[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Notices]
[Page 37753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18349]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Sulfadimethoxine and Ormetoprim in Chukar Partridge Feed;
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
environmental data to be used in support of a new animal drug
application (NADA) or supplemental NADA for use of Type C medicated
feed containing sulfadimethoxine and ormetoprim in chukar partridges,
for the prevention of coccidiosis caused by Eimeria kofoidi and E.
legionensis. The data, contained in Public Master File (PMF) 5157, were
compiled under National Regional Support Project No. 7 (NRSP-7)
(formerly the Interregional Research Project No. 4 (IR-4)), a national
agricultural program for obtaining clearances for use of new drugs in
minor animal species or in any animal species for 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, 301-827-3125.
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 sulfadimethoxine and ormetoprim
in chukar partridge feed 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, the combination of sulfadimethoxine/
ormetoprim is subject to section 512 of the act (21 U.S.C. 360b) which
requires that its use in chukar partridges be the subject of an
approved NADA or supplemental NADA. Partridges are a minor species
under Sec. 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)). The NRSP-7
Project, Northeastern Region, New York State College of Veterinary
Medicine, Cornell University, Ithaca, NY 14853-6401, has filed data and
information that demonstrate safety and effectiveness to chukar
partridges consuming sulfadimethoxine/ormetoprim-containing feed for
the prevention of coccidiosis caused by E. kofoidi and E. legionensis.
NRSP-7 has also filed an environmental assessment (EA) that adequately
addresses the potential impacts due to use of the drug product.
Approval of an application based on the data and information in this
file requires added information concerning the environmental impact of
the manufacturing site. The EA will be displayed when the NADA is
approved, so that the manufacturing site environmental impact can be
included in the assessment. The EA may be seen at 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.
The use of the drug in chukar partridges has an inherent withdrawal
period both when introduced into the game preserves and the period
between dosing and maturity. Therefore, the Center for Veterinary
Medicine has waived the requirements for conducting a tissue residue
depletion study.
The data and information are contained in PMF 5157. 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 part 20
(21 CFR part 20) and 21 CFR 514.11(e)(2)(ii), a summary of target
animal safety and effectiveness data and information in the PMF
submitted to support approval of an application may be seen in the
Dockets Management Branch (address above) between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: July 11, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-18349 Filed 7-18-96; 8:45 am]
BILLING CODE 4160-01-F