Document ID: FDA-2008-N-0039-0097
Agency: fda
Document Type: Notice
Title: Implantation or Injectable Dosage Form New Animal Drugs: Flunixin - Final Rule
Posted Date: 2009-02-12T05:00Z

[Federal Register: February 12, 2009 (Volume 74, Number 28)]
[Rules and Regulations]               
[Page 6993-6994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe09-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2008-N-0039]

 
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

AGENCY: Food and Drug Administration, HHS.

[[Page 6994]]

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 Cross Vetpharm Group Ltd. The 
supplemental ANADA provides for the veterinary prescription use of 
flunixin meglumine solution by intravenous injection in dairy cattle 
for control of pyrexia associated with acute bovine mastitis.

DATES: This rule is effective February 12, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed supplemental ANADA 200-387 that 
provides for veterinary prescription use of FLUNAZINE (flunixin 
meglumine) Injectable Solution intravenously in dairy cattle for 
control of pyrexia associated with acute bovine mastitis. The 
supplemental ANADA is approved as of December 18, 2008, and the 
regulations are amended in 21 CFR 522.970 to reflect the approval.
    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 Subject in 21 CFR Part 522

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.970, revise paragraphs (b)(2) and (b)(4) to read as 
follows:

Sec.  522.970  Flunixin.

* * * * *
    (b) * * *
    (2) See No. 057561 for use as in paragraphs (e)(1), (e)(2)(i)(A), 
(e)(2)(ii)(A), and (e)(2)(iii) of this section.
* * * * *
    (4) See Nos. 055529, 059130, and 061623 for use as in paragraphs 
(e)(1) and (e)(2) of this section.
* * * * *

    Dated: February 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-2941 Filed 2-11-09; 8:45 am]

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