82 FR 37454 - Proposed Information Collection Activity; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 82, Issue 153 (August 10, 2017)
Administration for Children and Families
Federal Register Volume 82, Issue 153 (August 10, 2017)
| Page Range | 37454-37456 | |
| FR Document | 2017-16854 |
[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)] [Notices] [Pages 37454-37456] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![37454 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
Design and Implementation Study is conducted in four sites. The proposed reducing teen sexual activity and
complete; data collection related to the extension is necessary to complete associated risk behaviors.
Performance Analysis Study will be ongoing follow-up data collection. The Respondents: Youth participants who
complete in late summer 2017. This resulting data will be used in a rigorous agreed to participate in the study upon
notice is specific to data collection program impact analysis to assess the enrollment in the four impact study
activities for the Impact and In-Depth effectiveness of each program in sites.
Implementation Study, which is being
ANNUAL BURDEN ESTIMATES
Total/annual Number of Average burden Total/annual
Instrument number of responses per hours per burden hours
respondents respondents response
Second follow-up survey ......................................................................... 325 1 .75 244
Estimated Total/Annual Burden DEPARTMENT OF HEALTH AND quality of classroom processes, and
Hours: 244 HUMAN SERVICES children’s outcomes. The study will
In compliance with the requirements include up to 189 community-based and
Administration for Children and Head Start ECE centers spread across
of Section 3506(c)(2)(A) of the
Families seven different metropolitan areas in the
Paperwork Reduction Act of 1995, the
United States.
Administration for Children and Proposed Information Collection To test the effectiveness of the
Families is soliciting public comment Activity; Comment Request curricular and professional
on the specific aspects of the development models, the VIQI project
Title: Variations in Implementation of
information collection described above. will consist of a 3- or 4-group
Quality Interventions (VIQI) Project:
Copies of the proposed collection of experimental design in the pilot study
Data Collection.
information can be obtained and OMB No.: New Collection. and a 3-group experimental design in
comments may be forwarded by writing Description: The Administration for the impact evaluation and the process
to the Administration for Children and Children and Families (ACF), Office of study in which the initial quality and
Families, Office of Planning, Research Planning, Research and Evaluation other characteristics of ECE centers are
and Evaluation, 330 C Street SW., (OPRE) proposes to collect information measured. The centers then will be
Washington, DC 20201, Attn: OPRE as part of the Variations in stratified based upon select information
Reports Clearance Officer. Email Implementation of Quality Interventions collected—by setting type (e.g., Head
address: OPREinfocollection@ (VIQI): Examining the Quality-Child Start and community-based ECE
acf.hhs.gov. All requests should be Outcomes Relationship in Child Care centers) and initial levels of quality—
identified by the title of the information and Early Education Project. and randomly assigned to one of the
collection. The VIQI Project will inform intervention conditions where they will
policymakers, practitioners, and be offered curricular and professional
The Department specifically requests
stakeholders about effective ways to development supports aimed at
comments on (a) whether the proposed support the quality and effectiveness of strengthening the quality of classroom
collection of information is necessary early care and education (ECE) centers and teacher practices, or to a business-
for the proper performance of the for promoting young children’s learning as-usual comparison condition.
functions of the agency, including and development. In partnership with In the pilot study, 24 centers in one
whether the information shall have ECE centers across the United States metropolitan area will participate in the
practical utility; (b) the accuracy of the that serve young children with diverse VIQI Project. Information about center
agency’s estimate of the burden of the economic backgrounds, the VIQI Project and staff characteristics and classroom
proposed collection of information; (c) aims to (1) identify dimensions of and teacher practices will be collected
the quality, utility, and clarity of the quality within ECE settings that are key (1) to stratify and randomly assign
information to be collected; and (d) levers for promoting children’s centers; (2) to describe how the different
ways to minimize the burden of the outcomes; (2) inform what levels of interventions are implemented and are
collection of information on quality are necessary to successfully experienced by centers and teachers;
respondents, including through the use support children’s developmental gains; and (3) to document the treatment
of automated collection techniques or (3) identify drivers that facilitate and differentials across research conditions.
other forms of information technology. inhibit successful implementation of The information will then be used to
Consideration will be given to interventions aimed at strengthening adjust and to refine the research design
comments and suggestions submitted quality; and (4) understand how these and measures that will be used in the
within 60 days of this publication. relations vary across different ECE impact evaluation and process study.
settings, staff, and children. To achieve In the impact evaluation and process
Mary Jones, these aims, the VIQI Project will include study, 165 centers in seven metropolitan
ACF/OPRE Reports Clearance Officer. a year-long pilot study that will pilot up areas will participate in the VIQI
mstockstill on DSK30JT082PROD with NOTICES
[FR Doc. 2017–16843 Filed 8–9–17; 8:45 am] to three curricular and professional Project. Information about center and
BILLING CODE 4184–37–P development models, followed by a staff characteristics and classroom and
year-long impact evaluation and process teacher practices will be collected (1) to
study that involve testing the stratify and randomly assign centers; (2)
effectiveness of two curricular and to identify subgroups of interest; (3) to
professional development models that describe how the interventions are
aim to strengthen teacher practices, the implemented and are experienced by
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![37456 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Average
Annual Number of
Total number burden Annual burden
Instrument number of responses per
of respondents hours per hours
respondents respondent response
Follow-up classroom observation protocol (teacher bur-
den) .................................................................................. 543 181 2 0.30 109
Follow-up protocol for child assessments in Impact Eval-
uation only (child burden) ................................................. 1980 660 1 1 660
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 observation protocol (teacher bur-
den) .................................................................................. 72 24 1 0.30 7
Interview/Focus group protocol (administrator, teacher/as-
sistant teacher and coach burden) .................................. 322 107 1 1.5 161
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Electronic Submissions
Hours: 7,289. HUMAN SERVICES Submit electronic comments in the
In compliance with the requirements following way:
Food and Drug Administration
of Section 3506(c)(2)(A) of the • Federal eRulemaking Portal:
Paperwork Reduction Act of 1995, the [Docket No. FDA–2013–D–1279] https://www.regulations.gov. Follow the
Administration for Children and instructions for submitting comments.
Families is soliciting public comment Qualification of Medical Device
Comments submitted electronically,
on the specific aspects of the Development Tools; Guidance for
including attachments, to https://
Industry, Tool Developers, and Food
information collection described above. www.regulations.gov will be posted to
and Drug Administration Staff;
Copies of the proposed collection of the docket unchanged. Because your
Availability
information can be obtained and comment will be made public, you are
comments may be forwarded by writing AGENCY: Food and Drug Administration, solely responsible for ensuring that your
to the Administration for Children and HHS. comment does not include any
Families, Office of Planning, Research, ACTION: Notice. confidential information that you or a
and Evaluation, 330 C Street SW., third party may not wish to be posted,
Washington, DC 20201, Attn: OPRE SUMMARY: The Food and Drug such as medical information, your or
Reports Clearance Officer. Email Administration (FDA or Agency) is anyone else’s Social Security number, or
address: OPREinfocollection@ announcing the availability of the confidential business information, such
guidance entitled ‘‘Qualification of as a manufacturing process. Please note
acf.hhs.gov. All requests should be
Medical Device Development Tools that if you include your name, contact
identified by the title of the information
(MDDT).’’ This document formalizes the information, or other information that
collection.
MDDT program and provides guidance identifies you in the body of your
The Department specifically requests to FDA staff, industry, healthcare comments, that information will be
comments on (a) whether the proposed providers, researchers, and patient and posted on https://www.regulations.gov.
collection of information is necessary consumer groups on a new voluntary • If you want to submit a comment
for the proper performance of the process within the Center for Devices with confidential information that you
functions of the agency, including and Radiological Health (CDRH) for do not wish to be made available to the
whether the information shall have qualification of medical device public, submit the comment as a
practical utility; (b) the accuracy of the development tools (MDDT) for use in written/paper submission and in the
agency’s estimate of the burden of the device development and evaluation manner detailed (see ‘‘Written/Paper
proposed collection of information; (c) programs. In addition, the guidance Submissions’’ and ‘‘Instructions’’).
the quality, utility, and clarity of the discusses the framework of an MDDT,
including definitions of applicable Written/Paper Submissions
information to be collected; and (d)
ways to minimize the burden of the terms, criteria for evaluating an MDDT Submit written/paper submissions as
collection of information on for a specific context of use, follows:
respondents, including through the use considerations for qualification, and the • Mail/Hand delivery/Courier (for
of automated collection techniques or contents of a qualification package. FDA written/paper submissions): Dockets
considered comments on the draft Management Staff (HFA–305), Food and
other forms of information technology.
guidance and revised the guidance as Drug Administration, 5630 Fishers
Consideration will be given to
appropriate. Lane, Rm. 1061, Rockville, MD 20852.
comments and suggestions submitted
mstockstill on DSK30JT082PROD with NOTICES
within 60 days of this publication. DATES: Submit either electronic or • For written/paper comments
written comments on this guidance at submitted to the Dockets Management
Mary Jones, any time. General comments on Agency Staff, FDA will post your comment, as
ACF/OPRE Certifying Officer. guidance documents are welcome at any well as any attachments, except for
[FR Doc. 2017–16854 Filed 8–9–17; 8:45 am] time. information submitted, marked and
BILLING CODE 4184–23–P ADDRESSES: You may submit comments identified, as confidential, if submitted
as follows: as detailed in ‘‘Instructions.’’
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Document Created: 2017-08-10 01:01:13
Document Modified: 2017-08-10 01:01:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 82 FR 37454 |
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