2010-47. Certain Other Dosage Form New Animal Drugs; Sevoflurane

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 abbreviated new animal drug application (ANADA) filed by Halocarbon Products Corp. The ANADA provides for the use of sevoflurane inhalant anesthetic in dogs.

DATES:

This rule is effective January 8, 2010.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661, filed ANADA 200-467 that provides for use of Sevoflurane, an inhalant anesthetic, in dogs. Halocarbon Products Corp.'s Sevoflurane is approved as a generic copy of SEVOFLO (sevoflurane), sponsored by Abbott Laboratories, under NADA 141-103. The ANADA is approved as of November 27, 2009, and the regulations are amended in § 529.2150 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 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 529

• Animal drugs

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 529 is amended as follows:

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 529 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 529.2150

[Amended]

2. In paragraph (b) of § 529.2150, remove “Nos. 000074 and 060307” and in its place add “Nos. 000074, 012164, and 060307”.

Dated: January 4, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.