[Federal Register Volume 72, Number 14 (Tuesday, January 23, 2007)]
[Notices]
[Page 2891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Hydrogen Peroxide Solution for Control of Various Fungal and 
Bacterial Diseases in 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, and environmental 
data that may be used in support of a new animal drug application 
(NADA) or supplemental NADA for use of a 35 percent solution of 
hydrogen peroxide by immersion for control of mortality in several life 
stages of certain freshwater-reared finfish species due to various 
fungal and bacterial diseases. The data, contained in Public Master 
File (PMF) 5639, were compiled by the United States Geological Survey, 
Biological Resources Section, Upper Midwest Environmental Sciences 
Center.

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 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: Hydrogen peroxide solution used by immersion 
for control of mortality in several life stages of certain freshwater-
reared finfish species due to various fungal and bacterial diseases 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, 
hydrogen peroxide 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 United States Geological Survey, Biological Resources Section, 
Upper Midwest Environmental Sciences Center, 2630 Fanta Reed Rd., La 
Crosse, WI 54603, has provided effectiveness and target animal safety 
data; and an environmental assessment (EA) for use of a 35 percent 
solution of hydrogen peroxide by immersion for control of mortality in 
certain freshwater-reared finfish species in several life stages due to 
various fungal and bacterial diseases. These data and the EA are 
contained in PMF 5639.
    FDA has reviewed the EA, carefully considered the environmental 
impacts of the use of a 35 percent solution of hydrogen peroxide on 
freshwater finfish, and has concluded that the use will not have a 
significant impact on the human environment. A finding of no 
significant impact (FONSI) has been prepared and is also contained in 
PMF 5639.
    Sponsors of NADAs or supplemental NADAs may, without further 
authorization, reference the PMF 5639 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 5639 or requirements 
for approval of an NADA or supplemental NADA may contact Joan C. 
Gotthardt (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 
5639 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. The EA and FONSI contained in PMF 5639 have also 
been placed in the docket.

    Dated: January 11, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-947 Filed 1-22-07; 8:45 am]
BILLING CODE 4160-01-S