[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71505-71506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-16PA]


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 (SEED) Phase 3--New--National 
Center on Birth Defects and Developmental Disabilities (NCBDDD), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Autism spectrum disorders (ASD) are a group of neurodevelopmental 
disorders characterized by qualitative impairments in social 
interaction and communication and stereotyped behaviors and interests. 
Recent systematic population surveys and routine monitoring systems in 
the U.S. and other countries indicate the prevalence to be 1-2%. Apart 
from the identification of some rare genetic conditions that are 
commonly associated with autism, causal mechanisms for the disorder 
largely remain unknown.
    The Children's Health Act of 2000 mandated CDC to establish autism 
surveillance and research programs to address the number, incidence, 
and causes of autism and related developmental disabilities. Under the 
provisions of this act, NCBDDD funded five Centers for Autism and 
Developmental Disabilities Research and Epidemiology (CADDRE) through 
program announcements in FY2001 and FY2002; CDC's NCBDDD served as the 
sixth CADDRE site.
    For the first funding cycle (2001-2006), each CADDRE grantee had 
three core objectives: To develop a protocol for a multi-site 
collaborative epidemiologic study focused on autism (which was 
eventually named the Study to Explore Early Development [SEED]); to 
conduct surveillance of autism and other developmental disabilities; 
and to conduct site-specific investigator-initiated studies on autism. 
In FY 2006, through a second CADDRE funding cycle, five grantees were 
awarded. The CADDRE activities for the second funding cycle (2006-2011) 
were limited to implementation of the first phase of SEED (subsequently 
known as SEED 1). CDC served as the sixth CADDRE SEED 1 site during 
this period. A second phase of SEED (SEED 2) was funded under a third 
funding cycle (2011-2016). Five CADDRE grantees received the awards. 
Again, CDC served as the sixth SEED 2 site.
    A third phase of SEED (SEED 3) was funded in July 2016. Five 
extramural sites were funded. Together with the CDC, they will 
implement the SEED 3 collaborative protocol. The SEED 3 protocol for 
identification of study participants, recruitment, and study data 
collection flow will be similar to the protocols for SEED 1 and 2.
    However, while all SEED phases have the same research goals and the 
same basic study design, data collection has been greatly streamlined 
and revised between SEED 1, SEED 2, and SEED 3. Many study instruments 
and data collection components included in the SEED 1 protocol are not 
included in the SEED 3 protocol; two instruments included in the SEED 3 
protocol were developed subsequent to SEED 1 to capture an abbreviated 
version of information that had been included on some of the 
discontinued SEED 1 forms and to capture some additional information 
overlooked in the SEED 1 protocol; and instruments included in all 
phases of SEED underwent review and minor revision subsequent to SEED 1 
to address ambiguities and difficulties experienced during SEED 1 data 
collection. Implementing this phase of SEED will increase the total 
SEED pooled sample size for investigation of high priority hypotheses. 
Maintaining the same basic study design and general protocol integrity 
will ensure that data pooling can be achieved across SEED phases.
    Families will be identified from each of the 3 groups: Autism 
Spectrum Disorder (ASD), other developmental delay or disorder 
comparison group (DD), and a second comparison group of children 
randomly drawn from the entire study cohort population (POP). It is 
expected that the 6 SEED 3 study sites will have a total of 2,106 
children enroll and complete the study protocol. The data collection 
process will take approximately 9 hours 10 minutes (ASD group); 5 hours 
30 minutes (POP group); 2 hours 45 minutes (DD group) to complete, 
which includes (1) maternal telephone interview with questions about 
maternal reproductive history and

[[Page 71506]]

pregnancy with the index child, (2) parent-completed questionnaires 
about parental and child health and child development, (3) in-person 
child developmental evaluation, (4) maternal and child anthropometry 
measurements, and (5) biosampling from biological parents and child.
    There are no costs to participants other than their time. The total 
estimated annual burden hours are 7,118.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of        Number        burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Mother All potential participants sent  Invitation Packet/                 1,718               1           10/60
 mailing.                                Response Card.
Mother Potentially eligible with        Invitation Call Script               859               1           30/60
 contact by study staff.                 and Social
                                         Communication
                                         Questionnaire.
Mother Eligible, consented, and         Enrollment Packet.......             469               1           20/60
 enrolled; assigned to the ASD
 workflow based on enrollment intake.
Mother Completed this study step......  Follow-up Phone Call                 422               1           15/60
                                         Script and Pregnancy
                                         Reference Form.
                                        Maternal Interview Call.             422               1               1
                                        Self-Administered Forms.             375               1          105/60
                                        Follow-up Call 2........             375               1           20/60
                                        Clinic/Home Visit--                  328               1          225/60
                                         Developmental
                                         Assessment.
Father Completed this study step......  Clinic/Home Visit--                  164               1           15/60
                                         Saliva Collection
                                         (optional--on own).
Child Completed this study step.......  Clinic/Home Visit--                  328               1          135/60
                                         Developmental
                                         Assessment.
Mother All potential participants sent  Invitation Packet/                 1,466               1           10/60
 mailing.                                Response Card.
Mother Potentially eligible with        Invitation Call Script               733               1           30/60
 contact by study staff.                 and Social
                                         Communication
                                         Questionnaire.
Mother Eligible, consented, and         Enrollment Packet.......             334               1           20/60
 enrolled; assigned to the POP
 workflow based on enrollment intake.
Mother Completed this study step......  Follow-up Phone Call                 301               1           15/60
                                         Script and Pregnancy
                                         Reference Form.
                                        Maternal Interview Call.             301               1               1
                                        Self-Administered Forms.             267               1          105/60
                                        Follow-up Call 2........             267               1           20/60
                                        Clinic/Home Visit--                  234               1           50/60
                                         Developmental
                                         Assessment.
Father Completed this study step......  Clinic/Home Visit--                  117               1           15/60
                                         Saliva Collection
                                         (optional--on own).
Child Completed this study step.......  Clinic/Home Visit--                  234               1           90/60
                                         Developmental
                                         Assessment.
Mother All potential participants sent  Invitation Packet/                   641               1           10/60
 mailing.                                Response Card.
Mother Potentially eligible with        Invitation Call Script               321               1           30/60
 contact by study staff.                 and Social
                                         Communication
                                         Questionnaire.
Mother Eligible, consented, and         Enrollment Packet.......             175               1           20/60
 enrolled; assigned to the DD workflow
 based on enrollment intake.
Mother Completed this study step......  Follow-up Phone Call                 158               1           15/60
                                         Script and Pregnancy
                                         Reference Form.
                                        Maternal Interview Call.             158               1               1
                                        Self-Administered Forms.             140               1           55/60
                                        Follow-up Call 2........             140               1           20/60
----------------------------------------------------------------------------------------------------------------


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. 2016-25061 Filed 10-14-16; 8:45 am]
 BILLING CODE 4163-18-P