Risk Communication Advisory Committee; Notice of Meeting, 64467 [2016-22553]
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Federal Register / Vol. 81, No. 182 / Tuesday, September 20, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Risk Communication
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on
November 7, 2016, from 8:30 a.m. to 5
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
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:
Natasha Facey, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3354, Silver Spring,
MD 20993–0002, 301–796–5290,
Natasha.Facey@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 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: On November 7, 2016, the
committee will discuss and make
recommendations on FDA’s draft
Strategic Plan for Risk Communication
and Health Literacy. The purpose of the
Strategic Plan for Risk Communication
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:13 Sep 19, 2016
Jkt 238001
and Health Literacy is to clarify how the
Agency can communicate the benefits
and risks of FDA-regulated products to
target audiences more effectively, and so
promote better informed decision
making. The committee will also hear
presentations on some of FDA’s external
communications and how these
communications relate to the draft
Strategic Plan for Risk Communication
and Health Literacy.
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 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 November 1, 2016.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. to 2:30 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 October
21, 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 speak by October 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 Sheryl Clark at
Sheryl.Clark@fda.hhs.gov or 240–402–
5273 at least 7 days in advance of the
meeting.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
64467
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site 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: September 13, 2016.
Janice Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–22553 Filed 9–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2648]
Announcement of Requirements and
Registration for the 2016 Food and
Drug Administration Naloxone App
Competition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
2016 FDA Naloxone App Competition
(Competition), a prize competition
under the America COMPETES
Reauthorization Act of 2010
(COMPETES Act). The Competition is
an effort to help reduce deaths
associated with prescription opioid and
heroin overdose by seeking innovative
approaches to help reduce preventable
harm associated with opioids.
Specifically, the goal of this
Competition is to spur innovation
around the development of a low-cost,
scalable, crowd-sourced mobile phone
application that helps increase the
likelihood that opioid users, their
immediate personal networks, and first
responders are able to identify and react
to an overdose by administering
naloxone, a medication that reverses the
effects of opioid overdose.
DATES: The Competition begins
September 20, 2016.
1. Registration for the Competition:
September 23 to October 7, 2016
2. Naloxone App Code-a-Thon: October
19 and October 20, 2016
3. Submission Period: September 23 to
November 7, 2016
SUMMARY:
E:\FR\FM\20SEN1.SGM
20SEN1
Agencies
[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Page 64467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22553]
[[Page 64467]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Risk Communication Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Risk Communication Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on November 7, 2016, from 8:30 a.m. to
5 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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: Natasha Facey, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 3354, Silver Spring, MD 20993-0002, 301-796-5290,
Natasha.Facey@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 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: On November 7, 2016, the committee will discuss and make
recommendations on FDA's draft Strategic Plan for Risk Communication
and Health Literacy. The purpose of the Strategic Plan for Risk
Communication and Health Literacy is to clarify how the Agency can
communicate the benefits and risks of FDA-regulated products to target
audiences more effectively, and so promote better informed decision
making. The committee will also hear presentations on some of FDA's
external communications and how these communications relate to the
draft Strategic Plan for Risk Communication and Health Literacy.
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 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
November 1, 2016. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. to 2:30 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 October 21, 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 speak by October 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 Sheryl Clark at Sheryl.Clark@fda.hhs.gov or 240-402-5273 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 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: September 13, 2016.
Janice Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-22553 Filed 9-19-16; 8:45 am]
BILLING CODE 4164-01-P