[Federal Register: July 25, 2006 (Volume 71, Number 142)]
[Page 42097]
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). The meeting will 
be open to the public.
    Name of the 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 August 29, 2006, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Montgomery 
Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact: Michael Bailey, 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 
Hotline, 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.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for a non-invasive device for use 
as a complement to clinical breast examination in asymptomatic women 
between the ages of 30 to 39. Background information, including the 
agenda and questions for the committee, will be available to the public 
one business day before the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panel
 (click on ``Upcoming CDRH Advisory Panel/

Committee Meetings'').
    Procedure: 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 
August 22, 2006. Oral presentations from the public will be scheduled 
between approximately 8:15 a.m. and 8:45 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 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 
August 22, 2006.
    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 accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams at 
least 7 days in advance of the meeting at 301-827-7291.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11773 Filed 7-24-06; 8:45 am]