Notice2022-18440
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 26, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 165 (Friday, August 26, 2022)</title>
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[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Notices]
[Pages 52571-52572]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18440]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-22IK]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Study to Explore Early Development (SEED)
Follow-up Study to the Office of Management and Budget (OMB) for review
and approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on October 4,
2021 to obtain comments from the public and affected agencies. CDC did
not receive comments related to the previous notice. This notice serves
to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Study to Explore Early Development (SEED), Follow-up Study--New--
National Center on Birth Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
In 2016, an estimated one in 54 children eight years of age living
in 11 communities across the United States had autism spectrum disorder
(ASD), a developmental disability that can cause significant social,
communication, and behavior challenges. Total annual costs associated
with ASD have been estimated between $11.5-60.9 billion (2011, US
dollars), yet major gaps in knowledge remain about risk factors for
ASD, and associated challenges and needs for persons with ASD and their
families. Additionally, while most research on ASD has focused on
children, ASD is considered a lifelong condition, and although an
estimated 70,000 to 111,000 youth with ASD turn 18 years of age
annually, little is known about the transition to adolescence and
adulthood for persons with ASD. Despite the call to address transition
and lifespan issues in the Autism CARES Acts of 2014 and 2019, only 2%
of ASD funding from 2008-2018 was spent on lifespan issues. The 2016-
2017 Interagency Autism Coordinating Committee (IACC) Strategic Plan
highlighted the need for more information about the services and
support needed to maximize the quality of life for people on the autism
spectrum, especially as individuals with ASD progress into adulthood.
The Study to Explore Early Development (SEED) was originally
initiated to address the Children's Health Act of 2000, which mandated
CDC to conduct ASD surveillance and implement research programs to
address the number, incidence, and causes of ASD and related
developmental disabilities. SEED was a multi-phase, multi-site, case-
control study comparing children with ASD, identified at ages 2-5
years, to children with other non-ASD developmental disabilities (DD),
and from the general population (POP). SEED was initially implemented
in three phases during 2007-2021. The current information collection
request is to conduct longitudinal follow-up studies of SEED 1-3
participants at older ages, thereby addressing the priorities
established in the Autism CARES Acts of 2014 and 2019, and the need for
research highlighted in the IACC Strategic Plan.
Given the size of the original SEED birth cohorts and the wealth of
baseline information collected, a follow-up study of participants can
help us address the research gaps described above. The information
collected from this study will allow us to better understand the
developmental trajectory of children with ASD, their health outcomes
and co-occurring conditions at older ages, and the associated early
predictors of these outcomes, including intellectual abilities.
The data collected in this study also provides the opportunity to
obtain important self-reported measures of well-being among young
adults with ASD. Recent evidence suggests that individuals with ASD,
with average to above average levels of intellectual functioning, may
still struggle with
[[Page 52572]]
activities of daily living. Yet, adults with special needs are often
required to have an intellectual disability in order to qualify for
services. This data will allow investigators to describe the gap
between intellectual ability and daily living skills in adolescents
with ASD to inform public policies on eligibility for services.
Additionally, because most SEED 1 participants will reach young
adulthood (i.e., age 18 years) in years 2021-2026, data collected
through this study will provide an opportunity to assess changes in
service access and utilization that may occur following high school
exit. This period is particularly challenging for young adults with ASD
who can experience poor outcomes across multiple domains (i.e.,
employment, education, social engagement, independent living, and
access to health and mental health care service, in association with
the loss of well-integrated school-based services). Hence, through
surveying SEED 1 participants before and after their anticipated exit
from high school, data collected through this study could provide
important information on the loss of services and emerging issues that
can inform service delivery and programs on the supports needed to
achieve greater independence.
Initial follow-up surveys of SEED participants will be conducted
with the parents of the children who previously participated in SEED
because it is the parents who provided consent for follow-up studies.
However, many emerging issues surrounding the transition to adulthood
among adolescents with ASD require self rather than parental report
(e.g., self-reported symptoms of anxiety, depression, quality of life,
social camouflaging, gender identity, sexuality, and relationships).
Therefore, children who originally participated at age 2-5 years who
are now adolescents and young adults, will be contacted through their
parents and asked if they wish to provide informed consent for
participation in surveys.
CDC requests OMB approval for an estimated 2,089 annual burden
hours. There are no costs to respondents other than their time to
participate.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Caregiver.................................... Review of enrollment call script and consent for first 2,057 1 10/60
follow-up survey.
Caregiver.................................... First follow-up core survey of SEED 1-3 caregivers....... 1,234 1 40/60
Caregiver.................................... First follow-up survey supplement for caregivers of 411 1 20/60
children.
Caregiver.................................... First follow-up survey supplement for caregivers of 411 1 20/60
adolescents.
Caregiver.................................... First follow-up survey supplement for caregivers of young 411 1 20/60
adults.
Caregiver.................................... Review of enrollment call script and consent, and Second 350 1 10/60
follow-up survey of SEED 1 caregivers.
Caregiver and Adult Child.................... Review of enrollment call script and consent by 165 1 10/60
caregivers and young adults.
Adult Child.................................. Second follow-up survey of SEED 1 adult children......... 165 1 30/60
Children aged 8-22 years and their caregivers Review of enrollment and informed consent or assent, In- 229 1 90/60
person assessment of intellectual abilities.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-18440 Filed 8-25-22; 8:45 am]
BILLING CODE 4163-18-P
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