Proposed Data Collections Submitted for Public Comment and Recommendations, 65217-65218 [2014-26031]

Download as PDF Federal Register / Vol. 79, No. 212 / Monday, November 3, 2014 / Notices Michelle Consolazio at least seven (7) days in advance of the meeting. ONC is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://healthit.hhs.gov for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. No. 92–463, 5 U.S.C., App. 2). Dated: October 22, 2014. Michelle Consolazio, FACA Lead, Office of Policy, Office of the National Coordinator for Health Information Technology. [FR Doc. 2014–26058 Filed 10–31–14; 8:45 am] BILLING CODE 4150–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–15–15CT] mstockstill on DSK4VPTVN1PROD with NOTICES Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden, 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. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404–639–7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. 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 VerDate Sep<11>2014 17:37 Oct 31, 2014 Jkt 235001 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. Written comments should be received within 60 days of this notice. Proposed Project Sudden Death in the Young Registry—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Every year, infants, children and youth die suddenly and unexpectedly from previously undiagnosed conditions. Little is known about the risk factors leading to SDY, although underlying genetic conditions contribute in some cases. For example, the risk of SDY is known to be higher for infants and children with heartrelated conditions or neurological conditions such as epilepsy. However, estimates of the annual incidence of Sudden Death in the Young (SDY) vary broadly due to differences in definitions, inconsistencies in classifying cause of death on death certificates, differing case ascertainment methodologies, and other factors. To address this gap in knowledge, the Centers for Disease Control and Prevention (CDC), the National Heart, Lung and Blood Institute (NHLBI), and the National Institute for Neurological Disorders and Stroke (NINDS) are collaborating with selected states and partner organizations to create the Sudden Death in the Young Registry (SDYr). The SDYr will establish the first uniform reporting system for SDY based on shared standards for reviewing and classifying deaths involving infants and children <19 years of age, and the systematic participation of individuals with expertise in key medical specialties. Up to 15 state health departments will receive funding from CDC to report standardized information to a central database for compilation and analysis. In addition, each awardee PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 65217 will establish an advanced clinical review team consisting of a forensic pathologist, neurologist, epileptologist, and pediatric cardiologist to supplement its existing Child Death Review (CDR) process. Specialized medical expertise is essential to the accurate determination of cause of death. The SDYr will build on ongoing collaborations involving state-based child death review teams, CDC, the National Institutes of Health (NIH), the Health Resources and Services Administration (HRSA), and the National Center for the Review and Prevention of Child Deaths (NCRPCD) at the Michigan Public Health Institute (MPHI). The MPHI–NCRPCD is a nonprofit organization dedicated to preventing child deaths and serious injuries. The MPHI–NCRPCD provides technical assistance and training on death scene investigation, and prevention strategies, to partner organizations including state and local governments. The MPHI–NCRPCD also supports a Web-based National Child Death Review Case Reporting System that states can use on a voluntary basis to manage their state-specific CDR data. The system is currently used by 43 states free of charge. Due to variability in case definitions and reporting procedures, the system does not produce national estimates, but serves as a vital repository of information to facilitate state-based surveillance and public health activities. Utilizing MPHI–NCRPCD Case Reporting System (CRS) infrastructure, MPHI and CDC have previously collaborated with nine states to strengthen case definition and surveillance for sudden unexpected infant death (SUID) involving infants < one year of age. The SDYr will build on this collaboration by increasing the number of participating states, systematically engaging key medical experts in the review of deaths of children <19 years of age, and requiring the collection and reporting of standardized data elements. States participating in the SDYr will report information through a special module called the NCRPCD–CRS–SDY Module. This information collection procedure was selected due to its familiarity to the majority of states, MPHI’s successful collaborations with multiple partners, and shared interest in developing and promulgating best practices for the identification, classification, and prevention of SDY. De-identified information collected through the SDYr will be used to generate estimates of the prevalence of SDY due to cardiac and neurologic conditions; to elucidate risk factors; and E:\FR\FM\03NON1.SGM 03NON1 65218 Federal Register / Vol. 79, No. 212 / Monday, November 3, 2014 / Notices to develop evidence-based prevention strategies for SDY. The SDYr will also create the infrastructure for future expanded research. CDC is authorized to collect this information by Section 241 of the Public Health Service Act [42 U.S.C. 241]. CDC estimates that the participating states will collect data on approximately 1,000 SDY cases per year (20–150 per state, with an average of 67 per state). No information will be collected directly from family members of the deceased. CDC estimates that each specialist on the advanced clinical review team will devote 15 minutes to the review and completion of the autopsy check list and other records associated with each death reported through the SDYr. For participating state health departments, the estimated burden for entering each case into the case reporting system is 30 minutes. OMB approval is requested for three years. Reporting is required for cooperative agreement awardees. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent State Health Department .................. Pediatric Cardiologist ........................ Epileptologist ..................................... Neurologist ........................................ Forensic Pathologist ......................... Total ........................................... NCRPCD–CRS–SDY NCRPCD–CRS–SDY NCRPCD–CRS–SDY NCRPCD–CRS–SDY NCRPCD–CRS–SDY 67 67 67 67 67 30/60 15/60 15/60 15/60 15/60 503 251 251 251 251 ........................................................... ........................ ........................ ........................ 1,507 BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–14–0530] mstockstill on DSK4VPTVN1PROD with NOTICES Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden, 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. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404–639–7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper 17:37 Oct 31, 2014 Total burden (in hours) 15 15 15 15 15 [FR Doc. 2014–26031 Filed 10–31–14; 8:45 am] Jkt 235001 Module Module Module Module Module Average burden per response (in hours) .......... .......... .......... .......... .......... 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. VerDate Sep<11>2014 Number responses per respondent Number of respondents Form name 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. Written comments should be received within 60 days of this notice. Proposed Project EEOICPA Dose Reconstruction Interviews and Forms (OMB No. 0920– 0530, expires 02/28/2015)—Extension— National Institute for Occupational Safety and Health (NIOSH), Centers for PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS). Background and Brief Description On October 30, 2000, the Energy Employees Occupational Illness Compensation Program Act of 2000 (42 U.S.C. 7384–7385) was enacted. This Act established a federal compensation program for employees of the Department of Energy (DOE) and certain of its contractors, subcontractors and vendors, who have suffered cancers and other designated illnesses as a result of exposures sustained in the production and testing of nuclear weapons. Executive Order 13179, issued on December 7, 2000, delegated authorities assigned to ‘‘the President’’ under the Act to the Departments of Labor (DOL), Health and Human Services, Energy and Justice. The Department of Health and Human Services (DHHS) was delegated the responsibility of establishing methods for estimating radiation doses received by eligible claimants with cancer applying for compensation. NIOSH is applying the following methods to estimate the radiation doses of individuals applying for compensation. In performance of its dose reconstruction responsibilities, under the Act, NIOSH is providing voluntary interview opportunities to claimants (or their survivors) individually and providing them with the opportunity to assist NIOSH in documenting the work history of the employee by characterizing the actual work tasks performed. In addition, NIOSH and the claimant may identify incidents that E:\FR\FM\03NON1.SGM 03NON1

Agencies

[Federal Register Volume 79, Number 212 (Monday, November 3, 2014)]
[Notices]
[Pages 65217-65218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26031]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15CT]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, 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. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 or send comments to 
Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or 
send an email to omb@cdc.gov.
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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. Written comments should be received within 60 
days of this notice.

Proposed Project

    Sudden Death in the Young Registry--New--National Center for 
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    Every year, infants, children and youth die suddenly and 
unexpectedly from previously undiagnosed conditions. Little is known 
about the risk factors leading to SDY, although underlying genetic 
conditions contribute in some cases. For example, the risk of SDY is 
known to be higher for infants and children with heart-related 
conditions or neurological conditions such as epilepsy. However, 
estimates of the annual incidence of Sudden Death in the Young (SDY) 
vary broadly due to differences in definitions, inconsistencies in 
classifying cause of death on death certificates, differing case 
ascertainment methodologies, and other factors.
    To address this gap in knowledge, the Centers for Disease Control 
and Prevention (CDC), the National Heart, Lung and Blood Institute 
(NHLBI), and the National Institute for Neurological Disorders and 
Stroke (NINDS) are collaborating with selected states and partner 
organizations to create the Sudden Death in the Young Registry (SDYr). 
The SDYr will establish the first uniform reporting system for SDY 
based on shared standards for reviewing and classifying deaths 
involving infants and children <19 years of age, and the systematic 
participation of individuals with expertise in key medical specialties. 
Up to 15 state health departments will receive funding from CDC to 
report standardized information to a central database for compilation 
and analysis. In addition, each awardee will establish an advanced 
clinical review team consisting of a forensic pathologist, neurologist, 
epileptologist, and pediatric cardiologist to supplement its existing 
Child Death Review (CDR) process. Specialized medical expertise is 
essential to the accurate determination of cause of death.
    The SDYr will build on ongoing collaborations involving state-based 
child death review teams, CDC, the National Institutes of Health (NIH), 
the Health Resources and Services Administration (HRSA), and the 
National Center for the Review and Prevention of Child Deaths (NCRPCD) 
at the Michigan Public Health Institute (MPHI). The MPHI-NCRPCD is a 
non-profit organization dedicated to preventing child deaths and 
serious injuries. The MPHI-NCRPCD provides technical assistance and 
training on death scene investigation, and prevention strategies, to 
partner organizations including state and local governments. The MPHI-
NCRPCD also supports a Web-based National Child Death Review Case 
Reporting System that states can use on a voluntary basis to manage 
their state-specific CDR data. The system is currently used by 43 
states free of charge. Due to variability in case definitions and 
reporting procedures, the system does not produce national estimates, 
but serves as a vital repository of information to facilitate state-
based surveillance and public health activities.
    Utilizing MPHI-NCRPCD Case Reporting System (CRS) infrastructure, 
MPHI and CDC have previously collaborated with nine states to 
strengthen case definition and surveillance for sudden unexpected 
infant death (SUID) involving infants < one year of age. The SDYr will 
build on this collaboration by increasing the number of participating 
states, systematically engaging key medical experts in the review of 
deaths of children <19 years of age, and requiring the collection and 
reporting of standardized data elements. States participating in the 
SDYr will report information through a special module called the 
NCRPCD-CRS-SDY Module. This information collection procedure was 
selected due to its familiarity to the majority of states, MPHI's 
successful collaborations with multiple partners, and shared interest 
in developing and promulgating best practices for the identification, 
classification, and prevention of SDY.
    De-identified information collected through the SDYr will be used 
to generate estimates of the prevalence of SDY due to cardiac and 
neurologic conditions; to elucidate risk factors; and

[[Page 65218]]

to develop evidence-based prevention strategies for SDY. The SDYr will 
also create the infrastructure for future expanded research. CDC is 
authorized to collect this information by Section 241 of the Public 
Health Service Act [42 U.S.C. 241].
    CDC estimates that the participating states will collect data on 
approximately 1,000 SDY cases per year (20-150 per state, with an 
average of 67 per state). No information will be collected directly 
from family members of the deceased. CDC estimates that each specialist 
on the advanced clinical review team will devote 15 minutes to the 
review and completion of the autopsy check list and other records 
associated with each death reported through the SDYr. For participating 
state health departments, the estimated burden for entering each case 
into the case reporting system is 30 minutes.
    OMB approval is requested for three years. Reporting is required 
for cooperative agreement awardees. There are no costs to respondents 
other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                      Number      Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
State Health Department.......  NCRPCD-CRS-SDY                15              67           30/60             503
                                 Module.
Pediatric Cardiologist........  NCRPCD-CRS-SDY                15              67           15/60             251
                                 Module.
Epileptologist................  NCRPCD-CRS-SDY                15              67           15/60             251
                                 Module.
Neurologist...................  NCRPCD-CRS-SDY                15              67           15/60             251
                                 Module.
Forensic Pathologist..........  NCRPCD-CRS-SDY                15              67           15/60             251
                                 Module.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,507
----------------------------------------------------------------------------------------------------------------


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. 2014-26031 Filed 10-31-14; 8:45 am]
BILLING CODE 4163-18-P