Attachment E.1 - VIQI 60-day Federal Register Notice

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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 .........................................................................

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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

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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

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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

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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

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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) ...

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189
178
1086

63
59
362

1
1
1

0.50
0.50
0.75

32
30
272

543

181

1

0.67

121

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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

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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]
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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:

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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.’’

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