[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63225-63226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Ear, Nose and Throat Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

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: Ear, Nose and Throat 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 November 8, 2013, from 8 
a.m. to 6 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.

[[Page 63226]]

    For those unable to attend in person, the meeting will also be 
Webcast. The Webcast will be available at the following link: https://collaboration.fda.gov/entdevices.
    Contact Person: Natasha Facey, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 1544, Silver Spring, MD 20993, 301-796-5290, 
[email protected], 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 November 8, 2013, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval (PMA) application for the Nucleus[supreg] HybridTM 
L24 Implant System sponsored by Cochlear Americas. The proposed 
Indications for Use for the Nucleus[supreg] HybridTM L24 
Implant System (as stated in the PMA) is as follows:
    The Nucleus[supreg] HybridTM L24 Implant System is 
intended for patients aged 18 years and older who have residual low-
frequency hearing sensitivity and bilateral severe to profound high 
frequency sensorineural hearing loss, and who obtain limited benefit 
from bilateral hearing aids.
    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: 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 31, 2013. 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 October 22, 2013. 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 October 24, 2013.
    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. Requests for sign language interpretation or 
Communication Access Realtime Translation (CART)/captioning must be 
made 2 weeks in advance of the meeting, no later than October 25, 2013.
    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: October 18, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-24832 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P