[Federal Register: December 6, 2006 (Volume 71, Number 234)]
[Page 70780]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Neurological 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 Committee: Neurological 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 26, 2007, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington, DC North/Gaithersburg, Salons A, B, 
and C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Janet L. Scudiero, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3737, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512513. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss and make recommendations on a 
premarket notification application for a device intended for the 
treatment of major depressive disorder. The committee will also hear 
and discuss post approval study reports for two recently approved 
neurological device premarket approval applications. The agency intends 
to make background available to the public no later than 1 business day 
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 the agency 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 2006 and scroll down to 

the appropriate advisory committee link.
    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 
January 19, 2007. Oral presentations from the public will be scheduled 
for 30 minutes at the beginning of the committee deliberations and for 
30 minutes near the end of the committee deliberations. 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 January 11, 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 January 12, 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, 
Conference Management Staff, at 301-827-7291, at least 7 days in 
advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 29, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-20552 Filed 12-5-06; 8:45 am]