[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Page 14861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1324]
Science Board to the Food and Drug Administration Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Science Board to
the Food and Drug Administration. 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 FDA and
its mission, including emerging issues within the scientific community.
Additionally, the Science Board advises the Agency on keeping pace with
technical and scientific developments, including in regulatory science;
provides input into the Agency's research agenda; and advises 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. The meeting will be open to the public.
DATES: The meeting will be held on April 23, 2018, from 9 a.m. to 4:30
p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503, Section A), 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/scienceboard2018/. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver
Spring, MD 20993, 301-796-4769, [email protected], 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 website
at https://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.
SUPPLEMENTARY INFORMATION:
Agenda: The Science Board will hear a report from the Center for
Biologics Evaluation and Research Program Review Subcommittee; hear
about FDA's Patient Affairs Initiative; and discuss how the Agency can
leverage its existing tools and authorities, and work with
stakeholders, to better address the complex scientific, public health,
and technology challenges it faces today.
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 website 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 website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
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
April 18, 2018. Oral presentations from the public will be scheduled
between approximately 3:30 p.m. and 4:30 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 April 13, 2018. 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 April 16, 2018.
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
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 website at https://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: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07105 Filed 4-5-18; 8:45 am]
BILLING CODE 4164-01-P