Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title
NIDA REI: Racial Equity Visionary Award Program for Research at Minority Serving Institutions on Substance Use and Racial Equity (DP1 Clinical Trial Optional)
Activity Code

DP1 NIH Director’s Pioneer Award (NDPA)

Announcement Type
New
Related Notices

August 25, 2022 - Notice of Pre-Application Technical Assistance Webinar for NIDA RFAs to support research to advance equity for racial and ethnic minority groups affected by disparities related to substance use and consequences of substance use. See Notice NOT-DA-22-071

RFA-DA-23-013 - NIDA REI: Addressing Racial Equity in Substance Use and Addiction Outcomes Through Community-Engaged Research (R01 Clinical Trial Optional)

RFA-DA-23-023 - NIDA REI: Reaching Equity at the Intersection of HIV and Substance Use: Novel Approaches to Address HIV Related Health Disparities in Underserved Racial/Ethnic Populations (R01 Clinical Trial Optional)

RFA-DA-23-024 - NIDA REI: Reaching Equity at the Intersection of HIV and Substance Use: Novel Approaches to Address HIV Related Health Disparities in Underserved Racial/Ethnic Populations (R34 Clinical Trial Optional)

RFA-DA-23-025 - NIDA REI: Coordination Center to Support Racial Equity and Substance Use Disparities Research (U24 Clinical Trial Not Allowed)

RFA-DA-23-028 - NIDA REI: Research on Neurocognitive Mechanisms Underlying the Impact of Structural Racism on the Substance Use Trajectory (R61/R33 Clinical Trial Optional)

RFA-DA-23-029 - NIDA REI: Research at Minority Serving Institutions on Neurocognitive Mechanisms Underlying the Impact of Structural Racism on the Substance Use Trajectory (R61/R33 Clinical Trial Optional)

RFA-DA-23-032 - NIDA REI: Addressing Racial Equity in Substance Use and Addiction Outcomes Through Community-Engaged Research at Minority Serving Institutions (R01 Clinical Trial Optional)

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-DA-23-031
Companion Funding Opportunity
RFA-DA-23-026 , DP1 NIH Director's Pioneer Award (NDPA)
Assistance Listing Number(s)
93.279
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is a part of NIDA’s Racial Equity Initiative (REI), with goals that include promoting racial equity in NIDA’s research portfolio. This announcement invites applications supporting independent, early career or established scholars who self-identify as health equity, health disparities, or social determinants of health experts with the skills to make exceptionally creative contributions to the study of equity for underserved U.S. racial and/or ethnic minority groups that experience poorer outcomes related to substance use and substance use disorders.

This award supports transformative, boundary-pushing applications that may be risky or at a stage too early to fare well in the traditional peer review process. This FOA is a limited-competition annoucement, open to institutions meeting the eligibility criteria in Section III (below). All institutions are eligible to submit applications for the companion FOA, RFA-DA-23-026.

Key Dates

Posted Date
August 09, 2022
Open Date (Earliest Submission Date)
October 14, 2022
Letter of Intent Due Date(s)

30 days prior to Application Due Date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 14, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023
November 14, 2023 Not Applicable Not Applicable March 2024 May 2024 July 2024
November 14, 2024 Not Applicable Not Applicable March 2025 May 2025 July 2025

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

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

Expiration Date
November 15, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Racial Equity Visionary Award Program embraces transformative science by supporting independent investigators proposing highly innovative research that 1) challenges scientific paradigms that perpetuate inequities, and 2) lays groundwork for large scale efforts to impact substance use-related disparities that affect underserved U.S. racial and/or ethnic minority populations. PIs are expected to self-identify as health equity, health disparities, or social determinants of health researchers and have prior experience conducting collaborative research projects with one or more underserved racial and/or ethnic minority population groups. The application should reflect an exceptionally creative approach to problem solving and a long-term commitment to solution-oriented research with underserved racial and/or ethnic minority communities.

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

Evidence suggests that patterns of substance use, consequences of substance use, and access to services to prevent and treat substance use disorders vary significantly across populations. Structural factors, including racism and discriminatory practices, create conditions that lead to population-level health disparities. While various research studies document the disparities, relatively few researchers seek to bring a deep understanding of the social construction of race and its manifestations in the daily lives of U.S. residents to inform system-level changes to policy and practice.

The NIH is committed to supporting health equity research to 1) improve minority health and reduce health disparities and 2) remove the barriers to advancing health disparities research?(for more information, see the NIH Minority Health and Health Disparities Strategic Plan 2021-2025. 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 racial and ethnic disparities in outcomes related to drug use and HIV.? The REI funding opportunity announcements (FOAs) 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.?

Research Objectives

The Racial Equity Visionary Award program is designed to support health equity scholars conducting clinical research to better understand and/or intervene on systemic factors that drive disparities for racial and/or ethnic minority populations related to NIDA’s mission. For NIH, the definition of clinical research is broad, and includes epidemiological and behavioral studies, intervention research, outcomes research/health services research in addition to patient-oriented research (see the NIH Grants Policy Statement). Investigators may propose to conduct various types of studies, such as natural experiments, cohort studies, policy research, optimization research, pilot/feasibility intervention trials, modeling studies, qualitative/mixed-methods research studies, or human laboratory trials. Pilot or preliminary data may be included in the application, but they are not required for this award.

Applications include an essay describing research to advance health equity for one or more underserved racial and/or ethnic minority populations that bear a disproportionate share of the health, social, and legal consequences of substance use (e.g., deaths, injuries, infections, disorders, homelessness, arrests, job loss). For the purposes of this FOA, health equity is defined as all people having the opportunity to reach their full health potential and no one being disadvantaged from achieving this potential because of social position or other socially determined circumstances. Applications should justify the selction of study populations using data that illustrate significant present and/or historical discrimination, mistreatment, isolation, or inequity. Investigators may propose projects addressing equity at the intersection of race/ethnicity and another social or demographic characteristic (e.g., sex, gender, sexuality, socioeconomic status, age, geographic location, education level, disability status, immigrant status, English language proficiency)

The Racial Equity Visionary Award projects must involve collaborations with community members who represent the population affected by inequities, particularly individuals with lived experience. In addition, investigators are encouraged to engage contributors from various stakeholder communities as needed such as lay health workers, community leaders, patient advocates, and service providers. PIs are strongly encouraged to collaborate with individuals from the impacted community throughout the research process.

In the application essay, the PI should integrate justifications for the proposed research from 1) academic scholarship/literature and 2) perspectives and lessons gleaned from direct interaction with community members representing underrepresented racial and/or ethnic minority groups. Literature, methods, and intellectual capital fromrelevant disciplines (e.g., ethnic studies, social epidemiology, psychology, neuroscience, ecology, sociology, engineering, economics, anthropology, communications science, social work, urban planning, data science) and experts should be embraced. Investigators are encouraged to consider research frameworks that reflect system-level influences and avoid stigmatizing populations or pathologizing behaviors. PIs should utilize community-engaged research, community-based participatory research, community action research, or related strategies in the conduct of their work. In addition, studies that involve innovative use of data collection and analysis methodologies, such as data-intensive research efforts, are encouraged.

While the Racial Equity Visionary award is a single-investigator award, the application essay must address how diverse perspectives will be brought to bear on the problem throughout the course of the project period. For example, partnership building efforts between the PI and other talented investigators and collaborators who bring unique skills, expertise, and/or lived experiences to the research should be described.

Investigators whose research is aligned with NIH HIV research priorities (see NOT-OD-20-018) must apply for the NIDA Avant-Garde Award Program for HIV/AIDS and Substance Use Disorder (PAR-20-221) rather than the Racial Equity Visionary Award. This FOA (RFA-DA-23-031) and the companion FOA (RFA-DA-23-026) do not fund HIV research.

NIDA’s Racial Equity Initiative: Common Goals and Collaboration

NIDA’s REI seeks to address persistent racial and ethnic disparities in substance use and related 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.

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. 

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

NIDA intends to commit approximately $2,000,000 to fund 2-3 awards each year between this FOA and the companion FOA, RFA-DA-23-026.

Award Budget

Application budgets are limited to $700,000 in direct costs per year.

Award Project Period

The maximum project period allowed is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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.  awards 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 administratively withdrawn.

Foreign Institutions

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. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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, e.g., 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 the purpose of this FOA, multiple PD(s)/PI(s) are not allowedThe Project Director/Principal Investigator (PD/PI) is the only individual who can be listed on the SF424 form.

NIH intramural investigators are not eligible for support under this program.

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).

Only one application is allowed per PI per receipt date.

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 investigators collaborating on the project
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov.

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

Agency Routing Identifier: Enter “N/A”.

Type of Application: Must be “New”.

Proposed Project: Start date: July 1st

Total Federal Funds Requested: Enter $3,500,000.

Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds: Enter $3,500,000. (See note below.)

Estimated Program Income: Enter $0.

Note: The Budget Request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total - $3.5 million - should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds." Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.

Cover Letter: Provide names and affiliations of significant collaborators for the Racial Equity Visionary Award project.

Biosketches of collaborators are not allowed. Provision of names here is only to help exclude conflicts during reviewer assignment. Information regarding any collaborators may be included in the essay.

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Project Summary/Abstract: Attach an abstract describing the goals of the project and relevance to achieving health equity for underserved U.S. racial/ethnic groups that experience poorer outcomes related to substance use and substance use disorders.

Project Narrative: In 2-3 sentences written in plain language, describe how the proposed research will lead to innovations in achieving equity for underserved U.S. racial/ethnic groups populations.

Bibliography & References Cited: DO NOT USE. Reference citations cannot be attached here but may be included in the essay.

Equipment: DO NOT USE.

Other Attachments: Provide a single attachment with the file name and document title "Institutional Information." This attachment should provide evidence for the applicant organization's eligibility to apply for RFA-DA-23-031.  Specifically, describe the applicant organization's history of and commitment to supporting the academic success of students who are underrepresented in the biomedical sciences as per the institutional eligibility criterion #3 described in Section III. Eligibility Information.

SF424(R&R) Senior/Key Person Profile

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

Profile – Project Director/Principal Investigator Field – Attach Biographical Sketch: Attach the PD(s)/PI(s) biographical sketch using the sample format on the Biographical Sketch Format Page shown in the Application Guide, omitting Section A (Personal Statement) and Section D (Research Support). No biographical sketches of potential collaborators or other key personnel are to be submitted and will not be accepted.

Current and Pending Support: Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project.

Profile – Senior Key Person 1: DO NOT USE. Submit information only for PD/PI. Information on collaborators or other key personnel is not required but may be included in the Essay.

Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE. Only the PD/PI may serve as senior/key personnel.
Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch.

R&R Subaward Budget
PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: DO NOT USE.

Research Strategy: Upload the essay here. Describe the applicant’s innovative vision for a program of research that 1) challenges scientific paradigms that perpetuate inequities, and 2) lays groundwork for large scale efforts to impact substance use-related disparities that affect underserved U.S. racial/ethnic populations. The essay should describe the PI's qualifications to conduct the proposed research and view of the major challenges and opportunities in reducing disparities related to substance use or SUD outcomes for one or more racial/ethnic minority group. The essay should provide evidence of the applicant's qualifications to conduct research related to health equity, health disparities affecting underserved racial and/or ethnic minority communities, or social determinants of health. No detailed scientific plan should be provided since the research strategy is expected to evolve during the tenure of the grant. Figures and illustrations may be included but must fit within the page limit. References to peer-reviewed literature are not required, but, if included, must fit within the page limit. Do not include links to websites to provide further information. The essay should include the following sections in the order given with the headings as shown below:

Project title: The project title must be included at the beginning of the essay.

Project description: What is the scientific problem or challenge that will be addressed, and why is this important? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to groundbreaking or paradigm-shifting results and how might these results lead to innovations in prevention, treatment, or recovery? As required by this FOA, provide justification for the proposed research from a) academic scholarship/literature and b) perspectives and lessons gleaned from direct interaction with community members representing underrepresented racial/ethnic minority groups. Describe the project collaborators, particularly those representing the interests of stakeholder groups and relevant racial and/or ethnic minority communities. Describe how the research plan will incorporate community-engaged research, community-based participatory research, community action research, or related strategies, as required by this FOA. If the initial strategy/approach does not work out as planned, what alternative strategies/approaches might be employed?

Evidence of innovativeness: What evidence can be provided to support the innovativeness of the proposed project? What theoretical and/or methodological innovations related to health equity research will be utilized?

Qualifications of the PI: What are the PI's qualifications to lead this project and prior experience conducting collaborative, health equity-focused research? Narrative should support the PI's ability to successfully conduct research projects involving underserved racial and/or ethnic minority populations.

Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 35% or 4.2 person months of his/her research effort to the project supported by the Racial Equity Visionary Award Program. Applications without such a statement will be considered incomplete.

Letter of Support: Provide 1 letter of support from a collaborator for the Racial Equity Visionary Award project. This letter of support should provide evidence that the PI has developed a working relationship that may be leveraged during the project period. This letter does not count against the page limit for the Research Strategy.

PLEASE NOTE: Complete applications require 1 letter of support AND 3 letters of reference (see below).

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 modifications also apply:

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

No Appendix Materials are allowed.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. 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.

Letters of Reference

Letters of reference are an important aspect of the application. The PI must arrange to have three (and no more than three) letters of reference submitted on their behalf. Applications that are missing letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted. Applicants are responsible for monitoring the submission of the letters to ensure that three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the submission status in the NIH Commons.

Letters may be submitted beginning October 14, 2022; October 14, 2023; and October 14, 2024 for the pending receipt date.

To submit a letter of reference, the referee will need the following information:

  • Funding Opportunity Number (FOA) for this announcement: RFA-DA-23-031
  • The PI's eRA Commons User Name (Note: Referees do not need to be registered in the Commons and do not need their own Commons User Name – only the Commons User Name of the applicant is required);
  • The PI's first and last name (note – the name must match exactly the applicant's name in the Commons)
  • The URL to the letter submission page: https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new

The deadline for receipt of all reference letters is 5:00 p.m. (local time of the referee) on November 14, 2022; November 14, 2023; and November 14, 2024.

Letters of reference are confidential. Applicants will not have access to the letters. Email confirmations will be sent to both the applicant and the referee. The confirmation sent to the applicant will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and PI names, a confirmation number, and the date and time the letter was submitted.

Note: Since email can be unreliable, it is the applicant's responsibility to check the status of his/her letters of reference periodically in the Commons.

Instructions for Referees

PIs are strongly encouraged to send the following to their referees:

You are being asked to prepare a letter of reference for a prospective NIH grant PIn. Letters must be submitted to the NIH eRA Commons at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new by 5:00 p.m. (local time of the referee), on November 14, 2022; November 14, 2023; November 14 2024. Late letters will not be accepted and applications with fewer than three letters may not be reviewed. Letters must be submitted electronically – paper copies will not be accepted. Note: The letter submission page can be accessed without signing into the Commons, and referees do not need to be registered in the Commons.

The prospective PI's name should be placed at the top of the letter. Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information.

In two pages or less, describe the prospective PI's qualities that support this individual's scientific innovativeness and creativity. When possible, give specific examples that illustrate these qualities. Address the likelihood that the prospective PI will conduct groundbreaking research in the proposed research area. If you are able, please comment on the individual's qualifications to conduct collaborative research projects involving one or more underserved racial and/or ethnic minority population groups.

Referees must enter the following information when submitting letters:

REFEREE INFORMATION (the individual providing the letter of reference):

  • Referee’s First and Last Name
  • Referee’s Email Address
  • Referee’s Institution/Affiliation
  • Referee’s Department

PI INFORMATION (applicants must send this information to their referees):

  • PI's Commons Username (User ID), (Important – this must be the prospective PI's, not the referee’s, Commons Username (User ID). The letter will not be linked to the appropriate application if the PI's Username is not entered here.)
  • PI's Last Name. (Note: must match exactly the prospective PI's name in the Commons).
  • Funding Opportunity Number (FOA) of this announcement: RFA-DA-23-031
  • Confirmation Number (Required only when resubmitting a letter, that is, when submitting a revised or changed/corrected letter for the current FOA).

Email confirmations will be sent to both the applicant and the referee following submission of the letter. The email confirmation will include a Confirmation Number that will be required when submitting revised or changed/corrected letters. Print the confirmation email for your records.

Note: Referees letters submitted in support of Racial Equity Visionary Award applications must be current; new letters of reference are required for each new application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

NIDA Racial Equity Visionary Award (DP1) applications are meant to support individual scientists of exceptional creativity who propose research projects that could have a major impact on promoting equity for underserved racial and/or ethnic minoritycommunities in the U.S. that experience poorer outcomes related to substance use and substance use disorders. NIDA Racial Equity Visionary Award applications do not require preliminary data, scientific aims, or a detailed research plan. Accordingly, reviewers will emphasize the following:

  • the importance of the scientific problem and the potential impact of the research,
  • the novelty and innovativeness of the approach, and
  • evidence of the PI's potential for creative and innovative research
  • evidence of the PI's qualifications to conduct collaborative, health equity-focused research

Applications that are complete will be reviewed by a multidisciplinary scientific review group of outside experts convened by The National Institute on Drug Abuse in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the stated review criteria. PIs forapplications that are deemed to be highly meritorious will be invited for interviews by a multidisciplinary scientific review group. Final selection of awardees will be made by the Director, National Institute on Drug Abuse, NIH, based on the outcome of the peer review, concurrence of National Advisory Council on Drug Abuse, and programmatic considerations. Final selections will be announced publicly.

Applications that are not selected for interview phase of review will be designated as “Not Discussed” and will not receive a numerical Overall Impact score. Applications selected for the second phase of review (interview) will receive summary statements with a numerical Overall Impact score.

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 the FOA: To what extent will successful completion of the proposed project contribute to our understanding of health equity as it relates to substance use outcomes for one or more underserved racial and/or ethnic minority population(s)?

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 the FOA: Does the application provide sufficient evidence for the investigator's qualifications to conduct collaborative health equity, health disparities, or social determinants of health research involving one or more underserved racial and/or ethnic minority community?

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 the FOA: Does the proposed research integrate theoretical and/or methodological innovations related to health equity research?

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 the FOA: Does the application propose meaningful engagement of community partners in the research strategy? Do plans to incorporate the diverse perspectives add signficant value to the project?

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?

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

Not applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

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:

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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

Application Submission Contacts

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

Finding Help Online: 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Scientific/Research Contact(s)

Aria Davis Crump, Sc.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0881
email: aria.crump@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Amy Bucheimer
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: amy.bucheimer@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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