[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Pages 9200-9201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03820]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16PA; Docket No. CDC-2016-0021]


Proposed Data Collections 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 to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the Study to 
Explore Early Development (SEED) Phase 3.

DATES: Written comments must be received on or before April 25, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0021 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Leroy A. Richardson, Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 6501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of the 
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 the 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 OMB for 
approval. To comply with this requirement, we are publishing this 
notice of a proposed data collection as described below.
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. Comments are invited on: (a) Whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information shall 
have practical utility; (b) the accuracy of the agency's estimate of 
the burden of the proposed collection of information; (c) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; (d) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques or other forms of information technology; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. Written comments should be received within 60 
days of this notice.

Proposed Project

    Study to Explore Early Development 3 (SEED 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% to 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 (California, Colorado, 
Maryland, North Carolina and Pennsylvania); 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--currently ongoing with completion in 2016). Five 
CADDRE grantees received the awards. Again, CDC served as the sixth 
SEED 2 site.
    Four extramural sites plus the CDC site will implement the SEED 3 
collaborative protocol. The SEED 3 protocol for identification of study 
participants, recruitment, and study data collection flow will be very 
similar to the protocols for SEED 1 and 2.
    Modifications that will be implemented in the third round of data 
collection include recruitment from a more recent cohort of children, 
strategies to improve response rates, and a further reduction in the 
data collection protocol. No data collection instruments/exams used in 
SEED 2 will be revised in SEED 3; however, some instruments will not be 
retained in the protocol to reduce participant burden.
    Families will be identified from each of the 3 groups: Autism 
Spectrum Disorder (ASD), other developmental

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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 5 SEED 3 study sites will have a total 
of 1,875 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 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, (5) 
biosampling from biological parents and child, and (6) abstraction of 
maternal prenatal and labor and delivery medical records. The estimated 
total burden hours are 18,431. There are no costs to participants other 
than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of        Number        burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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Parent........................  SCQ.............           1,875               1           30/60             938
Parent........................  Pregnancy                  1,875               1           15/60             469
                                 Reference form.
Parent........................  Maternal                   1,875               1           60/60           1,875
                                 Interview.
Parent........................  Self-                      1,875               1           88/60           2,750
                                 Administered
                                 Forms.
Parent........................  HIPAA Medical              1,500               1           20/60             500
                                 Records Release.
Parent/Child..................  Clinic/Home                3,000               1          238/60          11,900
                                 Visit--Developm
                                 ental
                                 Assessment.
                                                 ----------------                                ---------------
    Total.....................  ................          12,000  ..............  ..............          18,431
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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. 2016-03820 Filed 2-23-16; 8:45 am]
 BILLING CODE 4163-18-P