[Federal Register Volume 63, Number 80 (Monday, April 27, 1998)]
[Notices]
[Page 20638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11087]


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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 May 28 and 29, 1998, 9 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Joan C. Standaert, Center for Drug Evaluation and 
Research (HFD-110), Food and Drug Administration, 5600 Fishers Lane, 
Rockville MD 20857, 419-259-6211, or John B. Schupp (HFD-21), 301-443-
5455, 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 May 28, 1998, the committee will discuss biologics 
license application, 98-0012, Centocor, Inc.'s, AvakineTM 
(Infliximab), for treatment of patients with Crohn's disease. An 
indication is sought to: (1) Reduce signs and symptoms in patients with 
moderate to severe disease activity in whom conventional therapies are 
inadequate, and (2) close entercutaneous fistulas. On May 29, 1998, the 
committee will hold a general discussion on guidance for the study of 
drugs to treat Crohn's disease.
    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 May 21, 1998. 
Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 10 a.m., on May 28, 1998. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 21, 1998, 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: April 17, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-11087 Filed 4-24-98; 8:45 am]
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