[Federal Register: January 23, 2007 (Volume 72, Number 14)]
[Notices]
[Page 2891]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ja07-57]
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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: joan.gotthardt@fda.hhs.gov.
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