Document ID: FDA-2010-N-0001-0127
Agency: fda
Document Type: Notice
Title: Meetings: Endocrinologic and Metabolic Drugs Advisory Committee
Posted Date: 2010-10-19T04:00Z

[Federal Register: October 19, 2010 (Volume 75, Number 201)]
[Notices]               
[Page 64313-64314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc10-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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.
    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 7, 2010, 
from 8 a.m. to 5 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 ``White Oak Conference 
Center Parking and Transportation Information for FDA Advisory 
Committee Meetings''.
    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: 
301-847-8540, e-mail: paul.tran@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512536. 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 7, 2010, the committee will discuss the 
safety and efficacy of new drug application (NDA) 20-0063, proposed 
tradename CONTRAVE (naltrexone HCl/bupropion HCl) extended-release 
tablets, manufactured by Orexigen Therapeutics, Inc., for the 
treatment of obesity and weight management, including weight loss 
and maintenance of weight loss in patients with an initial body mass 
index (BMI) of equal to or greater than 30 kilograms (kg) per square 
meter, or a BMI equal to or greater than 27 kg per square meter with 
one or more risk factors (e.g. diabetes, dyslipidemia, or 
hypertension). The BMI is a measure of body weight (mass) based on a 
person's weight and height, and is a widely-used tool for doctors in 
assessing optimum weights for a patient.
    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, 2010. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. 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 12, 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 15, 
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

[[Page 64314]]

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: October 14, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.

[FR Doc. 2010-26251 Filed 10-18-10; 8:45 am]
BILLING CODE 4160-01-P