Food and Drug Administration, HHS.
Notice.End Preamble Start Supplemental Information
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).Start Signature
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