[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Page 71045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29528]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

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 February 10, 2012, from 
8 a.m. to 6 p.m.
    Location: Hilton Washington, DC North/Gaithersburg, salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone 
number is (301) 977-8900.
    Contact Person: Avena Russell, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1535, Silver Spring, MD 20993-0002, [email protected], 
(301) 796-3805, or FDA Advisory Committee Information Line, 1-(800) 
741-8138, (301) 443-0572 in the Washington, DC area), and follow the 
prompts to the desired center or product area. 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 February 10, 2012, the committee will discuss and make 
recommendations regarding the possible reclassification of cranial 
electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 
48062), FDA issued a proposed rule which, if made final, would make CES 
devices Class III requiring premarket approval. In response to the 
proposed rule, FDA received petitions under section 515(b)(2)(B) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) 
requesting a change in classification. The reclassification petitions 
are available for public review and comment at http://www.regulations.gov under docket number FDA-2011-N-0504. The committee 
discussion will include the existing data to support CES safety and 
effectiveness and whether the data are sufficient to develop special 
controls to support regulation of these devices under Class II.
    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://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 
February 6, 2012. Oral presentations from the public will be scheduled 
between approximately 10 a.m. and 11 a.m. Those individuals interested 
in making 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 27, 2012. 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 30, 2012.
    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 James Clark at 
[email protected] or (301) 796-5293, 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://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29528 Filed 11-15-11; 8:45 am]