60 day FRN

Att. 2 - 60dy Published FRN.pdf

Congenital Heart Survey to Recognize Outcomes, Needs, and Well-Being

60 day FRN

OMB: 0920-1122

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Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices
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. 2017–19957 Filed 9–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–1122; Docket No. CDC–2017–
0070]

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 efforts 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 reinstatement of the data
collection project titled ‘‘Congenital
Heart Surveillance to Recognize
Outcomes, Needs and well-being
(CHSTRONG).’’ CDC collects
CHSTRONG data to provide public
health question insight, aid in the
development of services, and inform for
the proper allocation of resources to
improve long-term health and
wellbeing.
DATES: Written comments must be
received on or before November 20,
2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0070 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

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SUMMARY:

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access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment
should be submitted 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 copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, 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 OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
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

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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.
Proposed Project
Congenital Heart Survey To Recognize
Outcomes, Needs, and well-being (CH
STRONG) (OMB Control Number: 0920–
1122, Expiration 07/31/2017)—
Reinstatement with change—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Congenital heart defects (CHDs) are
the most common type of structural
birth defects, affecting approximately 1
in 110 live-born children. In prior
decades, many CHDs were considered
fatal during infancy or childhood, but
with tremendous advances in pediatric
cardiology and cardiac surgery, at least
85% of patients now survive to
adulthood and there are approximately
1.5 million adults with CHD living in
the United States.
With vast declines in mortality from
pediatric heart disease over the past 30
years, it is vital to evaluate long-term
outcomes and quality of life issues for
adults with CHD. However, U.S. data on
long-term outcomes, quality of life
issues, and comorbidities of adults born
with CHD are lacking. U.S. data is
needed to provide insight into the
public health questions that remain for
this population and to develop services
and allocate resources to improve longterm health and wellbeing.
The initial request for this project was
one year, but there was a delay in
recruitment that results in a change in
the recruitment process. Therefore, an
additional 24 months is being requested.
The three sites decided to conduct more
intensive and time-consuming tracking
and tracing to identify more accurate
contact information for all eligible
individuals. In addition to more
intensive tracking and tracing, the sites
decided to send recruitment materials in
batches rather than all at once. This
ensured that problems with the
recruitment process were caught
immediately and could be modified in
subsequent rounds of recruitment. Due
to these delays and changes in
recruitment process, CH STRONG data
collection is expected to last an
additional 24 months and conclude two
years after receiving an extension from
OMB.

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Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices

For this project, we will use data from
U.S. state birth defect surveillance
systems to identify a population-based
sample of individuals 18 to 45 years of
age born with CHD. We will then use an
automated process of searching state
databases and online search engines, as
well as have individuals perform more
time-intensive online searches to find
current addresses for those eligible
participants and mail surveys to them

inquiring about their barriers to health
care, quality of life, social and
educational outcomes, and transition of
care from childhood to adulthood. The
information collected from this
population-based survey will be used to
inform current knowledge, allocate
resources, develop services, and,
ultimately, improve long-term health of
adults born with CHD.

We estimate sending a survey to 4,183
individuals with CHD over a 2-year
period, and receiving completed surveys
from 2,928 individuals (70%). The
survey takes approximately 20 minutes
to complete. The contact information
form takes approximately two minutes
to complete. There are no costs to
participants other than their time. The
total estimated annual burden hours are
711.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent

Number of
respondents

Type of respondents

Form name

Individuals aged 18–45 years who
were born with a congenital heart
defect.
English-speaking mothers of respondents.
Spanish-speaking mothers of respondents.

Survey questionnaire .......................

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

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

Average
burden
per response
(in hours)

Total
burden hours

2,092

20/60

697

Contact Information Form—English

356

2/60

Contact Information Form—Spanish

2/60

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

711

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. 2017–20008 Filed 9–19–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Agency Recordkeeping/Reporting
Requirements Under Emergency
Review by the Office of Management
and Budget (OMB)
Title: Administration for Children &
Families (ACF) Electronic Case
Management System (ECMRS).

OMB No.: Revision of 0970–0461.
Description: The recent climatic
events of Hurricane Harvey and
Hurricane Irma have created
catastrophic disasters in Texas,
Louisiana, Puerto Rico, U.S. Virgin
Islands, and Florida. President Trump
has declared these climatic events as
major disaster declarations. FEMA is
providing assistances to these states and
territories under declaration numbers
DR–4332 & DR–4337.
There are looming public health
issues related to flooding, and especially
among at risk populations. Risks
include contracting water-borne and
vector-borne diseases, substance abuse,
and mental health concerns, including
PTSD, depression, anxiety, and
homelessness.
Therefore, it is essential for the
mission of ACF to activate the
Immediate Disaster Case Management

(IDCM) Electronic Case Management
Record System (ECMRS). The ECMRS
will be used to collect and manage
information from the disaster affected
clients. This information includes
demographics, disaster caused unmet
needs, and referrals provided. The
information collected is critical to
develop a recovery plan for each
survivor.
Respondents: Clients.

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ANNUAL BURDEN ESTIMATES
Instrument

Number of
respondents

Number of
responses per
respondent

Average
burden hours
per response

Total burden
hours

Immediate Disaster Case Management ..........................................................

406,500

Additional Information: ACF is
requesting that OMB grant a 180-day
approval for this information collection
under procedures for emergency
processing by September 22, 2017. A
copy of this information collection, with
applicable supporting documentation,
may be obtained by calling the