New Animal Drugs for Use in Animal Feeds; Lincomycin, 33386-33387 [E7-11611]

Download as PDF 33386 Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Rules and Regulations 235); Sec. 2455, Pub. L. 103–355, 108 Stat. 3327 (31 U.S.C. 6101 note); 5 U.S.C. 301; U.S.C. 6101 note. § 12.75 I [Removed] 3. Remove § 12.75. § 12.913 I regulations to update a telephone number for the Office of Information Services and an NRC Web site location. This document is necessary to inform the public of these changes to the NRC’s regulations. EFFECTIVE DATE: June 18, 2007. FOR FURTHER INFORMATION CONTACT: Thomas Smith, Office of Information Services, Nuclear Regulatory Commission, Washington, DC 20555– 0001, 301–415–7043, e-mail TES@nrc.gov. [Removed] 4. Remove § 12.913. PART 42—GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) [REMOVED] I 5. Remove part 42. 6. The authority for part 43 continues to read as follows: I Authority: E.O. 12549 (3 CFR, 1986 Comp., p. 189); E.O. 12689 (3 CFR, 1989 Comp., p. 235); Sec. 2455, Pub. L. 103–355, 108 Stat. 3327 (31 U.S.C. 6101 note); 5 U.S.C. 301; 31 U.S.C. § 43.510 [Amended] 7. Amend § 43.510(c) by removing the citation ‘‘43 CFR Part 42’’ and adding ‘‘2 CFR Part 180’’ in its place. I § 43.630 [Amended] 8. Amend § 43.630 by removing the phrase ‘‘the common rule, Governmentwide Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive Order 12689’’ and adding the citation ‘‘2 CFR part 180’’ in its place. I § 43.670 The NRC is revising its regulations to update a telephone number for the Office of Information Services and an NRC Web site location. The Web site contains detailed guidance on making electronic submissions to the agency. This guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information. SUPPLEMENTARY INFORMATION: PART 43—GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) [Amended] Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(1) and (2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule. Paperwork Reduction Act Statement This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 9. Amend § 43.670 by removing the phrase ‘‘the common rule, Governmentwide Debarment and Suspension (Nonprocurement), that implements Executive Order 12549 and Executive Order 12689’’ and adding the citation ‘‘2 CFR part 180’’ in its place. Public Protection Notification [FR Doc. 07–2949 Filed 6–15–07; 8:45 am] Regulatory Analysis I BILLING CODE 4310–RF–M If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection. RIN 3150–AI18 A regulatory analysis has not been prepared for this final rule. This final rule makes only minor administrative changes to the regulations that reference a telephone number and an NRC Web site, and imposes no burden on licensees. Therefore, a regulatory analysis is not necessary. Administrative Changes Backfit Analysis Nuclear Regulatory Commission. ACTION: Final rule. The NRC has determined that these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(1); therefore a backfit analysis is not necessary. NUCLEAR REGULATORY COMMISSION pwalker on PROD1PC71 with RULES 10 CFR Chapter I AGENCY: SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its VerDate Aug<31>2005 17:03 Jun 15, 2007 Jkt 211001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 Congressional Review Act In accordance with the Congressional Review Act, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB. Because these amendments deal solely with agency organization and procedure, and represent minor administrative matters which do not raise any significant policy or regulatory issue, the NRC has determined that notice and comment is not necessary under the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(A), and that in any event there is good cause for dispensing with such notice and comment under 5 U.S.C. 553(d)(3)(B). In addition, the NRC has determined that good cause exists for making the rule immediately effective upon publication, as provided for under 5 U.S.C. 553(d)(3), because the amendments represent minor administrative matters which do not raise any significant policy or regulatory issue and do not impose any significant regulatory requirement upon any regulated entity or person. I For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, 42 U.S.C. 2201, as amended, and 42 U.S.C. 5841, the NRC is adopting the following amendments to 10 CFR Chapter I to read as follows: 10 CFR Chapter I [Amended] I 1. In Chapter I revise all references to ‘‘(301) 415–6030’’ to read ‘‘(301) 415– 0439’’. I 2. In Chapter I revise all references to ‘‘https://www.nrc.gov/site-help/eie.html’’ to read ‘‘https://www.nrc.gov/site-help/ e-submittals.html’’. Dated at Rockville, Maryland, this 4th day of June, 2007. For the Nuclear Regulatory Commission. Luis A. Reyes, Executive Director for Operations. [FR Doc. E7–11708 Filed 6–15–07; 8:45 am] BILLING CODE 7590–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Lincomycin AGENCY: Food and Drug Administration, HHS. E:\FR\FM\18JNR1.SGM 18JNR1 Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Rules and Regulations ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for the use of lincomycin in feed of swine weighing greater than 250 pounds and for the addition of a reproductive cautionary statement to labeling. DATES: FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. Pharmacia & Upjohn Co., a Div. of Pfizer, Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 97–505 that provides for use of LINCOMIX 20 (lincomycin hydrochloride) and LINCOMIX 50 Feed Medications in single-ingredient Type B and Type C medicated feeds for swine weighing greater than 250 pounds and for the addition of a reproductive caution statement to labeling. The supplemental application is approved as of May 23, 2007, and the regulations are amended in 21 CFR 558.325 to reflect the approval. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows: I 2. In § 558.325, add paragraph (c) and in the table in paragraphs (d)(2)(i) through (d)(2)(iv), in the ‘‘Limitations’’ column, remove ‘‘Not to be fed to swine that weigh more than 250 lb.’’ wherever it occurs to read as follows: I Lincomycin. 17:03 Jun 15, 2007 Jkt 211001 * * * * (c) Special considerations—(1) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following directions: ‘‘CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.’’ (2) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions: ‘‘CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.’’ (3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions: (i) No. 000009: ‘‘CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed.’’ (ii) Nos. 043733 and 051311: ‘‘CAUTION: Not to be fed to swine that weigh more than 250 lb.’’ * * * * * Dated: June 8, 2007. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E7–11611 Filed 6–15–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9331] Authority: 21 U.S.C. 360b, 371. * 2007. pwalker on PROD1PC71 with RULES 1. The authority citation for 21 CFR part 558 continues to read as follows: I § 558.325 This rule is effective June 18, VerDate Aug<31>2005 PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 33387 RIN 1545–BG46 Deemed IRAs in Governmental Plans/ Qualified Nonbank Trustee Rules Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and removal of temporary regulations. AGENCY: SUMMARY: This document contains final regulations under section 408 of the Internal Revenue Code. The final regulations provide special rules for a governmental unit which seeks to qualify as a nonbank trustee of a deemed IRA that is part of its qualified employer plan. These final regulations affect only such governmental units. DATES: Effective Date: June 18, 2007. Applicability Date: For dates of applicability, see § 1.408–2(e)(8)(iv). FOR FURTHER INFORMATION CONTACT: Linda L. Conway, 202–622–6090, or Cathy A. Vohs, 202–622–6090 (not tollfree numbers). SUPPLEMENTARY INFORMATION: Background This document contains final amendments to the Income Tax Regulations (26 CFR Part 1) under section 408 of the Internal Revenue Code of 1986 (Code). On July 22, 2004, temporary and proposed regulations under section 408 were issued. A notice of proposed rulemaking (REG–101447– 04) was published in the Federal Register (69 FR 43786). The text of the temporary regulations also served as the text of the proposed regulations. The text of temporary § 1.408–2(e)(8) was published in the same issue of the Federal Register (69 FR 43735). The RIN published in connection with that notice of proposed rulemaking was 1545–BD07. However, due to technical difficulties that RIN is no longer valid and the RIN number of these final regulations is 1545–BG46. No comments were received regarding the proposed regulations. Explanation of Provisions and Summary of Comments These final regulations amend § 1.408–2(e) of the regulations to provide that a governmental unit may serve as the trustee of any deemed IRA established by that governmental unit as part of its qualified employer plan if that governmental unit establishes to the E:\FR\FM\18JNR1.SGM 18JNR1

Agencies

[Federal Register Volume 72, Number 116 (Monday, June 18, 2007)]
[Rules and Regulations]
[Pages 33386-33387]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Lincomycin

AGENCY: Food and Drug Administration, HHS.

[[Page 33387]]


ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, 
Inc. The supplemental NADA provides for the use of lincomycin in feed 
of swine weighing greater than 250 pounds and for the addition of a 
reproductive cautionary statement to labeling.

DATES: This rule is effective June 18, 2007.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Div. of Pfizer, 
Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 
97-505 that provides for use of LINCOMIX 20 (lincomycin hydrochloride) 
and LINCOMIX 50 Feed Medications in single-ingredient Type B and Type C 
medicated feeds for swine weighing greater than 250 pounds and for the 
addition of a reproductive caution statement to labeling. The 
supplemental application is approved as of May 23, 2007, and the 
regulations are amended in 21 CFR 558.325 to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.325, add paragraph (c) and in the table in paragraphs 
(d)(2)(i) through (d)(2)(iv), in the ``Limitations'' column, remove 
``Not to be fed to swine that weigh more than 250 lb.'' wherever it 
occurs to read as follows:


Sec.  558.325  Lincomycin.

* * * * *
    (c) Special considerations--(1) Labeling of Type A medicated 
articles and Type B and Type C medicated feeds containing lincomycin 
shall bear the following directions: ``CAUTION: Do not allow rabbits, 
hamsters, guinea pigs, horses, or ruminants access to feeds containing 
lincomycin. Ingestion by these species may result in severe 
gastrointestinal effects.''
    (2) Labeling of Type A medicated articles and Type B and Type C 
medicated feeds containing lincomycin intended for use in swine shall 
bear the following directions: ``CAUTION: Occasionally, swine fed 
lincomycin may within the first 2 days after the onset of treatment 
develop diarrhea and/or swelling of the anus. On rare occasions, some 
pigs may show reddening of the skin and irritable behavior. These 
conditions have been self-correcting within 5 to 8 days without 
discontinuing the lincomycin treatment.''
    (3) Labeling of Type A medicated articles and single-ingredient 
Type B and Type C medicated feeds containing lincomycin intended for 
use in swine shall bear the following directions:
    (i) No. 000009: ``CAUTION: The effects of lincomycin on swine 
reproductive performance, pregnancy, and lactation have not been 
determined. Not for use in swine intended for breeding when lincomycin 
is fed at 20 grams per ton of complete feed.''
    (ii) Nos. 043733 and 051311: ``CAUTION: Not to be fed to swine that 
weigh more than 250 lb.''
* * * * *

    Dated: June 8, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E7-11611 Filed 6-15-07; 8:45 am]
BILLING CODE 4160-01-S

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