Food and Drug Administration, HHS.
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.
This rule is effective April 30, 2009.Start Further Info Start Printed 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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects in 21 CFR Part 524End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 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”.End Amendment Part Start Signature
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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