The purpose of this Funding Opportunity Announcement (FOA) is to support high priority research at the intersection of HIV and substance use. This FOA invites innovative research projects with the potential to open new areas of HIV/AIDS research and/or lead to new avenues for prevention, treatment and cure of HIV among people who use drugs (PWUD). Applications submitted under this FOA are required to have a detailed research plan, preliminary data, and a clear description of the nexus with substance use. This FOA is open to both individual researchers and research teams and includes all areas of research from basic science to clinical and implementation research. All studies must focus on NIH HIV/AIDS Research Priorities: NOT-OD-20-018: UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.

RFA-DA-25-060: High Priority HIV and Substance Use Research (RM1 Clinical Trial Optional)

March 31, 2025

This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s) National Institutes of Health (NIH)

Components of Participating Organizations National Institute on Drug Abuse (NIDA)

Funding Opportunity Title High Priority HIV and Substance Use Research (RM1 Clinical Trial Optional)

Activity Code RM1

Announcement Type New

Related Notices

• See Notices of Special Interest associated with this funding opportunity
• January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029.
• March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
• March 20, 2024 - Notice of Pre-Application Technical Assistance Webinar for RFA-DA-25-060. See Notice NOT-DA-24-019.
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON) RFA-DA-25-060

Companion Funding Opportunity RFA-DA-22-040, R01 Research Project

Number of Applications See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93.279

Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to support high priority research at the intersection of HIV and substance use. This NOFO invites research projects with the potential to open new areas of basic and clinical HIV/AIDS research and/or lead to new avenues for prevention, treatment and cure of HIV among people who use addictive substances. This initiative is open only to research teams of three to six PD/PIs proposing to pursue challenging research questions at the intersection of HIV and substance use. Teams are encouraged to consider far-reaching objectives that will produce major advances in high priority HIV research areas for the institute and the NIH (NOT-OD-20-018: UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding). This NOFO addresses basic science, epidemiologic, clinical, intervention, and implementation research related to HIV in people with substance use and substance use disorders (SUDs).

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.

Expiration Date New Date: March 6, 2027 per issuance of NOT-OD-26-029. (Original Expiration Date: January 08, 2027)

Due Dates for E.O. 12372 Not Applicable

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

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

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

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

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The purpose of this notice of funding opportunity (NOFO) is to support high priority research at the intersection of HIV and substance use. This NOFO invites research projects with the potential to open new areas of basic and clinical HIV/AIDS research and/or lead to new avenues for prevention, treatment and cure of HIV among people who use addictive substances. The scope of this NOFO includes basic science, epidemiologic, clinical, intervention, and implementation research. This initiative is open only to research teams of three to six PD/PIs proposing to pursue challenging research questions at the intersection of HIV and substance use. Teams are encouraged to consider far-reaching objectives that will produce major advances in high priority HIV research areas for the institute and the NIH (NOT-OD-20-018: UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding).

The proposed program goal must only be achievable by an interdisciplinary, collaborative research plan that creatively combines a variety of expertise, approaches and/or research methodologies. Applications submitted under this NOFO are required to have a detailed research plan, preliminary data, and a clear description of the nexus between HIV and substance use.

This NOFO is not intended for applications proposing projects that only expand existing research programs, nor for applications that focus only on development of new technologies, medications and/or infrastructure. Additionally, the RM1 program is distinct from the National Institute on Drug Abuse (NIDA) P01, NIDA P50, and NIH parent R01 initiatives because it will support a single-focused, ambitious, and challenging project that cannot be addressed by individual R01 applications.

Background

Substance use remains a key driver of new HIV infections and an important factor affecting clinical and health outcomes related to HIV and HIV-associated comorbidities. People who use substances often experience gaps in the HIV care continuum. New HIV cases in the US disproportionately occur among young adults, while persons living with HIV have increasingly longer lives which necessitate a lifespan perspective and recognition that patterns of substance use can vary across the life course. People living chronically with HIV and substance use also face the risk of multiple cardiovascular, respiratory, neurological and psychiatric comorbidities that affect health outcomes. This NOFO is therefore designed to attract exceptionally talented teams of investigators to conduct cutting-edge research at the intersection of HIV and substance use to stimulate basic HIV/substance use research and inform effective HIV prevention, care and cure strategies. Listed below are the NIDA’s HIV research priorities:

• Prevent new infections and transmission of HIV among people with substance use and substance use disorders (SUDs) and their sexual and/or injection partners.
• Increase the understanding of HIV etiology, pathogenesis, spread, and persistence among people with substance use and SUDs.
• Address comorbidities and improve health outcomes among people with HIV and use addictive substances.
• Accelerate scientific discoveries at the intersection of HIV/AIDS and substance use research.

Program Objectives and Scope

Applications responding to this NOFO are required to have a single overarching goal and an integrated research plan that incorporates multiple perspectives and disciplines to deliver transformative outcome(s) within the 5-year award period.

This NOFO will support interdisciplinary teams that seek to cross methodologic and conceptual boundaries through interdisciplinary collaboration to achieve a single, focused, and transformative goal. The research goal must be well-defined and sufficiently focused so that meaningful outcomes can be accomplished within 5 years. It should also be of sufficient scope and complexity that it can only be achieved through an integrative interdisciplinary team effort and not by individual, parallel, or series of efforts. All contributions by each team member and components of the research plan are expected to come together in ways that are synergistic, integrated, and essential to the overarching goal.

Applications submitted under this NOFO are required to have a detailed research plan, preliminary data, and a clear description of the intersection between HIV and substance use that will be addressed. The proposed program goal must only be achievable by an interdisciplinary, collaborative research plan that creatively combines a variety of expertise, approaches and/or research methodologies. The major thrust of the project must align with NIDA and NIH HIV research priorities described above. Addictive substances that are of interest include opioids, nicotine, cocaine, methamphetamine, other stimulants, prescription drugs, cannabinoids, xylene, or combinations of drugs (including alcohol).

The list below includes representative, but not exhaustive, examples of interdisciplinary opportunities applicable to high priority research at the intersection of HIV and substance use:

• Challenges existing paradigms of HIV testing, prevention an/or care, and overcomes long-standing roadblocks to progress in these areas.
• Develops new strategies based on systems-science approaches to drive innovative, transformative approaches of HIV testing, prevention, and/or care.
• Basic, translational, and/or clinical collaborations with a goal of reaching a significantly higher mechanistic understanding HIV and HIV latency in the central nervous system (CNS) including neurocognitive impairment in the context of HIV and substance use.
• Overcomes challenges in providing optimized ‘whole-person’ care (treatment for HIV, SUD, and comorbidities, and support services) that requires collaborations across various disciplines including clinical sciences, social and behavioral sciences, health economics, computational statistics, epidemiology, and implementation science etc.
• Address social determinants of health as they relate to the intersection of HIV and substance use in ways that go beyond descriptive research or interventions that focus on individual-level consequences of social/structural factors affecting health.
• Scientific efforts requiring integration of previously siloed and/or disparate areas of scientific, clinical or technical expertise relevant to HIV and substance use research fields.
• Challenges that necessitate bridging across species, systems (3D-tissue models), scales and disciplines to reveal shared/generalizable and/or unique biological processes linked to pathogenesis and persistence of HIV and the HIV-related comorbidities.

Particularly in the case of clinical and/or implementation science applications, multidisciplinary teams are encouraged to partner with the potential end-users of the knowledge/data that would be generated (e.g., AIDS service organizations, public health officials, health departments, justice systems, policymakers, community organizations, clinical providers, etc.). These partnerships should be documented and can include new or existing relationships. The application should describe these relationships and indicate how knowledge would be used to inform decision-making and practices in their settings.

Non-Responsiveness Criteria:

Applications deemed to be non-responsive will not proceed to review and will be withdrawn. The following are considered non-responsive to this NOFO:

• Applications including research that does not align with NIDA and NIH HIV research priorities described above.
• Applications focused solely on alcohol exposure.
• Applications proposing only to discover and/or develop a small molecule, biologic therapeutic, or therapeutic device to treat SUD or HIV and HIV-associated comorbidities.
• Clinical trials designed to answer only specific questions related to safety, tolerability, acceptability, or efficacy of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions (e.g., phase I, phase II, phase III, or pivotal clinical trials). PIs are strongly encouraged to discuss any planned clinical trial in consideration for this opportunity with the scientific program contact to avoid errors in interpretation.
• Applications proposing only clinical epidemiological or observational studies, genetic studies, or comparative effectiveness research. Applicants are encouraged to pursue other appropriate NIDA and other multi-IC HIV funding opportunities to pursue these types of studies.
• Applications proposing research and data collection outside the US will not be accepted. Applications that include foreign components are permitted where they support domestic research projects to be conducted in the US.

Program Organization

This NOFO calls for highly transformative, innovative and bold programs with a single well-defined overarching objective instead of multiple specific aims and/or projects.

This program also requires a Multiple PD/PI (MPI) structure with three to six PD/PIs who will each bring a distinct scientific viewpoint or expertise necessary to pursue the transformative goal. Each PI is expected to provide a significant, indispensable, and distinct contribution to the project. Teams must not be dominated by a single individual. Applications for smaller projects with one or two PD/PIs should consider submitting a multi-PD/PI application to the "NIH Research Project Grant (Parent R01)" or the companion funding opportunity for this NOFO i.e. RFA-DA-22-040.

When applicable, applications proposing studies with human subject samples are strongly encouraged to use NIDA funded and co-funded data and specimen resources openly available for investigators engaged in research on HIV and SUDs. Examples include: PhenX Toolkit (https://www.phenxtoolkit.org/), NIDA Longitudinal Cohort studies of people with HIV and SUD, MACS/WIHS Combined Cohort Study (MWCCS) (https://statepi.jhsph.edu/mwccs/), International epidemiology Databases to Evaluate AIDS, (IeDEA) (https://www.iedea.org/), The National NeuroAIDS Tissue Consortium (NNTC) (https://nntc.org/), The CNS HIV Antiretroviral Therapy Effects Research Study (CHARTER) (https://nntc.org/charter-study-0) and Veterans Aging Cohort Study (VACS) (https://medicine.yale.edu/intmed/vacs/).

The success of team science hinges on well-managed team interactions, clear timelines and benchmarks for success. Therefore, the following four components are required as "Other Project Information" as an attachment (see Section IV for instructions). Applications that fail to include these attachments will be considered incomplete and will be withdrawn.

1. Team Management Plan Information in the “Multiple PD/PI Leadership Plan” leadership plan is complementary to the Team Management plan; whereas the “Multiple PD/PI Leadership Plan” describes leadership by and interactions across the PD/PIs, the “Team Management Plan” focuses on management of the whole team/key personnel. Studies of team science have highlighted the need for effective management to achieve program goals, especially as the team size increases. Many resources exist to aid in developing effective team-based programs (see e.g., the NCI Collaboration and Team Science Field Guide). The team management plan will address the following points (see section IV):

   • Organizational structure, team composition, and roles
   • Procedures and structures for resolving conflict among the research team
   • Shared vision, contributions, and distributed responsibility for decision-making
   • Resource sharing and allocation
   • Credit assignment
   • Knowledge Transfer
   • Coordination and communication
   • Intra-team data sharing, archiving, and preservation

   Because teams will likely include individuals from widely divergent scientific backgrounds, teams are expected to have a shared vision and a defined plan for communication and management of shared responsibilities, interpersonal interactions, and professional credit. Teams are expected to have at a minimum adequate HIV and substance use expertise together with other needed skill categories to accomplish the overall goal of the program. It is highly recommended that a scientific project manager or program coordinator is included in the team. Depending on the specific data needs of the project, resource sharing and management systems and/or hiring of professional data science staff should also be considered.

2. Timeline and Benchmarks for Success The research goal for this team science effort is expected to be feasible, well-defined, and sufficiently focused so that transformative outcomes can be achieved within 5 years. Teams are expected to be intentional about integrating efforts; the extent of integration will be reflected in the presence and types of activities, planned outcomes, and/or framework that will combine and integrate efforts across disciplines and team members. Benchmarking is a data-driven process that helps you create standards to measure the team's success. Setting benchmarks (milestones) is a simple way to set clear expectations for the team.

3. Organization Chart A diagram explaining the overall structure of the research program and how the various teams/components fit within the overall goal for the program

4. Infrastructure, partnerships and collaborations As applicable to the program, applications are to include a table listing resources (tool kits, data platforms, training or other such relevant resources) and Partnerships and/or collaborations (e.g. AIDS-service organizations, community-based organizations, health departments, substance use agencies, health care funding organizations). Projects that incorporate multiple streams related to HIV and substance use services (e.g., those supported by CDC, HRSA, and/or SAMHSA) are encouraged for studies focusing on transformation of service delivery.

Important points to consider before applying:

Consultation with NIDA program staff

Only applications that have research aligned with NIDA and NIH HIV research priorities will be accepted under this NOFO. Priority will be given to integrated teams pursuing a focused transformative goal with defined 5-year outcomes. It is strongly recommended that potential applicants consult the NIDA Program staff about relevance and scope, research objective and approach, and anticipated budget very early in the planning stage and a minimum of 8 weeks before submission of an application. Applicants should provide a draft of the title, planned goal, team composition, and budget. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO. During the consultation phase, if the proposed project does not meet the programmatic needs of this NOFO, applicants will be strongly encouraged to consider other NIDA funding opportunities.

Rigor and Transparency

As part of NIH, NIDA strives for rigor and transparency in all research it funds. For this reason, NIDA explicitly emphasizes the NIH application instructions related to rigor and transparency. For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner. If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.

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

Funding Instrument Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

• New
• Resubmission
• Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial? Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? See here.

Funds Available and Anticipated Number of Awards NIDA intends to commit $3.0 M in FY 2025, 2026, and 2027 to fund one-two awards.

Award Budget Individual award budgets are not to exceed $1.5M per Fiscal Year in direct costs and should reflect the actual scope of the proposed project.

Award Project Period The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

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

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

Foreign Organizations

• Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
• Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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

Eligible Individuals (Program Director/Principal Investigator) 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.

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.

This NOFO requires a multiple PD/PI application, with 3-6 PDs/PIs. Each of the Principal Investigators in the team of 3-6 investigators is required to have equivalent effort because the NOFO expects each PI to provide a significant, indispensable, and distinct contribution to the project. Teams should not be dominated by a single individual. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Generally, each PD/PI should devote at least 2.4 person months (i.e., the equivalent of 20% effort on a full-year appointment, 26.7% on a 9-month appointment, or 40% on a 6-month appointment) throughout the duration of the award. Multiple PD/PI leadership plan is required as a special attachment. Visit the multiple PD/PI Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide, and the Grant Policy Statement on Multiple Principal Investigators. Minimum allowed efforts by the PDs/PIs are described in the R&R Budget instructions in Part 2. Section IV.2.

PD(s)/PI(s) who have an active NIDA R35 award can participate as a Collaborator instead of a PD/PI as part of the 50% effort on their current R35 award and may not receive additional funds from this award.

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 Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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: nida_NOFO_inquiries@nida.nih.gov

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

For this specific NOFO, the Research Strategy section is limited to 15 pages.

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

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

• SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

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

  Other Attachments:

  1. Team Management Plan (Required – 3 pages maximum): As an "Other Attachment" entitled “Team Management Plan.pdf”, applicants must address how the entire group will function to accomplish program objectives and vision. Team management approaches raised in the subsections listed below should be described in the Plan. Note that a "Multiple PD/PI Leadership Plan" is also required as a separate attachment, and the information in that plan should not be duplicated here. Whereas the “Multiple PD/PI Leadership Plan” focuses on leadership by and interactions across the PD/PIs, the “Team Management Plan” focuses on management of the whole team/key personnel. Applicants are encouraged to consult resources to aid in developing effective team-based programs (see e.g., the NCI Collaboration and Team Science Field Guide and literature on the Science of Team Science) and/or participate in team-science related training. Applications that exceed the 3-page limit will be withdrawn.

     • Organizational structure, team composition, and roles: The program management structure must avoid giving any single individual undue authority that prevents contributions from the wider team for setting program priorities, resource distribution, and reward. NIDA recognizes that strong leadership is required for complex team efforts to be successful, while at the same time effective team leadership requires decision-making based on an amalgam of interests, expertise, and roles, guided by recognized project objectives. Of note, teams are expected to have at a minimum adequate HIV and SUD expertise together with other needed skill categories to accomplish the overall goal of the program. Applicants should develop a management structure based on project objectives that effectively promote the proposed research. The structure should account for team composition, personnel roles, institutional resources, and policies. NIDA does not specify any particular organizational structure, as this may vary across research questions and groups. Inclusion of a scientific project manager or coordinator as a Senior/Key Person with adequate authority is strongly recommended. If a project manager or coordinator is included, describe how the qualifications of this individual are appropriate for such a role, for the subject matter, and scale of the proposed project.
     • Shared vision, contributions, and responsibility for decision-making: The Team Management Plan must include a description of how the PD/PIs will establish and sustain an interdisciplinary team of researchers with an optimal range of backgrounds, expertise, and skills to successfully accomplish the goals of the program. One key consideration is that teams employing complementary approaches and having a broad array of areas of intellectual and technical expertise are more productive if the process for making decisions incorporates different points of view. The Team Management Plan should describe how major decisions will be made or how conflicts will be resolved. A key characteristic that distinguishes productive teams is the degree that all member contributions are valued. Strategies for building and maintaining group participation to develop collective intelligence are encouraged.
     • Resource sharing and allocation across the team: Applications must describe management and decision-making processes that promote collective input for allocation of program resources with flexibility when resources may need to be dynamically reallocated to achieve programmatic goals. A plan for how intra-team, institutional, or regional resources that are integral to the team goals will be shared and made accessible to team members should also be included.
     • Credit assignment: A plan for how credit will be shared, especially with early-career researchers, must be included. Methods for attributing contributions to publications should be described to enable individual professional assessment in joint projects.
     • Knowledge transfer: Knowledge transfer across disciplines and career stages is critical to innovative team science. Describe activities that will facilitate bridging of knowledge across disparate disciplines. Regarding bridging knowledge across career stages, an important and meaningful impact of team science may come from shaping the next generation of neuroscientists. Because of the interdisciplinary expertise of the research groups, trainees are exposed to and can learn multiple scientific languages and methodologies, resulting in multi-faceted, early-career researchers. Plans for how trainees will be immersed in, and benefit from, these approaches should be also described. This could include shared mentorship, inter-lab meetings, all-hands tutorials, shared meeting and document space, inter-lab visits, and trainee presentations.
     • Coordination and Communication plans: Practical aspects must be described, including frequency, logistics, and infrastructure of real time communication across all key personnel, consultants, trainees, and other significant contributors regardless of effort level. If a scientific project manager or coordinator is included, describe his/her role in coordinating team activities and communication.
     • Intra-team data sharing, archiving, and preservation: A framework for sharing and/or integrating data across team members must be customized to fit the science and the specific data needs of the project. The plan and costs for this are distinct from the Data Management and Sharing Plan because the intra-team data plan focuses on data sharing and management across the team members rather than on sharing data to the public. Plans for data archiving and long-term preservation for team use should also be described. Depending on the needs and challenges of managing team data, applicants may also include and justify data/resource sharing and management systems and/or hiring of professional data science staff.

  2. Timeline and Benchmarks for Success (Required – 2 pages maximum): As an "Other Attachment" entitled “Timeline and Benchmarks for Success.pdf”, applicants should include a project timeline in the form of a Gantt chart/table (or similar) that includes all major tasks to be performed during the project as well as critical benchmarks for success. The chart should also include estimated start and completion dates for those tasks and should identify the contributions expected from each PD/PI toward accomplishing each task. The RM1 NOFO emphasizes integration. It is expected that pursuit of the research goal will require substantial and integrated contributions across the PD/PIs. Highlight specific activities and/or planned outcomes that serve to combine and integrate efforts across disciplines and team members.

  3. Organization Chart (Required – one page): A diagram explaining the overall structure of the research program and how the various teams/components fit within the overall program

  4. Infrastructure, partnerships and collaborations (Required – 3 pages maximum): As applicable to the program, applications are to include a table listing resources (tool kits, data platforms, training and other relevant tools as applicable), partnerships and/or collaborations e.g, CDC, HRSA or SAMHSA, and community-based organizations.

• SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

• PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

• PHS 398 Research Plan All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: This NOFO calls for highly transformative, innovative and bold programs with a single well-defined overarching objective instead of multiple specific aims and/or projects. Therefore, the Specific Aims section must include research components that are integrated across, all contributing to a single research goal. The research goal should also be of sufficient scope and complexity that it can only be achieved through an integrative team effort and not by individual, parallel, or series of efforts.

  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.

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

• PHS Human Subjects and Clinical Trials Information 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.

• PHS Assignment Request Form 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.

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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.

See 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 Team Management Plan, a Timeline and Benchmarks for Success, an Organization Chart, and an Infrastructure, partnerships and collaborations table submitted as Other Project Information as an attachment. Applications that fail to include Team Management Plans, Timelines and Benchmarks for Success, Organization Charts, and Infrastructure, partnerships and collaborations tables will be considered incomplete and will be withdrawn.

Post Submission Materials 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.

For this particular announcement, note the following:

• The ‘High Priority HIV and Substance Use Research’ program invites applications that propose innovative research that by nature assumes some degree of risk and are relatively more ambitious and audacious than the traditional NIH applications. Reviewers should evaluate if there is strong rationale and likelihood of high impact if the proposed studies are successful. Although reviewers will consider feasibility, unavoidable risks that are intrinsic to new and innovative approaches should not be penalized.
• 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 will the proposed program's integrated team research effort be transformative and uniquely advance a scientific area?
  • To what extent does the goal challenge existing paradigms, overcome long-standing roadblocks to progress, and/or develop new synergies between different scientific fields?
  • Is the program of sufficient scope and complexity to warrant a team approach?
  • Does the single scientific goal require an integrated interdisciplinary effort?
  • Can definitive outcomes be accomplished during the 5-year funding period?
  • Does the application adequately describe whether prior research that serves as the key support for the proposed project employed rigorous practices such as minimization of potential experimenter biases, robust experimental designs, transparent reporting of results and analyses, and careful interpretation?
  • How does the application address ambiguity, weaknesses, or limitations in rigor of the prior research, if applicable?

• 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:

  • Is the planned effort by the PDs/PIs complementary, appropriate, and sufficient for the work proposed?
  • Are the investigator backgrounds and expertise appropriate for addressing the proposed scientific problem?
  • Does the team have adequate HIV and SUD expertise?
  • Is it clear that each investigator is necessary and will contribute to achieving the goals of the program?
  • Teams must not be dominated by a single individual. Is there evidence for synergistic interactions among PD/PIs beyond the additive benefits of additional investigators?
  • If the application includes collaborating investigators who will not receive direct support, is it clear how these investigators will participate in the program?
  • If foreign investigators are involved, are they uniquely qualified to participate in the team?

  Team Management Plan (Attachment):

  • Does the team management plan instill confidence that fair and adequate governance processes will be used for decision-making, conflict resolution, and resource allocation?
  • Does the plan ensure that all investigators will have a voice in decision-making and that no single PD/PI will become overly dominant?
  • Does it provide for effective team leadership and management with shared responsibility and decision-making processes?
  • Is the team plan sufficiently detailed to create a sustainable environment for maintaining integration, productivity, and shared vision?
  • Does the management plan include adequate plans for shared professional credit?
  • Does the management plan include adequate plans for knowledge transfer?
  • To what extent will trainees be involved in and benefit from this team science?
  • If shared research resources will be utilized, are plans adequate to ensure that all team members will have the access they require?
  • Are plans for team coordination and communication adequate?
  • If a scientific program manager or coordinator is proposed, are the qualifications and role of this individual appropriate?
  • Are adequate plans presented to establish and sustain a team of researchers with an optimal range of backgrounds, expertise and skills, and plans to arrive at major decisions, accounting for different points of view?
  • Are adequate plans presented to manage intra-team data sharing, archiving, and preservation?

• 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:

  • Does the program involve innovative ideas or approaches that would be very difficult to pursue through independently funded individual or multiple PD/PI research project grants?
  • Does the program involve innovative combinations of distinct scientific fields and/or intellectual viewpoints to address its goals?
  • Is innovation evident in the method by which distinct areas of science are combined?

• 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) as required by statute, inclusion (or exclusion) of individuals on the basis of sex, 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, sex, 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 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:

  • Is the program presented as a single, focused scientific goal instead of multiple aims?
  • Does the combination of scientific expertise (represented by the PD/PIs) present a compelling case that collaborative, interdisciplinary research will enable scientific advance?
  • To what extent will the strategy, planned outcomes, and activities designed to integrate and combine efforts across fields and team members?
  • Are all contributions by each team member and pieces of the experimental plan synergistic, integrated, and essential to the goal?
  • Does the work plan make adequate use of existing institutional and/or regional resources?
  • If new resources or equipment are requested, are they well justified and not redundant with resources available elsewhere in the institution or region?
  • Although feasibility is considered, unavoidable risks that are intrinsic to new and innovative approaches should not be penalized.

  Timeline and Benchmarks for Success (Attachment):

  • Are the timeline and benchmarks proposed appropriate for accomplishing the single scientific goal?
  • Is there sufficient detail on the timing and duration of key project tasks?
  • Are the timelines proposed for achieving project goals realistic and inclusive of necessary steps, but also efficient without adding unnecessary steps?
  • Do the contributions from the PD/PIs suggest a high degree of commitment, integration, and collaboration?
  • Does the proposed research incorporate adequate methodological rigor where applicable, including, but not limited to, clear rationale for the chosen model(s) and primary/secondary endpoint(s), clear descriptions of tools and parameters, blinding, randomization, adequate sample size, pre-specified inclusion/exclusion criteria, appropriate handling of missing data and outliers, appropriate controls, preplanned analyses, and appropriate quantitative techniques?
  • Do the applicants clearly indicate the exploratory vs. confirmatory components of the study, consider study limitations, and plan for transparent reporting of all methods, analyses, and results so that other investigators can evaluate the quality of the work and potentially perform replications?

• 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:

  • Are the resources and infrastructure adequate for accomplishing the single scientific goal and supporting team science?
  • Is there synergy to be gained from the involvement of multiple departments and/or institutions?
  • If foreign organizations are involved, do they provide unique resources that are not otherwise available?

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, Racial and Ethnic 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, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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

• Resubmissions For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

• Renewals Not Applicable

• Revisions For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

• Applications from Foreign Organizations Not Applicable.
• Select Agent Research Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
• Resource Sharing Plans Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
• Authentication of Key Biological and/or Chemical Resources: For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

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

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

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

• ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
• Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
• Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
• Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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

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

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to 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 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.”

Cooperative Agreement Terms and Conditions of Award Not Applicable

3. Data Management and Sharing

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

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 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (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 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

• 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@od.nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

• Vasundhara Varthakavi, DVM, PhD National Institute on Drug Abuse (NIDA) Phone: 301-443-2146 Email: vasundhara.varthakavi@nih.gov
• Richard A. Jenkins, PhD National Institute on Drug Abuse (NIDA) Phone: 301-443-1923 Email: richard.jenkins@nih.gov
• Kathleen Borgmann, PhD National Institute on Drug Abuse (NIDA) Phone: 301-594-6561 Email: kathleen.borgmann@nih.gov
• Raul N. Mandler, MD, FAAN, FANA National Institute on Drug Abuse (NIDA) Phone: 301-480-2541 Email: raul.mandler@nih.gov

Peer Review Contact(s)

• NIDA Review National Institute on Drug Abuse (NIDA) Email: NIDAReview@nida.nih.gov

Financial/Grants Management Contact(s)

• Chief Grants Management Officer National Institute of Drug Abuse (NIDA) Email: NIDAGrantsManagement@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.

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

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NIH Funding Opportunities and Notices

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