[Federal Register Volume 79, Number 5 (Wednesday, January 8, 2014)]
[Notices]
[Pages 1382-1383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00089]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Anesthesiology and Respiratory Therapy 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: Anesthesiology and Respiratory Therapy 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 20, 2014, from
8 a.m. to 6 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.
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.
Contact Person: Shanika Craig, Food and Drug Administration, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg.
66, Rm. 1613, Silver Spring, MD 20993, 301-796-6639,
[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 February 20, 2014, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application regarding the Inspire II Upper Airway Stimulator,
sponsored by Inspire Medical Systems, Inc. The Inspire II Upper Airway
Stimulator is a permanently implanted device intended to treat moderate
to severe obstructive sleep apnea in patients who are not effectively
treated by continuous positive airway pressure devices. The device
stimulates the hypoglossal nerve synchronous with inspiration in order
to contract the patient's upper airway muscles and help maintain airway
patency during sleep.
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
[[Page 1383]]
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
February 10, 2014. On February 20, 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
January 31, 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 February 3,
2014.
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 James Clark,
Committee Management Staff, [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: January 3, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00089 Filed 1-7-14; 8:45 am]
BILLING CODE 4160-01-P