[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 [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