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their local chapters and districts as well
as on a national level. They provide
ATSDR with information on their
outreach efforts in support of the
Registry on a monthly basis.
There are no costs to the respondents
other than their time. Participation in
this proposed information collection is
completely voluntary. The total number
of burden hours requested is 1,946
hours.

researchers and has added a respondent
type. Researchers can request access to
specimens, data, or both collected by
the National ALS Registry for their
research projects. ATSDR will review
applications for scientific validity and
human subjects’ protection and make
data/specimens available to approved
researchers. ATSDR is collaborating
with ALS service organizations to
conduct outreach activities through

collection includes blood, urine, and
saliva. The postmortem collection
includes the brain, spinal cord, cerebral
spinal fluid (CSF), bone, muscle, and
skin.
In addition to fulfilling the two-part
Congressional mandate, the Registry is
designed to be a tool for ALS
researchers. Now that the Registry has
matured, ATSDR has made data and
specimens available to approved

ESTIMATED ANNUALIZED BURDEN HOURS
Total burden
(in hours)

Form name

Person with ALS ............

ALS Case Validation Questions ..........................
ALS Case Registration Form ..............................
Voluntary Survey Modules ..................................
Disease Progression Survey* ..............................
ALS Biorepository Specimen Processing Form
and In-Home Collection.
ALS Biorepository Saliva Collection ....................
ALS Registry Research Application Form ...........
Annual Update .....................................................
Chapter/District Outreach Reporting Form ..........

1,670
1,500
750
750
325

1
1
1
3
1

2/60
10/60
85/60
5/60
30/60

56
250
1,063
188
163

350
36
24
135

1
1
1
12

10/60
30/60
15/60
5/60

59
18
6
135

National Office Outreach Reporting Form ...........

2

12

20/60

8

..............................................................................

........................

........................

........................

1,946

Researchers ..................
ALS Service Organization.
Total ........................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–10836 Filed 5–23–19; 8:45 am]
BILLING CODE 4163–18–P

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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

SUMMARY:

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Average
burden per
response
(in hours)

No. of
responses per
respondent

No. of
respondents

Type of respondents

VerDate Sep<11>2014

19:46 May 23, 2019

Jkt 247001

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

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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;

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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

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.

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

khammond on DSKBBV9HB2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

Mother, ASD workflow. All potential
participants sent mailing.
Mother, ASD workflow. Potentially eligible with contact by study staff.
Mother, ASD workflow. Eligible, consented, and enrolled; assigned to
the ASD workflow based on enrollment intake.
Mother, ASD workflow. Completed
this study step.

Invitation Packet/Response Card ....

1,718

1

10/60

286

Invitation Call Script and Social
Communication Questionnaire.
Enrollment Packet ............................

859

1

30/60

430

469

1

20/60

156

422

1

15/60

106

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18:10 May 23, 2019

Follow-up Phone Call Script and
Checklist and Pregnancy Reference Form.

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Type of respondents

Mother, ASD workflow.
this study step.
Mother, ASD workflow.
this study step.
Mother, ASD workflow.
this study step.
Mother, ASD workflow.
this study step.

422

1

1

422

Completed

Self-Administered Forms .................

375

1

105/60

656

Completed

Follow-up Call 2 ...............................

375

1

20/60

125

Completed

Clinic/Home Visit—Developmental
Assessment, saliva collection,
overall consent.
Clinic/Home Visit—Saliva Collection

328

1

225/60

1,230

164

1

15/60

41

Clinic/Home Visit—Developmental
Assessment.
Invitation Packet/Response Card ....

328

1

135/60

738

1,466

1

10/60

244

Invitation Call Script and Social
Communication Questionnaire.
Enrollment Packet ............................

733

1

30/60

367

334

1

20/60

111

Follow-up Phone Call Script and
Checklist and Pregnancy Reference Form.
Maternal Interview Call ....................

301

1

15/60

75

301

1

1

301

Self-Administered Forms .................

267

1

105/60

467

Follow-up Call 2 ...............................

267

1

20/60

89

Developmental Assessment, saliva
collection, overall consent.
Clinic/Home Visit—Saliva Collection

234

1

50/60

195

117

1

15/60

29

Clinic/Home Visit—Developmental
Assessment, saliva collection.
Invitation Packet/Response Card ....

234

1

90/60

351

641

1

10/60

107

Invitation Call Script and SCQ .........

321

1

30/60

161

Enrollment Packet ............................

175

1

20/60

58

Follow-up Phone Call Script, and
Checklist and Pregnancy Reference Form.
Maternal Interview Call ....................

158

1

15/60

40

158

1

1

158

Self-Administered Forms .................

140

1

55/60

128

Follow-up Call 2 ...............................

140

1

20/60

47

.....................................................

........................

........................

........................

7,118

DD workflow. Completed this
step.
DD workflow. Completed this
step.
DD workflow. Completed this
step.

Total ...........................................

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

VerDate Sep<11>2014

Total burden
(in hours)

Maternal Interview Call ....................

Mother, POP workflow. Completed
this study step.
Mother, POP workflow. Completed
this study step.
Mother, POP workflow. Completed
this study step.
Mother, POP workflow. Completed
this study step.
Father, POP workflow. Completed
this study step.
Child, POP workflow. Completed this
study step.
Mother, DD workflow. All potential
participants sent mailing.
Mother, DD workflow. Potentially eligible with contact by study staff.
Mother, DD workflow. Eligible, consented, and enrolled; assigned to
the DD workflow based on enrollment intake.
Mother, DD workflow. Completed this
study step.

khammond on DSKBBV9HB2PROD with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Completed

Father, ASD workflow. Completed
this study step.
Child, ASD workflow. Completed this
study step.
Mother, POP workflow. All potential
participants sent mailing.
Mother , POP workflow. Potentially
eligible with contact by study staff.
Mother , POP workflow. Eligible, consented, and enrolled; assigned to
the POP workflow based on enrollment intake.
Mother, POP workflow. Completed
this study step.

Mother,
study
Mother,
study
Mother,
study

Number of
respondents

Form name

18:10 May 23, 2019

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