[Federal Register Volume 65, Number 151 (Friday, August 4, 2000)]
[Notices]
[Page 47992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Tilmicosin Phosphate Injection 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 effectiveness and target animal safety data that may be 
used in support of a new animal drug application (NADA) or supplemental 
NADA for veterinary prescription use of tilmicosin phosphate injection 
for treatment of bacterial pneumonia in sheep. The data, contained in 
Public Master File (PMF) 5673, 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: Tilmicosin phosphate injection, used for the 
treatment of sheep 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, tilmicosin phosphate 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, Southern Region, University of Florida, 
Gainesville, FL 32610, has provided effectiveness and target animal 
safety data for veterinary prescription use of tilmicosin phosphate 
injection in sheep for treatment of bacterial pneumonia due to 
Pasteurella (Mannheimia) haemolytica. These data are contained in PMF 
5673.
    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 that 
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; data concerning human food safety; 
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: July 25, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-19300 Filed 8-3-00; 8:45 am]
BILLING CODE 4160-01-F