[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.

[[Page 24146]]

 
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
                                                                                         ---------------------------------------------------------------
    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