[Federal Register Volume 64, Number 201 (Tuesday, October 19, 1999)]
[Notices]
[Page 56352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27158]
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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
