[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