[Federal Register: January 27, 2006 (Volume 71, Number 18)]
[Notices]               
[Page 4593-4594]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja06-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 March 7, 2006, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn Gaithersburg, The Ballrooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Sohail Mosaddegh, 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: mosaddeghs@cder.fda.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512543. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss TYSABRI (natalizumab) biologic 
license application 125104/15; Biogen Idec Inc., for an indication in 
patients with relapsing forms of multiple sclerosis to reduce the 
frequency of clinical exacerbations. The committee will discuss the 
risks (including progressive multifocal leukoencephalopathy) associated 
with TYSABRI (natalizumab) administration, its efficacy in the 
treatment of multiple sclerosis relapses

[[Page 4594]]

and/or disability, its possible return to the marketplace, and its 
proposed risk management plan(s).
    The background material will become available no later than the day 
before the meeting and will be posted on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
 under the heading ``Peripheral 

and Central Nervous System Drugs Advisory Committee (PCNS)'' (click on 
the year 2006 and scroll down to PCNS meetings.)
    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 February 28, 
2006. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before February 28, 2006, 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 Sohail Mosaddegh 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: January 17, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1006 Filed 1-26-06; 8:45 am]

BILLING CODE 4160-01-S