[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Notices]
[Pages 30339-30340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14297]
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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 may 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.
Date and Time: The meeting will be held on June 16, 1999, 10 a.m.
to 5 p.m.
Location: Hilton Hotel, Salons C, D, and E, 620 Perry Pkwy.,
Gaithersburg, 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 (http://www.fda.gov/cdrh/upadvmtg) for up-to-date information
on this meeting.
Agenda: The committee will discuss, make recommendations, and vote
on premarket approval application for computer-guided surgical
instruments for use in endoscopic surgery.
Procedure: On June 16, 1999, from 10 a.m. to 1:30 p.m., and from 2
p.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 June 11,
[[Page 30340]]
1999. Oral presentations from the public will be scheduled between
approximately 10:15 a.m. and 10:45 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 June 9, 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 June 16, 1999, from 1:30 p.m. to
2 p.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential commercial information (5 U.S.C.
552b(c)(4)). This portion of the meeting will be closed to permit
discussion of this information.
FDA regrets that it was unable to publish this notice 15 days prior
to the June 16, 1999, General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee meeting. Because the agency believes
there is some urgency to bring this issue to public discussion and
qualified members of the General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee were available at this time, the
Commissioner 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: June 2, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
[FR Doc. 99-14297 Filed 6-3-99; 11:59 am]
BILLING CODE 4160-01-F
