[Federal Register Volume 69, Number 148 (Tuesday, August 3, 2004)]
[Notices]
[Page 46553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17628]



[[Page 46553]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Tylosin Tartrate for Foulbrood in Honeybees; 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 safety data that may be used in support of a new 
animal drug application (NADA) or supplemental NADA for use of tylosin 
tartrate for the control of American foulbrood (Paenibacillus larvae) 
in honeybees. The data, contained in Public Master File (PMF) 5783, 
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 minor 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-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Tylosin tartrate soluble powder used for the 
control of American foulbrood (P. larvae) in honeybees 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, tylosin tartrate 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. Honeybees 
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, 
human food safety, and environmental safety data for use of tylosin 
tartrate soluble powder for the control of American foulbrood in 
honeybees. These data, contained in PMF 5783, were reviewed by FDA and 
found satisfactory to support those aspects of an original or 
supplemental NADA.
    Sponsors of NADAs or supplemental NADAs may, without further 
authorization, reference the PMF 5783 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; and data concerning 
manufacturing methods, facilities, and controls. Persons desiring more 
information concerning PMF 5783 or requirements for approval of an NADA 
or supplement may contact Joan C. Gotthardt (see FOR FURTHER 
INFORMATION CONTACT).

    Dated: July 27, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-17628 Filed 8-2-04; 8:45 am]
BILLING CODE 4160-01-S