[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80948-80949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Endocrinologic and Metabolic Drugs 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: Endocrinologic and Metabolic Drugs Advisory 
Committee.

[[Page 80949]]

    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 22, 2012, 
from 8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 
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 Bldg. 1.
    Contact Person: Paul Tran, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, (301) 796-9001, 
Fax: (301) 847-8533, email: [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: The committee will discuss the safety and efficacy of 
new drug application (NDA) 22-580, proposed trade name QNEXA 
(phentermine/topiramate) Controlled-Release Capsules, manufactured 
by VIVUS, Inc., as an adjunct to diet and exercise for weight 
management in patients with a body mass index (BMI) equal to or 
greater than 30 kilograms (kg) per square meter or a BMI equal to or 
greater than 27 kg per square meter if accompanied by weight-related 
comorbidities.
    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 
February 7, 2012. 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 30, 2012. 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 
January 31, 2012.
    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 Paul Tran 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: December 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33059 Filed 12-23-11; 8:45 am]
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