[Federal Register: February 7, 2002 (Volume 67, Number 26)]
[Page 5830]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

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: Gastrointestinal 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 March 19, 2002, from 8 
a.m. to 5:30 p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact Person: Thomas H. Perez, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6758, e-mail: PerezT@cder.fda.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 12538. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss standards in study designs of 
clinical trials testing the efficacy and safety of chemopreventive 
agents that are being developed to gain FDA approval in reducing the 
risk of sporadic colorectal adenomatous polyps and sporadic colorectal 
    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 by March 11, 
2002. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 11, 2002, 
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 
    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 Thomas H. Perez 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: January 31, 2002.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-2951 Filed 2-6-02; 8:45 am]