[Federal Register Volume 64, Number 216 (Tuesday, November 9, 1999)]
[Notices]
[Pages 61115-61116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29223]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Gastroenterology and Urology 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: Gastroenterology and Urology 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 19, 1999, 8
a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Mary J. Cornelius, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194, ext. 118, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12523. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will discuss, make recommendations, and vote
on a premarket approval application for an optical device intended to
assist in the evaluation of colonic polyps using laser-induced
autofluorescence.
Procedure: On November 19, 1999, from 8:30 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
[[Page 61116]]
person by November 15, 1999. Oral presentations from the public will be
scheduled between approximately 9:15 a.m. and 9:45 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 November 15, 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 November 19, 1999, from 8 a.m.
to 8:30 a.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential commercial information
regarding pending and future device issues (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 November 19, 1999, Gastroenterology and Urology 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 Gastroenterology and Urology 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: October 29, 1999.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 99-29223 Filed 11-8-99; 8:45 am]
BILLING CODE 4160-01-F
