Research Determination

Project Determination

Drug Overdose Surveillance and Epidemiology System (DOSE)

Project ID:	0900f3eb823acbcf
Accession #:	NCIPC-ESB-5/29/24-acbcf
Project Contact:	Seung Hee Lee
Organization:	NCIPC
Status:	Pending Clearance
Intended Use:	Project Determination
Estimated Start Date:	09/01/23
Estimated Completion Date:	08/31/28
CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:	0920-1268

Description

Priority

Standard

CDC Priority Area for this Project

Not selected

Determination Start Date

05/29/24

Description

The Drug Overdose Surveillance and Epidemiology (DOSE) system funds 50 health departments (49 state health departments and the health department of the District of Columbia; i.e., ND is the only state not funded of the 50 states). For DOSE Syndromic Surveillance (SyS) data, 48 health departments (OK and CA do not participate in SyS) rapidly share existing Emergency Department (ED) data on counts of ED visits involving eight required nonfatal drug overdose indicators (suspected all drug, all opioid, heroin, fentanyl, benzodiazepine, all stimulant, methamphetamine, and cocaine overdoses), plus the number of total ED visits of any cause, using the Rapid ED overdose data form and standard CDC case definitions. In addition, for DOSE ED/Inpatient Hospitalization Discharge data, 35 jurisdictions (34 states (OK and CA participates in Discharge only) and the District of Columbia ) submit line-level discharge/billing data on ED visits and/or inpatient hospitalizations involving a drug poisoning (i.e., line-level data on visits with any T36-T50 ICD-10-CM code, including all intents and encounters, underdosing, and adverse effects), in a CSV data form. Funded jurisdictions receive discharge data from the Hospital Association. Jurisdictions submitting discharge/billing data also submit aggregate data on total ED visits and/or hospitalizations (of any cause) using the ED/Hospital billing discharge data form. For both SyS and Discharge data, CDC provided SAS/R programs that populates the data forms. Please note, this project determination is only for the DOSE component of the NOFO (attached as supplement file) and that a separate project determination was submitted on 4/30 to cover the programmatic component and the overall NOFO. Please also refer to the ICR for DOSE (OMB Control No: 0920-1268).

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure Submission

No

IMS Activation Name

Not selected

Submitted through IMS clearance matrix

Not selected

Primary Scientific Priority

Not selected

Secondary Scientific Priority (s)

Not selected

Task Force Responsible

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

To rapidly identify outbreaks and provide situational awareness of changes in emergency department (ED) visits and/or inpatient hospitalizations involving eight required nonfatal drug overdose indicators (suspected all drug, all opioid, heroin, fentanyl, benzodiazepine, all stimulant, methamphetamine, and cocaine overdoses) at the local, state, and regional level. This goal will be accomplished by standardizing and enhancing sharing of existing ED and/or inpatient hospitalization data locally collected by 50 health departments (49 state health departments, and the health department of the District of Columbia) with CDC.

Objective

DOSE will improve situational awareness of federal, state, and local health departments of emerging drug overdose outbreaks and the progression of the drug overdose epidemic. DOSE will enhance public awareness of the progression of the opioid overdose epidemic and other emerging drug overdose threats in their area: Limited timely local and state data is available on nonfatal and fatal drug overdoses. DOSE will enhance local health department surveillance of suspected nonfatal all drug, all opioid, heroin, fentanyl, benzodiazepine, all stimulant, cocaine, and methamphetamine overdoses. Additional line-level discharge data may provide more opportunities to analyze the context around nonfatal drug overdoses.

Does your project measure health disparities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project investigate underlying contributors to health inequities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project propose, implement, or evaluate an action to move towards eliminating health inequities?

No

Activities or Tasks

Purchase, Use, or Transfer of Information, Data, Biospecimens or Materials

Target Population to be Included/Represented

Other-Individuals who visit an ED or hospital to receive treatment for a drug, opioid, fentanyl, heroin, b

Tags/Keywords

Drug Overdose

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

The project will leverage ED syndromic data and ED/hospitalization discharge/billing data already routinely collected by state health departments. No new data will be systematically collected from EDs, and health departments will be reimbursed by CDC for the burden related to sharing syndromic and billing/discharge data with CDC.

Collection of Info, Data, or Bio specimens

For DOSE SyS data, 48 funded health departments (47 state and the District of Columbia) will rapidly share existing ED syndromic data with CDC on a monthly basis using the Rapid ED overdose data form and standard CDC case definitions. Data may come from different local ED data systems but is expected to cover at least 80% of ED facilities in the jurisdiction (e.g., state). Specifically, some health departments conduct rapid overdose surveillance using local ED syndromic systems, while others conduct surveillance using CDC’s National Syndromic Surveillance Program (NSSP), which receives near real-time ED data from health departments or their partners on approximately 78% of ED facilities in the United States. Regardless of the data source, CDC will require all participating health departments to provide counts of ED visits involving suspected nonfatal all drug, all opioid, heroin, fentanyl, benzodiazepine, all stimulant, cocaine, and methamphetamine overdoses by county, age group, sex, race and ethnicity, and time (i.e., month and year) in a standardized manner using the Rapid ED overdose data form, which is an Excel data template. This form also collects data quality indicators such as percent of ED visits missing data on key variables (i.e., metadata). In order to assess and improve rapid ED data sharing and facilitate reporting of overdose burden (counts, rates), DOSE discharge data will be collected from a subset of 35 participating health departments (34 states and Washington, D.C.) and will also be asked to share line-level data on ED visits and/or inpatient hospitalizations involving a drug poisoning (i.e., line-level data on visits with any T36-T50 ICD-10-CM code, including all intents and encounters, underdosing, and adverse effects), in a CSV file. Line-level data include standard variables from the UB04/CMS1450 billing form (including age, sex, discharge diagnoses, etc.). Additionally, aggregate data on total ED visits and/or hospitalizations by county, age group, sex, race and ethnicity, and time (i.e., month and year) will be shared with CDC on a yearly basis using a standardized Excel data form, the ED/Hospital billing discharge data form. This form also collects data quality indicators such as percent of ED visits or inpatient hospitalizations missing data on key variables (i.e., metadata).

Expected Use of Findings/Results and their impact

Improve local, state, and regional situational awareness of drug, opioid, heroin, fentanyl, benzodiazepine, stimulant, methamphetamine, and cocaine overdose trends and response to acute local and multi-state drug outbreaks.

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 Agreement	Overdose Data to Action in States	CDC-RFA-CE-23-0002	2023	5

HSC Review

Regulation and Policy

Do you anticipate this project will need IRB review by the CDC IRB, NIOSH IRB, or through reliance on an external IRB?

No

Will you be working with an outside Organization or Institution? No

Institutions
Institution	FWA #	FWA Exp. Date	Funding	Funding Restriction Amount

Institution	Funding Restriction Percentage	Funding Restriction Reason	Funding Restriction has been lifted

Institution	Institution Role(s)	Institution Project Title	Institution Project Tracking #	Prime Institution

Institution	Regulatory Coverage	IRB Review Status

Institution	Registered IRB	IRB Registration Exp. Date	IRB Approval Status

Institution	IRB Approval Date	IRB Approval Exp. Date	Relying Institution IRB

Staff
Staff Member	SIQT Exp. Date	Citi Biomedical Exp. Date	Citi Social and Behavioral Exp. Date	Citi Good Clinical Exp. Date	Staff Role	Email	Phone #	Organization/ Institution
Seung HeeLee	06/20/2026				Program Lead	xde5@cdc.gov	770-488-6020	EPIDEMIOLOGY AND SURVEILLANCE BRANCH

DMP
Proposed Data Collection Start Date	09/01/23
Proposed Data Collection End Date	08/31/28
Proposed Public Access Level	Public
Public Access justification	Select aggregate DOSE data (with suppression rules applied) will be available on a CDC website in the form of an interactive dashboard with options to download data into a CSV file. The website for syndromic data is: https://www.cdc.gov/overdose-prevention/data-research/facts-stats/dose-dashboard-nonfatal-surveillance-data.html?CDC_AAref_Val=https://www.cdc.gov/drugoverdose/nonfatal/dose/surveillance/dashboard/index.html and for billing/discharge data is: https://www.cdc.gov/overdose-prevention/data-research/facts-stats/dose-dashboard-nonfatal-discharge-data.html?CDC_AAref_Val=https://www.cdc.gov/drugoverdose/nonfatal/dose/discharge/dashboard/index.html:
How Access Will Be Provided for Data	Downloadable CSV files from the website.
Plans for archival and long-term preservation of the data	The data will live in the dashboard but will also be preserved in a CDC network user-protected folder for security.

Spatiality (Geographic Location)
Country	State/Province	County/Region
United States	Alabama
United States	Arizona
United States	Arkansas
United States	California
United States	Colorado
United States	Connecticut
United States	Kentucky
United States	Louisiana
United States	Maine
United States	Maryland
United States	Massachusetts
United States	Michigan
United States	Minnesota
United States	Mississippi
United States	Missouri
United States	Montana
United States	Nebraska
United States	Nevada
United States	New Hampshire
United States	New Jersey
United States	New Mexico
United States	New York
United States	North Carolina
United States	Ohio
United States	Oklahoma
United States	Oregon
United States	Pennsylvania
United States	Rhode Island
United States	South Carolina
United States	South Dakota
United States	Tennessee
United States	Texas
United States	Utah
United States	Vermont
United States	Virginia
United States	Washington
United States	West Virginia
United States	Wisconsin
United States	Wyoming
United States	Alaska
United States	Delaware
United States	District of Columbia
United States	Florida
United States	Georgia
United States	Hawaii
United States	Idaho
United States	Illinois
United States	Indiana
United States	Iowa
United States	Kansas

Determinations
Determination	Justification	Completed	Entered By & Role
HSC: Does NOT Require HRPO Review	Not Research - Public Health Surveillance 45 CFR 46.102(l)(2)	06/08/24	Ferdon_Corinne (djz4) CIO HSC
PRA: PRA does not apply	Qualifies for a regulatory exclusion:No Information being collected Justification:Secondary data analysis	06/08/24	Ferdon_Corinne (djz4) OMB / PRA