E7-10270. 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.

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://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: [phone], e-mail: [e-mail], 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 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://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.