80 FR 44129 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 142 (July 24, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 142 (July 24, 2015)
| Page Range | 44129-44130 | |
| FR Document | 2015-18146 |
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)] [Notices] [Pages 44129-44130] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 44129
approaches in turn are expected to would be introduced in a location that semen testing program are 1,664 hours
reduce the risk of Ebola resurgence and has not previously been affected. incurred by 1,000 participants. There
mitigate stigma for thousands of CGH requests a three-year OMB are no other costs to the respondents
survivors. The information is likewise approval for this information collection other than their time.
critical to reducing the risk that Ebola request. The total burden hours for each
ESTIMATED ANNUALIZED BURDEN HOURS
Number of re- Avg. burden
Number of re- Total burden
Type of respondents Form name sponses per per response
spondents (in hrs.)
respondent (in hrs.)
Male Ebola Survivors ≥15 years Baseline Questionnaire ......................... 1,000 1 20/30 667
old.
Male Ebola Survivors ≥15 years Follow-up Questionnaire ........................ 1,000 8 10/60 1,334
old.
Male Ebola Survivors ≥15 years Consent Form ........................................ 1,000 1 2/30 67
old.
Total ...................................... ................................................................ ........................ ........................ ........................ 2,067
Leroy A. Richardson, the collection of information on those broadly due to differences in
Chief, Information Collection Review Office, who are to respond, including through definitions, inconsistencies in
Office of Scientific Integrity, Office of the the use of appropriate automated, classifying cause of death on death
Associate Director for Science, Office of the electronic, mechanical, or other certificates, variable ages and types of
Director, Centers for Disease Control and technological collection techniques or study populations, and differing case
Prevention. other forms of information technology, ascertainment methodologies. Because
[FR Doc. 2015–18147 Filed 7–23–15; 8:45 am] e.g., permitting electronic submission of complete information has not been
BILLING CODE 4163–18–P responses; and (e) Assess information collected on the incidences, causes, and
collection costs. risk factors, lack of evidence fuels
To request additional information on disagreements about the best prevention
DEPARTMENT OF HEALTH AND the proposed project or to obtain a copy approaches.
HUMAN SERVICES of the information collection plan and
instruments, call (404) 639–7570 or SDY Registry
Centers for Disease Control and send an email to omb@cdc.gov. Written To address this knowledge gap, the
Prevention comments and/or suggestions regarding Centers for Disease Control and
the items contained in this notice Prevention (CDC), in collaboration with
[30Day–15–15CT]
should be directed to the Attention: the National Heart, Lung, and Blood
Agency Forms Undergoing Paperwork CDC Desk Officer, Office of Management Institute (NHLBI) and the National
Reduction Act Review and Budget, Washington, DC 20503 or Institute of Neurological Disorders and
by fax to (202) 395–5806. Written Stroke (NINDS) at the National
The Centers for Disease Control and comments should be received within 30 Institutes of Health (NIH) have
Prevention (CDC) has submitted the days of this notice. implemented the Sudden Death in the
following information collection request Young (SDY) Registry (DP14–1403) to
to the Office of Management and Budget Proposed Project
provide technical assistance to improve
(OMB) for review and approval in Sudden Death in the Young the current work of existing Child Death
accordance with the Paperwork Registry—New—National Center for Review (CDR) programs. The SDY
Reduction Act of 1995. The notice for Chronic Disease Prevention and Health Registry is an expansion of the CDC’s
the proposed information collection is Promotion (NCCDPHP), Centers for Sudden Unexpected Infant Death (SUID)
published to obtain comments from the Disease Control and Prevention (CDC). Case Registry (currently DP12–1202),
public and affected agencies. Background and Brief Description which provides technical assistance to
Written comments and suggestions state grantees so they can monitor
from the public and affected agencies Sudden Death in the Young (SDY) sudden unexpected deaths in children
concerning the proposed collection of Every year, infants, children and up to age one in their state.
information are encouraged. Your adolescents die suddenly and By building on CDC’s successful SUID
comments should address any of the unexpectedly from previously Case Registry, the SDY Registry also
following: (a) Evaluate whether the undiagnosed conditions. Sudden Death provides technical assistance to grantees
proposed collection of information is in the Young (SDY) is defined as any so they can improve their state’s
necessary for the proper performance of death of an infant, child, or young adult information on infant and child deaths.
the functions of the agency, including (up to the age mandated by each state), This includes two additions to their
whether the information will have investigated by the medical examiner or usual CDR program: (1) Entering new
asabaliauskas on DSK5VPTVN1PROD with NOTICES
practical utility; (b) Evaluate the coroner office, except homicides, SDY information from sources already
accuracy of the agencies estimate of the suicides, overdoses, poisonings, or other available at CDR reviews, (2) conducting
burden of the proposed collection of external injury deaths, for example from an advanced clinical review of a sub-set
information, including the validity of fire or as a passenger in a motor vehicle of SDY cases to allow for a more
the methodology and assumptions used; accident. technical and medical review of
(c) Enhance the quality, utility, and SDY deaths are not routinely or information already compiled. The
clarity of the information to be systematically reported, so estimates of intended result will be complete and
collected; (d) Minimize the burden of the annual incidence of SDY vary timely grantee-based infant and child
VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1](https://thefederalregister.org/doc/80_FR_44271/page/1.svg)
![44130 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
death information that can be used to voluntarily participate in the web-based and its usual CDR process, enter new
guide program and policy decisions at NCRPCD Case Reporting System. This SDY variables specific to SDY deaths.
the state and local levels. Case Reporting System provides a The data will be entered into the
Child Death Review (CDR) standardized way to compile infant and NCRPCD Case Reporting System,
child death information, already version 4.0. The SDY variables are
Child Death Review (CDR) programs accessed and reviewed by state and available to all users of the Case
function in every state, and the program local teams. Local and state teams own Reporting System, grantees and non-
is often mandated by the state. Case their data and identifiable data (if grantees alike. In addition, unfunded
reviews occur at the local and state entered at all) is not available to anyone local and state CDR teams may wish to
level, depending on the state. States use but the state that owns the data. The conduct specialized advanced clinical
their data to inform prevention NCRPCD Case Report (Version 4.0), reviews and are not prohibited from
strategies and to evaluate the success of available to all CDR programs that use doing so. The SDY Registry aims to
state programs in reducing infant and the Case Reporting System, will include improve data completeness and
child deaths as well as producing new SDY variables. The CDC is asking timeliness of the data entered by
annual reports. SDY Registry grantees to enter new SDY providing technical assistance to
The National Center for the Review
variables into this pre-existing system grantees only.
and Prevention of Child Death
(NCRPCD) provides support and and to use an advanced review to For the purposes of this ICR, a
technical assistance to CDR programs. provide a more in-depth review of a ‘‘respondent’’ is a SDY Registry grantee
This program is funded by the Health sub-set of cases. funded by CDC. As a grantee for CDC’s
Resources and Services Administration Information Collection Request (ICR) cooperative agreement, the respondent
(HRSA). The NCRPCD support covers a agrees to compile a specifically defined
broad array of process-oriented CDR The activities relevant to this set of SDY information about a defined
issues such as forming multi- Information Collection Request (ICR) are set of deaths of children through the
disciplinary teams, moving from state to that SDY Registry (i.e., grantee) CDR state’s CDR program. CDC estimates that
local reviews and strengthening programs will convene an advanced 900 cases will be reported over a three-
partnerships with the local forensic clinical review team of physicians with year period. There are no costs to
community. In addition, the NCRPCD specialties relevant to SDY, and will, respondents other than their time. The
provides support to CDR programs who through the advanced clinical review total annualized burden hours are 2,250.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number
Number of burden per
Type of respondent Form name responses per
respondents response
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, the proposed information collection is other forms of information technology,
Chief, Information Collection Review Office, published to obtain comments from the e.g., permitting electronic submission of
Office of Scientific Integrity, Office of the public and affected agencies. responses; and (e) Assess information
Associate Director for Science, Office of the Written comments and suggestions collection costs.
Director, Centers for Disease Control and from the public and affected agencies To request additional information on
Prevention.
concerning the proposed collection of the proposed project or to obtain a copy
[FR Doc. 2015–18146 Filed 7–23–15; 8:45 am] information are encouraged. Your of the information collection plan and
BILLING CODE 4163–18–P comments should address any of the instruments, call (404) 639–7570 or
following: (a) Evaluate whether the send an email to omb@cdc.gov. Written
proposed collection of information is comments and/or suggestions regarding
DEPARTMENT OF HEALTH AND necessary for the proper performance of the items contained in this notice
HUMAN SERVICES
the functions of the agency, including should be directed to the Attention:
Centers for Disease Control and whether the information will have CDC Desk Officer, Office of Management
Prevention practical utility; (b) Evaluate the and Budget, Washington, DC 20503 or
accuracy of the agencies estimate of the by fax to (202) 395–5806. Written
[30Day–15–0576] burden of the proposed collection of comments should be received within 30
information, including the validity of days of this notice.
Agency Forms Undergoing Paperwork
the methodology and assumptions used;
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Reduction Act Review Proposed Project
(c) Enhance the quality, utility, and
The Centers for Disease Control and clarity of the information to be Possession, Use, and Transfer of
Prevention (CDC) has submitted the collected; (d) Minimize the burden of Select Agents and Toxins (OMB Control
following information collection request the collection of information on those No. 0920–0576, Expiration Date 11/30/
to the Office of Management and Budget who are to respond, including through 2015)—Revision—Office of Public
(OMB) for review and approval in the use of appropriate automated, Health Preparedness and Response,
accordance with the Paperwork electronic, mechanical, or other Centers for Disease Control and
Reduction Act of 1995. The notice for technological collection techniques or Prevention (CDC).
VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1](https://thefederalregister.org/doc/80_FR_44271/page/2.svg)
Document Created: 2018-02-23 09:24:55
Document Modified: 2018-02-23 09:24:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 44129 |
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