[Federal Register Volume 62, Number 10 (Wednesday, January 15, 1997)]
[Notices]
[Pages 2165-2166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0488]
Use of Clorsulon Drench in 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 target animal safety and effectiveness data, human food
safety data, and environmental data to be used in support of a new
animal drug application (NADA) or supplemental NADA for use of a
suspension containing 8.5 percent clorsulon as a drench in goats for
the treatment of adult liver fluke infestation. The data, contained in
Public Master File (PMF) 5440, 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 diseases that occur 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.
[[Page 2166]]
FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1659.
SUPPLEMENTARY INFORMATION: The use of clorsulon suspension in goats is
a new animal drug use 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,
clorsulon suspension is subject to section 512 of the act (21 U.S.C.
360b), which requires that its use in goats be the subject of an
approved NADA or supplemental NADA. Goats are a minor specie under
Sec. 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)).
The NRSP-7 Project, Southern Region, University of Florida,
Gainesville, FL 32610, has filed data and information that demonstrate
safety and effectiveness to goats orally drenched with a suspension
containing 8.5 percent of clorsulon for the treatment of adult liver
fluke (Fasciola hepatica) infestation. NRSP-7 has also filed human food
safety data and an environmental assessment that adequately addresses
the potential impacts due to use of the drug product.
The data and information are contained in PMF 5440. 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 reference to the PMF, animal drug labeling and other data needed for
approval, such as manufacturing methods, facilities, and controls, and
information addressing the potential environmental impacts (including
occupational) of the manufacturing process. Persons desiring more
information concerning the PMF or requirements for approval of an NADA
may contact Naba K. Das (address above).
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of target animal safety,
effectiveness, and human safety data and information provided in this
PMF 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.
Dated: January 6, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-1022 Filed 1-14-97; 8:45 am]
BILLING CODE 4160-01-F
