60 day FRN

Published 60-Day FRN for SEED Teen_2017-08706.pdf

The Study to Explore Early Development - Teen Follow-up Study (SEED-TEEN)

60 day FRN

OMB: 0920-1219

Document [pdf]
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Federal Register / Vol. 82, No. 82 / Monday, May 1, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Average
burden per
response
(in hours)

Form name

DP13–1315 Partners ......................................

Case Study Interview Guide for DP1–1315
Partners.
Web-based survey .........................................

2

1

1

780

1

15/60

In-Depth Interview Guide ...............................

5

1

0.5

NCCCP and NSBT Program Directors, Staff,
Coalition Members, and Partners.
NCCCP and NSBT Program Directors, Staff,
Coalition Members, and Partners.

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–08705 Filed 4–28–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17ADR; Docket No. CDC–2017–
0042]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the Study to Explore Early
Development, Teen Follow-Up Study
(SEED Teen).
DATES: Written comments must be
received on or before June 30, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0042 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
SUMMARY:

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Number of
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Type of respondents

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Instructions: All submissions received
must include the agency name and
Docket number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE., MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 6501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of the information they
conduct or sponsor. In addition, the
PRA also requires Federal agencies to
provide a 60-day notice in the Federal
Register concerning each proposed
collection of the information, including
each new proposed collection, each
proposed extension of existing
collection of information, and each
reinstatement of previously approved
information collection before submitting
the collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited 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) ways to enhance the
quality, utility, and clarity of the

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information to be collected; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Study to Explore Early Development,
Teen Follow-Up Study (SEED Teen)—
New—National Center on Birth Defects
and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Autism spectrum disorder (ASD) is a
neurodevelopmental disorder
characterized by impairments in social
interaction and communication and
stereotyped behaviors and interests. The
U.S. prevalence of ASD is estimated at
1% to 2%. In addition to the profound,
lifelong impacts on individuals’
functioning given the core deficits in
social-communication abilities, a high
proportion of children with ASD also
have one or more other developmental
impairments such as intellectual
disability or attention-deficithyperactivity-disorder and children
with ASDs have higher than expected

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Federal Register / Vol. 82, No. 82 / Monday, May 1, 2017 / Notices

prevalences of health conditions such as
obesity, asthma and respiratory
disorders, eczema and skin allergies,
migraine headaches, and
gastrointestinal symptoms and
disorders.
Historically, young children have
been the focus of ASD research:
Diagnosis and symptom detection at
young ages, prenatal or early-life risk
factors, and the effect of early
intervention programs. Meanwhile, the
number of children diagnosed with ASD
each year has steadily increased and, as
children age, the prevalence of adults
diagnosed with ASD will likewise
increase for several decades. Despite
this ongoing demographic shift —which
some have called ‘‘the autism
tsunami’’—there has been relatively
little research on ASD in adolescence
and adulthood.
While there is research showing that
the majority of ASD diagnoses made in
early childhood are retained in
adolescence with mostly stable in
symptom severity, there are major gaps
in our understanding of the health,
functioning, and experiences of
adolescents with ASD and other
developmental disabilities. Many of
these topics are especially relevant to
public health: Adolescents and adults
with ASD have been shown to have
frequent health problems, high
healthcare utilization and specialized
service needs, high caregiving burden,
require substantial supports to perform
daily activities, are likely to be bullied,
or isolated from society, and are likely
to have food allergies or put on

restrictive diets of questionable benefit.
Many of these problems emerge after
early childhood, and more studies are
needed to estimate the frequency,
severity, and predictive factors for these
important outcomes in diverse cohorts
of individuals with autism and other
developmental conditions.
SEED Teen is a follow-up study of
children who participated in the first
phase of the SEED case-control study
(SEED 1) in 2007–2011 when they were
2 to 5 years of age. SEED includes one
of the largest cohorts of children
assembled with ASD. Children will be
identified from four SEED sites in
Georgia, Maryland, North Carolina, and
Pennsylvania. Three groups of children
will be included: Children with ASD,
children with other developmental
(non-ASD) conditions (DD comparison
group), and children from the general
population who were initially sampled
from birth records (POP comparison
group).
The children and parents previously
enrolled in SEED 1 represent a unique
opportunity to better understand the
long-term trajectory of children
identified as having ASD at early ages.
Mothers or other primary caregivers
who participated in SEED 1 will be recontacted when their child is 13–17
years of age and asked to complete two
self-administered questionnaires (SEED
Teen Health and Development Survey
and the Social Responsiveness Scale)
about their child’s health, development,
education, and current functioning.
Information from this study will allow
researchers to assess the long-term

health and functioning of children with
ASD and other developmental
disabilities, family impacts associated
with ASD and other DDs, and service
needs and use associated with having
and ASD and other DDs, particularly
during the teen years.
We estimate that 1,410 SEED families
are potentially eligible to participate in
SEED Teen. Reading the letter and other
materials in the invitation mailing will
take approximately five minutes. We
estimate that a minimum of 60% of
parents/caregivers sent the invitation
mailing or will be successfully
contacted and participate in the
invitation call (approximately 15
minutes). We estimate that 80% of the
families who participate in the
invitation call will meet the eligibility
criteria for SEED Teen and 70% of those
will enroll in SEED Teen. We assume all
enrolled families will complete the
follow-up call to confirm data collection
packet receipt (approximately 10
minutes) and will review the materials
in the data collection packet. Finally,
we estimate that 90% of enrolled
parents/caregivers will complete two
self-administered questionnaires (SEED
Teen Health and Development Survey
and the Social Responsiveness Scale)
and two supplemental consent forms.
The two questionnaires will take
approximately 60 minutes to complete,
plus an additional 5 minutes to read and
sign the informed consent. Therefore,
we estimate the total burden hours are
911. There are no costs to participants
other than their time.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number
responses
per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

Type of respondents

Form name

Eligible families who were enrolled in SEED 1 ...........
Eligible families who were enrolled in SEED 1 ...........
Families who agreed to participate in SEED Teen .....
Families who agreed to participate in SEED Teen .....
Families who agreed to participate in SEED Teen .....

1,410
846
474
474
427

1
1
1
1
1

5/60
15/60
10/60
5/60
40/60

118
212
79
40
284

Families who agreed to participate in SEED Teen .....
Families who agreed to participate in SEED Teen .....

Invitation Packet ...........................
Invitation Call Script .....................
Follow-up Call Checklist ..............
Data Collection Packet ................
SEED Teen Health and Development Survey.
Social Responsiveness Scale ......
Supplemental Consent Forms .....

427
427

1
1

20/60
5/60

142
36

Total .....................................................................

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

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

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

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

911

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–08706 Filed 4–28–17; 8:45 am]
BILLING CODE 4163–18–P

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Federal Register / Vol. 82, No. 82 / Monday, May 1, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Procedural Justice Informed
Alternatives to Contempt (PJAC).
OMB No.: 0970—NEW.
Description
The Office of Child Support
Enforcement (OCSE) within the
Administration for Children and
Families (ACF) is proposing data
collection activity as part of the
Procedural Justice Informed
Alternatives to Contempt Demonstration
(PJAC). In September 2016, OCSE issued
grants to six child support agencies to
provide alternative approaches to the
contempt process with the goal of
increasing parents’ compliance with
child support orders by building trust
and confidence in the child support
agency and its processes. PJAC is a fiveyear project (the first year of which is
dedicated to planning) that will allow
grantees to learn whether incorporating
principles of procedural justice into
child support business practices
increases reliable child support
payments. In addition to increasing
reliable payments, the PJAC
intervention aims to reduce arrears,
minimize the need for continued
enforcement actions and sanctions, and
reduce the inefficient use of contempt
proceedings.
The PJAC evaluation will yield
information about the efficacy of
applying procedural justice principles
via a set of alternative services to the
current contempt process. It will
generate extensive knowledge regarding
how PJAC programs operate, the effects
the programs have, and whether their
benefits exceed their costs. The
information gathered will be critical to
informing future policy decisions
related to contempt.
The PJAC evaluation will include the
following three interconnected
components or ‘‘studies’’:

1. Implementation Study. The goal of
the implementation study is to provide
a detailed description of the PJAC
programs—how they are implemented,
their participants, the contexts in which
they are operated, and their promising
practices. The implementation study
will also assess whether the PJAC
interventions are implemented as
intended (implementation fidelity) as
well as how the treatment implemented
differed from the status quo (treatment
contrast). The detailed descriptions will
assist in interpreting program impacts
and identifying program features and
conditions necessary for effective
program replication or improvement.
Key activities of the implementation
study will include: (1) A Management
Information System (MIS) for collection
and analysis of program participation
data to track participant engagement in
PJAC activities; (2) semi-structured
interviews with program staff and staff
from selected community partner
organizations; (3) semi-structured
interviews with program participants to
learn about their experiences in PJAC;
and (4) a staff questionnaire to gather
broader quantitative information on
program implementation and staff
experiences.
2. Impact Study: The goal of the
impact study is to provide rigorous
estimates of the effectiveness of the six
programs using an experimental
research design. Program applicants
who are eligible for PJAC services will
be randomly assigned to either a
program group that is offered program
services or to a control group that is not
offered those services. The random
assignment process will require child
support program staff to complete a
brief data entry protocol. The impact
study will rely on administrative data
from state and county child support
systems, court records, criminal justice
records, and data from the National
Directory of New Hires. Administrative
records data will be used to estimate
impacts on child support payments,
enforcement actions, contempt
proceedings, jail stays, and employment
and earnings. The impact study will
also include a follow-up survey of
participants that will be administered
approximately 12 months after random

assignment to a subset of the sample.
The survey will gather information on
participant experiences with the child
support program and family court,
family relationships, parenting and coparenting, informal child support
payments, and job characteristics. In an
effort to enhance response rates, the
PJAC survey firm will attempt to track
survey sample members at a few points
over the 12-month follow-up period in
order to stay in touch with them and
gather updated contact information from
them.
3. Benefit-Cost Study: The benefit-cost
study will estimate the costs and
benefits associated with the
implementation and impact of the PJAC
interventions. The study will examine
the costs and benefits from the
perspective of the government,
noncustodial parents, custodial parents
and their children, and society. Once
measured, particular impacts or
expenditures will constitute benefits or
costs, depending on which analytical
perspective is considered. For each of
the perspectives, pertinent benefits and
costs will be added together to
determine the net value of the program.
Key hypothesized benefits and costs to
be assessed include increased PJAC
intervention costs, reduced costs for
contempt actions, increased payments
from non-custodial parents, reduced
court costs, and reduced jail time,
among others. The benefit-cost study
will rely on the results of the impact
study, analysis of participation data
from the MIS, and results of a staff time
study in order to quantify various PJACrelated costs and benefits.
This 60-Day Notice covers the
following data collection activities: (1)
Staff data entry for random assignment;
(2) Study MIS to track program
participation; (3) Staff and community
partner interview topic guide; (4)
Participant interview topic guide; and
(5) Participant survey tracking letter.
Respondents
Respondents for the first information
collection phase include study
participants and grantee staff and
community partners. Specific
respondents per instrument are noted in
the burden table below.

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ANNUAL BURDEN ESTIMATES

Staff data entry for random assignment ............................

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Number of
responses per
respondent

Number of
respondents

Instrument

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120

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Average
burden hours
per response

150

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0.05

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Total burden
hours
900

Total annual
burden hours
300


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