Implantation or Injectable Dosage Form New Animal Drugs: Flunixin

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

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.

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

BILLING CODE 4160-01-S