[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, Prandin<SUP>TM</SUP> or Actulin<SUP>TM</SUP> 
(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, Evista<SUP>TM</SUP> (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