[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
