[Federal Register: October 19, 1999 (Volume 64, Number 201)]
[Notices]               
[Page 56352]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc99-86]                         




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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 November 4, 1999, 9 a.m. 
to 4:30 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: 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: On November 4, 1999, the committee will discuss and make 
recommendations on the reclassification of constrained total hip 
arthroplasty devices. The committee will also discuss the development 
of computer controlled surgical systems designed for use in orthopaedic 
procedures.
    Procedure: On November 4, 1999, from 9 a.m. to 3 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 
October 29, 1999. On November 4, 1999, oral presentations from the 
public regarding the reclassification of constrained total hip 
arthroplasy devices and the development of computer controlled surgical 
systems designed for use in orthopaedic procedures will be scheduled 
between approximately 11 a.m. and 11:30 a.m. and between approximately 
2:30 p.m. and 3 p.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person by October 29, 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.
    Closed Presentation of Data: On November 4, 1999, from 3 p.m. to 4 
p.m., the meeting will be closed to permit a sponsor to present to the 
committee trade secret and/or confidential commercial information on a 
clinical study design. This portion of the meeting will be closed to 
permit discussion of this information (5 U.S.C. 552b(c)(4)).
    Closed Committee Deliberations: On November 4, 1999, from 4 p.m. to 
4:30 p.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)).
    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. 99-27158 Filed 10-18-99; 8:45 am]
BILLING CODE 4160-01-F