[Federal Register Volume 65, Number 10 (Friday, January 14, 2000)]
[Notices]
[Pages 2415-2416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-981]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology 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). At least one
portion of the meeting will be closed to the public.
Name of the Committee: Obstetrics and Gynecology 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 January 24, 2000, from 9
a.m. to 6 p.m., and January 25, 2000, from 8 a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Elisa D. Harvey, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180, or FDA Advisory
Committee Information Line, 1-800-741-8138 (or 301-443-0572 in the
Washington, DC area), code 12524. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On January 24, 2000, the committee will discuss, make
recommendations, and vote on a premarket approval application for a
fetal pulse oximeter. On January 25, 2000, the committee will discuss a
draft guidance document on adhesion barrier products intended for use
in pelvic and/or abdominal surgery. The draft guidance document is
available to the public on the Internet at http://www.fda.gov/cdrh/ode/
resorbable.pdf and http://www.fda.gov/cdrh/ode/1356.html, or by
contacting CDRH Facts-on-Demand at 1-800-899-0381 or 301-827-0111,
specify number 1356 when prompted for the document shelf number.
Procedure: On January 24, 2000, from 9 a.m. to 6 p.m., and January
25, 2000, from 9 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 January 20, 2000. Oral
presentations from the public will be scheduled between approximately
9:15 a.m. and 9:45 a.m. and 5 p.m. and 5:30 p.m. on January 24, 2000,
and between approximately 9:30 a.m. and 10 a.m. on January 25, 2000.
Time allotted for each presentation may be limited. Those desiring to
make formal presentations should notify the contact person before
January 20, 2000, and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and address
of proposed participants, and an indication of the approximate time
requested to make their presentation.
Closed Committee Deliberations: On January 25, 2000, from 8 a.m. to
9 a.m., the meeting will be closed to the public. The committee will
hear and review trade secret and/or confidential commercial information
on pending and future applications under review. This portion of the
meeting will be closed to permit discussion of this information (5
U.S.C. 552b(c)(4)).
FDA regrets that it was unable to publish this notice 15 days prior
to the January 25, 2000, Obstetrics and Gynecology Devices Panel of the
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 Obstetrics and
[[Page 2416]]
Gynecology Devices Panel of the Medical Devices Advisory Committee were
available at this time, the Commissioner of Food and Drugs 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: January 10,2000
Linda A. Suydam,
Senior Associate Commissioner
[FR Doc. 00-981 Filed 1-13-00; 8:45 am]
BILLING CODE 4160-01-F