[Federal Register: August 1, 2002 (Volume 67, Number 148)]
[Notices]               
[Page 49945]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au02-66]                         


[[Page 49945]]

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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's regulatory issues.
    Date and Time: The meeting will be held on September 25, 26, and 
27, 2002, from 8 a.m. to 5 p.m.
    Location: Hilton, The Ballroom, 8727 Colesville Rd., Silver Spring, 
MD.
    Contact Person: Kathleen Reedy or LaNise Giles, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug 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: 
reedyk@cder.fda.gov, 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 September 25, 2002, the committee will discuss 
appropriate designs for clinical trials of new osteoporosis treatments. 
On September 26, 2002, the committee will discuss the safety and 
efficacy of biologic licensing application BL 103979, FABRAZYME 
(agalsidase beta, Genzyme Corp.) for the treatment of Fabry's disease. 
On September 27, 2002, the committee will discuss the safety and 
efficacy of biologic licensing application BL 103977, REPLAGAL 
(agalsidase alfa, Transkaryotic Therapies) for the treatment of Fabry's 
disease.
    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 September 17, 
2002. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before September 17, 2002, 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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact LaNise Giles at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 22, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-19375 Filed 7-31-02; 8:45 am]
BILLING CODE 4160-01-S