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: Academic Research Enhancement Award (AREA) Training a Diverse Data Science Workforce for Addiction Research (R15 Clinical Trial Not Allowed)
Activity Code

R15 Academic Research Enhancement Award (AREA)

Announcement Type
New
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • December 21, 2023 - Notice of Change to Eligibility Information for RFA-DA-24-026. See Notice NOT-DA-23-048
  • October 19, 2023 - Notice of Change to section for RFA-DA-24-026, "NIDA REI: Academic Research Enhancement Award (AREA) Training a Diverse Data Science Workforce for Addiction Research (R15 Clinical Trial Not Allowed)". See Notice NOT-DA-23-039
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Notice of Funding Opportunity (NOFO) Number
RFA-DA-24-026
Companion Funding Opportunity
RFA-DA-24-025 , R25 Education Projects
Assistance Listing Number(s)
93.279
Funding Opportunity Purpose

This notice of funding opportunity (NOFO) is a part of the National Institute on Drug Abuse's (NIDA s) Racial Equity Initiative (REI).

The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing research experience that intersects drug addiction and data science primarily for undergraduate students, and enhancing the drug addiction research environment that applies data science at applicant institutions.

The over-arching goal of this R15 program is to train a diverse data science workforce to leverage the potential of artificial intelligence and machine learning (AI/ML) to accelerate the pace of socio-behavioral and biomedical innovation in drug addiction research. The establishment of mutually beneficial partnerships to enhance the participation of researchers from diverse backgrounds and communities experiencing health disparities is expected.

Help in determining the Organization Funding Level can be found here or https://grants.nih.gov/grants/funding/r15.htm.

Key Dates

Posted Date
September 20, 2023
Open Date (Earliest Submission Date)
December 24, 2023
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 - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
January 24, 2024 Not Applicable Not Applicable July 2024 August 2024 September 2024

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
January 25, 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 How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

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

Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The National Institutes of Health (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, the National Institute on Drug Abuse (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 notice of funding opportunities (NOFO) 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. NIDA has issued several REI NOFOs to support highly innovative, solution-focused research studies to address persistent disparities in the United States affecting racial and ethnic minority communities. Along with these research studies, NIDA established the Coordination Center to create synergy and linkages across projects funded under NIDA's Racial Equity Initiative (REI) funding opportunity announcements and to optimize the impact of individual REI projects by strengthening community-engaged research efforts and supporting the dissemination and usage of research products and innovations.

The NIH is continuing to make a special effort to stimulate research at educational institutions that provide baccalaureate and/or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, which NIH has implemented through the Academic Research Enhancement Award (AREA) program. This funding opportunity announcement aims to support AREA grants to undergraduate-focused institutions that do not receive substantial funding from the NIH, in order to provide data science for drug addiction research experiences for undergraduate students and enhance the data science for addiction research environment at these institutions. AREA funds are intended to support new and renewal data science for addiction research projects proposed by faculty members of eligible institutions (see Part 2. Section III.1).

The main objective of this NOFO is to train a diverse data science workforce for drug addiction research through the following : (1) provide support for meritorious data science for drug addiction research at undergraduate-focused institutions or institutional components; (2) strengthen the data science for drug addiction research environment at these institutions/components; and (3) give undergraduate students an opportunity to gain significant data science for drug addiction research experience through active involvement in the research. For the purpose of this announcement, an undergraduate-focused institution/component is one in which the undergraduate enrollment is greater than the graduate enrollment. Research projects must focus on leveraging the potential of artificial intelligence and machine learning (AI/ML) to accelerate the pace of biomedical and socio-behavioral innovation in drug addiction research and training a diverse data science workforce in drug addiction research field.

The AREA program will enable qualified scientists to receive support for small-scale data science for drug addiction research projects. It is anticipated that investigators supported under the AREA program will benefit from the opportunity to conduct independent data science for addiction research; that the grantee institution will benefit from a data science for addiction research environment strengthened through AREA grants; and that students at recipient institutions will benefit from exposure to and participation in scientific research in the field of data science for addiction science so that they consider careers in this area. This AREA NOFO emphasizes the engagement and inclusion of undergraduates in research.

The research project must involve undergraduate students, and the research team must be composed primarily of undergraduate students. Student involvement in research may include participation in the design of experiments and controls, collection and analysis of data, execution and troubleshooting of experiments, presenting at meetings, drafting journal articles, collaborative interactions, participation in lab meetings to discuss results and future experiments, etc. The AREA program is a research grant program, not a training or fellowship program, and, as such, applications should not include training plans such as didactic training or non-research activities relating to professional development. Masters and doctoral candidates may be supported on these research projects, but their inclusion should be carefully considered. In all cases, the majority of students conducting research through the award must be undergraduates. Since diversity strengthens the research environment, AREA projects are encouraged to include students from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce (See NOT-OD-20-031). This NOFO does not provide for support of research from Health Professional Schools as defined in Section III.1 regardless of student composition.

An AREA application submitted to this NOFO may include other investigators, such as technicians, collaborators or consultants, or other individuals such as high school students, post baccalaureate participants, graduate students, or postdoctoral fellows. However, involvement of such individuals does not fulfill the goal to engage undergraduate students in eligible environments to research. Due to the multi-disciplinary nature of data science research, the establishment of mutually beneficial partnerships to enhance the participation of researchers from diverse backgrounds and communities experiencing health disparities is expected.

The NIH has recognized the importance of increasing the capacity of experts in computation, data science, and related fields to move into the biomedical and socio-behavioral research space in the NIH Strategic Plan for Data Science. There are currently multiple strategies to enhance the data science workforce at NIH, expand the national research workforce, and engage a broader community in the biomedical and clinical research fields. Rapid increase in the volume of data generated through Electronic Health Records (EHR) and other biomedical and socio-behavioral research presents exciting opportunities for developing data science approaches for biomedical research and improving healthcare. However, there are several challenges that hinder more widespread use of AI/ML technologies, including cost, capability for widespread application, and access to appropriate infrastructure, resources, and training. Additionally, there is a need for a diverse workforce to identify and mitigate the risk of creating and perpetuating harmful biases in its practice, algorithms, and outcomes inadvertently cultivating health disparities and inequities. Another critical issue is that underrepresented groups often lack financial, infrastructure, and training capacity to apply data science methods to research questions of interest to them. In response to some of these challenges in 2023, NIH launched the Science Collaborative for Health disparities and Artificial intelligence bias Reduction(ScHARe), which is a cloud-based social science data platform designed to accelerate research in health disparities, health care outcomes, and artificial intelligence bias mitigation strategies.

There are many opportunities to train a diverse data science workforce who can leverage the potential of AI/ML to accelerate the pace of biomedical and socio-behavioral innovation in drug addiction substance use research and establish mutually beneficial partnerships to enhance the participation of researchers from diverse backgrounds and communities experiencing health disparities. It is critical to provide support for meritorious research, strengthen the research environments and collaborations for successful data science projects and expose undergraduate and/or graduate students in such environments to meritorious research in this area.

Goals/Research Objectives

This NOFO seeks to provide drug addiction research experiences that applies data science, for undergraduate students to inspire a diverse cohort of future data science researchers to focus on solving public health problems related to drug addiction.

NIDA supports innovative research addressing critical issues of neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, HIV/AIDS, and co-occurring opportunistic infections (e.g., viral hepatitis C, tuberculosis, sexually transmitted infections) associated consequences in substance using populations, medication development, or other research areas relevant to drug abuse. NIDA priorities are further described in the NIDA Strategic Plan (see https://www.drugabuse.gov/about-nida/strategic-plan/directors-message) and on the NIDA Notice of Special Interest webpage (see https://www.drugabuse.gov/research/nida-research-programs-activities/nida-notice-special-interest-nosi). Applicants are encouraged to contact a program official to discuss the proposed application.

Program elements of interest include, but are not limited to:

  • Utilizing AI/ML for research specific to drug addiction
  • Forming partnerships/collaborations to provide infrastructure and resources for AI/ML applications and research conducted by diverse research teams with a focus on communities experiencing health disparities
  • Identifying resources and training needed for data science of addiction research, particularly AI/ML approaches and at institutions that provide baccalaureate and/or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support

NIDA’s Racial Equity Initiative: Common Goals and Collaboration

NIDA’s REI seeks to address persistent racial and ethnic disparities in drug addiction 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, policymakers, research volunteers, and the public.

NIH encourages the formation of research teams that represent diverse perspectives, backgrounds and academic and technical disciplines, as well as the submission of research applications from all eligible institutions. In accordance with the NIDA REI Initiative, NIDA encourages applications supporting researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women (see NOT-OD-20-031 and NOT-OD-22-019).

Pre-Application Consultation

Applicants are strongly encouraged to consult with the NIDA Scientific/Research Contacts early in the application development process. Early contact provides an opportunity for IC staff to discuss the program scope and goals and to provide information and guidance.

Applications not responsive to this NOFO include:

  • Projects with no engagement with the AI/ML community, or no AI/ML expertise in the proposed collaboration
  • Projects lacking a Recruitment Plan to Enhance Diversity

Applications will be considered non-responsive and will not be reviewed if out of scope for this NOFO.

PI Meeting Attendance

It is expected that awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, as well as other activities. Awardees should also be willing to participate in virtual meetings organized by NIH.

Special Considerations

NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

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

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 NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIDA intends to commit $1.5M in FY 2024 to fund 6-10 awards from this R15 and the companion R25.

Award Budget

Applicants may request up to $300,000 in direct costs for the entire project period of up to 3 years.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

In addition, all organizations must meet the following two criteria:

  1. The applicant organization must be an accredited public or non-profit private school that grants baccalaureate or advanced degrees in biomedical or behavioral sciences
  2. The applicant organization may not receive research support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in each of 4 of the last 7 years.
  • Note that all activity codes are included except the following: C06, S10, and all activity codes starting with a G.

Institutions with Health Professional Schools or Colleges

For institutions composed of multiple academic components (i.e., schools or colleges), the criterion of financial eligibility is based on the amount of NIH research grant monies received, not by the institution (university) as a whole, but by the individual health professional school/college or by the sum of "Other Academic components" (as defined in this section) where the PD/PI has a primary appointment (e.g., School of Arts and Science, School of Medicine, College of Nursing, School of Pharmacy, etc.). Thus, each of the following is considered independently when determining the financial eligibility of the applicant organization.

  • Health professional school/college: Accredited public or non-profit private school/college that grants a terminal health professional degree (e.g., MD, DDS, DO, PharmD, BSN, DVM, DrPH, OD, DPT, DC, ND, DPM).
  • Accreditation must be provided by a body approved for such purpose by the Secretary of Education.
  • Health professional schools/colleges that meet the above requirements may include schools or colleges of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry.
  • Other Academic component: Once the health professional schools/colleges have been excluded, the financial eligibility of the Other Academic component is determined by the sum of all remaining schools, colleges, and free-standing institutes of the institution (university).

Additional Eligibility Guidance

A signed letter is required from the Provost or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission according to the eligibility criteria indicated above. See the application instructions for "Other Attachments" on the SF424(R&R) Other Project Information form in Section IV.2 Instructions for Application Submission. Final eligibility will be validated by NIH prior to award.

To assist in determining eligibility, organizations are encouraged to use the NIH RePORT website under NIH Awards by Location & Organization.

An AREA grant is permitted to have a subcontract to a non-AREA-eligible institution. However, applicants should keep the goals of the AREA program in mind when preparing the application, which include strengthening the research environment of eligible institutions and exposing students from eligible institutions to research. It is expected that the majority of the research will be directed by the PD(s)/PI(s) at the grantee institution.

Although foreign institutions are not eligible, applications may include a foreign collaboration, component, or consortium.

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. 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.

To be eligible for an AREA grant, the PD(s)/PI(s) must meet the following additional criteria:

  • The PD(s)/PI(s) must have a primary appointment at an AREA eligible institution.
  • The PD(s)/PI(s) may not be the PD(s)/PI(s) of an active NIH research grant, including another AREA grant, at the time of award of an AREA grant, although he or she may be one of the Key Personnel for an active NIH grant held by another PD/PI.
  • The PD(s)/PI(s) may not be awarded more than one AREA grant at a time, although he or she may hold successive new or renewal grants.

Note: These eligibility criteria only apply to the PD(s)/PI(s) of the application, not to other Key Personnel such as collaborators and consultants.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to: NIDALetterofIntent@nida.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 NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities & Other Resources: This attachment should include the following information:

  • A qualification of the students of the applicant institution and any information or estimate of the number who have obtained a baccalaureate degree and gone on to obtain an academic or professional doctoral degree in the health-related sciences during the last five years.
  • Description of the special characteristics of the applicant institution that make it appropriate for an AREA grant awarded through this NOFO, where the goals of this NOFO are to: (1) provide support for meritorious research at undergraduate-focused institution or institutional components; (2) strengthen the research environment at these institutions/components; and (3) give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research.
  • Description of the likely impact of an AREA grant on the PD(s)/PI(s).
  • Description of the likely impact of an AREA grant on the research environment of the applicant institution.
  • Description of the likely impact of the AREA grant on the ability of undergraduate students at the institution to gain experience conducting biomedical research.
  • Provide a description of the resources of the grantee institution available for the proposed research (e.g., equipment, supplies, laboratory space, release time, matching funds, etc.).
  • Although the majority of the research must be directed by the PD(s)/PI(s) and conducted at the applicant institution, limited use of special facilities or equipment at another institution is permitted. For any proposed research sites other than the applicant institution, provide a brief description of the resources and access students will need and have to these resources.

Other Attachments: The application must include a PDF-formatted letter named "ProvostLetter.pdf" (without quotation marks). For MPI applications a signed Provost letter is required from each involved institution. The letter must be signed by the Provost or similar official with institution-wide responsibility attesting to the following information:

  • The eligible academic component(s) (i.e., the college/school level) has more undergraduates than graduate students as of the date of submission.
  • All the non-health professional components of the institution together have received support from the NIH totaling no more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 years, as described in Section III, "Eligible Organization".
  • Validation that the PD(s)/PI(s) has (or in the case of a multiple PD/PI application that all PD(s)/PI(s) have) a primary appointment at the qualifying component (i.e., the college/school level).
SF424(R&R) Senior/Key Person Profile

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

Biographical Sketch: The PD(s)/PI(s) should include a summary of his or her previous and/or current experience supervising undergraduate and/or graduate students in research in the Personal Statement. The PD(s)/PI(s) should indicate which peer-reviewed publications or other research products involved undergraduate and/or graduate students under his or her supervision.

R&R or Modular Budget

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

  • The total budget for all years of the proposed project must be requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are not required and will not be accepted with the application.
  • Applicants submitting an application with direct costs of $250,000 or less (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the Modular Budget.
  • Applicants submitting an application with direct costs of $250,001 - $300,000 (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the R&R Budget.
  • Students must be compensated for their participation in the lab's research and in accord with institutional policies. Salaries can be requested for students in the R15 budget or other resources at the university can be used to pay them for their participation. Undergraduate students who are compensated from the R15 grant or other institutional funds should receive at least the national minimum wage. Compensation through course credit hours towards graduation is allowable, but must be justified. If universities/colleges provide room and board for summer research students, details must be provided in the application.
  • NIH does not fund stipends for undergraduates on R15 awards.

Modular Budget (direct costs of $250,000 or less)

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

Budget Period 1: Direct Costs

Direct Costs less Consortium F&A: Select the appropriate dollar amount from the drop-down list. This number must not exceed $250,000

Budget Justification:

Personnel Justification: Since a primary objective of the AREA program is to engage undergraduate students in meritorious research, the research team must be composed primarily of undergraduate students from the applicant institution/AREA-eligible component. Indicate aspects of the proposed research in which undergraduate students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.

R&R Budget (direct costs of $250,001 to $300,000)

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

Budget Period 1: Direct Costs

Total Direct Costs less Consortium F&A: This number must not exceed $300,000.

Budget Justification:

Personnel Justification: Since a primary objective of the AREA program is to engage undergraduate students to meritorious research, the research team must be composed primarily of undergraduate students from the applicant institution/AREA-eligible component. Indicate aspects of the proposed research in which undergraduate students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.

Meetings and Travel: The applicants are encouraged to budget for travel costs to support attendance of one PD/PI for a 3-day in-person meeting in the Washington DC area, annually for the duration of the award.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Describe how the proposed plan can achieve the specific aims using a research team composed primarily of undergraduate students and enhance and leverage data science skills. Describe how undergraduate students will be engaged in and supervised in conducting hands-on, rigorous research. Describe how undergraduate students will participate in research activities such as planning, execution, and/or analysis of the research. Formal training plans (e.g., non-research activities, didactic training, seminars) should not be provided, although a brief description of activities related to enhancing students' research capabilities and progress (e.g., the use of individual development plans, etc.) is permitted.

Recruitment Plan to Enhance Diversity (NOT-OD-20-031):

The applicant must provide a Recruitment Plan to Enhance Diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups. The Recruitment Plan to Enhance Diversity must be included within the allowable page limits for the research strategy.

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
Appendix:

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the 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 field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The main objective of this NOFO is to train a diverse data science workforce for drug addiction research through the following: : (1) provide support for meritorious research at undergraduate-focused institution or institutional components; (2) strengthen the research environment at these institutions/components; and (3) give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research. For the purpose of this announcement, an undergraduate institution/component is one in which the undergraduate enrollment is greater than the graduate enrollment.

Scientific foundation for the proposed research should be established using preliminary data (if available) and/or published data. Although preliminary data are not required for an R15 application, they may be included if available.

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 NOFO:

To what extent does the proposed project address an important aspect or important need in data science for addiction research? How adequate is the evidence that the proposed research will significantly advance the goals of the program and the scientific areas? If funded, how adequately will the AREA grant have a substantial effect on the applicant institution in terms of strengthening the research environment and exposing undergraduate students to research?

To what extent will implementation of the proposed research advance skills in innovative data science methods and approaches relevant to drug addiction research? To what extent is the research applicable across a range of biomedical, behavioral and social science areas? How well is the research opportunity justified and based on addressing important gaps in existing opportunities?

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 NOFO:

Does the PD/PI have adequate capability of providing both administrative and scientific leadership to the development and implementation of the proposed research? How adequate is the evidence that an appropriate level of effort will be devoted by the program leadership to ensure the intended goal of the research is accomplished? If applicable, to what extent are the faculty good role models for the participants by nature of their scientific accomplishments? 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?

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 NOFO:

How adequately does the proposed research leverageAI/ML to accelerate the pace of data science for drug addiction research? To what extent does the proposed research developing or utilizing latest best practices to improve the knowledge and/or skills of those involved in the research and the larger community? To what extent does the proposed research include state-of-the-art data science approaches?

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 NOFO:

How well does the proposed research clearly state its goals and objectives, including engagement of undergraduate students? How adequate is the evidence that the research is based on a sound rationale, and utilize sound approaches?

How well does the proposed research integrate different disciplines? How adequate is the plan for disseminating the information to as large an audience as possible? How well does the proposed research enhance targeted data science skills?

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 NOFO:

How well does the application provide sufficient evidence that students at the AREA-eligible institution/academic component have in the past and/or are likely in the future to pursue careers in the biomedical sciences? How adequate is the the PD/PI(s) time and institutional support to conduct the proposed project?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the Recruitment Plan to Enhance Diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

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

  • 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.
  • Compliance with resource sharing policies.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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 will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

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. Data Management and Sharing

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

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

4. Reporting

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Scientific/Research Contact(s)

Division of Neuroscience and Behavior
Susan Wright, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6683
Email: susan.wright@nih.gov

Division of Epidemiology, Services and Prevention Research
Janet Kuramoto-Crawford, PhD, MHS
National Institute on Drug Abuse (NIDA)
Telephone: (301) 443-8856
Email: janet.kuramoto-crawford@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)

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6705
Email: ericka.wells@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 and 2 CFR Part 200.

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