Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background 

The NIH Helping to End Addiction Long-Term® (HEAL) Initiative: This study is part of the NIH’s HEAL initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative® bolsters research across NIH to (1) improve treatment for opioid misuse and addiction, and (2) enhance pain management. More information about the HEAL Initiative is available at https://heal.nih.gov.

Justice Community Overdose Innovation Network (JCOIN): JCOIN has two broad, complementary goals: to build the evidence base for the delivery of substance use disorder (SUD) treatment services for individuals involved in the criminal-legal system, and to build capacity to implement effective services for SUD, overdose prevention, and related co-occurring conditions. Phase I of JCOIN supported a consortium of practitioner-partnered research projects focused primarily on testing strategies to connect individuals with effective opioid use disorder (OUD) treatment at key transition points between the criminal-legal system and community-based healthcare. Phase I supported 13 multi-site clinical trials and more than 50 additional research protocols including surveys, modeling, dissemination, pilot studies and other projects. The network was supported by a Coordination and Translation Center (CTC) and a Methodology and Advanced Analytics Resource Center (MAARC).

Given the recent evolution of both the epidemiology of the overdose crisis and public policies intended to support overdose prevention efforts, new research is needed to take effective interventions to scale in jails, courts, and community corrections, and to rigorously test new and emerging models for effectively addressing the complex needs of individuals with SUD and/or high overdose risk. Of particular importance is the coordination of services between public health and public safety agencies, to ensure continuity of care for individuals as they transition between these systems. 

To support research on effective interventions and implementation strategies for addressing SUD, overdose risk, and common co-occurring conditions in these populations and systems, the National Institute on Drug Abuse (NIDA) solicits applications for JCOIN Phase II. The purpose of Phase II is to bring together a national network of investigators and practitioner partners to conduct an array of research and capacity building activities to improve the delivery of effective interventions for adults and youth, spanning the key points of the sequential intercept model (i.e., crisis intervention, emergency response, law enforcement diversion/deflection, pre-trial services, courts, jail, prison, re-entry services, probation, parole).

Network Structure and Objectives

The structure of the network will include multiple research centers, working in collaboration with four complementary resource and support centers. Clinical Research Hubs (RFA-DA-25-025) are expected to conduct large multi-site studies; Innovation Hubs (RFA-DA-25-062) are intended to support smaller-scale studies. Both Research and Innovation Hubs will have the capacity to conduct collaborative pilot studies with other awardees. The CTC (RFA-DA-24-069) will facilitate collaboration among the Hubs, conduct novel dissemination and implementation research, and engage in an array of capacity building activities to engage practitioners and other key stakeholders. The MAARC (RFA-DA-24-068) will provide infrastructure for data submission, data sharing, and analytic support, while conducting novel survey and modeling studies. An Economic Research Resource Center (ERRC; this NOFO) will facilitate collaboration across Hubs on the collection, analysis, and comparison of cost data; conduct original research; and develop tools to support practitioners and decision-makers. A Community Engaged Research Resource Center (CERRC: RFA-DA-25-026) will directly engage persons with lived experience; provide research opportunities for new and early career investigators; and provide additional support to the Hubs. 

A visual depiction of the structure and organization of this initiative can be found at this link: https://nida.nih.gov/sites/default/files/images/JCOINPhase2.jpg

It is imperative that prospective applicants read the NOFOs associated with each of these components, in order to fully understand the intended structure and operation of the network, the scope of the component awards, and the expectations for awardees.

An informational webinar for potential applicants will be held on July 25 at 2:00pm EDT. When available, a registration link and more information will be posted at: https://nida.nih.gov/news-events/meetings-events/2024/07/jcoin-phase-ii-informational-webinar-potential-applicants.

This NOFO seeks applications for the JCOIN Phase II Economic Research Resource Center (ERRC). 

JCOIN PHASE II ECONOMIC RESEARCH RESOURCE CENTER: Scope of Activities and Purpose

The primary purpose of the JCOIN ERRC is to conduct, support, and disseminate cost and economic analyses to inform decisions about service delivery for individuals involved in the criminal legal system who are at elevated risk of overdose. These activities will include assessment and recommendations for JCOIN Clinical Research Hub study protocols; conducting original research projects that will contribute new and generalizable knowledge about economic topics related to overdose prevention in criminal legal-involved populations, leveraging JCOIN’s network of participants and stakeholders; the development and dissemination of practical tools and related resources to inform decision-making by practitioners and policymakers; and on-demand technical assistance and consultation for JCOIN-affiliated researchers as well as for criminal legal and behavioral health practitioners. The end goal is to provide resources that can lead to informed decision-making about the implementation of interventions, services, and models of care to address the need for overdose prevention and substance use treatment services among individuals involved in the criminal legal system, whether they are incarcerated or seeking care in the community.

The ERRC will be one of four coordination and resource centers providing support to JCOIN grantees. Collaboration and coordination among these entities is essential to ensure clear communication, avoid duplication of effort, and promote the overall objectives of the network.

In support of these goals, the ERRC will perform four required activities:

A. Research Support for JCOIN Hubs (Measurement, Analysis, and Potential Data Harmonization)

The ERRC will provide support to the JCOIN Phase II Hubs by identifying potential economic research questions that could be answered by one or more hubs, recommending measures and methods for addressing those questions, and providing assistance necessary to support analyses of these data. Applicants should review the NOFOs soliciting JCOIN Phase II Clinical Research Hubs (RFA-DA-25-025) and Innovation Hubs (RFA-DA-25-062) to become familiar with the topics, scope, and stage (effectiveness, implementation, or hybrid effectiveness-implementation) of potential awards. ERRC applicants should be prepared to support economic analyses ranging from cost and cost-effectiveness of novel service delivery models, to the estimation of costs of implementing evidence-based practices in criminal legal systems. Hubs are likely to propose a range of measures that may be more or less able to support cost/economic analyses; likewise, they may have more or less personnel capacity to do so, and such analyses may be more or less appropriate for their research questions.

The ERRC should be prepared to “meet these projects where they are” in terms of readiness and capacity. The ERRC will complete a structured needs assessment with each Clinical Research Hub within the first 4 months after award, and with each Innovation Hub within the first 12 months after award, to identify needs, capacity, and opportunities; and make measurement and analytic recommendations for individual hubs and the network as a whole that are mindful of the resources and timelines of the individual studies. For the duration of the award, the ERRC will serve as a resource and support center to advise the JCOIN hubs (and other potential JCOIN-supported projects, as needed and as resources allow), and to collaborate on analyses with individual projects, groups of projects, or Network-wide. The ERRC is intended to add value to the JCOIN research portfolio above and beyond the hub projects.

B. Original Research Projects

Applicants must plan to conduct a total of four methodological research projects over the 5-year project performance period.

Each of these projects must have a cost or economic focus and be directly relevant to an aspect of the overdose crisis in the broad context of criminal legal systems. “Cost or Economic” is intentionally broadly defined and may include but is not limited to research relating to cost-effectiveness of interventions; insurance, payers, and payment structures (e.g., incentives; contract models) as they relate to service access/utilization; definition or measurement of constructs necessary to support cost analyses (e.g., quality of life measures); research examining economic stability indicators as social determinants of health and their impact on engagement in and outcomes of behavioral health services at the patient or community level; development of models that accurately capture the costs and/or savings to criminal-legal systems of delivering substance use treatment or overdose prevention services; etc.

A proposal for the first project, to begin in Year 1, is to be included in the application. The remaining research projects will be determined after award. . These should emerge organically after reviewing the JCOIN Phase II studies; considering input from the JCOIN Community Advisory Board and the Steering Committee (SC); identifying emerging policy, financing, or other systemic changes that could be productively addressed through an economic framework; and/or in response to specific research questions identified by JCOIN practitioner partners. Delayed onset studies will not proceed without the input and approval of NIDA scientific and program staff.

C. Development and Dissemination of Practitioner-Facing Tools and Resources

Leaders of criminal legal systems and community-based behavioral health agencies considering whether to adopt overdose prevention or treatment interventions need to be able to estimate the actual costs of implementation, ongoing delivery, and the likely return on that investment. There are few validated, user-friendly tools available to support these business needs. The ERRC will propose a plan for developing and disseminating a variety of practitioner-facing tools and resources to inform practical decision-making. Original tools and resources may be designed by the ERRC team based on their own ideas and experience, but applicants are also strongly encouraged to plan to assess and integrate information from research and practitioner resources throughout the JCOIN network – including integrating information based on research conducted by the JCOIN Phase II Clinical Research Hubs and Innovation Hubs; findings or secondary analyses of JCOIN Phase I research studies; and direct communication with practitioners affiliated with the individual hubs or convened by the CTC or the CERRC.

Products developed under this set of activities may include, for example, cost estimation tools or processes; tools or strategies to inform “make or buy” decisions (i.e., offering a service in-house vs. contracting with an external provider organization); resources to inform the selection of evidence-based practices to be implemented based on cost and cost-effectiveness considerations; etc. Applicants should anticipate working with the JCOIN CTC to disseminate these products, tools, and resources. The CTC has the capacity to host online courses, webinars, podcasts, and similar activities targeting general or specific audiences, and has the expertise to develop brief explainers, infographics, and other tools that effectively translate complex concepts for broad reach. ERRC applicants should not duplicate these translation and dissemination efforts.

D. Consultation and Technical Assistance

JCOIN-funded researchers (i.e., those affiliated with Clinical Research Hubs, Innovation Hubs, support or coordination centers, diversity supplements, JCOIN rapid innovation grants, JCOIN training programs, or analogous awards) may have occasional need for technical assistance or limited consultation related to economic analyses. Likewise, personalized consultation may be necessary for practitioners to maximize the utility of tools and products developed by the ERRC. The ERRC must propose a plan for delivering time-limited technical assistance, learning tools, instructional opportunities, or similar consultation to JCOIN-affiliated researchers and to the broader researcher and practitioner communities that work at the intersection of public health and public safety. The plan should describe a feasible scope of activity, including the types of consultation that might be provided, a strategy for promoting the availability of consultations and prioritizing requests, and the team’s capacity to deliver these supports. This activity must be coordinated in tandem with the Technical Assistance Core of the CTC (described in RFA-DA-24-069); the TA Core may make referrals to the ERRC of practitioner requests received specific to economic topics.

As warranted based on requests received, the ERRC is encouraged to develop webinars, short online courses, or stand-alone tools to address common research questions about selecting, collecting, integrating, and analyzing cost data in the context of effectiveness and implementation trials, and considerations needed for conducting this work in criminal legal contexts. These resources should be made available to both JCOIN and the broader research community through the online platform available through the CTC.

Special Considerations: NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

Commons IDs for Senior/Key Personnel: Applicants are reminded that NIH requires all individuals listed on the R&R Senior/Key Person Profile (Expanded) Form to have an eRA Commons username (Commons ID). This includes non-academic collaborators meeting the definition of Senior/Key Personnel. See NOT-OD-21-109 and NOT-OD-24-042. Information about how to obtain Commons IDs for non-academic collaborators is included in FAQs at: https://grants.nih.gov/faqs#/applying-electronically.htm.  

HEAL PI Meeting Attendance: The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

Network Participation: All JCOIN Phase II investigators are expected to participate in monthly SC or work group calls with the research hubs and coordinating and support centers. Anticipate one in-person meeting for the Network each year, in the Washington DC area; assume travel for up to 3 team members for a 2-day meeting. The ERRC should also anticipate monthly (virtual) coordination meetings with the CTC, MAARC, and CERRC throughout Year 1, and quarterly meetings thereafter.

During the first year, JCOIN Phase II grantees will collaborate to identify a set of common measures to be used, as relevant, across studies, and will determine policies and processes for data sharing and collaborative analysis. All participants in the Network will have opportunities to collaborate on emergent, shared priorities.

Pre-Application Consultation: Potential applicants are strongly encouraged to consult with NIDA program staff early in the application development process. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project relative to the intent of this NOFO. See Scientific/Program Contacts in Section VII.

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO and will not be reviewed

• Applications that do not include plans for conducting all four required activities (research support for JCOIN Hubs; original research projects; practitioner-facing tools; consultation and technical assistance).  

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Travel and Meetings: JCOIN Phase II will be supported by multiple coordination and resource centers; frequent communication and clear lanes of activity among all components will be essential. For budget and planning purposes, anticipate monthly (virtual) coordination meetings with the CTC, MAARC, and CERRC throughout Year 1, and quarterly meetings thereafter.

Applicants should budget for up to 3 project staff to attend one in-person JCOIN SC meeting per year; assume each meeting is 2 days and is in Bethesda, Maryland. ERRC project leadership should also anticipate attendance at monthly virtual SC meetings for the duration of the award. One ERRC PI is expected to attend the annual HEAL Scientific Meeting each year – for budget purposes, assume this is a 2-day meeting in the Washington DC area.

Research Projects: The required research project in Year 1 should not exceed $100,000 direct costs. In Years 2-4, allocate an additional $100,000 direct costs per year to support the required delayed-onset research projects.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy:

Use subheadings within the Research Strategy to clearly identify each of the four required activities to be conducted by the JCOIN ERRC: Research support for JCOIN hubs; Original research projects; Development and dissemination of practitioner-facing tools; and Consultation and technical assistance.

A. Research Support for JCOIN Hubs (Measurement, Analysis, and Potential Data Harmonization) [required]

Describe a plan for meeting (virtually) and conducting a needs assessment with each Clinical Research Hub within the first 4 months after award. Needs assessments should be focused on understanding the Hubs’ research projects and identifying: existing plans (if any) and additional suitable opportunities for conducting cost/economic analyses; hub personnel (if any) assigned to these activities/analyses; which relevant measures (if any) they proposed to collect, from what sources, at what point in the project; and any cost analyses planned. Inclusion of hubs’ practitioner partners in these discussions, where feasible, is strongly encouraged.

Describe a plan for using the results of the Hub needs assessments to inform hub-specific and cross-hub recommendations for: (a) measures that could be collected to add or enhance some/all studies’ potential to address cost/economic questions, particularly those of relevance to practitioner partners; (b) important research questions that could be answered by analyzing data across some or all studies; and (c) opportunities to harmonize or coordinate analyses across some or all studies. These recommendations should be mindful of the personnel and resource limits of the projects and the priorities of their practitioner partners. These insights and recommendations must be discussed first with the NIDA Science Officer, and then presented to the JCOIN SC (or an SC-designated workgroup) for discussion no later than 6 months post-award so as not to delay the hubs’ protocol, IRB, or other necessary approvals.

In addition, describe a plan for meeting (virtually) with each Innovation Hub within the first 12 months after award, to identify potential needs and opportunities for integrating cost or economic measures into their studies, and to identify potential topics of common interest across the entire network. Meetings with all of the JCOIN Phase II hubs should inform plans for the creation of tools and delivery of technical assistance in Activities C and D, below.

B. Original Research Projects [required]

Applicants must plan to conduct four methodological research projects over the 5-year project performance period.

Provide a detailed plan for the first of these projects, to begin in Year 1. Demonstrate the necessary expertise and capacity to execute this study. Provide an anticipated timeline for data acquisition and analysis. Explain how the proposed project will make a unique and valuable contribution to generalized knowledge while also being of practical utility to criminal legal or treatment system actors. Describe a vision for how the methodologies developed or questions addressed in the proposed project could result in tools or other resources that could be disseminated to researchers, practitioners, policymakers, or other communities of interest, or could directly inform the work of the Network.

Anticipate conducting three additional research projects that will emerge organically based on interactions with JCOIN grantees or in response to emergent areas of priority interest in the criminal legal or treatment systems or their environments. These studies will be specified post-award, and may not proceed without review and approval of NIDA program staff.

C. Development and Dissemination of Practitioner-Facing Tools and Resources [required]

Describe plans and expertise to develop practical, user-friendly tools to support criminal legal or behavioral health agency leaders in estimating the costs associated with key decision points regarding service delivery and interagency service coordination. Provide examples of the types of tools/resources envisioned, and the applicants’ experience and expertise developing analogous products. Applicants are strongly encouraged to anticipate resources that could be developed in partnership with one or more of the JCOIN Hubs and their practitioner partners. Describe plans for working effectively with the JCOIN CTC to disseminate these products and track their use.

D. Consultation and Technical Assistance [required]

Describe a plan and personnel capacity to offer on-demand consultation and technical assistance for researchers and practitioners regarding cost and economic topics. The intended audience will be JCOIN-affiliated researchers, as well as criminal legal or behavioral health agencies – the latter may include agencies not directly affiliated with JCOIN hubs. Describe a process for providing targeted research consultation to these audiences over the life of the ERRC award. Specifically, propose a process by which such requests will be submitted, prioritized (in the case of unexpected demand), and tracked; propose a reasonable scope of available support (e.g., maximum hours per consultation or other metric); and describe personnel available to respond to these requests. Describe plans to coordinate and cross-refer inquiries as needed with the CTC’s Technical Assistance Core.

Articulate a vision for developing webinars, short courses, and/or other educational resources that respond to anticipated or actual technical assistance requests and may be accessed on-demand by researchers and practitioners through the online platform managed by the CTC. 

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

The HEAL Initiative has additional requirements that must be addressed in the Data management and Sharing plan. All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEAL’s compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy). Specifically, HEAL applicants must include:

• Plans to submit data and metadata (and code, if applicable) to a HEAL-Compliant data repository (https://www.healdatafair.org/resources/guidance/selection) and follow requirements of the selected repository
• Plans to register your study with the HEAL platform within one year of award (https://heal.github.io/platform-documentation/study-registration/) 
• Plans to submit HEAL-defined study-level metadata within one year of award (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) and https://heal.github.io/platform-documentation/slmd_submission/.
• HEAL pain clinical studies must include plan to use HEAL core Common Data Elements (https://heal.nih.gov/data/common-data-elements). HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. 
• To the extent possible, all other (non-pain) HEAL studies conducting clinical trials or research involving human subject are expected to use questionnaires by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements) if applicable and relevant to their research. 
• Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.
• To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms.  

HEAL has developed additional details and resources to fulfill these requirements (https://www.healdatafair.org/resources/road-map). 

HEAL Public Access and Data Sharing Policy: 

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications (https://heal.nih.gov/about/public-access-data). Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/. For more detail and specific data sharing requirements, see Section 4. Other plans.  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication. 

• For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access 
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Resource Center address the needs of the research network that it will serve? Is the scope of activities proposed for the Resource Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

• To what extent is the proposed research project likely to contribute to generalized knowledge about important economic factors as they related to the overdose crisis in the context of criminal legal systems?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing economic research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, plans for conflict resolution, and organizational structure appropriate for the Resource Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

• To what extent is there evidence that the team has experience and expertise in conducting cost/economic research, including in collaboration with other research teams?
• To what extent do the applicants bring the necessary expertise and capacity to provide consultation, support, and technical assistance to JCOIN investigators and criminal legal system practitioners?

Innovation

Does the application propose novel measurement and analytic concepts in coordinating the research projects the Resource Center will serve? Are the concepts novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of measurement and analytic concepts proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Resource Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this NOFO:

• To what extent does the applicant demonstrate an understanding of the structure and purpose of the JCOIN Phase II program? Do they articulate reasonable plans for collaborating and coordinating with the research hubs, other coordination and resource centers, and NIDA?
• How well does the applicant demonstrate a vision for integrating economic analyses into the work of the research hubs? To what extent does the applicant recognize and have a plan for working with the likely wide variation in data resources, capacity, and baseline readiness of hubs’ research projects?
• To what extent does the applicant describe plans for developing practitioner-facing tools to provide insight into real-world cost and economic concerns? Are these tools likely to be of practical utility to the practitioners (i.e., to guide decision-making)?
• Do the applicants provide a detailed description of at least one original research project? If successful, is the project likely to contribute to generalized knowledge beyond the specific JCOIN context?

Environment

Will the institutional environment in which the Resource Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Resource Center proposed? Will the Resource Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Specific to this NOFO:

• To what extent does the applicant have the necessary infrastructure and resources to support JCOIN research teams, and practitioners within and outside the JCOIN network?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Serving as project director(s) responsible for the overall management of activities within the ERRC.
• Representing the ERRC as a member of the Justice Community Overdose Innovation Network (JCOIN) SC.
• Participating as appropriate in activities to coordinate among NIDA community engaged research efforts involving justice-involved populations. This participation may include collaboration and consultation with other NIH award recipients; the appropriate sharing of information, data, and research materials; and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection, as appropriate.
• Data Management, Analysis, and Access: Data generated are the property of the award recipient. The recipient must provide NIDA with access to all research data generated under this award, subject to rules specified in any Certificates of Confidentiality. Data must be shared upon request with the SC and any subcommittees reporting to the SC, when appropriate.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH Project Scientist(s) will work closely with the PD(s)/PI(s) of the ERCC, the other JCOIN Phase II coordination and resource centers, and the Clinical Research Hubs to ensure integration and coordination among these components in performing their intended roles in the network.
• The NIH Project Scientist(s) will have one (1) vote on the SC, regardless of how many NIH Project Scientists participate across the network.
• The assigned Project Scientist(s) will be responsible for: (1) overseeing the activities of the ERRC, along with the other entities delineated above, to ensure that activities and services are coordinated and supportive of the functioning of the network; (2) providing advice and guidance on the research and network support activities to be provided by the ERRC, to ensure that these meet the needs of the network and are of high scientific priority and utility; (3) facilitating contact between the ERRC and other JCOIN-funded projects and relevant NIH-funded projects; and (4) regular communication with ERRC leadership to ensure smooth operation and early identification and correction of problems.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The SC is the primary governing body of the Cooperative. Award recipients must participate in the SC. The SC or its designated committees develops policies and procedures guiding the network and serves as a forum to facilitate collaboration, identify research gaps and opportunities, and integrate insights from practitioners. PI/PDs and Project Scientist will each have a vote on the SC and other NIH program officials may participate in a non-voting capacity.  The chair of the committee will be selected by vote.  Award recipients agree to abide by the procedures and policies established by the SC.
• JCOIN is intended to be a national resource, and as such, the ERRC must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents, consistent with its Data Management and Sharing Plan, as approved by NIDA.
• The PD(s)/PI(s) provide, in concert with the NIDA staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
• Award recipients and NIDA will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.
• All award recipients and NIDA will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research and beyond.
• The SC will facilitate these joint activities and, in particular, development of collaborative research protocols, human subjects and other regulatory protocols, data harmonization, publication and dissemination plans, and other network policies and procedures as needed.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

The HEAL Initiative has additional requirements that must be addressed in the Data management and Sharing plan. All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEAL’s compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy). Specifically, HEAL applicants must include:

• Plans to submit data and metadata (and code, if applicable) to a HEAL-Compliant data repository (https://www.healdatafair.org/resources/guidance/selection) and follow requirements of the selected repository
• Plans to register your study with the HEAL platform within one year of award (https://heal.github.io/platform-documentation/study-registration/) 
• Plans to submit HEAL-defined study-level metadata within one year of award (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) and https://heal.github.io/platform-documentation/slmd_submission/.
• HEAL pain clinical studies must include plan to use HEAL core Common Data Elements (https://heal.nih.gov/data/common-data-elements). HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. 
• To the extent possible, all other (non-pain) HEAL studies conducting clinical trials or research involving human subject are expected to use questionnaires by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements) if applicable and relevant to their research. 
• Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.
• To the extent possible, HEAL recipients are expected to integrate broad data sharing consent language into their informed consent forms.  

HEAL has developed additional details and resources to fulfill these requirements (https://www.healdatafair.org/resources/road-map). 

HEAL Public Access and Data Sharing Policy: 

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications (https://heal.nih.gov/about/public-access-data). Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/. For more detail and specific data sharing requirements, see Section 4. Other plans.  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication. 

• For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access 
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Report and ensure immediate public access to HEAL-funded publications  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication.  

• For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access  
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests   

Prior to publication, HEAL expects investigators to alert their program officers of upcoming manuscripts to ensure coordination of communication and outreach efforts.  

Award recipients and their collaborators are required to acknowledge HEAL Initiative support by referencing in the acknowledgment sections of any relevant publication:

“This research was supported by the National Institutes of Health through the NIH HEAL Initiative (https://heal.nih.gov) under award number [include specific grant/contract/award number; with NIH grant number(s) in this format: R01GM987654].” 

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Julia Zur, Ph.D.
National Institute on Drug Abuse (NIDA)
Email: Julia.Zur@nih.gov 

Dharmendar (Dharm) Rathore, Ph.D.
National Institute on Drug Abuse (NIDA)
Email: Dharmendar.Rathore@nih.gov

Ericka Wells
National Institute on Drug Abuse (NIDA)
Email: Ericka.Wells@nih.gov 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.