Supporting-Statement-B_Sudden Death in the Young

Authorizing Legislation: Public Health Service Act [42 U.S.C. 241] Section 301(a) and Section 317K, 42 USC 241(a), 42 USC 247b-12 and the Sudden Unexpected Death Data Enhancement and Awareness Act, Public Law Number 113-236 (enacted into law on December 18, 2014)
Screenshots of web-based data collection pages: Data Collection Tools
1. SDY Module Section I
2. Advanced Review Discussion Topics
3. SDY Module Section N
Federal Register Notice
1. 60-day package
2. 30-day package

MPHI Security Policy, #06-02
NCFRP Child Death Review – Case Reporting System Security Information
Institutional Request for Determination of Research Status:

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

B1. Respondent Universe and Sampling Methods

An extension for surveillance of a census (all) sudden deaths in the young (0-19 years old) within 12 awardee jurisdictions is being sought; thus, no sampling methods are employed. Awardees on average compile data for an estimated 606 cases per year. All SDY cases have data entry completed on the SDY Module. Approximately 50% of all SDY cases, or 303 cases continue to the advanced review process each year.

B2. Procedures for the Collection of Information

Through their existing child death review (CDR) programs, awardees compile data for SDY cases on a defined set of SDY questions and enter them into the existing SDY module that is part of a larger National Fatality Review-Case Reporting System (NFR-CRS) run through the Michigan Public Health Institute’s (MPHI) National Center for Fatality Review and Prevention (NCFRP) program. The enhanced SDY modules I and N (Attachments 2a and 2b), which contain approximately 70 variables, are completed for each case, yet not every variable applies to every case. Data is abstracted from primary data sources, including medical examiner/coroner reports, death investigation reports, medical records, and child protective services records. For approximately 303 of these cases, awardee jurisdictions also convene an advanced review team with relevant clinical expertise, including state health personnel, pediatric cardiologists, pediatric neurologists or epileptologists, and forensic pathologists. This advanced review team comprehensively reviews information from multiple data sources, discusses the information and uses the information to classify cases according to a standardized algorithm that differentiates causes. Additional information from these advanced case reviews is added to the SDY module as applicable. Password-controlled access for awardees is administered by the NCFRP per NCFRP’s data security policies and user agreements. (Attachments 4 and 5)

B3. Methods to Maximize Response Rates and Deal with No Response

Efforts are made to maximize the response rate as achieving population-level representativeness and data completeness is the primary purpose of this funding. CDC provides guidance to awardees on strategies to minimize missing or unknown responses to SDY variables. These methods include building partnerships with agencies that collect the primary data and providing feedback to these agencies so they might improve the quality of the data. As outlined in the funding announcement for the cooperative agreement, CDC and the Data Coordinating Center at MPHI provide awardees with a quarterly Data Quality Summary report that includes the frequency of missing and unknown responses that are considered essential to the case definition and classification protocol. This allows CDC and the awardee to track the outcome of data improvement strategies and to track awardees’ progress over time. The goal is for the Registry to capture complete information from data abstracted from primary sources that allows states and jurisdictions to calculate accurate and reliable SDY incidence.

B4. Tests of Procedures or Methods to be Undertaken

This data collection is an extension of a previously approved information collection (OMB #0920-1092, Expiration 09/30/2025). All the variables in the SDY module have been used for the last 10 years. While CDC is not proposing any 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; 2) obtain more accurate estimates of the amount of time needed to completed 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.

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

There are no statistical aspects related to the SDY Registry.

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

There are no statistical aspects related to the SDY Registry.

Many individuals were consulted on the following: availability of data; frequency of collection; the clarity of instruction and record keeping; disclosure; reporting format; and the data elements to be recorded, disclosed, or reported. Experts CDC consulted formed the SDY Steering Committee, as listed in the table below.

Table 1. External Consultations Sudden Death in the Young (SDY) Experts Consulted
Biorepository
Years consulted	Name	Occupation	Role	Contact information
2014 - current	Mark Russell	Cardiologist	Director of Biorepository, University of Michigan	[email protected] 734-764-5176
2018-current	Sarah Geisler	Laboratory Technician	Biorepository Lead Tech, UMI	[email protected] 734-615-2429
2018 - current	Lindsay Wilkerson	Laboratory Technician	Biorepository Lead, University of Michigan	[email protected] 734-615-2429
2015-2016	Lauren Bienemann	Laboratory Technician	Biorepository Lead, University of Michigan	n/a
2016-2018	Alissa Novack	Laboratory Technician	Biorepository Lead, University of Michigan	n/a
Data Coordinating Center at Michigan Public Health Institute
2015 - current	Meghan Faulkner	SDY Data Coordinating Center Director	Data Manager for SDY Case Registry, Technical Assistance	[email protected] 517-324-6014
2014 - current	Heather MacLeod	SDY Data Coordinating Center Senior Project Manager	Primary contact for SDY; expertise in genetic counseling, Technical Assistance	[email protected] 630-432-9918
2018-current	Krisha Felzke	SDY DCC Project Coordinator	Technical Assistance	[email protected] 517-324-8339
2018-current	Erik Buczkowski	SDY DCC Data Manager	Data Manager for SDY Case Registry, Technical Assistance	[email protected] 517-324-6061
2014-2107	Teri Covington	Directions of the National Center for Fatality Review and Prevention	Expert in fatality review protocols and procedures	n/a
National Institutes of Health
2014 - current	Kristin Burns	Medical Officer, National Heart, Lung, and Blood Institute (NHLBI)	Overall lead for SDY Case Registry Study. Primary contact for questions related to cardiac conditions	[email protected] 301-594-6859
2020-current	Bryanna Schwartz	Medical Officer, NHLBI	Secondary lead for questions related to cardiac conditions	[email protected] 301-594-8868
2014 - 2021	Jonathan Kaltman	Branch Chief, NHLBI	Overall project guidance	[email protected] 301-435-0528
2014 - current	Vicky Whittemore	Program Director, National Institute of Neurologic Disorders and Stroke	Sudden Unexpected Death in Epilepsy (SUDEP) and epilepsy	[email protected] 301-496-1917
2014-2016	Ellen Rosenberg	Clinical Trial Specialist, NHLBI	Consent Expert	n/a
Centers for Disease Control and Prevention
2019-current	Tiffany Colarusso, MD	Team Lead, DRH/IMPT	project guidance	[email protected]
2023-current	Alexa Erck-Lambert	Epidemiologist/Program Manager, DRH/IMPT	Data Support and Technical Support	[email protected]
2014- current	Sharyn Parks Brown	Epidemiologist, DRH/IMPT	Lead Epidemiologist and Data support	[email protected]
2014- 2023	Carrie Shapiro-Mendoza, PhD	Branch Chief, DRH/IMPT	project guidance	[email protected]
2014- 2023	Niu Tian, MD	Medical Officer	project guidance	[email protected]

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Supporting Statement B template
Subject	Supporting Statement B template
Author	Centers for Disease Control and Prevention
File Modified	0000-00-00
File Created	2025-09-19