[Federal Register: October 25, 1999 (Volume 64, Number 205)]
[Notices]               
[Page 57472-57473]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25oc99-71]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Gastrointestinal 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: Gastrointestinal Drugs Advisory Committee
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on November 16, 1999, 9 
a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Joan C. Standaert, Center for Drug Evaluation and 
Research (HFD-180), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 419-259-6211, or John M. Treacy (HFD-21), 301-827-
7001, 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 new drug application 21-107, 
Lotronex<SUP>TM</SUP> (alosteron HCI), Glaxo-Wellcome Pharmaceuticals, 
to be indicated for treatment of irritable bowel in female patients 
with diarrhea predominance.

[[Page 57473]]

    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 November 9, 
1999. Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 10 a.m. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before November 9, 1999, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 12, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-27758 Filed 10-22-99; 8:45 am]
BILLING CODE 4160-01-F