[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17155-17156]
From the Federal Register Online via the Government Publishing 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, [email protected],
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
[email protected], 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