[Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Notices]
[Page 14281-14282]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr07-48]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0090]
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 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
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 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.
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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 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]
BILLING CODE 4160-01-S