Submission for OMB Review; 30-Day Comment Request: State and Community Tobacco Control Research Initiative Evaluation (NCI), 56818-56819 [2014-22586]
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56818
Federal Register / Vol. 79, No. 184 / Tuesday, September 23, 2014 / Notices
about REMS programs, understand and
comply with REMS requirements, and
compare requirements across REMS to
minimize confusion associated with
complying with multiple REMS
programs.
C. Scope of the Report
This report describes the Agency’s
findings concerning strategies to
standardize REMS where appropriate,
with the goal of reducing the burden of
implementing REMS on practitioners,
patients, and others in various health
care settings. This report contains
project plans to: (1) Increase access to
REMS-related information through the
use of SPL, (2) enhance the Agency’s
REMS Web page to better meet the
needs of stakeholders, (3) assess the
feasibility of using accredited CE
courses for prescriber training, and (4)
enhance existing tools for prescribers to
communicate with patients regarding
risks of drugs with REMS, and how
those risks should be weighed against
the potential benefits of the drug.
III. Electronic Access
Persons with access to the Internet
may obtain the document on FDA’s Web
site at https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm350852.htm or https://
www.regulations.gov.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov. After
consideration of comments, FDA will
finalize the report and project plans.
The Agency intends to post updates to
the project plans on FDA’s Web site.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: September 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22513 Filed 9–22–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: State and
Community Tobacco Control Research
Initiative Evaluation (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on June 6, 2014 (79
FR 32742) and allowed 60 days for
public comment. One public comment
was received. The purpose of this notice
is to allow an additional 30 days for
public comment. The National Cancer
Institute (NCI), National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Elizabeth M. Ginexi, Ph.D.,
Tobacco Control Research Branch,
Behavioral Research Program, Division
of Cancer Control and Population
Sciences, National Cancer Institute,
9609 Medical Center Drive, Room 3E564
MSC 9761, Bethesda, Maryland 20892–
9761 or call non-toll-free number 240–
276–6765 or email your request,
including your address to: LGinexi@
mail.nih.gov. Formal requests for
SUMMARY:
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
additional plans and instruments must
be requested in writing.
Proposed Collection: State and
Community Tobacco Control Research
Initiative Evaluation (SCTC), 0925–
NEW, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute State and Community Tobacco
Control Research Initiative is a program
within the Tobacco Control Research
Branch in the Behavioral Research
Program of the Division of Cancer
Control and Population Sciences. The
program targets 4 high-priority tobacco
control research areas at the state and
community level in the United States:
(1) Secondhand smoke policies, (2)
Tobacco tax and pricing policies, (3)
Mass media countermeasures and
community and social norms, and (4)
Tobacco industry practices. The
initiative supports innovative research
to yield rapid and actionable findings
for state and community tobacco control
programs. The purpose of the evaluation
is to assess the dissemination,
implementation, and community
collaboration processes of the grantees
and their respective state and
community partners and stakeholders.
The evaluation will utilize archival
grant project data and archival data
collected from the scientists in the first
two years of the initiative. The
evaluation also will collect new data to:
(1) Determine relationships,
interactions, and connectedness among
different network partnerships over time
and with policy makers; (2) assess the
utility of research tools, interventions,
products, and findings from the
perspective of key tobacco control
stakeholders; and (3) determine key
indicators for broad adoption of
research products. Results will address
research-to-practice gaps by providing a
critical window into the process of
disseminating evidence-based research
tools, products, and science findings in
community public health settings.
Intended audiences include staff at NIH
Institutes and Centers interested in
supporting translation/dissemination
and implementation science.
OMB approval is requested for one
year. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
112.
E:\FR\FM\23SEN1.SGM
23SEN1
56819
Federal Register / Vol. 79, No. 184 / Tuesday, September 23, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Data collection type
SCTC Scientist ......................
Affiliated Partner ....................
Web Survey .................................................
Web Survey .................................................
Telephone Interview .....................................
Script to Schedule Telephone Interview ......
Telephone Interview .....................................
Telephone Interview .....................................
Telephone Interview .....................................
Expert Panel ................................................
Consent Form ..............................................
Telephone Script to Schedule Interview ......
Telephone Interview .....................................
Pilot Project ...........................
Working Group ......................
Coordinating Center ..............
PI/Co-PI .................................
60
71
21
7
6
6
2
18
18
6
21
Dated: September 17, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
access this number through TTY by
calling the toll-free Federal Relay
Service at (800) 877–8339.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–22586 Filed 9–22–14; 8:45 am]
Background
In his 2013 State of the Union
address, President Obama announced
the establishment of the Promise Zones
initiative to partner with high-poverty
communities across the country to
create jobs, increase economic security,
expand educational opportunities,
increase access to quality, affordable
housing, and improve public safety.1 On
January 8, 2014, the President
announced the first five Promise Zones,
which are located in: San Antonio, TX;
Philadelphia, PA; Los Angeles, CA;
Southeastern Kentucky, KY; and the
Choctaw Nation of Oklahoma, OK. Each
of these communities (three urban, one
rural, and one tribal) submitted a plan
on how it will partner with local
business and community leaders to
make investments that reward hard
work and expand opportunity. In
exchange, the Federal government is
helping these Promise Zone designees
secure the resources and flexibility they
need to achieve their goals.2 The urban
designations were conferred by HUD,
while the rural and tribal designations
were conferred by USDA.
BILLING CODE 4140–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. 5774–N–02]
Promise Zones Initiative: Second
Round Application Process
Office of Assistant Secretary for
Housing—Federal Housing
Commissioner, HUD.
ACTION: Notice.
AGENCY:
Through this notice, HUD
provides notice on the selection process,
criteria, and application submission for
the second round of the Promise Zone
initiative.
DATES: Application due date is 5:00 p.m.
on November 21, 2014.
ADDRESSES: Interested eligible
organizations are invited to submit
applications for a Promise Zone
designation. Questions or comments
regarding the application process
should be directed by email to
Promisezones@hud.gov. Questions or
comments may also be directed by
postal mail to the Office of the Deputy
Assistant Secretary for Economic
Development, U.S. Department of
Housing and Urban Development, 451
Seventh Street SW., Room 7244,
Washington, DC 20410, ATTN: Second
Round Promise Zone selections.
FOR FURTHER INFORMATION CONTACT:
Brooke Bohnet, U.S. Department of
Housing and Urban Development, 451
7th Street SW., Washington, DC 20410;
telephone number 202–402–6693. This
is not a toll-free number. Persons with
hearing or speech impairments may
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SUMMARY:
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Promise Zones Benefits
The Promise Zone designation
partners the Federal government with
local leaders who are addressing
multiple community revitalization
challenges in a collaborative way and
have demonstrated a commitment to
results. Further, Promise Zones will be
assigned Federal staff to help navigate
1 See https://www.whitehouse.gov/the-press-office/
2013/02/15/fact-sheet-president-s-plan-ensurehard-work-leads-decent-living.
2 See https://www.whitehouse.gov/the-press-office/
2014/01/08/fact-sheet-president-obama-s-promisezones-initiative.
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1
1
Average
burden per
response
(in hours)
20/60
20/60
40/60
5/60
40/60
40/60
40/60
90/60
5/60
5/60
40/60
Total annual
burden hours
20
24
14
1
4
4
1
27
2
1
14
the array of Federal assistance and
programs already available to them. In
addition, eligible applicants in Promise
Zones will receive any available (a)
preference for certain competitive
Federal programs and (b) technical
assistance. Subject to enactment by
Congress, businesses investing in
Promise Zones or hiring residents of
Promise Zones will be eligible to receive
tax incentives. Altogether, this package
of assistance will help local leaders
accelerate efforts to revitalize their
communities.
The Promise Zone designation will be
for a term of 10 years and may be
extended as necessary to capture the full
term of availability of the Promise Zone
tax incentives, if the tax incentives are
enacted. During this term, the specific
benefits made available to Promise
Zones may vary from year to year, and
sometimes more often than annually,
due to changes in Federal agency
policies and changes in appropriations
and authorizations for relevant
programs. All assistance provided to
Promise Zones is subject to applicable
regulations, statutes, and changes in
federal agency policies, appropriations,
and authorizations for relevant
programs. Subject to these limitations,
the Promise Zone designation commits
the Federal government to partner with
local leaders who are addressing
multiple community revitalization
challenges in a collaborative way and
have demonstrated a commitment to
results.
Response to Public Comment
On April 17, 2014, HUD published a
notice in the Federal Register 79 FR
21785 to solicit comments from first
round applicants, interested parties, and
the general public on the first round of
the Promise Zones initiative and the
proposed selection process for the
second round of the Promise Zone
initiative. The public comment period
E:\FR\FM\23SEN1.SGM
23SEN1
Agencies
[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56818-56819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22586]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: State and
Community Tobacco Control Research Initiative Evaluation (NCI)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Institutes of Health
(NIH), has submitted to the Office of Management and Budget (OMB) a
request for review and approval of the information collection listed
below. This proposed information collection was previously published in
the Federal Register on June 6, 2014 (79 FR 32742) and allowed 60 days
for public comment. One public comment was received. The purpose of
this notice is to allow an additional 30 days for public comment. The
National Cancer Institute (NCI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Elizabeth M. Ginexi, Ph.D., Tobacco Control
Research Branch, Behavioral Research Program, Division of Cancer
Control and Population Sciences, National Cancer Institute, 9609
Medical Center Drive, Room 3E564 MSC 9761, Bethesda, Maryland 20892-
9761 or call non-toll-free number 240-276-6765 or email your request,
including your address to: LGinexi@mail.nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
Proposed Collection: State and Community Tobacco Control Research
Initiative Evaluation (SCTC), 0925-NEW, National Cancer Institute
(NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The National Cancer
Institute State and Community Tobacco Control Research Initiative is a
program within the Tobacco Control Research Branch in the Behavioral
Research Program of the Division of Cancer Control and Population
Sciences. The program targets 4 high-priority tobacco control research
areas at the state and community level in the United States: (1)
Secondhand smoke policies, (2) Tobacco tax and pricing policies, (3)
Mass media countermeasures and community and social norms, and (4)
Tobacco industry practices. The initiative supports innovative research
to yield rapid and actionable findings for state and community tobacco
control programs. The purpose of the evaluation is to assess the
dissemination, implementation, and community collaboration processes of
the grantees and their respective state and community partners and
stakeholders. The evaluation will utilize archival grant project data
and archival data collected from the scientists in the first two years
of the initiative. The evaluation also will collect new data to: (1)
Determine relationships, interactions, and connectedness among
different network partnerships over time and with policy makers; (2)
assess the utility of research tools, interventions, products, and
findings from the perspective of key tobacco control stakeholders; and
(3) determine key indicators for broad adoption of research products.
Results will address research-to-practice gaps by providing a critical
window into the process of disseminating evidence-based research tools,
products, and science findings in community public health settings.
Intended audiences include staff at NIH Institutes and Centers
interested in supporting translation/dissemination and implementation
science.
OMB approval is requested for one year. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 112.
[[Page 56819]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Data collection Number of responses per per response Total annual
type respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
SCTC Scientist................ Web Survey...... 60 1 20/60 20
Affiliated Partner............ Web Survey...... 71 1 20/60 24
Telephone 21 1 40/60 14
Interview.
Script to 7 1 5/60 1
Schedule
Telephone
Interview.
Pilot Project................. Telephone 6 1 40/60 4
Interview.
Working Group................. Telephone 6 1 40/60 4
Interview.
Coordinating Center........... Telephone 2 1 40/60 1
Interview.
PI/Co-PI...................... Expert Panel.... 18 1 90/60 27
Consent Form.... 18 1 5/60 2
Telephone Script 6 1 5/60 1
to Schedule
Interview.
Telephone 21 1 40/60 14
Interview.
----------------------------------------------------------------------------------------------------------------
Dated: September 17, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-22586 Filed 9-22-14; 8:45 am]
BILLING CODE 4140-01-P