[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