[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]


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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
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                                                                                      Number      Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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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
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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. 2015-18146 Filed 7-23-15; 8:45 am]
 BILLING CODE 4163-18-P