[Federal Register Volume 66, Number 90 (Wednesday, May 9, 2001)]
[Notices]
[Pages 23719-23720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11732]


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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 May 21, 2001, 1 p.m. to 
5 p.m., and May 22, 2001, 8 a.m. to 5 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Joyce M. Whang, 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 Hotline, 1-800-741-8138 (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 May 21, 2001, the committee will discuss a supplement to 
a premarket approval application (PMA) for an intrapartum fetal pulse 
oximeter. The committee will also hear a presentation on the clinical 
trial of an intrapartum fundal pressure belt intended to reduce the 
incidence of operative deliveries. On May 22, 2001, in the morning 
session, the committee will discuss air and gas emboli associated with 
operative hysteroscopy. In the afternoon session, the committee will 
discuss uterine artery embolization. Background information and 
questions to the committee will be available to the public on May 18, 
2001, on the Internet at http://www.fda.gov/cdrh/panelmtg.html.
    Procedure: On May 21, 2001, from 1 p.m. to 5 p.m. and May 22, 2001, 
from 10 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 May 11, 2001. On May 21, 2001, oral 
presentations from the public will be scheduled between approximately 
1:30 p.m. and 2 p.m., and on May 22, 2001, oral presentations from the 
public will be scheduled between approximately 11:30 a.m. and 11:45 
a.m., and between approximately 2:45 p.m. and 3 p.m. Time allotted for 
each presentation may be limited. Those desiring to make formal 
presentations should notify the contact person before May 11, 2001, 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 May 22, 2001, from 8 a.m. to 10 
a.m., the meeting will be closed to the public to permit FDA to present 
to the

[[Page 23720]]

committee trade secret and/or confidential commercial information (5 
U.S.C. 552b(c)(4)) regarding pending and future device issues. In 
addition, the committee will discuss and review trade secret and/or 
confidential commercial information presented by a sponsor.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the May 21 and 22, 2001, 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 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: May 4, 2001.
Bonnie Malkin,
Special Assistant to the Senior Associate Commissioner.
[FR Doc. 01-11732 Filed 5-4-01; 4:54 pm]
BILLING CODE 4160-01-S