Document ID: FDA-2008-N-0039-0043
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
Posted Date: 2008-05-15T04:00Z

[Federal Register: May 15, 2008 (Volume 73, Number 95)]
[Rules and Regulations]               
[Page 28036-28037]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my08-8]                         

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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 IVX Animal Health, Inc. The

[[Page 28037]]

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 May 15, 2008.

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: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed supplemental ANADA 200-124 
that provides for veterinary prescription use of Flunixin Meglumine 
Injection intravenously in lactating dairy cattle for control of 
pyrexia associated with acute bovine mastitis. The supplemental ANADA 
is approved as of April 24, 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 Subjects 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 Nos. 057561 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 Nos. 055529 and 059130 for use as in paragraphs (e)(1) and 
(e)(2) of this section.
* * * * *

    Dated: May 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-10856 Filed 5-14-08; 8:45 am]

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