AGENCY: Food and Drug Administration, HHS.
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 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, 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
Date and Time: The meeting will be held on November 18, 2015, from
9 a.m. until 4 p.m.
Location: Food and Drug Administration, White Oak 31, Rm. 1503,
Section A, 10903 New Hampshire Ave., 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/scienceboard1115/. Answers to commonly asked questions including
information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist,
Office of the Commissioner, Food and Drug Administration, White Oak
Bldg. 1 Rm. 3309, 10903 New Hampshire Ave., Silver Spring, MD 20993,
301-796-4769, firstname.lastname@example.org, 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
Agenda: The Science Board will be provided with updates from the
Center for Food Safety and Applied Nutrition, Centers for Excellence in
Regulatory Science and Innovation, Evaluation Subcommittee and the ORA
Food Emergency Response Network Evaluation Subcommittee. The Board will
hear about the scope of FDA's involvement in precision medicine, as
well as an overview of specific health informatics initiatives
including precision FDA, Open FDA, and Chillax. The Board will also
hear about FDA's laboratory safety initiative. A recipient of one of
the FY 2014 Scientific Achievement Awards (selected by the Board) will
provide an overview of the activities for which the award was 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 meeting
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 11, 2015. Oral presentations from the public will be scheduled
between approximately 3 and 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 November 11, 2015. 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 November 13, 2015.
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
disabilities. If you require accommodations due to a disability, please
contact Rakesh Raghuwanshi 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).