[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24144-24146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10839]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-1171; Docket No. CDC-2019-0036]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Study to Explore Early
Development (SEED) Phase 3. This study evaluates potential risk factors
for Autism Spectrum Disorders (ASD) and the behavioral and health
characteristics of children with autism by conducting a case control
study to compare them with children who have other developmental
disabilities and children from the general population.
DATES: CDC must receive written comments on or before July 23, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0036 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Lead, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the
agency name and Docket Number. CDC will post, without change, all
relevant comments to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a contact Jeffrey M. Zirger, Information
Collection Review Office, Centers for Disease Control and Prevention,
1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-
7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
[[Page 24145]]
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
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 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
remain largely 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 nine hours 10 minutes (ASD group); five hours 30 minutes
(POP group); two hours 45 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 Total burden
respondents respondent (in hours) (in hours)
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Mother, ASD workflow. All potential Invitation Packet/Response Card........ 1,718 1 10/60 286
participants sent mailing.
Mother, ASD workflow. Potentially eligible with Invitation Call Script and Social 859 1 30/60 430
contact by study staff. Communication Questionnaire.
Mother, ASD workflow. Eligible, consented, and Enrollment Packet...................... 469 1 20/60 156
enrolled; assigned to the ASD workflow based
on enrollment intake.
Mother, ASD workflow. Completed this study step Follow-up Phone Call Script and 422 1 15/60 106
Checklist and Pregnancy Reference Form.
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Mother, ASD workflow. Completed this study step Maternal Interview Call................ 422 1 1 422
Mother, ASD workflow. Completed this study step Self-Administered Forms................ 375 1 105/60 656
Mother, ASD workflow. Completed this study step Follow-up Call 2....................... 375 1 20/60 125
Mother, ASD workflow. Completed this study step Clinic/Home Visit--Developmental 328 1 225/60 1,230
Assessment, saliva collection, overall
consent.
Father, ASD workflow. Completed this study step Clinic/Home Visit--Saliva Collection... 164 1 15/60 41
Child, ASD workflow. Completed this study step. Clinic/Home Visit--Developmental 328 1 135/60 738
Assessment.
Mother, POP workflow. All potential Invitation Packet/Response Card........ 1,466 1 10/60 244
participants sent mailing.
Mother , POP workflow. Potentially eligible Invitation Call Script and Social 733 1 30/60 367
with contact by study staff. Communication Questionnaire.
Mother , POP workflow. Eligible, consented, and Enrollment Packet...................... 334 1 20/60 111
enrolled; assigned to the POP workflow based
on enrollment intake.
Mother, POP workflow. Completed this study step Follow-up Phone Call Script and 301 1 15/60 75
Checklist and Pregnancy Reference Form.
Mother, POP workflow. Completed this study step Maternal Interview Call................ 301 1 1 301
Mother, POP workflow. Completed this study step Self-Administered Forms................ 267 1 105/60 467
Mother, POP workflow. Completed this study step Follow-up Call 2....................... 267 1 20/60 89
Mother, POP workflow. Completed this study step Developmental Assessment, saliva 234 1 50/60 195
collection, overall consent.
Father, POP workflow. Completed this study step Clinic/Home Visit--Saliva Collection... 117 1 15/60 29
Child, POP workflow. Completed this study step. Clinic/Home Visit--Developmental 234 1 90/60 351
Assessment, saliva collection.
Mother, DD workflow. All potential participants Invitation Packet/Response Card........ 641 1 10/60 107
sent mailing.
Mother, DD workflow. Potentially eligible with Invitation Call Script and SCQ......... 321 1 30/60 161
contact by study staff.
Mother, DD workflow. Eligible, consented, and Enrollment Packet...................... 175 1 20/60 58
enrolled; assigned to the DD workflow based on
enrollment intake.
Mother, DD workflow. Completed this study step. Follow-up Phone Call Script, and 158 1 15/60 40
Checklist and Pregnancy Reference Form.
Mother, DD workflow. Completed this study step. Maternal Interview Call................ 158 1 1 158
Mother, DD workflow. Completed this study step. Self-Administered Forms................ 140 1 55/60 128
Mother, DD workflow. Completed this study step. Follow-up Call 2....................... 140 1 20/60 47
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Total...................................... ....................................... .............. .............. .............. 7,118
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Jeffrey Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-10839 Filed 5-23-19; 8:45 am]
BILLING CODE 4163-18-P