82 FR 43991 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 181 (September 20, 2017)

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.

[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Notices]
[Pages 43991-43992]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20008]


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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

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 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 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 
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 long-term 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.

[[Page 43992]]

    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
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                                                                                      Average
                                                     Number of       Number of      burden  per    Total  burden
      Type of respondents           Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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Individuals aged 18-45 years    Survey                     2,092               1           20/60             697
 who were born with a            questionnaire.
 congenital heart defect.
English-speaking mothers of     Contact                      356               1            2/60              12
 respondents.                    Information
                                 Form--English.
Spanish-speaking mothers of     Contact                       63               1            2/60               2
 respondents.                    Information
                                 Form--Spanish.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             711
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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. 2017-20008 Filed 9-19-17; 8:45 am]
 BILLING CODE 4163-18-P