[Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Page 14281-14282]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2007N-0090]

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of 

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 
    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 June 13, 2007, from 8 
a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``2007N-0090'' and follow the 

prompts to submit your statement. Written comments should be submitted 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by 
close of business on May 30, 2007. All comments will be posted without 
change, including any personal information provided. Comments received 
on or before May 30, 2007, will be provided to the committee before or 
at the meeting.
    Location: Hilton Silver Spring, 8727 Colesville Rd., Silver Spring, 
MD. The hotel telephone number is 301-589-5200.
    Contact Person: Cathy A. Groupe, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, FAX: 301-827-6776, e-mail: Cathy.Groupe@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.
    Agenda: The committee will discuss the efficacy and safety of new 
drug application (NDA) 21-888, proposed tradename Zimulti (rimonabant), 
20 milligrams tablets, Sanofi-Aventis, as an adjunct to diet and 
exercise for obesity management in patients with a body mass index 
equal to or greater than 30 kilograms (kg) per square meter, or a body 
mass index equal to or greater than 27 kg per square meter if 
accompanied by at least one cardiovascular risk factor.
    FDA intends to make background material available to the public no 
later than 1 business day before the meeting. If FDA is unable to post 
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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 May 
30, 2007. 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 May 22, 2007. 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 on or before 
May 21, 2007.

[[Page 14282]]

    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Cathy Groupe at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 20, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-5506 Filed 3-26-07; 8:45 am]