CDC Determination: IRB Approval is Not Required

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Print Date: 1/25/22

Title:

Drug Overdose Surveillance and Epidemiology System (DOSE)

Project Id:

0900f3eb81a4d4d1

Accession #:

NCIPC-ESB-10/24/19-4d4d1

Project Contact:

Alana M Vivolo

Organization:

NCIPC/DOP/ESB/MORB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

09/01/2019

Estimated Completion Date:

08/31/2023

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

0920-1268

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

Entered By & Role

5/18/21

Angel_Karen C. (idy6) CIO HSC

5/18/21

Angel_Karen C. (idy6) OMB / PRA

5/18/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

45 CFR 46.102(l)(2)

PRA:
PRA Applies

ICRO:
PRA Applies

Completed

OMB Approval date: 8/30/19
OMB Expiration date: 8/31/22

Description & Funding
Description
Priority:

Standard

Determination Start Date:

04/16/21

Description:

The Drug Overdose Surveillance and Epidemiology (DOSE) system funds 52 health departments (50 state health
departments, the health department of Puerto Rico and the health department of the District of Columbia) to
rapidly share existing ED data on counts of ED visits involving suspected drug, opioid, heroin, and stimulant
overdoses using two standard data forms (i.e., the Rapid ED overdose data form and the ED discharge overdose
data form) and standard CDC case definitions.

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

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-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
involving suspected drug, opioid, heroin and stimulant overdoses at the local, state, and regional level. This goal
will be accomplished by standardizing and enhancing sharing of existing ED data locally collected by 52 health
departments (all 50 state health departments, the health department of Puerto Rico, 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 opioid 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 drug, opioid, heroin and stimulant overdoses and assist states in mandatory reporting
requirements of overdose.

Does this project include interventions,
services, or policy change work aimed at

Not Selected

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improving the health of groups who have
been excluded or marginalized and/or
decreasing disparities?:
Project does not incorporate elements of
health equity science:

Not Selected

Measuring Disparities:

Yes

Studying Social Determinants of Health
(SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research Not Selected
and Practice:
Other:

Not Selected

Activities or Tasks:

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

Target Populations to be
Included/Represented:

Other

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 ; CDC is providing funding

Method Categories:

Surveillance Support; Technical Assistance

Methods:

The project will leverage ED syndromic data and hospital discharge data on ED visits already routinely collected by
state and territorial 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 ED data with CDC.

Collection of Info, Data or Biospecimen:

Fifty-two funded health departments (50 state health departments, Puerto Rico, and the District of Columbia) will
rapidly share existing ED 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 75% of
ED visits in the jurisdiction (e.g., state). Specifically, some health departments conduct rapid overdose surveillance
using local ED syndromic systems or hospital discharge data, 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 60% of ED visits in the United States. Regardless of the data source, CDC will
require all participating health departments to provide counts of ED visits involving suspected drug, opioid, heroin,
and stimulant overdoses by county, age group, sex, 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, all 52 participating health departments will also be asked to share counts of ED
visits involving suspected drug, opioid, heroin and stimulant overdoses by county, age group, sex, and time (i.e.,
month and year) from more finalized hospital discharge files, the current surveillance standard. The data will be
shared with CDC on a quarterly or yearly basis using a standardized Excel data form, the ED discharge overdose
data form, and standard CDC case definitions.

Expected Use of Findings/Results and their
impact:

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

Could Individuals potentially be identified
based on Information Collected?

No

- Individuals who visit an ED to receive treatment for a drug, opioid, heroin, or stimulant overdose

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Cooperative Agreement

Overdose Data to Action (OD2A)

CE19-1904

2019

4

Budget Amount

HSC Review

Regulation and Policy
Do you anticipate this project will be
submitted to the IRB office

No

Estimated number of study participants
Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

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Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA
Privacy Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from
target language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing
those bested about HIV serostatus

No Selection

Human genetic testing is planned now or in
the future

No Selection

Involves long-term storage of identfiable
biological specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New
Drug exemption or Investigational Device
Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

Alana
Vivolo

06/24/2024

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

09/14/2021

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Program
Lead

[email protected]

770-4881244

MORBIDITY
TEAM

Data
DMP
Proposed Data Collection Start Date:

9/1/19

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Proposed Data Collection End Date:

8/31/23

Proposed Public Access Level:

Public

Public Access Justification:

DOSE data 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 is currently under development but our current website includes some of this
data: https://www.cdc.gov/drugoverdose/data/nonfatal/case.html

How Access Will Be Provided for Data:

Downloadable CSV files from the website.

Plans for Archival and Long Term
Preservation:

The data will live in the dashboard but will also be preserved in a CDC network user-protected folder for security.

Spatiality
Country

State/Province

United States

South Carolina

United States

Washington, D.C.

United States

Wisconsin

United States

West Virginia

United States

Washington

United States

Virginia

United States

Vermont

United States

Utah

United States

Texas

United States

Tennessee

United States

Rhode Island

United States

Pennsylvania

United States

Oregon

United States

Oklahoma

United States

Ohio

United States

North Carolina

United States

New York

United States

New Mexico

United States

New Jersey

United States

New Hampshire

United States

Alabama

United States

Alaska

United States

Arizona

United States

Arkansas

United States

California

United States

Colorado

United States

Connecticut

United States

Delaware

United States

Florida

United States

Georgia

United States

Hawaii

United States

Idaho

United States

Illinois

United States

Indiana

United States

Iowa

County/Region

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United States

Kansas

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

Dataset
Dataset
Title

Dataset
Description

Data
Publisher/Owner

Public
Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection
End Date

Dataset yet to be added...

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