Submission for OMB Review; Comment Request, 34530-34531 [2017-15523]
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Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
application and approval process for
survey vendors who want to participate
in collecting QHP enrollee experience
data.
The QHP Enrollee Survey, which is
based on the CAHPS® Health Plan
Survey, will be used to (1) help
consumers choose among competing
health plans, (2) provide actionable
information that the QHPs can use to
improve performance, (3) provide
information that regulatory and
accreditation organizations can use to
regulate and accredit plans, and (4)
provide a longitudinal database for
consumer research. CMS completed two
rounds of developmental testing
including 2014 psychometric testing
and 2015 beta testing of the QHP
Enrollee Survey. The psychometric
testing helped determine psychometric
properties and provided an initial
measure of performance for
Marketplaces and QHPs to use for
quality improvement. Based on
psychometric test results, CMS further
refined the questionnaire and sampling
design to conduct the 2015 beta test of
the QHP Enrollee Survey. CMS
previously obtained clearance for the
2016 and 2017 administrations of the
QHP Enrollee Survey.
At this time, CMS is requesting to
renew approval for the information
collection related to the QHP Enrollee
Experience Survey in 2018–2020. These
activities are necessary to ensure that
CMS fulfills legislative mandates
established by section 1311(c)(4) of the
Affordable Care Act to develop an
‘‘enrollee satisfaction survey system’’
and provide such information on
Marketplace Web sites. CMS is also
seeking approval to remove eight survey
questions beginning with the 2018
survey administration. With the removal
of these eight questions, the revised
total estimated annual burden hours of
national implementation of the QHP
Enrollee Survey is 22,523 hours with
90,015 responses. The revised total
annualized burden over three years for
this requested information collection is
67,569 hours and the total average
annualized number of responses is
270,045 responses. Form Number:
CMS–10488 (OMB control number:
0938–1221); Frequency: Annually;
Affected Public: Public sector
(Individuals and Households), Private
sector (Business or other for-profits and
Not-for-profit institutions); Number of
Respondents: 90,015; Total Annual
Responses: 90,015; Total Annual Hours:
22,523. (For policy questions regarding
this collection contact Nidhi Singh Shah
at 301–492–5110.)
VerDate Sep<11>2014
19:30 Jul 24, 2017
Jkt 241001
Dated: July 20, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–15589 Filed 7–24–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Behavioral Interventions to
Advance Self-Sufficiency Next
Generation (BIAS–NG).
OMB No.: New Collection.
Description: The Office of Planning,
Research and Evaluation (OPRE) in the
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS)
requests Office of Management and
Budget (OMB) approval for a 3-year
pilot generic clearance to collect data as
part of rapid cycle testing and
evaluation, in order to inform the design
of interventions informed by behavioral
science and to better understand the
mechanisms and effects of such
interventions. These interventions,
which will be in the program area
domains of Temporary Assistance for
Needy Families (TANF) and child
welfare, are intended to improve
outcomes for participants in these
programs.
OPRE plans to conduct the Behavioral
Interventions to Advance SelfSufficiency Next Generation (BIAS–NG)
project. This project will use behavioral
insights to design and test interventions
intended to improve the efficiency,
operations, and efficacy of human
services programs. The BIAS–NG
project will apply behavioral insights to
a range of ACF programs including
TANF, Child Welfare, and other
program areas to be determined. This
notice is specific to data collection with
TANF and Child Welfare sites; when
and if the project desires to work in
other program areas, OPRE will publish
a Federal Register notice allowing for
public comment and will submit a new
information collection request for that
work. Under this pilot generic
clearance, OPRE plans to work with
approximately six sites to conduct
approximately two tests per site, for a
total of approximately 12 tests of
behavioral interventions.
The design and testing of BIAS NG
interventions will be rapid and iterative.
Each specific intervention will be
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
designed in consultation with agency
leaders and launched quickly. To
maximize the likelihood that the
intervention produces measurable,
significant, positive effects on outcomes
of interest, rapid cycle evaluation
techniques will be employed in which
proximate outcomes will be measured to
allow the research team to rapidly
iterate and adjust the intervention
design, informing subsequent tests.
Due to the rapid and iterative nature
of this work OPRE seeks generic
clearance to conduct this research.
Following standard OMB requirements
for generic clearances, once instruments
are tailored to a specific site and the
site’s intervention, OPRE will submit an
individual generic information
collection request under this umbrella
clearance. Each request will include the
individual instrument(s), a justification
specific to the individual information
collection, a description of the proposed
intervention, and any supplementary
documents. Each specific information
collection will include two submissions:
First, a submission for the formative
stage research and second, a submission
for the test and evaluation materials. In
this notice we describe the types of
information expected to be collected for
each test and the expected burden.
To ensure maximal relevance to the
domain areas selected (i.e., Child
Welfare and TANF), the project has
identified a set of broad problems that
affect entire domain areas rather than
problems that are idiosyncratic to a
particular program. In each of the
approximately six sites with which the
project will work under this clearance,
interventions will be designed and
tested using an approach called
behavioral diagnosis and design which
will involve determining how identified
problems operate within each site’s
specific context, diagnosing behavioral
reasons for those problems, designing
interventions informed by behavioral
insights, and rigorously testing the
interventions. Information will be
collected throughout this process. The
information that will be collected is
specific to each of the sites, will not be
collected indefinitely, and is not
intended to be interpreted as applicable
to other sites or to other programs. In
addition, in working with the project to
design the behavioral interventions to
be tested, some sites may decide to
change what data they collect and/or the
questions they ask the public to answer.
Such decisions will be controlled by the
sites, not by the project.
In order to define and diagnose
program challenges and design
appropriate interventions, OPRE plans
to conduct interviews and focus groups
E:\FR\FM\25JYN1.SGM
25JYN1
34531
Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
with administrators, staff, and/or clients
in each of the approximately six sites.
OPRE will field client and/or staff
surveys in order to hear from a breadth
of perspectives. In addition to
interviews, focus groups, and surveys,
OPRE anticipates observing program
activities and reviewing documents and
administrative data. This information
will be critical to diagnosing where and
why programs are facing challenges and
which behavioral interventions may
have an impact.
During the testing phase OPRE
anticipates conducting mixed-methods
evaluations consisting of
implementation, impact, and cost
research for the approximately two tests
in each of the approximately six total
sites that will be engaged across the two
program areas included under this
clearance, TANF and Child Welfare (for
a total of 12 tests). To better understand
how the intervention is being
implemented and its effects, OPRE
anticipates conducting interviews and
focus groups with program
administrators, staff, and/or clients in
each site. Because not all outcomes of
interest (for example, improved
understanding of and/or satisfaction
with the foster parent recruitment
process) are reflected in administrative
records, OPRE anticipates conducting
client surveys and staff surveys.
Interest in participating in BIAS–NG
is expected to be high, and it is not
expected that systematic recruitment of
sites will be necessary. Within each site,
we do not intend to do any active
recruitment as all those who are eligible
will be enrolled in the study and
randomization will be conducted using
a list of those who meet the eligibility
criteria. Findings from these tests will
be publicized through multiple
dissemination channels, which may
include but are not limited to reports on
individual tests, a final synthesis report,
presentations at conferences and
meetings, scholarly journal articles,
webinars, social media, press outreach,
newsletters, etc.
Respondents: (1) Program
Administrators, (2) Program Staff and
(3) Program Clients.
TOTAL BURDEN HOURS
Total number
of respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Diagnosis and Design Phase
Administrator interviews/focus groups .....................................................
Staff interviews/focus groups ...................................................................
Client interviews/focus groups .................................................................
Client survey ............................................................................................
Staff Survey .............................................................................................
24
48
48
600
120
1
1
1
1
1
1
1
1
.25
.25
24
48
48
150
30
48
96
96
6,000
120
1
1
1
1
1
1
1
1
.25
.25
48
96
96
1,500
30
Evaluation Phase
mstockstill on DSK30JT082PROD with NOTICES
Administrator interviews/focus groups .....................................................
Staff interviews/focus groups ...................................................................
Client interviews/focus groups .................................................................
Client Survey ...........................................................................................
Staff survey ..............................................................................................
Estimated Total Burden Hours: 2,070
hours.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
VerDate Sep<11>2014
19:30 Jul 24, 2017
Jkt 241001
Desk Officer for the Administration for
Children and Families.
Mary Jones,
ACF/OPRE, Certifying Officer.
[FR Doc. 2017–15523 Filed 7–24–17; 8:45 am]
BILLING CODE 4184–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4180]
Voluntary Medical Device
Manufacturing and Product Quality
Program; Public Workshop; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
workshop entitled ‘‘Voluntary Medical
Device Manufacturing and Product
Quality Program.’’ The purpose of the
public workshop is to announce the
proposed framework and preliminary
outline of a voluntary pilot program that
recognizes an independent assessment
of manufacturing and product quality.
The workshop is intended to discuss the
framework of the voluntary pilot
program, information on the
independent assessment, details of
participation, rules of engagement,
monitoring and performance
expectations, as well as potential
modifications to FDA’s oversight actions
in response to demonstrated
manufacturing quality performance.
FDA is soliciting public feedback to aid
in the development of science-based
approaches to regulatory decision
making for assessing manufacturing
quality, extent of manufacturing related
submissions, and how to better allocate
resources to lower the regulatory burden
on manufacturers and FDA.
E:\FR\FM\25JYN1.SGM
25JYN1
]]>Agencies
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34530-34531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15523]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Behavioral Interventions to Advance Self-Sufficiency Next
Generation (BIAS-NG).
OMB No.: New Collection.
Description: The Office of Planning, Research and Evaluation (OPRE)
in the Administration for Children and Families (ACF), U.S. Department
of Health and Human Services (HHS) requests Office of Management and
Budget (OMB) approval for a 3-year pilot generic clearance to collect
data as part of rapid cycle testing and evaluation, in order to inform
the design of interventions informed by behavioral science and to
better understand the mechanisms and effects of such interventions.
These interventions, which will be in the program area domains of
Temporary Assistance for Needy Families (TANF) and child welfare, are
intended to improve outcomes for participants in these programs.
OPRE plans to conduct the Behavioral Interventions to Advance Self-
Sufficiency Next Generation (BIAS-NG) project. This project will use
behavioral insights to design and test interventions intended to
improve the efficiency, operations, and efficacy of human services
programs. The BIAS-NG project will apply behavioral insights to a range
of ACF programs including TANF, Child Welfare, and other program areas
to be determined. This notice is specific to data collection with TANF
and Child Welfare sites; when and if the project desires to work in
other program areas, OPRE will publish a Federal Register notice
allowing for public comment and will submit a new information
collection request for that work. Under this pilot generic clearance,
OPRE plans to work with approximately six sites to conduct
approximately two tests per site, for a total of approximately 12 tests
of behavioral interventions.
The design and testing of BIAS NG interventions will be rapid and
iterative. Each specific intervention will be designed in consultation
with agency leaders and launched quickly. To maximize the likelihood
that the intervention produces measurable, significant, positive
effects on outcomes of interest, rapid cycle evaluation techniques will
be employed in which proximate outcomes will be measured to allow the
research team to rapidly iterate and adjust the intervention design,
informing subsequent tests.
Due to the rapid and iterative nature of this work OPRE seeks
generic clearance to conduct this research. Following standard OMB
requirements for generic clearances, once instruments are tailored to a
specific site and the site's intervention, OPRE will submit an
individual generic information collection request under this umbrella
clearance. Each request will include the individual instrument(s), a
justification specific to the individual information collection, a
description of the proposed intervention, and any supplementary
documents. Each specific information collection will include two
submissions: First, a submission for the formative stage research and
second, a submission for the test and evaluation materials. In this
notice we describe the types of information expected to be collected
for each test and the expected burden.
To ensure maximal relevance to the domain areas selected (i.e.,
Child Welfare and TANF), the project has identified a set of broad
problems that affect entire domain areas rather than problems that are
idiosyncratic to a particular program. In each of the approximately six
sites with which the project will work under this clearance,
interventions will be designed and tested using an approach called
behavioral diagnosis and design which will involve determining how
identified problems operate within each site's specific context,
diagnosing behavioral reasons for those problems, designing
interventions informed by behavioral insights, and rigorously testing
the interventions. Information will be collected throughout this
process. The information that will be collected is specific to each of
the sites, will not be collected indefinitely, and is not intended to
be interpreted as applicable to other sites or to other programs. In
addition, in working with the project to design the behavioral
interventions to be tested, some sites may decide to change what data
they collect and/or the questions they ask the public to answer. Such
decisions will be controlled by the sites, not by the project.
In order to define and diagnose program challenges and design
appropriate interventions, OPRE plans to conduct interviews and focus
groups
[[Page 34531]]
with administrators, staff, and/or clients in each of the approximately
six sites. OPRE will field client and/or staff surveys in order to hear
from a breadth of perspectives. In addition to interviews, focus
groups, and surveys, OPRE anticipates observing program activities and
reviewing documents and administrative data. This information will be
critical to diagnosing where and why programs are facing challenges and
which behavioral interventions may have an impact.
During the testing phase OPRE anticipates conducting mixed-methods
evaluations consisting of implementation, impact, and cost research for
the approximately two tests in each of the approximately six total
sites that will be engaged across the two program areas included under
this clearance, TANF and Child Welfare (for a total of 12 tests). To
better understand how the intervention is being implemented and its
effects, OPRE anticipates conducting interviews and focus groups with
program administrators, staff, and/or clients in each site. Because not
all outcomes of interest (for example, improved understanding of and/or
satisfaction with the foster parent recruitment process) are reflected
in administrative records, OPRE anticipates conducting client surveys
and staff surveys.
Interest in participating in BIAS-NG is expected to be high, and it
is not expected that systematic recruitment of sites will be necessary.
Within each site, we do not intend to do any active recruitment as all
those who are eligible will be enrolled in the study and randomization
will be conducted using a list of those who meet the eligibility
criteria. Findings from these tests will be publicized through multiple
dissemination channels, which may include but are not limited to
reports on individual tests, a final synthesis report, presentations at
conferences and meetings, scholarly journal articles, webinars, social
media, press outreach, newsletters, etc.
Respondents: (1) Program Administrators, (2) Program Staff and (3)
Program Clients.
Total Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Total number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Diagnosis and Design Phase
----------------------------------------------------------------------------------------------------------------
Administrator interviews/focus groups....... 24 1 1 24
Staff interviews/focus groups............... 48 1 1 48
Client interviews/focus groups.............. 48 1 1 48
Client survey............................... 600 1 .25 150
Staff Survey................................ 120 1 .25 30
----------------------------------------------------------------------------------------------------------------
Evaluation Phase
----------------------------------------------------------------------------------------------------------------
Administrator interviews/focus groups....... 48 1 1 48
Staff interviews/focus groups............... 96 1 1 96
Client interviews/focus groups.............. 96 1 1 96
Client Survey............................... 6,000 1 .25 1,500
Staff survey................................ 120 1 .25 30
----------------------------------------------------------------------------------------------------------------
Estimated Total Burden Hours: 2,070 hours.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 330 C Street SW.,
Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All
requests should be identified by the title of the information
collection. Email address: OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration
for Children and Families.
Mary Jones,
ACF/OPRE, Certifying Officer.
[FR Doc. 2017-15523 Filed 7-24-17; 8:45 am]
BILLING CODE 4184-07-P
