analysis.

TABLE 1 TO PARAGRAPH (g)(1)—OIL ANALYSIS FOR ALL AFFECTED ENGINES

TABLE 2 TO PARAGRAPH (g)(5)—REPLACEMENT FOR GROUPS 3 AND 4 ENGINES

analysis required by paragraph (g)(2) of this

This AD also requires EASA AD government and the States, or on the

SUPPLEMENTARY INFORMATION: in the NPRM. None of the changes will

new or more restrictive airworthiness Regulatory Findings (d) Subject

(2) This AD affects AD 2010–26–05, accordance with, European Union Aviation

Branch, FAA; or EASA; or Dassault 39–22576; AD 2023–21–04]

distribution of power and Accordingly, under the authority

PART 39—AIRWORTHINESS (j) Alternative Methods of Compliance DEPARTMENT OF TRANSPORTATION

ibr-locations or email fr.inspection@nara.gov.

Action Labor cost Parts cost Cost per product

(g)(2) of the SNPRM to correspond with

Costs of Compliance The FAA estimates the following

Figure 1 to Paragraph (g)(l)- Compliance Times for CT7-5A2, CT7-5A3, CT7-9B,

CT7-9Bl, and CT7-9B2 Model Engines

Inspection Type Initial inspection of the Repeat inspection interval

Cleaning and During first propeller During every propeller

Figure 2 to Paragraph (g)(2)-Compliance Times for CT7-7A, CT7-7Al, CT7-9C,

and CT7-9C3 Model Engines

Inspection Type Initial inspection of the Repeat inspection interval

Cleaning and During the first propeller During every propeller

this AD, whichever occurs

Figure 3 to Paragraph (h)(l) - CT7-5/-7 Inspection Threshold and Interval

Inspection / Initial Repetitive Inspection / Reference

*** FOR CT7-5

*** FOR CT7-7

Figure 4 to Paragraph (h)(2) - CT7-9 Inspection Threshold and Interval

Inspection / Initial Repetitive Inspection / Reference

*** FOR CT7-9C/9C3