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 Department of Health and Human Services Centers for Disease Control and Prevention [30Day-17-17ADR]
 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 
                    *omb@cdc.gov.*
                     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 
                    ( print 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
Type of respondents
Form name
Number of
                             respondents
Number of
                             responses per 
                             respondent
Average
                             burden per 
                             response 
                             (in hours)Eligible families who were enrolled in SEED 1
Invitation Packet
470
1
5/60Eligible families who were enrolled in SEED 1
Invitation Call Script
282
1
15/60Families who agreed to participate in SEED Teen
Follow-up Call
158
1
10/60Families who agreed to participate in SEED Teen
Data Collection Packet
158
1
5/60Families who agreed to participate in SEED Teen
SEED Teen Health and Development Survey
142
1
40/60Families who agreed to participate in SEED Teen
Social Responsive-ness Scale
142
1
20/60Families who agreed to participate in SEED Teen
Supplemental Consent forms
142
1
5/60
 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