[Federal Register: December 16, 2005 (Volume 70, Number 241)]
[Notices]
[Page 74823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de05-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Nonprescription Drugs Advisory Committee and
the 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 Committees: Nonprescription Drugs Advisory Committee (NDAC)
and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on January 23, 2006, from 8
a.m. to 5 p.m.
Location: Holiday Inn Select Bethesda, Versailles Ballrooms, 8120
Wisconsin Ave., Bethesda, MD. The hotel telephone number is 301-652-
2000.
Contact Person: Darrell Lyons, 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: lyonsd@cder.fda.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area) codes 3014512541 or 3014512536. Please call
the Information Line for up-to-date information on this meeting.
Agenda: The committees will consider the safety and efficacy of new
drug application (NDA) 21-887, proposing over-the-counter (OTC) use of
ORLISTAT (tetrahydrolipstatin) capsules (60 milligrams (mg)),
GlaxoSmithKline Consumer Healthcare, L.P., to promote weight loss in
overweight adults when used along with a reduced calorie and low fat
diet. The background material will become available no later than the
day before the meeting and will be posted under NDAC or EMDAC's docket
site 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 2006 and scroll down to NDAC or EMDAC).
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
Written submissions may be made to the contact person by January 13,
2006. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before January 13, 2006, 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.
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 Darrell Lyons 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: December 2, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-24101 Filed 12-15-05; 8:45 am]
BILLING CODE 4160-01-S