Agency Forms Undergoing Paperwork Reduction Act Review, 2674-2675 [2014-00585]
Download as PDF
<![CDATA[
2674
Federal Register / Vol. 79, No. 10 / Wednesday, January 15, 2014 / Notices
Each of the consent agreements
announced today includes injunctive
relief provisions requiring the settling
parties to satisfy a standard of
‘‘competent and reliable scientific
evidence’’ before again making the
claims at issue. Each consent agreement
further defines ‘‘competent and reliable
scientific evidence’’ as requiring, among
other things, two adequate and wellcontrolled human clinical studies
(randomized controlled trials or RCTs)
of the product. I encourage the
Commission to explore more fully
whether the articulation and scope of
injunctive relief in these and similar
settlements strikes the right balance
between deterring deceptive advertising
and preserving for consumers the
benefits of truthful claims. The optimal
amount and type of evidence to
substantiate a future claim will vary
from case to case. Similarly, a factspecific inquiry may justify specially
crafted injunctive relief in certain cases,
such as bans, performance bonds or
document retention requirements for
underlying study data. I look forward to
working with my fellow Commissioners
to continue to examine and evaluate our
formulation of the competent and
reliable scientific evidence standard, as
well as the ancillary injunctive
provisions in consent agreements, in
order to best protect consumers from the
costs imposed upon them by deceptive
advertising while encouraging
competition and truthful advertising
that benefits consumers.
[FR Doc. 2014–00560 Filed 1–14–14; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–0916]
Agency Forms Undergoing Paperwork
Reduction Act Review
wreier-aviles on DSK5TPTVN1PROD with NOTICES
The Centers for Disease Control and
Prevention (CDC) publishes a list of
relevant to the benefits and costs of substantiating
a particular claim. These factors include: the type
of claim, the product, the consequences of a false
claim, the benefits of a truthful claim, the cost of
developing substantiation for the claim, and the
amount of substantiation experts in the field believe
is reasonable.’’ FTC Policy Statement Regarding
Advertising Substantiation, appended to Thompson
Medical Co., 104 F.T.C. 648, 839 (1984), aff’d, 791
F.2d 189 (D.C. Cir. 1986), cert. denied, 479 U.S.
1086 (1987). Formulating the required level of
substantiation for injunctive relief should
necessarily be grounded in the factors set forth in
this policy statement, although additional
considerations might also be relevant.
VerDate Mar<15>2010
14:04 Jan 14, 2014
Jkt 232001
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Evaluation of Core Violence and
Injury Prevention Program (Core
VIPP)—Revision—(0920–0916,
Expiration 1/13/2014)—National Center
for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Injuries and their consequences,
including unintentional and violencerelated injuries, are the leading cause of
death for the first four decades of life,
regardless of gender, race, or
socioeconomic status. More than
179,000 individuals in the United States
die each year as a result of unintentional
injuries and violence, more than 29
million others suffer non-fatal injuries
and over one-third of all emergency
department (ED) visits each year are due
to injuries.1 In 2000, injuries and
violence ultimately cost the United
States $406 billion, with over $80
billion in medical costs and the
remainder lost in productivity.1 Most
events that result in injury and/or death
from injury could be prevented if
evidence-based public health strategies,
practices, and policies were used
throughout the nation.
CDC’s National Center for Injury
Prevention and Control (NCIPC) is
committed to working with their
partners to promote actions that reduce
injuries, violence, and disabilities by
providing leadership in identifying
priorities, promoting tools, and
monitoring effectiveness of injury and
violence prevention, and to promote
effective strategies for the prevention of
injury and violence and their
consequences. One tool NCIPC will use
to accomplish this goal is through the
use of the Core Violence and Injury
Prevention Program (Core VIPP). This
program funds state health departments
(SHDs) to build their capacity to
disseminate, implement, and evaluate
evidence-based/best practice programs
and policies. This evaluation will
1 Finkelstein EA, Corso PS, Miller TR, Associates.
Incidence and Economic Burden of Injuries in the
United States. New York: Oxford University Press;
2006.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
consider the implementation and
outcomes of Core VIPP during the fiveyear funding period from August 2011
to July 2016. The Core VIPP will
support funded states in building
capacity and achieving health impact in
their states. The key components of
violence and injury prevention (VIP)
capacity for Core Base Integration
Component (BIC) VIPP are defined as:
infrastructure, evaluation, strategies,
collaboration, and surveillance.
CDC requests OMB approval to
continue to collect program evaluation
data for Core VIPP for an additional
three-year period. The purpose of the
evaluation is to track states’ progress
toward: (1) Achieving the Performance
Measures identified in the Funding
Opportunity Announcement (FOA); (2)
building and/or sustaining their VIP
capacity; and (3) achieving their focus
area SMART (Specific, Measurable,
Attainable, Reasonable, and Timebound) objectives. The ability of states
to make progress towards their SMART
objectives will serve as a measure of
Core VIPP’s impact on the burden of
violence and injury related morbidity
and mortality in funded states.
The primary data collections methods
will be used in the evaluation include:
(1) Interim and annual progress reports,
(2) online surveys, and (3) interviews.
The progress reports will track states’
performance measures and the activities
stated in the Core VIPP FOA and
monitor states’ progress toward their
focus area SMART objectives; the online
survey will be used to measure grantees’
changes in VIP capacity. Interviews will
be used to provide more in-depth
information about the key facilitators
and barriers states have encountered
while implementing their violence
prevention programs.
The table below details the
annualized number of respondents, the
average response burden per interview,
and the total response burden for the
surveys and telephone interviews.
Estimates of burden for the survey are
based on previous experience with
evaluation data collections conducted
by the evaluation staff. The State of the
States (SOTS) web-based survey
assessment will be completed by 20
Core Funded State Health Departments
(SHDs) and will take 3 hours to
complete. The SOTS Financial Module
will also be completed by the 20 BIC
funded SHD and will take 1 hour to
complete. The supplemental SOTS
Survey Questions will be completed by
20 BIC funded SHDs and take 1.5 hours
to complete. The BIC telephone
interviews will take 1.5 hours and will
be completed by the 20 Core funded
SHDs.
E:\FR\FM\15JAN1.SGM
15JAN1
2675
Federal Register / Vol. 79, No. 10 / Wednesday, January 15, 2014 / Notices
The Regional Network Leader (RNL)
surveys will be completed by the 5 RNL
funded SHDs and will take 1 hour to
complete a telephone interview. The
four Surveillance Quality Improvement
(SQI) funded SHDs will complete a onehour telephone interview. The four
Motor Vehicle Child Injury Prevention
Policy (MVP) SHDs will complete a
telephone interview that will take one
hour to complete.
There are no costs to respondents
other than their time. The total
estimated annual burden hours are 163.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
Core VIPP Funded SHD Injury Program director.
Core VIPP Funded SHD Injury Program director.
Core VIPP Funded SHD Injury Program management and staff.
Core VIPP Funded SHD Injury Program management and staff.
RNL awardees ................................................
RNL awardees ................................................
State of the States Survey (SOTS)—Attachment C.
SOTS Financial Module—Attachment E ........
RNL awardees ................................................
SQI awardees .................................................
MVP awardees ................................................
LeRoy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–00585 Filed 1–14–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–14–0941]
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
VerDate Mar<15>2010
14:04 Jan 14, 2014
Jkt 232001
Proposed Project
Evaluation of Dating Matters:
Strategies to Promote Healthy Teen
Relationships TM (0920–0941,
Expiration 5/31/2016)—Revision—
National Center for Injury Prevention
and Control (NCIPC)—Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Dating Matters: Strategies to Promote
Healthy Teen Relationships TM is the
Centers for Disease Control and
Prevention’s new teen dating violence
prevention initiative.
To address the gaps in research and
practice, CDC has developed Dating
Matters, teen dating violence prevention
program that includes programming for
students, parents, educators, as well as
policy development. Dating Matters is
based on the current evidence about
what works in prevention and focuses
on high-risk, urban communities where
participants include: Middle school
students age 11 to 14 years; middle
school parents; brand ambassadors;
Frm 00044
Fmt 4703
Sfmt 4703
1
3
20
1
1
20
1
1.5
20
1
1.5
5
5
1
1
1
1
5
1
1
4
4
RNL Telephone Interview—Attachment G .....
RNL Network Satisfaction Survey—Attachment H.
RNL Needs Assessment Survey—Attachment I.
SQI Telephone Interview—Attachment J .......
MVP Telephone Interview—Attachment K ....
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Average
burden per
response
(in hrs.)
20
Supplemental SOTS Survey Questions—Attachment F.
BIC Telephone Interview—Attachment D ......
PO 00000
Number of
responses
per
respondent
Number of
respondents
1
1
1
1
educators; school leadership; program
implementers; community
representatives; and local health
department representatives in the
following communities: Alameda
County, California; Baltimore,
Maryland; Broward County, Florida;
and Chicago, Illinois. In the evaluation,
a standard model of TDV prevention
(Safe Dates administered in 8th grade)
will be compared to a comprehensive
model (programs administered in 6th,
7th, and 8th grade as well as parent,
educator, policy, and communications
interventions).
The primary goal of the current
proposal is to amend the available
administration formats for the student
follow-up survey for the participating
youth as they matriculate into high
school and to propose the use of
monetary gifts for the completion of the
student follow-up survey by high school
youth to the approved outcome and
implementation evaluation of Dating
Matters in the four metropolitan cities to
determine its feasibility, cost, and
effectiveness. Following Dating Matters
program participants into high school
may prove challenging and without a
high response rate, the evaluation
design may be compromised. To address
such concerns, we are requesting to
provide a nominal monetary gift to
participants in an amount up to $25.
The use of this monetary gift is critical
to maintain a high response rate of this
high-risk and highly mobile sample.
Response rates for the follow-up survey
were anticipated to be 90%, however, in
E:\FR\FM\15JAN1.SGM
15JAN1
]]>Agencies
[Federal Register Volume 79, Number 10 (Wednesday, January 15, 2014)]
[Notices]
[Pages 2674-2675]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00585]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-0916]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
Evaluation of Core Violence and Injury Prevention Program (Core
VIPP)--Revision--(0920-0916, Expiration 1/13/2014)--National Center for
Injury Prevention and Control (NCIPC), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Injuries and their consequences, including unintentional and
violence-related injuries, are the leading cause of death for the first
four decades of life, regardless of gender, race, or socioeconomic
status. More than 179,000 individuals in the United States die each
year as a result of unintentional injuries and violence, more than 29
million others suffer non-fatal injuries and over one-third of all
emergency department (ED) visits each year are due to injuries.\1\ In
2000, injuries and violence ultimately cost the United States $406
billion, with over $80 billion in medical costs and the remainder lost
in productivity.\1\ Most events that result in injury and/or death from
injury could be prevented if evidence-based public health strategies,
practices, and policies were used throughout the nation.
---------------------------------------------------------------------------
\1\ Finkelstein EA, Corso PS, Miller TR, Associates. Incidence
and Economic Burden of Injuries in the United States. New York:
Oxford University Press; 2006.
---------------------------------------------------------------------------
CDC's National Center for Injury Prevention and Control (NCIPC) is
committed to working with their partners to promote actions that reduce
injuries, violence, and disabilities by providing leadership in
identifying priorities, promoting tools, and monitoring effectiveness
of injury and violence prevention, and to promote effective strategies
for the prevention of injury and violence and their consequences. One
tool NCIPC will use to accomplish this goal is through the use of the
Core Violence and Injury Prevention Program (Core VIPP). This program
funds state health departments (SHDs) to build their capacity to
disseminate, implement, and evaluate evidence-based/best practice
programs and policies. This evaluation will consider the implementation
and outcomes of Core VIPP during the five-year funding period from
August 2011 to July 2016. The Core VIPP will support funded states in
building capacity and achieving health impact in their states. The key
components of violence and injury prevention (VIP) capacity for Core
Base Integration Component (BIC) VIPP are defined as: infrastructure,
evaluation, strategies, collaboration, and surveillance.
CDC requests OMB approval to continue to collect program evaluation
data for Core VIPP for an additional three-year period. The purpose of
the evaluation is to track states' progress toward: (1) Achieving the
Performance Measures identified in the Funding Opportunity Announcement
(FOA); (2) building and/or sustaining their VIP capacity; and (3)
achieving their focus area SMART (Specific, Measurable, Attainable,
Reasonable, and Time-bound) objectives. The ability of states to make
progress towards their SMART objectives will serve as a measure of Core
VIPP's impact on the burden of violence and injury related morbidity
and mortality in funded states.
The primary data collections methods will be used in the evaluation
include: (1) Interim and annual progress reports, (2) online surveys,
and (3) interviews. The progress reports will track states' performance
measures and the activities stated in the Core VIPP FOA and monitor
states' progress toward their focus area SMART objectives; the online
survey will be used to measure grantees' changes in VIP capacity.
Interviews will be used to provide more in-depth information about the
key facilitators and barriers states have encountered while
implementing their violence prevention programs.
The table below details the annualized number of respondents, the
average response burden per interview, and the total response burden
for the surveys and telephone interviews. Estimates of burden for the
survey are based on previous experience with evaluation data
collections conducted by the evaluation staff. The State of the States
(SOTS) web-based survey assessment will be completed by 20 Core Funded
State Health Departments (SHDs) and will take 3 hours to complete. The
SOTS Financial Module will also be completed by the 20 BIC funded SHD
and will take 1 hour to complete. The supplemental SOTS Survey
Questions will be completed by 20 BIC funded SHDs and take 1.5 hours to
complete. The BIC telephone interviews will take 1.5 hours and will be
completed by the 20 Core funded SHDs.
[[Page 2675]]
The Regional Network Leader (RNL) surveys will be completed by the
5 RNL funded SHDs and will take 1 hour to complete a telephone
interview. The four Surveillance Quality Improvement (SQI) funded SHDs
will complete a one-hour telephone interview. The four Motor Vehicle
Child Injury Prevention Policy (MVP) SHDs will complete a telephone
interview that will take one hour to complete.
There are no costs to respondents other than their time. The total
estimated annual burden hours are 163.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Core VIPP Funded SHD Injury Program State of the States 20 1 3
director. Survey (SOTS)--
Attachment C.
Core VIPP Funded SHD Injury Program SOTS Financial Module-- 20 1 1
director. Attachment E.
Core VIPP Funded SHD Injury Program Supplemental SOTS Survey 20 1 1.5
management and staff. Questions--Attachment F.
Core VIPP Funded SHD Injury Program BIC Telephone Interview-- 20 1 1.5
management and staff. Attachment D.
RNL awardees.......................... RNL Telephone Interview-- 5 1 1
Attachment G.
RNL awardees.......................... RNL Network Satisfaction 5 1 1
Survey--Attachment H.
RNL awardees.......................... RNL Needs Assessment 5 1 1
Survey--Attachment I.
SQI awardees.......................... SQI Telephone Interview-- 4 1 1
Attachment J.
MVP awardees.......................... MVP Telephone Interview-- 4 1 1
Attachment K.
----------------------------------------------------------------------------------------------------------------
LeRoy Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-00585 Filed 1-14-14; 8:45 am]
BILLING CODE 4163-18-P
