82_FR_44172 82 FR 43991 - Proposed Data Collection Submitted for Public Comment and Recommendations

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)

Page Range43991-43992
FR Document2017-20008

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 Issue 181 (Wednesday, September 20, 2017)
[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.

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

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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden  per    Total  burden
      Type of respondents           Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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



                                                                         Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices                                           43991

                                                Leroy A. Richardson,                                    access to the docket to read background               maintaining information, and disclosing
                                                Chief, Information Collection Review Office,            documents or comments received, go to                 and providing information; to train
                                                Office of Scientific Integrity, Office of the           Regulations.gov.                                      personnel and to be able to respond to
                                                Associate Director for Science, Office of the              Please note: All public comment                    a collection of information, to search
                                                Director, Centers for Disease Control and               should be submitted through the                       data sources, to complete and review
                                                Prevention.                                             Federal eRulemaking portal                            the collection of information; and to
                                                [FR Doc. 2017–19957 Filed 9–19–17; 8:45 am]             (Regulations.gov) or by U.S. mail to the              transmit or otherwise disclose the
                                                BILLING CODE 4163–18–P                                  address listed above.                                 information.
                                                                                                        FOR FURTHER INFORMATION CONTACT: To                   Proposed Project
                                                                                                        request more information on the
                                                DEPARTMENT OF HEALTH AND                                                                                        Congenital Heart Survey To Recognize
                                                                                                        proposed project or to obtain a copy of
                                                HUMAN SERVICES                                                                                                Outcomes, Needs, and well-being (CH
                                                                                                        the information collection plan and
                                                                                                        instruments, contact Leroy A.                         STRONG) (OMB Control Number: 0920–
                                                Centers for Disease Control and                                                                               1122, Expiration 07/31/2017)—
                                                Prevention                                              Richardson, Information Collection
                                                                                                        Review Office, Centers for Disease                    Reinstatement with change—National
                                                [60Day–17–1122; Docket No. CDC–2017–                    Control and Prevention, 1600 Clifton                  Center on Birth Defects and
                                                0070]                                                   Road NE., MS–D74, Atlanta, Georgia                    Developmental Disabilities (NCBDDD),
                                                                                                        30329; phone: 404–639–7570; Email:                    Centers for Disease Control and
                                                Proposed Data Collection Submitted                                                                            Prevention (CDC).
                                                for Public Comment and                                  omb@cdc.gov.
                                                Recommendations                                         SUPPLEMENTARY INFORMATION: Under the                  Background and Brief Description
                                                                                                        Paperwork Reduction Act of 1995 (PRA)                    Congenital heart defects (CHDs) are
                                                AGENCY: Centers for Disease Control and                 (44 U.S.C. 3501–3520), Federal agencies               the most common type of structural
                                                Prevention (CDC), Department of Health                  must obtain approval from the Office of               birth defects, affecting approximately 1
                                                and Human Services (HHS).                               Management and Budget (OMB) for each                  in 110 live-born children. In prior
                                                ACTION: Notice with comment period.                     collection of information they conduct                decades, many CHDs were considered
                                                                                                        or sponsor. In addition, the PRA also                 fatal during infancy or childhood, but
                                                SUMMARY:    The Centers for Disease                     requires Federal agencies to provide a
                                                Control and Prevention (CDC), as part of                                                                      with tremendous advances in pediatric
                                                                                                        60-day notice in the Federal Register                 cardiology and cardiac surgery, at least
                                                its continuing efforts to reduce public                 concerning each proposed collection of
                                                burden and maximize the utility of                                                                            85% of patients now survive to
                                                                                                        information, including each new                       adulthood and there are approximately
                                                government information, invites the                     proposed collection, each proposed
                                                general public and other Federal                                                                              1.5 million adults with CHD living in
                                                                                                        extension of existing collection of                   the United States.
                                                agencies to take this opportunity to                    information, and each reinstatement of                   With vast declines in mortality from
                                                comment on proposed and/or                              previously approved information                       pediatric heart disease over the past 30
                                                continuing information collections, as                  collection before submitting the                      years, it is vital to evaluate long-term
                                                required by the Paperwork Reduction                     collection to OMB for approval. To                    outcomes and quality of life issues for
                                                Act of 1995. This notice invites                        comply with this requirement, we are                  adults with CHD. However, U.S. data on
                                                comment on reinstatement of the data                    publishing this notice of a proposed                  long-term outcomes, quality of life
                                                collection project titled ‘‘Congenital                  data collection as described below.                   issues, and comorbidities of adults born
                                                Heart Surveillance to Recognize                            Comments are invited on: (a) Whether               with CHD are lacking. U.S. data is
                                                Outcomes, Needs and well-being                          the proposed collection of information                needed to provide insight into the
                                                (CHSTRONG).’’ CDC collects                              is necessary for the proper performance               public health questions that remain for
                                                CHSTRONG data to provide public                         of the functions of the agency, including             this population and to develop services
                                                health question insight, aid in the                     whether the information shall have                    and allocate resources to improve long-
                                                development of services, and inform for                 practical utility; (b) the accuracy of the            term health and wellbeing.
                                                the proper allocation of resources to                   agency’s estimate of the burden of the                   The initial request for this project was
                                                improve long-term health and                            proposed collection of information; (c)               one year, but there was a delay in
                                                wellbeing.                                              ways to enhance the quality, utility, and             recruitment that results in a change in
                                                DATES: Written comments must be                         clarity of the information to be                      the recruitment process. Therefore, an
                                                received on or before November 20,                      collected; (d) ways to minimize the                   additional 24 months is being requested.
                                                2017.                                                   burden of the collection of information               The three sites decided to conduct more
                                                ADDRESSES: You may submit comments,                     on respondents, including through the                 intensive and time-consuming tracking
                                                identified by Docket No. CDC–2017–                      use of automated collection techniques                and tracing to identify more accurate
                                                0070 by any of the following methods:                   or other forms of information                         contact information for all eligible
                                                   • Federal eRulemaking Portal:                        technology; and (e) estimates of capital              individuals. In addition to more
                                                Regulations.gov. Follow the instructions                or start-up costs and costs of operation,             intensive tracking and tracing, the sites
                                                for submitting comments.                                maintenance, and purchase of services                 decided to send recruitment materials in
                                                   • Mail: Leroy A. Richardson,                         to provide information. Burden means                  batches rather than all at once. This
                                                Information Collection Review Office,                   the total time, effort, or financial                  ensured that problems with the
                                                Centers for Disease Control and                         resources expended by persons to                      recruitment process were caught
                                                Prevention, 1600 Clifton Road NE., MS–                  generate, maintain, retain, disclose or               immediately and could be modified in
sradovich on DSKBBY8HB2PROD with NOTICES




                                                D74, Atlanta, Georgia 30329.                            provide information to or for a Federal               subsequent rounds of recruitment. Due
                                                   Instructions: All submissions received               agency. This includes the time needed                 to these delays and changes in
                                                must include the agency name and                        to review instructions; to develop,                   recruitment process, CH STRONG data
                                                Docket Number. All relevant comments                    acquire, install and utilize technology               collection is expected to last an
                                                received will be posted without change                  and systems for the purpose of                        additional 24 months and conclude two
                                                to Regulations.gov, including any                       collecting, validating and verifying                  years after receiving an extension from
                                                personal information provided. For                      information, processing and                           OMB.


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                                                43992                          Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices

                                                  For this project, we will use data from                               inquiring about their barriers to health                                         We estimate sending a survey to 4,183
                                                U.S. state birth defect surveillance                                    care, quality of life, social and                                             individuals with CHD over a 2-year
                                                systems to identify a population-based                                  educational outcomes, and transition of                                       period, and receiving completed surveys
                                                sample of individuals 18 to 45 years of                                 care from childhood to adulthood. The                                         from 2,928 individuals (70%). The
                                                age born with CHD. We will then use an                                  information collected from this                                               survey takes approximately 20 minutes
                                                automated process of searching state                                    population-based survey will be used to                                       to complete. The contact information
                                                databases and online search engines, as                                 inform current knowledge, allocate                                            form takes approximately two minutes
                                                well as have individuals perform more                                   resources, develop services, and,                                             to complete. There are no costs to
                                                time-intensive online searches to find                                  ultimately, improve long-term health of                                       participants other than their time. The
                                                current addresses for those eligible                                    adults born with CHD.                                                         total estimated annual burden hours are
                                                participants and mail surveys to them                                                                                                                 711.
                                                                                                                       ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                    Number of                   Average
                                                                                                                                                                         Number of                   responses                   burden                     Total
                                                          Type of respondents                                                Form name                                  respondents                     per                   per response              burden hours
                                                                                                                                                                                                    respondent                 (in hours)

                                                Individuals aged 18–45 years who                         Survey questionnaire .......................                                2,092                              1                  20/60                 697
                                                  were born with a congenital heart
                                                  defect.
                                                English-speaking mothers of re-                          Contact Information Form—English                                                356                           1                      2/60                  12
                                                  spondents.
                                                Spanish-speaking mothers of re-                          Contact Information Form—Spanish                                                 63                           1                      2/60                   2
                                                  spondents.

                                                     Total ...........................................   ...........................................................   ........................   ........................   ........................            711



                                                Leroy A. Richardson,                                                       OMB No.: Revision of 0970–0461.                                            (IDCM) Electronic Case Management
                                                Chief, Information Collection Review Office,                               Description: The recent climatic                                           Record System (ECMRS). The ECMRS
                                                Office of Scientific Integrity, Office of the                           events of Hurricane Harvey and                                                will be used to collect and manage
                                                Associate Director for Science, Office of the                           Hurricane Irma have created                                                   information from the disaster affected
                                                Director, Centers for Disease Control and                               catastrophic disasters in Texas,
                                                Prevention.                                                                                                                                           clients. This information includes
                                                                                                                        Louisiana, Puerto Rico, U.S. Virgin                                           demographics, disaster caused unmet
                                                [FR Doc. 2017–20008 Filed 9–19–17; 8:45 am]                             Islands, and Florida. President Trump                                         needs, and referrals provided. The
                                                BILLING CODE 4163–18–P                                                  has declared these climatic events as                                         information collected is critical to
                                                                                                                        major disaster declarations. FEMA is
                                                                                                                                                                                                      develop a recovery plan for each
                                                                                                                        providing assistances to these states and
                                                DEPARTMENT OF HEALTH AND                                                                                                                              survivor.
                                                                                                                        territories under declaration numbers
                                                HUMAN SERVICES                                                          DR–4332 & DR–4337.                                                               Respondents: Clients.
                                                                                                                           There are looming public health
                                                Administration for Children and                                         issues related to flooding, and especially
                                                Families                                                                among at risk populations. Risks
                                                Agency Recordkeeping/Reporting                                          include contracting water-borne and
                                                Requirements Under Emergency                                            vector-borne diseases, substance abuse,
                                                Review by the Office of Management                                      and mental health concerns, including
                                                and Budget (OMB)                                                        PTSD, depression, anxiety, and
                                                                                                                        homelessness.
                                                  Title: Administration for Children &                                     Therefore, it is essential for the
                                                Families (ACF) Electronic Case                                          mission of ACF to activate the
                                                Management System (ECMRS).                                              Immediate Disaster Case Management

                                                                                                                                  ANNUAL BURDEN ESTIMATES
                                                                                                                                                                                                    Number of                   Average
                                                                                                                                                                         Number of                                                                      Total burden
                                                                                               Instrument                                                                                         responses per               burden hours
                                                                                                                                                                        respondents                                                                        hours
                                                                                                                                                                                                    respondent                per response

                                                Immediate Disaster Case Management ..........................................................                               406,500                         1                          1                  406,500



                                                  Additional Information: ACF is                                        Administration for Children and                                               of Information and Regulatory Affairs,
sradovich on DSKBBY8HB2PROD with NOTICES




                                                requesting that OMB grant a 180-day                                     Families, Reports Clearance Officer,                                          Office of Management and Budget,
                                                approval for this information collection                                Robert Sargis at (202) 690–7275. Email                                        Paperwork Reduction Project, Desk
                                                under procedures for emergency                                          address: rsargis@acf.hhs.gov.                                                 Officer for ACF.
                                                processing by September 22, 2017. A                                       Comments and questions about the
                                                copy of this information collection, with                               information collection described above
                                                applicable supporting documentation,                                    should be directed to the following
                                                may be obtained by calling the                                          address by September 22, 2017. Office


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Document Created: 2018-10-24 14:24:04
Document Modified: 2018-10-24 14:24:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before November 20, 2017.
ContactTo 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]
FR Citation82 FR 43991 

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