Document ID: FDA-2014-N-0238-0001
Agency: fda
Document Type: Notice
Title: Neurological Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting; Request for Comments
Posted Date: 2014-03-27T04:00Z

[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17155-17156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0238]

Neurological Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting; Request for Comments

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). 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 April 24, 2014, from 8 
a.m. to 6 p.m.
    Location: Holiday Inn, Main Ballroom, 2 Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900.
    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, Avena.Russell@fda.hhs.gov, 
301-796-3805, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm 
and scroll down to the appropriate advisory committee meeting link, or 
call the advisory committee information line to learn about possible 
modifications before coming to the meeting.
    Agenda: On April 24, 2014, the committee will discuss the current 
knowledge about the safety and effectiveness of aversive conditioning 
devices that are intended to deliver a noxious electrical stimulus to a 
patient to modify undesirable behavioral characteristics. FDA is 
convening this committee to seek clinical and scientific expert opinion 
on the risks and benefits of certain aversive conditioning devices 
based on available scientific data and information. The Agency is 
considering whether to ban aversive conditioning devices that are 
intended to administer a noxious electrical stimulus to a patient to 
modify undesirable behavioral characteristics. The meeting will concern 
only devices classified under 21 CFR 882.5235 (aversive conditioning 
device, class II) that are not self-administered. Devices which deliver 
a noxious electrical stimulus automatically are not considered to be 
self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) 
sets forth the standard for banning devices. Under that provision, in 
order to ban a device, FDA must make a finding that a device ``presents 
substantial deception or an unreasonable and substantial risk of 
illness or injury'' based on all available data and information. FDA 
regulations provide additional details about the procedures and 
standards for banning a device (21 CFR part 895).
    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 meeting 
link.
    Procedure: FDA will work with affected industry, professional 
organizations, and societies that have an interest in aversive 
conditioning devices and who wish to make a presentation separate from 
the general open public hearing; time slots on April 24, 2014, between 
approximately 11 a.m. and 12 p.m. Representatives from industry, 
professional organizations and societies interested in making formal 
presentations to the committee should notify the contact person on or 
before March 28, 2014.
    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 April 14, 
2014. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.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 April 4, 2014. 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 April 7, 2014.
    FDA is opening a docket for public comment on this document. The 
docket number is FDA-2014-N-0238. The docket will close on June 24, 
2014. Interested persons are encouraged to use the docket to submit 
electronic or written comments regarding this meeting. Comments 
received on or before April 14, 2014, will be provided to the committee 
for their consideration. Comments received after May 27, 2014 will be 
taken into consideration by the Agency.
    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    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 accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams at 
Annmarie.Williams@fda.hhs.gov, or 301-796-5966 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.

[[Page 17156]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 20, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-06766 Filed 3-26-14; 8:45 am]
BILLING CODE 4160-01-P