[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4055-4056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-1122]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Congenital Heart Survey To Recognize 
Outcomes, Needs, and well-being (CH STRONG) to the Office of Management 
and Budget (OMB) for review and approval. CDC previously published a 
``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on 09/20/2017 to obtain comments from the 
public and affected agencies. CDC did not receive comments related to 
the previous notice. This notice serves to allow an additional 30 days 
for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) 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;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) 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 submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Congenital Heart Surveillance To Recognize Outcomes, Needs, and 
Well-being (CHSTRONG) (OMB Control Number 0920-1122,Expiration 07/31/
2017)--Reinstatement with Change--National Center on Birth Defects and 
Developmental Disabilities, 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 were 
delays in recruitment due to challenges with tracking and tracing 
individuals for correct addresses. The three sites, Metro-Atlanta 
Congenital Defect Program (MACDP), University of Arizona, and 
University of Arkansas, decided to conduct more intensive and time-
consuming tracking and tracing to identify more accurate contact 
information for all eligible individuals and for those individuals 
whose materials were returned as undeliverable. At MACDP, this required 
modifying a contract to include the task of tracking and tracing 2,313 
individuals. While the large majority of tracking and tracing at all 
three sites took place in the first year of the project, including that 
for the 2,313 individuals above, an additional 1,115 mothers of 
eligible individuals need to be sent a contact information form to 
assist to locating their child. Due to these delays and changes in the 
recruitment process, CH STRONG data collection is expected to last an 
additional 24 months and conclude two years after receiving OMB 
approval.
    Since July 2016, the three CH STRONG sites identified 9,228 
individuals with CHD through their respective birth defects registries. 
The CH STRONG project has successfully tracked and traced 6,417 
individuals for current contact information. To date, the three sites 
have sent recruitment materials to 3,651 individuals (40% of all 
individuals).
    The purpose of this survey is to collect information on barriers to 
health care, quality of life, social and educational outcomes, and 
transition of care from childhood to adulthood among adults born with 
CHD. Currently, Congress has appropriated approximately $4 million per 
year to CDC to conduct surveillance among adults with CHD.
    CH STRONG will survey adults aged 18 to 45 years of age and born 
with a CHD as identified through the birth defects surveillance system 
in three participating sites in the United States. The information 
collected from this cohort will be used to identify the healthcare, 
educational, and social service needs of adults with CHDs. Findings 
will be reported through peer-reviewed publications, presentations at 
state and national conferences, and webinars and reports to partners 
who work on CHD. The findings will be used by national, state and local 
organizations to allocate resources and develop services and programs 
for adults with CHD.
    With the information collected in this survey, the CDC, along with 
its partners, will have information on healthcare

[[Page 4056]]

needs and quality of life among a U.S. population-based group of adults 
with CHD. This information will inform local, state, and federal 
resource allocation for services targeting U.S. adults with CHD, a 
group that is increasing in size and currently totals over 1.5 million. 
Additionally, clinicians will have information to counsel families of 
children with CHD on how to prepare for their child's future. Without 
the information, needed resource allocation and services for adults and 
information on long-term outcomes for children with CHD are unknown.
    Across the three sites, there are 2,766 individuals that were 
tracked and traced in the first year of the project, but have not yet 
been recruited to participate in the survey. Additionally, mothers of 
1,115 individuals will be sent a letter and contact information form to 
assist in reaching their child. It is estimated that half of these 
mothers will complete the form (n=556); 85% (n=474) in English and 15% 
(n=83) in Spanish. Therefore, with the 2,766 yet to be recruited, and 
the approximately 556 individuals that will be successfully tracked and 
traced through the mother's contact form, approximately 3,322 potential 
respondents will be contacted. It is expected that approximately 70%, 
or 2,325 respondents, will participate.
    The total estimated annual burden hours are 563.

                                                            Estimated Annualized Burden Hours
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                                                                                                                      Average burden
             Type of respondents                         Form name                Number of      Number  responses  per response  (in     Total burden
                                                                                 respondents      per  respondent         hours)             hours
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Individuals aged 18-45 years who were born    Survey questionnaire..........              1,661                  1              20/60                554
 with a congenital heart defect.
English-speaking mothers of respondents.....  Contact Information Form--                    237                  1               2/60                  8
                                               English.
Spanish-speaking mothers of respondents.....  Contact Information Form--                     42                  1               2/60                  1
                                               Spanish.
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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. 2018-01585 Filed 1-26-18; 8:45 am]
 BILLING CODE 4163-18-P