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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits grant applications proposing exploratory research projects focused on further development and validation of emerging technologies with new or improved capabilities for targeting, probing, or assessing molecular and cellular features of cancer biology for basic or clinical cancer research. Well-suited applications must propose to advance technologies that offer the potential to accelerate and/or enhance research in a cancer-relevant field. Technologies proposed for development may be intended to have widespread applicability but must be focused on improving molecular and/or cellular characterizations of cancer.

This NOFO utilizes the R33 mechanism and is suitable for projects which have overcome major feasibility gaps for the technology or methodology, as demonstrated by supportive preliminary data, but still require further development and rigorous validation to encourage adoption by the research community. Projects may involve further development of a novel technology to address an unmet technical need in cancer research or clinical care and should include a rigorous validation strategy to establish repeatable, reliable performance of the technology in a cancer-relevant biological context of use. Projects proposing to apply existing technologies where the novelty resides in the use of the technology or the biological or clinical question being pursued, and not the technical capabilities being developed, are not responsive to this NOFO and will not be reviewed.

This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

The IMAT Program

Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, validation, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI's other technology-focused programs, the IMAT program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct population-scale studies, address and reduce disparities in clinical care, and assist in clinical decision-making.

The current issuance of the IMAT Program consists of four separate NOFOs that cover the following two areas:

• Molecular and Cellular Analysis Technology Development for Cancer Research is intended to support the development of technologies with novel measurement, probing, or targeting of cancer-relevant targets at the molecular or cellular level which may in turn accelerate basic, epidemiologic, or clinical cancer research.
  • RFA-CA-25-001 (R61): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology.
  • RFA-CA-25-002 (this NOFO, R33): Supports the advanced development and robust validation of the technology following completion of the initial phase of development.
• Cancer-Relevant Biospecimen Science Technologies is centered on the development and validation of novel technologies to improve and reduce variability in the collection, processing, handling, preservation, or isolation of cancer-relevant biospecimens and their derivatives, including tools to assess their quality and biological integrity. 
  • RFA-CA-25-003 (R61): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology.
  • RFA-CA-25-004 (R33): Supports the advanced development and robust validation of the technology following completion of the initial phase of development.

Additional information about the IMAT Program and its individual NOFOs can be found on the IMAT website.

Specific Research Objectives and Scope of this NOFO 

The proposed projects must be focused on the advanced development, optimization, and validation of an emerging molecular or cellular analysis technology in a biologically relevant system. In addition, all projects proposed in response to this NOFO must involve all the following general attributes:

• Further development of a novel tool with potential for substantial improvements over current approaches and/or adding qualitatively new research capabilities.
• New or improved technical capabilities that are potentially transformative to research in laboratory, epidemiology, and/or in clinical settings, and beyond providing incremental improvements to existing capabilities.
• Rigorous study design with a verifiable approach based on well-defined performance measures (see below for a description of performance measures).

For details on addressing these requirements, see Section IV. Application and Submission Information.

Responsive Technologies and Scientific Scope

Responsive technologies include relevant novel platforms, assays, instrumentation, devices, and associated methods. These technologies may be intended for molecular and/or cellular analyses in vitro, in situ, and/or in vivo (with some exceptions listed below), and may target the needs of basic, diagnostic, translational, epidemiological, and/or clinical cancer research or otherwise address issues associated with cancer health disparities. The proposed projects must clearly be focused on the development of generally applicable technologies to advance cancer research, NOT on pursuing specific discoveries with these tools. As novel technologies can create new or exacerbate existing cancer health disparities, developers are encouraged to comment on how the proposed approach will address or otherwise mitigate such effects. 

Technology development projects in any area of cancer-related research are encouraged. Technologies may target cancer-relevant atomic, molecular, sub-cellular, and/or cellular features. At the core of any project must be a novel analysis or targeting capability (encompassing novel devices, materials, or chemical/biochemical approaches). General areas of interest include, but are not limited to, the following:

• Novel technologies to distinguish, assess, and/or monitor cancer stages and progression or cancer-associated immunity (both for point of care and for remote monitoring of patients outside a clinical setting);
• Novel technologies that may aid the elucidation of basic mechanisms underlying cancer initiation and progression;
• New methods, tools, and procedures that may generally facilitate processes related to early cancer detection, screening and/or cancer risk assessment (e.g., technologies to detect and analyze metabolic states and signatures predictive of cancer);
• Technologies that can facilitate and/or enhance molecular analyses in cancer epidemiology and population sciences (e.g., remote methods to monitor molecular and cellular features of individuals outside a laboratory or clinical setting, tools to monitor and analyze the impact of environmental factors or physical activity, tools to enable population-scale genomics or survival cancer research);
• Technologies to facilitate/accelerate the processes of drug discovery or development of generic approaches to improve drug delivery;
• Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations or otherwise examine factors contributing to cancer health disparities; and
• Technologies to newly enable cancer research or clinical control in low-resource settings, which may include practicality-of-use in locations with limited clinical or laboratory infrastructure, use in non-traditional healthcare settings, and affordability.

Applications must include quantitative performance measures. Performance measures are a means of judging the success of the project and technical function of the new technology (device, assay, etc.). Performance measures should be well-described, quantifiable, and scientifically justified. Critical components for proposed measures include the numerically described target of performance as well as the means by which it will be assessed. For additional details on this requirement, see Section IV. Application and Submission Information. 

Non-Responsive Projects

The following aspects/characteristics remain outside the scope of the IMAT Program and this NOFO. Applications proposing projects with any of the following characteristics will not be reviewed:

• Pursuit of a biological or clinical hypothesis for which the novelty of the project resides in the biological or clinical question (i.e., traditional biological-hypothesis driven research) and NOT in the novel technical capability being developed;
• Instrumentation for whole-body or in vivo imaging;
• Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology;
• Biomarker discovery or biomarker validation;
• Development of probes or tagging agents for specific target molecules (though generalizable contrast agents or probes with broad targeting capabilities or broad potential application are allowed);
• Development of drugs or therapies; and/or
• Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling with the exception of projects which include limited amounts of software development or computational efforts as might be needed to develop new devices or methods.

Additionally, an application lacking appropriate performance measures, as determined by the NCI program staff, will not be reviewed. As there are several unique review considerations for this NOFO, applicants must address the requested items outlined for the Research Plan in Section IV. Application and Submission Information.

IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this NOFO are encouraged to contact the Scientific/Research Contact listed below.

Alternative Opportunities

Related IMAT NOFO: Applicants proposing projects that still involve a critical question as to the overall feasibility of the approach should consider applying to the companion NOFO (RFA-CA-25-001) which uses the R61 mechanism. NOTE: Applications proposing to use novel technologies for hypothesis-driven research or merge complementary technologies without a substantial requirement for further development or clear need for analytical validation are beyond the scope of the IMAT program solicitations altogether.

Other technology-related funding opportunities. Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software development solutions should consider one of the Informatics Technologies for Cancer Research (ITCR) opportunities. Researchers who emphasize the assessment of whole-body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP) for information on additional funding opportunities.

Annual Meeting

An annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the development of technologies for cancer research and clinical care for cancer patients. All investigators supported through this NOFO  are required to attend this meeting each year, lasting 2-3 days, unless otherwise notified by NCI program officials.

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.

 Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Kelly Crotty, Ph.D.
Center for Strategic Scientific Initiatives
National Cancer Institute (NCI)
Telephone: 240-255-0917 
Email: [email protected]

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 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:

Specific Aims: Include a brief subsection "Statement of Potential Impact" on the expected potential of the proposed technology to transform cancer research or  clinical practice.

The following questions should be addressed within this statement:

• What is the new capability provided by the proposed technology? How may it be expected to be highly impactful on biomedical research and medicine?
• How will the proposed technology overcome limitations of currently available technologies or alternative approaches to enable cancer research?

Research Strategy: Applicants may organize their research strategy as desired, but must address the following required aspects:

Importance of the Research

• Describe the new or improved technical capabilities that will be advanced and validation. The project must focus on the further development of a novel technology beyond the early-stage proof of concept demonstration and engage a rigorous validation of the novel capability in a cancer-relevant biological context of use. The technology must off substantial improvements over currently available approaches to address an unmet need in basic, preventative, diagnostic, translational, epidemiological, and/or clinical cancer research. Applications should provide appropriate background/preliminary data to justify that the proposed technology has passed the pilot developmental stage and shows promise. Applications based on work supported by a prior IMAT R21 or R61 award must describe the extent to which the aims of the prior IMAT award have been achieved. For applications not based on work supported by a prior IMAT award, an equivalent level of evidence should be provided.
• Describe the potential impact of the proposed tool on cancer research or clinical care. Applicants are encouraged to explain the significance of the proposed work and describe the unmet technical need from the research community that will be addressed by the technology, as well as its anticipated use in laboratory research and/or clinical settings. As novel technologies can create new or exacerbate existing cancer health disparities, applicants should describe how they plan to address or otherwise mitigate such effects and how populations affected by health disparities, or data from these populations, will be integrated into the proposed study. 

Rigor and Feasibility

• Describe the technical approach, including the steps to evaluate and rigoroulsy validate the proposed technology within the context of its intended use, anticipated difficulties, and possible workarounds. 

Quantitative Performance Measures

• There must be a dedicated subsection within the Research Strategy labeled “Performances Measures.” Performance measures are an objective measure of the target performance capabilities and must include the numerically described target of performance as well as the means by which it will be assessed. 
• Performance measures are specific to the technology being developed. They should be carefully selected and precisely defined. Whenever appropriate, the proposed measures should be presented in the context of current technologies to substantiate the anticipated transformative potential. 
• Performance measures should appropriately address any key risk factors for the project. They are a means of demonstrating success for the validation of the technology. 
• For some specific aims, it may be sufficient to define a single performance measure. For others, multiple performance measures may be more appropriate. 
• Performance measures may be a measure of sensitivity, specificity, throughput, resolution, a price point, or any other measure or test to demonstrate progress towards the aims. They must be well-described, quantifiable, and scientifically justified. 
• An example of a properly described performance measure could be achieving a detection limit of X femtogram per microliter of a sample with a p-value <0.05 under conditions a, b, and c with 95% confidence limits +/- Y fg over a concentration range of g to h. 
• See Section V. Application Review Information for information on review criteria related to performance measures.

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-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 (CSR) and responsiveness by NCI, 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 NCI, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

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]

Kelly Crotty, Ph.D.
National Cancer Institute (NCI)
Telephone:  240-255-0917
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
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.