2017-20008. 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.

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: [phone]; Email: [e-mail].

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.

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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
Individuals aged 18-45 years who were born with a congenital heart defect	Survey questionnaire	2,092	1	20/60	697
English-speaking mothers of respondents	Contact Information Form—English	356	1	2/60	12
Spanish-speaking mothers of respondents	Contact Information Form—Spanish	63	1	2/60	2
Total					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.