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 primarily to the Commissioner of Food and Drugs and other
appropriate officials on specific complex scientific and technical
issues important to 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 those 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 June 4, 2014, from
approximately 8:30 a.m. until 4:30 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503, sections B and C), Silver
Spring, MD 20993. 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 Chief Scientist,
Office of the Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4286, Silver Spring, MD 20993, 301-796-
4627, 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: On June, 4, 2014, the Science Board will discuss and make
recommendations on the draft final report from the Center for Biologics
Evaluation and Research's postmarketing safety review subcommittee. The
committee will be asked to support forming a new subcommittee to
evaluate the Commissioner's Fellowship Program. The committee will be
presented with an overview of current issues surrounding heparin
sourcing issues for discussion. A recipient of one of the fiscal year
2013 Scientific Achievement Awards (selected by the Science 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 May
28, 2014. Oral presentations from the public will be scheduled between
approximately 3 p.m. 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 May 20, 2014. 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 May 21, 2014.
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).