[Federal Register Volume 79, Number 212 (Monday, November 3, 2014)]
[Notices]
[Pages 65217-65218]
From the Federal Register Online via the Government Publishing 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 [email protected].
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