[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draft guidance document on adhesion barrier products intended for use 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 The draft guidance document is 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 <a href="http://www.fda.gov/cdrh/ode/
resorbable.pdf">http://www.fda.gov/cdrh/ode/
resorbable.pdf</a> 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