[Federal Register Volume 64, Number 138 (Tuesday, July 20, 1999)]
[Notices]
[Pages 38909-38910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18383]


=======================================================================
-----------------------------------------------------------------------

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 July 29, 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 Hotline, 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 urethral bulking and 
coaptation device for the treatment of stress urinary incontinence due 
to intrinsic sphincter insufficiency. The committee will also discuss 
possible revisions to the document entitled ``Draft Guidance For 
Preparation of PMA Applications for Testicular Prostheses,'' issued 
March 16, 1993. Single copies of the draft guidance are available to 
the public by calling 1-800-899-0381 or 301-827-0111, and requesting 
Facts-On-Demand document number 809, or on the Internet at ``http://
www.fda.gov/cdrh/ode/oderp809.html''.
    Procedure: On July 29, 1999, from 8:30 a.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 
July 23, 1999. Oral presentations from the public will be scheduled 
between approximately 9 a.m. and 9:30 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 July 23, 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 July 29, 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 (5 U.S.C. 
552b(c)(4)) regarding present and future FDA issues.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the

[[Page 38910]]

July 29, 1999 Medical Devices Advisory Committee meeting. Because the 
agency believes there is some urgency to bring these issues to public 
discussion and qualified members 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: July 29, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-18383 Filed 7-19-99; 8:45 am]
BILLING CODE 4160-01-F