82 FR 44184 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 182 (September 21, 2017)

[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44184-44185]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-17ADR]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 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 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

[[Page 44185]]

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 will be 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 
303.
    There are no costs to participants other than their time.

                                        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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Eligible families who were enrolled in  Invitation Packet.......             470               1            5/60
 SEED 1.
Eligible families who were enrolled in  Invitation Call Script..             282               1           15/60
 SEED 1.
Families who agreed to participate in   Follow-up Call..........             158               1           10/60
 SEED Teen.
Families who agreed to participate in   Data Collection Packet..             158               1            5/60
 SEED Teen.
Families who agreed to participate in   SEED Teen Health and                 142               1           40/60
 SEED Teen.                              Development Survey.
Families who agreed to participate in   Social Responsive-ness               142               1           20/60
 SEED Teen.                              Scale.
Families who agreed to participate in   Supplemental Consent                 142               1            5/60
 SEED Teen.                              forms.
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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. 2017-20067 Filed 9-20-17; 8:45 am]
BILLING CODE 4163-18-P