83 FR 14861 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 67 (April 6, 2018)

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.

[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Page 14861]
From the Federal Register Online  [www.thefederalregister.org]
[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