[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Page 14123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5469]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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    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 April 24, 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: The committee will discuss, make recommendations and vote 
on a premarket approval application (PMA) for the Scandinavian Total 
Ankle Replacement System, sponsored by Link America, Inc. This system 
is intended for use as a noncemented implant to replace a painful 
arthritic and/or severely deformed ankle due to rheumatoid arthritis, 
primary arthrosis, or posttraumatic arthrosis.
    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 
April 10, 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. 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 April 2, 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 April 3, 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, 
Conference Management Staff, 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: March 20, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-5469 Filed 3-23-07; 8:45 am]
BILLING CODE 4160-01-S