[Federal Register Volume 65, Number 141 (Friday, July 21, 2000)]
[Rules and Regulations]
[Page 45282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18458]


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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 topical veterinary prescription use of selamectin solution for the 
additional indication for control of intestinal hookworm and roundworm 
infections in cats.

DATES: This rule is effective July 21, 2000.

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) in 
dogs and cats for the additional indication for control of intestinal 
hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) 
infections in cats. The supplemental NADA is approved as of June 13, 
2000, and the regulations are amended in 21 CFR 524.2098 to reflect the 
approval. The basis of 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)(iii)), this approval for nonfood-
producing animals qualifies for 3 years of marketing exclusivity 
beginning June 13, 2000, because the application contains substantial 
evidence of 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.
    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.

    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.


    2. Section 524.2098 is amended by revising the third sentence in 
paragraph (d)(2) to read as follows:


Sec. 524.2098  Selamectin.

* * * * *
    (d) * * *
    (2) * * * Treatment and control of intestinal hookworm (Ancylostoma 
tubaeforme) and roundworm (Toxocara cati) infections in cats. * * *
* * * * *

    Dated: July 3, 2000.
David R. Newkirk,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 00-18458 Filed 7-20-00; 8:45 am]
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