Document ID: FDA-2009-N-0664-0122
Agency: fda
Document Type: Notice
Title: Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2009-11-19T05:00Z

[Federal Register: November 19, 2009 (Volume 74, Number 222)]
[Notices]               
[Page 59986]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no09-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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 12 and 13, 
2010, from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 
301-589-5200.
    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 January 12, 2010, the committee will discuss new drug 
application (NDA) 21-348, ZAVESCA (miglustat), 100 milligram (mg) 
capsules, by Actelion Pharmaceuticals, Ltd., proposed for the 
treatment of progressive neurological manifestations (symptoms 
related to the nervous system) in patients with Niemann-Pick Disease 
(type C). On January 13, 2010, the committee will discuss NDA 22-
562, CARBGLU (carglumic acid), 200 mg tablets, by Orphan Europe 
SARL, proposed for the treatment of hyperammonemia (elevated levels 
of ammonia in the blood) in patients with N acetyl glutamate 
synthetase (NAGS) deficiency, an inherited disorder that causes 
ammonia to accumulate in the blood.
    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/
AdvisoryCommittees/Calendar/default.htm. Scroll down to the 
appropriate advisory committee link.
    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 on or before 
December 28, 2009. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. on both days. 
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 
December 17, 2009. 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 
December 18, 2009.
    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 meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27741 Filed 11-18-09; 8:45 am]

BILLING CODE 4160-01-S