[Federal Register Volume 72, Number 116 (Monday, June 18, 2007)]
[Rules and Regulations]
[Pages 33386-33387]
From the Federal Register Online via the Government Publishing 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.

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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: 
[email protected].

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.

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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

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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