Addendum

To: File
From: Rosanna Beltre M.P.H Digitally signed by Rosanna Beltre -S
Deputy Director Date: 2021.05.11 11:10:22 -04'00'
Division of Regulatory Project Management
Office of Science
Through: Matthew Holman PhD
Director Digitally signed by Matthew R. Holman -S
Office of Science Date: 2021.05.11 14:01:20 -04'00'
Subject: Addendum to the Office of Science (OS) Premarket Application Review Prioritization Plan

Background

On August 31, 2020, OS signed the Premarket Application Review Prioritization Plan, which outlined CTP’s approach to
prioritize the expected increase in premarket applications due to the Deeming rule. As anticipated OS has receive a
significant increase in the number of premarket applications for all three premarket pathways. This addendum seeks
to outline additional applications selected for subsequent scientific review cycles for Substantial Equivalence (SE)
Reports, Exemption from Substantial Equivalence (EX REQ) Requests, and Premarket Tobacco Product Applications
(PMTAs).

Randomization and Submission Selection Process

The August 31, 2020 Prioritization memo identified that CTP senior leadership prioritized the top ENDS market share
manufactures in PMTA queue one. 1 The memo also identified the dates selected (April 1 - August 31, 2020) for early
randomization for the remaining PMTA, EX REQ, and SE scientific review slots for Wave I for PMTA, and Waves 1 and 2
for the EX REQ and SE programs. After early randomization waves of scientific review kicked-off OS staff waited for all
applications received and submitted as of September 9, 2020 to be processed by the Document Control Center (DCC).
Once processing was completed OS staff used the previously established processed outline below:
x Pull an iTrac report for all applications submitted as of April 1, 2020 through September 9, 2020 that had not
yet moved into scientific review for each individual premarket program.
x Exported the iTrac report to Excel and used the submitter organization data to identify the list of
manufacturers; if a manufacturer appeared more than once due to spelling differences those duplicates were
removed.
x Amendments submitted that were not a response to a deficiency letter were also removed, for example
administrative updates which may include points of contact changes.
x For SE and EX REQ only if there were multiple product categories, only one category was selected within a
review team. The other categories remained in queue for a later time.
x For SE only, removed applications that were solely for a Product Quantity Change SE Report. 2
x The randomization function in Excel was used to randomly generate a series of numbers, each manufacturer
was a assigned a randomly generated number. This number was used to sort the list and set review ranking

1See OS Briefing memos dated April 23 rd, 2020 and May 5 th, 2020 for additional options considered and OS recommendations.
2A Product Quantity Change SE Report is for a tobacco product that is to be marketed in a different quantity but is otherwise identical to a
predicate tobacco product (either a tobacco product that was commercially marketed as of February 15, 2007 or to a tobacco product that has
been found by FDA to be SE.)
Memorandum: Addendum to OS Premarket Application Review Prioritization Plan (continued) Page 2

order.
x For SE and EX REQ, if the total number of products exceeded the maximum review capacity for an applicant,
the randomization function was used to set the review order by submission and product. 3
o If multiple submissions were received, first randomization was performed by submission
o Second, if more than maximum review capacity was present within a submission, or across
submissions, randomization was performed by product

Because the iTrac report does not contain application status, some of these ranked manufacturers will fall off the ranked
list due to receiving a Refuse to Accept or Refuse to File action (PMTA only). In those circumstance, OS staff moved to
the next ranked applicant for processing and scientific review selection.

PMTA Submission Selection

Subsequent Scientific reviews kick-offs included PMTAs for all marketed deemed and statutorily regulated tobacco
products that were not top market share (Queue 2). This means that all subsequent scientific review cycles for new
application were exclusively from Queue 2 as no additional PMTAs for deemed and statutorily regulated tobacco
products not marketed or ENDS products that include a device that incorporates age-verification technology (Queue 3)
were identified. Appendix A identifies all PMTAs processed through Acceptance and Filing selected for scientific review
for PMTA wave two and three.

EX and SE Submission Selection Process

Unlike PMTAs, there is a single EX REQ and SE queue. Similar to PMTA OS Staff pulled an iTrac report for all remaining
submissions received between April 1, 2020 through September 9, 2020. The randomization process outlined above was
utilized to select manufacturers to enter scientific review for both EX REQ and SE. Appendix B list all applicants that were
successfully processed for Acceptance that were selected for scientific and respective waves.

3 Each review team has a maximum bundle of 15 tobacco products.

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