Risk Communication Advisory Committee; Notice of Meeting, 79346-79347 [2015-31893]
Download as PDF
mstockstill on DSK4VPTVN1PROD with NOTICES
79346
Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
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.
Agenda: On January 21, 2016, the
Committee will meet in an open session
to discuss safety and effectiveness data,
including challenge study endpoints, for
licensure of food allergy
immunotherapy products, and the
clinical development of aeroallergen
immunotherapy products for the
prevention of respiratory allergic
disease.
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 January 6, 2016.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 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
December 29, 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 speak by December 31, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
VerDate Sep<11>2014
17:38 Dec 18, 2015
Jkt 238001
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 Janie Kim 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/Advisory
Committees/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. 2015–31894 Filed 12–18–15; 8:45 am]
BILLING CODE 4164–01–P
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: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
Contact Person: Lee L. Zwanziger,
Risk Communication Staff, Office of
Planning, Food and Drug
Administration, 10903 New Hampshire
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 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.
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 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 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
E:\FR\FM\21DEN1.SGM
21DEN1
Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
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
https://www.fda.gov/Advisory
Committees/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than January 20, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:38 Dec 18, 2015
Jkt 238001
Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 594–4306.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Performance Measurement Information
System.
OMB No.: 0906–xxxx—NEW.
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting Program
(MIECHV), administered by HRSA in
partnership with the Administration for
Children and Families (ACF), supports
voluntary, evidence-based home visiting
services during pregnancy and to
parents with young children up to
kindergarten entry. States and territories
(as well as nonprofit organizations
selected to provide services in nonparticipating states and territories) are
eligible to receive funding from the
Home Visiting Program and have
flexibility to tailor the program to serve
the specific needs of their communities.
Need and Proposed Use of the
Information: HRSA will use the
proposed information to demonstrate
program accountability and
continuously monitor and provide
oversight to state and territory Home
Visiting Program grantees. The
information will also be used to provide
quality improvement guidance and
technical assistance to grantees and help
inform the development of early
childhood systems at the national, state,
and local level. HRSA is seeking to
collect demographic, service utilization,
and select clinical indicators for
participants enrolled in home visiting
services. In addition, HRSA will collect
a set of standardized performance and
system outcome indicators that
correspond with the statutorily
identified benchmark areas.
Demographic, Service Utilization, and
Clinical Indicators Data: These data will
describe the population served by the
Home Visiting Program, including the
unduplicated count of the number of
participants and participant groups by
race and ethnicity. These data will
provide other socio-demographic
ADDRESSES:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
79347
characteristics of program participants
and their utilization of services, such as
program retention. Additionally, these
data will describe several select clinical
indicators of program participants, such
as a child’s usual source of medical
care. This information will be collected
from participants at enrollment in home
visiting services and aggregated and
reported to HRSA by state/territory
grantees once annually.
Performance and System Outcome
Benchmark Data: These data constitute
a discrete set of standardized
performance and system outcome
indicators that correspond with the
statutorily identified benchmark areas.
These data will provide aggregate totals,
percentages, and rates for performance
and system outcome indicators that are
salient to the Home Visiting Program,
home visiting services more generally,
and the at-risk populations served.
These data will be collected from
participants based on the appropriate
measurement period defined for each
measure and aggregated and reported to
HRSA by state/territory grantees once
annually.
This information will be used to
demonstrate accountability with
legislative and programmatic
requirements. It will also be used to
monitor and provide continued
oversight for grantee performance and to
target technical assistance resources to
grantees. In the future, it is anticipated
that Home Visiting Program funding
decisions may be allocated based on
grantee performance, including on
benchmark performance areas.
Likely Respondents: Home Visiting
Program grantees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
E:\FR\FM\21DEN1.SGM
21DEN1
Agencies
[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79346-79347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://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 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.
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 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
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 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: 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