
[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]               
[Page 57968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se10-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Gastroenterology and Urology 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: Gastroenterology and Urology 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 2 and 3, 2010, 
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 
Perry Pkwy., Gaithersburg, MD.
    Contact Person: Margaret McCabe-Janicki, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-
796-7029, or FDA Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), code 3014512523. 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 2, 2010, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application (PMA) for SOLESTA, sponsored by Oceana 
Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal 
incontinence in patients who have failed conservative therapy. On 
December 3, 2010, the committee will discuss, make recommendations, and 
vote on information related to the PMA for the LAP-BAND Adjustable 
Gastric Banding System, sponsored by Allergan. The sponsor is 
requesting an expanded Indication for Use for their LAP-BAND Adjustable 
Gastric Banding System to include weight reduction in patients with a 
Body Mass Index (BMI) of at least 35 kg/m\2\ or a BMI of at least 30 
kg/m\2\ with one or more comorbid conditions.
    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 18, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on December 2 and 3, 2010. 
Those desiring to make 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 10, 2010. 
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 11, 2010.
    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: September 17, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-23842 Filed 9-22-10; 8:45 am]
BILLING CODE 4160-01-S

