Research Determination

Print Date: 11/15/24

Title:

Expanding Capacity and Partnerships to Address the Overdose Epidemic NOFO

Project Id:

0900f3eb82472207

Accession #:

NCIPC-PPEB-9/15/24-4010a

Project Contact:

JESSICA G WOLFF

Organization:

NCIPC/DOP/PPEB

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

09/30/2024

Estimated Completion Date:

09/30/2028

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

Determinations

Determination

Justification

Completed

Entered By & Role

10/21/24

Halstead_Mary (ygg9) CIO HSC

10/21/24

Halstead_Mary (ygg9) OMB / PRA

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:
PRA Applies

Description & Funding
Description
Priority:

Standard

Date Needed:

10/31/2024

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

10/21/24

Description:

The purpose of the Expanding Capacity and Partnerships to Address the Overdose Epidemic NOFO is to leverage the services of a
public health organization to provide staffing support to state, local, and territorial health departments to strengthen their
implementation of evidence-based overdose prevention and response activities and enhance their partnerships with public safety.
Strategies and activities will include hiring, retaining, and training field staff within the state, local, and territorial health departments,
capacity building for field staff and jurisdictions, evaluating efforts to continually improve staffing and capacity building, documenting
the impact of the programs, and building partnerships with local, state, and federal partners. The NOFO will support two distinct
components in these areas: Component A: Capacity Building for the Overdose Response Strategy (ORS); and Component B:
Capacity Building for OD2A-S and OD2A: LOCAL. The expected period of performance outcome is to expand the capacity within
state, local, and territorial health departments through the hiring, retaining, and training of field staff that will conduct overdose
prevention and surveillance work and partner with public safety.

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

Drug overdoses remain the leading cause of injury-related death in the United States. CDC estimates that nearly 108,000
Americans have died from a drug overdose in the 12-month period ending December 2023 [2]. Recently, overdose deaths have
been linked to the rapid increase in synthetic opioids [3], including illicitly manufactured fentanyl (IMF), and a resurgence of
stimulants [4], particularly methamphetamine, into the illicit drug supply. This cooperative agreement is intended to enhance the
capacity of health departments to conduct overdose prevention work by leveraging a public health organization to provide staffing
and training of supported staff, build the expertise of staff in health departments, and strengthen collaboration and coordination
within and across health departments to advance overdose prevention and response work that is associated with OD2A-S, OD2A:
LOCAL, and the ORS.

Objective:

The objectives under the two required components are: Component A: To expand capacity of the ORS by 1) hiring, retaining, and
training Public Health Analysts (PHAs) that will strengthen partnerships and collaborations between public health and public safety
partners; 2) providing continual process improvement for the ORS; and 3) providing resources, training, and technical assistance to
meet the needs of PHAs; and Component B: To expand capacity of OD2A-S and OD2A: LOCAL by 1) hiring, retaining, training, and
building enhanced capacity of field staff supporting critical overdose surveillance and prevention activities; 2) creating training
opportunities and resources for field staff; and 3) enhancing partnership engagements with non-federal and federal entities.

Does your project measure health disparities among No
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?:

No

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

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens ; Programmatic Work

Target Populations to be Included/Represented:

General US Population

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 ; Activity originated and designed by non-CDC staff (awardee or external
collaborator) ; CDC employees will participate as co-authors in presentation(s) or publication(s) ; CDC employees will provide
substantial technical assistance or oversight ; CDC is providing funding

Method Categories:

Survey; Technical Assistance; Other - Programmatic Reporting
Data collection directed by CDC will be administered through two instruments: the ORS Annual Evaluation Survey and the ORS
Quarterly Reporting Template. An ICR is being developed for these data collections. The ORS Annual Evaluation Survey will be

Methods:

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results and their impact:

disseminated each year for up to 3 years to solicit feedback on how the ORS program operated in the previous year (e.g., the
survey disseminated in 2026 will ask respondents to reflect on their experiences with the program in 2025). The survey will be
administered through SmartSheet, an online data collection platform. The Overdose Response Strategy Team Reporting System
(ORSTRS) is a web-based platform used for all reporting. ORS teams, made up of a Drug Intelligence Officer (DIO) and Public
Health Analyst, will be required to provide summaries of implemented activities and challenges encountered, detailed descriptions
of sub activities and their dates of completion, success stories, progress updates, and implementation plans within each sub activity
on a quarterly basis for the duration of the CoAg once OMB approval is obtained. Data collection that is not directed by CDC and
solely at the direction and discretion of CDCF will include post-conference surveys, post-regional meeting surveys, and postwebinar surveys. CDCF will conduct these surveys to inform their program implementation efforts and this information collection will
not be directed or sponsored by CDC.
The ORS Annual Survey will be collected via Smartsheet, an online data collection platform. Smartsheet was selected because it
provides a secure, cost-effective way to create the survey, disseminate it via email, track responses, and conduct initial data
analysis and visualizations of responses. The ORS Annual Evaluation Survey will be disseminated each year for up to 3 years to
solicit feedback on how the ORS program operated in the previous year (e.g., the survey disseminated in 2026 will ask respondents
to reflect on their experiences with the program in 2025). The survey will be administered through SmartSheet, an online data
collection platform, to each of the 5 key respondent groups: Drug Intelligence Officers (n=61), Public Health Analysts (n=61), public
health partners in each ORS jurisdiction (n=70), public safety partners in each ORS jurisdiction (n=70), and the national ORS
management and coordination team (n=25). Public health and public safety partners in each jurisdiction will be individuals who
serve as designated site leads for ORS teams. In some cases, a jurisdiction may have multiple site leads or multiple jurisdictions
may share a site lead. Each respondent group will receive a survey version tailored to their respective group, with 44 questions for
PHAs and DIOs, 31 questions for partners, and 18 questions for the ORS national management and coordination team. For closeended questions, respondents will be asked to use a Likert scale (strongly agree, agree, disagree, strongly disagree, I don#t know)
to indicate the degree to which they agree with statements in each of the five sections. The survey will include an option for ORS
teams and partners to provide examples of the impact of ORS partnerships following each of the five close-ended questions. All
respondents will be asked five additional open-ended questions to describe challenges, suggestions and visions for the future of the
program. The survey will be open for two weeks and two reminder emails will be sent. Responses will be anonymous. ORS teams
will be required to provide summaries of implemented activities and challenges encountered, detailed descriptions of sub activities
and their dates of completion, success stories, progress updates, and implementation plans within each sub activity on a quarterly
basis. The Overdose Response Strategy Team Reporting System (ORSTRS) is a web-based platform used for all reporting. The
main purpose of ORSTRS is to track and monitor ORS teams# activities across the ORS network to improve program monitoring,
evaluation and reporting to partners, like ONDCP and CDC. Data collection includes adding projects, tracking projects through
updates, and reviewing projects with commentary. Users add projects and project updates that national reviewers can track and
review with commentary. Project updates include documents, presentations, and success stories. PHAs and DIOs are expected to
report project activities on a quarterly basis. Reports will be due 15 days after the quarter ends or the following business day, if the
15th falls on the weekend or a holiday. CDC and CDCF developed the aforementioned ORSTRS web-based platform that will be
used to collect the work plan and quarterly updates outlined in this data collection. The data entry interface of ORSTRS was
developed through a subcontract with Mathematica, a research and data analytics consultancy.
Although program monitoring is an essential element of public health programs, data collected for this purpose are not generalizable
and will be used to improve the implementation of ORS activities and strategies. In addition, because this is not a research
cooperative agreement, funded recipients are not required to implement rigorous research designs that have strong internal validity,
produce generalizable knowledge, or allow for causal attribution. Aggregate-level information collected from the Annual Survey will
be disseminated to ORS teams and to the public via an annual Program Evaluation Report within 3 months of the survey closing.
Information collected through the Quarterly Reporting Template in ORSTRS will be disseminated to ORS teams and to the public
via the ORS Annual Report. The annual report will be disseminated via email to CDC and ONDCP leadership, and to ORS teams
and their partners. The report will also be posted to the ORS website. Data from both the Annual Survey and the Quarterly
Reporting Template will largely be used to develop programmatic reports, tools, and implementation guides for the purposes of

program improvement. The information collected will not be used to make generalizable statements about the population of interest.
However, in collaboration with ORS teams, other dissemination tools such as webinar, abstracts, presentations, and manuscripts
may be developed.
Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

CDC Cooperative Agreement

Expanding Capacity and Partnerships to Address the Overdose Epidemic

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Original Budget Yr

# Years Award

Budget Amount

2024

4

17000000.00

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

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 HIPAA 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
Institution

FWA
#

National Foundation for Centers for Disease Control and
Prevention

Institution
National Foundation for Centers for Disease Control and Prevention

FWA Exp
Date

Funding

Funding Restriction
Amount

Expanding Capacity and Partnerships to Address the Overdose
Epidemic

Funding Restriction Percentage

Funding Restriction Reason

Funding Restriction has been Lifted

Institution

Institution Role(s)

Institution
Project Title

National Foundation for Centers for
Disease Control and Prevention

Receiving Direct HHS Support (Prime Awardee); Designing or Developing Project and/or Data
Collection Instrument(s); Providing Technical Assistance; Implementing the Project

Institution
Project
Tracking #

Prime
Institution

Institution

Regulatory Coverage

IRB Review Status

National Foundation for Centers for Disease Control and Prevention

Not Engaged in Conduct of Non-Exempt Human Research

Not Applicable

Institution

Registered IRB

IRB Registration Exp. Date

IRB Approval Status

National Foundation for Centers for Disease Control and Prevention

Institution

IRB Approval Date

IRB Approval Exp. Date

Relying Institution IRB

National Foundation for Centers for Disease Control and Prevention

Staff
Staff
Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Staff
Role

Email

Phone

Organization

Cherie
RooksPeck

11/30
/2024

05/03/2025

Program
Official

whq4@cdc.
gov

4046396429

APPLIED PREVENTION
SCIENCE TEAM

JESSICA
WOLFF

08/15
/2026

06/20/2027

Technical
Monitor

nmn3@cdc.
gov

4044985070

PREVENTION PROGRAMS
AND EVALUATION BRANCH

Olga
Costa

07/07
/2026

Project
Officer

onq8@cdc.
gov

4044985942

DIVISION OF OVERDOSE
PREVENTION

Data
DMP
Proposed Data Collection Start Date:

1/1/26

Proposed Data Collection End Date:

9/30/28

Proposed Public Access Level:

Public

Public Access Justification:

Public access to the data will be made available through reports that share the data in aggregate, such as annual reports and
program evaluation reports.

How Access Will Be Provided for Data:

Public access to the data will be made available through reports that share the data in aggregate, such as annual reports and
program evaluation reports. These reports will be made available and posted to program websites that are publicly available. No PII
will be collected.

Plans for Archival and Long Term Preservation:

Information will be maintained by CDC Foundation and will comply with the privacy and security standards.

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

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

Current

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

ORS Annual Evaluation SurveyPublic Health Partner

Data Collection Form

ORS Annual Evaluation Survey- Public Health Partner.
docx

Current

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

NOFO

Notice of Funding Opportunity

Foa_Content_of_CDC-RFA-CE-24-0161.docx

Current

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

ORS Quarterly Reporting
Template Data Dictionary

Data Collection Form

ORS Quarterly Reporting Template Data Dictionary.docx

Current

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

SSA_ORS Data Collection

Paperwork Reduction Act Form

SSA_ORS Data Collection.docx

Current

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

ORS Annual Evaluation Survey Public Safety Partner

Data Collection Form

ORS Annual Evaluation Survey - Public Safety Partner.
docx

Current

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

ORS Annual Evaluation SurveyDrug Intelligence Officer

Data Collection Form

ORS Annual Evaluation Survey- Drug Intelligence Officer.
docx

Current

Wolff_Jessica
(nmn3)
Project Contact

09/30/2024

ORS Annual Evaluation SurveyORS Management_Coordination
Team (1)

Data Collection Form

ORS Annual Evaluation Survey- ORS
Management_Coordination Team (1).docx

Current

ORS Annual Evaluation Survey-

Data Collection Form

Public Health Analyst (1)

ORS Annual Evaluation Survey- Public Health Analyst (1).
docx