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 Opportunities (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 DCDC will facilitate collaboration among the RRHs 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.

Regional Research Hubs: Scope of Activities and Purpose

This NOFO specifically seeks applications for RRHs. A priority for the proposed HIV/Justice research hubs is to engage justice system stakeholders and HIV/SUD treatment stakeholders in geographic regions where there is a disproportionate HIV burden – generally speaking, these tend to be areas in which little justice system research has been conducted at all. Study sites outside of the EHE priority jurisdictions may be selected with adequate justification. The use of phased awards will allow researchers time to establish and build partnerships with justice and healthcare (HIV and SUD) service providers in these geographic areas, engage them meaningfully in the study design process, and assess feasibility by pilot testing interventions and study procedures. The initiative will focus on HIV prevention and treatment services, in tandem with SUD treatment. The overarching goal is to develop effective, replicable, scalable models for delivering integrated HIV/SUD services in high-risk areas and to high-risk populations involved in the criminal legal system.

Each RRH is strongly encouraged to form its own structure for obtaining local stakeholder input on an ongoing basis. This may include a community advisory board (CAB) or similar structure. Optimally, stakeholders will bring perspectives at multiple levels (patient, provider, program, payer) relevant to the RRH’s proposed research project. Note that RRH CABs are distinct from, and complementary to, the activities being conducted by the PERC. RRH CABs should reflect the population, infrastructure, and priorities of the communities in which the RRH projects are based. The PERC activities are designed to bring a broader patient-centered perspective that will contribute to the generalizability of these projects.

RRHs will be supported through phased awards with four required activities:

1. In the R61 phase, conduct a pilot test of key components of a service delivery model(s) or implementation strategy to improve the delivery of HIV diagnosis, prevention and treatment and SUD treatment, recovery and/or harm reduction services for populations with criminal legal system involvement. This pilot test, along with justice agency and health care (HIV and SUD) service provider input, and input from the companion PERC advisory panel, will inform the final design of the implementation trial to be conducted in the R33 phase.
2. Also during the R61 phase, engage with other funded projects and the DCDC to select a set of common measures to be collected across all R33 studies.
3. During the R33 phase, conduct a hybrid implementation-effectiveness trial in at least three distinct communities (as defined below), focused on testing a service delivery model to improve engagement in HIV diagnosis, prevention and treatment and SUD treatment, recovery, and/or harm reduction by individuals involved with the criminal legal system with SUD. Periodically and strategically seek and receive input from members of the companion PERC to ensure that research questions and study results directly address the input of individuals with lived experience in HIV, SUD, and criminal legal system involvement, and are informed by the experience of individuals from outside the hub’s communities and service systems.
4. During the R33 phase, reserve funds to support the RRH’s engagement in at least one collaborative pilot study with one or more other RRHs. The topic and scope of the collaborative pilot study will be determined post-award by the RRH teams (i.e., these will be delayed onset studies), and will be designed to leverage opportunities that uniquely draw on the characteristics of the funded RRHs, communities, and partner agencies. Collaborative pilot studies will require NIDA Program Officer approval prior to launch.

See additional details provided in the Research Plan instructions under Section IV.2 of this NOFO.

Network Participation: The RRH investigators are expected to participate in monthly steering committee or work group calls with the other RRH, PERC, and DCDC investigators. One annual in-person meeting for the Network, in the Washington DC area, to include key project staff for each RRH (likely 4-5 team members), should be anticipated. During the R61 phase, RRH awardees will collaborate with other RRHs and the DCDC to identify a set of common measures to be collected across all studies in the R33 phase, and determine policies and processes for data sharing and collaborative analysis. All participants in the Network will have opportunities to collaborate on emergent, shared priorities.

Definitions: Communities and Community Partner Organizations

Communities: RRH applications are required to focus on service delivery within one or more of the EHE priority jurisdictions – that is, the 50 counties accounting for the majority of new HIV diagnoses, and seven states with substantial rural HIV burden – or communities with demonstrated HIV burden among their criminal legal system involved population. Strong justification should be provided for selecting communities outside of the EHE priority jurisdictions. For the purpose of this NOFO, applicants may propose to engage multiple priority jurisdictions, or multiple distinct catchment areas or service delivery areas within the same priority state or county. In selecting sites, applicants should consider the likelihood that the proposed service delivery model would be scalable beyond the participating sites.

Criminal Legal System/Justice System: For the purposes of this NOFO, “criminal legal system” and “justice system” 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. Applicants may focus on one or more intercept points.

Applicants must demonstrate collaboration with at least one criminal legal agency either located in or serving at least one target community, with plans to engage appropriate partners in a total of three communities (as defined above) by the end of the R61 phase. Depending on the communities selected, applicants may choose to partner with a single correctional facility or agency that has a large volume of clients returning to multiple distinct service delivery areas (e.g., neighborhoods, cities, counties). In either case, applicants should provide data on the flow of clients from the criminal legal agency to the communities of interest.

HIV and SUD Service Providers: In each target community, applicants must 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.

Phased Awards and Required Milestones

This NOFO uses a R61/R33 Exploratory/Developmental Phased Award activity code. Support will be provided for up to 5 years, which includes a 1-year R61 phase, followed by up to 4 years of support for the R33 phase upon successfully meeting the R61 milestones.

The R61 phase is a planning phase during which awardees will engage with partnering criminal legal agencies, HIV/SUD providers, and other key stakeholders to build cross-system collaborations. Agency partners from at least one community must be named in the application; by the end of the R61 phase, RRHs should have established working relationships and secured the commitment of criminal legal agencies and HIV/SUD service providers in a total of at least three communities to participate in the R33 trial. In the R61 phase, with these agency collaborators, the RRH will identify priority areas for improvements in the delivery of HIV prevention and treatment services to populations with criminal legal involvement and SUD; identify and secure access to relevant data sources (if applicable); formalize necessary interagency agreements; and conduct a pilot trial focused on assessing acceptability and feasibility of implementing evidence-based HIV interventions (see CDC resources) alone or in combination with evidence-based SUD interventions in a defined segment of the justice system. The pilot trial should inform the final design of a multisite trial to be conducted in at least three communities in the R33 phase.

Also, during the R61 phase, awardees will collaborate with other RRHs and the DCDC to identify a set of common measures to be collected across all studies in the R33 phase, and determine policies and processes for data sharing and collaborative analysis. (Data harmonization and technical support for data sharing will be the responsibility of the DCDC; see RFA-DA-24-023 for details.) Study designs for the R33 phase will be expected to incorporate these measures. R33 study designs should also be informed by consultation with the PERC’s patient advisory panel (see RFA-DA-22-022 for more details).

Applications must include a set of milestones for the R61 phase. Milestones should be written such that their achievement is a strong indication of the applicant’s readiness to move to the R33 phase. Achievement of R61 milestones will be one critical factor in determining whether an award will transition to the R33 phase. Applicants are strongly encouraged to include contingency plans to proactively confront potential delays in meeting the milestones. 

The goal of the R61 phase of the award is to demonstrate readiness and capacity – including necessary interagency partnerships – to execute the proposed R33 trial. For transition to the R33 phase, recipients must submit a transition package no less than two months before the completion of the R61 phase. The transition plan must include the R61 progress report describing in detail the progress towards the R61 milestones and a description of how research proposed for the R33 phase will be supported by the completion of the R61 phase milestones. These materials will be evaluated by NIH program staff to determine if the milestones were met. Achieving the R61 milestones is a necessary but not sufficient condition for transition to the R33 phase. R33 funding decisions will be based on the original R61/R33 peer review recommendations, successful completion of transition milestones, any proposed changes to the R33 research based on R61 findings, program priorities, and availability of funds.

The primary objective of the R33 phase will be to conduct a multisite clinical trial testing a proposed model for delivering evidence-based HIV prevention and treatment services in combination with evidence-based SUD services in a defined segment of the criminal legal system in at least three distinct communities. The proposed trial must include a significant implementation research component – that is the study must incorporate a Hybrid 2 or Hybrid 3 (implementation-effectiveness) trial. Each R33 trial will be expected to collect the common measures agreed upon during the R61 phase, and to periodically consult with the PERC’s patient advisory panel.

During the R33 phase, each RRH is expected to identify at least one opportunity to conduct a collaborative pilot trial with one or more other RRHs. The purpose of these pilot trials is to take advantage of opportunities to conduct research across the systems and communities participating in the broader HIV/Justice Research Network. These projects could include, for example, pilot studies to assess whether an intervention or implementation strategy used in one R33 is scalable to other communities, or they could capitalize on an emergent opportunity, such as a local policy change or high priority questions introduced by the PERC’s patient advisory panel. Guidance for budgeting these collaborative pilot projects is provided in Section IV.2 of this NOFO.

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.

Pre-Application Consultation:

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

Applications Not Responsive to this NOFO:

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

• Applications that have not included Letters of Support from relevant criminal legal agencies and HIV and SUD service providers in at least one community.
• Applications that do not include a timeline and milestones attachment (see instructions in Section IV. SF424 (R&R) Other Project Information).
• Applications that do not include a stakeholder engagement plan (see instructions in Section IV.2, SF424 (R&R) Other Project Information).
• Applications that do not include both HIV and SUD-relevant outcomes.
• Applications that include research sites in communities outside the US and its territories.
• Applications that do not propose research in at least 3 communities. At least one community must be named in the Research Strategy, while the other 2 must be identified by the completion of the R61 phase.
• Applications that do not provide justification for selection of any communities that are outside of the EHE priority jurisdictions.

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.

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: NIDALetterofIntent@mail.nih.gov

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

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:

Timeline & Milestones (Required - 2 page maximum)

Applicants must include a Timeline and Milestones attachment, clearly specifying proposed milestones and when those milestones are expected to be achieved. Milestones for both phases should be specified, though it is expected that R33 milestones may change based on results from the R61 phase for awards that transition to the R33 phase. 

Stakeholder Engagement Plan (Required – 2 page maximum)

Applications must include detailed plans for engaging key stakeholders, including patients, families, providers, payers, and community leaders, as appropriate to the specific goals of their study.  

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 question(s).
• 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.

In the biosketches, highlight the experience of the PD(s)/PI(s) in engaging with patients and others directly affected by HIV, SUD, and criminal legal involvement. In the biosketches, document the experience of co-investigators or collaborators in the criminal legal system, HIV service, and SUD treatment.

R&R Budget

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

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).

Travel for annual meetings:

• Include costs associated with annual in-person 2-day meetings in the Washington, DC area for approximately 4-5 team members.

Collaborative Pilot Projects

• Applicants must budget $100,000/year (direct costs) during the R33 phase for collaborative 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:

(these agreements should be consistent with the data sharing expectations of the DMS Policy and the DMS Plan) Specific Aims:

In the single page attachment allowed for the specific aims, provide an overview of the overarching research question of interest as well as include clearly marked headers for “R61 Specific Aims” and “R33 Specific Aims” with brief descriptions of the aims specific to each phase of the study. Articulate the overall goals that will guide the proposed efforts, clearly specifying the service gap that is addressed.

Research Strategy:

Present an overview of the state of the science, current status and relevance of the proposed activities, and consideration of long-term sustainability and scalability of the proposed efforts.

Address the following criteria:

Significance: Within the R61 and R33, coherently address a single set of research questions and goals, with the R61 phase establishing feasibility and necessary partnerships for the R33 phase. Given this tight integration, only one Significance section is needed.

Provide a scientific justification for the proposed population and intervention strategy. For the R33 phase, at least three communities are required, but only one is required to be identified in the application. Additional communities can be recruited as part of the R61 phase. If the communities have been selected, they must be among the EHE Priority Jurisdictions or communities with demonstrated HIV burden among their criminal legal system involved population. Strong justification must be provided for selecting communities outside of the EHE Priority Jurisdictions. If communities have not been selected, a process for determining selection criteria must be articulated.

Innovation: Given this tight integration of the R61/R33 phases, only one Innovation section is needed. Explain how the proposed project, if successful, would lead to innovations that could improve HIV/SUD service delivery to individuals with criminal legal system involvement. Design the proposed intervention model to build on at least one of the interventions identified in the CDC Compendium of clinical interventions to diagnose, treat, and prevent HIV. Preliminary data is not required nor is it required that teams have worked together previously. However, for applications without preliminary data, provide a strong scientific premise and establish a strong rationale for how solving the challenges outlined in the application would improve HIV and substance use outcomes.

Approach: Provide separate Approach sections for the R61 and R33 phases, as described below. It is not necessary to repeat any information or details in the R33 section that are described in the R61 section. Applications must also include a Timeline & Milestones attachment as described in the SF424(R&R) Other Project Information. The approach sections may reference this attachment and limit what is repeated from this attachment, except where necessary for clarity.

R61 (Phase 1) Approach:

Include the following in the R61 Approach section:

• Specify the service gaps being targeted
• Plans for how the justice, SUD treatment provider, and HIV service provider will work with the research team in each community
• Plans for engagement with patients in the selected communities, which may include paid patient representatives as part of the research teams
• Plans for engagement with the PERC, to include periodic consultation with the PERC’s patient advisory panel
• Plans to prepare for the clinical trial in the R33, including working with the DCDC and the other RRH investigators to create a set of core measures
• Evidence that a sufficient sample size can be recruited to answer the proposed research questions
• Description of plans to enhance the likelihood that innovations developed in the application will be sustained, including engaging relevant stakeholders
• Description of issues of health disparities and health inequities and the relevance to the interventions or services being studied
• Specification of relevant milestones (see below)
• Contingency plans if milestones cannot be achieved
• For RRHs that have not yet identified at least three communities, plans for identifying and recruiting communities into the study

The R61 Approach section must include milestones that are expected to be achieved by the end of the R61 phase. Include milestones that are specific, quantifiable, and scientifically justified, and do not simply restate the specific aims for the R61 phase.

Examples of Milestones to transition to the R33 Phase:

• Demonstration of active engagement and partnership in a minimum of three communities, to include representation from the criminal legal system, HIV services, and SUD treatment organizations
• Fully executed Memorandum of Understandings, letters of support, and data sharing agreements from partnering departments, agencies or stakeholders (note: these data sharing agreements must be consistent with the data sharing expectations of the NIH DMS policy and the investigator's DMS plan)
• Finalized intervention and research protocols necessary to launch the R33 phase of the project, including assessments that incorporate the agreed upon network Common Data Elements (CDEs) and plans to involve PERC advisors and/or local CABs
• Preliminary data demonstrating feasibility of R33 phase
• Institutional Review Board (IRB) and Office for Human Research Protections approval for the R33 phase

For applications where there is no preliminary data or where new partnerships are proposed, be especially attentive to proposing milestones that will help establish the feasibility of the proposed R33 project.

R33 (Phase 2) Approach:

Although the Research Strategy for the R33 phase is expected to be broad and flexible due to the nature of the explorative research in the R61 phase, describe the Research Strategy for the R33 phase of the award in enough detail for reviewers to evaluate the merit of this component of the application, based on anticipated results.

For the R33 phase, include a clinical trial and all relevant information in the PHS Human Subjects and Clinical Trials Information section, with the understanding that the overall design of the R33 phase may be modified based on findings from the R61 phase, in consultation with NIH program staff. For the R33 phase Research Strategy, include plans to collaborate with other hubs on delayed onset studies.

Interaction with HIV/Justice Supportive Infrastructure

Awards made under this NOFO are part of a coordinated initiative and, as such, will have access to a robust set of supportive infrastructure resources. perform the proposed work, however it is also expected that additional needs could arise. Specifically, the HIV/Justice program will provide R61/R33 applicants with supportive infrastructure in the following areas:

• Data infrastructure, coordination of CDEs, and data sharing resources
• Economic & modeling support
• Dissemination and implementation supports
• Patient engagement expertise and resources

Describe how the RRH could take advantage of the supportive infrastructure and engage with the network. At a minimum, applicants should expect to engage in a kickoff meeting with all recipients of the Justice/HIV network awards and in monthly steering committee or work group meetings. Work group meeting participation may be more frequent in the first year of the project. Most meetings will take place virtually, but applicants should plan for one in-person meeting per year. In addition, all RRH applicants should include plans to participate in annual meetings with the PERC advisors and plans for regular check-ins with NIDA program staff.

Individual PERC advisory panel members will be offered the opportunity to be more deeply involved in an RRH study. The PERC will develop a process for soliciting interest from the RRHs, and for “matchmaking” with an appropriate PERC patient advisor. This matchmaking process will ensure that the opportunity is mutually beneficial for both the advisor and the RRH project. When such matches are identified, the PERC advisor will be incorporated as a member of the research team or as a paid consultant for a discrete activity during the R33 phase of the study. Support for the PERC advisor involvement may be covered in full or in part by the PERC. The nature and scope of these projects will be determined by the network (RRH PIs, PERC PI and patient advisors, Coordinating Center PI). The NIDA Science Officer will also be involved in study design. These should be proposed and budgeted as delayed onset studies and may not proceed without the approval of the NIDA Program Official. In light of the anticipated PERC infrastructure, describe potential opportunities for interaction with the PERC patient advisors. 

Describe the roles of PD(s)/PI(s) and criminal legal system/community partners and describe how they are suited to those roles given their experience and training.

Multiple PI/PD Leadership Plan: For applications proposing multiple PD(s)/PI(s), describe the PDs/PIs' complementary and integrated experience and skills, and describe an approach, governance, and plans for conflict resolution and organizational structure appropriate for the proposed research hub.

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, letters of support from those individuals and a description of their planned participation in the project must be included. Also, include letters of support from other relevant stakeholders, including consultants, who will facilitate one or more aims of the proposed project.

• Predictive, simulation, geospatial, and cost modeling to aid in forecasting service needs
• Costing tools to estimate costs of implemented changes and their outcomes

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.

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 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.

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

Section V. Application Review Information

1. Criteria

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

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the 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?

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: How are issues of sustainability and scalability addressed in the application? How strong is the plan to recruit communities among the EHE Priority Jurisdictions, or communities with demonstrated HIV burden among their criminal legal system involved population? If the application proposes research outside of an Ending the HIV Epidemic priority jurisdiction, how strong is the justification for conducting research in another community or the process to determine selection criteria? 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?

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

Specific to this NOFO: To what extent are criminal legal system, HIV service, and SUD treatment providers included as co-Investigators or collaborators? How much experience do the PD(s)/PI(s) have engaging with patients and others directly affected by HIV, SUD, and criminal legal involvement? 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?

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 does the proposed intervention model build on at least one of the interventions identified in the CDC Compendium of clinical interventions to diagnose, treat, and prevent HIV? How well does the proposed project have the potential to provide insights that would support new or different ways of addressing the HIV and SUD service gaps for individuals with experience in the criminal legal system? How well does the application address the scalability and sustainability of the innovations being studied? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

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?

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 well-conceived are the plans for stakeholder engagement and patient engagement? How adequate is the plan to collaborate with at least one criminal legal agency, either located in or serving at least one target community, and plans to engage appropriate partners in a total of three communities by the end of the R61 phase? How well does the proposed approach establish partnerships with HIV and SUD service providers offering a full menu of evidence-based diagnostic, prevention and treatment services?  How well does the application take into consideration the issues of health disparities and health inequities and the relevance to the interventions or services being studied? How strong is the R33 phase plan to include a significant implementation research component, i.e., a Hybrid 2 or Hybrid 3 (implementation-effectiveness) trial? How well-defined, well-described and quantifiable are the Milestones? How clear is it that the R33 phase of the study will build on the R61 if the R61 milestones are achieved? 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?

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

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 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, 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.”

Not Applicable

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.

In addition, applicants must:

• Provide updates at least annually on implementation of the PEDP.

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.

Section VII. Agency Contacts

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

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

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

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

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

Carrie Mulford, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6473
Email: NIDAHIVCJNetwork@nida.nih.gov

Dharmendar Rathore, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email:dharmendar.rathore@nih.gov

Ericka Wells
National Institute on Drug Abuse (NIDA)
Phone: 301-827-6705
Email:wellse2@nida.nih.gov

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.