
[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Notices]               
[Page 55114-55115]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se08-114]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
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). At least one 
portion of the meeting will be closed 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 October 21, 2008, from 8 
a.m. to 5 p.m.
    Location: Crowne Plaza Hotel/Washington DC-Silver Spring, The 
Ballrooms, 8777 Georgia Ave., Silver Spring, MD, 301-589-0800.
    Contact Person: Paul Tran, 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: paul.tran@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512536. Please call the Information Line 
for up-to-date information on this meeting. A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
meeting.
    Agenda: On October 21, 2008, the committee will begin with a closed 
session from 8 a.m. to 11 a.m. Following the closed session, from 11 
a.m. to 5 p.m., the meeting will be open to the public. The committee 
will discuss the safety and efficacy of biologic license application 
(BLA) 125291, MYOZYME (alglucosidase alfa), Genzyme Corp., for the 
treatment of late onset Pompe disease.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: On October 21, 2008, from 11 a.m. to 5 p.m., the meeting 
is open to the public. 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 on 
or before October 7, 2008. Oral presentationsfrom the public will be 
scheduled between approximately 12 noon and 1 p.m. Those desiring to 
make formal oral presentations should notify the contact person 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 on or before September 29, 2008. Time allotted 
for each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by September 30, 2008.
    Closed Committee Deliberations: On October 21, 2008, from 8 a.m. to 
11 a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
During this session, the committee will discuss the manufacturing as 
well as relevant biochemical and physiochemical attributes of 
alglucosidase alfa and how they impact clinical efficacy.
    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 Paul Tran at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee

[[Page 55115]]

meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 16, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-22437 Filed 9-23-08; 8:45 am]

BILLING CODE 4160-01-S
