40879
Rules and Regulations
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Parts 318 and 319
[Docket No. 02–019–2]
Phytosanitary Treatments; Location of
Treatment Schedules and Other
Requirements; Correction
AGENCY: Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule; correction.
SUMMARY: We are correcting errors in the
amendatory instructions in our final
rule that removed the Plant Protection
and Quarantine Treatment Manual from
the list of materials incorporated by
reference and added treatment
schedules and related requirements
from that document to our
phytosanitary treatments regulations.
The final rule was effective and
published in the Federal Register on
June 7, 2005 (70 FR 33263–33326,
Docket No. 02–019–1).
DATES: Effective July 15, 2005.
FOR FURTHER INFORMATION CONTACT: Ms.
Meredith C. Jones, Regulatory
Coordination Specialist, PPQ, APHIS,
4700 River Road Unit 141, Riverdale,
MD 20737–1236; (301) 734–7467.
SUPPLEMENTARY INFORMATION: In a final
rule effective and published in the
Federal Register on June 7, 2005 (70 FR
33263–33326, Docket No. 02–019–1), we
amended the plant health regulations by
adding to 7 CFR part 305 treatment
schedules and related requirements that
had appeared in the Plant Protection
and Quarantine Treatment Manual and
by removing the Plant Protection and
Quarantine Treatment Manual from the
list of materials is incorporated by
reference into the regulations.
In the final rule, it was our intention
to amend the regulations by, among
other things:
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• In § 318.58–4a, redesignating
paragraphs (b) through (d) as paragraphs
(a) through (c), respectively;
• Revising the newly redesignated
paragraph § 318.58–4a(a);
• In § 319.37–6(d)(2), redesignating
footnote 9 as footnote 8 and revising the
newly redesignated footnote 8;
• Amending § 319.56–2h; and
• In § 319.56–2h(d), removing the
words ‘‘the Plant Protection and
Quarantine Treatment Manual’’ and
adding the words ‘‘part 305 of this
chapter’’ in their place.
However, our amendatory
instructions that were intended to
accomplish these changes were either
absent or erroneous. This document
corrects these errors.
■ In FR Doc. 05–9387, published on June
7, 2004 (70 FR 33263–33326), make the
following corrections:
§ 318.58–4a [Corrected]
■ 1. On page 33324, in the amendments
to 7 CFR part 318, in instruction 34 for
§ 318.58–4a, instruction b. is corrected to NRC staff has become aware of changes
read as follows, and a new instruction d. in the Technical Specifications (TS)
is added to read as follows:
■ b. By redesignating paragraphs (b)
through (d) as paragraphs (a) through (c), rule is published in the proposed rule
respectively.
■ d. By revising newly redesignated
paragraph (a) to read as set forth below.
§ 319.37–6 [Corrected]
■ 2. On page 33324, in the third column,
in § 319.37–6, footnote number 3 is
corrected to read footnote number 8.
§ 319.56–2h [Corrected]
■ 3. On page 33325, in the amendments
to 7 CFR part 319, instruction 58 for
§ 319.56–2h is corrected to read as
follows, and in instruction 58,
instruction c. is corrected to read as
follows:
■ 58. Section 319.56–2h is amended as
follows:
■ c. In paragraph (d), by removing the
words ‘‘the Plant Protection and
Quarantine Treatment Manual’’ and
adding the words ‘‘part 305 of this
chapter’’ in their place.
Done in Washington, DC, this 7th day of proposed rule on May 25, 2005 (70 FR
July, 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–13853 Filed 7–14–05; 8:45 am]
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Federal Register
Vol. 70, No. 135
Friday, July 15, 2005
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 72
RIN 3150–AH72
List of Approved Spent Fuel Storage
Casks: Standardized NUHOMS–24P,
–52B, –61BT, –32PT, –24PHB, and
–24PTH Revision; Withdrawal of Direct
Final Rule
AGENCY: Nuclear Regulatory
Commission.
ACTION: Direct final rule; withdrawal.
SUMMARY: The Nuclear Regulatory
Commission (NRC) is withdrawing a
direct final rule that would have revised
the NUHOMS–24P, –52B, –61BT,
–32PT, –24PHB, and –24PTH cask
system listing within the list of
approved spent fuel storage casks to
include Amendment No. 8 to the
Certificate of Compliance (CoC). The
NRC is taking this action because the
associated with this CoC. A notice
withdrawing the companion proposed
section of this Federal Register.
FOR FURTHER INFORMATION CONTACT:
Jayne M. McCausland, Office of Nuclear
Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555, telephone (301)
415–6219 (e-mail: jmm2@nrc.gov).
SUPPLEMENTARY INFORMATION: On May
25, 2005 (70 FR 29931), the NRC
published in the Federal Register a
direct final rule amending its
regulations in 10 CFR 72.214 to revise
the Standardized NUHOMS System
listing within the ‘‘List of Approved
Spent Fuel Storage Casks’’ to include
Amendment No. 8 to the CoC.
Amendment No. 8 modifies the present
cask system by adding a new spent fuel
storage and transfer system, designated
the NUHOMS–24PTH System. The
direct final rule was to become effective
on August 8, 2005. The NRC also
concurrently published a companion
30015).
The NRC has become aware of
changes in the TS associated with this
CoC; therefore, the NRC is withdrawing
the direct final rule. The NRC will
publish a direct final rule, and its
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 40880 Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Rules and Regulations
companion proposed rule, after the
needed revisions to the TS are made.
Dated at Rockville, Maryland, this 6th day
of July, 2005.
For the Nuclear Regulatory Commission.
Martin J. Virgilio,
Acting Executive Director for Operations.
[FR Doc. 05–13933 Filed 7–14–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 2005N–0201]
Change of Name and Address;
Technical Amendment
AGENCY: Food and Drug Administration,
HHS.
Final rule; technical
ACTION:
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to reflect a change in the
name and address for the Association of
Official Analytical Chemists
International (AOAC). This action is
editorial in nature and is intended to
improve the accuracy of the agency’s
regulations.
DATES: This rule is effective July 15,
2005.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy and
Planning (HF–27), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: This
document amends FDA’s regulations to
reflect the name and address change of
AOAC by removing the outdated name
and address wherever it appears and by
adding the new name and address in its
place in 21 CFR parts 2, 10, 101, 102,
106, 114, 130, 131, 133, 135, 136, 137,
139, 145, 146, 150, 155, 156, 160, 161,
163, 164, 166, 168, 169, 172, 173, 176,
177, 178, 184, 189, 211, 226, 520, and
573.
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(5 U.S.C. 553). Notice and public
procedure are unnecessary because FDA
is merely correcting nonsubstantive
errors.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR chapter I is
amended as follows:
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Chapter I [Nomenclature changes]
■ 1. Parts 2, 101, 102, 106, 114, 130, 131,
133, 135, 136, 137, 139, 145, 146, 150,
155, 156, 160, 161, 163, 164, 166, 168,
169, 172, 173, 176, 177, 178, 184, 189,
211, 226, 520, and 573 are amended by
removing the text set forth below
wherever it appears and adding new text
in its place as follows:
■ A. Remove:
‘‘Association of Official Analytical
Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg,
MD 20877–2504’’, or
‘‘Association of Official Analytical
Chemists International, 481 North
Frederic Ave., suite 500, Gaithersburg,
MD 20877–2504’’, or
‘‘Association of Official Analytical
Chemists International, 481 North
Frederick Ave., suite 500,
Gaithersbuerg, MD 20877–2504’’, or
‘‘Association of Official Analytical
Chemists International, 481 North
Frederick Ave., Suite 500, Gaithersburg,
MD 20877–2504’’, or
‘‘Association of Official Analytical
Chemists International, 481 North
Frederick Ave, suite 500, Gaithersburg,
MD 20877–2504’’, or
‘‘AOAC INTERNATIONAL, 481 North
Frederick Ave., suite 500, Gaithersburg,
MD 20877–2504’’, or
‘‘Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201–3301’’, or
‘‘Association of Official Analytical
Chemists, P.O. Box 540, Benjamin
Franklin Station, Washington, DC
20044’’.
■ B. Add:
‘‘Association of Official Analytical
Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg,
MD 20877’’.
PARTS 2, 10, 101, and 211 [AMENDED]
■ 2. In addition to the amendments set
forth in the previous paragraph, in 21
CFR parts 2, 10, 101, and 211 add the
word ‘‘International’’ after the words
‘‘Association of Official Analytical
Chemists’’ in the following places:
a. Section 2.19 where it appears in the
first sentence, after the words ‘‘to utilize
the methods of analysis of the’’;
b. Section 10.95(d)(8)(v);
c. Section 101.70(f);
d. Section 101.81(c)(2)(ii)(B)(2) in the
first sentence;
e. Appendix A to part 101; and
f. Section 211.194(a)(2) in the third
sentence.
Dated: July 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–13898 Filed 7–14–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Lincomycin and Spectinomycin
Soluble Powder
AGENCY: Food and Drug Administration,
HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Cross Vetpharm Group Ltd. The
ANADA provides for the oral use of
lincomycin and spectinomycin soluble
powder to create a solution
administered in the drinking water of
chickens as an aid in the control of
airsacculitis.
DATES: This rule is effective July 15,
2005.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, e-
mail: daniel.benz@fda.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–380 that provides for use
of SPECLINX–50 (spectinomycin
dihydrochloride pentahydrate and
lincomycin hydrochloride
monohydrate) Water Soluble Powder to
create a solution administered in the
drinking water of chickens. This
solution acts as an aid in the control of
airsacculitis caused by either
Mycoplasma synoviae or M.
gallisepticum susceptible to lincomycin-
spectinomycin and complicated chronic
respiratory disease (air sac infection)
caused by Escherichia coli and M.
gallisepticum susceptible to lincomycin-
spectinomycin. Cross Vetpharm Group
Ltd.’s SPECLINX–50, Water Soluble
Powder is approved as a generic copy of
Pharmacia & Upjohn Co.’s L-S 50 Water
Soluble Powder, approved under NADA
046–109. The ANADA is approved as of
June 7, 2005, and the regulations are
amended in 21 CFR 520.1265 to reflect
the approval. The basis of approval is
discussed in the freedom of information
summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
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