[Federal Register Volume 64, Number 175 (Friday, September 10, 1999)]
[Rules and Regulations]
[Page 49082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23466]


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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; Doramectin

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 further use of doramectin in cattle for treatment and control of 
the gastrointestinal roundworm Trichostrongylus axei L4 and for control 
of and protection from reinfection with Haemonchus placei for 35 days 
after treatment.

EFFECTIVE DATE: September 10, 1999.
FOR FURTHER INFORMATION CONTACT: Thomas Letonja, Center for Veterinary 
Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7576.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed supplemental NADA 141-095 that provides for topical 
use of Dectomax (doramectin) pour-on solution for further use 
on cattle for treatment and control of T. axei L4 and for control of 
and protection from reinfection with H. placei for 35 days after 
treatment. The supplemental NADA is approved as of August 10, 1999, and 
the regulations are amended in 21 CFR 524.770(d)(2) to reflect this 
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 supplemental 
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 supplemental approval 
for food-producing animals qualifies for 3 years of marketing 
exclusivity beginning August 10, 1999, because the supplement contains 
substantial evidence of the effectiveness of the drug involved, any 
studies of animal safety or, in the case of food-producing animals, 
human food safety studies (other than bioequivalence or residue 
studies) required for approval of the supplement and conducted or 
sponsored by the applicant. Exclusivity applies only to the added 
indication for use of doramectin topical in cattle for treatment and 
control of T. axei L4 and for control of and protection from 
reinfection with H. placei for 35 days after treatment.
    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.
    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 524.770 is amended by revising paragraph (d)(2) to read 
as follows:


Sec. 524.770  Doramectin.

* * * * *
    (d) * * *
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and 
sucking lice, horn flies, and mange mites. To control infections and to 
protect from reinfection with Cooperia oncophora and Dictyocaulus 
viviparus for 21 days, Ostertagia ostertagi, C. punctata, and 
Oesophagostomum radiatum for 28 days, and Haemonchus placei for 35 days 
after treatment.
* * * * *

    Dated: August 27, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation.
[FR Doc. 99-23466 Filed 9-9-99; 8:45 am]
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