[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Rules and Regulations]
[Page 15564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3006]


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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 Norbrook Laboratories, Ltd. 
The supplemental ANADA provides for the veterinary prescription use of 
flunixin meglumine solution by intravenous injection in lactating dairy 
cattle for control of fever associated with bovine respiratory disease 
and endotoxemia, and for control of inflammation in endotoxemia.

DATES: This rule is effective March 29, 2006.

FOR FURTHER INFORMATION CONTACT: Christopher Melluso, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed supplemental ANADA 200-308 that 
provides for veterinary prescription use of Flunixin Injection 
intravenously in lactating dairy cattle for control of fever associated 
with bovine respiratory disease and endotoxemia, and for control of 
inflammation in endotoxemia. The supplemental ANADA is approved as of 
March 1, 2006, 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.
    FDA 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 522.970 is amended by revising paragraph (e)(2)(iii) to read 
as follows:


Sec.  522.970  Flunixin.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Do not slaughter for food use within 4 days of 
last treatment. A withdrawal period has not been established for use in 
preruminating calves. Do not use in calves to be processed for veal. 
For Nos. 000061, 055529, and 059130: Do not use in dry dairy cows. Milk 
that has been taken during treatment and for 36 hours after the last 
treatment must not be used for food. For No. 057561: Not for use in 
lactating or dry dairy cows.
* * * * *

    Dated: March 20, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-3006 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S