[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Notices]
[Page 42951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20255]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Amoxicillin Injection for Sheep; Availability of Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of effectiveness, target animal safety, and human food
safety data that may be used in support of a new animal drug
application (NADA) or supplemental NADA for veterinary prescription use
of amoxicillin injection for treatment of bacterial pneumonia in sheep.
The data, contained in Public Master File (PMF) 5433, 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
Unit (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, 301-827-7569.
SUPPLEMENTARY INFORMATION: Amoxicillin injection, used for the
treatment of sheep for bacterial pneumonia due to Pasteurella spp. and
Haemophilis spp., is a new animal drug 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, amoxicillin is subject to section 512 of the act (21
U.S.C. 360b), requiring 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 target animal safety, effectiveness, and
human food safety data for veterinary prescription use of amoxicillin
injection in sheep for treatment of bacterial pneumonia due to
Pasteurella spp. and Haemophilis spp. 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.
Data and information on safety and effectiveness are contained in
PMF 5433. 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 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, data concerning
manufacturing methods, facilities, and controls, and information
addressing potential environmental impacts of the manufacturing
process. Persons desiring more information concerning the PMF or
requirements for approval of an NADA or supplement 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 safety and effectiveness
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, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 29, 1999.
George A. Mitchell,
Acting Deputy Director, Center for Veterinary Medicine.
[FR Doc. 99-20255 Filed 8-5-99; 8:45 am]
BILLING CODE 4160-01-F
