[Federal Register Volume 68, Number 167 (Thursday, August 28, 2003)]
[Rules and Regulations]
[Page 51705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21986]


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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; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 Veterinary Laboratories, Inc. The ANADA 
provides for the use of lincomycin injectable solution in swine for the 
treatment of infectious arthritis and mycoplasma pneumonia. Additional 
action is also being taken because we did not specify the concentration 
of lincomycin solution approved under the ANADA in the final rule that 
published in the Federal Register of May 14, 2002.

DATES: This rule is effective August 28, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Veterinary Laboratories, Inc., 12340 Santa 
Fe Dr., Lenexa, KS 66215, filed ANADA 200-315 that provides for use of 
Lincomycin (lincomycin hydrochloride monohydrate) Injection in swine 
for the treatment of infectious arthritis and mycoplasma pneumonia. 
Veterinary Laboratories, Inc.'s Lincomycin Injection is approved as a 
generic copy of Pharmacia & Upjohn Co.'s LINCOMIX Injectable, approved 
under NADA 034-025. The ANADA is approved as of April 2, 3003, 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 revised to specify the concentration 
of lincomycin solutioin approved under ANADA 200-274 (67 FR 34387, May 
14, 2002).
    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 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.

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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 522 is 
amended as follows:

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

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

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

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2. Section 522.1260 is amended by revising paragraphs (a) and (b) to 
read as follows:


Sec.  522.1260  Lincomycin.

    (a) Specifications. Each milliliter of solution contains lincomycin 
hydrochloride monohydrate equivalent to:
    (1) 25, 50, 100, or 300 milligrams (mg) lincomycin.
    (2) 25, 100, or 300 mg lincomycin.
    (3) 300 mg 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 use of concentrations in paragraph (a)(1) of 
this section as in paragraph (e) of this section.
    (2) No. 000857 for use of concentrations in paragraph (a)(2) of 
this section as in paragraph (e)(2) of this section.
    (3) No. 046573 for use of concentration in paragraph (a)(3) of this 
section as in paragraph (e)(2) of this section.
* * * * *

    Dated: August 7, 2003.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 03-21986 Filed 8-27-03; 8:45 am]
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