83 FR 4055 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 19 (January 29, 2018)

Page Range		4055-4056
FR Document		2018-01585

Federal Register, Volume 83 Issue 19 (Monday, January 29, 2018)

[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4055-4056]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01585]

-----------------------------------------------------------------------

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 omb@cdc.gov. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Type of respondents Form name Number of Number responses per response (in Total burden
respondents per respondent hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

4056 Federal Register / Vol. 83, No. 19 / Monday, January 29, 2018 / Notices

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

ESTIMATED ANNUALIZED BURDEN HOURS
Number Average burden
Number of Total burden
Type of respondents Form name responses per per response
respondents hours
respondent (in hours)

Individuals aged 18–45 years Survey questionnaire ............ 1,661 1 20/60 554
who were born with a con-
genital heart defect.
English-speaking mothers of Contact Information Form— 237 1 2/60 8
respondents. English.
Spanish-speaking mothers of Contact Information Form— 42 1 2/60 1
respondents. Spanish.

Leroy A. Richardson, The Office of Management and Budget Proposed Project
Chief, Information Collection Review Office, is particularly interested in comments
Office of Scientific Integrity, Office of the
Zika Reproductive Health and
that:
Associate Director for Science, Office of the (a) Evaluate whether the proposed Emergency Response Call-Back Survey,
Director, Centers for Disease Control and collection of information is necessary 2018—New—National Center for
Prevention. for the proper performance of the Chronic Disease Prevention and Health
[FR Doc. 2018–01585 Filed 1–26–18; 8:45 am] functions of the agency, including Promotion (NCCDPHP), Centers for
BILLING CODE 4163–18–P whether the information will have Disease Control and Prevention (CDC).
practical utility; Background and Brief Description
(b) Evaluate the accuracy of the
DEPARTMENT OF HEALTH AND agencies estimate of the burden of the In May 2015, the World Health
HUMAN SERVICES proposed collection of information, Organization reported the first local
including the validity of the mosquito-borne transmission of Zika
Centers for Disease Control and methodology and assumptions used; virus in the Western Hemisphere.
Prevention (c) Enhance the quality, utility, and Through the course of the outbreak,
clarity of the information to be local transmission was identified in at
[30Day–18–18KS] least 50 countries or territories in the
collected;
(d) Minimize the burden of the Americas; within the United States,
Agency Forms Undergoing Paperwork
collection of information on those who widespread mosquito born transmission
Reduction Act Review
are to respond, including, through the was documented in the territories of
In accordance with the Paperwork use of appropriate automated, Puerto Rico and the U.S. Virgin Islands,
Reduction Act of 1995, the Centers for electronic, mechanical, or other with localized transmission in Florida
Disease Control and Prevention (CDC) technological collection techniques or and Texas. In addition, in the
has submitted the information other forms of information technology, continental United States, there has
collection request titled ‘‘Zika e.g., permitting electronic submission of been a large number of travel-related
Reproductive Health and Emergency responses; and cases with infection occurring through
Response Call-Back Survey, 2018’’ to (e) Assess information collection mosquito born and sexual transmission.
the Office of Management and Budget costs. In response to the Zika virus outbreak,
(OMB) for review and approval. CDC To request additional information on and evidence that Zika virus infection
previously published a ‘‘Proposed Data the proposed project or to obtain a copy during pregnancy is a cause of
Collection Submitted for Public of the information collection plan and microcephaly and other adverse
Comment and Recommendations’’ instruments, call (404) 639–7570 or pregnancy and infant outcomes, CDC’s
notice on April 27, 2017 to obtain send an email to omb@cdc.gov. Direct Emergency Operations Center was
comments from the public and affected written comments and/or suggestions activated to respond to the Zika virus
sradovich on DSK3GMQ082PROD with NOTICES

agencies. CDC received one comment, regarding the items contained in this outbreak from January 22, 2016–
which was unrelated to the proposed notice to the Attention: CDC Desk September 29, 2017. Given the adverse
information collection. This notice Officer, Office of Management and pregnancy and birth outcomes
serves to allow an additional 30 days for Budget, 725 17th Street NW, associated with Zika virus infection
public and affected agency comments. Washington, DC 20503 or by fax to (202) during pregnancy, through this response
CDC will accept all comments for this 395–5806. Provide written comments CDC developed specific
proposed information collection project. within 30 days of notice publication. recommendations for preconception

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Document Created: 2018-01-27 00:57:46
Document Modified: 2018-01-27 00:57:46

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		83 FR 4055

83 FR 4055 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 83, Issue 19 (January 29, 2018)

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