[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5686-5687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03102]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-1092]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Sudden Death in the Young (SDY) Case 
Registry'' to the Office of Management and Budget (OMB) for review and 
approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on November 
6, 2018 to obtain comments from the public and affected agencies. CDC 
received no comments related to the previous notice. This notice serves 
to allow an additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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.

[[Page 5687]]

    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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Sudden Death in the Young Registry--Reinstatement with Change--
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) is defined as a sudden and 
unexpected death in an infant, child, or young adults (up to age 20), 
which is not explained by homicide, suicide, overdose, or the result of 
an external cause that was the only and obvious reason for the fatal 
injury, or terminal illnesses. Injury deaths where there may have been 
an initiating natural cause (e.g., drowning or death of the driver in a 
motor vehicle accident, which may have been triggered by an underlying 
cardiac or neurological condition) are also included in the definition.
    SDY deaths are not systematically monitored and estimates of the 
annual incidence of SDY vary due to differences in definitions, 
inconsistencies in classifying cause, variable age and study 
populations, and differing case ascertainment methodologies. Because 
standardized information has not been collected on the incidence, 
causes, and risk factors, developing evidence-based prevention measures 
has been challenging.
    To address these gaps, CDC, in collaboration with the National 
Heart, Lung, and Blood Institute and the National Institute of 
Neurological Disorders and Stroke at the National Institutes of Health 
implemented the SDY Case Registry in 2015 (OMB #0920-1092, Expiration 
12/31/2018). Standardized data collected through the SDY Case Registry 
has been used by the NIH and CDC awardees to generate estimates of the 
incidence of SDY; to elucidate risk factors; and to develop evidence-
based prevention strategies for SDY. The SDY Registry also creates 
infrastructure for future research about previously unknown or 
unrecognized risk factors for, and causes of, these deaths.
    This information collection request is to reinstate OMB approval 
for the SDY Registry. By continuing the prior work of the SDY Registry, 
the information collected under this request will allow CDC to provide 
technical assistance to awardees so they can improve their 
jurisdiction's information on SDY. This includes two additions to their 
routine Child Death Review (CDR) program: (1) Entering SDY information 
from existing data sources (e.g., medical records, autopsy reports) 
used during CDR review into the established web-based NCFRP Case 
Reporting System; and (2) convening clinicians with three different 
types of expertise (pediatric cardiology; pediatric neurology or 
epileptology; and forensic pathology) to conduct advanced clinical 
reviews of a subset of SDY cases to allow for a more thorough review of 
information compiled and to generate additional data about the 
classification of the death. The intended result will be data that can 
establish incidence and guide program and policy decisions at the 
state/jurisdiction and local levels.
    CDC estimates that the participating states/jurisdictions will 
collect data on approximately 739 SDY cases per year. For participating 
states/jurisdictions, burden is estimated for reporting required case 
information. Based on historical program information, it is estimated 
that approximately half (370) of the 739 estimated SDY cases each year 
will undergo an advanced clinical review and classification of cause by 
a team of three medical experts.
    This reinstatement request differs from the previously approved 
information collection in reducing the number of burden hours. While 
CDC is not proposing changes to any of the data collection tools, the 
SDY module, or the advanced review process, CDC has, with experience, 
been able to: (1) Obtain better estimates of the actual numbers of 
respondents anticipated on average per jurisdiction; (2) obtain more 
accurate estimates of the amount of time needed to complete the SDY 
modules; (3) better determine the number of cases that will need to 
continue to advance review and the types of medical experts that are 
needed. Because of these changes, despite the increase in participating 
jurisdiction, the net estimated burden is lower. OMB approval is 
requested for three years. The total estimated annual burden is 521 
hours. There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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State Health Personnel................  SDY Module I............              14              53           10/60
Medical Experts.......................  Advanced Review.........              42              26           15/60
State Health Personnel................  SDY Module N............              14              53           10/60
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Jeffrey Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-03102 Filed 2-21-19; 8:45 am]
 BILLING CODE 4163-18-P