[Federal Register Volume 62, Number 118 (Thursday, June 19, 1997)]
[Notices]
[Pages 33426-33427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 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 regulatory issues.
    Date and Time: The meeting will be held on July 14 and 15, 1997, 
8:30 a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, 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 (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    Agenda: On July 14, 1997, the committee will consider a draft 
guidance document on the study and evaluation of intrapartum continuous 
monitors for fetal oxygen saturation (fetal pulse oximeters) and fetal 
tissue pH. This document was prepared based on presentations and 
committee discussion at a meeting of this committee held on July 22, 
1996. For the remainder of July 14, 1997, and continuing through July 
15, 1997, the committee will consider a draft guidance document on the 
study and evaluation of in vivo devices for the detection of cervical 
cancer. Single copies of these two guidance documents will be available 
to the public after June 14, 1997, by contacting the Division of Small 
Manufacturers Assistance, 1350 Piccard Dr., Rockville, MD 20851, 1-800-
638-2041, or from the Internet: http://www.fda.gov.cdrh.draftgui.html.
    Procedure: On July 14, 1997, from 9:30 a.m. to 5 p.m., and on July 
15, 1997, 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 June 30, 1997. Oral presentations 
from the public will be scheduled between approximately 8:30 a.m. and 
9:30 a.m., on July 15, 1997. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before June 30, 1997, 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 14, 1997, from 8:30 a.m. to 
9:30 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
FDA staff will

[[Page 33427]]

present to the committee commercial information regarding various 
medical devices used in obstetrics and gynecology that are currently 
being evaluated by FDA.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C app. 2).

    Dated: June 12, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-16125 Filed 6-18-97; 8:45 am]
BILLING CODE 4160-01-F