[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Notices]
[Page 56194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28556]
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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). At least one
portion of the meeting will be closed 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 November 19 and 20,
1997, 8 a.m. to 5 p.m., and on November 21, 1997, 8 a.m. to 3 p.m.
Location:
November 19, 1997: Bethesda Ramada Inn, Embassy Ballroom, 8400
Wisconsin Ave., Bethesda, MD.
November 20 and 21, 1997: Holiday Inn Bethesda, Versailles
Ballrooms I and II, 8120 Wisconsin Ave., Bethesda, MD.
Contact Person: Kathleen R. Reedy or Karen M. Templeton-Somers,
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, 1-800-741-8138 (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 November 19, 1997, the committee will discuss new drug
application (NDA) 20-741, PrandinTM or ActulinTM
(repaglinide, Novo Nordisk) for the treatment of type 2 diabetes in
patients whose hyperglycemia cannot be controlled satisfactorily by
diet and exercise alone. On November 20, 1997, the committee will
discuss NDA 20-815, EvistaTM (raloxifene hydrochloride, Eli
Lilly and Co.) for the prevention of postmenopausal osteoporosis. On
November 21, 1997, the committee will meet in closed session to permit
discussion and review of trade secret and/or confidential information.
Procedure: On November 19 and 20, 1997, from 8 a.m. to 5 p.m., the
meeting is open to the public. 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
November 14, 1997. Oral presentations from the public will be scheduled
between approximately 8 a.m. and 8:30 a.m. on November 19 and 20, 1997.
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before
November 14, 1997, 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.
Closed Committee Deliberations: On November 21, 1997, 8 a.m. to 3
p.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The
investigational new drug (IND) and Phase I and II drug products in
process will be presented and recent action on selected NDA's will be
discussed.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 22, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-28556 Filed 10-28-97; 8:45 am]
BILLING CODE 4160-01-F
