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Rule

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

Action

Final Rule.

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA adds Mycoplasma bovis to the bovine respiratory disease (BRD) pathogens for which use of an injectable solution containing florfenicol and flunixin meglumine is an approved treatment.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective September 3, 2010.

FOR FURTHER INFORMATION CONTACT: Back to Top

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: Back to Top

Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068, filed a supplement to NADA 141-299 that provides for use of RESFLOR GOLD (florfenicol and flunixin meglumine), a combination drug injectable solution. The supplement adds M. bovis to the BRD pathogens for which the use of this product is approved. The supplemental NADA is approved as of June 7, 2010, and the regulations in 21 CFR 522.956 are amended 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)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental 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 Back to Top

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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 Back to Top

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

Authority:

21 U.S.C. 360b.

2.In § 522.956, revise paragraph (d)(2) to read as follows:

§ 522.956 Florfenicol and flunixin.

(d) * * *

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

end regulatory text

Dated: August 31, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

[FR Doc. 2010-22039 Filed 9-2-10; 8:45 am]

BILLING CODE 4160-01-S

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