[Federal Register: December 16, 2005 (Volume 70, Number 241)]
[Page 74823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Joint Meeting of the Nonprescription Drugs Advisory Committee and 
the 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 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-
    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 
    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 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]