80 FR 60905 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 195 (October 8, 2015)

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 Congenital Heart Surveillance to Recognize Outcomes, Needs and well-being (CHSTRONG). CDC seeks to collect data for the purpose of providing insight into the public health questions that remain for the population and to develop services and allocate resources to improve long-term health and wellbeing.

[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60905-60906]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-15BHD; Docket No. CDC-2016-0088]


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 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 Congenital Heart 
Surveillance to Recognize Outcomes, Needs and well-being (CHSTRONG). 
CDC seeks to collect data for the purpose of providing insight into the 
public health questions that remain for the population and to develop 
services and allocate resources to improve long-term health and 
wellbeing.

DATES: Written comments must be received on or before December 7, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0088 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the 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 
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 Surveillance To Recognize Outcomes, Needs, and 
Well-being (CHSTRONG)--New--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 long-term health and wellbeing.
    For this one-year 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 state 
databases and online search engines to find current addresses for those 
individuals and mail surveys to them inquiring about their barriers to

[[Page 60906]]

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 identifying 7,500 individuals with CHD in the birth 
defects surveillance systems, obtaining current addresses and sending 
surveys to 5,625 individuals with CHD (75%), and receiving completed 
surveys from 4,500 individuals (80%). The survey takes approximately 25 
minutes to complete, which includes 5 minutes to read the informed 
consent and 20 minutes to answer survey questions. Therefore, we 
estimate the total burden hours are 1,875.
    There are no costs to participants other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                    Number of       Number of       burden per     Total burden
      Type of respondent           Form name       respondents    responses per    response  (in       hours
                                                                    respondent        hours)
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Individuals with CHD.........  Informed consent           4,500                1            5/60             375
Individuals with CHD.........  Survey..........           4,500                1           20/60           1,500
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    Total....................  ................  ..............  ...............  ..............           1,875
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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. 2015-25647 Filed 10-7-15; 8:45 am]
 BILLING CODE 4163-18-P