Research Determination

Print Date: 1/17/24

Title:

OD2A-Local Component C - Linkage to and Retention in Care Surveillance

Project Id:

0900f3eb8222fe30

Accession #:

NCIPC-ESB-9/18/23-199cc

Project Contact:

Seung Hee Lee

Organization:

NCIPC/DOP/ESB

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

09/01/2023

Estimated Completion Date:

08/31/2028

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

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

10/2/23

Duncan_Elizabeth (slz5) CIO HSC

10/2/23

Angel_Karen C. (idy6) OMB / PRA

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Standard

Date Needed:

10/12/2023

Determination Start Date:

10/02/23

Description:

Twelve local health departments funded through the OD2A: LOCAL (Overdose Data to Action: Limiting Overdose through
Collaborative Actions in Localities) cooperative agreement have also been funded to implement a surveillance system to collect
standardized indicators on linkage to and retention in care surveillance. Recipients will submit aggregate data to CDC every 6
months beginning December 2024.

IMS/CIO/Epi-Aid/Lab-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

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

Monitor linkage to and retention in care among individuals with opioid use disorder and/or stimulant use disorder in a subset of
county/local health departments funded through OD2A: LOCAL. This goal will be accomplished by standardizing methods and
indicators used by local health departments to collect data on linkage to and retention in care for substance use disorder (SUD).
This is a formative project among 12 funded county/local health departments. Lessons learned will be used to expand the program
into a more comprehensive surveillance system in the future, potentially expanding to states. The project will also provide actionable
data that localities can use to plan prevention activities. Funded health departments will collect standardized indicators of linkage to
care for SUD and submit aggregate data to CDC on a 6-month basis via Partner#s Portal. There will be a 12-month planning period
(Sept 2023 # Aug 2024). Funded jurisdictions begin submitting data to CDC on September 2024. This project will be PRA
applicable, and we are in the process of developing an ICR.

Objective:

Component C funds 12 local health departments to track the extent to which individuals misusing drugs or with substance use
disorder are linked to evidence-based treatment, harm reduction services, and supports through the Cascade of Care (CoC) for
Opioid Use Disorder and/or Stimulant Use Disorder. Program success hinges on generating actionable data that jurisdictions can
leverage to enhance and fine-tune their linkage to and retention in care programs. Component C will also foster a robust foundation
for deriving insights into disparities, unmet needs, and optimal practices across the CoC. Finally, data must be shared with CDC to
inform and enhance regional and national linkage to care efforts.

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

Yes

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

Yes

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population ; Prisoners ; American Indian or Alaska Native ; Asian ; Black or African American ; Hispanic or Latino ;
Native Hawaiian or Other Pacific Islander - Persons with an opioid use disorder or stimulant use disorder ; White ; Female ; Male ;
Adult 18-24 years ; Older adults > 64 years ; Patient ; Other - Persons with an opioid use disorder or stimulant use disorder

Tags/Keywords:

Linkage to care ; Drug Overdose ; health disparities ; Retention in care

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 employees will provide substantial technical assistance or
oversight ; CDC is providing funding

Method Categories:

Surveillance Support

Methods:

CDC will provide TA on how to create a surveillance system for collection of standardized data for Linkage to and Retention in Care
strategy.

Collection of Info, Data or Biospecimen:

Twelve local health departments were funded by CDC in September 2023 to collect programmatic data on linkage to care among
individuals with SUD identified via key entry points to care and leverage other existing data sources. Funded health departments will
use the OD2A: LOCAL Linkage to Care Data Submission Template, an Excel data template, to collect standardized indicators of
linkage to care for opioid and stimulant use disorders and aggregate data will be submitted to CDC on a 6-month basis via
Partner#s Portal. A Privacy Impact Assessment was already done on the system. Some indicators will be required, and some will be
optional.

Expected Use of Findings/Results and their impact:

CDC plans to disseminate results widely and publicly. In coordination with funded jurisdictions, CDC may share analyses and
results to highlight progress in establishing standardized linkage to care surveillance. Data will be used by CDC and jurisdictions to
enhance and fine-tune linkage to and retention in care programs and also provide insights in disparities, unmet needs, and optimal
practices across the Continuum of Care for opioid and stimulant use disorders.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

No

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

Funding #

CDC Cooperative
Agreement

Overdose Data to Action Limiting Overdose through Collaborative Actions in Localities
(OD2A LOCAL)

CDC-RFA-CE-230003

HSC Review

HSC Attributes
Other - Public Health Surveillance with local health
authorities.

Additional Ethical Considerations
New collection of data and potential access to identifiers
are both OK under public health surveillance. The public
health surveillance exclusion is for the collection/use of
information and/or biospecimens to improve public health
/inform public health action. It must be conducted,
supported, requested, ordered, required or authorized
by a public health authority, and it must be limited to
activities necessary to allow a public health authority to
identify, monitor, asses, or investigates potential public
health signals, onsets of disease outbreaks, or
conditions of public health importance.

Yes

Original
Budget Yr

# Years
Award

2023

5

Budget
Amount

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

Estimated number of study participants

Population - Children

N/A

Protocol Page #:

Population - Minors

N/A

Protocol Page #:

Population - Prisoners

N/A

Protocol Page #:

Population - Pregnant Women

N/A

Protocol Page #:

Population - Emancipated Minors

N/A

Protocol Page #:

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

Will you be working with an outside Organization or Institution? Yes

Institutions yet to be added .....

Staff
Staff Member

SIQT Exp.
Date

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff
Role

Email

Phone

Organization

Program
Lead

yzv4@cdc.
gov

770-4883766

EPIDEMIOLOGY AND
SURVEILLANCE BRANCH

Emily Neusel
Ussery

03/29/2026

Sarah Konefal

08/22/2026

Program
Lead

urt2@cdc.
gov

--

OVERDOSE MORBIDITY TEAM

Seung Hee
Lee

06/20/2026

Program
Lead

xde5@cdc.
gov

770-4886020

EPIDEMIOLOGY AND
SURVEILLANCE BRANCH

10/29/2024

Data
DMP
Proposed Data Collection Start Date:

9/1/24

Proposed Data Collection End Date:

8/31/28

Proposed Public Access Level:

Public

Public Access Justification:

CDC recognizes the critical importance of maintaining standards of data quality, upholding individual and institutional privacy and
confidentiality, and ensuring impartiality in the sharing of public health data. CDC stores all data received by recipients in an accesscontrolled share folder, which resides on the CDC Network. The CDC Network follows all National Institute of Standards and
Technology (NIST) requirements for data security.

How Access Will Be Provided for Data:

OThe current plan is to publicly share aggregate data on standardized indicators that are validated during the planning year (9/2023
# 8/2024) and during the first year of data collection (9/2024 # 8/2025). These indicators will be shared in a #Downloadable CSV
files from a CDC website#. Data may only be shared at the US regional level due to the sensitivity of the data. This plan will be
revised on 9/2024 after the planning year.

Plans for Archival and Long Term Preservation:

The data collected for Linkage to and Retention in Care (LTC) Surveillance will be handled and stored in compliance with the
Federal Records Act. This ensures that all data, records, and related documentation will be appropriately archived and preserved
for the required retention periods in accordance with federal regulations and guidelines.

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Dataset yet to be added...

Supporting Info
No Supporting Info

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date