[Federal Register Volume 82, Number 82 (Monday, May 1, 2017)]
[Notices]
[Pages 20343-20345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08706]


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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

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 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.
    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 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-deficit-hyperactivity-disorder and children 
with ASDs have higher than expected

[[Page 20344]]

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 re-contacted 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.

                                        Estimated Annualized Burden Hours
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                                                                                 Number      Average
                                                                  Number of    responses    burden per    Total
         Type of respondents                   Form name         respondents      per        response    burden
                                                                               respondent   (in hours)    hours
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Eligible families who were enrolled    Invitation Packet.......        1,410            1         5/60       118
 in SEED 1.
Eligible families who were enrolled    Invitation Call Script..          846            1        15/60       212
 in SEED 1.
Families who agreed to participate in  Follow-up Call Checklist          474            1        10/60        79
 SEED Teen.
Families who agreed to participate in  Data Collection Packet..          474            1         5/60        40
 SEED Teen.
Families who agreed to participate in  SEED Teen Health and              427            1        40/60       284
 SEED Teen.                             Development Survey.
Families who agreed to participate in  Social Responsiveness             427            1        20/60       142
 SEED Teen.                             Scale.
Families who agreed to participate in  Supplemental Consent              427            1         5/60        36
 SEED Teen.                             Forms.
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    Total............................  ........................  ...........  ...........  ...........       911
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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