Hydrogen Peroxide Solution for Control of Various Fungal and Bacterial Diseases in Fish; Availability of Data, 2891 [E7-947]

Download as PDF mstockstill on PROD1PC70 with NOTICES Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Notices premarket approval application for the Cormet 2000 Hip Resurfacing System, sponsored by Corin U.S.A. This system is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with noninflammatory degenerative arthritis or inflammatory arthritis. FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. 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Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–946 Filed 1–22–07; 8:45 am] BILLING CODE 4160–01–S 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. 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 freshwaterreared 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, email: 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 2891 species under § 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 § 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 E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 72, Number 14 (Tuesday, January 23, 2007)]
[Notices]
[Page 2891]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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

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