[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Page 57095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Pediatric Oncology Subcommittee of the 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: Pediatric Oncology Subcommittee of the 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 December 4, 2012, from 8 
a.m. to 5:30 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.
    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: [email protected], 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 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 subcommittee will receive a presentation on pediatric 
provisions mandated by the Food and Drug Administration Safety and 
Innovation Act. This will be an awareness presentation and there will 
not be a formal Committee discussion or recommendation. In addition, 
information will be presented regarding pediatric development plans for 
four products that are in development for an adult oncology indication. 
The subcommittee will consider and discuss issues relating to the 
development of each product for pediatric use and provide guidance to 
facilitate the formulation of written requests for pediatric studies, 
if appropriate. The four products under consideration are: (1) 
Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, 
application submitted by Threshold Pharmaceuticals, Inc.; (3) 
volasertib (BI 6727), application submitted by Boehringer Ingelheim 
Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application 
submitted by Amgen Inc.
    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 
November 19, 2012. Oral presentations from the public will be scheduled 
between approximately 9:15 a.m. to 9:30 a.m., 11:15 a.m. to 11:30 a.m., 
2:05 p.m. to 2:20 p.m., and 4:10 p.m. to 4:25 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 8, 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 November 9, 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: September 11, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-22794 Filed 9-14-12; 8:45 am]
BILLING CODE 4160-01-P