[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Notices]
[Pages 47821-47822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19484]


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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

[[Page 47822]]

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 September 15 and 16, 
2010, from 8 a.m. to 5 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College (UMUC), 3501 University Blvd. East, 
Adelphi, MD. The hotel telephone number is 301-985-7300.
    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, e-
mail: [email protected], 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 September 15, 2010, the committee will discuss the 
results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01-
392), for new drug application (NDA) 20-632, MERIDIA (sibutramine 
hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories, 
for treatment of obesity. The SCOUT study was a randomized, double-
blind, placebo-controlled trial, which is a kind of clinical trial 
designed to provide data with strong measures of accuracy and 
reliability. The SCOUT trial evaluated the potential benefits of weight 
loss with MERIDIA on major cardiovascular (heart and blood circulation) 
adverse events. The preliminary results of the SCOUT trial indicated 
that clinical trial participants who received MERIDIA instead of 
placebo (no active drug) had a higher incidence of major cardiovascular 
adverse events that was statistically significant.
    On September 16, 2010, the committee will discuss the safety and 
efficacy of new drug application (NDA) 22-529, with the proposed trade 
name LORQESS (lorcaserin hydrochloride) Tablets, sponsored by Arena 
Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight 
management in patients with a 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 if accompanied by weight-related 
co-morbidities (which include, for example: High blood pressure, heart 
disease, or diabetes). 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 
August 31, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on both days. 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 August 23, 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 August 24, 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 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: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-19484 Filed 8-6-10; 8:45 am]
BILLING CODE 4160-01-S