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.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research.

This NOFO runs in parallel with another NOFO of identical scientific scope, PAR-25-096, which utilizes the Exploratory/Developmental Grant (R21) mechanism.

Background and Rationale

NIH and other research funding organizations support numerous studies that generate a large amount of phenotypical, exposure, behavioral, clinical and genomic data, which continue to be made available to the scientific community. Many of these datasets have not been analyzed to their full potential and further investigation will provide opportunities to answer important research questions at a relatively low cost.

Several NCI programs support population science research that spans the cancer control continuum, e.g., in genomic, epidemiology, surveillance, health services, behavioral science, and cancer survivorship to understand and clarify cancer risk, progression, and outcomes. These studies generate a wealth of individual- and population-level data, including molecular, lifestyle, clinical, demographic, and environmental data. Leveraging these various types of existing data through innovative data modeling and analysis allows new questions to be addressed and helps to advance the field of cancer research. NIH has made it a priority to make data more Findable, Accessible, Interoperable and Reusable (FAIR) to researchers to further biomedical research, through several sharing policies, including the 2015 Genomic Data Sharing (GDS) Policy and the 2023 NIH Policy for Data Management and Sharing. Enhanced data sharing is also a key priority of the NCI, as highlighted by the NCI Cancer Moonshot Public Access and Data Sharing Policy and by the National Cancer Plan goal to maximize data utility by sharing and using available data to achieve rapid progress against cancer. NIH requirements for data sharing in grant proposals, combined with public and private sector initiatives by donors, journals, and foundations, have led to unprecedented amounts of available data for secondary research, which have been successfully utilized to discover novel biomarkers of disease and to find novel uses for existing therapeutics.

The goal of this initiative is to encourage applications from institutions/organizations that propose to conduct innovative secondary data analyses to address knowledge gaps in cancer control using innovative approaches and integration of existing datasets with the ultimate aim of further elucidating cancer risk and related outcomes.  The initiative will stimulate innovative methods and leveraging of existing data sources whose number is expected to continue increasing as more data becomes available through data sharing.  

Specific Research Objectives and Scope of the NOFO 

Analyses that incorporate the vast amount of genomic, clinical, environmental, surveillance, health services, vital statistics, behavioral, and other types of data obtained in recent years, have great potential to illuminate the complex interactions among the environment, behavior, genes, and gene products, to redefine cancer across the continuum, and to lead to novel hypotheses regarding prevention and treatment of cancer.

Applicants are encouraged to leverage existing data and perform innovative analyses of the existing data. Applications may include new aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions.

Specifically, this NOFO encourages applications that leverage existing data and could include one or more of (but not limited to) the following aspects:

• Link together and analyze through system epidemiology approaches longitudinal multi-level/domain data types, including genomic, other omics, biomarker, environmental, socio-demographic, behavioral, economic, clinical, health care delivery, disease, screening, and vital statistics (e.g., mortality) data to study specific cancer types and/or across cancers and related conditions; data can be obtained from registry, case-control, cohort, and clinical studies and should be appropriately combined and harmonized; linking could be performed by matching entities (e.g., people, direct links of the same respondents) or through external variables (e.g., geocodes, different geographic levels) to assess for multi-level influences (e.g., census tract, county, or state).
• Facilitate utilization of newly developed or updated resources, tools, and guidelines in population-scale cancer research (e.g., human genome reference or other molecular annotations, Informatics tools, or population descriptors guidelines).
• Employ innovative analytic techniques that demonstrate or promote methodological advances in genomic and epidemiologic cancer research and that accelerate population-scale genomics research, e.g., through integration of multiple data types derived from humans and obtained through various single cell and/or bulk tissue molecular techniques (germline and/or somatic genomics, transcriptomics, proteomics, metabolomics) to better understand complex interactions among genes and gene products in the context of cancer.
• Assess cancer-related behavioral health questions and risk factors (e.g., physical performance, anthropometric testing, dietary intake, exercise, physical and social environment, cancer screening, tobacco or alcohol use, sleep hygiene, etc.) through innovative methods, tools, or technology.
• Advance image analysis and extraction of behavioral and environmental information (e.g., street-level digital images, aerial images, medical images, etc.) and accelerate or automate geospatial data cleaning, processing, and analysis to address cancer related questions.
• Develop analytical strategies for cancer surveillance.
• Advance research in healthcare delivery to better understand factors that affect methods of cancer detection (screen versus symptom) and/or inequitable use of primary and secondary prevention strategies.
• Serve cancer survivors and their communities by predicting and assessing patients' diagnosis, trajectory, comorbidities, response to treatment, and symptom management.
• Address questions related to health inequities and disparities and augment implementation and translation of research findings into practice by generating or improving related methods, tools, or technology (e.g., for medical image processing in low resource settings to improve precision risk management, or for reducing machine learning biases from inaccurate data representation of the diversity of society).

This NOFO capitalizes on NCI and NIH past investments in several programs that have supported from basic biological to clinical biomedical research by leveraging the generated molecular, lifestyle, clinical, and environmental data to conduct new investigations in cancer control and population sciences, including cancer healthcare delivery, surveillance, behavior, epidemiology, and population-scale 'omics research. All data analyses must concern research designed to elucidate cancer etiology, incidence, prevalence, natural history, pathophysiology, or related outcomes, including cancer related conditions and disorders.

NCI focus. Applicants should consider the relevance of their proposed analyses to those NCI programs and priorities that can be tackled through the study of existing data. Potential applicants are encouraged to speak with the listed NCI program officials to discuss the relevance of the proposed research topic(s).

NIA focus. NIA welcomes applications that analyze and/or integrate genetic, 'omics, behavioral, social, and other datasets for the contribution of aging as a risk factor for the pathogenesis of adult cancers.  Potential applicants are encouraged to communicate with the NIA program officials to discuss their research interests and their relevance to this NOFO.

NIDCR focus. NIDCR supports secondary data analysis and data integration research in the assessment of cancer risk, progression, and outcomes that are relevant to oral, oropharyngeal, and salivary gland cancers. NIDCR will also consider applications that incorporate new statistical or computational methods to help improve the accessibility and/or speed of dissemination of data resources. Potential applicants are encouraged to speak with the listed NIDCR program officials to discuss the relevance of the proposed research topic(s).

NHGRI focus. NHGRI welcomes applications that develop new approaches for elucidating the genetic architecture of human health and disease which are broadly generalizable across diseases, phenotypes, and health outcomes (e.g., risk prediction or reduction, survival, or response to treatment) in addition to cancer. NHGRI is particularly interested in applications to develop novel methods for integrating multiple types of genomic data and other data types. Projects that focus only on tumor genomics will not be appropriate for NHGRI funding. NHGRI encourages leveraging data available through NHGRI’s Genomic Data Science Analysis, Visualization, and Informatics Lab-Space (AnVIL).

Data Sources

Applicants are encouraged to collaborate with investigators holding publicly as well as non-publicly available data sets, using innovative statistical strategies to harmonize and link methodologically comparable datasets and sharing with the research community the harmonized datasets.

Applicants are encouraged to leverage the large volume of data publicly available to the scientific community. Some examples currently include (but are not limited to) the following:

• Genotype and phenotype datasets deposited in the database of Genotypes and Phenotypes (dbGaP);
• Gene expression profiles deposited in Gene Expression Omnibus (GEO) and high-throughput functional genomics experiments and assays deposited in the ArrayExpress archive;
• DNA/RNA binding and DNA accessibility/methylation experiments deposited in the Encyclopedia of DNA Elements (ENCODE);
• Genotype and RNA-seq data across tissue sites and cell lines deposited in the Genotype-Tissue Expression (GTeX) and Developmental GTeX (dGTeX) projects;
• Proteomic data measured by mass spectrometry in cancer biospecimens from CPTAC and ICPC deposited in the Proteomic Data Commons (PDC);
• Multidimensional maps of genomic changes across cancer types based on paired tumor and normal tissue sets collected from cancer patients deposited in The Cancer Genome Atlas Program (TCGA);
• Sequencing data from human samples deposited in the NCBI Short Read Archive (SRA) and in the NCI Cancer Data Service (CDS);
• Harmonized cancer genomic datasets deposited in the NCI Genomic Data Commons (GDC);
• Imaging information linked to clinical and genomic data across cancer sites available in The Cancer Imaging Archive (TCIA) and the NCI Imaging Data Commons (IDC);
• Data on therapy outcomes from clinical trials and patient registries such as the Pediatric Proton Consortium Registry (PPCR);
• Epidemiological, clinical, and molecular data from established cancer cohorts such as the follow-up of the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial and others in the Cancer Epidemiology Descriptive Cohort Data (CEDCD), as well as from newer cancer cohorts such as the Connect for Cancer Prevention Study;
• The Surveillance, Epidemiology, and End Results (SEER) Program Data & Software, including SEER*Stat, SEER-Medicare, SEER-Medicaid, SEER-CHAPS, and SEER-MHOS;
• Data from the NCI funded research network of US healthcare delivery systems Population-based Research to Optimize the Screening Process (PROSPR) DataShare, the Patterns of Care (POC) initiative, the Social Determinants of Health Dataset, and other healthcare delivery datasets;
• Population-level health survey data such as the National Health Interview Survey (NHIS), the National Health and Nutrition Examination Survey (NHANES), the Behavioral Risk Factor Surveillance System (BRFSS), the Medical Expenditures, Panel Survey (MEPS), the Health Information National Trends Survey (HINTS), the Tobacco Use Supplement to the Current Population Survey (TUS-CPS), TUS-CPS datasets linked to other US Census Bureau research datasets and National Death Index registry (e.g., the Tobacco Longitudinal Mortality Study (TLMS) and sub-linkages);
• Behavioral and social science data in the Inter-university Consortium for Political and Social Research (ICPSR) data repository;
• Genetic and health information from half a million UK participants stored in the UK Biobank;
• Electronic Health Record (EHR) data, genomic data, physical measurements, survey responses and wearable data collected from the All of Us Research Program participants;
• Data available through the Data and Specimen Hub (DASH), including the Environmental influences on Child Health Outcomes (ECHO) data;
• The NIH Common Fund-supported Gabriella Miller Kids First Data Resource Center and the trans-NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Data Coordinating Center Data Hub;
• Genetic, lifestyle, and exposure data from Veterans partners in the Million Veteran Program (MVP);
• Genomic, other 'omic, and phenotype data available through NHGRI’s Genomic Data Science Analysis, Visualization, and Informatics Lab-Space (AnVIL);
• Other datasets, including those listed in the NIH resources page and HHS data hub page.

This mechanism can also be used to retrospectively harmonize measures across disparate datasets and to merge secondary data sets with other data sets to better address important research hypotheses. For example, if allowed by informed consent, genetic datasets could be matched with hospital datasets or vital statistics.

Applicants who plan to utilize data not currently in their possession (originated from another party) should confirm availability of the data and the willingness and permissibility of the original investigators to share the data for the purposes of the secondary analyses (letters of support and/or data access approval are encouraged), in accordance with all applicable rules for the protection of human subjects.

Collaborations and Authorship

Projects developed in response to this NOFO should include complementary and integrated expertise and experience to conduct the proposed data analyses. Any publications resulting from awards funded under this NOFO must include acknowledgment of the source of shared data and any funding sources which supported the initial data collection. If appropriate, applicants should discuss co-authorship plans with original and/or contributing investigator(s) prior to submitting an application.

Data Sharing

Awardees are expected to broadly share the cleaned and harmonized datasets, software, programmed codes, and analysis tools developed for the analysis of the data, when appropriate and consistent with the participant informed consent. Costs for making data publicly available, when appropriate and not already available, may be included in the budget, as long as the archival activities are pertinent to the proposed secondary analyses. Plans for archiving must include adequate dataset documentation and explanation so that it can be used by researchers not associated with the original study.

Other Requirements 

Applications can be related to but must be distinct from the specific aims and methods of the original data collection.

The primary analyzed data can be derived/redefined from existing data but should not be newly collected from study participants nor newly generated from existing biological specimens.

The NOFO will allow up to 10% of the budget towards new data generation for validation of key findings.

Non-Responsive Applications

The following types of studies are outside the scope of this NOFO and applications describing them will be considered non-responsive:

• Studies that propose to collect or generate new data for purposes other than limited validation of key findings;
• Studies that propose to analyze only data obtained from non-human samples;
• Studies that propose to carry out currently ongoing data analysis or to maintain and distribute data sets.

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

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

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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 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.

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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 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 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.

The NOFO  will allow up to 10% of the budget towards new data generation for validation of key findings.

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:

Research Strategy: The Research Strategy should clearly describe the following within the appropriate section:

• Significance: All applications should include an overall strategy that leverages existing clinical, environmental, surveillance, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. All data analyses must concern research designed to elucidate cancer etiology, incidence, prevalence, natural history, pathophysiology, or related outcomes, from basic biological research to clinical cancer research and cancer control and population sciences, including cancer healthcare delivery, surveillance, behavior, epidemiology, and population-scale 'omics research. The study design should incorporate at least one of the following features: development or application of novel analytical approaches; exploration and integration of multiple clinical, environmental, surveillance, vital statistics, behavioral, lifestyle, genomic, and molecular data types; incorporation of additional studies or alternative datasets; and/or investigation of phenotypes not studied before using the proposed existing dataset. 
• Approach: Applications should clearly describe the proposed analytical methods, their feasibility, and innovation in comparison to other existing methods and include possible method evaluation and validation plans. Applicants should demonstrate knowledge of the proposed dataset(s) and include details on data source, number of individuals, number and type of samples, type of clinical, environmental, surveillance, vital statistics, behavioral, lifestyle, genomic, and molecular information available and included in the analysis. Applicants should address (including through statistical power calculations) how the proposed dataset(s) are suitable and sufficient to fulfill the research aims and describe approaches to overcome challenges associated with small sample sizes, be these cancer types, cell types, or unique human populations. The proposed analyses should be feasible within the timeline proposed. This NOFO is tailored to cost-effective studies that reutilize existing resources for secondary data analysis, which may lead to findings that warrant experimental, clinical, or other validations. Any proposed new data generation within these applications should be limited (<10% of the budget) to the validation of key findings. If appropriate to the proposed science, applicants should describe how their findings could be further tested or validated in a follow-up independent study. While it is expected and understood that the research proposal will be constrained by the limited availability of existing data in groups currently underrepresented in biomedical research, the research plan should nevertheless adequately describe the investigators efforts, successes, and challenges in finding and including in the analysis any relevant available datasets representing these populations, as well as address the translational relevance of findings to these populations and/or specific needs for follow-up studies based on data to become available in the near future.

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): 

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.  
• Awardees are expected to broadly share the cleaned and harmonized datasets, analysis tools and any other software developed for the secondary analysis and integration of the data, when appropriate and consistent with the participant informed consent. Sharing of adequate documentation and explanation is also expected so that data and tools can be used by researchers not associated with the original study.

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.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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.

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

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

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.

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. 

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

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 (CSR), 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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. 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 the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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.

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]

Melissa Rotunno, Ph.D.
Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute (NCI)
Telephone: 240-276-7245
Email: [email protected]

Jiayin (Jerry) Li, M.D., Ph.D.
Division of Cancer Biology (DCB), National Cancer Institute (NCI)
Telephone: 240-276-6210
Email: [email protected]

Miguel R. Ossandon, Ph.D.
Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: [email protected]

Wendy Wang, Ph.D.
Division of Cancer Prevention (DCP), National Cancer Institute (NCI)
Telephone: 240-276-7117
Email: [email protected]

Max Guo, Ph.D.
Division of Aging Biology (DAB)
National Institute on Aging (NIA)
Phone: 301-402-7747
Email: [email protected]

Noffisat O. Oki, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-402-6778
Email: [email protected]

Erin Ramos
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301.480.3288
E-mail: [email protected]

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Jessi Perez
National Institute on Aging (NIA) 
Telephone: 301-402-7739
Email: [email protected] 

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-827-4630
E-mail: [email protected]

Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: [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 2 CFR Part 200.