[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Notices]
[Pages 20824-20825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Albendazole Suspension for Goats; Availability of Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of effectiveness, target animal safety, and human food 
safety, and environmental data that may be used in support of a new 
animal drug application (NADA) or supplemental NADA for oral use of 
albendazole suspension for treatment of adult liver flukes in 
nonlactating goats. The data, contained in Public Master File (PMF) 
5582, were compiled under National Research Support Project-7 (NRSP-7), 
a national agricultural research program for obtaining clearances for 
use of new drugs in minor animal species and for special uses.

ADDRESSES: Submit NADA's or supplemental NADA's to the Document Control 
Unit (HFV-199), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT: Gillian A. Comyn, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7568.

SUPPLEMENTARY INFORMATION: Albendazole suspension, used for the 
treatment of adult liver flukes (Fasciola hepatica) in nonlactating 
goats, is a new animal drug under section 201(v) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(v)). As a new animal 
drug, albendazole is subject to section 512 of the act (21 U.S.C. 
360b), requiring that its uses in goats be the subject of an approved 
NADA or supplemental NADA. Goats are a minor species under 
Sec. 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)).
    The NRSP-7 Project, Western Region, College of Veterinary Medicine, 
University of California, Davis, CA 95616, has provided target animal 
safety, effectiveness, human food safety, and environmental data for 
oral use of

[[Page 20825]]

albendazole solution for treatment of adult liver flukes (Fasciola 
hepatica) in nonlactating goats. These data are contained in PMF 5582.
    Under 21 CFR 25.15(d) and 25.33(d)(4), sponsors of NADA's and 
supplemental NADA's for drugs in minor species, including wildlife and 
endangered species, are categorically excluded from the requirement to 
prepare an environmental assessment or an environmental impact 
statement when the drug has been approved for use in another or the 
same species where similar animal management practices are used. The 
categorical exclusion applies unless, as defined in Sec. 25.21 (21 CFR 
25.21), extraordinary circumstances exist which indicate that the 
proposed action may significantly affect the quality of the human 
environment. Therefore, based upon information available, FDA agrees 
that when the application is submitted, the applicant may claim a 
categorical exclusion under Sec. 25.33(d)(4) provided that the 
applicant can state that to the best of the applicant's knowledge, as 
in Sec. 25.21, no extraordinary circumstances exist. It is assumed that 
the applicant has made a reasonable effort to determine that no 
extraordinary circumstances exist.
    Sponsors of NADA's or supplemental NADA's may, without further 
authorization, reference the PMF 5582 to support approval of an 
application filed under Sec. 514.1(d). An NADA or supplemental NADA 
must include, in addition to reference to the PMF, animal drug labeling 
and other information needed for approval, such as: Data supporting 
extrapolation from a major species in which the drug is currently 
approved or authorized reference to such data; data concerning 
manufacturing methods, facilities, and controls; and information 
addressing potential environmental impacts of the manufacturing 
process. Persons desiring more information concerning the PMF or 
requirements for approval of an NADA or supplement may contact Gillian 
A. Comyn (address above).
    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, from 
9 a.m. to 4 p.m., Monday through Friday.

    Dated: March 20, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-9571 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F