[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Page 55491]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 55491]]



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 October 31, 2006, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons 
C, D, and E, 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, 301-594-1184, 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 the post approval study reports for two recently approved 
neurological device premarket approval applications. Background 
information for the topics, including the agenda and questions for the 
committee, will be available to the public 1 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 
October 17, 2006. 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. 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 October 17, 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: September 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 06-8114 Filed 9-21-06; 8:45 am]