[Federal Register Volume 64, Number 123 (Monday, June 28, 1999)]
[Notices]
[Pages 34659-34660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16315]
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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 July 26, 1999, 10:30
a.m. to 5 p.m., and July 27, 1999, 7:30 a.m. to 2:30 p.m.
Location: Hilton Hotel, Salons B and C, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Hany W. Demian or Mark N. Melkerson, 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.
[[Page 34660]]
Agenda: On July 27, 1999, the committee will discuss and make
recommendations on the classification of bone dowel devices of human
origin.
Procedure: On July 27, 1999, from 7:30 a.m. to 2:30 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
July 16, 1999. Oral presentations from the public regarding the
classification of bone dowel devices will be scheduled between
approximately 8:45 a.m. and 9:45 a.m. on July 27, 1999. Near the end of
committee deliberations, a 30-minute open public session will be
conducted for interested persons to address issues specific to the
submission before the committee. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person by July 16, 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 Committee Deliberations: On July 26, 1999, from 10:30 a.m.
to 5 p.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential commercial information on a product
development protocol. 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: June 22, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-16315 Filed 6-25-99; 8:45 am]
BILLING CODE 4160-01-F
