[Federal Register Volume 67, Number 135 (Monday, July 15, 2002)]
[Notices]
[Pages 46527-46528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oxytetracycline Hydrochloride for Marking Fish; 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, human food safety, 
and environmental data that may be used in support of a new animal drug 
application (NADA) or supplemental NADA for use of a solution of 
oxytetracycline hydrochloride for skeletal marking of finfish by 
immersion. The data, contained in Public Master File (PMF) 5667, 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 NADAs or supplemental NADAs 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: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-131), Food and Drug Administration, 7500 
Standish Pl.,

[[Page 46528]]

Rockville, MD 20855, 301-827-7571, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Oxytetracycline hydrochloride soluble 
powder, used in solution for skeletal marking of juvenile finfish by 
immersion as an aid in identification 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, oxytetracycline hydrochloride 
is subject to section 512 of the act (21 U.S.C. 360b), requiring that 
its uses be the subject of an approved NADA or supplemental NADA. Fish 
are a minor species under Sec. 514.1(d)(1)(ii) (21 CFR 
514.1(d)(1)(ii)).
    The NRSP-7 Project, North Eastern Region, New York State College of 
Veterinary Medicine, Cornell University, Ithaca, NY 14850, has provided 
target animal safety, effectiveness, human food safety, and 
environmental data for use of oxytetracycline hydrochloride soluble 
powder for skeletal marking of fish by immersion. These data are 
contained in PMF 5667.
    Under Secs.  25.15(d) and 25.33(d)(4) (21 CFR 25.15(d) and 
25.33(d)(4)), sponsors of NADAs and supplemental NADAs 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 defined 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 NADAs or supplemental NADAs may, without further 
authorization, reference the PMF 5667 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 PMF 5667 or 
requirements for approval of an NADA or supplement may contact Joan C. 
Gotthardt (see FOR FURTHER INFORMATION CONTACT).
    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 PMF 5667 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 27, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-17749 Filed 7-12-02; 8:45 am]
BILLING CODE 4160-01-S