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33386 Federal Register / Vol. 72, No.

116 / Monday, June 18, 2007 / Rules and Regulations

235); Sec. 2455, Pub. L. 103–355, 108 Stat. regulations to update a telephone Congressional Review Act
3327 (31 U.S.C. 6101 note); 5 U.S.C. 301; number for the Office of Information
U.S.C. 6101 note. In accordance with the Congressional
Services and an NRC Web site location. Review Act, the NRC has determined
§ 12.75 [Removed] This document is necessary to inform that this action is not a major rule and
the public of these changes to the NRC’s has verified this determination with the
■ 3. Remove § 12.75. regulations. Office of Information and Regulatory
§ 12.913 [Removed] EFFECTIVE DATE: June 18, 2007. Affairs of OMB.
FOR FURTHER INFORMATION CONTACT:
Because these amendments deal
■ 4. Remove § 12.913.
Thomas Smith, Office of Information solely with agency organization and
PART 42—GOVERNMENTWIDE Services, Nuclear Regulatory procedure, and represent minor
DEBARMENT AND SUSPENSION Commission, Washington, DC 20555– administrative matters which do not
(NONPROCUREMENT) [REMOVED] 0001, 301–415–7043, e-mail raise any significant policy or regulatory
TES@nrc.gov. issue, the NRC has determined that
■ 5. Remove part 42. notice and comment is not necessary
SUPPLEMENTARY INFORMATION: The NRC under the Administrative Procedure Act
PART 43—GOVERNMENTWIDE is revising its regulations to update a (APA), 5 U.S.C. 553(b)(3)(A), and that in
REQUIREMENTS FOR DRUG-FREE telephone number for the Office of any event there is good cause for
WORKPLACE (FINANCIAL Information Services and an NRC Web dispensing with such notice and
ASSISTANCE) site location. The Web site contains comment under 5 U.S.C. 553(d)(3)(B). In
detailed guidance on making electronic addition, the NRC has determined that
■ 6. The authority for part 43 continues submissions to the agency. This good cause exists for making the rule
to read as follows: guidance discusses, among other topics, immediately effective upon publication,
Authority: E.O. 12549 (3 CFR, 1986 Comp., the formats the NRC can accept, the use as provided for under 5 U.S.C. 553(d)(3),
p. 189); E.O. 12689 (3 CFR, 1989 Comp., p. of electronic signatures, and the because the amendments represent
235); Sec. 2455, Pub. L. 103–355, 108 Stat. treatment of nonpublic information. minor administrative matters which do
3327 (31 U.S.C. 6101 note); 5 U.S.C. 301; 31 not raise any significant policy or
U.S.C. Environmental Impact: Categorical
Exclusion regulatory issue and do not impose any
§ 43.510 [Amended] significant regulatory requirement upon
The NRC has determined that this any regulated entity or person.
■ 7. Amend § 43.510(c) by removing the final rule is the type of action described ■ For the reasons set out in the
citation ‘‘43 CFR Part 42’’ and adding ‘‘2 in categorical exclusion 10 CFR
CFR Part 180’’ in its place. preamble and under the authority of the
51.22(c)(1) and (2). Therefore, neither an Atomic Energy Act of 1954, as amended,
§ 43.630 [Amended] environmental impact statement nor an the Energy Reorganization Act of 1974,
environmental assessment has been as amended, and 5 U.S.C. 552 and 553,
■ 8. Amend § 43.630 by removing the prepared for this final rule.
phrase ‘‘the common rule, Government- 42 U.S.C. 2201, as amended, and 42
wide Debarment and Suspension Paperwork Reduction Act Statement U.S.C. 5841, the NRC is adopting the
(Nonprocurement), that implements following amendments to 10 CFR
This final rule does not contain a new Chapter I to read as follows:
Executive Order 12549 and Executive or amended information collection
Order 12689’’ and adding the citation ‘‘2 requirement subject to the Paperwork 10 CFR Chapter I [Amended]
CFR part 180’’ in its place. Reduction Act of 1995 (44 U.S.C. 3501 ■ 1. In Chapter I revise all references to
§ 43.670 [Amended] et seq.). ‘‘(301) 415–6030’’ to read ‘‘(301) 415–
0439’’.
■ 9. Amend § 43.670 by removing the Public Protection Notification
■ 2. In Chapter I revise all references to
phrase ‘‘the common rule, Government- If a means used to impose an ‘‘http://www.nrc.gov/site-help/eie.html’’
wide Debarment and Suspension information collection does not display to read ‘‘http://www.nrc.gov/site-help/
(Nonprocurement), that implements a currently valid OMB control number, e-submittals.html’’.
Executive Order 12549 and Executive the NRC may not conduct or sponsor,
Order 12689’’ and adding the citation ‘‘2 Dated at Rockville, Maryland, this 4th day
and a person is not required to respond of June, 2007.
CFR part 180’’ in its place. to, the information collection. For the Nuclear Regulatory Commission.
[FR Doc. 07–2949 Filed 6–15–07; 8:45 am]
Regulatory Analysis Luis A. Reyes,
BILLING CODE 4310–RF–M
A regulatory analysis has not been Executive Director for Operations.
prepared for this final rule. This final [FR Doc. E7–11708 Filed 6–15–07; 8:45 am]

NUCLEAR REGULATORY rule makes only minor administrative BILLING CODE 7590–01–P

COMMISSION changes to the regulations that reference


a telephone number and an NRC Web
10 CFR Chapter I site, and imposes no burden on DEPARTMENT OF HEALTH AND
licensees. Therefore, a regulatory HUMAN SERVICES
RIN 3150–AI18 analysis is not necessary.
Food and Drug Administration
Administrative Changes Backfit Analysis
AGENCY: Nuclear Regulatory The NRC has determined that these 21 CFR Part 558
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Commission. amendments do not involve any


New Animal Drugs for Use in Animal
ACTION: Final rule. provisions which would impose backfits
Feeds; Lincomycin
as defined in 10 CFR 50.109(a)(1);
SUMMARY: The Nuclear Regulatory therefore a backfit analysis is not AGENCY: Food and Drug Administration,
Commission (NRC) is amending its necessary. HHS.

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Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Rules and Regulations 33387

ACTION: Final rule. PART 558—NEW ANIMAL DRUGS FOR DEPARTMENT OF THE TREASURY
USE IN ANIMAL FEEDS
SUMMARY: The Food and Drug Internal Revenue Service
Administration (FDA) is amending the ■ 1. The authority citation for 21 CFR
animal drug regulations to reflect part 558 continues to read as follows: 26 CFR Part 1
approval of a supplemental new animal
Authority: 21 U.S.C. 360b, 371. [TD 9331]
drug application (NADA) filed by
Pharmacia & Upjohn Co., a Div. of RIN 1545–BG46
■ 2. In § 558.325, add paragraph (c) and
Pfizer, Inc. The supplemental NADA in the table in paragraphs (d)(2)(i)
provides for the use of lincomycin in Deemed IRAs in Governmental Plans/
through (d)(2)(iv), in the ‘‘Limitations’’ Qualified Nonbank Trustee Rules
feed of swine weighing greater than 250 column, remove ‘‘Not to be fed to swine
pounds and for the addition of a AGENCY: Internal Revenue Service (IRS),
that weigh more than 250 lb.’’ wherever
reproductive cautionary statement to Treasury.
it occurs to read as follows:
labeling. ACTION: Final regulations and removal of
DATES: This rule is effective June 18, § 558.325 Lincomycin. temporary regulations.
2007. * * * * *
SUMMARY: This document contains final
FOR FURTHER INFORMATION CONTACT: Joan (c) Special considerations—(1) regulations under section 408 of the
C. Gotthardt, Center for Veterinary Labeling of Type A medicated articles Internal Revenue Code. The final
Medicine (HFV–130), Food and Drug and Type B and Type C medicated feeds regulations provide special rules for a
Administration, 7500 Standish Pl., containing lincomycin shall bear the governmental unit which seeks to
Rockville, MD 20855, 301–827–7571, e- following directions: ‘‘CAUTION: Do qualify as a nonbank trustee of a
mail: joan.gotthardt@fda.hhs.gov. not allow rabbits, hamsters, guinea pigs, deemed IRA that is part of its qualified
SUPPLEMENTARY INFORMATION: Pharmacia horses, or ruminants access to feeds employer plan. These final regulations
& Upjohn Co., a Div. of Pfizer, Inc., 235 containing lincomycin. Ingestion by affect only such governmental units.
E. 42d St., New York, NY 10017, filed these species may result in severe DATES: Effective Date: June 18, 2007.
a supplement to NADA 97–505 that gastrointestinal effects.’’ Applicability Date: For dates of
provides for use of LINCOMIX 20 (2) Labeling of Type A medicated applicability, see § 1.408–2(e)(8)(iv).
(lincomycin hydrochloride) and articles and Type B and Type C FOR FURTHER INFORMATION CONTACT:
LINCOMIX 50 Feed Medications in medicated feeds containing lincomycin Linda L. Conway, 202–622–6090, or
single-ingredient Type B and Type C intended for use in swine shall bear the Cathy A. Vohs, 202–622–6090 (not toll-
medicated feeds for swine weighing following directions: ‘‘CAUTION: free numbers).
greater than 250 pounds and for the Occasionally, swine fed lincomycin may SUPPLEMENTARY INFORMATION:
addition of a reproductive caution within the first 2 days after the onset of
statement to labeling. The supplemental Background
treatment develop diarrhea and/or
application is approved as of May 23, swelling of the anus. On rare occasions, This document contains final
2007, and the regulations are amended some pigs may show reddening of the amendments to the Income Tax
in 21 CFR 558.325 to reflect the skin and irritable behavior. These Regulations (26 CFR Part 1) under
approval. section 408 of the Internal Revenue
conditions have been self-correcting
Approval of this supplemental NADA Code of 1986 (Code). On July 22, 2004,
within 5 to 8 days without
did not require review of additional temporary and proposed regulations
discontinuing the lincomycin under section 408 were issued. A notice
safety or effectiveness data or treatment.’’
information. Therefore, a freedom of of proposed rulemaking (REG–101447–
information summary is not required. (3) Labeling of Type A medicated 04) was published in the Federal
The agency has determined under 21 articles and single-ingredient Type B Register (69 FR 43786). The text of the
CFR 25.33(a)(1) that this action is of a and Type C medicated feeds containing temporary regulations also served as the
type that does not individually or lincomycin intended for use in swine text of the proposed regulations. The
cumulatively have a significant effect on shall bear the following directions: text of temporary § 1.408–2(e)(8) was
the human environment. Therefore, (i) No. 000009: ‘‘CAUTION: The published in the same issue of the
neither an environmental assessment effects of lincomycin on swine Federal Register (69 FR 43735). The RIN
nor an environmental impact statement published in connection with that
reproductive performance, pregnancy,
is required. notice of proposed rulemaking was
and lactation have not been determined.
1545–BD07. However, due to technical
This rule does not meet the definition Not for use in swine intended for difficulties that RIN is no longer valid
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because breeding when lincomycin is fed at 20 and the RIN number of these final
it is a rule of ‘‘particular applicability.’’ grams per ton of complete feed.’’ regulations is 1545–BG46. No comments
Therefore, it is not subject to the
(ii) Nos. 043733 and 051311: were received regarding the proposed
congressional review requirements in 5
‘‘CAUTION: Not to be fed to swine that regulations.
U.S.C. 801–808.
weigh more than 250 lb.’’
Explanation of Provisions and
List of Subjects in 21 CFR Part 558 * * * * * Summary of Comments
Animal drugs, Animal feeds. Dated: June 8, 2007. These final regulations amend
■ Therefore, under the Federal Food, Steven D. Vaughn, § 1.408–2(e) of the regulations to
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Drug, and Cosmetic Act and under Director, Office of New Animal Drug provide that a governmental unit may
authority delegated to the Commissioner Evaluation, Center for Veterinary Medicine. serve as the trustee of any deemed IRA
of Food and Drugs and redelegated to [FR Doc. E7–11611 Filed 6–15–07; 8:45 am] established by that governmental unit as
the Center for Veterinary Medicine, 21 BILLING CODE 4160–01–S
part of its qualified employer plan if
CFR part 558 is amended as follows: that governmental unit establishes to the

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