[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]
BILLING CODE 4160-01-F
