
[Federal Register Volume 77, Number 82 (Friday, April 27, 2012)]
[Notices]
[Pages 25184-25185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Oncologic 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: Oncologic 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 June 20, 2012, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, 
White Oak Conference Center, (Rm. 1503), 10903 New Hampshire Avenue, 
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: Caleb Briggs, Pharm.D., Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., WO31-2417, Silver Spring, MD 20993-0002, (301) 796-
9001, Fax: (301) 847-8533, email: ODAC@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), to find out further information regarding FDA 
advisory committee information. 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 advisory committee information line 
or visit our Web site at http://www.fda.gov/AdvisoryCommittees/default.htm to learn about possible modifications before coming to 
the meeting.
    Agenda: On June 20, 2012, during the morning session, the 
committee will discuss new drug application (NDA) 203213, with the 
established name semuloparin sodium injection, application submitted 
by sanofi-aventis U.S. LLC. The proposed indication (use) for this 
product is for the prophylaxis of venous thromboembolism (VTE) in 
patients receiving chemotherapy for locally advanced or metastatic 
pancreatic or lung cancer or for locally advanced or metastatic 
solid tumors with a VTE risk score >=3.
    During the afternoon session, the committee will discuss NDA 
202714, with the proposed trade name Kyprolis (carfilzomib) for 
injection, application submitted by Onyx Pharmaceuticals, Inc. The 
proposed indication (use) for this product is for the treatment of 
patients with relapsed and refractory (recurring and/or not 
responsive to other treatments) multiple myeloma who have received 
at least 2 prior lines of therapy that included a proteasome 
inhibitor and an immunomodulatory agent.
    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 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 
June 6, 2012. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 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 May 29, 2012. 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

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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 May 30, 2012.
    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 Caleb Briggs 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: April 19, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-10154 Filed 4-26-12; 8:45 am]
BILLING CODE 4160-01-P


