[Federal Register: November 9, 2007 (Volume 72, Number 217)]
[Notices]
[Page 63617-63618]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no07-80]
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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 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
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
[[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
meetings.
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]
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