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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

HEAL Initiative

The NIH HEAL Initiative: This study is part of the NIH’s Helping to End Addiction Long-term (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 Background

The Justice Community Overdose Innovation Network (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 in both criminal-legal and treatment settings. Phase I of JCOIN established a consortium of practitioner-partnered research projects focused primarily on testing strategies to connect individuals to evidence-based opioid use disorder (OUD) treatment at key transition points between the criminal-legal system and the community. Phase I supported 13 multi-site clinical trials and more than 50 additional distinct research protocols including survey, modeling, dissemination, and pilot studies, supplements, and ancillary projects. The Network was supported by a Coordination and Translation Center (CTC) and a Methodology and Advanced Analytics Resource Center (MAARC).

Given recent evolution of both the epidemiology of the overdose crisis and public policy 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 at earlier points of the sequential intercept model.

JCOIN Phase II will consist of three highly integrated components: multiple research hubs that will each execute multi-site implementation or effectiveness trials in one or more segments of the criminal-legal system; a Coordination and Translation Center, which will provide logistical support, capacity building, national stakeholder engagement, and broad dissemination of research results; and a Methodology and Advanced Analytics Resource Center, which will provide a wide array of data and analytic support services.

This notice of funding opportunity (NOFO) seeks applications for a Methodology and Advanced Analytics Resource Center.

Methodology and Advanced Analytics Resource Center: Scope of Activities and Purpose

It is imperative that applicants for the Methodology and Advanced Analytics Resource Center carefully review the companion NOFO for the JCOIN Phase II Coordination and Translation Center (U2C) (RFA-DA-24-069) and the Notice of Intent to Publish a NOFO for Research Hubs (NOT-DA-25-025) to understand the full mission of JCOIN - Phase II.

The JCOIN Methodology and Advanced Analytics Resource Center (MAARC) is expected to provide analytic and data support for the network, bridging Phase I and Phase II Research Hubs and projects. This includes support for Phase I data cleaning, harmonization, sharing, archiving, and closeout, and for onboarding and ongoing support of Phase II projects. The MAARC will also conduct novel empirical research to ensure timely understanding of changes in current practices in the United States related to addressing OUD and overdose in criminal-legal settings and affected individuals. Activities will include providing overall leadership and coordination of centralized data management; data infrastructure support, inclusive of any data harmonization activities; providing resources for advanced methodological and analytical techniques across the network; conducting research on dynamic changes in policy and practice in criminal-legal and relevant community-based service settings; and conducting novel studies applying cutting edge analytical techniques to existing data and data collected across the JCOIN network.

The JCOIN Phase II Methodology and Advanced Analytics Resource Center (MAARC) will include 7 cores:

Administrative Core: The Administrative Core will provide overarching resources and organizational structure and management to the Center. Leadership of this core will meet regularly with NIDA program and scientific staff to review timelines and milestones and identify emerging issues. The Administrative Core will collaborate closely with the JCOIN Phase II Coordination and Translation Center to monitor the needs of research projects across the entire JCOIN Phase II network and provide appropriate support. The Administrative Core will also collaborate closely with the Coordination and Translation Center to ensure findings are methodologically sound, translatable, and relevant to stakeholders within criminal-legal and community-based service settings. Applicants will plan for transition activities in Year 1 that support closeout of JCOIN Phase I projects and onboarding of JCOIN Phase II projects, with ongoing support as appropriate.

Data and Analytics Support Core: The purpose of the Data and Analytics Support Core is to facilitate the collection, archiving, and storage of data collected by the Research Hubs, and facilitate internal (JCOIN) and external (public) data sharing. In Phase I, JCOIN clinical trials were required to upload patient data for a set of core measures on a quarterly basis to a central, secure JCOIN data portal; those data could then be accessed (by permission) by JCOIN researchers to support harmonized cross-project analyses. Additionally, the Phase I MAARC facilitated access to standalone data sets that were collected through JCOIN projects (e.g., national surveys) for JCOIN research teams to use in primary analyses. In Phase II, the MAARC should anticipate continuing to make these kinds of harmonized and analysis-ready files available and facilitate their use by the network. Finally, the MAARC should anticipate creating or assisting Phase I hubs with the creation of final public use data files of their clinical trial data for sharing via the HEAL Data Ecosystem and eventual archiving in a HEAL-compliant data repository. Leadership of this core will require expertise in data management and data sharing, and subject matter expertise (at minimum, in substance use disorders, health services research, and criminal justice) to fully support the science proposed in the research hubs. Additionally, this core is expected to provide statistical support for analytic requests from researchers within the network, and for rapid-turnaround requests for NIDA. This core is also responsible for establishing mechanisms to support collaborative data-focused efforts and shared learning across the JCOIN network.

Technical Assistance/Consultation Core: Activities of this core will support on-demand technical assistance (consultation) and provide appropriate resources to JCOIN Phase I PIs, JCOIN Phase II researchers, and scientists outside of the JCOIN enterprise. The MAARC’s anticipated role is to offer consultation, information, guidance, and limited-scope analytical assistance to researchers on accessing and analyzing secondary data from Phase I projects, surveys and other datasets compiled by Phase II projects, and to support conducting harmonized analyses (where feasible) of Phase II project data. In consultation with the Survey Core, this core will develop a system to solicit suggestions from JCOIN researchers and outside stakeholders on priority items to include in JCOIN’s national public opinion and jail surveys. This core will also work closely with the JCOIN Coordination and Translation Center’s Technical Assistance Core (CTCTAC) to provide limited-scope data-focused technical and analytical support to external stakeholders seeking support through the CTCTAC when appropriate.

Survey Core: This core will support national surveys about topics broadly relevant to substance use, stigma, behavioral health, criminal-legal systems, and public health. These surveys will provide important context for understanding the evolution of service delivery and public opinion across the lifespan of JCOIN projects. Applicants will conduct at least 1 nationally representative public opinion survey in each of years 2 through 5, and provide a plan for making these data rapidly available to JCOIN research teams for collaborative analyses. Additionally, applicants will field one national survey of substance use services in correctional settings in Year 3. In consultation with the Technical Assistance Core, this Core will develop a strategy for soliciting input from JCOIN researchers and outside stakeholders on priority topics to be included in these national surveys. Additional surveys may be proposed and developed post-award in response to JCOIN research hub interests and in consultation with NIDA.

Geospatial Core: Activities in this core will support innovative geospatial analysis that address important gaps in the environmental context of OUD and overdoses in justice-involved populations. Applicants may propose to develop resources that enable visualization of important spatial information including but not limited to treatment service availability, distribution of support services that address social determinants of health, distribution of health services that impact overdose deaths (harm reduction services, HIV/HCV services, etc), or how access to mobile vans might be optimized to address community overdose rates. Applicants must propose and describe at least one geospatial research project in the application, and include a planning year to develop additional projects post-award in response to JCOIN research hub interests and in consultation with NIDA.

Modeling Core: The modeling core will leverage advanced analytical approaches to conduct novel research using existing data and data acquired through JCOIN-funded studies. Simulation modeling approaches may be used to address scientific gaps that are not easily addressed in clinical trials, or important systemic challenges that constrain responses to the overdose crisis in justice-involved populations. Examples of these topic areas include but are not limited to: extending the findings of existing Phase I projects or studies proposed in Phase II; attending to staffing challenges within justice settings; or identifying potential solutions to implementation barriers. This core will also use bibliometric data and other objective research output measures to assess productivity and collaboration of the Phase I JCOIN projects. Applicants will propose and describe at least one modeling research project in the application, and include a planning year to develop additional projects post-award in response to JCOIN research hub interests and in consultation with NIDA.

Policy Landscape Core: Local, state, and Federal policies, laws and regulations related to overdose prevention and substance use service delivery, particularly impacting the criminal-legal system as an intervention point, are rapidly changing, and many opportunities for generating insights into the effectiveness of emerging policies and practices go uncaptured. These are potentially important contextual variables and implementation determinants for JCOIN studies and can impact the translation and scale-up of research results. This core will inventory and characterize major policy/legal/funding environmental changes at the state and national level and produce datasets, mapping tools, and related resources that can be used by JCOIN researchers and other stakeholders to inform their work. These data are not intended to be gathered primarily through public opinion surveys or interviews, although surveys of key policymakers may be one component of this work. Applicants will propose a research plan for this core, and include a planning year to develop additional projects post-award in response to JCOIN research hub interests and in consultation with NIDA.

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.

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.

Diversity: In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Please refer to Notice of NIH's Interest in Diversity?NOT-OD-20-031?for more details.

Engaging People with Lived Experience and Other Collaborators: People with lived experience (e.g., patients, patient advocates, caregivers, families, community leaders) have important insights that can improve meaningful outcomes, uptake of research findings, and health equity across the continuum of research from basic through implementation studies. The perspectives of other relevant collaborators (e.g., health service providers, payors, public health agencies, community-based organizations, biotech, pharma) can further improve research impact. The NIH HEAL initiative strongly encourages applicants to specify their plan for meaningful engagement of people with lived experience and other collaborators in the research process. Meaningful engagement will vary with the focus of the research but should at minimum ensure that researchers are connecting with relevant collaborators and incorporating their perspectives throughout the conception, implementation, and dissemination of the research. Meaningful engagement should address what the researchers will learn and how the people with lived experience and/or collaborators will benefit from the partnership. To promote health equity, as is relevant for the research proposed, it is recommended that at least two people with lived experience from populations who experience health disparities should be meaningfully engaged in these efforts.

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 recipients 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.

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

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

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 Institutions) 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 SF 424 (R&R) 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. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

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 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: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

, with the following additional requirements:

The Research Strategy must consist of the following sub-sections with the indicated page limits:

Sub-section A Administrative Core (6 pages)

Sub-section B Data and Analytics Support Core (12 pages)

Sub-section C Technical Assistance Core (6 pages)

Sub-section D Survey Core (6 pages)

Sub-section E Geospatial Core (6 pages)

Sub-section F Modeling Core (6 pages)

Sub-section G Policy Landscape Core (6 pages)

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

With the following additional instructions:

PD/PIs are required to expend at least 2.0 person-months effort annually on the award over the entire period of support. In a multi-PI application, at least one PD/PI is required to commit a minimum of 2.0 person-months annually over the life of the grant award.

The success of the MAARC Data and Analytics Support Core and the Technical Assistance Core is dependent on key personnel with deep expertise in data infrastructure, quantitative and qualitative data analysis, and various study designs (e.g., cluster randomized trials, stepped wedge designs, hybrid implementation-effectiveness trials, etc). Further, subject matter expertise in the measurement of substance use disorder and related variables is necessary to support data harmonization and consultation requests from JCOIN researchers and outside stakeholders. Applicants are encouraged to attend carefully to these responsibilities and propose a plan for staffing these cores accordingly with the appropriate personnel and effort.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Requirements for Participating in Network Activities

Participation in Steering Committee Meetings: Budgets should include funds for travel for 6-8 members from the center. For planning purposes, assume two (2) planning and coordination meetings with NIDA and the Coordination and Translation Center will be held in Rockville, Maryland during Year 1, and that one (1) JCOIN Steering Committee (SC) meetings will be held in Rockville, Maryland in each of the remaining years. Anticipate all meetings are 2 days in length.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Describe specific aims for the MAARC, including the key responsibilities and overall goals of the Center.

Research Strategy:

The Research Strategy must consist of Sections A G, as designated below. Applications that do not include all required sections will be considered non-responsive and will be returned without review.

The MAARC should be viewed as interrelated Cores that provide support to individual Research Hubs, to the network as a whole, and to the greater community of stakeholders engaged in working with justice-involved populations. Prepare sections A-G with this broader context and goal in mind. Describe the overall structure of the proposed MAARC. Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of JCOIN, and how combined resources create capabilities that are more than the sum of the parts. Throughout sections A-G, address how the specified responsibilities will be executed to establish the research resources, and include details on workflow plans and timelines.

If the application includes activities that span multiple institutions, explain how those activities will be coordinated across institutions, and how the proposed activities will effectively engage and collaborate with other relevant activities at participating institutions. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the network.

Applications must include the categories listed below as subheadings in the applications and address each of the bullets within each respective subheading:

Sub-section A Administrative Core (6 pages)

The Administrative Core of the MAARC provides overarching resources and organizational structure and management of the Cores and Projects. As part of this section, applicants must address the following:

• Explain how the Core will establish and implement the basic governance, operational, and policy structures for the MAARC. This involves setting up committees and coordinating their execution. If the different elements (Sections B-G) will be based at different locations, provide a strong plan for communication and collaboration. Applicants are encouraged to convene a multidisciplinary, skilled team that provides synergy to the overall initiative.
• Provide a plan for supporting orderly closeout of the JCOIN Phase I awards, including plans for data sharing and data archiving. Provide an overall vision for onboarding new JCOIN Phase II hubs, establishing policies for data collection, harmonization, uploading, and sharing, and how the MAARC will provide ongoing support for data processing and analysis.
• Explain how this Core will interface with the other Research Cores in the MAARC. Provide a strong plan to ensure that key personnel will collaborate effectively. Describe an appropriate plan for work-flow and a timeline for meeting key deadlines.
• Describe processes and activities through which the MAARC will assess and anticipate needs of JCOIN researchers and outside stakeholders, and how other Cores will be engaged to address those needs.
• Explain how Core staff will lead the proposed program and interact with other MAARC cores, relevant organizations or departments within and outside the applicant institution, and the rest of the JCOIN network, with a particular emphasis on collaboration and coordination with the Coordination and Translation Center.
• In coordination with the Data and Analytics Support Core, describe a plan for providing training infrastructure for data set utilization, data archiving support, and analytic techniques both within the JCOIN network and to external stakeholders.
• Describe a plan for working collaboratively with the Coordination and Translation Center, Research Hubs, and NIH staff, to respond to data and administrative requests.
• Describe a plan for performing site visits to Research Hubs address emergent problems in data collection, data analysis, or study design, if needed.

Sub-section B Data and Analytics Support Core (12 pages)

The Research Strategy should specify the overall vision of the Data and Analytics Support Core and how this supports the overall JCOIN objectives. Research Hubs are likely to utilize a variety of study designs and require a range of support; these may include but are not limited to: economic and cost-effectiveness analyses; big data analytics; multi-level modeling; longitudinal data analysis; management and analysis of administrative data, claims data, and electronic health record data; missing data techniques; analysis of randomized controlled trial data; data visualization and visual analytics; and qualitative data analysis. In this section, applicants must address the following:

• Describe the team's analytic expertise and capacity to provide expert consultation to JCOIN researchers in these and any other domains of specialized expertise relevant to substance use and overdose in criminal-legal settings and populations.
• Describe a transition plan for Year 1 that includes support for a secure, central JCOIN data sharing platform, and supporting the orderly closeout of JCOIN Phase I projects (including a proposed approach to data archiving and data sharing consistent with the HEAL Data Sharing requirements).
• Describe a plan for onboarding Phase II Research Hubs in Year 2, including establishing expectations for data sharing, data uploads, and collaborative cross-hub analyses.
• Describe a plan to facilitate regular automatic data uploads from participating Phase II Research Hubs, and a formal plan for data retrieval. This plan should detail the pros and cons of each proposed approach for ensuring seamless automatic data uploads. This plan may change once the final composition of Phase II Research Hubs is known.
• Describe the team’s expertise in processes for linking administrative data across systems (e.g., justice and behavioral health) with appropriate considerations for privacy, as well as expertise in analyzing this kind of linked data.
• Describe a plan for providing statistical support for analytic requests and rapid-turnaround requests from JCOIN researchers including NIDA. These requests may include analyses to support publications as well as reports for research, practice, and policymaking audiences.
• Describe a plan to support the ongoing data collection, management, and sharing of quantitative and qualitative data across JCOIN Phase II studies. Data systems and processes must adhere to the FAIR (findable, accessible, interoperable, and re-useable) principles. The approach should include protections attending to the highest standards of data security and privacy concerns, particularly with regard to protection of personally identifiable information. Describe gatekeeping processes governing access to data from JCOIN Phase II trials while they are still underway
• Describe plans, in conjunction with other Cores, to identify relevant sources of data external to the JCOIN network and establishing protocols for data linkage or data access to advance the overall scientific goals of the network.
• Describe plans for facilitating collaborative data-focused efforts and shared learning across the JCOIN network (e.g., workgroups, online resources, listservs, etc.)
• Articulate a vision for establishing common data elements for both quantitative and qualitative data collection across the network for JCOIN Phase II projects.
• Describe plans to develop data sharing and data use agreements to support harmonization and data use among Research Hubs and the eventual creation of public use datafiles.
• Describe a plan to engage representatives from each Phase I and Phase II project to facilitate utilization of the JCOIN data and address data concerns/challenges that arise from the Research Hubs.

Sub-section C Technical Assistance Core (6 pages)

The goal of this Core is to support secondary analyses of data from JCOIN Phase I projects, and from additional Phase II projects as their data become available. Applicants must describe comprehensive strategies to offer statistical and analytic consultation, information, and guidance to individuals within and outside the network seeking to conduct secondary analyses of these data. Additionally, in consultation with the Survey Core, the Technical Assistance Core will formalize a process for soliciting suggestions from researchers and community stakeholders on topics that may be integrated in planned national surveys. As part of this section, applicants should address the following:

• Describe the team's subject matter expertise in bundling variables from different datasets to form useful analytic packages. Describe the team’s capacity and proposed approach to facilitate secondary data analyses of JCOIN Phase I data. Describe plans to collaborate with the Data and Analytics Support Core to support technical assistance requests from researchers and community stakeholders for analysis of JCOIN data.
• Because the technical assistance needs for the Phase II research hubs will not be known until after award, applicants should describe plans for engaging subject matter experts in OUD treatment, overdose, harm reduction, and recovery support services for justice-involved populations. Expertise in the structure and operation of criminal-legal systems is highly encouraged.
• Describe a plan to facilitate public dissemination and engagement with data generated by the JCOIN Phase I network (in collaboration with the Coordination and Translation Center).
• Describe a plan to provide support in conducting sophisticated quantitative and qualitative analysis.
• In collaboration with the Survey Core, describe a plan for soliciting input from researchers and stakeholders on questions that might be added to planned national surveys.
• Describe plans and capacity to work with the JCOIN Coordination and Translation Center’s Technical Assistance Core (CTCTAC) to provide limited-scope data-focused technical and analytical support to external stakeholders seeking support through the CTCTAC when appropriate.

Sub-section D Survey Core (6 pages)

Approaches to addressing substance use and overdose in criminal-legal and community treatment settings are implemented against a backdrop of evolving public opinion and public policy. The purpose of this core is to conduct survey research to measure how national trends in practice and opinion change over time. As part of this section, applicants should address the following:

• Describe plans to conduct at least one national public opinion survey to be executed every year in Years 2-5. Topics may address opinions and knowledge gaps regarding current criminal-legal system practices, evidence-based treatment practices, harm reduction services, recovery and related support services, public financing of such services, and other topics broadly relevant to JCOIN Phase II studies or evolving local or national trends. Describe the proposed approach to study design (including sampling and weighting), plans to ensure scientific rigor, and projected timeline for data collection and analysis.
• Describe plans to field a national survey of jail administrators in Year 3, on the use of evidence-based treatments to address substance use and overdose, and other relevant topics. This survey should complement but not be limited to questions asked in periodic, publicly available surveys conducted by the Bureau of Justice Statistics. Describe a proposed study design, including sampling and recruitment, plans to ensure scientific rigor, and projected timeline for data acquisition and analysis. Plans should assume that NIDA will facilitate access to a national sampling frame.
• Describe plans for working with the Coordination and Translation Center to ensure rapid translation of insights and findings from these surveys and dissemination to relevant audiences.
• Describe a process for how this Core will engage with the Technical Assistance/Consultation Core to solicit and incorporate questions into national surveys from network researchers and stakeholders.
• Additional surveys may be developed post-award in consultation with NIDA and JCOIN Phase II Research Hubs. Outline a process for soliciting input across the network and evaluating emerging research priorities on an annual basis.

Sub-section E Geospatial Core (6 pages)

Successful OUD treatment and overdose prevention in justice-involved individuals can be shaped by environmental factors. Some of these factors include social determinants of health, placement of and access to treatment and harm reduction services, and other public health infrastructure. The Geospatial Core will support innovative projects that will leverage geospatial data to yield insights into the spatial contexts surrounding the overdose crisis. Examples of techniques that could be leveraged in this Core include, but are not limited to: geospatial modeling, data visualization and visual analytics, and geospatial intelligence. As part of this section, applicants should address the following:

• Propose a vision for research to be conducted by this Core, including details for at least one research project that could address a knowledge gap in the distribution of services or resources needed to effectively address an aspect of the overdose crisis. Describe the proposed study design, plans to ensure scientific rigor, and detailed timeline for data acquisition and analysis.
• For the remaining years of this award, a research agenda will be set annually with input from the network and subject to approval by NIDA. This could include a program to support pilot studies undertaken in collaboration with JCOIN Phase II research hubs. Outline a process for soliciting input across the network, evaluating emerging research priorities, and proposing concepts for NIDA approval on an annual basis.

Sub-section F Modeling Core (6 pages)

Advanced Methodology Research Project(s) will leverage advanced analytical approaches to conduct novel research using existing data and data acquired through the network. Examples of modeling techniques that could be used in the required project include, but are not limited to: simulation modeling, agent-based modeling, system science, network analysis, or similar. As part of this section, applicants should address the following:

• Propose (1) one research project that could provide cross-cutting information on opportunities to make maximal impact in the targeted settings. Clinical Trials are not allowed for this component, so proposed projects should leverage existing data sources and/or observational data only. A detailed plan should describe how the proposed project will be a unique and valuable contribution to the JCOIN network; a justification for selection of data sources and analytical techniques; plans for participant recruitment and retention, if proposed; and a detailed timeline for data acquisition and analysis.
• To evaluate the productivity (output and cross-hub collaboration) of JCOIN’s Phase I sites, propose a plan to gather and analyze bibliometric and other objective output data (publications, funded grant applications, etc.) of Phase I research teams. This activity should be anticipated to occur in Year 3. Assume NIDA will provide access to a roster of Phase I researchers to facilitate this process. Describe the proposed study design, plans to ensure scientific rigor, and detailed timeline for data acquisition and analysis.
• For the remaining years of this award, a research agenda will be set annually with input from the network and subject to approval by NIH. This could include a program to support pilot studies undertaken in collaboration with JCOIN Phase II research hubs. Outline a process for soliciting input across the network, evaluating emerging research priorities, and proposing concepts for NIDA approval on an annual basis.

Sub-section G Policy Landscape Core (6 pages)

The Policy Landscape Core will inventory and characterize major policy/legal/funding environment changes at the state and national level and produce datasets, mapping tools, and related resources that can be used by JCOIN researchers and other stakeholders to inform their work. These resources are not intended to be gathered primarily through surveys, although interviews of key policymakers may be one component of this work. This Core will leverage a range of scientific strategies and cutting-edge tools to provide real-time or near-real time tracking of changing laws and policies related to service delivery and its financing, with a primary focus on the broader environment related to criminal-legal systems and populations. As part of this section, applicants should address the following:

• Propose a vision for research to be conducted by this Core. Describe an approach to creating an inventory of state laws relevant to addressing an aspect of the overdose crisis in criminal-legal settings or populations. Use a specific example of a law and describe the proposed research strategy. Include an anticipated timeline for completing such an inventory and development of analytic files or data visualization tools. Describe the strengths and limitations of these data for analysis and how this will be communicated to ende users of the resources . Provide a plan for updating these resources at regular intervals.
• Separately, describe an approach to creating an inventory of policies or practice guidelines that are not codified in law but vary by state and likely influence service delivery in criminal-legal settings or populations. Use a specific case example and describe the proposed strategy for compiling the data. Include plans for ensuring data integrity, and include an anticipated timeline for completing such an inventory and development of analytic files or data visualization tools. Provide a plan for updating these resources at regular intervals.
• Additional inventories of the policy landscape are likely to be developed post-award in consultation with NIDA and based on the specific interests of the JCOIN Phase II Research Hubs. Outline a process for soliciting input across the network and evaluating emerging research priorities on an annual basis.

Letters of support:

Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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 SF424 (R&R) 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 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 requirement (https://www.healdatafair.org/resources/road-map).

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

See Part 1. 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. Overview Information 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 SF424 (R&R) 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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 SF424 (R&R) 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.

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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this NOFO:

Administrative Core:

• Does the Director have the leadership and research qualifications to lead the Administrative Core?
• Does the team have experience in supporting large-scale multi-site studies and/or networks?

Data and Analytics Support Core

• Does the Core include analytic and subject matter expertise to provide expert consultation in research areas relevant to substance use and overdose in criminal-legal settings and populations?
• Does the Core include sufficient support for analytic requests and rapid-turnaround requests from researchers including NIDA?

Technical Assistance Core

• Does the Core include subject matter expertise in bundling variables from different datasets to form useful analytic packages?
• Does the Core describe the capacity to provide expert consultation on OUD and overdose topics in justice-involved populations?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in 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?

Specific to this NOFO:

Administrative Core:

• Does the core meet needs of the network and coordination across the MAARC?
• Is the MAARC structure sufficient, including its internal and external procedures for managing the activities of the MAARC and the network?
• Is there an appropriate plan for establishing and maintaining effective communication and cooperation among the MAARC cores? With the CTC? With the Research Hubs? Across the network as a whole?
• If investigators for different Cores will be located at different institutions, is a strong plan for coordination presented?
• Does the application describe a plan for providing training infrastructure for data set utilization, data archiving support, and analytic techniques both within the network and to external stakeholders?

Data and Analytics Support Core

• Is there a transition plan for Year 1 that includes continuing support for a central data sharing platform, and supporting the orderly closeout of Phase I projects including plans for data sharing and data archiving?
• IIs there a plan to support the ongoing data collection, management, storage and archiving of quantitative and qualitative data across Phase II studies? Does this plan address data security, data standards, and data quality?
• Is there a plan for onboarding Phase II Research Hubs in Year 2, including supporting research hub data harmonization, creating data use agreements, establishing expectations for data sharing, data uploads, and collaborative cross-hub analyses?
• Is there a plan to facilitate automatic data uploads from participating Phase II Research Hubs, and a formal plan for data retrieval? Does this plan detail the pros and cons of each proposed approach for ensuring seamless automatic data uploads?
• Are there plans to optimize and support the use of data via secondary data analyses?
• Are there plans to engage representatives from each Phase I and II project to facilitate utilization of the data and address data concerns/challenges that arise from the Research Hubs?

Technical Assistance Core

• Does this core include a comprehensive plan to consultation on a range of analytic approaches relevant to OUD and overdose among justice-involved populations and criminal-legal settings? Do these approaches cover a wide range of study designs and address both qualitative and quantitative data?
• Is there a formal plan to solicit input from researchers and stakeholders on topic areas to include in national surveys?

Survey Research Core

• Are there plans to conduct at least one annual national public opinion survey in Years 2-5? To what extent do the plans for these surveys reflect rigorous study designs likely to yield insights into public perspectives on addiction policy and practice?
• Does the approach include a strong plan for conducting a national survey of jail administrators?
• Is there a plan for rapid translation of insights through coordination and collaboration with other components of the network?

Geospatial Research Core

• Does the plan propose one or more innovative geospatial projects?
• Is there a strong plan for how the research project(s) will interface with the network?

Modeling Research Core

• Does the plan propose one or more innovative modeling projects?
• Is there a plan to conduct a network analysis based on bibliographic information to assess productivity and collaboration of the Phase I projects?
• Is there a strong plan for how the research projects will interface with the network?

Policy Landscape Core

• Is there a coherent vision for conducting inventories of laws and policies likely influence practices in the criminal-legal system and/or outcomes for justice-involved populations?
• Do the proposed projects include a rigorous methodology likely to yield valid results?
• Is there a plan for making analytic files and visualization tools public in a timely manner?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

For Renewals, the committee will consider the progress made in the last funding period.

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.

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that 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.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, 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 45 CFR Part 75.205 and 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 45 CFR Part 75 and 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 Core Director(s) responsible for the integration and management of activities within the Methodology and Advanced Analytics Resource Center (MAARC).
• Organizing a local Executive Committee for day-to-day management of the MAARC, coordinating across all of the MAARC components,
• Serving as a member of the JCOIN Steering Committee (SC).
• Participating in the overall coordination of NIH research efforts in justice settings; 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.
• 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 DHHS, 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), the SC, and the PIs of all JCOIN network components in order to ensure proper conduct of the MAARC.
• 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 MAARC, along with the other entities delineated above, to ensure that activities and services are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the MAARC runs in accordance with NIH policies and procedures, and is consistent with the mission of the NIH to improve public health; (3) providing input on the design, execution, and analysis of MAARC survey, modeling, and policy research protocols including proposed and delayed onset studies as described above; (4) serving as a point of contact for investigators with the NIH; and (5) communicating with Center leadership to ensure that the MAARC operates smoothly.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 notice of award. Areas of Joint Responsibility include:
• The SC is the primary governing body of the Cooperative. Award recipients must participate in the SC. The SC reviews and approves the research agenda, develops and monitors policies and procedures guiding the research activities, and oversees communications. Award recipients agree to abide by the procedures and policies established by the SC.
• Data Management, Analysis, and Access: Data generated are the property of the recipient . Research sites must provide requested data to the CTC and MAARC in a timely fashion in accordance with the policies and procedures established in study protocols and by the SC. In addition, the CTC, MAARC and all research sites must provide NIDA with access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by reci pients . Data must be shared upon request with the SC and subcommittees reporting to the SC when appropriate.
• JCOIN is intended to be a national resource, and as such, the MAARC must be prepared to share the network data under provisions that safeguard the privacy and confidentiality of respondents. Thus, the MAARC proposal should include explicit indications of how they will make their data available for broad use and on what timetable. The MAARC will provide for data sharing consistent with the network data 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.
• 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 research protocols, human subjects and other regulatory protocols, data harmonization, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

HEAL Data Sharing Requirements

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.?All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy. HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem (https://heal.nih.gov/about/heal-data-ecosystem), as described in HEAL’s compliance guidance (See Already Funded section: https://heal.nih.gov/data/complying-heal-data-sharing-policy):
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1. Select a HEAL Compliant data repository (https://www.healdatafair.org/resources/guidance/selection)

• Data generated by HEAL Initiative-funded projects must be submitted to study-appropriate, HEAL-compliant, data repositories to ensure the data is accessible via the HEAL Initiative Data Ecosystem.
• Some repositories require use of specific data dictionaries or structured data elements, so knowing your repository’s requirements up front can help reduce the burden of preparing data for submission.
• HEAL-funded recipients must follow requirements for selected repository

2. Within one year of award, register your study with the HEAL platform (https://heal.github.io/platform-documentation/study-registration/)

• This process will connect the Platform to information about your study and data, including metadata, and identify the selected repository. HEAL requests initial submission within one year of award, with annual updates, and to be updated in accordance with any release of study data.

3. Within one year of award, submit HEAL-specific study-level metadata.

• Some of the required study-level metadata (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) will be auto-populated as part of the registration process.
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4. Submit data and metadata (and code, if applicable) to HEAL-Compliant repository

• At the completion of the study and/or when prepared to make the final data deposits in the repositor(ies) of choice, ensure your study registration (https://heal.github.io/platform-documentation/study-registration/) is complete.
• The NIH HEAL Initiative expects data used in publications to be submitted to repositories at the time of or prior to publication, and no later than the end of the project period.

5. Additional Requirements for HEAL Initiative studies conducting clinical research or research involving human subjects.

These studies must meet the following additional requirements:

• HEAL Initiative trials that are required to register in clinicaltrials.gov should reference support from and inclusion in the HEAL Initiative by including the standardized terms the HEAL Initiative (https://heal.nih.gov/) in the Study Description Section.
• All new HEAL clinical pain studies are required to use core questionnaires required by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements). Outside of the core questionnaires, studies should select questionnaires from among the repository of supplemental questionnaires that are already being used by other HEAL clinical pain studies. The program has created the CDE files containing standardized variable names, responses, coding, and other information for all of these questionnaires The program has also formatted the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C 794 (d); https://www.govinfo.gov/content/pkg/USCODE-2011-title29/html/USCODE-2011-title29-chap16-subchapV-sec794d.htm) which require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.
• Studies that wish to use questionnaires not already included in the HEAL CDE repository should consult with their program official and the HEAL CDE team. New questionnaires will be considered for inclusion in the repository on a case-by-case basis and only when appropriate justification is provided.
• 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. For additional information, visit the HEAL CDE Program (https://heal.nih.gov/data/common-data-elements).
• 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.
• To the extent possible, HEAL recipients are expected to integrate broad data sharing consent language into their informed consent forms.

Additional details, resources, and tools to assist with data related activities can be found at https://www.healdatafair.org/.

All data collected as part of the NIH HEAL Initiative are so collected under a Certificate of Confidentiality and entitled to the protections thereof. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution’s NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d). Failure to adhere to this criterion may result in enforcement actions.

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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 (currently 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 45 CFR Part 75 and 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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Shelley Su, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-3869
Email: [email protected]

Beda Jean-Francois, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]

Valerie Maholmes, PhD, CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: [email protected]

Dharmendar (Dharm) Rathore, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: [email protected]

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6705
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

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 45 CFR Part 75 and 2 CFR Part 200.