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[Federal Register Volume 65, Number 114 (Tuesday, June 13, 2000)]
[Notices]
[Pages 37155-37156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14805]

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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 [email protected], 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, ZelmacTM (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, LotronexTM (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
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