[Federal Register Volume 67, Number 227 (Monday, November 25, 2002)]
[Notices]
[Pages 70611-70612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29808]


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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 January 13, 14, and 15, 
2003, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Karen M. Templeton-Somers, 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, e-mail: 
[email protected], 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 January 13, 2003, 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 January 14, 2003, the committee will discuss the safety and efficacy 
of biologic licensing application BL 103977, REPLAGAL (agalsidase alfa, 
Transkaryotic Therapies, Inc.) for the treatment of Fabry's disease. On 
January 15, 2003, the committee will discuss the safety and efficacy of 
biologic licensing application BL 125058, ALDURAZYME (laronidase, 
BioMarin Pharmaceutical, Inc.) for the treatment of 
mucopolysaccharidosis.
    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 January 6, 
2003. 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 January 6, 2003, 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.

[[Page 70612]]

    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 Karen M. Templeton-
Somers 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: November 15, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-29808 Filed 11-22-02; 8:45 am]
BILLING CODE 4160-01-S