[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
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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