[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72953-72954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No: FDA-2011-N-0002]


Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug 
Administration (Science Board).
    General Function of the Committee: The Science Board provides 
advice primarily to the Commissioner of Food and Drugs and other 
appropriate officials on specific complex and technical issues, as well 
as emerging issues within the scientific community in industry and 
academia. Additionally, the Science Board provides advice to the Agency 
on keeping pace with technical and scientific evolutions in the fields 
of regulatory science, on formulating an appropriate research agenda, 
and on upgrading its scientific and research facilities to keep pace 
with these changes. It will also provide the means for critical review 
of Agency sponsored intramural and extramural scientific research 
programs.

[[Page 72954]]

    Date and Time: The meeting will be held on January 6, 2012, from 9 
a.m. to 4 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.
    For those unable to attend in person, the meeting will also be 
webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard/. 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: Martha Monser, Office of the Commissioner, Food and 
Drug Administration, 10903 New Hampshire Ave, Bldg. 32, rm. 4286, 
Silver Spring MD 20993-0002, (301) 796-4627, or FDA Advisory Committee 
Information Line, 1-(800) 741-8138 (301) 443-0572 in the Washington, DC 
area), and follow the prompt 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 Science Board will hear about and provide input 
regarding the two Centers for Excellence in Regulatory Science and 
Innovation. The Science Board will also hear updates regarding the 
Scientific Computing/JANUS program, and FDA's Scientific Integrity 
Policy. FDA's Modernizing Toxicology Working Group will present an 
overview to the Science Board for input and discussion. The Center for 
Drug Evaluation and Research (CDER) will provide their response to the 
May 2011 Subcommittee Report regarding the Review of the FDA/CDER 
Pharmacovigilance Program.
    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 
December 30, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 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 December 22, 2011. 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 December 23, 2011.
    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 Ms. Martha Monser, 
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: November 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-30416 Filed 11-25-11; 8:45 am]
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