[Federal Register: January 10, 2001 (Volume 66, Number 7)]
[Notices]               
[Page 1995]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja01-107]                         

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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 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 29, 2001, 8 a.m. 
to 5 p.m.
    Location: Marriott Washingtonian Center, Salons A, B, and C, 9751 
Washingtonian Blvd., 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 (301-443-0572 in the 
Washington, DC area), code 12524. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for an endometrial ablation device.
    Procedure: On January 29, 2001, 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 19, 2001. Oral presentations from the public will be scheduled 
between approximately 9:30 a.m. and 10 a.m. and between approximately 
3:30 p.m. and 4 p.m. Time allotted for each presentation may be 
limited. Those desiring to make formal presentations should notify the 
contact person before January 19, 2001, 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 January 29, 2001, from 8 a.m. to 
9 a.m., the meeting will be closed to the public to permit FDA to 
present to the committee trade secret and/or confidential commercial 
information (5 U.S.C. 552b(c)(4)) regarding pending and future device 
issues.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 28, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-682 Filed 1-9-01; 8:45 am]
BILLING CODE 4160-01-S