[Federal Register: December 26, 2001 (Volume 66, Number 247)]
[Notices]
[Page 66423-66424]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de01-72]
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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 January 10, 2002, from
9:30 a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact: 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: The committee will discuss, make recommendations, and vote
on premarket approval application (PMA) for a spinal fusion cage with a
growth
[[Page 66424]]
factor soaked in a collagen sponge intended for use to treat lumbar
degenerative disc disease. Background information, including the agenda
and questions for the committee, will be available to the public on
January 9, 2002, on the Internet at http://www.fda.gov/cdrh/
panelmtg.html.
Procedure: On January 10, 2002, from 9:30 a.m. to 1 p.m., and from
2 p.m. to 5 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 January 4, 2002. Oral presentations from the
public will be scheduled between approximately 9:30 a.m. and 10 a.m. on
January 10, 2002. Near the end of the committee deliberations for the
PMA, a 30-minute open public session will be conducted for interested
persons to address issues specific to the submission before the
committee. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before January 4, 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.
Closed Presentation of Data: On January 10, 2002, from 1 p.m. to 2
p.m., the meeting will be closed to the public to permit the committee
to discuss and review trade secret and/or confidential commercial
information presented by a sponsor (5 U.S.C. 552b(c)(4)).
FDA regrets that it was unable to publish this notice 15 days prior
to the January 10, 2002, Orthopaedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee meeting. Because the agency
believes there is some urgency to bring this issue 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: December 18, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-31578 Filed 12-21-01; 8:45 am]
BILLING CODE 4160-01-S