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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) 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

The US cannot end the HIV epidemic without attending to the risks and service needs of individuals involved with the criminal legal system. Populations identified in the federal Ending the HIV Epidemic (EHE) Initiative are over-represented in the criminal legal system, although the initiative does not specifically address justice-related settings. These over-represented populations include people who inject drugs, as well as key populations where drug use often contributes to sexual risks, such as sex workers and members of sexual gender minorities. NIDA has a long and productive history of conducting research on addiction services in justice settings. At the same time, a robust toolkit of clinical interventions to diagnose, treat, and prevent HIV exists (see CDC Compendium), but more research is needed to address significant service delivery gaps at all points of the HIV care cascade, particularly for justice-involved populations.

Network Structure & Objectives

Three interrelated Notices of Funding Opportunity (NOFOs) will collectively support a research network focused on addressing the need for integrated HIV and substance use disorder (SUD) services in justice-involved populations: RFA-DA-24-015 seeks multiple Regional Research Hubs (RRHs); RFA-DA-24-023 will support one Data Coordination and Dissemination Center (DCDC); and RFA-DA-24-022 will support one Patient Engagement Resource Center (PERC). Collectively, this HIV/Justice Research Network will focus on developing scalable models for delivering HIV diagnostic, prevention and treatment services for individuals with substance use disorders (not limited to opioid use disorders) who are involved in the criminal legal system, including both adults and juveniles, whether within carceral settings (jails and prisons); under community supervision (probation and parole); or at earlier intercept points (e.g., diversion, deflection, courts). Intervention approaches to address HIV should be focused on the EHE strategies (diagnose, treat, prevent, respond), as appropriate to the needs of the population and study design. The Data Coordination and Dissemination Center will facilitate collaboration among the Research Hubs and ensure translation and dissemination of study findings and related resources to key audiences best positioned to influence practice change. The PERC will directly engage persons with lived experience in HIV, SUD, and the criminal legal system and ensure that patient perspectives are broadly represented across the entirety of the network’s activities.

Data Coordination and Dissemination Center: Scope of Activities and Purpose

It is imperative that applicants for the Data Coordination and Dissemination Center carefully review the companion NOFOs for the RRHs (U01) (RFA-DA-24-015) and PERC (RFA-DA-24-022) to understand the full mission of this initiative.

This NOFO seeks applications for a DCDC to provide overarching infrastructure support to this network, including the RRHs and the PERC. Specific responsibilities of the DCDC will include administrative and logistical support; data and analytic support; dissemination and stakeholder engagement support; as well as targeted research projects to support the overall work of the network.

The DCDC will support the RRHs, each of which will conduct a phased research project with the goal of developing effective, replicable, scalable models for delivering integrated HIV/SUD services for criminal legal populations in communities with disproportionate HIV burden and to high-risk populations. The RRH phased awards will include an R61 pilot phase and a R33 phase where each Hub will conduct a multi-site hybrid effectiveness implementation study. RRHs will be expected to use common measures across the R33 studies and will also conduct collaborative research projects with other RRHs. The PERC will directly engage persons with lived experience in HIV, SUD, and the criminal legal system and ensure that patient perspectives are broadly represented across the entirety of the network’s activities. The DCDC will play a critical role in facilitating coordination and collaboration across the network to support these activities, including facilitating efforts around common measures and collaborative research projects across the Regional Research Hubs and working collaboratively with the PERC to address stakeholder engagement.

Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the network by working together with individual RRHs and the PERC. 

Elements of the Data Coordination and Dissemination Center

The DCDC will provide the following services and resources to the network:

Administrative Coordination and Communication:

The DCDC will provide overall infrastructure support to the HIV/Justice Research Network as a whole. This includes the following administrative coordination and communication activities:

• Provide logistical support and hosting monthly executive committee meetings and an annual in-person executive committee meeting throughout the project period. The executive committee will be composed of research investigators, patient, and stakeholder representatives from each research center; investigators from the PERC; and the DCDC. These meetings will provide a forum to  (1) present research updates; (2) share research resources; and (3) identify opportunities for synergy and collaboration (e.g., data harmonization, protocol modifications).
• Coordinate trans-network working groups that arise to support synergistic activities within this network (e.g., publication policy, data policy, biostatistics, and subject recruitment).
• Establish internal and external facing communication infrastructure.
• Provide resources and support for coordinated tracking of network-wide projects and progress

Dissemination Support and Stakeholder Engagement:

The DCDC will be expected to lead efforts to translate network findings into resources of interest to external stakeholders. To achieve this goal, the DCDC will be responsible for facilitating bidirectional communication and translation between network investigators and external stakeholders. External stakeholder groups include practitioners and policymakers at local, state, and federal levels across a range of criminal legal settings and community-based HIV and SUD services providers that work with justice-involved populations (see below for operational definitions). Responsibilities will include:

• Identifying key audiences for dissemination and engagement and best pathways to communicate with these audiences.
• Developing courses, resources, and other research-based materials to support widespread adoption of science-based practices and interventions. The DCDC is expected to work closely with the RRHs and PERC to determine what dissemination support and products would be most beneficial to the projects and the field more broadly. Each year the grant is active, the DCDC will collaboratively develop a work plan to provide timely support.
• Track publications, products, and other materials developed by the RRHs and PERC and facilitate the dissemination of these materials, including creating translational products for various audiences.
• Rigorous tracking of metrics to better understand the utilization and uptake of the products created.

Rapid Research Projects:

Policies and practices are rapidly changing and many opportunities for generating insights into the effectiveness of emerging policies and practices go uncaptured. As well, key research questions may emerge from collaborative discussions across the network. The DCDC is expected to provide a flexible structure to be responsive to these emerging needs, including capacity to conduct novel policy, modeling, survey and/or epidemiological research to help support the efforts of the RRHs and broaden the impact of the network. Responsibilities include:

• Proposing one research project to take place during the first year of the network that could provide cross-cutting information on opportunities to make maximal impact in the targeted settings.
• For remaining years of the network, a research agenda will be set annually with input from the network and subject to approval by NIH. Applicants should outline a process for soliciting input across the network and evaluating emerging research priorities on an annual basis.

Data and Analytic Support:

The DCDC is expected to provide robust services related to data and analytic support, including the following activities:

• Provide NIH with quarterly reports on overall network progress related to participant recruitment, enrollment, findings from the clinical research centers within this network, and other progress metrics.
• Facilitate and support efforts by the RRHs to select and implement Common Measures, Data Sharing, and Data Coordination. This may include conducting pilot work to assist in the selection and prioritization of measures. Common Measures will be selected through collaborative discussions among the RRHs and PERC. This work is expected to build upon core measures that have already been developed for related initiatives, such as the Justice Community Opioid Innovation Network (JCOIN). See: https://nida.nih.gov/research/nida-research-programs-activities/justice-system-research.
• Provide resources to support and expand upon economic analyses proposed by RRHs if necessary and/or lead network-wide economic analysis efforts.
• Develop and implement a plan for data sharing and collaborative analyses across the network, including providing shared infrastructure while the awards are active and taking the lead in planning and coordinating data archiving efforts.
• Provide resources to supplement/support analytic efforts for pilot studies and cross-hub research efforts as needed.

See additional details provided in the Research Plan instructions under Section IV of this NOFO.

Definitions: Communities and Community Partner Organizations

For the purposes of this NOFO, the DCDC should consider stakeholder engagement with the following definitions in mind:

Criminal Legal Systems: RRH projects will take place in justice or criminal legal settings. For the purposes of this NOFO, “criminal legal systems” or "justice systems" are used interchangeably. They are broadly defined to include prisons, jails, drug courts and other problem-solving courts, diversion and deflection programs, transitions to secure settings from communities (e.g., central intake facilities), transitions from secure settings to communities (i.e., re-entry), and community corrections (probation and parole). Juvenile justice systems are also permitted. This initiative may include projects that focus on one or more intercept points from the perspective of the sequential intercept model.

HIV and SUD Service Providers: RRH projects must also establish partnerships with HIV and SUD service providers offering a full menu of evidence-based diagnostic, prevention and treatment services. The definition of service providers is intentionally broad to account for state and local variation in how and where services are delivered, as long as the providers collectively offer the full array of evidence-based interventions to address HIV and SUD. Nontraditional entities such as syringe service programs and other harm reduction services, mobile health units, and peer recovery services may be included. The actual configuration of HIV and SUD partners is expected to vary based on the study design and the configuration of the service delivery system in the target areas. It is acceptable for a project, with clear justification, to engage a single healthcare entity serving multiple distinct communities. In this case, design considerations regarding enrollment, randomization, follow-up, contamination, and generalizability should be clearly addressed.

Applicants should consult and strongly consider use of the core measures developed for the Justice Community Opioid Innovation Network (JCOIN), available at: https://nida.nih.gov/research/nida-research-programs-activities/justice-system-research. Where appropriate, successful applicants will be encouraged to collect common organizational, environmental or other contextual data in addition to patient-level common measures.

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.

Plan for Enhancing Diverse Perspectives (PEDP). ?This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

The following applications will be considered non-responsive and will not be reviewed:

• Applications that do not include descriptions of all required activities (see Section IV.2, Research Strategy, Sections A-E)
• Applications lacking a Plan for Enhancing Diverse Perspectives 

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.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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 Policy on Late Submission of Grant 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 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 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 SF424 (R&R) 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 instructions.

The Research Strategy must consist of the following subsections with the indicated page limits:

Section A: Overall Plan and Structure: required - 6 pages

Section B: Administrative Coordination and Communication: required - ?6 pages

Section C: ?Dissemination Support and Stakeholder Engagement - 6 pages

Section D: Rapid Research Projects - 6 pages

Section E: Data and Analytic Support - 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, with the following additional instructions.

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

In an “Other Attachment” entitled “Plan for Enhancing Diverse Perspectives,” all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1 page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research questions.
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

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

Within the biosketches, highlight the subject matter expertise of the PD(s)/PI(s) in addiction health services, justice research, implementation science, communications, and curriculum development. Include the biosketch(es) of one or more collaborators who have experience working with practitioners in real-world implementation settings.

R&R Budget

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

Annual Meetings

• Include costs associated with hosting annual 2-day in-person Network meetings in the Washington, DC area, to be attended by approximately 30-50 people.

PEDP Implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

Rapid Research Projects: 

Budget a minimum of $200,000 and a maximum of $300,000 (direct costs) to support the proposed Rapid Research Projects.

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 DCDC, including the key responsibilities and overall goals of the Center. 

Research Strategy: 

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

The Data Coordination and Dissemination Center should be viewed as a resource center that provides support to individual research centers, to the network as a whole, and to the greater community of stakeholders engaged in working at the intersection of the criminal legal system, substance use disorders, and HIV prevention and treatment. Prepare sections A-E with this broader context and goal in mind. Describe the overall structure of their proposed Data Coordination and Dissemination Center.  Throughout sections A-E, address how the specified responsibilities will be executed to establish the research resources, and include details on workflow plans and timelines. 

Include a diverse set of expertise within the team to provide multi-disciplinary perspectives.

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: 

Section A. Overall Plan and Structure (6 pages): 

Include the following:

• Describe the overall organizational structure of their proposed Data Coordination and Dissemination Center (DCDC). Include a description of the unique advantages or capabilities of the proposed center and how it will support and interact with the broader HIV/Justice Research Network, including the RRHs and PERC.
• Describe the goals of the overall HIV/Justice Research Network and how the DCDC will relate to the Regional Research Hubs (RRH) and Patient Engagement Resource Center (PERC).
• The DCDC should be viewed as interrelated elements that provide support to individual RRHs and to the Network as a whole. Because each element should be strong individually and complementary to the other elements and the broader HIV/Justice Research Network, describe the synergy across elements. Explain how different elements of the DCDC, including key personnel, will interact, why they are essential to accomplishing the overall goals of the HIV/Justice Research Network and how combined resources create capabilities that are more than the sum of the parts. 
• Detail the team's expertise in the following areas: HIV prevention and treatment; SUD treatment services; services delivered in criminal legal settings; communications; implementation science; curriculum development.
• Provide a strong plan to ensure that key personnel will collaborate effectively. 
• If the different elements (Sections B-E) will be based at different locations, provide a strong plan for communication and collaboration. Applicants are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the overall initiative.
• Describe workflow plans and timelines.

Section B. Administrative Coordination and Communication (6 pages):

Outline plans to provide the following: 

• Provide logistical support and hosting monthly Executive Committee meetings and an annual in-person Executive Committee meeting throughout the grant award. Describe plans to provide a forum to discuss the activities of the HIV/Justice Research Network as a whole, including: (1) research updates; (2) share research resources; (3) opportunities of synergy and collaboration (e.g., data harmonization, protocol modifications).
• Coordinate trans-network workgroups that arise to support synergistic activities within this network (e.g., publication policy, data policy, biostatistics, and participant recruitment).
• Establish internal and external facing communication infrastructure.
• Provide resources and support for coordinated tracking of network-wide projects and progress.
• Confirm that the DCDC will secure a HIPAA-compliant videoconferencing license to be used in hosting meetings with grantees and external stakeholders. 

Section C. Dissemination Support and Stakeholder Engagement (6 pages): 

Outline plans to provide the following:

• Identifying key audiences for dissemination and engagement and best pathways to communicate with these audiences.
• Developing courses, resources, and other research-based materials to support widespread adoption of science-based practices and interventions. The DCDC is expected to work closely with the RRHs and the PERC to determine what dissemination support and products would be most beneficial to the projects and the field more broadly. Each year the grant is active, the DCDC will collaborate with the RRHs and PERC to develop a work plan to provide timely support to achieve shared goals and vision.Describe how the DCDC will approach and lead this collaborative effort. 
• Approach to tracking publications, products, and other materials developed by the RRH’s and PERC and facilitating the dissemination of these materials, including creating translational products for various audiences.
• Rigorous tracking of metrics to better understand the utilization and uptake of the products created.

Section D. Rapid Research Projects (6 pages)

Outline plans to provide the following:

• In the course of executing pilot trials, engaging with key stakeholders, and identifying collaborative research goals, the HIV/Justice Research Network is expected to identify additional or emergent priority topics for rapid investigation. These projects may range from piloting core measures to survey and modeling research to implementation trials. Describe the capacity to flexibly conduct discrete rapid turnaround research projects.
• Propose one research project to take place during the first year of the network that could provide cross-cutting information on opportunities to make maximal impact in the targeted settings..
• For remaining years of the network, a research agenda will be set annually with input from the network and subject to approval by NIH. Outline a process for soliciting input across the network and evaluating emerging research priorities on an annual basis. Applicants are strongly encouraged to specify one or more implementation science frameworks that will guide the approach to these activities. 
• As part of this effort, applicants may propose approaches to support pilot projects from both within and outside the network. If applicants choose this approach, describe the program and how ideas will be vetted. Note that all projects funded through this core must receive NIH approval before commencing.

Please see Section IV R&R Budget for additional guidance. 

Section E. Data and Analytic Support (6 pages)

Outline plans to provide the following:

• Provide NIH with quarterly reports on overall network progress related to participant recruitment, enrollment, findings from the clinical research centers within this network, and other progress metrics.
• Facilitate and support efforts by the RRH’s to select and implement Common Measures, Data Sharing, and Data Coordination. This may include conducting pilot work to assist in the selection and prioritization of measures. Common Measures will be selected through collaborative discussions among the RRH’s and PERC. This work is expected to build upon core measures that have already been developed for related initiatives, such as the Justice Community Opioid Innovation Network (JCOIN). See: https://nida.nih.gov/research/nida-research-programs-activities/justice-system-research.
• Provide resources to support and expand upon economic analyses proposed by RRH’s, if necessary, and/or lead network-wide economic analysis efforts.
• Develop and implement a plan for supporting and providing a platform for data sharing and collaborative analyses across the network, including providing shared infrastructure while the awards are active and taking the lead in planning and coordinating data archiving efforts.
• Provide resources to supplement/support analytic efforts for pilot studies and cross-hub research efforts as needed.

Multiple PD/PI Leadership Plan: For applications proposing multiple PDs/PIs, describe the PDs/PIs' complementary and integrated experience and skills.

Letters of Support: For justice system, HIV, SUD treatment, and behavioral health partner organizations who have been identified and agreed to participate at the time of application, include letters of support from those individuals and a description of their planned participation in the project. Also, include letters of support from other relevant stakeholders, including consultants, who will facilitate one or more aims of the proposed project.

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. 

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.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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.

Treat all studies in the Novel Research Projects section after the Year 1 project as Delayed Onset studies.

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 Policy on Late Application Submission.

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 include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

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.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

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

Any instructions provided here are in addition to the instructions 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.

For this particular announcement, note the following:

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the 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?

In addition, for applications involving clinical trials

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

Specific to this NOFO: To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

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?

In addition, for applications involving clinical trials

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

Specific to this NOFO:

• How adequate is the evidence of synergistic, multidisciplinary expertise that will support the overall goals of the HIV/Justice Research Network? 
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

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?

In addition, for applications involving clinical trials

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

Specific to this NOFO: To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation? 

How novel are the proposed approaches for disseminating emergent findings and resources from the network?

How novel is the proposed approach to supporting the goals of the HIV/Justice Research Network through Rapid Research Projects? How innovative is the Year 1 Rapid Research Project?

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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific to this NOFO:

• How strong and coherent is the proposed approach for the overall management and coordination of the DCDC? 
• How well does the application address all elements of the DCDC, including the Overall Plan and Structure, Administrative Coordination and Communication, Dissemination support and Stakeholder Engagement, Rapid Research Projects and Data and Analytic Support?
• How strong are the plans for administrative coordination and communication resources to support the network?
• How strong is the stakeholder engagement plan? 
• How responsive is the proposed approach to supporting the goals of the HIV/Justice Research Network through Rapid Research Projects?
• How likely is it that the proposed Year 1 Rapid Research Project will support and enhance the work of the Regional Research Hubs? 
• How clear is the proposed approach for providing data and analytic resources to support the work of the Regional Research Hubs and the Patient Engagement Resource Center?
• How strong are the synergies across the proposed activities in the DCDC?
• Across the team, how adequate is the evidence of expertise in the following areas: HIV prevention and treatment; SUD treatment services; services delivered in criminal legal settings; communications; implementation science; curriculum development?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

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?

In addition, for applications involving clinical trials

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

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

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

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

Specific to this NOFO: To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Drug Abuse 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.

1. 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, including the PEDP.

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 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.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

• Federal wide Research Terms and Conditions
• 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 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.htmlandhttps://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 (DHHS) grant administration regulations at 45 CFR Parts 75, 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 award recipient(s) 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 recipient(s) for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

The PD(s)/PI(s) of the HIV/Justice Research Network Data Coordination and Dissemination Center (DCDC) in consultation with the NIDA program staff will provide communications infrastructure and logistical support for meetings of the HIV/Justice Research Network Program recipients and provide dissemination and implementation resources for the HIV/Justice Research Network’s Regional Research Hubs (RRH) and Patient Engagement Resource Center (PERC).

As outlined in this NOFO, the DCDC will establish support resources to coordinate, enhance, and support the work of the RRHs and the PERC. The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIDA staff in those aspects of scientific and technical management of the DCDC as stated in these terms and conditions.

• The PD(s)/PI(s) of the DCDC will have the primary responsibility to closely work with the RRH directors to identify and support synergies that may emerge across projects, including support work groups, common data measures, collaborative pilot studies, and other emergent research needs.
• The DCDC PD(s)/PI(s) will have the primary responsibility to convene periodic meetings of the HIV/Justice Research Network recipients to facilitate communication about their current research efforts that may be mutually beneficial to the broader program, as well as to facilitate interaction between the Research Hubs and the PERC.
• The DCDC PD(s)/PI(s) will have the primary responsibility for naming representatives to a Stakeholder Panel, and to periodically convene that panel to discuss barriers and potential solutions to implementing specific evidence-based practices for HIV and SUD prevention and treatment in justice settings.
• The DCDC PD(s)/PI(s) will support research projects designed to complement and extend the work of Network.
• Provide updates at least annually on implementation of the PEDP.
• 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 cooperative agreement will be assigned to one or more Project Scientists (PS). The PS will have substantial programmatic involvement that is above and beyond the normal stewardship role in the award and will be named in the award notice. The responsibilities of the PS include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants. The PS will participate in the definition of objectives and approaches used by the DCDC in coordinating activities of the HIV/Justice Research Network, providing consultation to the RRHs, engaging the Stakeholder Panel, and designing evaluation and research activities.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) and the PS will work closely in evaluating the most appropriate methods used to coordinate activities of the HIV/Justice Research Network Program and monitor the effectiveness of the implementation supports provided to the RRHs under this cooperative agreement.

Given the nature of the activities of this award, where the DCDC works with multiple RRHs each executing their own local studies, it is recognized that timelines, activities, and interim objectives may require revision and renegotiation during the course of the project period. The DCDC Program Director/Principal Investigator and NIDA Program Officer must agree to all such revisions.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. The first member will be named by the DCDC PD/PI; the second will be named by NIH; and a third individual with relevant expertise will be named by the other two appointees. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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.

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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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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]

Carrie Mulford, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6473
Email: [email protected]

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

Ericka Wells 
National Institute on Drug Abuse (NIDA)
Phone: 301-827-6705
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.