[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Pages 6332-6333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01944]



Food and Drug Administration

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

Science Board to the Food and Drug Administration; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 scientific and technical 
issues important to the FDA and its mission, including emerging issues 
within the scientific community. Additionally, the Science Board 
provides advice to the Agency on keeping pace with technical and 
scientific developments including in regulatory science; and input into 
the Agency's research agenda; and on upgrading its scientific and 
research facilities and training opportunities. It will also provide, 
where requested, expert review of Agency-sponsored intramural and 
extramural scientific research programs.
    Date and Time: The meeting will be held on Wednesday, February 27, 
2013, from approximately 8:30 a.m. to 5:15 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993. 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

[[Page 6333]]

Oak Campus.'' Please note that visitors to the White Oak Campus must 
enter through Building 1.
    Contact Person: Martha Monser, Office of the Chief Scientist, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, 
Silver Spring, MD 20993, 301-796-4627, 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: On February 27, 2013, the Science Board will be provided 
with updates and/or draft reports from the Center for Devices and 
Radiological Health Research Review subcommittee and the Global Health 
subcommittee. A progress update will be presented regarding the 
recently established Center for Biologics Evaluation and Review Post-
Marketing Safety Review subcommittee. An update on the plan to 
establish a new subcommittee to evaluate the Agency's continuing work 
to address the challenges identified in Science Board's 2007 ``Science 
and Mission at Risk'' Report will be presented. Plans will also be 
presented and a proposed charge reviewed for a second subcommittee to 
assess similar issues with respect to information technology including 
evaluation of scientific data utilization, data liberation and 
innovation. Overviews of genomics activities at the Centers for Food 
Safety and Applied Nutrition and Veterinary Medicine will be presented, 
along with plans for an Agency-wide working group to address cross-
cutting genomics activities. Finally, recipients of the FY2012 
Scientific Achievement awards (selected by the Science Board) will 
provide overviews of the activities for which the awards were given.
    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 
Wednesday, February 20, 2013. Oral presentations from the public will 
be scheduled between approximately 4:30 p.m. and 5 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 
Tuesday, February 12, 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 
Wednesday, February 13, 2013.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
    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 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: January 24, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-01944 Filed 1-29-13; 8:45 am]