[Federal Register Volume 69, Number 48 (Thursday, March 11, 2004)]
[Rules and Regulations]
[Pages 11506-11507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5488]


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

DATES:  This rule is effective March 11, 2004.

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: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed ANADA 200-351 that provides 
for use of Lincomycin (lincomycin hydrochloride monohydrate) 
Injectable, USP in swine for the treatment of infectious arthritis and 
mycoplasma pneumonia. Phoenix Scientific's Lincomycin Injectable is 
approved as a generic copy of Pharmacia & Upjohn Co.'s LINCOMIX 
Injectable, approved under NADA 034-025. The ANADA is approved as of 
February 13, 2004, 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.
    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 Division of Dockets Management 
(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.

[[Page 11507]]

Sec.  522.1260  [Amended]

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2. Section 522.1260 Lincomycin is amended in paragraph (b)(2) by 
removing ``No. 000857'' and by adding in its place ``Nos. 000857 and 
059130''.

    Dated: March 3, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-5488 Filed 3-10-04; 8:45 am]
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