80_FR_61100 80 FR 60905 - Proposed Data Collection Submitted for Public Comment and Recommendations

80 FR 60905 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 195 (October 8, 2015)

Page Range60905-60906
FR Document2015-25647

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 Congenital Heart Surveillance to Recognize Outcomes, Needs and well-being (CHSTRONG). CDC seeks to collect data for the purpose of providing insight into the public health questions that remain for the population and to develop services and allocate resources to improve long-term health and wellbeing.

Federal Register, Volume 80 Issue 195 (Thursday, October 8, 2015) 
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60905-60906]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-15BHD; Docket No. CDC-2016-0088]


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 Congenital Heart 
Surveillance to Recognize Outcomes, Needs and well-being (CHSTRONG). 
CDC seeks to collect data for the purpose of providing insight into the 
public health questions that remain for the population and to develop 
services and allocate resources to improve long-term health and 
wellbeing.

DATES: Written comments must be received on or before December 7, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0088 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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.

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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

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 Surveillance To Recognize Outcomes, Needs, and 
Well-being (CHSTRONG)--New--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.
    For this one-year 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 state 
databases and online search engines to find current addresses for those 
individuals and mail surveys to them inquiring about their barriers to

[[Page 60906]]

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 identifying 7,500 individuals with CHD in the birth 
defects surveillance systems, obtaining current addresses and sending 
surveys to 5,625 individuals with CHD (75%), and receiving completed 
surveys from 4,500 individuals (80%). The survey takes approximately 25 
minutes to complete, which includes 5 minutes to read the informed 
consent and 20 minutes to answer survey questions. Therefore, we 
estimate the total burden hours are 1,875.
    There are no costs to participants other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                    Number of       Number of       burden per     Total burden
      Type of respondent           Form name       respondents    responses per    response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Individuals with CHD.........  Informed consent           4,500                1            5/60             375
Individuals with CHD.........  Survey..........           4,500                1           20/60           1,500
                                                ----------------------------------------------------------------
    Total....................  ................  ..............  ...............  ..............           1,875
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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. 2015-25647 Filed 10-7-15; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 60905 Proposed Merger is consummated. If the the population and to develop services use of automated collection techniques Commission determines that Integra is and allocate resources to improve long- or other forms of information not an acceptable acquirer, or that the term health and wellbeing. technology; and (e) estimates of capital manner of the divestitures is not DATES: Written comments must be or start-up costs and costs of operation, acceptable, the proposed Order requires received on or before December 7, 2015. maintenance, and purchase of services the parties to unwind the sale of rights ADDRESSES: You may submit comments, to provide information. Burden means to Integra and then divest the products identified by Docket No. CDC–2016– the total time, effort, or financial to a Commission-approved acquirer 0088 by any of the following methods: resources expended by persons to within six months of the date the Order • Federal eRulemaking Portal: generate, maintain, retain, disclose or becomes final. The proposed Order Regulation.gov. Follow the instructions provide information to or for a Federal further allows the Commission to for submitting comments. agency. This includes the time needed appoint a trustee in the event the parties • Mail: Leroy A. Richardson, to review instructions; to develop, fail to divest the products as required. Information Collection Review Office, acquire, install and utilize technology The Order also requires the parties to Centers for Disease Control and and systems for the purpose of appoint Quantic Regulatory Services, Prevention, 1600 Clifton Road, NE., collecting, validating and verifying LLC as interim monitor to ensure the MS–D74, Atlanta, Georgia 30329. information, processing and parties comply with the obligations Instructions: All submissions received maintaining information, and disclosing pursuant to the Consent Agreement and must include the agency name and and providing information; to train to keep the Commission informed about Docket Number. All relevant comments personnel and to be able to respond to the status of the transfer of the assets received will be posted without change a collection of information, to search and rights to Integra. to Regulations.gov, including any data sources, to complete and review The purpose of this analysis is to personal information provided. For the collection of information; and to facilitate public comment on the access to the docket to read background transmit or otherwise disclose the Consent Agreement, and it is not documents or comments received, go to information. intended to constitute an official Regulations.gov. Proposed Project interpretation of the proposed Order or FOR FURTHER INFORMATION CONTACT: To to modify its terms in any way. Congenital Heart Surveillance To request more information on the Recognize Outcomes, Needs, and Well- By direction of the Commission. proposed project or to obtain a copy of being (CHSTRONG)—New—National Donald S. Clark, the information collection plan and Center on Birth Defects and Secretary. instruments, contact the Information Developmental Disabilities (NCBDDD), [FR Doc. 2015–25604 Filed 10–7–15; 8:45 am] Collection Review Office, Centers for Centers for Disease Control and Disease Control and Prevention, 1600 Prevention (CDC). BILLING CODE 6750–01–P Clifton Road NE., MS–D74, Atlanta, Georgia 30329; phone: 404–639–7570; Background and Brief Description Email: omb@cdc.gov. Congenital heart defects (CHDs) are DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Under the the most common type of structural HUMAN SERVICES Paperwork Reduction Act of 1995 (PRA) birth defects, affecting approximately 1 Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies in 110 live-born children. In prior Prevention must obtain approval from the Office of decades, many CHDs were considered Management and Budget (OMB) for each fatal during infancy or childhood, but [60Day–16–15BHD; Docket No. CDC–2016– collection of information they conduct with tremendous advances in pediatric 0088] or sponsor. In addition, the PRA also cardiology and cardiac surgery, at least Proposed Data Collection Submitted requires Federal agencies to provide a 85% of patients now survive to for Public Comment and 60-day notice in the Federal Register adulthood and there are approximately Recommendations concerning each proposed collection of 1.5 million adults with CHD living in information, including each new the United States. With vast declines in AGENCY: Centers for Disease Control and proposed collection, each proposed mortality from pediatric heart disease Prevention (CDC), Department of Health extension of existing collection of over the past 30 years, it is vital to and Human Services (HHS). information, and each reinstatement of evaluate long term outcomes and quality ACTION: Notice with comment period. previously approved information of life issues for adults with CHD. collection before submitting the However, U.S. data on long term SUMMARY: The Centers for Disease collection to OMB for approval. To outcomes, quality of life issues, and Control and Prevention (CDC), as part of comply with this requirement, we are comorbidities of adults born with CHD its continuing efforts to reduce public publishing this notice of a proposed are lacking. U.S. data is needed to burden and maximize the utility of data collection as described below. provide insight into the public health government information, invites the Comments are invited on: (a) Whether questions that remain for this general public and other Federal the proposed collection of information population and to develop services and agencies to take this opportunity to is necessary for the proper performance allocate resources to improve long-term comment on proposed and/or of the functions of the agency, including health and wellbeing. continuing information collections, as whether the information shall have For this one-year project, we will use mstockstill on DSK4VPTVN1PROD with NOTICES required by the Paperwork Reduction practical utility; (b) the accuracy of the data from U.S. state birth defect Act of 1995. This notice invites agency’s estimate of the burden of the surveillance systems to identify a comment on Congenital Heart proposed collection of information; (c) population-based sample of individuals Surveillance to Recognize Outcomes, ways to enhance the quality, utility, and 18 to 45 years of age born with CHD. We Needs and well-being (CHSTRONG). clarity of the information to be will then use state databases and online CDC seeks to collect data for the collected; (d) ways to minimize the search engines to find current addresses purpose of providing insight into the burden of the collection of information for those individuals and mail surveys public health questions that remain for on respondents, including through the to them inquiring about their barriers to VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\08OCN1.SGM 08OCN1

60906 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices health care, quality of life, social and ultimately, improve long-term health of takes approximately 25 minutes to educational outcomes, and transition of adults born with CHD. complete, which includes 5 minutes to care from childhood to adulthood. The We estimate identifying 7,500 read the informed consent and 20 information collected from this individuals with CHD in the birth minutes to answer survey questions. population-based survey will be used to defects surveillance systems, obtaining Therefore, we estimate the total burden inform current knowledge, allocate current addresses and sending surveys hours are 1,875. resources, develop services, and, to 5,625 individuals with CHD (75%), and receiving completed surveys from There are no costs to participants 4,500 individuals (80%). The survey other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondent Form name responses per respondents response hours respondent (in hours) Individuals with CHD ......................... Informed consent ........................... 4,500 1 5/60 375 Individuals with CHD ......................... Survey ............................................ 4,500 1 20/60 1,500 Total ........................................... ......................................................... ........................ .......................... ........................ 1,875 Leroy A. Richardson, ADDRESSES: You may submit comments, extension of existing collection of Chief, Information Collection Review Office, identified by Docket No. CDC–2016– information, and each reinstatement of Office of Scientific Integrity, Office of the 0087 by any of the following methods: previously approved information Associate Director for Science, Office of the Federal eRulemaking Portal: collection before submitting the Director, Centers for Disease Control and Regulation.gov. Follow the instructions collection to OMB for approval. To Prevention. for submitting comments. comply with this requirement, we are [FR Doc. 2015–25647 Filed 10–7–15; 8:45 am] Mail: Leroy A. Richardson, publishing this notice of a proposed BILLING CODE 4163–18–P Information Collection Review Office, data collection as described below. Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS– Comments are invited on: (a) Whether DEPARTMENT OF HEALTH AND D74, Atlanta, Georgia 30329. the proposed collection of information HUMAN SERVICES Instructions: All submissions received is necessary for the proper performance must include the agency name and of the functions of the agency, including Centers for Disease Control and Docket Number. All relevant comments whether the information shall have Prevention received will be posted without change practical utility; (b) the accuracy of the to Regulations.gov, including any agency’s estimate of the burden of the [60 Day–16–15BHH; Docket No. CDC–2016– personal information provided. For proposed collection of information; (c) 0087] access to the docket to read background ways to enhance the quality, utility, and documents or comments received, go to clarity of the information to be Proposed Data Collection Submitted Regulations.gov. collected; (d) ways to minimize the for Public Comment and Please note: All public comment should be burden of the collection of information Recommendations submitted through the Federal eRulemaking on respondents, including through the AGENCY: Centers for Disease Control and portal (Regulations.gov) or by U.S. mail to the use of automated collection techniques Prevention (CDC), Department of Health address listed above. or other forms of information and Human Services (HHS). FOR FURTHER INFORMATION CONTACT: To technology; and (e) estimates of capital ACTION: Notice with comment period. request more information on the or start-up costs and costs of operation, proposed project or to obtain a copy of maintenance, and purchase of services SUMMARY: The Centers for Disease the information collection plan and to provide information. Burden means Control and Prevention (CDC), as part of instruments, contact the Information the total time, effort, or financial its continuing efforts to reduce public Collection Review Office, Centers for resources expended by persons to burden and maximize the utility of Disease Control and Prevention, 1600 generate, maintain, retain, disclose or government information, invites the Clifton Road, NE., MS–D74, Atlanta, provide information to or for a Federal general public and other Federal Georgia 30329; phone: 404–639–7570; agency. This includes the time needed agencies to take this opportunity to Email: omb@cdc.gov. to review instructions; to develop, comment on proposed and/or acquire, install and utilize technology SUPPLEMENTARY INFORMATION: Under the continuing information collections, as and systems for the purpose of Paperwork Reduction Act of 1995 (PRA) required by the Paperwork Reduction collecting, validating and verifying (44 U.S.C. 3501–3520), Federal agencies Act of 1995. This notice invites information, processing and must obtain approval from the Office of comment on the Personal Protective maintaining information, and disclosing mstockstill on DSK4VPTVN1PROD with NOTICES Management and Budget (OMB) for each Equipment Information (PPE-Info) and providing information; to train collection of information they conduct Database which is a compendium of personnel and to be able to respond to or sponsor. In addition, the PRA also personal protective equipment (PPE) a collection of information, to search requires Federal agencies to provide a Federal regulations and consensus data sources, to complete and review 60-day notice in the Federal Register standards. the collection of information; and to concerning each proposed collection of DATES: Written comments must be information, including each new transmit or otherwise disclose the received on December 7, 2015. proposed collection, each proposed information. VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\08OCN1.SGM 08OCN1


Document Created: 2015-12-15 08:42:45
Document Modified: 2015-12-15 08:42:45
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 December 7, 2015.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 Citation80 FR 60905 
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