81 FR 64467 - Risk Communication Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 182 (September 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 182 (September 20, 2016)
| Page Range | 64467-64467 | |
| FR Document | 2016-22553 |
[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)] [Notices] [Page 64467] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22553] [[Page 64467]] ----------------------------------------------------------------------- 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: http://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 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. 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 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 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 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: 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
![Federal Register / Vol. 81, No. 182 / Tuesday, September 20, 2016 / Notices 64467
DEPARTMENT OF HEALTH AND and Health Literacy is to clarify how the FDA is committed to the orderly
HUMAN SERVICES Agency can communicate the benefits conduct of its advisory committee
and risks of FDA-regulated products to meetings. Please visit our Web site at
Food and Drug Administration target audiences more effectively, and so http://www.fda.gov/
[Docket No. FDA–2016–N–0001] promote better informed decision AdvisoryCommittees/
making. The committee will also hear AboutAdvisoryCommittees/
Risk Communication Advisory presentations on some of FDA’s external ucm111462.htm for procedures on
Committee; Notice of Meeting communications and how these public conduct during advisory
communications relate to the draft committee meetings.
AGENCY: Food and Drug Administration, Strategic Plan for Risk Communication Notice of this meeting is given under
HHS. and Health Literacy. the Federal Advisory Committee Act (5
ACTION: Notice. FDA intends to make background U.S.C. app. 2).
material available to the public no later
SUMMARY: The Food and Drug than 2 business days before the meeting. Dated: September 13, 2016.
Administration (FDA) announces a If FDA is unable to post the background Janice Soreth,
forthcoming public advisory committee material on its Web site prior to the Acting Associate Commissioner, Special
meeting of the Risk Communication meeting, the background material will Medical Programs.
Advisory Committee. The general be made publicly available at the [FR Doc. 2016–22553 Filed 9–19–16; 8:45 am]
function of the committee is to provide location of the advisory committee BILLING CODE 4164–01–P
advice and recommendations to the meeting, and the background material
Agency on FDA’s regulatory issues. The will be posted on FDA’s Web site after
meeting will be open to the public. the meeting. Background material is DEPARTMENT OF HEALTH AND
DATES: The meeting will be held on available at http://www.fda.gov/ HUMAN SERVICES
November 7, 2016, from 8:30 a.m. to 5 AdvisoryCommittees/Calendar/
p.m. default.htm. Scroll down to the Food and Drug Administration
ADDRESSES: FDA White Oak Campus, appropriate advisory committee meeting
10903 New Hampshire Ave., Bldg. 31, link. [Docket No. FDA–2016–N–2648]
Conference Center, the Great Room (Rm. Procedure: Interested persons may
1503), Silver Spring, MD 20993–0002. present data, information, or views, Announcement of Requirements and
Answers to commonly asked questions orally or in writing, on issues pending Registration for the 2016 Food and
including information regarding special before the committee. Written Drug Administration Naloxone App
accommodations due to a disability, submissions may be made to the contact Competition
visitor parking, and transportation may person on or before November 1, 2016.
Oral presentations from the public will AGENCY: Food and Drug Administration,
be accessed at: http://www.fda.gov/
be scheduled between approximately HHS.
AdvisoryCommittees/
AboutAdvisoryCommittees/ 1:30 p.m. to 2:30 p.m. Those individuals ACTION: Notice.
ucm408555.htm. interested in making formal oral
presentations should notify the contact SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: Administration (FDA) is announcing the
person and submit a brief statement of
Natasha Facey, Office of the 2016 FDA Naloxone App Competition
the general nature of the evidence or
Commissioner, Food and Drug (Competition), a prize competition
arguments they wish to present, the
Administration, 10903 New Hampshire under the America COMPETES
names and addresses of proposed
Ave., Bldg. 32, Rm. 3354, Silver Spring, Reauthorization Act of 2010
participants, and an indication of the
MD 20993–0002, 301–796–5290, (COMPETES Act). The Competition is
approximate time requested to make
Natasha.Facey@fda.hhs.gov, or FDA an effort to help reduce deaths
their presentation on or before October
Advisory Committee Information Line, 21, 2016. Time allotted for each associated with prescription opioid and
1–800–741–8138 (301–443–0572 in the presentation may be limited. If the heroin overdose by seeking innovative
Washington, DC area). A notice in the number of registrants requesting to approaches to help reduce preventable
Federal Register about last minute speak is greater than can be reasonably harm associated with opioids.
modifications that impact a previously accommodated during the scheduled Specifically, the goal of this
announced advisory committee meeting open public hearing session, FDA may Competition is to spur innovation
cannot always be published quickly conduct a lottery to determine the around the development of a low-cost,
enough to provide timely notice. speakers for the scheduled open public scalable, crowd-sourced mobile phone
Therefore, you should always check the hearing session. The contact person will application that helps increase the
Agency’s Web site at http:// notify interested persons regarding their likelihood that opioid users, their
www.fda.gov/AdvisoryCommittees/ request to speak by October 25, 2016. immediate personal networks, and first
default.htm and scroll down to the Persons attending FDA’s advisory responders are able to identify and react
appropriate advisory committee meeting committee meetings are advised that the to an overdose by administering
link, or call the advisory committee Agency is not responsible for providing naloxone, a medication that reverses the
information line to learn about possible access to electrical outlets. effects of opioid overdose.
modifications before coming to the FDA welcomes the attendance of the
meeting. DATES: The Competition begins
public at its advisory committee
sradovich on DSK3GMQ082PROD with NOTICES
September 20, 2016.
SUPPLEMENTARY INFORMATION: meetings and will make every effort to
Agenda: On November 7, 2016, the accommodate persons with disabilities. 1. Registration for the Competition:
committee will discuss and make If you require accommodations due to a September 23 to October 7, 2016
recommendations on FDA’s draft disability, please contact Sheryl Clark at 2. Naloxone App Code-a-Thon: October
Strategic Plan for Risk Communication Sheryl.Clark@fda.hhs.gov or 240–402– 19 and October 20, 2016
and Health Literacy. The purpose of the 5273 at least 7 days in advance of the 3. Submission Period: September 23 to
Strategic Plan for Risk Communication meeting. November 7, 2016
VerDate Sep<11>2014 17:13 Sep 19, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1](https://thefederalregister.org/doc/81_FR_64649/page/1.svg)
Document Created: 2018-02-09 13:20:33
Document Modified: 2018-02-09 13:20:33
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The meeting will be held on November 7, 2016, from 8:30 a.m. to 5 p.m. | |
| 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, [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. | |
| FR Citation | 81 FR 64467 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR