[Federal Register Volume 65, Number 1 (Monday, January 3, 2000)]
[Notices]
[Pages 133-134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-34068]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
General and Plastic Surgery 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: General and Plastic Surgery 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.
[[Page 134]]
Date and Time: The meeting will be held on January 12, 2000, 10
a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: David Krause, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12519. Please call the Information Line or access the
Internet address of http://www.fda.gov/cdrh/panelmtg.html for up-to-
date information on this meeting.
Agenda: The committee will discuss, make recommendations, and vote
on a premarket approval application for an Absorbable Adhesion Barrier
Device.
Procedure: On January 12, 2000, from 10:30 a.m. to 5 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
December 29, 1999. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 11:30 a.m., and between approximately
3 p.m. and 3:30 p.m. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before January 5, 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 January 12, 2000, from 10 a.m.
to 10:30 a.m., the meeting will be closed to permit FDA to present to
the committee trade secret and/or confidential commercial information
(5 U.S.C. 552b(c)(4)) relating to pending issues and applications.
FDA regrets that it was unable to publish this notice 15 days prior
to the January 12, 2000, General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee meeting. Because the agency
believes there is some urgency to bring these issues to public
discussion and qualified members of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee meeting were
available at this time, the Commissioner of Food and Drugs concluded
that it was in the public interest to hold this meeting even if there
was not sufficient time for the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C., app. 2).
Dated: December 21, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-34068 Filed 12-29-99; 2:12 pm]
BILLING CODE 4160-01-F
