
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Page 67766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27957]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Science Board to the Food and Drug Administration Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    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 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, rakesh.raghuwanshi@fda.hhs.gov, 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 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 
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 
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 
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 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).

    Dated: October 28, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-27957 Filed 11-2-15; 8:45 am]
 BILLING CODE 4164-01-P


