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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

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                               ( print 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