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[Federal Register: June 8, 2001 (Volume 66, Number 111)]
[Notices]               
[Page 30935-30936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn01-71]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Endocrinologic and Metabolic Drugs Advisory Committe; 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's regulatory issues.
    Date and Time: The meeting will be held on July 26 and 27, 2001, 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact: Kathleen Reedy or LaNise Giles, Center for Drug Evaluation 
and Research (HFD-21), Food and Drug

[[Page 30936]]

Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers 
Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX 301-827-6776, 
or e-mail: <A HREF="mailto:reedyk@cder.fda.gov">reedyk@cder.fda.gov</A>, 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 July 26, 2001, the committee will discuss new drug 
application (NDA) 21-332, Symlin<SUP>TM</SUP> (pramlintide acetate, 
Amylin Pharmaceuticals, Inc.) as an adjunctive therapy to insulin to 
improve glycemic and metabolic control in patients with type 1 or type 
2 diabetes mellitus alone or in combination with oral hypoglycemic 
agents. On July 27, 2001, the committee will discuss NDA 21-318, 
Forteo<SUP>TM</SUP> (teriparatide injection, rDNA origin, Eli Lilly and 
Co.) for the treatment of osteoporosis in men and in postmenopausal 
women.
    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 July 20, 2001. 
Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 11:30 a.m. each day. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 20, 2001, 
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: May 31, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-14410 Filed 6-7-01; 8:45 am]
BILLING CODE 4160-01-S

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