[Federal Register Volume 67, Number 93 (Tuesday, May 14, 2002)]
[Rules and Regulations]
[Pages 34387-34388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Lincomycin

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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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 Alpharma, Inc. The ANADA provides for use 
of an injectable lincomycin solution for the treatment of infectious 
arthritis and mycoplasma pneumonia in swine.

DATES:  This rule is effective May 14, 2002.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed ANADA 200-274 that provides for the use 
of Lincomycin (lincomycin HCl) Injectable 30% by intramuscular 
injection for the treatment of infectious arthritis and mycoplasma 
pneumonia in swine. Alpharma's Lincomycin Injectable 30%

[[Page 34388]]

is approved as a generic copy of Pharmacia & Upjohn Co.'s LINCOMIX 300, 
approved under NADA 34-025. The application is approved as of February 
1, 2002, and the regulations are amended in 21 CFR 522.1260 to reflect 
the approval. The basis of approval is discussed in the freedom of 
information summary. Section 522.1260 is also being amended to reflect 
a current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    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 522

    Animal drugs.

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
    2. Section 522.1260 is amended by revising the section heading and 
paragraphs (a), (b), (e)(1)(i), (e)(1)(iii), (e)(2)(i), and (e)(2)(iii) 
to read as follows:


Sec. 522.1260  Lincomycin.

    (a) Specifications. Each milliliter of solution contains lincomycin 
hydrochloride monohydrate equivalent to 25, 50, 100, or 300 milligrams 
(mg) of lincomycin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (e) of this section.
    (1) No. 000009 for uses as in paragraph (e) of this section.
    (2) No. 046573 for use as in paragraph (e)(2) of this section.
* * * * *
    (e) * * *
    (1) * * *
    (i) Amount. 5 mg per pound (/lb) of body weight twice daily or 10 
mg/lb body weight once daily by intramuscular injection; 5 to 10 mg/lb 
body weight one or two times daily by slow intravenous injection.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. 5 mg/lb body weight once daily by intramuscular 
injection for 3 to 7 days.
* * * * *
    (iii) Limitations. Do not treat within 48 hours of slaughter.

    Dated: April 26, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-11933 Filed 5-13-02; 8:45 am]
BILLING CODE 4160-01-S