[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8078-8079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
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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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
research programs.
Date and Time: The meeting will be held on March 1, 2016, from 8:30
a.m. until 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503, Section A), Silver
Spring, MD 20993-0002. 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/scienceboard0316/. 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, Bldg. 1 Rm.
3309, 10903 New Hampshire Ave., 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 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: The Science Board will hear about and discuss: (1) The role
of opioids in pain management; (2) scientific challenges facing FDA in
supporting the development of pain medications, including opioids, that
have reduced risks of being abused; (3) scientific challenges facing
FDA in seeking to understand the real-world use of opioids to treat
pain, including the impact of opioids with potentially less risk for
abuse; (4) the role that FDA plays as a part of a larger Federal,
State, and local response to the challenges of providing appropriate
pain treatment while reducing opioid abuse; and (5) postmarket
surveillance activities related to opioids. The Science Board will also
receive a final report from the Centers of Excellence in Regulatory
Science and Innovation Program Evaluation Subcommittee.
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
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
February 23, 2016. Oral presentations from the public will be scheduled
between approximately 3:15 and 4:15 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 February 23, 2016. 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 February 25, 2016.
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 Mr. 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the March 1, 2016, meeting of the Science Board. Because the Agency
believes there is some urgency to bring these issues to public
discussion and qualified members of the Science Board were available at
this time, the Commissioner of Food and Drugs concluded that it was in
the public interest to hold this meeting even if there was not
sufficient time for the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
[[Page 8079]]
Dated: February 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03152 Filed 2-16-16; 8:45 am]
BILLING CODE 4164-01-P