[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54693-54695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21IK; Docket No. CDC-2021-0107]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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

[[Page 54694]]

general public and other Federal agencies the opportunity to comment on 
a proposed and/or continuing information collection, as required by the 
Paperwork Reduction Act of 1995. This notice invites comment on a 
proposed information collection project titled Study to Explore Early 
Development (SEED) Follow-up Studies. This follow-up study will allow 
CDC to better understand the developmental trajectory of children with 
autism spectrum disorder, their health outcomes and co-occurring 
conditions at older ages, and the associated early predictors of these 
outcomes, including intellectual abilities.

DATES: CDC must receive written comments on or before December 3, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0107 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

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 Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7118; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
(https://www.federalregister.gov/) concerning each proposed collection 
of 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 the OMB for approval. To comply with this requirement, we 
are publishing this notice of a proposed data collection as described 
below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Study to Explore Early Development (SEED) Follow-up Studies--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, 
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 to 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 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 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 (e.g., 
employment, education, social engagement, independent living, and 
access to health and mental health care services 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 support needed to 
achieve greater independence.
    Initial follow-up surveys of SEED participants will be conducted 
with the parents of the children who previously

[[Page 54695]]

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). 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 6,193 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    Total burden
                                                    respondents     respondent      (in hours)         hours
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Parent........................  Review of                  5,850               1           10/60             975
                                 invitation
                                 letter and call
                                 script for
                                 first follow-up
                                 survey.
Parent........................  First follow-up            3,900               1           40/60           2,600
                                 core survey of
                                 SEED 1-3
                                 parents.
Parent........................  First follow-up            1,300               1           20/60             433
                                 survey
                                 supplement for
                                 parents of
                                 children.
Parent........................  First follow-up            1,300               1           20/60             433
                                 survey
                                 supplement for
                                 parents of
                                 adolescents.
Parent........................  First follow-up            1,300               1           20/60             433
                                 survey
                                 supplement for
                                 parents of
                                 adults.
Parent........................  Second follow-up           1,105               1           10/60             184
                                 survey of SEED
                                 1 parents.
Adult Child...................  Invitation and               520               1           10/60              87
                                 informed
                                 consent script.
Adult Child...................  Second follow-up             520               1           30/60             260
                                 survey of SEED
                                 1 adult
                                 children.
Children age 8-22 years or      Parents or adult             472               1           10/60              79
 their parents.                  children
                                 receiving
                                 informed
                                 consent or
                                 assent script.
Children age 8-22 years.......  In-person                    472               1           90/60             708
                                 assessment of
                                 intellectual
                                 abilities.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           6,193
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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. 2021-21524 Filed 10-1-21; 8:45 am]
BILLING CODE 4163-18-P