[Federal Register Volume 64, Number 173 (Wednesday, September 8, 1999)]
[Rules and Regulations]
[Page 48707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


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 provides 
for an additional indication for control of tick (Dermacentor 
variabilis) infestations in dogs.

EFFECTIVE DATE:  September 8, 1999.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed supplemental NADA 141-152 that provides for topical 
veterinary prescription use of RevolutionTM (selamectin) 
solution in dogs for the additional indication for control of tick (D. 
variabilis) infestations. The supplemental NADA is approved as of 
August 5, 1999, and the regulations are amended in 21 CFR 524.2098 in 
paragraphs (d)(1) and (d)(2) to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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)(i)), this approval for nonfood-
producing animals qualifies for 3 years of marketing exclusivity 
beginning August 5, 1999, because the supplemental application contains 
substantial evidence of the effectiveness of the drug involved, or any 
studies of animal safety, required for approval of the application and 
conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.33(d)(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.
    The 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.
    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

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

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


Sec. 524.2098     [Amended]

    2. Section 524.2098 Selamectin is amended in paragraph (d)(1) by 
removing the words ``once a month'' and in paragraph (d)(2) by revising 
the second sentence to read ``Treatment and control of sarcoptic mange 
(Sarcoptes scabiei) and control of tick (Dermacentor variabilis) 
infestations in dogs.''

    Dated: August 27, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 99-23336 Filed 9-7-99; 8:45 am]
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