[Federal Register Volume 61, Number 183 (Thursday, September 19, 1996)]
[Notices]
[Page 49327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ceftiofur Sodium for Sheep; 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, and human food 
safety data to be used in support of a new animal drug application 
(NADA) or supplemental NADA for the use of ceftiofur sodium sterile 
powder, reconstituted with sterile water, as an injectable for treating 
certain respiratory diseases of sheep. The data, contained in Public 
Master File (PMF) 5544, were compiled under National Research Support 
Project-7 (NRSP-7), a national agricultural research program for 
obtaining clearances for use of new drugs in minor animal species and 
for special uses.

ADDRESSES: Submit NADA's or supplemental NADA's to the Document Control 
Section (HFV-199), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855.

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 ceftiofur sodium sterile powder, 
reconstituted as a sterile aqueous injection, to treat sheep for 
respiratory disease 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, ceftiofur is subject to section 512 of the act 
(21 U.S.C. 360b), which requires that its uses in sheep be the subject 
of an approved NADA or supplemental NADA. Sheep are a minor species 
under Sec. 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)).
    The NRSP-7 Project, Western Region, University of California, 
Davis, CA 95616, has provided data and information that demonstrate 
safety and effectiveness to the target animal and human food safety for 
ceftiofur sterile powder, reconstituted as a sterile aqueous injectable 
solution for intramuscular use in sheep, to treat sheep respiratory 
disease (pneumonia) associated with Pasteurella haemolytica and/or P. 
multocida. NRSP-7 did not provide information concerning potential 
environmental impacts of the manufacturing process. Such information is 
required upon submission of an application relying on this file to 
support approval.
    The data and information on safety and effectiveness are contained 
in PMF 5544. Sponsors of NADA's or supplemental NADA's may, without 
further authorization, reference 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 information needed for approval, such as data 
supporting extrapolation from a major species in which the drug is 
currently approved, or authorized reference to such data, and data 
concerning manufacturing methods, facilities and controls, and 
information addressing potential environmental impacts of the 
manufacturing process.
    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 safety and 
effectiveness data and information in this PMF 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.

    Dated: September 4, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-24074 Filed 9-18-96; 8:45 am]
BILLING CODE 4160-01-F