[Federal Register Volume 64, Number 205 (Monday, October 25, 1999)]
[Notices]
[Pages 57472-57473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27758]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
LotronexTM (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
