[Federal Register: June 13, 2000 (Volume 65, Number 114)]
[Notices]
[Page 37155-37156]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn00-86]

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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's regulatory issues.
    Date and Time: The meeting will be held on June 26 and 27, 2000,
8:30 a.m. to 5:30 p.m.
    Location: Marriott Washington Center, Ballrooms A through E, 9751
Washington Blvd., Gaithersburg, 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.
    Agenda: On June 26, 2000, the committee will discuss new drug
application (NDA) 21-200, Zelmac<SUP>TM</SUP> (tegaserod), Novartis
Pharmaceuticals Corp., for the treatment of abdominal pain and
discomfort, bloating and altered bowel function in patients with
irritable bowel syndrome who have predominant symptoms of pain,
discomfort, and constipation. On June 27, 2000, the committee will
discuss risk management of post-marketing adverse events associated
with NDA 21-107, Lotronex<SUP>TM</SUP> (alosetron) Glaxo Wellcome.
    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 June 19, 2000.
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 June 19, 2000, 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.
    FDA regrets that it was unable to publish this notice 15 days prior
to the June 26 and 27, 2000, Gastrointestinal Drugs Advisory Committee
meeting. Because the agency believes there is some urgency to bring
this issue to public discussion and qualified members of the
Gastrointestinal Drugs Advisory Committee were available at this time,
the Commissioner of Food and Drugs concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

[[Page 37156]]

    Dated: June 5, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-14805 Filed 6-12-00; 8:45 am]
BILLING CODE 4160-01-F