[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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