[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Notices]
[Page 37926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 regulatory issues.
    Date and Time: The meeting will be held on August 6, 1997, 10 a.m. 
to 5 p.m., and August 7, 1997, 9:30 a.m. to 2 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, 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: On August 6, 1997, the committee will hear a presentation 
of the basic concepts of FDA's Product Development Protocol Process. 
The committee will discuss issues relating to a premarket approval 
application (PMA) for an implanted neuromuscular stimulator for the 
management of urinary urge incontinence. On August 7, 1997, the 
committee will discuss and advise FDA on the classification of External 
Penile Rigidity Devices and an update of the Triage list of 
gastroenterology and urology devices will be presented and discussed.
    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 July 30, 1997. 
Oral presentations from the public will be scheduled between 
approximately 10 a.m. and 11 a.m. on August 6, 1997, and between 
approximately 9 a.m. and 10 a.m. on August 7, 1997. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 30, 1997, 
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 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-18524 Filed 7-14-97; 8:45 am]
BILLING CODE 4160-01-F