[Federal Register Volume 66, Number 143 (Wednesday, July 25, 2001)]
[Notices]
[Page 38714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18425]


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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). The meeting will 
be open 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 August 17, 2001, from 
9:30 a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 20B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact: Jeffrey W. Cooper, Center for Devices and Radiological 
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1220, ext. 121, 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 a device for the treatment of 
fecal incontinence. Background information and questions for the 
committee will be available to the public on August 16, 2001, on the 
Internet at http://www.fda.gov/cdrh/panelmtg.html.
    Procedure: 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 August 9, 
2001. Oral presentations from the public will be scheduled between 
approximately 10 a.m. and 10:30 a.m., and between approximately 3:30 
p.m. and 4 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before August 9, 2001, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 19, 2001.
Linda A Suydam,
Senior Associate Commissioner for Policy.
[FR Doc. 01-18425 Filed 7-24-01; 8:45 am]
BILLING CODE 4160-01-S