[Federal Register Volume 78, Number 210 (Wednesday, October 30, 2013)]
[Notices]
[Page 64957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25583]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of two public advisory 
committees 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 December 9, 2013, from 8 
a.m. to 5:30 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White 
Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002. Information regarding special accommodations due 
to a disability, visitor parking, and transportation may be accessed 
at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the 
heading ``Resources for You,'' click on ``Public Meetings at the FDA 
White Oak Campus.'' Please note that visitors to the White Oak Campus 
must enter through Building 1.
    Contact Person: Cindy Hong, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Building 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, email: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The committees will discuss two biologics license 
applications (BLAs) for vedolizumab injection (proposed tradename 
Entyvio), submitted by Millennium Pharmaceuticals, Inc. BLA 125476 
proposes an indication for the treatment of adult patients with 
moderately to severely active ulcerative colitis who have had an 
inadequate response to, have lost response to, or were intolerant to 
either conventional therapy or a tumor necrosis factor-alpha 
(TNF[alpha]) antagonist. BLA 125507 proposes an indication for the 
treatment of adult patients with moderately to severely active Crohn's 
disease who have had an inadequate response to, have lost response to, 
or were intolerant to either conventional therapy or a TNF[alpha] 
antagonist.
    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 meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committees. 
Written submissions may be made to the contact person on or before 
November 22, 2013. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 p.m. Those individuals 
interested in making 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 November 14, 2013. 
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 November 15, 2013.
    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 Cindy Hong 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: October 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-25583 Filed 10-29-13; 8:45 am]
BILLING CODE 4160-01-P