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Food and Drug Administration, HHS.
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 December 13, 2007, from 8 a.m. to 5 p.m., and on December 14, 2007, from 8 a.m. to 1:15 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Michael Bailey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4100, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
Agenda: On December 13, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application for the Adiana Transcervical Sterilization System, sponsored by Cytyc Surgical Products. This device is indicated to be used as a permanent method for female sterilization. On December 14, 2007, the committee will have a general topic discussion of clinical trial design issues for endometrial ablation devices indicated for pre-menopausal women in whom childbearing is complete and who no longer desire menses (i.e., monthly period). The committee will also hear and discuss a post-approval study update for the ExAblate 2000 System from InSightec, Inc. The system is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link.
Procedure: On December 13, 2007, from 8 a.m. to 5 p.m., and on December 14, 2007, from 9 a.m. to 1:15 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 on or before November 29, 2007. Oral presentations from the public will be scheduled on December 13, 2007, between approximately 8:15 a.m. and 8:45 a.m. and between approximately 3:30 p.m. and 4 p.m., and on December 14, 2007, between approximately 10 a.m. and 10:15 a.m. and between approximately 11:15 a.m. and 12:15 p.m. Those desiring to make formal oral presentations should notify the contact person 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 on or before November 21, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 23, 2007.
Closed Presentation of Data: On December 14, 2007, from 8 a.m. to 9 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)). The committee will hear an update on device submissions currently under review.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to Start Printed Page 63618accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240-276-8932, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Start Signature
Dated: November 2, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-21979 Filed 11-8-07; 8:45 am]
BILLING CODE 4160-01-S