[Federal Register Volume 63, Number 35 (Monday, February 23, 1998)]
[Notices]
[Pages 8986-8987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4529]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Endocrinologic and Metabolic 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: Endocrinologic and Metabolic 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 March 12 and 13, 1998, 8 
a.m. to 5 p.m.
    Location: Holiday Inn Gaithersburg, Walker Room, Two Montgomery 
Ave., Gaithersburg, MD.
    Contact Person: Kathleen R. Reedy or LaNise S. Giles, Center for 
Drug Evaluation and Research (HFD-21), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory 
Committee Information Line, 1-800-

[[Page 8987]]

 741-8138 (301-443-0572 in the Washington, DC area), code 12536. Please 
call the Information Line for up-to-date information on this meeting.
    Agenda: On March 12, 1998, the committee will discuss a proposed 
draft of a guidance document for the development of drugs for the 
treatment of diabetes mellitis. On March 13, 1998, the committee will 
discuss New Drug Application 20-766, XenicalTM, (orlistat 
tetrahydrolipstatin, Hoffman-LaRoche) for long term treatment of 
obesity.
    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 March 6, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m. on March 12 and 13, 1998. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before March 
6, 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: February 18, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-4529 Filed 2-20-98; 8:45 am]
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