[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51588-51590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-1171]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Study to Explore Early Development(SEED) 
Phase 3 to the Office of Management and Budget (OMB) for review and 
approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on May 24, 
2019 to obtain comments from the public and affected agencies. CDC did 
not receive comments related to the previous notice. This notice serves 
to allow an additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202)

[[Page 51589]]

395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Study to Explore Early Development(SEED) Phase 3--Extension--
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 are 
implementing the SEED 3 collaborative protocol. The SEED 3 protocol for 
identification of study participants, recruitment, and study data 
collection flow is similar to the protocols for SEED 1 and 2. CDC 
obtained approval to collect information for SEED 3 in 2017 (OMB 0920-
1171). The current request is to obtain an extension of this approval 
so that data collection may continue beyond the current expiration date 
of 3/31/2020.
    While all SEED phases have the same research goals and the same 
basic study design, data collection was 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. 
No additional changes are requested from the SEED 3 protocol that 
initially obtained OMB approval. 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 three 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 six SEED 3 study sites will enroll a total of 2,106 
children and complete the study protocol. The data collection will take 
approximately 10 hours 35 minutes (ASD group); six hours 55 minutes 
(POP group); two hours 30 minutes (DD group) to complete, which 
includes (1) maternal telephone interview with questions about maternal 
reproductive history and 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Mother, ASD workflow All potential   Invitation Packet/Response            1,718               1           10/60
 participants sent mailing.           Card (Attachment 10a,d,g).
Mother, ASD workflow Potentially     Invitation Call Script and              859               1           30/60
 eligible with contact by study       (Attachment 11a) Social
 staff.                               Communication
                                      Questionnaire (Attachment
                                      3).
Mother, ASD workflow Eligible,       Enrollment Packet                       469               1           20/60
 consented, and enrolled; assigned    (Attachment 12a, c, d).
 to the ASD workflow based on
 enrollment intake.
Mother, ASD workflow Completed this  Follow-up Phone Call Script             422               1           15/60
 study step.                          and Checklist (Attachment
                                      13) and Pregnancy
                                      Reference Form and 5 a, b).
Mother, ASD workflow Completed this  Maternal Interview Call                 422               1               1
 study step.                          (Attachment 4).
Mother, ASD workflow Completed this  Self-Administered Forms                 375               1          105/60
 study step.                          (Attachment 6a-e, 6f or
                                      6g, 6h-i, 6k-l, and 6o-p).
Mother, ASD workflow Completed this  Follow-up Call 2                        375               1           20/60
 study step.                          (Attachment 14).

[[Page 51590]]

 
Mother, ASD workflow Completed this  Clinic/Home Visit--                     328               1          225/60
 study step.                          Developmental
                                      Assessment(Attachment 7b,
                                      c, g), saliva collection
                                      (Attachment 8a-d), overall
                                      consent (Attachment 15a).
Father, ASD workflow Completed this  Clinic/Home Visit--Saliva               164               1           15/60
 study step.                          Collection (Attachments 8b-
                                      d).
Child, ASD workflow Completed this   Clinic/Home Visit--                     328               1          135/60
 study step.                          Developmental Assessment
                                      (attachment 7a, 7d or 7e
                                      or 7f) and saliva
                                      collection (8a-d).
Mother, POP workflow All potential   Invitation Packet/Response            1,466               1           10/60
 participants sent mailing.           Card (Attachments 10c,
                                      10f, and 10g).
Mother , POP workflow Potentially    Invitation Call Script                  733               1           30/60
 eligible with contact by study       (Attachment 11c) and
 staff.                               Social Communication
                                      Questionnaire (Attachment
                                      3).
Mother , POP workflow Eligible,      Enrollment Packet                       334               1           20/60
 consented, and enrolled; assigned    (Attachments 12a, c, d).
 to the POP workflow based on
 enrollment intake.
Mother, POP workflow Completed this  Follow-up Phone Call Script             301               1           15/60
 study step.                          and Checklist (Attachment
                                      13) and Pregnancy
                                      Reference Form Attachments
                                      5a and 5b).
Mother, POP workflow Completed this  Maternal Interview Call                 301               1               1
 study step.                          (Attachment 4).
Mother, POP workflow Completed this  Self-Administered Forms                 267               1          105/60
 study step.                          (Attachment 6a-e, 6f or
                                      6g, 6h-i, 6k, 6n-p).
Mother, POP workflow Completed this  Follow-up Call 2                        267               1           20/60
 study step.                          (Attachment 14).
Mother, POP workflow Completed this  Developmental Assessment                234               1           50/60
 study step.                          saliva collection
                                      (Attachment 8a-d), overall
                                      consent (Attachment 15c).
Father, POP workflow Completed this  Clinic/Home Visit--Saliva               117               1           15/60
 study step.                          Collection (Attachments 8b-
                                      d).
Child, POP workflow Completed this   Clinic/Home Visit--                     234               1           90/60
 study step.                          Developmental Assessment
                                      Attachment 7a-c), saliva
                                      collection (Attachment 8a-
                                      d).
Mother, DD workflow All potential    Invitation Packet/Response              641               1           10/60
 participants sent mailing.           Card (Attachments 10b,
                                      10e, and 10g).
Mother, DD workflow Potentially      Invitation Call Script                  321               1           30/60
 eligible with contact by study       (Attachment 11b) and SCQ
 staff.                               (Attachment 3).
Mother, DD workflow Eligible,        Enrollment Packet                       175               1           20/60
 consented, and enrolled; assigned    (Attachment 12b-d).
 to the DD workflow based on
 enrollment intake.
Mother, DD workflow Completed this   Follow-up Phone Call Script             158               1           15/60
 study step.                          (Attachment 13) and
                                      Checklist and Pregnancy
                                      Reference Form
                                      (Attachments 5a and 5b).
Mother, DD workflow Completed this   Maternal Interview Call                 158               1               1
 study step.                          (Attachment 4).
Mother, DD workflow Completed this   Self-Administered Forms                 140               1           55/60
 study step.                          (Attachments 6a-d, 6j, 6m,
                                      and 6o-p).
Mother, DD workflow Completed this   Follow-up Call 2                        140               1           20/60
 study step.                          (Attachment 15b).
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-21169 Filed 9-27-19; 8:45 am]
BILLING CODE 4163-18-P