[Federal Register: August 21, 2008 (Volume 73, Number 163)]
[Notices]
[Page 49465]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au08-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0039]
Chloramine-T for Control of Bacterial Gill Disease in Freshwater-
Reared Salmonids; 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 use of chloramine-T by immersion for the control of mortality
in freshwater-reared salmonids due to bacterial gill disease. The data,
contained in Public Master File (PMF) 5893, were compiled by the U.S.
Department of the Interior, U.S. Fish and Wildlife Service, Aquatic
Animal Drug Approval Partnership Program.
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: Donald A. Prater, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail:
donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Chloramine-T used by immersion for control
of mortality in freshwater-reared salmonids due to bacterial gill
disease 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, chloramine-T is subject to section 512 of the act (21 U.S.C.
360b) which requires 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 U.S. Department of the Interior, U.S. Fish and Wildlife
Service, Aquatic Animal Drug Approval Partnership Program, 4050 Bridger
Canyon Rd., Bozeman, MT 59715, has provided effectiveness and target
animal safety data for use of chloramine-T by immersion for control of
mortality in freshwater-reared salmonids due to bacterial gill disease.
These data are contained in PMF 5893.
Sponsors of NADAs or supplemental NADAs may, without further
authorization, reference the PMF 5893 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 concerning
human food safety; and manufacturing methods, facilities, and controls.
Persons desiring more information concerning PMF 5893 or requirements
for approval of an NADA or supplemental NADA may contact the Center for
Veterinary Medicine (see FOR FURTHER INFORMATION CONTACT).
In accordance with the freedom of information provisions of 21 CFR
part 20, a summary of safety and effectiveness data provided in PMF
5893 to support approval of an application may be seen in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, from 9 a.m. to 4 p.m.,
Monday through Friday.
Dated: August 8, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-19299 Filed 8-20-08; 8:45 am]
BILLING CODE 4160-01-S