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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The current U.S. opioid epidemic has evolved into an opioid/stimulant epidemic, with mental illness co-morbidities more evident than in the past. Stimulant use has introduced new complexities to the epidemic in terms of behavioral consequences (e.g., psychosis, disorganized behavior), available treatments, and the need for new harm reduction strategies. Addressing the opioid epidemic is even more difficult in rural areas. Challenges specific to rural settings include the scarcity of behavioral health services due to low density of populations [e.g., fewer credentialed behavioral health practitioners, particularly prescribers for medications for opioid use disorder (MOUD)]. In rural areas, there is a greater reliance on publicly-funded services, and non-profit sectors may be limited. Limited access to reliable public broadband services, private vehicles or public transportation inhibit participation in services that are locally available and make common ways to extend reach (e.g., telehealth) difficult. Stigma regarding substance use (generally) and treatment and harm reduction modalities often is more evident than in metropolitan settings. Some systemic drivers of opioid use such as homelessness exist in rural and urban settings but may be more hidden in rural areas. This opioid/stimulant epidemic has entered a period of chronicity which requires a continuum of care that spans from prevention to treatment and recovery. This is reflected in current federal drug control strategies, including those for methamphetamine, which recommend prevention, particularly among youth and young adults, and further development of harm reduction strategies.

In 2017, the National Institute on Drug Abuse (NIDA) launched the Rural Opioid Initiative (https://ruralopioidinitiative.org), supporting research projects focused on local implementation and demonstration of services to meet the immediate needs for harm reduction infrastructure and referral to Hepatitis C virus (HCV) and/or MOUD care. This notice of funding opportunity (NOFO) will augment this earlier initiative, supporting the development and testing of prevention and/or expanded harm reduction strategies, facilitating the development of an evidence-based continuum of care in response to this continuing rural opioid/stimulant epidemic.

Purpose

This NOFO will support research projects that develop and test drug misuse prevention and/or harm reduction strategies, extending the continuum of care within U.S. rural communities impacted by the opioid/stimulant epidemic. The overall goal is to reduce drug use and associated risks and harms for individuals with unmet prevention and/or harm reduction needs. Research activities will be conducted in two phases (i.e., developmental R61 phase and implementation and effectiveness trial R33 phase). Each phase of the project must involve community partners and potential end users of the research findings. Projects should leverage the social capital and formal organizations that have arisen in rural communities during this epidemic (e.g., task forces). These projects should yield effective strategies to meet prevention and/or harm-reduction needs in diverse rural communities in the U.S.

Specific Topics of Research Interest

Projects need to identify ways to implement evidence-based practices that overcome the existing challenges noted above (e.g., low density of people and services, as well as the factors that limit access to existing services). Multi-component and multi-level (e.g., client/patient, providers, systems-level interventions) strategies are encouraged. Project aims should address how the locally-tailored strategies will lead to outcomes appropriate to implementing prevention (e.g., reducing individual or community drug use, prevent escalation including transition to injection) and/or harm reduction (e.g., reducing overdose, preventing HCV acquisition). Projects are required to propose sustainable, scalable, and equitable approaches for accelerating the movement of evidence-based and promising prevention and/or harm reduction strategies into routine use within rural communities. Increasing the likelihood of sustainability may be achieved by capitalizing on state and local initiatives (e.g., task force activities, opioid settlement funds) and/or make use of local stakeholder infrastructures (e.g., Communities That Care coalitions).

Projects supported through this NOFO will use the R61/R33 mechanism. Each phase of the project must involve meaningful engagement of community partners and potential end users of the research findings. These partners may include representatives of state or local health departments or other agencies responsible for funding substance use prevention, providers of harm reduction programs, drug treatment or other services relevant to the settings of the grant, as well as persons with lived experience with substance use and individuals associated with the justice system, education systems, emergency medical services, clinical settings, or medical providers. Existing task forces, community coalitions, community partnerships, etc. related to substance use should be incorporated, if present, to minimize overlap and duplication. The R61 phase is expected to be developmental and formative in nature and should focus on future sustainability and scalability of an intervention, based on meaningful inclusion of rural perspectives and priorities learned from community partners and potential end users of the research findings. During the R33 phase, research teams will test the implementation and effectiveness of the selected prevention and/or harm reduction strategies in the context of selected service or system settings. Selected strategies should address cross-cutting issues that are relevant to local communities such as stigma reduction and promotion of health equity. Research teams should build on existing research knowledge regarding implementation facilitators and barriers with local data collection, as needed. Aims related to implementation and effectiveness are required to be provided.

For this NOFO, substance use prevention refers to selective or indicated prevention strategies. The intention is to reduce risks for substance misuse, delay experimentation, or delay escalation to injection drug use or substance use disorder. Prevention services may be delivered in a range of settings, including schools, behavioral health centers, federally qualified health centers or rural health centers, social service settings such as child/family service agencies, juvenile and adult justice systems (including special problem courts) and other community venues. The objective is to introduce sustainable prevention programs where they do not exist and increase the depth, reach, and use of evidence-based principles.

Harm reduction generally refers to reducing the harms attributable to active drug use and, in traditional public health terms, may be seen as tertiary prevention. The most common harm reduction services include the provision of unused, sterile injection equipment in syringe service programs (SSPs). Services offered by SSPs also may include screening and referral for consequences of injection such as viral hepatitis, HIV, other infectious disease prevention such as condoms or pre-exposure prophylaxis and attention to basic needs such as hygiene or food. SSPs may be freestanding or incorporated into health departments, AIDS service organizations, free clinics or other settings and their other services may or may not be fully integrated with harm reduction. The objective here is to establish harm reduction services where they do not exist or to expand the scope of services with the expectation that local uptake of preventive services (e.g., HCV screening, syringe distribution) will increase and harmful effects of drug use will be reduced (e.g., fewer injection site infections, fewer cases of intentional or unintentional overdose, fewer new cases of viral hepatitis).

Responsive application s will document unmet prevention and/or harm reduction needs in the selected communities and address equity across various aspects of the research (e.g., the diversity of collaborator group members, the identification and recruitment of study participants, selection, and implementation of intervention strategies, etc.). Applications must demonstrate how they target communities at greatest risk of adverse events related to opioid use, and document appropriate indicators such as opioid overdose deaths, case reports of acute Hepatitis C infection, drug seizures, 911 calls for overdose, etc.

This NOFO seeks a range of research studies including, but not limited to, the following:

• Projects that test ways to incorporate peers into intervention implementation (e.g., outreach, service delivery).
• Efforts to expand the range of available prevention and/or harm reduction services through modalities such as Project ECHO and/or telehealth enabled by clinics, providers, or mobile services.
• Tests of strategies to build local capacity to deliver or expand the reach of prevention and/or harm reduction services through training and consultation among:
  • Healthcare providers (e.g., pediatricians, family practice physicians, internists, nurse practitioners), paraprofessionals (e.g., community health workers, recovery coaches),
  • First responders (e.g., emergency medical services, emergency departments, firefighters, law enforcement) to effectively respond to overdoses (e.g., stigma reduction, crisis intervention training, prevention of needlestick and sharps injuries) and/or engage in “warm hand-offs” to services.
• Integration of prevention and/or harm reduction services into comprehensive systems of substance use or behavioral health (e.g., hub and spoke models of substance use service delivery; behavioral health networks; harm reduction networks).
• Integration of prevention and/or harm reduction into novel settings including:
  • Primary care, including rural community health centers, emergency departments, and specialty settings that also deliver primary care services such as Planned Parenthood or AIDS service organizations,
  • Job Corps, vocational or rehabilitation training or other transitions to competitive employment serving high risk populations,
  • Programs for individuals experiencing physical disabilities,
  • Programs that provide outreach to individuals who are unhoused or receiving housing services.
• Studies of strategies to deliver prevention services to parents, children, youth and/or families involved in social service settings including:
  • Settings that serve people experienced intimate partner violence,
  • Clinical settings serving parents being treated for substance use disorder,
  • Diversion programs and other settings related to the justice system.

Community-engaged partnerships with rural organizations and residents who identify as historically marginalized are required. Selected strategies should address areas of broad concern such as stigma as experienced by people who use drugs and stigma as perceived from or enacted by service providers or other key members of the community (e.g., first responders).

Drug treatment is not primary focus of this NOFO; however, applicants will need to document existing treatment and recovery resources that serve their project’s area, including inpatient and outpatient services and available forms of MOUD. Applications should indicate how referrals to treatment resources will be made, as needed, as well as how they will determine eligibility for referral. All referrals to treatment should include a “warm handoff” rather than simply providing referral information. Projects also should address mental health crisis intervention and include protocols for managing suicidality, psychotic behavior, and other acute psychiatric conditions, as well as intentional or unintentional overdose.

Milestones & Transition to the R33 Phase

Research supported through this NOFO will be conducted in two phases using the R61/R33 Exploratory/Developmental Phased Award mechanism. Support will be provided for up to 5 years, which includes initial support of up to 2 years for the R61 phase, followed by up to 3 years of support for the R33 phase. Transition to the R33 phase is contingent upon successfully meeting proposed R61 milestones. See Section IV. 2. Content and Form of Application Submission, SF424(R*R) Other Project Information for instructions for milestones.

Applicants must include milestones that are expected to be achieved by the end of the R61 phase. Milestones should be specific, quantifiable, and scientifically justified to showcase readiness for the R33 phase; they should not be simply a restatement of the specific aims for the R61 phase. Applicants must include a discussion of the suitability of the proposed milestones for assessing success in the R61 phase and the implications of successful completion of these milestones for the proposed R33 phase of the project. These should include efforts to create structures that enable collaborations with community stakeholders and other potential users of data from the project to guide rural specific recommendations and any pilot/feasibility testing of intervention or implementation components needed to progress to the R33 phase, as well as plans to increase intervention sustainability and rural credibility during and beyond the project period.

For transition to the R33 phase, awardees must submit the transition package no less than two months before the completion of the R61 phase. The transition plan should 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 whether the milestones were achieved. 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.

Funding of the R61 phase and completion of milestones does not guarantee funding of the R33 phase of the project. Phase two (R33) will provide possible funding for up to 3 years to conduct a clinical trial examining implementation and effectiveness of prevention and/or harm reduction interventions in rural communities. Potential applicants are strongly encouraged to consult with NIDA Program staff early in the application development process to discuss alignment of their study ideas with research priorities.

Applications not responsive to this NOFO:

• Applications that do not focus on U.S. rural communities.
• Studies that only focus on substance use treatment and do not focus on prevention and/or harm reduction.
• Projects without community partnerships.
• Projects without proposed plans for intervention sustainability.
• Applications that do not include a milestone plan for the R61 phase.

Plan for Enhancing Diverse Perspectives (PEDP)

• This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21- 310, submitted as Other Project Information as an attachment (see Section IV).
• Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. 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. 

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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

Non-domestic (non-U.S.) components of U.S. Organizations are 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

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

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the 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: NIDALetterofIntent@mail.nih.gov

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

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

All instructions in the 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 requirements.

Other Attachments:

Milestones:

Applicants must include milestones that are expected to be achieved by the end of the R61 phase. Milestones should be specific, quantifiable, and scientifically justified to showcase readiness for the R33 phase; they should not be simply a restatement of the specific aims for the R61 phase. Milestones are expected to differ across funded awards. Applicants must include a discussion of the suitability of the proposed milestones for assessing success in the R61 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 phase of the project.

Examples of potential milestones for the R61 phase include but are not limited to:

• Community partnership: Evidence of having established at least one community partner from the community system of relevance, and a plan for collaborating over the course of the research project.
• Pilot/feasibility testing of any intervention components, if applicable.

Save your milestones document as: LastName_FirstInitial_Milestones 

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 historically 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.

R&R Budget

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

All applications should budget for travel to attend an annual meeting to be held in the Washington, DC metropolitan area to review areas of shared interest including potential harmonization of measures, data collection procedures and intervention content.

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).

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:

Exploratory/Developmental Phased Award

The research strategy should present an overview of the state of the science, current status and relevance of the proposed research, a detailed discussion of the specific protocol and approach to data collection, and demonstrate consideration of long-term sustainability and scalability of the proposed efforts. The research strategy should also include a description of the team’s experience with: (a) developing, testing, and implementing prevention interventions; (b) the identified study population and settings (people who use drugs in the U.S. rural communities); and (c) collaborating with community organizations.

The following criteria should be addressed:

Significance: The R61 and R33 should clearly address a single set of research questions and goals, with the R61 phase building capacity, developing infrastructure, and establishing feasibility for the clinical trial which will be conducted in the R33 phase. Given this integration, only one Significance section is needed.

The application should demonstrate an in-depth understanding of the significance of preventing substance misuse and use disorder for the population of focus in the proposed research. The significance of the proposed clinical trial, justification of the target population and need for the specific intervention proposed, and importance of the research questions should be clearly stated. The application should make clear how the results will expand the evidence base for preventing substance misuse or use disorder for a population involved in or experiencing risk for involvement in the U.S. rural areas.

Innovation: Given the integration of the R61/R33 phases, only one Innovation section is needed. The application should demonstrate knowledge of the particular risk, protective, and common experiences of their population of focus, an understanding of the common barriers to delivering effective preventive interventions and/or harm reduction strategies in the U.S. rural areas, and how the proposed intervention will be innovatively designed to address and inform solutions to those barriers and optimized for the population and setting. Applicants should demonstrate how their partnerships will facilitate this understanding and provide guidance for successful implementation. Applications should describe how the proposed research is innovative, as relevant, in terms of the population of focus, intervention development/adaptations, intervention delivery, the investigative and clinical team, the integration of the intervention within the rural community, data collection protocols, economic analysis, dissemination and sustainability plans, or other potential sources of innovation.

Approach: The application should contain separate Approach sections clearly labeled 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 already described in the R61 section.

Preliminary data, extensive background material or preliminary information are not required for an R61/R33 application; however, they may be included if available. Appropriate justification for the proposed approach can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.

Key elements that must be considered include:

• Demonstration how community-engaged partnerships with rural organizations and residents who identify as historically marginalized are present in study conceptualization, design, execution, and interpretation;
• Demonstrate how perspectives of potential end users of the services or interventions are being included;
• Description of long-term sustainability and scalability of the proposed efforts.

R61 (Phase 1) Approach:

Applicants may propose pilot/feasibility testing in the R61 phase approach. Pilot/feasibility testing may include fine-tuning an intervention or adapting an evidence-based intervention or implementation strategy. Applicants should identify available epidemiology and program data or collect pilot data that can be used to characterize drug use trends and available health services, as well as potential gap areas where prevention and/or harm reduction services are needed. The data should then inform the development and refinement of intervention and implementation strategies that meet specific prevention and/or harm reduction needs in these communities.

All projects should include the following in the R61 approach section:

• A proposed strategy for establishing one or more research partner(s) from community organizations of relevance, or a description of existing partnerships.
• Plans for pilot/feasibility testing of intervention components, if applicable.
• Plans to understand and address issues of equity, as relevant to the proposed research project.
• A rationale for the selected intervention for implementation with the identified population, with attention to whether the intervention is specific to the needs of their rural settings.
• Plans to enhance the likelihood that interventions tested will be sustained, if found to be effective.  

R33 (Phase 2) Approach

The research approach for the R33 phase should include detailed descriptions of the proposed implementation-effectiveness research. Intervention strategies should be sustainable after the project ends. To increase the likelihood of sustainability, representatives from local community organizations (e.g., health departments, state/local substance agencies, clinical providers should be included on the research team, and potential sources of intervention funding should be known, and intervention strategies should be modalities that partners are likely to continue after the conclusion of the project.

The R33 phase of the project should clearly describe the approach and address how it will contribute to the equitable and sustainable prevention and/or harm reduction strategies in the U.S. rural areas, including:

• Projects including implementation-related aims should have an implementation research logic model, with emphasis on implementation barriers/facilitators (determinants), how implementation strategies will address these determinants, and which implementation outcomes will be measured and expected to improve and illustrates the linkages between implementation strategies, intervention activities, outputs, and expected outcomes.
• The study design, justifying why the design is appropriate for the proposed research questions and how threats to internal validity will be mitigated.
• Primary and secondary outcomes that will be evaluated and the proposed measures. The expected sample size for the clinical trial, nature of the comparison/control group, expected attrition, power estimation, and methods for handling missing data.
• An analytical plan, including plans to examine whether the intervention or implementation strategies are associated with and account for changes in the outcomes of interest, including any core components of the interventions or strategies that impact the change.
• Discussion of the tools, instruments, or other methods that will be used to collect data on each output and outcome.
• Plans for inclusion of the community partner as an equitable contributor to the research, including the inclusion of community representatives as key personnel and community organizations as research sites.
• A timeline of activities to be completed in the R33 phase of the project.
• A discussion of any impediments that could require an addendum to the research plan or timeline with a discussion of alternative approaches.

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.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the 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 annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. 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: 

• To what extent does the application demonstrate understanding of the importance of preventing substance misuse and use disorder for the population of focus in the proposed research? 
• How will the proposed research build on past research and expand the evidence base for preventing substance misuse or use disorder among the population of focus? 
• How will the proposed research inform sustainability and scalability of community-engaged prevention? 
• 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: 

• Are relevant community partners identified, or is there a plan to develop a partnership with at least one community agency or organization during the R61 phase? 
• If relevant, how well are the roles for community partners clearly articulated, and how appropriate are they for the proposed research? 
• How adequate are the plans for community partnerships adequate to provide the research team with expertise on feasibility, implementation, and sustainability of the intervention? 
• 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 research have potential to lead to innovations in providing effective substance misuse preventive intervention services among the population of focus? 
• 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 are the milestones for the R61 phase well specified? 
• To what extent does the length of the R61 phase seem appropriate and relevant for the scope of work proposed? 
• How well are plans for the R33 phase well-articulated, including specification of research questions? 
• To what extent do the plans for the R33 phase build in a logical way on the R61 phase? 
• To what extent does the application take into account issues of equity, scalability, and sustainability of the intervention or approach? 
• How substantial and appropriate is the integration of community partners and potential end users in the research team? 
• To what extent does the approach address specific needs of the population of the focus? 
• To what extent does the application include a well-justified and appropriate plan for engaging community partners and potential end users of the research findings that can ensure that the research will be acceptable and relevant for the setting? 
• To what extent do they address how the applicants will ensure rapid release of data, including metadata, in a way that will be useful to the community? 
• 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

 Not Applicable

Renewals

 Not Applicable

Revisions

 Not Applicable

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate 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.”

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.

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 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.

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: 301-480-7075

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

Angela Lee-Winn, PhD
National Institute on Drug Abuse (NIDA)
p hone: 301-451-7206
Email: angela.lee-winn@nih.gov

JoyAnn Courtney, PhD
Office of Disease Prevention (ODP)
Phone: (301) 402-3911
E-mail: joyann.courtney@nih.gov

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

David Houppert  
National Institute on Drug Abuse (NIDA)  
P hone: 301-443-4675  
Email: david.houppert@nih.gov   

Section VIII. Other Information

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

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