Research Determination

Project Determination
Sudden Unexpected Infant Death (SUID) and Death in the Young (SDY)
Case Registry
Project ID:

0900f3eb81fccd1e

Accession #:

NCCDPHP-PIHT-9/8/22-ccd1e

Project Contact:

Carri Cottengim

Organization:

NCCDPHP/DRH/MIHB/PIHT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

04/30/22

Estimated Completion Date:

09/30/30

CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:

0920-1092

Description
Priority
Standard

Date Needed
01/09/23

Determination Start Date
09/08/22

Description
The Sudden Unexpected Infant Death (SUID) and Death in the Young (SDY) Case Registry is a CDC Division or Reproductive Health surveillance program. The Case
Registry improves and standardizes information about sudden death so recipients can better understand incidence and risk factors. Information collection and
reporting builds on existing, state-based procedures for Child Death Review (CDR). Through their existing CDR programs, recipients already conduct surveillance
and use the National Fatality Review-Case Reporting System (NFR-CRS). CDC funding provides technical assistance to these programs so they can improve their

case ascertainment, data quality and timeliness of the data. All recipients of the current multi-component NOFO (DP18-1806) compile complete and timely data for
an estimated 1000 cases per year, on a defined set of SUID and SDY questions and abstract the data into the NFR-CRS, run through the Michigan Public Health
Institute�s (MPHI) National Center for Fatality Review and Prevention (NCFRP) program. Data is abstracted into the NFR-CRS by states/jurisdictions using primary
data sources, including medical examiner/coroner reports, death investigation reports, medical records, and child protective services records. For approximately
370 of these cases per year, recipient jurisdictions funded for the SDY component conduct activities that are outside of their normal CDR programs. First, they
convene an advanced review team with relevant clinical expertise, including state health personnel, pediatric cardiologists, pediatric neurologists or epileptologists,
and forensic pathologists. Next, they comprehensively review individual case information from multiple data sources, discuss the information, and use the
information to classify cases according to a standardized algorithm that differentiates causes of death. Finally, they report the additional information from these
advanced case reviews into an SDY module of the NFR-CRS. These specific SDY activities, which are a subset of the overall program, require OMB approval (OMB
No. 0920-1092).

In FY2023, a new 5-year multi-component NOFO (DP23-2306) will continue the work and fund new applicants to participate in the SUID and

SDY Case Registry. In addition to continuing the SUID and SDY Case Registry activities described above, recipients of the new funding opportunity will improve
consistent abstraction of variables related to SDoH (e.g. housing insecurity) and apply a health equity lens to data analysis to inform prevention strategies,
including identifying and addressing disproportionately impacted communities. Also, as part of a new component in FY23, some recipients can choose to apply to
develop and implement prevention strategies to reduce disparities in incidence of SUID within jurisdictions. This is non-research public health surveillance program
to establish the incidence of SUID and SDY in funded jurisdictions, and in FY23 develop and implement prevention activities. CDC will provide technical assistance,
receiving de-identified data for quality assurance activities and surveillance reports. OMB approval under the Paperwork Reduction Act has been received (OMB No.
0920-1092) for the additional SDY activities which include a clinical discussion of already available data and data entry from this review into a module that has
been added on the NFR-CRS in order to capture information from the advanced review. These activities are outside of regular child death

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure Submission
No

IMS Activation Name
Not selected

Select the primary priority of the project
Not selected

Select the secondary priority(s) of the project
Not selected

Select the task force associated with the response
Not selected

CIO Emergency Response Name
Not selected

Epi-Aid Name
Not selected

Lab-Aid Name

Not selected

Assessment of Chemical Exposure Name
Not selected

Goals/Purpose
The SUID and SDY Case Registry gathers information to learn more about young people who die suddenly and unexpectedly. Babies, children, and young adults up
to age 20 are included in the SUID and SDY Case Registry.

Objective
The objectives of the SUID and SDY Case Registry surveillance program are to gather and store information about sudden child deaths to help to 1) count the
number and types of sudden deaths in babies, children and young adults up to age 20, 2) try to understand the causes and risk factors for the deaths, 3) see if
some children are more at risk of dying than others, and 4) find ways to prevent these deaths. Data is shared with CDC, who uses the data to provide technical
assistance to improve completeness (including missing and unknown responses) and timeliness of completed cases. The SUID and SDY Case Registry program
improves and standardizes case ascertainment so that funded states/local jurisdictions can improve understanding of the incidence and risk factors for sudden
death. SUID and SDY Case Registry data informs our understanding of the epidemiology of SUID and SDY, including the incidence, disparities, and risk factors.
These data elements are used to inform prevention strategies as well as develop best practices for surveillance of SUID and SDY. Additionally, the new FY2023 will
further address racial/ethnic and socioeconomic disparities by improving abstracted data and understanding of SDoH and the effect on SUID/SDY incidence which
will guide prevention in funded jurisdictions. In a subset of recipients this includes the development and implementation of prevention strategies to reduce infant
deaths using compiled data and American Academy of Pediatrics recommendations.

Does this project include interventions, services, or policy change work aimed at improving the health of groups who have been
excluded or marginalized and/or decreasing disparities?
Yes

Project does not incorporate elements of health equity science
Not selected

Measuring Disparities
Not selected

Studying Social Determinants of Health (SDOH)
Yes

SDOH Economic Stability
Yes

SDOH Education
Yes

SDOH Health Care Access
Yes

SDOH Neighborhood and Environment

Yes

SDOH Social and Community Context
Yes

SDOH Indices
Not selected

Other SDOH topics
Not selected

Assessing Impact
Not selected

Methods to Improve Health Equity Research and Practice
Not selected

Other
Not selected

Activities or Tasks
New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented
General US Population; Children; American Indian or Alaska Native; Asian; Black or African American; Hispanic or Latino; Native Hawaiian or Other Pacific
Islander; White; Female; Male-

Tags/Keywords
Infant Mortality; Child Mortality

CDC's Role
Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design and data collection as a condition
of any funding provided

Method Categories
Surveillance Support

Methods
Information collection and reporting for the SUID and SDY Case Registry builds on existing state-based procedures for Child Death Review (CDR) who already
abstract data into the National Fatality Review-Case Reporting System (NFR-CRS) about each case using existing data sources. CDC funds help recipients improve
this process. All data for the Case Registry is shared with CDC, from the NFR-CRS, who uses the data to provide technical assistance to improve completeness
(including missing and unknown responses) and timeliness of completed cases. Recipients participating in the SDY component, also compile data on a defined set
of SDY questions and enter them into the existing SDY module that is part of the existing NFR-CRS. For approximately 370 SDY cases, recipient jurisdictions
convene an advanced review team with relevant clinical expertise. The advanced review team comprehensively reviews information from multiple existing data

sources, discusses the information and uses the information to classify cases according to a standardized algorithm that differentiates causes. All the additional
information from these advanced case reviews including the classification of the death is entered into the SDY module. The FY23 NOFO will include these same
methods with the addition of a subset of recipients using their existing data to develop and implement prevention strategies to reduce infant deaths and share
lessons learned.

Collection of Info, Data, or Bio specimens
Through their existing CDR programs, recipients already conduct surveillance and use the National Fatality Review-Case Reporting System (NFR-CRS). CDC funding
provides technical assistance to these programs so they can improve their case ascertainment, data quality and timeliness of the data. Current practice is to
abstract data about each death from primary data sources, including medical examiner/coroner reports, death investigation reports, medical records, and child
protective services records. It is then entered into the web-based NFR-CRS. For the Case Registry no PII is shared with CDC. De-identified data is shared with CDC
who uses the data to provide technical assistance to improve completeness (including missing and unknown responses) and timeliness of completed cases and for
surveillance reports. The only new data collection as a result of this project is the specific SDY activities listed above, which are a subset of the overall program,
and have OMB approval (OMB No. 0920-1092).

Expected Use of Findings/Results and their impact
CDC shares findings with recipients and works with them by providing technical assistance to improve data over time. Data analyses beyond quality improvement
analyses conducted by CDC are determined by the recipients. Recipients use their data to develop targeted prevention strategies to reduce the number of infant
and childhood deaths. Data elements are used to establish incidence of SUID and SDY, inform prevention strategies and develop best practices for multi-state
surveillance of SUID and SDY. The data is made available externally via request, researchers can request data for analyses. The FY23 NOFO will include
developing and disseminating prevention tools and resources that will help other recipients use their own Registry data, findings, and recommendations to identify
gaps and barriers in health and social service systems and local policies that propagate racial/ethnic disparities in sleep-related deaths.

Could Individuals potentially be identified based on Information Collected?
No

Funding
Funding Type

Funding Title

Funding #

Original Fiscal
Year

# of Years
of Award

Budget
Amount

CDC Cooperative

SUID and SDY Case Registry (new)

DP23-2306

2023

5

3600000.00

SUID and SDY Case Registry

DP18-1806

2018

5

2200000.00

Agreement
CDC Cooperative
Agreement

HSC Review

Regulation and Policy
Do you anticipate this project will be submitted to the IRB office
No

Institutions
Institution

FWA #

FWA Exp.
Date

IRB Title

IRB Exp. Date

Funding #

Staff
Staff Member

SIQT Exp.
Date

Work Sfty Hlth Tm

10/25/2025

Citi
Biomedical
Exp. Date

Citi Social
and
Behavioral
Exp. Date

Citi Good
Clinical Exp.
Date

Staff Role

Email

Project Officer

eocwsh2@c

EMERGENCY

dc.gov

OPERATIONS

2 EOC

Phone #

Organization/
Institution

CENTER

DMP
Proposed Data Collection Start Date

09/29/18

Proposed Data Collection End Date

09/30/30

Proposed Public Access Level

Restricted

Data Use Type

Research Data Center

Data Use Type Data Use Type URL

www.keepingkidsalive.org

Data Use Contact

[email protected]

Public Access justification

A public use data set is not generated because the data is governed by data use agreements
between NCFRP and individual states and these agreements allow only for data sharing to
researchers who apply to use the data.

How Access Will Be Provided for Data

Data can be requested using the following link https://www.ncfrp.org/resources/datadissemination/ Researchers must be affiliated with eligible Receiving Institutions (i.e., an institution
of higher education, research organization, non-profit agency or government agency that either

employs or contracts with the Investigator). The Institution must be registered with the U.S. Office
for Human Research Protections. Any release of data will be subject to a signed Contract for Access
to and Use of Data (Contract for Data) between NCFRP and an authorized representative of the
Receiving Institution. An Application for De-identified Dataset must identify a principal investigator
(PI). The PI serves as the primary point of contact for all communications involving the Contract for
Data. The PI must sign the Contract for Data, by which the PI assumes responsibility for compliance
with all terms of the Contract for Data by employees of the Receiving Institution, including the dayto-day security of the electronic data and all printed output derived from the files. Each additional
researcher who will have access to the NCFRP dataset must be identified on the Application for Data
and must sign a Confidentiality Agreement. The applicants may not release or permit others to
release the dataset in whole or in part to any persons other than those identified in the Application
for Data. No data file that includes HIPAA-defined personally identifiable elements is available to
researchers. The complete Case Report tool contains more than 300 questions (approximately
2,600 data elements) about an individual fatality. (The Case Report form can be viewed and
downloaded at www.ncfrp.org.) Although states often enter HIPPA-defined personally identifiable
data elements (child’s name, address, date of birth, date of death, date of incident, and incident
county) into the NFR-CRS, all personally identifiable data elements will be removed from any
dataset made available to researchers. The data elements that will be removed from the dataset are
listed in the Application for Access to De-identified Dataset and in the DUA between NCFRP and the
state. Due to the potentially large size of the data set and the labor involved in assuring that
identifiers are not inadvertently put into the narrative section. The “Narrative” field contained in
Section O of the Case Report form will only be released to researchers under special circumstances
(i.e. smaller data sets).

Plans for archival and long-term preservation of

All data submitted via the Internet using the NFR-CRS are stored on a server located within the

the data

MPHI Data Center. Data are stored on this server indefinitely unless a state terminates the data use
agreement. Per the Data Use Agreement, if a state terminates its agreement, at their request, MPHI
will remove all of the case data from its server. However, state data stored on back up tapes cannot
be removed, but it will never be reported or disseminated by MPHI. MPHI will maintain all data in
accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives
and Records Administration (NARA) records retention policies and schedules and HHS/CDC policies
and shall not dispose of any records unless authorized by HHS/CDC. De-identified data sets
submitted to CDC are also stored indefinitely. They are housed on CDC servers and managed by the
CDC data steward. Currently there are no anticipated storage concerns for this data. These data are
considered official public records and are preserved according to The Federal Records Act of 1950
(amended to 44 U.S.C. Chapter 31). Retention of such records will follow the Scientific and

Research Project Retention Schedule available at: http://intranet.cdc.gov/ocoo/docs/sbiu/recordsmanagement/bb-scientific-research.docx.

Spatiality (Geographic Location)
Country

State/Province

County/Region

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:

Not Research - Public Health Surveillance

09/15/22

Redmond Leonard_Joan (jrl3) CIO HSC

09/15/22

Still-LeMelle_Terri (cse6) OMB / PRA

09/16/22

Zirger_Jeffrey (wtj5) ICRO Reviewer

Does NOT Require HRPO
Review

45 CFR 46.102(l)(2)

PRA:
PRA Applies
ICRO:

OMB Approval date: 09/09/22

PRA Applies

OMB Expiration date: 09/30/25