[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Agenda: On July 14, 1997, the committee will consider a draft
guidance document on the study and evaluation of intrapartum continuous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15, 1997, the committee will consider a draft guidance document on the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
