80 FR 79346 - Risk Communication Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 244 (December 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 244 (December 21, 2015)
| Page Range | 79346-79347 | |
| FR Document | 2015-31893 |
[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)] [Notices] [Pages 79346-79347] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31893] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Risk Communication 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: Risk Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on February 16, 2016, from 9 a.m. to 5 p.m. and February 17, 2016, from 9 a.m. to 4 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. 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: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3354, Silver Spring, MD 20993, 301-796-9151, FAX: 301- 847-3540, email: RCAC@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: On February 16 and 17, 2016, the Committee will discuss recent developments in risk communications and related sciences, and possible approaches and applications in the context of FDA communications. 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 9, 2016. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. on February 16, 2016, and 1 p.m. and 1:30 p.m. on February 17, 2016. 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 January 25, 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 [[Page 79347]] speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 2, 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 Lee L. Zwanziger 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: December 15, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-31893 Filed 12-18-15; 8:45 am] BILLING CODE 4164-01-P
![79346 Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
cannot always be published quickly FDA welcomes the attendance of the Ave., Bldg. 32, Rm. 3354, Silver Spring,
enough to provide timely notice. public at its advisory committee MD 20993, 301–796–9151, FAX: 301–
Therefore, you should always check the meetings and will make every effort to 847–3540, email: RCAC@
Agency’s Web site at http://www.fda. accommodate persons with disabilities. FDA.HHS.GOV, or FDA Advisory
gov/AdvisoryCommittees/default.htm If you require accommodations due to a Committee Information Line, 1–800–
and scroll down to the appropriate disability, please contact Janie Kim at 741–8138 (301–443–0572 in the
advisory committee meeting link, or call least 7 days in advance of the meeting. Washington, DC area). A notice in the
the advisory committee information line FDA is committed to the orderly Federal Register about last minute
to learn about possible modifications conduct of its advisory committee modifications that impact a previously
before coming to the meeting. meetings. Please visit our Web site at announced advisory committee meeting
Agenda: On January 21, 2016, the http://www.fda.gov/Advisory cannot always be published quickly
Committee will meet in an open session Committees/AboutAdvisoryCommittees/ enough to provide timely notice.
to discuss safety and effectiveness data, ucm111462.htm for procedures on Therefore, you should always check the
including challenge study endpoints, for public conduct during advisory Agency’s Web site at http://www.fda.
licensure of food allergy committee meetings. gov/AdvisoryCommittees/default.htm
immunotherapy products, and the Notice of this meeting is given under and scroll down to the appropriate
clinical development of aeroallergen the Federal Advisory Committee Act (5 advisory committee meeting link, or call
immunotherapy products for the U.S.C. app. 2). the advisory committee information line
prevention of respiratory allergic Dated: December 15, 2015. to learn about possible modifications
disease. before coming to the meeting.
Jill Hartzler Warner,
FDA intends to make background Agenda: On February 16 and 17,
material available to the public no later Associate Commissioner for Special Medical 2016, the Committee will discuss recent
than 2 business days before the meeting. Programs.
developments in risk communications
If FDA is unable to post the background [FR Doc. 2015–31894 Filed 12–18–15; 8:45 am]
and related sciences, and possible
material on its Web site prior to the BILLING CODE 4164–01–P approaches and applications in the
meeting, the background material will context of FDA communications.
be made publicly available at the FDA intends to make background
location of the advisory committee DEPARTMENT OF HEALTH AND material available to the public no later
meeting, and the background material HUMAN SERVICES than 2 business days before the meeting.
will be posted on FDA’s Web site after If FDA is unable to post the background
Food and Drug Administration
the meeting. Background material is material on its Web site prior to the
available at http://www.fda.gov/ [Docket No. FDA–2015–N–0001] meeting, the background material will
AdvisoryCommittees/Calendar/ be made publicly available at the
default.htm. Scroll down to the Risk Communication Advisory location of the advisory committee
appropriate advisory committee meeting Committee; Notice of Meeting meeting, and the background material
link. AGENCY: Food and Drug Administration, will be posted on FDA’s Web site after
Procedure: Interested persons may HHS. the meeting. Background material is
present data, information, or views, available at http://www.fda.gov/
ACTION: Notice.
orally or in writing, on issues pending AdvisoryCommittees/Calendar/
before the committee. Written This notice announces a forthcoming default.htm. Scroll down to the
submissions may be made to the contact meeting of a public advisory committee appropriate advisory committee meeting
person on or before January 6, 2016. of the Food and Drug Administration link.
Oral presentations from the public will (FDA). The meeting will be open to the Procedure: Interested persons may
be scheduled between approximately 1 public. present data, information, or views,
p.m. and 2 p.m. Those individuals Name of Committee: Risk orally or in writing, on issues pending
interested in making formal oral Communication Advisory Committee. before the committee. Written
presentations should notify the contact General Function of the Committee: submissions may be made to the contact
person and submit a brief statement of To provide advice and person on or before February 9, 2016.
the general nature of the evidence or recommendations to the Agency on Oral presentations from the public will
arguments they wish to present, the FDA’s regulatory issues. be scheduled between approximately 1
names and addresses of proposed Date and Time: The meeting will be p.m. and 1:30 p.m. on February 16,
participants, and an indication of the held on February 16, 2016, from 9 a.m. 2016, and 1 p.m. and 1:30 p.m. on
approximate time requested to make to 5 p.m. and February 17, 2016, from February 17, 2016. Those individuals
their presentation on or before 9 a.m. to 4 p.m. interested in making formal oral
December 29, 2015. Time allotted for Location: FDA White Oak Campus, presentations should notify the contact
each presentation may be limited. If the 10903 New Hampshire Ave., Building person and submit a brief statement of
number of registrants requesting to 31 Conference Center, the Great Room the general nature of the evidence or
speak is greater than can be reasonably (Rm. 1503), Silver Spring, MD 20993. arguments they wish to present, the
accommodated during the scheduled Answers to commonly asked questions names and addresses of proposed
open public hearing session, FDA may including information regarding special participants, and an indication of the
conduct a lottery to determine the accommodations due to a disability, approximate time requested to make
mstockstill on DSK4VPTVN1PROD with NOTICES
speakers for the scheduled open public visitor parking, and transportation may their presentation on or before January
hearing session. The contact person will be accessed at: http://www.fda.gov/ 25, 2016. Time allotted for each
notify interested persons regarding their AdvisoryCommittees/AboutAdvisory presentation may be limited. If the
request to speak by December 31, 2015. Committees/ucm408555.htm. number of registrants requesting to
Persons attending FDA’s advisory Contact Person: Lee L. Zwanziger, speak is greater than can be reasonably
committee meetings are advised that the Risk Communication Staff, Office of accommodated during the scheduled
Agency is not responsible for providing Planning, Food and Drug open public hearing session, FDA may
access to electrical outlets. Administration, 10903 New Hampshire conduct a lottery to determine the
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![Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices 79347
speakers for the scheduled open public ADDRESSES: Submit your comments, characteristics of program participants
hearing session. The contact person will including the Information Collection and their utilization of services, such as
notify interested persons regarding their Request Title, to the desk officer for program retention. Additionally, these
request to speak by February 2, 2016. HRSA, either by email to OIRA_ data will describe several select clinical
Persons attending FDA’s advisory submission@omb.eop.gov or by fax to indicators of program participants, such
committee meetings are advised that the 202–395–5806. as a child’s usual source of medical
Agency is not responsible for providing FOR FURTHER INFORMATION CONTACT: To care. This information will be collected
access to electrical outlets. request a copy of the clearance requests from participants at enrollment in home
FDA welcomes the attendance of the submitted to OMB for review, email the visiting services and aggregated and
public at its advisory committee HRSA Information Collection Clearance reported to HRSA by state/territory
meetings and will make every effort to Officer at paperwork@hrsa.gov or call grantees once annually.
accommodate persons with disabilities. (301) 594–4306. Performance and System Outcome
If you require accommodations due to a Benchmark Data: These data constitute
SUPPLEMENTARY INFORMATION:
disability, please contact Lee L. Information Collection Request Title: a discrete set of standardized
Zwanziger at least 7 days in advance of The Maternal, Infant, and Early performance and system outcome
the meeting. Childhood Home Visiting Program indicators that correspond with the
FDA is committed to the orderly
Performance Measurement Information statutorily identified benchmark areas.
conduct of its advisory committee
System. These data will provide aggregate totals,
meetings. Please visit our Web site at
OMB No.: 0906–xxxx—NEW. percentages, and rates for performance
http://www.fda.gov/Advisory Abstract: The Maternal, Infant, and and system outcome indicators that are
Committees/AboutAdvisoryCommittees/ Early Childhood Home Visiting Program salient to the Home Visiting Program,
ucm111462.htm for procedures on (MIECHV), administered by HRSA in home visiting services more generally,
public conduct during advisory partnership with the Administration for and the at-risk populations served.
committee meetings. Children and Families (ACF), supports
Notice of this meeting is given under These data will be collected from
voluntary, evidence-based home visiting participants based on the appropriate
the Federal Advisory Committee Act (5
services during pregnancy and to measurement period defined for each
U.S.C. app. 2).
parents with young children up to measure and aggregated and reported to
Dated: December 15, 2015. kindergarten entry. States and territories HRSA by state/territory grantees once
Jill Hartzler Warner, (as well as nonprofit organizations annually.
Associate Commissioner for Special Medical selected to provide services in non- This information will be used to
Programs. participating states and territories) are demonstrate accountability with
[FR Doc. 2015–31893 Filed 12–18–15; 8:45 am] eligible to receive funding from the legislative and programmatic
BILLING CODE 4164–01–P Home Visiting Program and have requirements. It will also be used to
flexibility to tailor the program to serve monitor and provide continued
the specific needs of their communities. oversight for grantee performance and to
DEPARTMENT OF HEALTH AND Need and Proposed Use of the target technical assistance resources to
HUMAN SERVICES Information: HRSA will use the grantees. In the future, it is anticipated
proposed information to demonstrate that Home Visiting Program funding
Health Resources and Services program accountability and
Administration decisions may be allocated based on
continuously monitor and provide grantee performance, including on
oversight to state and territory Home benchmark performance areas.
Agency Information Collection Visiting Program grantees. The
Activities: Submission to OMB for information will also be used to provide Likely Respondents: Home Visiting
Review and Approval; Public Comment quality improvement guidance and Program grantees.
Request technical assistance to grantees and help Burden Statement: Burden in this
AGENCY: Health Resources and Services inform the development of early context means the time expended by
Administration, HHS. childhood systems at the national, state, persons to generate, maintain, retain,
ACTION: Notice. and local level. HRSA is seeking to disclose or provide the information
collect demographic, service utilization, requested. This includes the time
SUMMARY: In compliance with Section and select clinical indicators for needed to review instructions; to
3507(a)(1)(D) of the Paperwork participants enrolled in home visiting develop, acquire, install and utilize
Reduction Act of 1995, the Health services. In addition, HRSA will collect technology and systems for the purpose
Resources and Services Administration a set of standardized performance and of collecting, validating and verifying
(HRSA) has submitted an Information system outcome indicators that information, processing and
Collection Request (ICR) to the Office of correspond with the statutorily maintaining information, and disclosing
Management and Budget (OMB) for identified benchmark areas. and providing information; to train
review and approval. Comments Demographic, Service Utilization, and personnel and to be able to respond to
submitted during the first public review Clinical Indicators Data: These data will a collection of information; to search
of this ICR will be provided to OMB. describe the population served by the data sources; to complete and review
OMB will accept further comments from Home Visiting Program, including the the collection of information; and to
the public during the review and unduplicated count of the number of transmit or otherwise disclose the
mstockstill on DSK4VPTVN1PROD with NOTICES
approval period. participants and participant groups by information. The total annual burden
DATES: Comments on this ICR should be race and ethnicity. These data will hours estimated for this ICR are
received no later than January 20, 2016. provide other socio-demographic summarized in the table below.
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Document Created: 2015-12-19 02:57:14
Document Modified: 2015-12-19 02:57:14
| 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. | |
| FR Citation | 80 FR 79346 |
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