Agency Forms Undergoing Paperwork Reduction Act Review, 44129-44130 [2015-18146]

Download as PDF 44129 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices approaches in turn are expected to reduce the risk of Ebola resurgence and mitigate stigma for thousands of survivors. The information is likewise critical to reducing the risk that Ebola would be introduced in a location that has not previously been affected. CGH requests a three-year OMB approval for this information collection request. The total burden hours for each semen testing program are 1,664 hours incurred by 1,000 participants. There are no other costs to the respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Baseline Questionnaire ......................... 1,000 1 20/30 667 Follow-up Questionnaire ........................ 1,000 8 10/60 1,334 Consent Form ........................................ 1,000 1 2/30 67 ................................................................ ........................ ........................ ........................ 2,067 Type of respondents Form name Male Ebola Survivors ≥15 years old. Male Ebola Survivors ≥15 years old. Male Ebola Survivors ≥15 years old. Total ...................................... 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. 2015–18147 Filed 7–23–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–15–15CT] asabaliauskas on DSK5VPTVN1PROD with NOTICES Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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 VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 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. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 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 Sudden Death in the Young (SDY) Every year, infants, children and adolescents die suddenly and unexpectedly from previously undiagnosed conditions. Sudden Death in the Young (SDY) is defined as any death of an infant, child, or young adult (up to the age mandated by each state), investigated by the medical examiner or coroner office, except homicides, suicides, overdoses, poisonings, or other external injury deaths, for example from fire or as a passenger in a motor vehicle accident. SDY deaths are not routinely or systematically reported, so estimates of the annual incidence of SDY vary PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 Avg. burden per response (in hrs.) Total burden (in hrs.) broadly due to differences in definitions, inconsistencies in classifying cause of death on death certificates, variable ages and types of study populations, and differing case ascertainment methodologies. Because complete information has not been collected on the incidences, causes, and risk factors, lack of evidence fuels disagreements about the best prevention approaches. SDY Registry To address this knowledge gap, the Centers for Disease Control and Prevention (CDC), in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) have implemented the Sudden Death in the Young (SDY) Registry (DP14–1403) to provide technical assistance to improve the current work of existing Child Death Review (CDR) programs. The SDY Registry is an expansion of the CDC’s Sudden Unexpected Infant Death (SUID) Case Registry (currently DP12–1202), which provides technical assistance to state grantees so they can monitor sudden unexpected deaths in children up to age one in their state. By building on CDC’s successful SUID Case Registry, the SDY Registry also provides technical assistance to grantees so they can improve their state’s information on infant and child deaths. This includes two additions to their usual CDR program: (1) Entering new SDY information from sources already available at CDR reviews, (2) conducting an advanced clinical review of a sub-set of SDY cases to allow for a more technical and medical review of information already compiled. The intended result will be complete and timely grantee-based infant and child E:\FR\FM\24JYN1.SGM 24JYN1 44130 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices death information that can be used to guide program and policy decisions at the state and local levels. Child Death Review (CDR) Child Death Review (CDR) programs function in every state, and the program is often mandated by the state. Case reviews occur at the local and state level, depending on the state. States use their data to inform prevention strategies and to evaluate the success of state programs in reducing infant and child deaths as well as producing annual reports. The National Center for the Review and Prevention of Child Death (NCRPCD) provides support and technical assistance to CDR programs. This program is funded by the Health Resources and Services Administration (HRSA). The NCRPCD support covers a broad array of process-oriented CDR issues such as forming multidisciplinary teams, moving from state to local reviews and strengthening partnerships with the local forensic community. In addition, the NCRPCD provides support to CDR programs who voluntarily participate in the web-based NCRPCD Case Reporting System. This Case Reporting System provides a standardized way to compile infant and child death information, already accessed and reviewed by state and local teams. Local and state teams own their data and identifiable data (if entered at all) is not available to anyone but the state that owns the data. The NCRPCD Case Report (Version 4.0), available to all CDR programs that use the Case Reporting System, will include new SDY variables. The CDC is asking SDY Registry grantees to enter new SDY variables into this pre-existing system and to use an advanced review to provide a more in-depth review of a sub-set of cases. Information Collection Request (ICR) The activities relevant to this Information Collection Request (ICR) are that SDY Registry (i.e., grantee) CDR programs will convene an advanced clinical review team of physicians with specialties relevant to SDY, and will, through the advanced clinical review and its usual CDR process, enter new SDY variables specific to SDY deaths. The data will be entered into the NCRPCD Case Reporting System, version 4.0. The SDY variables are available to all users of the Case Reporting System, grantees and nongrantees alike. In addition, unfunded local and state CDR teams may wish to conduct specialized advanced clinical reviews and are not prohibited from doing so. The SDY Registry aims to improve data completeness and timeliness of the data entered by providing technical assistance to grantees only. For the purposes of this ICR, a ‘‘respondent’’ is a SDY Registry grantee funded by CDC. As a grantee for CDC’s cooperative agreement, the respondent agrees to compile a specifically defined set of SDY information about a defined set of deaths of children through the state’s CDR program. CDC estimates that 900 cases will be reported over a threeyear period. There are no costs to respondents other than their time. The total annualized burden hours are 2,250. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent State health personnel .................................... Pediatric cardiologists ..................................... Epileptologists ................................................. Neurologists .................................................... Forensic pathologists ...................................... 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. 2015–18146 Filed 7–23–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention asabaliauskas on DSK5VPTVN1PROD with NOTICES [30Day–15–0576] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 SDY SDY SDY SDY SDY Module Module Module Module Module ................................................... ................................................... ................................................... ................................................... ................................................... the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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 PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 Number responses per respondent Number of respondents Form name 9 9 9 9 9 300 300 300 300 300 Average burden per response (in hours) 30/60 5/60 5/60 5/60 5/60 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. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Possession, Use, and Transfer of Select Agents and Toxins (OMB Control No. 0920–0576, Expiration Date 11/30/ 2015)—Revision—Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention (CDC). E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44129-44130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18146]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-15CT]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 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

Sudden Death in the Young (SDY)
    Every year, infants, children and adolescents die suddenly and 
unexpectedly from previously undiagnosed conditions. Sudden Death in 
the Young (SDY) is defined as any death of an infant, child, or young 
adult (up to the age mandated by each state), investigated by the 
medical examiner or coroner office, except homicides, suicides, 
overdoses, poisonings, or other external injury deaths, for example 
from fire or as a passenger in a motor vehicle accident.
    SDY deaths are not routinely or systematically reported, so 
estimates of the annual incidence of SDY vary broadly due to 
differences in definitions, inconsistencies in classifying cause of 
death on death certificates, variable ages and types of study 
populations, and differing case ascertainment methodologies. Because 
complete information has not been collected on the incidences, causes, 
and risk factors, lack of evidence fuels disagreements about the best 
prevention approaches.
SDY Registry
    To address this knowledge gap, the Centers for Disease Control and 
Prevention (CDC), in collaboration with the National Heart, Lung, and 
Blood Institute (NHLBI) and the National Institute of Neurological 
Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) 
have implemented the Sudden Death in the Young (SDY) Registry (DP14-
1403) to provide technical assistance to improve the current work of 
existing Child Death Review (CDR) programs. The SDY Registry is an 
expansion of the CDC's Sudden Unexpected Infant Death (SUID) Case 
Registry (currently DP12-1202), which provides technical assistance to 
state grantees so they can monitor sudden unexpected deaths in children 
up to age one in their state.
    By building on CDC's successful SUID Case Registry, the SDY 
Registry also provides technical assistance to grantees so they can 
improve their state's information on infant and child deaths. This 
includes two additions to their usual CDR program: (1) Entering new SDY 
information from sources already available at CDR reviews, (2) 
conducting an advanced clinical review of a sub-set of SDY cases to 
allow for a more technical and medical review of information already 
compiled. The intended result will be complete and timely grantee-based 
infant and child

[[Page 44130]]

death information that can be used to guide program and policy 
decisions at the state and local levels.
Child Death Review (CDR)
    Child Death Review (CDR) programs function in every state, and the 
program is often mandated by the state. Case reviews occur at the local 
and state level, depending on the state. States use their data to 
inform prevention strategies and to evaluate the success of state 
programs in reducing infant and child deaths as well as producing 
annual reports.
    The National Center for the Review and Prevention of Child Death 
(NCRPCD) provides support and technical assistance to CDR programs. 
This program is funded by the Health Resources and Services 
Administration (HRSA). The NCRPCD support covers a broad array of 
process-oriented CDR issues such as forming multi-disciplinary teams, 
moving from state to local reviews and strengthening partnerships with 
the local forensic community. In addition, the NCRPCD provides support 
to CDR programs who voluntarily participate in the web-based NCRPCD 
Case Reporting System. This Case Reporting System provides a 
standardized way to compile infant and child death information, already 
accessed and reviewed by state and local teams. Local and state teams 
own their data and identifiable data (if entered at all) is not 
available to anyone but the state that owns the data. The NCRPCD Case 
Report (Version 4.0), available to all CDR programs that use the Case 
Reporting System, will include new SDY variables. The CDC is asking SDY 
Registry grantees to enter new SDY variables into this pre-existing 
system and to use an advanced review to provide a more in-depth review 
of a sub-set of cases.
Information Collection Request (ICR)
    The activities relevant to this Information Collection Request 
(ICR) are that SDY Registry (i.e., grantee) CDR programs will convene 
an advanced clinical review team of physicians with specialties 
relevant to SDY, and will, through the advanced clinical review and its 
usual CDR process, enter new SDY variables specific to SDY deaths. The 
data will be entered into the NCRPCD Case Reporting System, version 
4.0. The SDY variables are available to all users of the Case Reporting 
System, grantees and non-grantees alike. In addition, unfunded local 
and state CDR teams may wish to conduct specialized advanced clinical 
reviews and are not prohibited from doing so. The SDY Registry aims to 
improve data completeness and timeliness of the data entered by 
providing technical assistance to grantees only.
    For the purposes of this ICR, a ``respondent'' is a SDY Registry 
grantee funded by CDC. As a grantee for CDC's cooperative agreement, 
the respondent agrees to compile a specifically defined set of SDY 
information about a defined set of deaths of children through the 
state's CDR program. CDC estimates that 900 cases will be reported over 
a three-year period. There are no costs to respondents other than their 
time. The total annualized burden hours are 2,250.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Number      Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
State health personnel................  SDY Module..............               9             300           30/60
Pediatric cardiologists...............  SDY Module..............               9             300            5/60
Epileptologists.......................  SDY Module..............               9             300            5/60
Neurologists..........................  SDY Module..............               9             300            5/60
Forensic pathologists.................  SDY Module..............               9             300            5/60
----------------------------------------------------------------------------------------------------------------


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. 2015-18146 Filed 7-23-15; 8:45 am]
 BILLING CODE 4163-18-P
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