[Federal Register: May 29, 2007 (Volume 72, Number 102)]
[Notices]
[Page 29519-29520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my07-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
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 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
previously
[[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
meeting.
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
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 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,
2007.
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 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]
BILLING CODE 4160-01-S