[Federal Register: November 25, 2002 (Volume 67, Number 227)]

[Notices]               

[Page 70611-70612]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr25no02-67]                         



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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: 

somersk@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 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]



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