Implantation or Injectable Dosage Form New Animal Drugs: Florfenicol and Flunixin

Federal Register: January 11, 2010 (Volume 75, Number 6)

Rules and Regulations

Page 1274-1275

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr11ja10-5

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 522

Docket No. FDA-2009-N-0665

Implantation or Injectable Dosage Form New Animal Drugs;

Florfenicol and Flunixin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for veterinary prescription use of a combination injectable solution containing

Page 1275

florfenicol and flunixin meglumine in cattle.

DATES: This rule is effective January 11, 2010.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for

Veterinary Medicine (HFV-130), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,

Roseland, NJ 07068, filed NADA 141-299 that provides for use RESFLOR

GOLD (florfenicol and flunixin meglumine), a combination injectable solution, for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle. The NADA is approved as of November 23, 2009, and the regulations in 21 CFR part 522 are amended by adding Sec. 522.956 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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

The agency has determined under 21 CFR 25.33 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. Add Sec. 522.956 to read as follows:

Sec. 522.956 Florfenicol and flunixin.

(a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) florfenicol and 16.5 mg flunixin (27.37 mg flunixin meglumine).

(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section.

(c) Tolerances. See Sec. Sec. 556.283 and 556.286 of this chapter.

(d) Conditions for use in cattle--(1) Amount. 40 mg florfenicol/kg body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/100 lbs) once, by subcutaneous injection.

(2) Indications for use. For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Animals intended for human consumption must not be slaughtered within 38 days of treatment. Do not use in female dairy cattle 20 months of age or older. Use of florfenicol in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.

Dated: December 31, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

FR Doc. 2010-209 Filed 1-8-10; 8:45 am

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