[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]
BILLING CODE 4160-01-F
