[Federal Register: May 29, 2007 (Volume 72, Number 102)]
[Page 29519-29520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2007N-0204]

Joint Meeting of the Gastrointestinal Drugs Advisory Committee 
and the Drug Safety and Risk Management Advisory Committee; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 Committees: Gastrointestinal Drugs Advisory Committee and 
the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 31, 2007, from 8 
a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``2007-- Efficacy and Safety of 

TYSABRI (natalizumab) for Patients With Moderately to Severely Active 
Crohn's Disease'' and follow the prompts to submit your statement. 
Written comments should be submitted to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. All comments received will be posted 
without change, including any personal information provided. Comments 
received on or before July 24, 2007, will be provided to the committee 
before the meeting.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Victoria Ferretti-Aceto, 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: 
Victoria.FerrettiAceto@fda.hhs.gov, or FDA Advisory Committee 

Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC 
area), codes 301-451-2538 and 301-451-2535. 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 

[[Page 29520]]

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 
    Agenda: The committee will discuss TYSABRI (natalizumab) biologic 
license application (BLA) 125104/33, Biogen Idec, Inc., for the 
proposed indication of inducing and maintaining sustained response and 
remission, and eliminating corticosteroid use in patients with 
moderately to severely active Crohn's disease with inflammation, as 
evidenced by elevated C-reactive protein level or another objective 
marker. The committee will discuss the risks (including progressive 
multifocal leukoencephalopathy) associated with TYSABRI (natalizumab) 
administration, its efficacy in the treatment of moderate to severe 
Crohn's disease, and proposed risk management plan(s).
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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 July 
18, 2007. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2:30 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 July 10, 2007. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonable 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 July 11, 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Victoria Ferretti-
Aceto 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: May 22, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-10270 Filed 5-25-07; 8:45 am]