[Federal Register Volume 69, Number 170 (Thursday, September 2, 2004)]
[Rules and Regulations]
[Page 53618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19987]



[[Page 53618]]

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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; Flunixin

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Agri Laboratories, Ltd. The 
supplemental ANADA provides for use of flunixin meglumine solution by 
intravenous injection for control of fever and inflammation in beef 
cattle and nonlactating dairy cattle.

DATES: This rule is effective September 2, 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: Agri Laboratories, Ltd., P.O. Box 3103, St. 
Joseph, MO 64503, filed a supplement to ANADA 200-061 that provides for 
veterinary prescription use of Flunixin Meglumine Injection by 
intravenous administration for control of fever and inflammation in 
beef cattle and nonlactating dairy cattle. The supplemental application 
is approved as of July 29, 2004, and the regulations are amended in 21 
CFR 522.970 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.


Sec.  522.970  [Amended]

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2. Section 522.970 is amended in paragraph (b)(1) by removing ``Nos. 
000061 and 059130'' and by adding in its place ``Nos. 000061, 057561, 
and 000856''; and in paragraph (b)(2) by removing ``Nos. 000856 and 
057561'' and by adding in its place ``No. 000856''.

    Dated: August 18, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-19987 Filed 9-1-04; 8:45 am]
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