[Federal Register: November 9, 2007 (Volume 72, Number 217)]
[Page 63617-63618]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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, 
    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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to

[[Page 63618]]

accommodate 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 2, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-21979 Filed 11-8-07; 8:45 am]