[Federal Register: November 21, 2003 (Volume 68, Number 225)]
[Notices]
[Page 65719]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no03-81]
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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). At least one
portion of the meeting will be closed 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 December 11, 2003, from
8:30 a.m. to 6 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Janet L. Scudiero, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, 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: The committee will discuss, make recommendations, and vote
on the reclassification of the intervertebral body fusion device (cage)
intended for spinal fusion procedures in skeletally mature adults with
degenerative disc disease at one or two levels from C2-C7 and L2-S1
using autogenous bone graft. The device does not include combination
products, such as the intervertebral body fusion device using
morphogenic proteins and scaffolds. Background information for the
topic, including the agenda and questions for the committee, will be
available to the public no later than 1 business day before the meeting
on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html.
Procedure: On December 11, 2003, from 9 a.m. to 6 p.m., the meeting
is open to the public. 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
December 1, 2003. Oral presentations from the public will be scheduled
between approximately 11:45 a.m. and 12:45 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before December 1, 2003,
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.
Closed Committee Deliberations: On December 11, 2003, from 8:30
a.m. to 9 a.m., the meeting will be closed to permit FDA to present to
the committee trade secret and/or confidential commercial information
regarding pending and future device issues. This portion of the meeting
will be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
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 Shirley Meeks,
Conference Management Staff, at 301-594-1283, ext. 105, 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: November 14, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-29070 Filed 11-20-03; 8:45 am]
BILLING CODE 4160-01-S