[Federal Register: January 23, 2007 (Volume 72, Number 14)]
[Page 2890-2891]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Orthopaedic and Rehabilitation Devices Panel of the Medical 
Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Orthopaedic and Rehabilitation Devices Panel of 
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 22, 2007, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Ronald P. Jean, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-3676, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512521. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On February 22, 2007, the committee will discuss, make 
recommendations and vote on a

[[Page 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 non-
inflammatory 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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 
    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]