PA-25-172: Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)

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.

Department of Health and Human Services

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Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)

Activity Code

R01

Research Project Grant

Announcement Type

Reissue of PAR-24-122

Related Notices

See Notices of Special Interest associated with this funding opportunity

• 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)

PA-25-172

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.393, 93.399

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Funding Opportunity Purpose

This notice of funding opportunity (NOFO) encourages applications for research in cancer control and population sciences. The overarching goal is to provide support to promote research efforts on novel scientific ideas that have the potential to substantially advance cancer research in statistical and analytic methods, epidemiology, cancer survivorship, cancer-related behaviors and behavioral interventions, health care delivery, digital health and data science, and implementation science.

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Key Dates

Posted Date

November 07, 2024

Open Date (Earliest Submission Date)

January 05, 2025

The following table includes NIH standard due dates marked with an asterisk.

Application Due Dates / Review and Award Cycles

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.

New / Renewal / Resubmission / Revision (as allowed)	Earliest Start Date	Review and Award Cycles (Scientific Merit Review / Advisory Council Review)
February 05, 2025 *	February 05, 2025 *	Scientific Merit Review: March 05, 2025 * / Advisory Council Review: Not Applicable / Start: July 2025
		Award: October 2025
		Award: December 2025
June 05, 2025 *	June 05, 2025 *	Scientific Merit Review: July 05, 2025 * / Advisory Council Review: Not Applicable / Start: November 2025
		Award: January 2026
		Start: April 2026
October 05, 2025 *	October 05, 2025 *	Scientific Merit Review: November 05, 2025 * / Advisory Council Review: Not Applicable / Start: March 2026
		Award: May 2026
		Award: July 2026
February 05, 2026 *	February 05, 2026 *	Scientific Merit Review: March 05, 2026 * / Advisory Council Review: Not Applicable / Start: July 2026
		Award: October 2026
		Award: December 2026
June 05, 2026 *	June 05, 2026 *	Scientific Merit Review: July 05, 2026 * / Advisory Council Review: Not Applicable / Start: November 2026
		Award: January 2027
		Award: April 2027
October 05, 2026 *	October 05, 2026 *	Scientific Merit Review: November 05, 2026 * / Advisory Council Review: Not Applicable / Start: March 2027
		Award: May 2027
		Award: July 2027
February 05, 2027 *	February 05, 2027 *	Scientific Merit Review: March 05, 2027 * / Advisory Council Review: Not Applicable / Start: July 2027
		Award: October 2027
		Award: December 2027
June 05, 2027 *	June 05, 2027 *	Scientific Merit Review: July 05, 2027 * / Advisory Council Review: Not Applicable / Start: November 2027
		Award: January 2028
		Award: April 2028
October 05, 2027 *	October 05, 2027 *	Scientific Merit Review: November 05, 2027 * / Advisory Council Review: Not Applicable / Start: March 2028
		Award: May 2028
		Award: July 2028

Expiration Date

January 08, 2028

Due Dates for E.O. 12372

Not Applicable

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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.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

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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

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Part 2. Full Text of Announcement

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Section I. Notice of Funding Opportunity Description

Purpose

This notice of funding opportunity (NOFO) calls for research on a broad range of scientific areas within NCI's Division of Cancer Control and Populations Sciences' (DCCPS) mission and portfolio, including but not limited to research in statistical and analytic methods, epidemiology and genomics, cancer survivorship, cancer-related behaviors, healthcare delivery, digital health and data science, and implementation science.

Background

Competition for research funding has grown increasingly more challenging, and the stakes are particularly high within NCI and NIH. In addition to an increasing number of R01 applications, another issue that the NCI is grappling with is the increasing average cost of grants, and the resulting increased competition for limited funds. Additionally, as the cost of grants continues to increase, scientists and policy-makers are concerned about the challenges early-stage investigators (ESIs) face, including the length of time it takes to achieve their first R01 award. Chief among those challenges is the unprecedented number of applicants competing for funding. This has become a focal point of NIH with the Next Generation Researchers Initiative, and in the call to action in the 21st Century Cures Act, "to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding and enhance training and mentorship programs for researchers."

This NOFO will promote research topics and scientific challenges in the population sciences that lend themselves to a shorter time span and reduced budget. This NOFO encourages and supports ESIs and grows the ESI applicant pool and portfolio.

Scope

The mission of NCI's Division of Cancer Control and Population Sciences (DCCPS) is to reduce risk, incidence, and deaths from cancer, as well as enhance the quality of life for cancer survivors. The division conducts and supports an integrated program of the highest quality genetic, epidemiologic, behavioral, social, applied, and surveillance cancer research. DCCPS-funded research aims to understand the causes and distribution of cancer in populations, support the development and delivery of effective interventions, and monitor and explain cancer trends in all segments of the population.

Through this NOFO, NCI encourages applications that address a variety of topics that are a high priority for DCCPS, including, but not limited to the following:

Statistical and Analytic Methods

• Decision modeling using simulation or other methods to determine efficient or cost-effective strategies for the prevention, early detection, or treatment of cancer.
• New methods and tools for determining geographic and temporal scales that are most relevant for research of different cancers.
• Spatial and temporal methodology that detects new patterns and trends in cancer burden, disparity, and cancer care delivery.
• Innovative tools and approaches for the analysis, reporting, visualization, and interpretation of cancer surveillance data.
• Statistical methods for generating new data and integrating existing data on the determinants of cancer-related risk factors in the general population and among subgroups, to assist in formulating clinical and public policies that address these factors.
• Statistical methods for using, harmonizing, and integrating data from surveys, large population-based databases, or research networks to monitor trends, patterns, and variations in cancer-related modifiable risk factors.
• Statistical methods for developing and validating tools for measuring the range of cancer-related risk factors such as diet, physical activity, sedentary behavior, sleep, weight management, and post-acute sequelae of COVID or long-COVID across the lifespan, sociocultural subgroups, and socioecological contexts.

Applied Informatics Methods for Cancer Surveillance

Methods and processes for developing, evaluating, and analyzing data linkage to expand and enhance the scope of cancer surveillance research across the cancer continuum using traditional cancer registry data [SEER] and novel data sources. Examples include, development and evaluation of novel data linkages, including methods to provide population-representative data, identification of gaps and biases and solutions for answering specific questions.

• Developing and testing semantic tools (e.g., ontologies, metadata repositories) to facilitate mapping and querying of cancer registry data with other linked data sources (e.g., claims, pharmacy data, genomic data, electronic medical record (EMR) data).

Environmental Epidemiology

• Studies investigating cancer risk associated with multiple exposures combined and/or exposures over time; geographic factors in multilevel analyses of cancer, such as neighborhood and social environments, as determinants of cancer risk.
• Evaluation of cancer risk associated with exogenous (e.g., chemical agents, infectious agents, radiation, medication, nutrition, tobacco, and drug use) and endogenous (e.g., metabolome, microbiome, adductome) factors, mixtures and interaction of these factors, and effects during early life and critical periods across the life course.
• Studies to investigate variation in profiling of epigenetic components with exposure to social-contextual factors; conduct epigenomic profiling to evaluate early-life experiences that contribute to social inadequacies in cancer risk; evaluate epigenetic changes during different developmental stages in response to social adversities; investigate interaction between socio-economic factors, environmental exposure, and epigenetic modifications.
• Studies on report back of environmental health research results and non-genomic data to study participants and key partners.

Genomic Epidemiology

• Studies investigating the role of both common and rare genetic variation in cancer susceptibility, particularly among those affected by rare cancers, cancer in high-risk families and across understudied populations, or those with cancer health disparities.
• Use of existing data sets to develop new methods and models for genetic epidemiologic research, especially methods to examine gene-gene and gene-environment interactions, integration with other -omics data (metabolomics, proteomics, transcriptomics, epigenomics, etc.), and interplay between the inherited and somatic genomes. In addition, studies to address the ethical, legal, and social issues (ELSI) of genomics research and cancer-related bioethics in general are of interest.

Systems Modeling in Cancer Epidemiology

• Studies examining the complex interplay of genetic, environmental, host, and societal factors operating over a prolonged time.
• Longitudinal measures and development of more sophisticated analytical methods that support comprehensive (e.g., systems or computational modeling) approaches to address combined contribution of risk factors to disease in populations.

Behavioral Research

• Research examining cancer-related behaviors and biobehavioral risk factors, as well as interventions and influences addressing biological, psychological, behavioral, social, environmental, and/or policy targets to promote healthy lifestyle behaviors in the general population, high-risk and underserved populations, and among cancer survivors.
• Development and/or evaluation of multilevel interventions that aim to influence combinations of biological, psychological, cognitive, behavioral, social, communication literacy, environmental, and/or policy targets on behavioral and cancer-related outcomes across the continuum of care.
• Use of conventional, social, and mobile media for cancer control and prevention observational studies and interventions.
• Investigate methods, measurements, and/or modeling of tobacco-related behavior patterns, trends, and determinants of tobacco use behaviors. Examples include novel product use and poly-tobacco product use behaviors, and the effects of diverse tobacco control interventions to improve public knowledge, prevent smoking initiation, or promote cessation among tobacco product users.
• Examine the effects of built, sociocultural, communication, and policy environments on cancer risk and behavioral risk factors.
• Psychological, biobehavioral, social, and other psychological characteristics (e.g., emotion, vision, attention, sensation, perception) that shape cancer risk and preventive behaviors or responses to cancer control strategies (e.g., policies, interventions, health communication).
• Integration of independent data sets to answer novel cancer control and prevention questions, including behavioral risk factors for cancer, such as tobacco use, sedentary behavior, poor weight management, and lack of medical adherence to screening and vaccine uptake.

Healthcare Delivery Research

• Patient-, clinician-, health care system-, and community-level factors that shape care access, quality, utilization, and outcomes of health care services across the cancer continuum.
• Overuse and underuse of guideline-recommended care across the cancer continuum and patterns of care among high-risk and underserved populations.
• Financial hardship due to drug costs and other direct and indirect costs of cancer treatment and the effects of federal or state policy on cancer-related care, insurance coverage, and financial hardship.
• Effects of cancer and its treatment on acute and long-term patient symptoms, functioning, and health outcomes and approaches to enhance the integration of palliative care during cancer treatment and post-treatment.
• Use of information technology and digital health approaches to improve cancer care delivery and patient health outcomes.
• Strategies to enhance prognostic awareness, goals of care, and advanced care planning to optimize end-of-life care.
• Understanding clinical pathways to cancer diagnosis (i.e., due to screening, surveillance or symptoms), and developing interventions to reduce time to diagnosis, particularly among people with limited access to care.
• Enhancing cancer care delivery resilience to climate-related disasters and public health emergencies.
• Studies advancing measures, measurement approaches, or novel methods to improve the design, implementation, and evaluation of multilevel cancer control interventions (e.g., symptoms and other patient-reported outcomes, measures of organizational characteristics, teaming and care coordination, burden of treatment).

Cancer Survivorship

• Identifying acute, late- and long-term effects of cancer and cancer treatment.
• Examining approaches to enhance care coordination (e.g., patient-provider and provider-provider), particularly among those with multiple chronic conditions.
• Research that explores transitions in care from oncology providers to primary care providers, and from pediatric to adult providers.
• Research that explores aging-related consequences of cancer and cancer treatment; and identifies aging phenotypes in cancer survivors.
• Observational or interventional studies of clinical, genomic, and lifestyle factors that influence cancer outcomes.
• Studies that investigate approaches to integrate cancer caregivers into the delivery of care for patients and survivors.
• Research to examine trends in adolescent and young adult survivors.
• Time series analysis/forecasting techniques, using relative survival estimates as data points, for projecting cancer death burden.

Digital Health and Data Science

Develop and evaluate digital health tools, technologies, and platforms that:

• Address unmet needs of high-risk, understudied, and/or underserved cancer populations.
• Assess cancer risk factors and/or improve behavioral and clinical outcomes (e.g., physical activity, UV radiation/sun exposure, cannabis/tobacco and alcohol use, sleep and circadian disruption, treatment adherence) and social determinants of health (e.g., built environment, social context, connectedness).
• Provide continuous personalized monitoring of physiological status, including technologies for monitoring social-emotional well-being, environmental contexts and exposures, and behavioral patterns for the prevention, early detection, and treatment of cancer.
• Capture clinically relevant patient-generated health data (e.g., use of wearable technologies and mobile apps to capture and intervene on cancer symptoms and treatment side effects).
• Test integration of and interventions using patient-generated health data in clinical settings.
• Leverage novel artificial intelligence, deep learning, and other data science tools supporting:
  • Implementation and adoption of digital health technologies in oncology.
  • Improved curation, integration, and meaningful clinical interpretation of cancer-related data.
  • Mitigation of algorithmic bias and reduction of cancer disparities.
  • Identification, development, and evaluation of digital phenotypes for improved cancer care and outcomes.
• Optimize engagement and performance of cancer survivors, caregivers, and healthcare providers through innovative technologies and resources that:
  • Enhance patient-provider communication, shared decision-making, and care coordination.
  • Facilitate accessible and cost-effective decentralized clinical trials.
  • Improve surveillance, reporting, and management of symptoms, adverse events, and late effects of cancer and its treatments.
• Implement novel asynchronous and synchronous telehealth models of cancer care delivery.

Implementation Science

• Valid, reliable, and, where possible, pragmatic measures to assess the implementation of interventions, including adaptation, feasibility, fidelity, maintenance, penetration, sustainability, and scale-up of a given intervention or set of implementation strategies, as well as implementation context and climate.
• Effectiveness and implementation of existing guidelines and best practices that are based on expert opinion or case studies only (and not based on experimental, quasi-experimental, or large observational studies), to help identify strategies that may reduce or modify the use of these guidelines, as needed.
• Developing and testing patient-provider communication strategies to encourage use of appropriate care in cancer delivery settings.
• Evaluating natural experiments of implementation of evidence-based interventions in cancer care delivery settings.

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed.

Studies of basic science aspects of cancer biology, such as studies of the following:

• Basic cellular pathways, mechanisms, and oncogenic events that drive the development of tumors and behavior of cancer cells;
• Development of in vivo or in vitro models of tumors, when the purpose is to interrogate basic oncogenic pathways or mechanisms.

Studies focusing on the development of novel diagnostics or therapies for cancer, such as studies of the following:

• Discovery, development, and evaluation of agents to treat cancer; chemotherapy, molecular targeted therapy, radiation therapy, gene therapy, biologics and immunotherapy;
• Development of innovative technologies and devices for cancer diagnosis;
• Development, evaluation, translation, and dissemination of the use of in vivo imaging or image guided interventions to detect, diagnose, treat, and provide prognosis and follow-up for cancer;
• Development of bioassays for the discovery and validation of cancer markers and their use in the clinic for defining prognosis and improving the prediction of response to therapy.

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.

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Section II. Award Information

Funding Instrument

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

• New
• Renewal
• Resubmission
• Revision

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.

Clinical Trial?

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.

Award Budget

The direct costs for any year may not exceed $250,000 (excluding consortium F&A costs). Within that limit, applications need to reflect the actual needs of the proposed project.

Award 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.

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Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

• 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
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
• Local Governments
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).
• Federal Government
  • Eligible Agencies of the Federal Government
• U.S. Territory or Possession
• Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations).
  • Foreign Organizations
  • 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.

are eligible to apply.

Required Registrations

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.

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

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

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

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

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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.

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.

• 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.
• Other Attachments:
  • 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:
    • 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.
    • 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-definedclinical 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.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

Information on the submission process and a definition of on-time submission are provided in the 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

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

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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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Review Criteria

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

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.

Innovation

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, or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Factor 2. Rigor and Feasibility

Approach

Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

• Rigor:

  • Evaluate the potential to produce unbiased, reproducible, robust data.
  • Evaluate the rigor of experimental design and whether appropriate controls are in place.
  • Evaluate whether the sample size is sufficient and well-justified.
  • Assess the quality of the plans for analysis, interpretation, and reporting of results.
  • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
  • For applications involving human subjects or vertebrate animals, also evaluate:
    • the rigor of the intervention or study manipulation (if applicable to the study design).
    • whether outcome variables are justified.
    • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
    • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
  • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

• Feasibility:

  • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
  • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex.
  • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Factor 3. Expertise and Resources

Investigator(s)

Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Additional Review Criteria

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

• Protections for Human Subjects
  For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
  For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

• Vertebrate Animals
  When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

• Biohazards
  When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

• Resubmissions
  For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

• Renewals
  For Renewals, the committee will consider the progress made in the last funding period.

• Revisions
  For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

• Authentication of Key Biological and/or Chemical Resources:
  For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support
  Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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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.

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

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:
  • NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General
  • 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.

Cooperative Agreement Terms and Conditions of Award

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 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.

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Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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]

Scientific/Research Contact(s)

Scott Rogers, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6932
Email: [email protected]

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]

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Section VIII. Other Information

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

Authority and Regulations

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

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