Part 1. Overview Information

Key Dates

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

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

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

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

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

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.



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose:

The purpose of this NOFO is to support research projects that test innovative approaches to implementing Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities.

Key Definitions:

Screening Brief Intervention Referral to Treatment or Prevention (SBIRT/P):

SBIRT, involves screening individuals for risk of ATOD use and misuse, briefly intervening with a conversation about harmful substance use, and referring individuals for treatment, as needed. The addition of preventive interventions to SBIRT is a novel approach to the delivery of early intervention and treatment services for adults at risk for ATOD use and misuse. The acronym SBIRT/P will be used to include the prevention of ATOD use and misuse by those who are at risk of developing these disorders.

Populations that experience health disparities (HD Populations):

Populations are defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include racial and ethnic minority populations (American Indian or Alaska Native, Asian American, Black or African American, Native Hawaiian or Pacific Islander, Latino or Hispanic), less privileged socioeconomic status (SES) populations, underserved rural populations, and sexual and gender minorities (SGM).

Background

The ADVANCE, Advancing Prevention Research for Health Equity, program was created to develop and test new interventions and new strategies to disseminate existing interventions that address the leading risk factors for death and disability in populations that experience health disparities in response to a portfolio performed in the NIH Office of Disease Prevention (ODP). The portfolio analysis of NIH-funded grants and cooperative agreements between fiscal years 2012-2017 showed that only 8.5% of all prevention research projects focused on preventing the leading risk factors or causes of death and disability. Additionally, an analysis that examined prevention research projects between 2016-2019 revealed that only 3.6% of the NIH-funded projects included a randomized intervention to address a leading risk factor for death and disability in populations that experience health disparities.

The Global Burden of Disease Project identified ATOD use and misuse in the top 10 leading risk factors for death and disability. Therefore, effective screening, treatments, and increased uptake of preventive interventions related to ATOD use and misuse risk factors are needed to improve population health and reduce disparities in morbidity and mortality.

Currently, screening, brief intervention, and referral to treatment (SBIRT) is recognized as an effective strategy to reduce ATOD use and misuse in adults. However, implementation of SBIRT in healthcare settings remains low, and much less is known about how screening and brief intervention can be used to also refer to prevention interventions, i.e., to prevent the onset of ATOD use and misuse or prevent escalation from misuse to disorder. Additionally, less work has been done on ways to effectively implement and scale SBIRT/P across diverse systems and settings and address barriers to effective referral to treatment or preventive interventions. This is especially true in populations that experience health disparities.

Research Objectives and Scope

This NOFO encourages research to develop and prospectively test implementation strategies that overcome known barriers to SBIRT/P for ATOD use and misuse in adult populations that experience health disparities.

Projects are strongly encouraged to include robust engagement with relevant healthcare and community partners (e.g., consumer advocacy groups, social service agencies, employers, and faith-based organizations, etc.) to enhance the acceptability, feasibility, and sustainability of SBIRT/P for ATOD use and misuse in adult populations that experience health disparities. It is expected that projects will examine and/or modify organizational and system contexts that improve the accessibility, utilization, efficiency, effectiveness, and quality of SBIRT/P. The proposed SBIRT/P intervention or implementation should improve health outcomes in populations that experience health disparities at the individual, interpersonal, organizational, or community level, or in combination.

Applicants must include a Plan to Enhance Diverse Perspectives (PEDP). For more information, see https://braininitiative.nih.gov/vision/plan-enhancing-diverse-perspectives

Examples of potential topic areas or approaches with HD populations include, but are not limited to, the following:

• Reconceptualization or adaptation of SBIRT/P to improve implementation and sustainability in different settings or populations, including examination of cost-effectiveness or the impact of different reimbursement models on health outcomes.
• Interventions testing strategies to implement or scale-up SBIRT/P in non-traditional settings (e.g., college campuses, churches, workplaces, social service agencies, justice settings) and provide appropriate linkages to services, as needed.
• Interventions that involve partnerships with community organizations to address barriers to follow-up or engagement in treatment or prevention services after referral, such as food or housing insecurity, lack of transportation or childcare, limited English proficiency, stigma, etc.
• SBIRT/P interventions for multiple substances (such as concurrent alcohol misuse in combination with tobacco use.)
• Interventions that address ATOD in addition to other risk factors (co-morbidities), such as high fasting glucose, mental health issues, high systolic blood pressure, low physical activity, etc.
• Organizational interventions to ensure equitable access to and delivery of SBIRT/P interventions.

Non-responsive Applications

• Projects that do not focus on NIH-designated populations that experience health disparities.
• Projects that do not prospectively test SBIRT/P to address ATOD use or misuse.

Specific Areas of Research Interest

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

There is research evidence that SBIRT is an effective strategy to screen for and reduce negative consequences associated with alcohol misuse and alcohol use disorder for individuals at all stages of life (youth, mid-age and older adults, pregnant people, etc.). The U.S. Preventive Services Task Force recommends that primary care clinicians screen all adults for alcohol use. Additional research is needed to improve implementation and sustainability of alcohol Screening, Brief Intervention, Referral to Treatment or Prevention (SBIRT/P) in health disparity populations and ensure that the referral to treatment or prevention portion of SBIRT/P is implemented. NIAAA seeks studies that evaluate effective models and new strategies that improve implementation and sustainability of alcohol SBIRT/P in these populations. Partnerships and leveraging resources with health, community, and other organizations that implement SBIRT/P are highly encouraged. Areas of interest include, but are not limited to:

• Increasing adoption, sustainability, and implementation effectiveness of SBIRT/P in preventing and reducing alcohol misuse, AUD, and related outcomes.
• Improving implementation of SBIRT/P in the U.S. racial and ethnic population groups in which its implementation remains limited (e.g., Black or African Americans), among individuals with disabilities, sexual and gender minorities, and other health disparity populations across the lifespan.
• Testing feasibility and effectiveness of integrated protocols for SBIRT/P for alcohol and co-occurring conditions, e.g., cannabis (marijuana) and other drug use, PTSD, and other mental health problems.
• Evaluating new technologies for improving adoption, implementation, and sustainability of SBIRT/P, including in rural, remote, and under-resourced communities.
• Establishing effectiveness of alcohol SBIRT/P in non-traditional settings outside of primary care, such as juvenile justice, community settings, and religious institutions.
• Evaluating SBIRT/P large-scale implementation to determine its impact at the individual, community, and population levels, cost-effectiveness, and sustainability.

National Institute on Drug Abuse (NIDA)

The United States Preventive Services Task Force (USPSTF) recommends screening adults 18 years or older for unhealthy drug use, including pregnant and postpartum women. There is a need for research to better understand the factors that support implementation, sustainability, and scaling of screening for substance use risk, substance misuse, and substance use disorder and referral to prevention and treatment services.

Areas of interest include, but are not limited to, research to:

• Test models for healthcare (including primary care, emergency departments, urgent care, school/college health centers) and other community settings (e.g., systems workplace, community, recreational, social services, criminal justice) to support screening and brief prevention and treatment interventions for substance use risk, substance misuse, and substance use disorder, as well as linkage to prevention and treatment services, especially among those who experience health disparities and have traditionally been excluded from research in healthcare systems and other settings.
• Test models and strategies for integrating screening and referral or linkage to prevention and treatment services into systems/practices (e.g., policies, algorithms, decision tools, reminders), and test strategies for sustainability.
• Test policies and systems reforms to establish infrastructure to support the implementation and sustainability of prevention interventions.
• Test the implementation factors, including the cross-sector partnerships, stakeholder decision-making factors, workforce supports, and community infrastructure needed to successfully implement screening and linkage to prevention and treatment services.
• Test innovative and new technologies to enhance implementation of screening and linkage to prevention and treatment services in multiple settings.

National Institute of Dental and Craniofacial Research (NIDCR)

Alcohol, tobacco, and other drug (ATOD) use has adverse effects on dental and oral health, and drug use during pregnancy increases the risk of craniofacial anomalies during prenatal development. Given its significance to dental, oral, and craniofacial health, NIDCR is committed to supporting research on the treatment and prevention of ATOD use. Screening, Brief Intervention, and Referral to Treatment or Prevention approaches are particularly well-suited to the dental setting, where ATOD screening may already be standard of care, and where oral health professionals may be positioned to deliver brief, clinically-relevant interventions, and then facilitate referrals to treatment or prevention services.

NIDCR’s Clinical Trials Program typically supports clinical trials through a phased funding mechanism, with a robust planning phase, followed by a clinical trial phase if planning is successful. To accommodate the R01 funding mechanism of this announcement, NIDCR will only consider clinical trial applications that propose early intervention development research, consistent with Stage 1 or Stage 2 in the NIH Stage Model of Behavioral Intervention Development. Such a project would propose to develop or adapt an SBIRT/P intervention for use in the dental setting and/or that incorporates dental, oral, or craniofacial health in the approach. Additionally, to allow for completion of the clinical trial during the time allowed in the R01 funding mechanism, NIDCR will only consider applications that focus on short-term outcomes (i.e., no more than 6 months past intervention delivery). Investigators seeking to conduct intervention research at a later stage in the intervention development pipeline are encouraged to apply through NIDCR’s Behavioral and Social Intervention Clinical Trial Planning and Implementation (PAR-21-317) funding announcement.

National Institute of Minority Health and Health Disparities (NIMHD)

Areas of specific interest to NIMHD include but are not limited to interventions that:

• Measurably reduce or eliminate existing disparities in who receives SBIRT/P within healthcare settings that serve diverse populations
• Combine SBIRT/P with other brief screening or preventive services (e.g., cancer screening, diabetes screening, HIV testing, vaccination)
• Address social and structural barriers to promote equitable referral to and engagement in ATOD treatment or prevention services
• Offer SBIRT/P in community-based settings (e.g., schools, workplaces, faith-based organizations, community centers) and facilitate linkage to ATOD treatment or prevention services
• Use innovative technologies to increase access to SBIRT/P and follow-up care in rural or other settings with limited resources or referral options

Office of Disease Prevention (ODP)

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for research that has strong implications for disease and injury prevention and health equity and that include innovative and appropriate research design, measurement, and analysis methods. Information on resources for designing studies using the best available methods is available at: https://researchmethodsresources.nih.gov/. For this NOFO, ODP is interested in interventions that involve more than one service sector (e.g., health, education, transportation, labor, etc.), to promote Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) by addressing social determinants of health for populations that experience health disparities. ODP does not award grants. Please contact one of the IC program contacts listed for questions related to funding.

Office of Research on Women's Health (ORWH)

The Office of Research on Women’s Health (ORWH) is part of the Office of the Director, NIH, and works with the 27 NIH Institutes and Centers to advance rigorous research of relevance to the health of women. ORWH does not award grants but co-funds women’s health-related applications and research projects that have received an award from one of the participating NIH Institutes and Centers (ICs) listed in the announcement. Applications seeking ORWH co-funding, in response to this Notice, should ensure that the proposed work is aligned with at least one goal and objective outlined in the Trans-NIH Strategic Plan for Women’s Health Research (https://www.nih.gov/women/strategicplan).

For this NOFO, ORWH is interested in research projects that address the impact of social determinants of health on the health of women and people assigned female at birth.Interdisciplinary interventions focused on overcoming barriers related to the multiple domains of gender (roles and norms, relations, power dynamics and structural sexism) that influence access to and receipt of SBIRT/P in populations of women historically understudied, underrepresented and underreported (U3) in health research are of particular interest. ORWH encourages intersectional approaches to research questions, study design, data collection, and evaluation. Projects considering community-based collaborations are highly encouraged.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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 Governments

• U.S. Territory or Possession

Other

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

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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 registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

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.

Page Limitations

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

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

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

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

• Participation of investigators from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Engagement with different types of institutions and organizations (e.g., research-intensive and research active, undergraduate-focused, minority-serving, community-based).
• Partnerships that may enhance geographic and regional diversity.
• Use of the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early-, and mid-career researchers.
• Training and mentoring opportunities encouraging participation of students, postdoctoral researchers, and co-investigators from diverse backgrounds.
• Transdisciplinary collaborations that require unique expertise and/or solicit diverse perspectives to address research questions.
• Inclusion of community-based partners to ensure alignment of research goals and activities with community values.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/vision/plan-enhancing-diverse-perspectives

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PEDP implementation costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

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

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: All the following are required: Identify the health disparities (HD) population(s) that will be the focus of the intervention and describe the disparities they experience related SBIRT/P. Explain how the proposed intervention addresses inequities or barriers in SBIRT/P (e.g., barriers to effective referral, type of brief intervention) in populations that experience HD. Describe the potential for the intervention to be sustainable or scalable after the project is completed. Identify and describe the roles responsibilities of healthcare and community partners (e.g., consumer advocacy groups, social service agencies, employers, and faith-based organizations, etc.). Provide a data analytic plan that specifies how multi-level factors, intervention effects and interactions, or outcomes will be handled, as appropriate.

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.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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.

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.

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).

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.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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, including the PEDP.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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

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

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

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 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their 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. 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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Not Applicable

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

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

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

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

Denise Stredrick, Ph.D.
Office of Disease Prevention
Telephone: 301-402-9749
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Elizabeth Anne Barr
ORWH - Office of Research on Women's Health
Phone: 301-402-7895
E-mail: [email protected]

Priscah Mujuru, DrPH, MPH, RN
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9765
Email: [email protected]

Dr. Joseph Ciccolo
National Cancer Institute (NCI)
Telephone: 301-639-0943
Email: [email protected]

Sarah Mellam Steverman
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-827-5435
E-mail: [email protected]

Leila Khaki, Dr. P.H
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301 594 2608
E-mail: [email protected]

Tatiana Balachova, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5726
Email: [email protected]

Miya Whitaker, Psy.D., M.A.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-0635
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 301-496-8634
Email: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Diana Rutberg, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 594-4798
E-mail: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.