[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Notices]
[Pages 52571-52572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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