Ophthalmic and Topical Dosage Form New Animal Drugs: Selamectin

Federal Register: April 30, 2009 (Volume 74, Number 82)

Rules and Regulations

Page 19877-19878

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

DOCID:fr30ap09-3

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 524

Docket No. FDA-2009-N-0665

Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin

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 a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA revises the minimum age of treatment from 6 weeks to 8 weeks for kittens treated with a topical selamectin solution.

DATES: This rule is effective April 30, 2009.

Page 19878

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for

Veterinary Medicine (HFV-110), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, filed a supplement to NADA 141-152 that provides for topical veterinary prescription use of REVOLUTION (selamectin) in dogs and cats. The supplemental NADA revises the minimum age of treatment from 6 weeks to 8 weeks for kittens. The supplemental NADA is approved as of April 6, 2009, and the regulations are amended in 21 CFR 524.2098 to reflect the approval.

Approval of these supplemental NADAs did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency 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 524

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 524 is amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part 524 continues to read as follows:

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

Sec. 524.2098 [Amended] 0 2. In Sec. 524.2098, in the last sentence in paragraph (d)(2), remove

``For dogs and cats 6 weeks of age and older'' and in its place add

``For dogs 6 weeks of age and older, and cats 8 weeks of age and older''.

Dated: April 23, 2009.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary

Medicine.

FR Doc. E9-9901 Filed 4-29-09; 8:45 am

BILLING CODE 4160-01-S