Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Notices 2891 

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. Background material is 

available athttp://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 8, 2007. 

Oral presentations from the public will 

be scheduled for 30 minutes at the 

beginning of the committee 

deliberations and for 30 minutes near 

the end of the deliberations on February 

22, 2007. Those desiring to make formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 31, 2007. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

February 1, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams at 301–827–7292 at least 7 

days in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 17, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–946 Filed 1–22–07; 8:45 am] 

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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 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 

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 

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