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

Background 

Liver diseases and liver cancer contribute to a significant health burden in the U.S. These conditions include chronic hepatitis B (HBV) and chronic hepatitis C (HCV) viral infections, nonalcoholic fatty liver disease (NAFLD; currently known as metabolic dysfunction associated steatotic liver disease [MASLD]), nonalcoholic steatohepatitis (NASH; currently known as metabolic dysfunction-associated steatohepatitis [MASH]), chronic liver disease (CLD; currently known as steatotic liver disease [SLD]), and liver cirrhosis, and liver cancer. Prevalence, severity and mortality of CLD and liver cancer are higher among all racial and ethnic minority populations, people with lower socioeconomic status (SES), and sexual and gender minority (SGM) populations. For example, HBV and HCV infection, which often serve as precursors and risk factors to liver diseases and liver cancer, are more prevalent among certain populations. Non–US-born people account for 69% of prevalent chronic HBV infections in the U.S. Chronic HBV prevalence is 14x higher among Asian Americans and Native Hawaiian and Pacific Islander persons than among White persons, although acute HBV is highest among Black persons, with a 1.5x higher prevalence than in White persons. American Indian and Alaska Native (AI/AN) persons are over twice as likely as White persons to develop chronic HCV. Hispanics/Latinos have a 1.4x higher risk than White persons of developing NAFLD or NASH. Disparities also exist in alcohol-related liver disease (ALD) and alcohol-related cirrhosis prevalence. Compared to White persons, all racial and ethnic minority populations have a higher burden of liver cancer, with AI/AN populations reporting an almost three-fold higher burden of liver cancer. Hepatocellular carcinoma (HCC) also disproportionately affects racial and ethnic minority populations. Preventable chronic liver diseases contribute to cirrhosis and HCC-related mortality. Poverty and low SES have also been linked to a 1.5 times increased risk of HCC incidence and over double the increased risk of CLD mortality, as well as other adverse liver disease and/or liver cancer outcomes. Based on limited data, SGM populations are disproportionately affected by HBV, HCV, and potentially NAFLD, as well as traditional risk factors for CLD, ALD, and liver cancer.

Research on the causes of these health disparities has been emerging in recent years. The common risk factors (e.g., toxin exposure, substance use, exposure to HBV/HCV infection) for CLD and liver cancer are well-established and are more frequently reported among populations experiencing disparities. These populations are more susceptible to risk factors that are shaped by multi-level, multi-domain influences (e.g., discrimination, economic status, immigration status, education, public safety, language, cultural barriers). Collectively known as social determinants of health (SDOH), these are multi-level social factors with an impact on human health that help to explain population-based differences in healthcare (i.e., screening, surveillance, and treatment) access, utilization, and literacy underlying liver disease and liver cancer health disparities. Co-infection with HIV, chronic disease comorbidity, food insecurity, and exposure to environmental pollutants are linked to adverse liver disease outcomes in populations experiencing liver disease and liver cancer disparities. The SDOH exposures and liver disease and liver cancer outcomes also differ based on intersectionality of belonging to multiple populations experiencing disparities. For example, Latinos of Mexican descent living in Southeast Texas experience a combination of risk factors that contribute to this population’s exceedingly high rates of liver disease and/or liver cancer. Individuals from populations experiencing health disparities are also more likely to be unaware of their elevated risk for CLD and liver cancer and may be living with undiagnosed, preventable, and curable conditions. To reduce CLD and liver cancer among populations experiencing health disparities, interventions addressing the interplay of systemic, environmental, behavioral, and biological pathways of liver disease and/or cancer susceptibility and progression are needed. 

Currently, the evidence on  effective liver disease or liver cancer interventions among populations with health disparities is limited. Although medical advances have made an HBV vaccine and treatment for HCV that cures 95% of cases over a 12-week treatment course available, however these interventions have been not implemented among populations with health disparities effectively. Community-based and/or policy-level interventions targeting SDOH and providing patients with access to streamlined comprehensive care have reduced or eliminated race and ethnicity-based disparities in treatment initiation and completion. For example, interventions among Asian American populations have successfully reduced population-level HBV and liver cancer incidence (rate per 100,000) in this population from 16 in 2007 to 10 in 2020. However, interventions rarely address or measure the influence of social and institutional systems and structures that influence health outcomes, such as laws, policies, and social norms, on disparate disease progression and clinical outcomes. Tailored interventions are needed to address worsening disparities in liver disease and liver cancer. 

Research Objectives

The objective of this initiative is to develop and test multidisciplinary and multi-level and/or multi-domain interventions that will effectively address liver disease and liver cancer disparities. These disparities reflect disproportionate disease burden and worse outcomes among populations experiencing health disparities. NIMHD-designated populations with health disparities include racial and ethnic minority populations, people with lower socioeconomic status (SES) status, and their intersectionality with living in underserved rural communities, SGM populations and/or people with disabilities (see https://www.nimhd.nih.gov/funding/nimhd-funding/funding-strategy.html).

The focus of this initiative is on improving screening, prevention, treatment, management, and survivorship of liver diseases and liver cancer among populations experiencing disparities. Interventions that target the complex causes or consequences of health disparities and address, identify, and promote protective factors of liver disease and/or liver cancer are encouraged. Interventions that extend beyond modifying individual-level health behavior are needed (i.e., interpersonal, community, societal). The proposed projects are encouraged to measure the multi-level and/or multi-domain SDOH addressed and affected by the intervention. The intervention research under this NOFO should be aimed at improving outcomes directly related to liver disease and/or liver health among populations experiencing disparities. NIMHD has a specific interest in projects that examine the impact of determinants at multiple domains (biological, behavioral, socio-cultural, environmental, physical environment, health system) acting at multiple levels (i.e., individual, interpersonal, community, societal) of socio-ecological influence (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html).

To advance health equity in this area, applicants are encouraged to conduct tailored interventions in a variety of settings (i.e., clinics, schools, community centers, pharmacies, workplaces, churches, justice settings, fitness centers), disaggregated subpopulations, and include unique considerations of persons belonging to multiple populations experiencing health disparities through an intersectional approach whenever possible. Projects should include U.S. studies of populations experiencing health disparities and are encouraged to include disaggregated subpopulations and consideration of immigration status, generation, and country of origin or heritage. Studies of SGM populations are expected to include unique relevant clinical factors. . Environmental measurements, including personal and intergenerational histories (e.g., geographic region, birthplace), are also encouraged to further elucidate contextual influences of liver disease and/or liver cancer among populations with disparities. Proposed interventions are encouraged to focus beyond increasing awareness and screening alone to include changes in modifiable factors of liver disease and/or liver cancer incidence and progression. Intervention projects addressing co-infections such as with HIV and chronic disease comorbidities (e.g., obesity, diabetes, SUD) are of interest. Multidisciplinary expertise and approaches appropriate to understand and overcome the challenges of developing and conducting multidimensional interventions to address disparities in liver disease and/or liver cancer are strongly encouraged.   

Investigators proposing to evaluate the effect of an intervention on a health-related biomedical, behavioral, or clinical outcome are strongly encouraged to use appropriate intervention study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application (additional information available at https://researchmethodsresources.nih.gov/). Applicants are strongly encouraged to assess SDOH using measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org), as appropriate. Interventions may also include health information technology applications (e.g., behavior monitoring tools, decision aids, health information portals, and others) and/or social media elements to improve disparities and improve health. “Natural experiments,” or the evaluation of an exposure or change not directly manipulated by the researcher, where liver disease and/or liver cancer-related health disparities can be assessed based on this variation in exposures, are also of interest. There is also a particular interest in interventions addressing liver disease and its risk factors at its earliest stages before progression to more chronic conditions occurs.

Projects should be community-engaged and culturally grounded. For this NOFO, we encourage approaches that include greater participation and collaboration with the community of interest, including shared leadership of community members in the research design and implementation of the project. Collaborations with relevant community and organizational entities may include researchers with relevant lived experience, community organizations, healthcare providers, public health organizations, consumer advocacy groups, and places of worship or religious institutions. Specifically, projects are expected to recognize the diversity of disproportionately affected populations and value of lived experiences to address the unique needs of a target community with cultural sensitivity and awareness of what may limit or facilitate the availability of resources. As appropriate for the research questions posed, inclusion of key community members in the conceptualization, planning and implementation of the research is encouraged. Research applications are also encouraged to propose culturally and environmentally appropriate interventions to generate better-informed hypotheses, improve adaptation based on real-world context and environment challenges, and enhance the translation of the research results into further implementation.

Specific Areas of Research Interest

Research topics of interest among population experiencing health disparities include, but are not limited to:

• Multi-level and/or multi-domain interventions developed to improve HBV and HCV screening uptake methods and approaches, including appropriate screening recommendations and linkage to prevention and care methods for persons belonging to multiple populations experiencing health disparities
•  Interventions that employ multi-level (Patient, Caregiver, Provider, System) culturally and linguistically diverse communication strategies to address multiple synergistic risk and protective environmental and behavioral factors to improve liver health, with at least alcohol, smoking, other substance use, and chemical exposures listed among the contributing factors
• Intervention strategies promoting HBV vaccination acceptance and linkage to care, reducing barriers to uptake, and improving successful series completion
• Interventions improving HBV and HCV health care navigation services, treatment access, disease management resources, linkage to timely care, adherence, and completion for persons with chronic infection
• Develop and conduct interventions promoting HCV treatment uptake, adherence, and completion among partially and untreated persons to reduce disparities and improve curability
• Interventions that are community engaged and incorporate non-invasive and accessible NAFLD, NASH, and/or CLD screening strategies to improve and facilitate risk detection and/or accelerated disease progression at earlier stages of liver disease and/or liver cancer
• Culturally appropriate, risk reduction and/or health promotion interventions addressing co-infections and or co-morbidities in underserved geographical areas or among immigrant persons, including adaptations of existing evidence-based intervention strategies addressing liver diseases and/or liver cancer disparities.
• Projects incorporating inter-generational and interpersonal factors through interventions addressing maternal-to-child transmission and/or family-level influences on liver disease and/or cancer liver cancer risk
• Interventions addressing the early-onset of well-established risk factors for liver disease and/or liver cancer (e.g., toxin exposure, substance use, exposure to HBV/HCV infection)
• Developing and testing interventions promoting resiliency, well-being, and/or protective factors, such as indigenous and cultural practices and resources adapted to specific populations and settings, that influence liver disease and/or cancer incidence and progression
• Interventions that incorporate structural and/or institutional discrimination that in addressing liver disease and/or liver cancer incidence and progression
• Interventions addressing CLD and/or liver cancer to improve disease prevention, self-management, and health care delivery across the continuum of care
• Develop and conduct interventions tailored to address unique considerations of the diagnostic and management pathway for persons with liver cancer (HCC) belonging to one or more populations experiencing health disparities
• Interventions to improve the access and quality of survivorship care and recommendations in liver cancer survivors
• Develop and conduct interventions addressing screening, disease management, and treatment of HBV, HCV, other liver diseases, and/or liver cancer in persons with or at risk of substance use disorders
• Policy-level interventions or natural experiments that address liver disease and/or liver cancer-related determinants of health and their impact on disparities

Participating NIH ICs have identified priority research areas below. Applicants are encouraged to speak with IC representatives for technical assistance (see Agency Contacts in Section VII). Applicants should ensure that the IC they wish to target participates in the NOFO to which they wish to submit. 

National Cancer Institute (NCI)

The National Cancer Institute’s (NCI) public health framework for ending cancer includes addressing modifiable determinants of health and eliminating persistent injustices through research at the individual, social, institutional, structural, environmental, and policy levels. NCI is deeply committed to a better understanding and development of evidence-based interventions that could address the health disparities witnessed in liver cancer.

For this NOFO, NCI areas of interest in intervention research include, but are not limited to:

• Intervention research focusing on environmental exposures, particularly exposures experienced by residents of environmental justice communities that are at greater risk for liver cancer and exposures occurring more frequently in populations experiencing liver cancer disparities. 
• Research on interventions intended to reduce health disparities in liver cancer that occur beyond HBV/HCV. We emphasize these areas because research gaps particularly exist for interventions that focus on non-viral factors in high-risk populations.
• Intervention research that will address multi-level and/or multi-domain social determinants of health (e.g., neighborhood and built environment, and social and community contexts) related to liver cancer disparities.
• Intervention research that promotes cancer control leading to equitable outcomes in liver cancer.  These studies may include research that spans topics of screening, prevention, treatment, management, and/or survivorship aspects of liver cancer in populations experiencing disparities and may focus on protective and/or upstream factors of liver cancer. 

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)

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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 How to Apply – Application Guide and the Table of Page Limits must be followed.

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

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Describe to what extent the project will contribute to advancing interventions addressing liver disease and/or liver cancer across multiple levels and/or multiple domains of socioecological influence among populations experiencing disparities.

Describe the liver disease and/or liver cancer-related health outcome addressed and population experiencing health disparities of focus in the proposed intervention. Projects are expected to provide a conceptual model of how the intervention will reduce liver disease and/or liver cancer disparities by addressing two or more socio-ecological levels or domains (see the NIMHD Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework.html). 

Specify how the intervention approach is multidisciplinary and describe how multiple marginalized identities will be considered. Indicate how the project will engage communities and various partners.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - 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, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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. Please note that the National Cancer Institute (NCI) will not consider proposals greater than $500,000. 

Post Submission Materials

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

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 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 . 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.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

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

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

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Olga M. Herren, Ph.D. 

National Institute on Minority Health and Health Disparities  (NIMHD )
Telephone: 301-402 -4492
Email: olga.herren @ nih.gov

Peter Hartsock
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: (301) 402-1964
E-mail: peter.hartsock@nih.gov

Behnoosh Momin, DrPH, MS, MPH
National Cancer Institute (NCI)
Phone: (240) 789-3981
Email: behnoosh.momin@nih.gov 

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

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov 

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 202-276-5699
Email: Dawn.Mitchum@nih.gov

Section VIII. Other Information

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

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