[Federal Register Volume 61, Number 25 (Tuesday, February 6, 1996)]
[Notices]
[Pages 4442-4443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2371]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0410]


Ivermectin Injection for American Buffalo; 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 target animal safety and effectiveness data and human 
food safety data to be used in support of a new animal drug application 
(NADA) or supplemental NADA for use of 1 percent ivermectin injection 
in American buffalo. The data, contained in Public Master File (PMF) 
5059, were compiled under National Research Support Project No. 7 
(NRSP-7), a national agricultural program for obtaining clearances for 
use of new drugs in minor animal species or in any animal species for 
the control of a disease that occurs infrequently or in limited 
geographical areas.

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, 301-827-3125.

FOR FURTHER INFORMATION CONTACT: Jean M. Cooper, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1653.

SUPPLEMENTARY INFORMATION: Ivermectin injection for use in American 
buffalo is a new animal drug under section 201(w) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(w)). As a new animal 
drug, ivermectin is subject to section 512 of the act (21 U.S.C. 360b) 
which requires that its uses in American buffalo be the subject of an 
approved NADA or supplemental NADA. American buffalo are a minor 
species under Sec. 514.1(d) (21 CFR 514.1(d)). The NRSP-7 Project, 
North Central Region, Michigan State University, East Lansing, MI 
48824, has provided data and information that demonstrate human food 
safety and safety and effectiveness to American buffalo subcutaneously 
administered 1 percent ivermectin injection (200 micrograms of 
ivermectin per kilogram of body weight) for the treatment and control 
of hypodermosis caused by Hypoderma bovis (grubs).
    The data and information are contained in PMF 5059. Sponsors of 
NADA's or supplemental NADA's may, without further authorization, refer 
to the PMF to support approval of an application filed under 
Sec. 514.1(d). An NADA or supplemental NADA must include, in addition 
to a reference to the PMF, animal drug labeling and other data needed 
for approval, such as manufacturing methods, facilities and controls, 
data supporting extrapolation from a major species in which the drug is 
currently approved, or authorized reference to such data, and 
information addressing the potential environmental impacts (including 
occupational) of the manufacturing process and use of the drug product. 
Persons desiring more information concerning the PMF or requirements 
for approval of an NADA may contact Jean M. Cooper (address above).
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and 21 CFR 514.11(e)(2)(ii), a summary of target 
animal safety and effectiveness data and human food safety data 
submitted to support approval of an application may be seen in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 
p.m., Monday through Friday.


[[Page 4443]]

    Dated: January 25, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-2371 Filed 2-5-96; 8:45 am]
BILLING CODE 4160-01-F