Document ID: FDA-2008-N-0039-0068
Agency: fda
Document Type: Notice
Title: Chloramine-T for Control of Bacterial Gill Disease in Freshwater- Reared Salmonids; Availability of Data
Posted Date: 2008-08-21T04:00Z

[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