[Federal Register: November 13, 2002 (Volume 67, Number 219)]
[Notices]
[Page 68878]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no02-99]
[[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