[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Page 62777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30914]
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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 regulatory issues.
Date and Time: The meeting will be held on December 11, 1997, 9
a.m. to 8 p.m., and December 12, 1997, 8 a.m. to 2 p.m.
Location: Holiday Inn, Versailles Ballrooms III and IV, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Jodi H. Nashman, 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 December 11, 1997, the committee will discuss, make
recommendations, and vote on one premarket approval application (PMA)
for a spinal intervertebral fusion device. Additionally, there will be
a general discussion of the minimum acceptable length of patient
followup for marketing approval of spinal implant devices. On December
12, 1997, the committee will discuss, make recommendations, and vote on
a PMA for an anti-adhesion barrier gel.
Procedure: On December 11, 1997, from 9 a.m. to 8 p.m., and on
December 12, 1997, from 9 a.m. to 2 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 3, 1997. Oral
presentations from the public regarding spinal intervertebral fusion
systems and devices will be scheduled between approximately 9 a.m. and
10 a.m., on December 11, 1997. Oral presentations from the public
regarding anti-adhesion barrier gels will be scheduled between 9 a.m.
and 10 a.m., on December 12, 1997. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before December 3, 1997, 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 12, 1997, from 8 a.m.
to 9 a.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4))
regarding present and future FDA issues.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 18, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-30914 Filed 11-24-97; 8:45 am]
BILLING CODE 4160-01-F
