Proposed Information Collection Activity; Comment Request, 37454-37456 [2017-16854]

Download as PDF 37454 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices Design and Implementation Study is complete; data collection related to the Performance Analysis Study will be complete in late summer 2017. This notice is specific to data collection activities for the Impact and In-Depth Implementation Study, which is being conducted in four sites. The proposed extension is necessary to complete ongoing follow-up data collection. The resulting data will be used in a rigorous program impact analysis to assess the effectiveness of each program in reducing teen sexual activity and associated risk behaviors. Respondents: Youth participants who agreed to participate in the study upon enrollment in the four impact study sites. ANNUAL BURDEN ESTIMATES Total/annual number of respondents Instrument Second follow-up survey ......................................................................... mstockstill on DSK30JT082PROD with NOTICES Estimated Total/Annual Burden Hours: 244 In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded 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. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments 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 practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Mary Jones, ACF/OPRE Reports Clearance Officer. [FR Doc. 2017–16843 Filed 8–9–17; 8:45 am] BILLING CODE 4184–37–P VerDate Sep<11>2014 17:03 Aug 09, 2017 Jkt 241001 Number of responses per respondents 325 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Variations in Implementation of Quality Interventions (VIQI) Project: Data Collection. OMB No.: New Collection. Description: The Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE) proposes to collect information as part of the Variations in Implementation of Quality Interventions (VIQI): Examining the Quality-Child Outcomes Relationship in Child Care and Early Education Project. The VIQI Project will inform policymakers, practitioners, and stakeholders about effective ways to support the quality and effectiveness of early care and education (ECE) centers for promoting young children’s learning and development. In partnership with ECE centers across the United States that serve young children with diverse economic backgrounds, the VIQI Project aims to (1) identify dimensions of quality within ECE settings that are key levers for promoting children’s outcomes; (2) inform what levels of quality are necessary to successfully support children’s developmental gains; (3) identify drivers that facilitate and inhibit successful implementation of interventions aimed at strengthening quality; and (4) understand how these relations vary across different ECE settings, staff, and children. To achieve these aims, the VIQI Project will include a year-long pilot study that will pilot up to three curricular and professional development models, followed by a year-long impact evaluation and process study that involve testing the effectiveness of two curricular and professional development models that aim to strengthen teacher practices, the PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Average burden hours per response 1 .75 Total/annual burden hours 244 quality of classroom processes, and children’s outcomes. The study will include up to 189 community-based and Head Start ECE centers spread across seven different metropolitan areas in the United States. To test the effectiveness of the curricular and professional development models, the VIQI project will consist of a 3- or 4-group experimental design in the pilot study and a 3-group experimental design in the impact evaluation and the process study in which the initial quality and other characteristics of ECE centers are measured. The centers then will be stratified based upon select information collected—by setting type (e.g., Head Start and community-based ECE centers) and initial levels of quality— and randomly assigned to one of the intervention conditions where they will be offered curricular and professional development supports aimed at strengthening the quality of classroom and teacher practices, or to a businessas-usual comparison condition. In the pilot study, 24 centers in one metropolitan area will participate in the VIQI Project. Information about center and staff characteristics and classroom and teacher practices will be collected (1) to stratify and randomly assign centers; (2) to describe how the different interventions are implemented and are experienced by centers and teachers; and (3) to document the treatment differentials across research conditions. The information will then be used to adjust and to refine the research design and measures that will be used in the impact evaluation and process study. In the impact evaluation and process study, 165 centers in seven metropolitan areas will participate in the VIQI Project. Information about center and staff characteristics and classroom and teacher practices will be collected (1) to stratify and randomly assign centers; (2) to identify subgroups of interest; (3) to describe how the interventions are implemented and are experienced by E:\FR\FM\10AUN1.SGM 10AUN1 37455 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices centers and teachers; (4) to document the treatment differentials across research conditions; and (5) to assess the impacts of each of the interventions on different dimensions of quality and teacher practices when compared to a business-as-usual comparison condition for the impact evaluation sample and separately for subgroups of interest. In addition, information about the background characteristics of families and children being served in the centers will be collected, as well as measures of children’s skills at the beginning and end of the year-long impact evaluation for a subset of children in these centers. This information will also be used (1) to define subgroups of interest defined by family and child characteristics, and (2) to assess the impacts of each of the interventions on children’s skills for the full impact evaluation sample and separately for subgroups of interest. Lastly, the information on quality, teacher practices and children’s skills will be used in a set of analyses that will rigorously examine the nature of the quality-to-child outcomes relationship by exploring the effects of different dimensions and thresholds (or levels) of quality on child outcomes for the full impact evaluation sample and separately for subgroups of interest. The data collection instruments for the VIQI Project include the following: (1) Instruments for Screening and Recruitment of ECE Centers will be used in the pilot study, impact evaluation, and process study to assess ECE centers’ eligibility, to inform the sampling strategy, and to recruit ECE centers to participate in the VIQI Project; (2) Baseline Instruments for the Pilot Study, Impact Evaluation, and Process Study will be used to collect background information about centers, classrooms, center staff, and families and children being served in the centers. All of the instruments will be administered at the beginning of the pilot study, impact evaluation, and process study, with the exception of the baseline survey administered to parents of children enrolled in participating ECE centers and the protocol for baseline assessments of children’s skills at the beginning of the impact evaluation and process study; (3) Follow-Up Instruments for the Pilot Study, Impact Evaluation, and Process Study will be used to inform how centers, classrooms, teachers, and children changed and to assess the impacts of each of the interventions over the course of the pilot study, impact evaluation, and process study. All of the instruments will be administered at the end of the pilot study, impact evaluation, and process study, with the exception of the protocol for follow-up assessments of children’s skills at the end of the impact evaluation and process study; and, (4) Fidelity of Implementation Instruments for Pilot Study and Process Study will be used to document how the curricular and professional development models are delivered and experienced by staff, to document treatment differentials across research conditions, and to provide context for interpreting the findings of the impact evaluation. Respondents: The target population of the VIQI Project will include staff members working in Head Start grantee and community-based child care oversight agencies, staff members working in 189 ECE centers in seven metropolitan areas across the United States, and parents and children being served in these centers. ANNUAL BURDEN ESTIMATES Total number of respondents Instrument Annual number of respondents Number of responses per respondent Average burden hours per response Annual burden hours Instruments for Screening and Recruitment of ECE Centers Landscaping protocol with Stakeholder Agencies (staff burden in Head Start (HS) grantee and communitybased child care agencies) .............................................. Screening protocol for phone calls (staff burden in HS grantees and community-based child care agencies) ..... Screening protocol for phone calls (HS and communitybased child care center staff burden) .............................. Protocol for in-person visits for screening and recruitment activities (staff burden in HS grantees and communitybased child care agencies) .............................................. Protocol for in-person visits for screening and recruitment activities (HS and community-based child care center staff burden) ..................................................................... 100 33 1 1.50 50 110 37 1 2 74 280 93 1 1.20 112 488 163 1 1.50 245 760 253 1 1.20 304 mstockstill on DSK30JT082PROD with NOTICES Baseline Instruments for the Pilot Study, Impact Evaluation, and Process Study Baseline administrator survey .............................................. Baseline coach survey ......................................................... Baseline teacher/assistant teacher survey .......................... Baseline parent/guardian information form in Impact Evaluation only ........................................................................ Baseline classroom observation protocol (teacher burden) Baseline protocol for child assessments in Impact Evaluation only (child burden) ..................................................... 236 223 1358 79 74 453 1 1 1 0.60 0.60 0.60 47 44 272 8,568 543 2,856 181 1 1 0.20 0.30 571 54 1980 660 1 0.50 330 Follow-Up Instruments for Pilot Study, Impact Evaluation, and Process Study Follow-up administrator survey ............................................ Follow-up coach survey ....................................................... Follow-up teacher/assistant teacher survey ........................ Teacher reports to questions about children in classroom (administered as part of the follow-up teacher survey) ... VerDate Sep<11>2014 17:03 Aug 09, 2017 Jkt 241001 PO 00000 Frm 00038 189 178 1086 63 59 362 1 1 1 0.50 0.50 0.75 32 30 272 543 181 1 0.67 121 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1 37456 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices ANNUAL BURDEN ESTIMATES—Continued Total number of respondents Instrument Follow-up classroom observation protocol (teacher burden) .................................................................................. Follow-up protocol for child assessments in Impact Evaluation only (child burden) ................................................. Annual number of respondents Number of responses per respondent Average burden hours per response Annual burden hours 543 181 2 0.30 109 1980 660 1 1 660 Fidelity of Implementation Instruments for Pilot Study and Process Study mstockstill on DSK30JT082PROD with NOTICES Coach Log ............................................................................ Teacher/assistant teacher Log ............................................ Implementation fidelity observation protocol (teacher burden) .................................................................................. Interview/Focus group protocol (administrator, teacher/assistant teacher and coach burden) .................................. Estimated Total Annual Burden Hours: 7,289. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded 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. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments 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 practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Mary Jones, ACF/OPRE Certifying Officer. [FR Doc. 2017–16854 Filed 8–9–17; 8:45 am] BILLING CODE 4184–23–P VerDate Sep<11>2014 17:03 Aug 09, 2017 Jkt 241001 117 1086 39 362 55 36 0.25 0.25 536 3258 72 24 1 0.30 7 322 107 1 1.5 161 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1279] Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Qualification of Medical Device Development Tools (MDDT).’’ This document formalizes the MDDT program and provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. In addition, the guidance discusses the framework of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. FDA considered comments on the draft guidance and revised the guidance as appropriate. SUMMARY: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: You may submit comments as follows: DATES: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ E:\FR\FM\10AUN1.SGM 10AUN1

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[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)]
[Notices]
[Pages 37454-37456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16854]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Title: Variations in Implementation of Quality Interventions (VIQI) 
Project: Data Collection.
    OMB No.: New Collection.
    Description: The Administration for Children and Families (ACF), 
Office of Planning, Research and Evaluation (OPRE) proposes to collect 
information as part of the Variations in Implementation of Quality 
Interventions (VIQI): Examining the Quality-Child Outcomes Relationship 
in Child Care and Early Education Project.
    The VIQI Project will inform policymakers, practitioners, and 
stakeholders about effective ways to support the quality and 
effectiveness of early care and education (ECE) centers for promoting 
young children's learning and development. In partnership with ECE 
centers across the United States that serve young children with diverse 
economic backgrounds, the VIQI Project aims to (1) identify dimensions 
of quality within ECE settings that are key levers for promoting 
children's outcomes; (2) inform what levels of quality are necessary to 
successfully support children's developmental gains; (3) identify 
drivers that facilitate and inhibit successful implementation of 
interventions aimed at strengthening quality; and (4) understand how 
these relations vary across different ECE settings, staff, and 
children. To achieve these aims, the VIQI Project will include a year-
long pilot study that will pilot up to three curricular and 
professional development models, followed by a year-long impact 
evaluation and process study that involve testing the effectiveness of 
two curricular and professional development models that aim to 
strengthen teacher practices, the quality of classroom processes, and 
children's outcomes. The study will include up to 189 community-based 
and Head Start ECE centers spread across seven different metropolitan 
areas in the United States.
    To test the effectiveness of the curricular and professional 
development models, the VIQI project will consist of a 3- or 4-group 
experimental design in the pilot study and a 3-group experimental 
design in the impact evaluation and the process study in which the 
initial quality and other characteristics of ECE centers are measured. 
The centers then will be stratified based upon select information 
collected--by setting type (e.g., Head Start and community-based ECE 
centers) and initial levels of quality--and randomly assigned to one of 
the intervention conditions where they will be offered curricular and 
professional development supports aimed at strengthening the quality of 
classroom and teacher practices, or to a business-as-usual comparison 
condition.
    In the pilot study, 24 centers in one metropolitan area will 
participate in the VIQI Project. Information about center and staff 
characteristics and classroom and teacher practices will be collected 
(1) to stratify and randomly assign centers; (2) to describe how the 
different interventions are implemented and are experienced by centers 
and teachers; and (3) to document the treatment differentials across 
research conditions. The information will then be used to adjust and to 
refine the research design and measures that will be used in the impact 
evaluation and process study.
    In the impact evaluation and process study, 165 centers in seven 
metropolitan areas will participate in the VIQI Project. Information 
about center and staff characteristics and classroom and teacher 
practices will be collected (1) to stratify and randomly assign 
centers; (2) to identify subgroups of interest; (3) to describe how the 
interventions are implemented and are experienced by

[[Page 37455]]

centers and teachers; (4) to document the treatment differentials 
across research conditions; and (5) to assess the impacts of each of 
the interventions on different dimensions of quality and teacher 
practices when compared to a business-as-usual comparison condition for 
the impact evaluation sample and separately for subgroups of interest. 
In addition, information about the background characteristics of 
families and children being served in the centers will be collected, as 
well as measures of children's skills at the beginning and end of the 
year-long impact evaluation for a subset of children in these centers. 
This information will also be used (1) to define subgroups of interest 
defined by family and child characteristics, and (2) to assess the 
impacts of each of the interventions on children's skills for the full 
impact evaluation sample and separately for subgroups of interest. 
Lastly, the information on quality, teacher practices and children's 
skills will be used in a set of analyses that will rigorously examine 
the nature of the quality-to-child outcomes relationship by exploring 
the effects of different dimensions and thresholds (or levels) of 
quality on child outcomes for the full impact evaluation sample and 
separately for subgroups of interest.
    The data collection instruments for the VIQI Project include the 
following:
    (1) Instruments for Screening and Recruitment of ECE Centers will 
be used in the pilot study, impact evaluation, and process study to 
assess ECE centers' eligibility, to inform the sampling strategy, and 
to recruit ECE centers to participate in the VIQI Project;
    (2) Baseline Instruments for the Pilot Study, Impact Evaluation, 
and Process Study will be used to collect background information about 
centers, classrooms, center staff, and families and children being 
served in the centers. All of the instruments will be administered at 
the beginning of the pilot study, impact evaluation, and process study, 
with the exception of the baseline survey administered to parents of 
children enrolled in participating ECE centers and the protocol for 
baseline assessments of children's skills at the beginning of the 
impact evaluation and process study;
    (3) Follow-Up Instruments for the Pilot Study, Impact Evaluation, 
and Process Study will be used to inform how centers, classrooms, 
teachers, and children changed and to assess the impacts of each of the 
interventions over the course of the pilot study, impact evaluation, 
and process study. All of the instruments will be administered at the 
end of the pilot study, impact evaluation, and process study, with the 
exception of the protocol for follow-up assessments of children's 
skills at the end of the impact evaluation and process study; and,
    (4) Fidelity of Implementation Instruments for Pilot Study and 
Process Study will be used to document how the curricular and 
professional development models are delivered and experienced by staff, 
to document treatment differentials across research conditions, and to 
provide context for interpreting the findings of the impact evaluation.
    Respondents: The target population of the VIQI Project will include 
staff members working in Head Start grantee and community-based child 
care oversight agencies, staff members working in 189 ECE centers in 
seven metropolitan areas across the United States, and parents and 
children being served in these centers.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                  Annual  number     Number of        Average
           Instrument              Total number         of         responses per   burden  hours   Annual burden
                                  of respondents    respondents     respondent     per  response       hours
----------------------------------------------------------------------------------------------------------------
                            Instruments for Screening and Recruitment of ECE Centers
----------------------------------------------------------------------------------------------------------------
Landscaping protocol with                    100              33               1            1.50              50
 Stakeholder Agencies (staff
 burden in Head Start (HS)
 grantee and community-based
 child care agencies)...........
Screening protocol for phone                 110              37               1               2              74
 calls (staff burden in HS
 grantees and community-based
 child care agencies)...........
Screening protocol for phone                 280              93               1            1.20             112
 calls (HS and community-based
 child care center staff burden)
Protocol for in-person visits                488             163               1            1.50             245
 for screening and recruitment
 activities (staff burden in HS
 grantees and community-based
 child care agencies)...........
Protocol for in-person visits                760             253               1            1.20             304
 for screening and recruitment
 activities (HS and community-
 based child care center staff
 burden)........................
----------------------------------------------------------------------------------------------------------------
                 Baseline Instruments for the Pilot Study, Impact Evaluation, and Process Study
----------------------------------------------------------------------------------------------------------------
Baseline administrator survey...             236              79               1            0.60              47
Baseline coach survey...........             223              74               1            0.60              44
Baseline teacher/assistant                  1358             453               1            0.60             272
 teacher survey.................
Baseline parent/guardian                   8,568           2,856               1            0.20             571
 information form in Impact
 Evaluation only................
Baseline classroom observation               543             181               1            0.30              54
 protocol (teacher burden)......
Baseline protocol for child                 1980             660               1            0.50             330
 assessments in Impact
 Evaluation only (child burden).
----------------------------------------------------------------------------------------------------------------
                   Follow-Up Instruments for Pilot Study, Impact Evaluation, and Process Study
----------------------------------------------------------------------------------------------------------------
Follow-up administrator survey..             189              63               1            0.50              32
Follow-up coach survey..........             178              59               1            0.50              30
Follow-up teacher/assistant                 1086             362               1            0.75             272
 teacher survey.................
Teacher reports to questions                 543             181               1            0.67             121
 about children in classroom
 (administered as part of the
 follow-up teacher survey)......

[[Page 37456]]

 
Follow-up classroom observation              543             181               2            0.30             109
 protocol (teacher burden)......
Follow-up protocol for child                1980             660               1               1             660
 assessments in Impact
 Evaluation only (child burden).
----------------------------------------------------------------------------------------------------------------
                    Fidelity of Implementation Instruments for Pilot Study and Process Study
----------------------------------------------------------------------------------------------------------------
Coach Log.......................             117              39              55            0.25             536
Teacher/assistant teacher Log...            1086             362              36            0.25            3258
Implementation fidelity                       72              24               1            0.30               7
 observation protocol (teacher
 burden)........................
Interview/Focus group protocol               322             107               1             1.5             161
 (administrator, teacher/
 assistant teacher and coach
 burden)........................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 7,289.
    In compliance with the requirements of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
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. Email address: 
OPREinfocollection@acf.hhs.gov. All requests should be identified by 
the title of the information collection.
    The Department specifically requests comments 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 practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) 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. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017-16854 Filed 8-9-17; 8:45 am]
 BILLING CODE 4184-23-P