[Federal Register Volume 63, Number 58 (Thursday, March 26, 1998)]
[Notices]
[Page 14718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7897]


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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 May 13, 14, and 15, 
1998, 8 a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, 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, 1-800-741-8138 (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 May 13, 1998, the committee will discuss the science of 
corticosteroid induced osteoporosis. On May 14, 1998, the committee 
will discuss new drug application (NDA) 20-866, ErgosetTM, 
(bromocryptine mesylate, Ergoscience) as monotherapy as an adjunct to 
diet to improve glycemic control in patients with non-insulin-dependent 
diabetes mellitus, whose hyperglycemia cannot be satisfactorily managed 
with diet alone; or concomitantly with a sulfonylurea when diet and 
ErgosetTM alone do not result in glycemic control. On May 
15, 1998, the committee will discuss NDA 20-898, ThyrogenTM, 
(thyrotropin alpha, rTSH, Genzyme) as an adjunct for the detection of 
thyroid cancer.
    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 8, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m. on May 13, 14, and 15, 1998. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before May 
8, 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: March 19, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7897 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F