83 FR 55546 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 215 (November 6, 2018)

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Sudden Death in the Young (SDY) Case Registry''. The goal of the SDY Case Registry is to compile standardized data on sudden and unexpected deaths among infants, children, and young adults, which are not explained by homicides, suicides, overdoses, or the result of an external cause that was the only and obvious reason for the fatal injury, or terminal illnesses.

[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Notices]
[Pages 55546-55548]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-1092; Docket No. CDC-2018-0095]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Sudden Death in the Young (SDY) 
Case Registry''. The goal of the SDY Case Registry is to compile 
standardized data on sudden and unexpected deaths among infants, 
children, and young adults, which are not explained by homicides, 
suicides, overdoses, or the result of an external cause that was the 
only and obvious reason for the fatal injury, or terminal illnesses.

DATES: CDC must receive written comments on or before January 7, 2019.

[[Page 55547]]


ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0095 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Sudden Death in the Young Registry--Revision--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 among 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. 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 continue 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.
    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    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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State Health Personnel........  SDY Module I....              14              53           10/60             124
Medical Experts...............  Advanced Review.              42              26           15/60             273

[[Page 55548]]

 
State Health Personnel........  SDY Module N....              14              53           10/60             124
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             521
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-24233 Filed 11-5-18; 8:45 am]
 BILLING CODE 4163-18-P