Interventions to Address Disparities in Liver Diseases and Liver Cancer (R01 - Clinical Trials Optional)

Interventions to Address Disparities in Liver Diseases and Liver Cancer (R01 - Clinical Trials Optional) is sponsored by National Institutes of Health (NIH). Supports multi-level and/or multi-domain intervention research to reduce disparities in liver diseases and liver cancer among populations experiencing health disparities in the U. S.

PAR-25-299: Interventions to Address Disparities in Liver Diseases and Liver Cancer (R01 - Clinical Trials Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Minority Health and Health Disparities ( NIMHD ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Cancer Institute ( NCI ) Funding Opportunity Title Interventions to Address Disparities in Liver Diseases and Liver Cancer (R01 - Clinical Trials Optional) R01 Research Project Grant March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose This initiative will support multi-level and/or multi-domain intervention research to reduce disparities in liver diseases and liver cancer among populations who experience health disparities in the United States (U.S.).

Funding Opportunity Goal(s) Health Disparities Research Project Grants (RPG) support innovative projects to enhance our understanding of biological mechanisms, social, behavioral, and health services that can directly and demonstrably contribute to the improvement in minority health and the elimination of health disparities within the US and its territories.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information 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 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), steatotic liver disease (SLD), and liver cirrhosis, and liver cancer.

There are racial and/or ethnic and socioeconomic status (SES) disparities in the prevalence of CLD and liver cancer risk factors, severity, and mortality of CLD. Selected examples include: Greater prevalence of HBV infection among Asian American, Native Hawaiian and Pacific Islander, and Black or African American populations compared with White persons.

Greater prevalence of chronic HCV in American Indian and Alaska Native (AI/AN) persons compared with White persons. Greater risk of developing NAFLD or NASH among Hispanic or Latino persons compared with White persons.

Greater prevalence of liver cancer among AI/AN populations Increased risk of hepatocellular carcinoma HCC incidence and CLD mortality among people with low SES or who are experiencing poverty 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 influences (such as perceived discrimination, economic status, immigration status, education, language and cultural barriers). Co-infection with HIV, chronic disease comorbidity, food insecurity, and exposure to pollutants are also linked to adverse liver disease outcomes in populations experiencing liver disease and liver cancer disparities.

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 pathways leading to liver disease and/or cancer susceptibility and progression are needed.

Currently, the evidence for effective liver disease or liver cancer interventions among populations with health disparities is limited. Medical advances have made a highly effective HBV vaccine and treatment for HCV that cures 95% of cases over a 12-week treatment course available. These interventions have not been implemented among populations with health disparities as effectively as needed.

Community-based and/or policy-level interventions targeting SDOH and providing patients with access to streamlined comprehensive care have reduced or eliminated health disparities in treatment initiation and completion in some populations.

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 norms, practices and policies on disparate disease progression and clinical outcomes.

Tailored interventions are needed to address worsening disparities in liver disease and liver cancer. 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. NIMHD-designated populations with health disparities can be found here https://www.

nimhd. nih. gov/resources/understanding-health-disparities/minority-health-and-health-disparities-definitions.

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). NIMHD encourages holistic research projects that considers contextual factors to understand and address health disparities (see the NIMHD Research Framework, https://www. nimhd.

nih. gov/about/overview/research-framework. html ).

Applicants are encouraged to conduct tailored interventions in a variety of settings (e.g., clinics, schools, community centers, pharmacies, workplaces, churches, fitness centers), disaggregated subpopulations, and include unique considerations of persons belonging to multiple populations experiencing health disparities whenever possible.

Projects should include U.S. studies of populations experiencing health disparities and are expected to include unique relevant clinical factors. Environmental (e.g., physical, social, built) measurements, as well as 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. Projects should be community-engaged.

For this NOFO, we encourage approaches that include greater participation and collaboration with the community of interest, including shared leadership with community members in the research design and implementation of the project.

Collaborations with relevant community and organizational entities may include researchers with relevant experience, community organizations, clinicians, public health organizations, consumer advocacy groups, and places of worship or religious institutions. 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 populations experiencing the highest rates of liver cancer risk, morbidity and mortality.

Interventions that employ multi-level (Patient, Caregiver, Clinician, System) contextually applicable 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 Risk reduction and/or health promotion interventions addressing co-infection and/or co-morbidities in areas and populations that have been understudied, including adaptations of existing evidence-based intervention strategies addressing liver diseases and/or liver cancer disparities.

Projects incorporating intergenerational 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 for multiple populations and settings, that influence liver disease and/or cancer incidence and progression 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.

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 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 through research at the individual, social, and environmental 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 who 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 improved 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 factors of liver cancer. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary ( https://grants. nih. gov/grants/glossary.

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

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period.

The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

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

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

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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission 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.

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

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.

For NIMHD, if there are foreign component(s), describe how the proposed activities at foreign sites will contribute to the knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States. 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.

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.

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.

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. 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. Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.

113 and NIH Grants Policy Statement Section 4. 1. 35 .

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] . 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 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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. Factor 1.

Importance of the Research (Significance and Innovation) Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.

Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study. Evaluate the extent to which innovation influences the importance of undertaking the proposed research.

Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies