82_FR_34671 82 FR 34530 - Submission for OMB Review; Comment Request

82 FR 34530 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 82, Issue 141 (July 25, 2017)

Page Range34530-34531
FR Document2017-15523

Federal Register, Volume 82 Issue 141 (Tuesday, July 25, 2017)
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34530-34531]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].
    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: 
[email protected], 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



                                                  34530                           Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices

                                                  application and approval process for                        Dated: July 20, 2017.                              designed in consultation with agency
                                                  survey vendors who want to participate                   William N. Parham, III,                               leaders and launched quickly. To
                                                  in collecting QHP enrollee experience                    Director, Paperwork Reduction Staff, Office           maximize the likelihood that the
                                                  data.                                                    of Strategic Operations and Regulatory                intervention produces measurable,
                                                                                                           Affairs.                                              significant, positive effects on outcomes
                                                     The QHP Enrollee Survey, which is
                                                  based on the CAHPS® Health Plan                          [FR Doc. 2017–15589 Filed 7–24–17; 8:45 am]           of interest, rapid cycle evaluation
                                                  Survey, will be used to (1) help                         BILLING CODE 4120–01–P                                techniques will be employed in which
                                                                                                                                                                 proximate outcomes will be measured to
                                                  consumers choose among competing
                                                                                                                                                                 allow the research team to rapidly
                                                  health plans, (2) provide actionable                     DEPARTMENT OF HEALTH AND                              iterate and adjust the intervention
                                                  information that the QHPs can use to                     HUMAN SERVICES                                        design, informing subsequent tests.
                                                  improve performance, (3) provide                                                                                  Due to the rapid and iterative nature
                                                  information that regulatory and                          Administration for Children and                       of this work OPRE seeks generic
                                                  accreditation organizations can use to                   Families                                              clearance to conduct this research.
                                                  regulate and accredit plans, and (4)                                                                           Following standard OMB requirements
                                                  provide a longitudinal database for                      Submission for OMB Review;                            for generic clearances, once instruments
                                                  consumer research. CMS completed two                     Comment Request                                       are tailored to a specific site and the
                                                  rounds of developmental testing                             Title: Behavioral Interventions to                 site’s intervention, OPRE will submit an
                                                  including 2014 psychometric testing                      Advance Self-Sufficiency Next                         individual generic information
                                                  and 2015 beta testing of the QHP                         Generation (BIAS–NG).                                 collection request under this umbrella
                                                  Enrollee Survey. The psychometric                           OMB No.: New Collection.                           clearance. Each request will include the
                                                  testing helped determine psychometric                       Description: The Office of Planning,               individual instrument(s), a justification
                                                  properties and provided an initial                       Research and Evaluation (OPRE) in the                 specific to the individual information
                                                  measure of performance for                               Administration for Children and                       collection, a description of the proposed
                                                  Marketplaces and QHPs to use for                         Families (ACF), U.S. Department of                    intervention, and any supplementary
                                                  quality improvement. Based on                            Health and Human Services (HHS)                       documents. Each specific information
                                                  psychometric test results, CMS further                   requests Office of Management and                     collection will include two submissions:
                                                  refined the questionnaire and sampling                   Budget (OMB) approval for a 3-year                    First, a submission for the formative
                                                  design to conduct the 2015 beta test of                  pilot generic clearance to collect data as            stage research and second, a submission
                                                  the QHP Enrollee Survey. CMS                             part of rapid cycle testing and                       for the test and evaluation materials. In
                                                  previously obtained clearance for the                    evaluation, in order to inform the design             this notice we describe the types of
                                                  2016 and 2017 administrations of the                     of interventions informed by behavioral               information expected to be collected for
                                                  QHP Enrollee Survey.                                     science and to better understand the                  each test and the expected burden.
                                                     At this time, CMS is requesting to                    mechanisms and effects of such                           To ensure maximal relevance to the
                                                  renew approval for the information                       interventions. These interventions,                   domain areas selected (i.e., Child
                                                  collection related to the QHP Enrollee                   which will be in the program area                     Welfare and TANF), the project has
                                                                                                           domains of Temporary Assistance for                   identified a set of broad problems that
                                                  Experience Survey in 2018–2020. These
                                                                                                           Needy Families (TANF) and child                       affect entire domain areas rather than
                                                  activities are necessary to ensure that
                                                                                                           welfare, are intended to improve                      problems that are idiosyncratic to a
                                                  CMS fulfills legislative mandates
                                                                                                           outcomes for participants in these                    particular program. In each of the
                                                  established by section 1311(c)(4) of the
                                                                                                           programs.                                             approximately six sites with which the
                                                  Affordable Care Act to develop an                           OPRE plans to conduct the Behavioral               project will work under this clearance,
                                                  ‘‘enrollee satisfaction survey system’’                  Interventions to Advance Self-                        interventions will be designed and
                                                  and provide such information on                          Sufficiency Next Generation (BIAS–NG)                 tested using an approach called
                                                  Marketplace Web sites. CMS is also                       project. This project will use behavioral             behavioral diagnosis and design which
                                                  seeking approval to remove eight survey                  insights to design and test interventions             will involve determining how identified
                                                  questions beginning with the 2018                        intended to improve the efficiency,                   problems operate within each site’s
                                                  survey administration. With the removal                  operations, and efficacy of human                     specific context, diagnosing behavioral
                                                  of these eight questions, the revised                    services programs. The BIAS–NG                        reasons for those problems, designing
                                                  total estimated annual burden hours of                   project will apply behavioral insights to             interventions informed by behavioral
                                                  national implementation of the QHP                       a range of ACF programs including                     insights, and rigorously testing the
                                                  Enrollee Survey is 22,523 hours with                     TANF, Child Welfare, and other                        interventions. Information will be
                                                  90,015 responses. The revised total                      program areas to be determined. This                  collected throughout this process. The
                                                  annualized burden over three years for                   notice is specific to data collection with            information that will be collected is
                                                  this requested information collection is                 TANF and Child Welfare sites; when                    specific to each of the sites, will not be
                                                  67,569 hours and the total average                       and if the project desires to work in                 collected indefinitely, and is not
                                                  annualized number of responses is                        other program areas, OPRE will publish                intended to be interpreted as applicable
                                                  270,045 responses. Form Number:                          a Federal Register notice allowing for                to other sites or to other programs. In
                                                  CMS–10488 (OMB control number:                           public comment and will submit a new                  addition, in working with the project to
                                                  0938–1221); Frequency: Annually;                         information collection request for that               design the behavioral interventions to
                                                  Affected Public: Public sector                           work. Under this pilot generic                        be tested, some sites may decide to
                                                  (Individuals and Households), Private                    clearance, OPRE plans to work with                    change what data they collect and/or the
mstockstill on DSK30JT082PROD with NOTICES




                                                  sector (Business or other for-profits and                approximately six sites to conduct                    questions they ask the public to answer.
                                                  Not-for-profit institutions); Number of                  approximately two tests per site, for a               Such decisions will be controlled by the
                                                  Respondents: 90,015; Total Annual                        total of approximately 12 tests of                    sites, not by the project.
                                                  Responses: 90,015; Total Annual Hours:                   behavioral interventions.                                In order to define and diagnose
                                                  22,523. (For policy questions regarding                     The design and testing of BIAS NG                  program challenges and design
                                                  this collection contact Nidhi Singh Shah                 interventions will be rapid and iterative.            appropriate interventions, OPRE plans
                                                  at 301–492–5110.)                                        Each specific intervention will be                    to conduct interviews and focus groups


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                                                                                            Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices                                                             34531

                                                  with administrators, staff, and/or clients                                sites that will be engaged across the two                     sites will be necessary. Within each site,
                                                  in each of the approximately six sites.                                   program areas included under this                             we do not intend to do any active
                                                  OPRE will field client and/or staff                                       clearance, TANF and Child Welfare (for                        recruitment as all those who are eligible
                                                  surveys in order to hear from a breadth                                   a total of 12 tests). To better understand                    will be enrolled in the study and
                                                  of perspectives. In addition to                                           how the intervention is being                                 randomization will be conducted using
                                                  interviews, focus groups, and surveys,                                    implemented and its effects, OPRE                             a list of those who meet the eligibility
                                                  OPRE anticipates observing program                                        anticipates conducting interviews and                         criteria. Findings from these tests will
                                                  activities and reviewing documents and                                    focus groups with program                                     be publicized through multiple
                                                  administrative data. This information                                     administrators, staff, and/or clients in                      dissemination channels, which may
                                                  will be critical to diagnosing where and                                  each site. Because not all outcomes of                        include but are not limited to reports on
                                                  why programs are facing challenges and                                    interest (for example, improved                               individual tests, a final synthesis report,
                                                  which behavioral interventions may                                        understanding of and/or satisfaction                          presentations at conferences and
                                                  have an impact.                                                           with the foster parent recruitment
                                                    During the testing phase OPRE                                                                                                         meetings, scholarly journal articles,
                                                                                                                            process) are reflected in administrative
                                                  anticipates conducting mixed-methods                                                                                                    webinars, social media, press outreach,
                                                                                                                            records, OPRE anticipates conducting
                                                  evaluations consisting of                                                                                                               newsletters, etc.
                                                                                                                            client surveys and staff surveys.
                                                  implementation, impact, and cost                                             Interest in participating in BIAS–NG                          Respondents: (1) Program
                                                  research for the approximately two tests                                  is expected to be high, and it is not                         Administrators, (2) Program Staff and
                                                  in each of the approximately six total                                    expected that systematic recruitment of                       (3) Program Clients.

                                                                                                                                          TOTAL BURDEN HOURS
                                                                                                                                                                                         Number of           Average
                                                                                                                                                                  Total number                                            Total burden
                                                                                               Instrument                                                                              responses per       burden hours
                                                                                                                                                                 of respondents                                              hours
                                                                                                                                                                                         respondent        per response

                                                                                                                                        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                                    Desk Officer for the Administration for                       workshop entitled ‘‘Voluntary Medical
                                                  hours.                                                                    Children and Families.                                        Device Manufacturing and Product
                                                     Additional Information: Copies of the                                  Mary Jones,
                                                                                                                                                                                          Quality Program.’’ The purpose of the
                                                  proposed collection may be obtained by                                                                                                  public workshop is to announce the
                                                                                                                            ACF/OPRE, Certifying Officer.
                                                  writing to the Administration for                                                                                                       proposed framework and preliminary
                                                                                                                            [FR Doc. 2017–15523 Filed 7–24–17; 8:45 am]
                                                  Children and Families, Office of                                                                                                        outline of a voluntary pilot program that
                                                                                                                            BILLING CODE 4184–07–P
                                                  Planning, Research and Evaluation, 330                                                                                                  recognizes an independent assessment
                                                  C Street SW., Washington, DC 20201,                                                                                                     of manufacturing and product quality.
                                                  Attn: OPRE Reports Clearance Officer.                                                                                                   The workshop is intended to discuss the
                                                  All requests should be identified by the                                  DEPARTMENT OF HEALTH AND                                      framework of the voluntary pilot
                                                  title of the information collection. Email                                HUMAN SERVICES                                                program, information on the
                                                  address: OPREinfocollection@                                                                                                            independent assessment, details of
                                                                                                                            Food and Drug Administration
                                                  acf.hhs.gov.                                                                                                                            participation, rules of engagement,
                                                     OMB Comment: OMB is required to                                        [Docket No. FDA–2017–N–4180]                                  monitoring and performance
                                                  make a decision concerning the                                                                                                          expectations, as well as potential
                                                                                                                            Voluntary Medical Device
                                                  collection of information between 30                                                                                                    modifications to FDA’s oversight actions
                                                                                                                            Manufacturing and Product Quality
                                                  and 60 days after publication of this                                                                                                   in response to demonstrated
                                                                                                                            Program; Public Workshop; Request
                                                  document in the Federal Register.                                                                                                       manufacturing quality performance.
                                                                                                                            for Comments
                                                  Therefore, a comment is best assured of                                                                                                 FDA is soliciting public feedback to aid
                                                  having its full effect if OMB receives it                                 AGENCY:        Food and Drug Administration,                  in the development of science-based
mstockstill on DSK30JT082PROD with NOTICES




                                                  within 30 days of publication. Written                                    HHS.                                                          approaches to regulatory decision
                                                  comments and recommendations for the                                      ACTION: Notice of public workshop;                            making for assessing manufacturing
                                                  proposed information collection should                                    request for comments.                                         quality, extent of manufacturing related
                                                  be sent directly to the following: Office                                                                                               submissions, and how to better allocate
                                                  of Management and Budget, Paperwork                                       SUMMARY:  The Food and Drug                                   resources to lower the regulatory burden
                                                  Reduction Project, Email: OIRA_                                           Administration (FDA, the Agency, or                           on manufacturers and FDA.
                                                  SUBMISSION@OMB.EOP.GOV, Attn:                                             we) is announcing the following public


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Document Created: 2018-10-24 11:20:43
Document Modified: 2018-10-24 11:20:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation82 FR 34530 

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