Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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. Funding Opportunity Description

Purpose

This FOA seeks to fund innovative community partnered research by diverse teams that addresses community-driven priorities for reducing disparities in outcomes for racial and ethnic minority populations related to substance use, addiction, and related health consequences including HIV. Research projects should demonstrate that they will have a major impact in improving outcomes related to substance misuse, with a goal of identifying or targeting strategies to prevent, reduce, or eliminate racial and/or ethnic disparities in substance use outcomes. This FOA solicits applications from minority serving institutions (see Section III. Eligibility information). NIDA recognizes the important role these institutions have played in supporting scientific research, particularly on diseases or conditions that disproportionately impact racial and/or ethnic minorities and other U.S. populations that experience health disparities. As these institutions are uniquely positioned to engage minority populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes, this announcement seeks to support exceptional projects that will contribute to capacity building within these institutions.

Background

The NIH is committed to supporting health equity research to 1) improve minority health and reduce health disparities in the United States and 2) remove the barriers to advancing health disparities research (for more information, see: NIH's statement on ending structural racism and the NIH/NIMHD Strategic Plan). In alignment with this NIH-wide effort, NIDA established the Racial Equity Initiative (REI), with goals that include promoting racial equity in NIDA’s research portfolio. Among the actions taken by NIDA, which were informed by internal and external meetings and listening sessions, the Institute has committed to a significant increase in funding for research to address disparities in outcomes related to drug use and HIV. The REI funding opportunity announcements seek to advance equity by supporting research and research training efforts that are consistent with NIDA’s mission and with best practices for conducting research with racial and ethnic minority populations.

The NIDA REI Research Gaps and Opportunities (RGO) workgroup convened a workshop in February 2021 with a goal of identifying bold new directions for research to operationalize a mandate for equity and address racial and ethnic minority health disparities in substance use and addiction. This FOA integrates and is responsive to the perspectives shared in this meeting.

Despite past research efforts, entrenched differences remain in outcomes related to substance use for racial and ethnic minority populations in the United States, who often experience structural racism which is related to less access to services and supoorts that could reduce substance use. Racial or ethnic minority groups continue to experience higher rates of substance misuse, addiction, and related conditions. Opioid and methamphetamine use and overdose have risen in recent years among Blacks, Hispanics and American Indians/Alaska Natives. Racial and ethnic minority groups also have worse substance use disorder treatment experiences and outcomes. These differences exist in the context of tremendous cultural strengths, strong values for family connection, and community efforts, all of which can help to improve substance misuse outcomes. While most individuals eventually enter recovery from addiction, efforts to improve outcomes can prevent drug addiction, hasten recovery, reduce suffering, prevent overdose and other harms, and improve individual and community health.

The historical narrative that there are inherent biological differences between racial groups has led to racial biases in research and subsequent clinical practice. While underserved racial and ethnic minority groups experience substance use and addiction disparities, there is nothing inherent in race or ethnicity that confers risk. Race and ethnicity are properly conceptualized as socially constructed racialized categories. Research has demonstrated that experiences of racism, racially or ethnically related structural barriers, and social and political determinants of health are strongly implicated in disparities in substance use outcomes. In addition, factors such as poverty, exposure to acute and chronic social stressors, experiences of discrimination, and less access to health care resources, healthy food and health-promoting activities all confer risk for substance misuse and poor addiction outcomes. These contextual factors pose such significant barriers that they are stronger drivers of outcomes than individual vulnerabilities. Research must shift from a focus on individual vulnerabilities and interventions to identify and address the complex, interacting structural inequities driven by racism and bias that are the root cause for differential outcomes.

To effectively address structural inequities, racism and bias, research must draw on diverse persecptives. One such perspective comes from community members, including those with lived experience of substance use, who bring first-hand knowledge of the unique strengths and barriers within the community that affect substance misuse and addiction. Incorporating community members into the research process increases the validity and rigor of the research and its likelihood of resulting in real-world impact. Additionally, relevant perspecties are likely to come from scholarly domains underutilized in NIH funded research, such as in ethnic studies, anthropology, communications science, sociology, social work, and urban planning which may provide needed depth to considerations of structural disadvantage, the understanding of race and ethnicity as social constructs, and expertise in conducting community engaged research.

Specific features of this FOA:

Key features of this FOA are designed to emphasize to applicants and peer reviewers that these applications should be different from conventional, investigator-initiated research applications where communities are not integrally engaged. These applications focus on the significance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on preliminary data or experimental details. Reviewers will be instructed to emphasize the significance and innovation of the application in their evaluations.

Interpretation and measurement of participant race or ethnicity:

Fully understanding how race and ethnicity relate to substance use outcomes demands that race and ethnicity be accurately conceptualized as racialized social constructs for measurement, analysis, and interpretation of findings. Justification and specific hypotheses should be provided for how race- and ethnicity-related constructs are used in analyses. Race and ethnicity should not serve as proxies for other constructs which may be the causes of disparities. An intersectional approach should be taken when appropriate. Applications that seek to simply document between-group differences without an examination of the process by which those differences arise or the process by which they can be ameliorated will be considered non-responsive to this FOA.

Structural factors and social determinants of health:

This FOA seeks novel, innovative projects that take a health equity approach and consider factors beyond individual level characteristics in seeking to understand and/or address racial or ethnic differences in substance use outcomes. For the purposes of this FOA, health equity is defined as every individual having the opportunity to attain their full health potential and no one being disadvantaged from achieving this potential because of social position or other socially determined circumstances. Research projects may, but are not required to, target for change (intervention research) or directly measure the structural level, but structural and community factors must be incorporated into the logic of the application. Applicants are encouraged to review the NIMHD research framework at https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html

Community engagement:

Applications responsive to this FOA must provide a plan for working collaboratively with communities. Community engaged research can take myriad forms, including Community Based Participatory Research (CPBR), participatory or community action research, participatory rapid appraisal, and others. The strategy selected should be appropriate for the community partner and the goals of the research project. The community engagement process should reflect power sharing, maintaining equity across partners, strategies to deal with disagreements, and the flexibility required to fit the needs, priorities, and capacities within communities. Community partners may be representatives from community-based organizations, faith-based organizations, advocates, health service providers, relevant public agencies (e.g., public health, criminal justice), American Indian or Alaska Native tribes, policymakers, and other experts.

Applicants must demonstrate that community partnerships are established prior to submission, that the research questions addressed are a priority for the community, and that the design and methods reflect community knowledge and input. Community partners may be investigators, community board members, key personnel, or any appropriate role. Applications should ensure research findings are disseminated to the public, including community members (i.e., not only academic publishing and conferences). Applications proposing intervention research should include discussion of how the intervention can be sustained after the research project is concluded and the potential for scalability beyond the study sites.

Optional planning period:

While community partnerships must be established prior to submission, the project timeline may include an initial planning period to further refine aspects of the research project. This optional planning period may be up to one year in duration. The purpose of this time is to enable funding for the effort community partners (as well as researchers) put toward the development of the specific approach and methods used for the study and ensure alignment between academic and community partners and the use of valid and appropriate measurement tools. For example, time may be spent to form partnership agreements for the conduct of the research project or to ensure that measures are valid and culturally relevant. Intervention or dissemination and implementation strategies, if applicable, may also be further refined in the first year to better reflect community preferences and unique cultural factors. Recruitment strategies may be further developed in the first phase, but the application must demonstrate feasibility or a strong rationale for anticipated success in recruitment. While this planning time is permitted, applicants should demonstrate feasibility of their project regardless of the outcomes of the work performed in the planning period.

Preliminary data are not required:

It is essential for applicants to provide a strong premise for the proposed research. However, because we are seeking bold new approaches, for this announcement, pilot data are not required but can be included if available.

Plan for enhancing diverse perspectives:

NIH and NIDA REI support the formation of research teams that represent diverse perspectives, backgrounds (see NOT-OD-20-031 and NOT-OD-22-019), and academic and technical disciplines, as well as the submission of research applications from all eligible institutions. Applications from researchers with diverse backgrounds underrepresented across roles and positions in research, including underrepresented racial and ethnic groups, persons with disabilities, and women are strongly encouraged to apply to this Funding Opportunity Announcement.

Applications submitted under this FOA must include a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application, which details the research team’s approach to fostering diversity, inclusivity, and accessibility in the project. Instructions for completing the PEDP are provided in Section IV. of this announcement. The PEDP will be evaluated as part of the application by the review committee and by the program staff for scientific and technical merit. Applications submitted without a PEDP will be considered incomplete and will be administratively withdrawn.

Research Objectives

Responsive research must take place in the United States and propose novel approaches to improving substance misuse related outcomes and decreasing racial and ethnic minority disparities in substance misuse, addiction, and related health outcomes. Research topics should be derived from the priorities and experience of the communities that are partnering in the research and that are expected to benefit from the research. Projects should be designed to solve or inform real world challenges, reflecting first-hand as well as scientific knowledge.

Research topics responsive to this FOA include etiology (see caveat below), prevention, harm reduction, treatment, services (including increasing use of evidence-based prevention or treatment through dissemination and implementation research), and research on medical consequences. Observational or intervention studies focused on etiology will only be considered responsive when investigators demonstrate a need to further understand mechanisms that will inform intervention.

Topics of interest for this FOA include the list below, however applications need not be limited to the topics on this list:

• Etiological studies that identify causal mechanisms that lead to differential patterns of onset of drug use and progression to substance use disorder (SUD) for racial or ethnic minority populations affected by disparities in drug use consequences and treatment utilization. Applications focusing on etiology must describe how the research will be used to inform intervention development and include investigators on the study team with intervention expertise to facilitate translation of research results to intervention research and practice.

• Identifying strategies derived from a structural orientation to mitigate the contribution of implicit and explicit bias, race-based discrimination and microaggressions that contribute to vulnerability to substance use and misuse

• Investigating patterns of access to and utilization of prevention and treatment services, including understanding and intervening to address stigma, mistrust, financial barriers, location, and other barriers described by research participants, community members or other stakeholders.

• Addressing bias within the educational and juvenile justice systems, including research on the impact of differential treatment on risk for poor outcomes related to drug use and drug involvement.

• Testing novel prevention or treatment interventions, or adapting existing interventions to make them more culturally specific or implementable within a specific service system (e.g., justice, child welfare, primary care)

Applications not responsive to this FOA:

• Studies that do not focus on one or more U.S. racial and ethnic minority populations, which include Blacks/African Americans, Hispanics or Latinos, American Indian and Alaska Natives, Asian-Americans, Native Hawaiians and Other Pacific Islanders, and/or multiracial individuals

• Projects that do not have an established community partnership in the United States

• Projects focused on substance use etiology that seek only to document differences and do not demonstrate how the research is necessary to improve the ability to develop interventions and explicitly state how the research findings will be used to inform intervention development and/or research

Additional Considerations

Definitions:

Community: A specific group of people, often living in a defined geographic area, who share a common culture, values, and norms and who are arranged in a social structure according to relationships the community has developed over a period of time. The term community encompasses worksites, schools, and health care sites (see https://www.cdc.gov/healthyplaces/terminology.htm). Communities may be self-defined (e.g., the Black/African American community in a city or county) or defined by the catchment area of local government or service providers (e.g., residents served by a county school district or community clinic). Additional examples of communities include but are not limited to neighborhoods, reservations or tribal communities, military bases, or college campuses. Virtual or other communities that do not reside in the same geographic location are not a priority for this initiative.

Community organization: A non-Federal, non-academic organization that provides goods, services, support, resources, or advocacy to members of a defined community. Examples include community or faith-based organizations, local businesses, neighborhood associations, labor unions, patient or consumer advocacy groups, public health departments, healthcare systems, school systems, law enforcement or criminal justice agencies, social service agencies, or departments of commerce, labor, transportation, housing, recreation. Governmental organizations at the local, regional, tribal, or state level fall within this definition.

NIDA’s Racial Equity Initiative: Common Goals and Collaboration

NIDA’s REI seeks to address persistent racial and ethnic disparities in substance abuse outcomes in the United States. All REI projects must include some form of community engagement in the conduct of the research, and all projects must commit to broad dissemination of research findings across multiple audiences, such as scientific, stakeholder groups, providers, policy makers, research volunteers, and the public.

A separate Coordination, Engagement, and Dissemination Center will be established to support all REI funded projects by providing technical assistance and resources to maximize the potential for projects to fulfill their commitments to active, community-engaged research and comprehensive dissemination activities (RFA-DA-23-025). Each project funded within the REI must plan to collaborate with the Center. The Center will act as a resource hub, providing consultation and technical assistance as needed on theoretical, measurement, data management, data analysis, and operational challenges encountered by project teams while producing scholarly products and community dissemination materials related to substance use and health equity. The Center will house shared resources and provide coordination for collaborative products or activities. PIs funded under this announcement will work collaboratively with the Center and other REI PIs, attend annual meetings of REI awardees, and attend other meetings as needed.

Study Design Considerations:

Investigators should justify their research and analytic design selection and provide adequate evidence of their ability to execute a rigorous and appropriate analysis of randomized or non-randomized study data. The study design should take into consideration community needs, priorities and infrastructure, sample size, and study context.

For intervention studies, rigorous research designs are expected, but investigators are not required to conduct randomized controlled trials (RCTs). If participants are assigned to study arms, other potentially appropriate study designs with randomization include parallel group or cluster-randomized trials (GRTs), individually randomized group-treatment trials (IRGTs), and stepped wedge group or cluster-randomized trials (SWGRTs). In these studies, special methods may be warranted for analysis and sample size estimation, particularly for small or hard to reach populations where traditional experimental randomization is not possible without impacts on bias or contamination.

When it is not possible to assign subjects to study arms, alternative rigorous research designs that provide robust evidence of intervention effectiveness include, but are not limited to, multiple baseline or repeated measures designs, interrupted time series studies, or stepped-wedge cluster randomized trials in which all subjects receive the intervention. The application should demonstrate the rigor of the chosen design.

Further, hybrid effectiveness-implementation studies, which allow early observational investigation of implementation processes while also testing intervention effectiveness, may be appropriate. Additional information is available at https://researchmethodsresources.nih.gov/.

Investigators are strongly encouraged to review the NIH Clinical Trials definitions and policies. (https://grants.nih.gov/policy/clinical-trials.htm). Applications that do not include all required documentation for clinical trials for review, but are determined to be clinical trials, may not be considered for funding.

American Indian and Alaska Native Focused Applications:

Applicants proposing work with American Indian or Alaska Native communities are encouraged to consult American Indian and Alaska Native Research in the Health Sciences: Critical Considerations for the Review of Research Applications https://dpcpsi.nih.gov/sites/default/files/Critical_Considerations_for_Reviewing_AIAN_Research_508.pdf

Special considerations

Establishment of a Standard delta-9-THC Unit to be used in Research:

Applications proposing research on cannabis or its main psychotropic constituent delta-9-THC are required to measure and report results using a standard delta-9-THC unit in all applicable human subjects research. The goal is to increase the comparability across cannabis research studies. A standard delta-9-THC unit is defined as any formulation of cannabis plant material or extract that contains 5 milligrams of delta-9-THC. A justification should be provided for human research that does not propose to use the standard unit. Please see https://grants.nih.gov/grants/guide/notice-files/NOT-DA-21-049.html NOT-DA-21-049 for additional details.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:

The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants:

The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth regarding existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see https://nida.nih.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/points-to-consider-regarding-tobacco-industry-funding-nida-applicants for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:

NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details. Note that not all measures will be meaningful for the community partner and adaptations may be required if measures are not culturally congruent.

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

To be eligible for this FOA, the applicant institution must be a domestic institution located in the United States and its territories which:

1. has received less than $25 million dollars per year (total costs) from NIH Research Project Grants (RPGs) in each of the preceding two fiscal years, calculated using NIH RePORTER; and

2. award graduate degrees in biomedical sciences; and

3. has a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or has a documented record of: (1) recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers and, (2) for institutions that deliver health care services, providing clinical services to medically underserved communities. .To demonstrate eligibility for this FOA, applicants are required to provide specific details addressing criterion #3 above as a part of a single attachment entitled "Institutional Information." Applications that do not include sufficient evidence of eligibility may be administratively withdrawn.

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 his/her 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 FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to: [email protected]

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

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

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

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

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

Other Attachments:

Institutional Information

Provide an Other Attachment entitled "Institutional Information." This attachment should provide evidence for the applicant organization's eligibility to apply for RFA-DA-23-032. Specifically, describe the applicant organization's history of and commitment to supporting the academic success ofstudents who are underrepresented in the biomedical sciences as per the institutional eligibility criterion #3 described in Section III. Eligibility Information.

Plan for Enhancing Diverse Perspectives (PEDP)

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

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally underrepresented 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 backgrounds, including those from underrepresented groups in research.

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

R&R or Modular 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.

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

Applications should clearly describe:

• The theoretical basis for the research proposed, including the process for developing, adapting, and tailoring the research to the community proposed.
• How research findings will significantly impact solutions to address racial or ethnic disparities in substance use, addiction, and related outcomes.
• The track record of the team in conducting health disparities, substance use, and community engaged research.
• If proposing intervention research, the potential for the intervention to be sustained after the project is over and/or scalable to other settings.
• A plan to disseminate research findings to the public, including community members

Applications should include the following related to study design:

• A plan to identify, test or intervene on mechanisms of action or mediational processes relating racial or ethnic status to health disparities in substance use or addiction

• Justification and specific hypotheses for how race- and ethnicity-related constructs are used in analyses.

• That the study design takes into consideration the community needs, priorities, infrastructure, sample size and study context

Applications should include the following related to community engaged research:

• A description of the established partnership between the researchers and community member/organization involved in the proposed research.

• The meaningful engagement of community partners across the duration of the research study, documenting respective roles in the project

• If a community partner is serving as multi-PI, evidence of accomplishment and connection within the community to support their role.

• That the research question addressed is prioritized by the community and reflects lived experience

• The letter of support from community partners should demonstrate a history of working with the scientific team, a commitment to participate, and that the questions addressed are a key priority for the community. Evidence of the partnership can also be addressed in the bio-sketches.

Letters of Support:

Provide all appropriate letters of support, including any letters necessary to demonstrate the support of community partners, collaborators, stakeholders/experts (e.g., end users), and others. Letters of support should specifically identify the roles of community partners in the research.

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. The following additional instructions apply:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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 FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

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?

Specific to this FOA:

Is a clear and appropriate theoretical basis provided for the proposed research?

Does the proposed research address an issue prioritized by the community?

If successful, will the research findings significantly impact solutions to addressing racial or ethnic disparities in substance use, addiction, and/or related outcomes?

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?

Investigator(s)

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

Specific to this FOA:

If a community partner is serving as a multi-PI, is there evidence of sufficient accomplishment and connection within the community to support their role?

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?

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?

Specific to this FOA:

Does the research proposed reflect lived experience and the priorities of the community?

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?

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Does the application justify the way race- and ethnicity-related constructs are used in analyses?

Are community collaborators and/or stakeholders meaningfully engaged across the duration of the research study?

Does the study design take into consideration community needs, priorities and infrastructure, sample size, and study context? Is it appropriate to achieve study aims?

For projects proposing interventions, does the application address the potential sustainability of the intervention after the research study has ended?

Does the team reflect an established community partnership?

Does the team have a track record of research involving health disparities, substance use, and community-engaged research?

Do team members represent diverse perspectives and is this evidenced in the PEDP?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

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?

Specific to this FOA:

Do the letters of support from key community stakeholders/partners demonstrate a history of working with the scientific team and that the questions addressed are prioritized by the community?

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?

Additional Review Criteria

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal 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

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

If a foreign component is proposed, reviewers will assess whether it will advance the overall research program because the foreign component provides unusual talent or resources that are not available domestically.

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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:(1)Data Sharing Plan; (2)Sharing Model Organisms; and (3)Genomic Data Sharing Plan (GDS).

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 FOA.

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 FOA. 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 VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA 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:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

Data Management and Sharing

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

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

3. 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 FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Sarah Vidal, PhD
Prevention Research Branch
National Institute on Drug Abuse NIDA)
Telephone: 301-827-5529
Email: [email protected]

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

Kwesi Wright
National Institute on Drug Abuse (NIDA)
Telephone: 301-451-0167
Email: [email protected]

Section VIII. Other Information

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

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