[Federal Register: October 19, 1999 (Volume 64, Number 201)]
[Notices]               
[Page 56351-56352]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc99-85]                         

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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