[Federal Register Volume 64, Number 201 (Tuesday, October 19, 1999)]
[Notices]
[Pages 56351-56352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27154]
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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.
[[Page 56352]]
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 5, 1999, 8:30
a.m. to 5:30 p.m. (this notice is for the second day of a 2-day
meeting).
Location: Corporate Bldg., conference rm. 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: William Freas or Sheila D. Langford, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD, 20852, 301-827-
0314, 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 postmarketing studies of Genzyme
Corporation's Carticel (autologous chondrocytes manipulated ex-vivo for
structural repair) indicated for treatment and repair of clinically
significant, articular cartilage defects in the knee. The discussion
will focus on issues specific to these studies and on more general ones
related to the feasibility of randomized controlled trials in the field
of orthopaedics.
Procedure: On November 5, 1999, from 8:30 a.m. to 5:30 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
November 1, 1999. Oral presentations from the public will be scheduled
between approximately 8:45 a.m. and 9:15 a.m. and between approximately
1:00 p.m and 1:30 p.m. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before November 1, 1999, 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 12, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-27154 Filed 10-18-99; 8:45 am]
BILLING CODE 4160-01-F
