[Federal Register Volume 67, Number 219 (Wednesday, November 13, 2002)]
[Notices]
[Page 68878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28853]



[[Page 68878]]

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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 November 20 and 21, 
2002, from 9:30 a.m. to 5 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Hany W. Demian, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-2036, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12521. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On November 20, 2002, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
a stair-climbing wheelchair. On November 21, 2002, the committee will 
discuss, make recommendations, and vote on a PMA for growth factors 
soaked in a collagen sponge used to treat tibial fractures. In 
addition, on November 21, 2002, the committee will have a general 
discussion on preclinical and clinical data for spinal devices. 
Background information for each day's topic, including the agenda and 
questions for the committee, will be available to the public 1 business 
day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the November 20, 2002, session will be 
posted on November 19, 2002; material for the November 21, 2002, 
session will be posted on November 20, 2002.
    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 by November 15, 
2002. On each day, oral presentations from the public will be scheduled 
for approximately 30 minutes at the beginning of each PMA topic and for 
approximately 30 minutes near the end of the committee deliberations. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
November 15, 2002, 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.
    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 301-594-1283, ext. 113, at least 7 days 
in advance of the meeting.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the November 20 and 21, 2002, Orthopaedic and Rehabilitation Devices 
Panel of the Medical Devices Advisory Committee meeting. Because the 
agency believes there is some urgency to bring these issues to public 
discussion and qualified members of the Orthopaedic and Rehabilitation 
Devices Panel of the Medical Devices Advisory Committee were available 
at this time, the Commissioner of Food and Drugs concluded that it was 
in the public interest to hold this meeting even if there was not 
sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 5, 2002.
Linda Arey Slkadany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-28853 Filed 11-12-02; 8:45 am]
BILLING CODE 4160-01-S