Document ID: FDA-2009-N-0665-0015
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin
Posted Date: 2009-04-30T04:00Z

[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Rules and Regulations]
[Pages 19877-19878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9901]

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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.

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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.

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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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.2098  [Amended]

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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]
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