[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Page 62419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


General and Plastic Surgery 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: General and Plastic Surgery 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 December 1, 2011, 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.
    Contact Person: Avena Russell, Food and Drug Administration, Center 
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 
66, rm. 1535, Silver Spring, MD 20993-0002, 301-796-3805, 
[email protected], 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 December 1, 2011, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application, sponsored by Contura, Inc., for AQUAMID, a new 
material (polyacrylamide) for use as a dermal filler for aesthetic 
treatment of wrinkles in the face. The AQUAMID dermal filler is 
intended for use in mid-to-deep sub-dermal implantation for the 
aesthetic treatment of moderate to severe facial wrinkles and folds, 
such as the nasolabial folds. 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 
November 22, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m., immediately following lunch. 
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 
November 14, 2011. 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 November 15, 
2011.
    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, 
Conference Management Staff, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 4, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-25969 Filed 10-6-11; 8:45 am]
BILLING CODE 4160-01-P