[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possible revisions to the document entitled ``Draft Guidance For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 Single copies of the draft guidance are available to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