Document ID: FDA-2008-N-0035-0001
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
Posted Date: 2008-01-16T05:00Z

[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Rules and Regulations]               
[Page 2808-2809]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-8]                         

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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 pyrexia associated with acute bovine mastitis.

DATES: This rule is effective January 16, 2008.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

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 pyrexia 
associated with acute bovine mastitis. The supplemental ANADA is 
approved as of December 19, 2007, 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.
    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 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:

[[Page 2809]]

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 paragraph (b)(2) and add paragraph (b)(4) 
to read as follows:

Sec.  522.970  Flunixin.

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

    Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E8-699 Filed 1-15-08; 8:45 am]

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