[Federal Register: March 1, 2002 (Volume 67, Number 41)]
[Notices]               
[Page 9456]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01mr02-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Joint Meeting of the Gastrointestinal Drugs Advisory Committee 
and the Drug Safety and Risk Management Subcommittee of the Advisory 
Committee for Pharmaceutical Science; 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: Gastrointestinal Drugs Advisory Committee and 
the Drug Safety and Risk Management Subcommittee of the Advisory 
Committee for Pharmaceutical Science.
    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 April 23, 2002, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, 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 at 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. Background materials 
for this meeting when available will be posted on the Internet one 
business day before the meeting 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.
    Agenda: The committee will discuss risk management for new drug 
application (NDA) 21-107, LOTRONEX (alosetron), GlaxoSmithKline.
    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 April 15, 
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 April 15, 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 
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 Thomas 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: February 22, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
Relations.
[FR Doc. 02-4890 Filed 2-28-02; 8:45 am]
BILLING CODE 4160-01-P