Document ID: FDA-2012-N-0001-0071
Agency: fda
Document Type: Notice
Title: Oncologic Drugs Advisory Committee: Notice of Meeting
Posted Date: 2012-05-24T04:00Z

[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31025-31026]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12588]

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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 July 25, 2012, from 8 
a.m. to 12:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., 
Building 31 Conference Center, the Great Room (Rm. 1503), 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.

[[Page 31026]]

    Contact Person: Minh Doan, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 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), and follow the prompts to the desired center or product area. 
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 and provide general advice on 
the extent to which, if any, the pre-surgical identification of 
clear cell carcinoma of the kidney using an imaging test provides 
useful clinical information.
    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 
July 10, 2012. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11:30 a.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 
June 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 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 
2, 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 Minh Doan 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: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12588 Filed 5-23-12; 8:45 am]
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