Notice2021-21524
Proposed Data Collection Submitted for Public Comment and Recommendations
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
October 4, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 86 Issue 189 (Monday, October 4, 2021)</title>
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[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54693-54695]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> 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 <a href="http://Regulations.gov">Regulations.gov</a>.
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:
<a href="/cdn-cgi/l/email-protection#1d72707f5d7e797e337a726b"><span class="__cf_email__" data-cfemail="5837353a183b3c3b763f372e">[email protected]</span></a>.
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
(<a href="https://www.federalregister.gov/">https://www.federalregister.gov/</a>) 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.
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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
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