[Federal Register Volume 65, Number 125 (Wednesday, June 28, 2000)]
[Notices]
[Page 39911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ceftiofur Sodium Injection for Goats; 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 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 ceftiofur sodium injection for treatment of bacterial pneumonia in 
goats. The data, contained in Public Master File (PMF) 5671, 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: Ceftiofur sodium injection, used for the 
treatment of goats for bacterial pneumonia, 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, ceftiofur sodium is subject 
to section 512 of the act (21 U.S.C. 360b), requiring that its uses in 
goats be the subject of an approved NADA or supplemental NADA. Goats 
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 ceftiofur 
sterile powder for reconstitution and injection in goats for treatment 
of bacterial pneumonia due to Pasteurella (Mannheimia) haemolytica and 
P. multocida. These data are contained in PMF 5671.
    Under 21 CFR 25.15(d) and Sec. 25.33(d)(4) (21 CFR 25.33(d)(4)), 
sponsors of NADA's and supplemental NADA's for drugs in minor species, 
including wildlife and endangered species, are categorically excluded 
from the requirement to prepare an environmental assessment or an 
environmental impact statement when the drug has been approved for use 
in another or the same species where similar animal management 
practices are used. The categorical exclusion applies unless, as in 
Sec. 25.21 (21 CFR 25.21), extraordinary circumstances exist which 
indicate that the proposed action may significantly affect the quality 
of the human environment. Therefore, based upon information available, 
FDA agrees that when the application is submitted, the applicant may 
claim a categorical exclusion under Sec. 25.33(d)(4) provided that the 
applicant can state that to the best of the applicant's knowledge, as 
in Sec. 25.21, no extraordinary circumstances exist. It is assumed that 
the applicant has made a reasonable effort to determine that no 
extraordinary circumstances exist.
    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 submitted to support approval of this 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 19, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-16293 Filed 6-27-00; 8:45 am]
BILLING CODE 4160-01-F