[Federal Register Volume 62, Number 179 (Tuesday, September 16, 1997)]
[Notices]
[Page 48665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24509]
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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). The meeting will
be open 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 October 6, 1997, 8:30
a.m. to 5 p.m., and October 7, 1997, 8:30 a.m. to 2 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), Obstetrics and Gynecology Devices Panel, code
12524. Please call the Information Line for up-to-date information on
this meeting.
Agenda: On October 6, 1997, the committee will discuss and make
recommendations on a premarket approval application for a thermal
endometrial ablation device. On October 7, 1997, the committee will
discuss and advise FDA on a petition for reclassification of home
uterine activity monitors from class III (premarket approval) to class
II (special controls).
Procedure: 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 September 29,
1997. Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9:30 a.m. on October 6 and 7, 1997. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
September 29, 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 required to make their presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 8, 1997
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-24509 Filed 9-15-97; 8:45 am]
BILLING CODE 4160-01-F
