It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

The purpose of this Funding Opportunity Announcement (FOA) is to support research projects offering new technical capabilities for cancer research and clinical oncology. The goals of this FOA are aligned with opportunities identified by the Blue Ribbon Panel (BRP) of the Beau Biden Cancer Moonshot^SM Initiative. While the BRP final report includes a specific recommendation for the Development of New Enabling Technologies, this FOA establishes responsive categories that incorporate recommendations for technology advancements indicated throughout the BRP final report. The four areas designated as scientific priorities targeted by this FOA are:

Area A. Enhanced experimental and analytical capabilities addressing complexities of cancer development;

Area B. New capabilities advancing precise clinical diagnosis of cancer patients;

Area C. Novel predictive ex vivo and/or in silico modeling approaches to accelerate preclinical research and development of personalized therapies; and

Area D. New technologies/approaches to improve biospecimen and data quality.

Specifically, this FOA solicits applications proposing advanced development, testing, and validation of emerging technologies/tools/capabilities with enabling potential for cancer research and/or clinical care in the identified areas of priority. Each application must be focused on one of the priority areas listed. Proposed projects are expected to establish new approaches against persistent challenges that are major obstacles to progress in the priority area selected (e.g., challenges related to biological variabilities across populations and/or across individual patients for a given tumor type). A key goal should be to demonstrate that the new technology/tool/capability proposed can overcome such persistent challenges. The emphasis is on the outcomes that could have a broadly enabling impact for equipping the targeted research fields. The innovation aspect is also important, as the proposed projects are expected to lead to the novel practical capabilities with high potential for transformative impact on the fields targeted.

Since the FOA focuses on advanced development of technologies/tools/capabilities, applications must be based on comprehensive preliminary proof-of-concept studies, substantiating the basic technical functionality of all contributing elements of the proposed technologies/tools/capabilities.

Essential aspect for this FOA is a rigorous technical validation of the proposed technology/tool/capability. As appropriate to specific projects, such technical validation should be applied to new approaches, systems, materials, devices, mathematical models, etc. The goal should be substantiating the readiness of the proposed solutions for adoption by targeted end-user research communities. Specifically, validation should ensure that the transformative, enabling functionality of the proposed technologies/tools/capabilities for cancer research and/or clinical care is thoroughly verified and objectively confirmed (using appropriate benchmarks and performance measures) by the end of the project period.

Key terms for the purposes of this FOA:

Enabling technology/tool/capability denotes either a single new technology, method, approach, capability that offers transformative potential or a novel combination of appropriate components that collectively offer enabling characteristics/transformative potential for the targeted area of priority.

Advanced technology development refers to research activities and other actions beyond the initial demonstration of feasibility, proof-of-concept, prototype stage, pilot studies, etc.

Technical validation refers to steps/actions needed to rigorously verify that the proposed new technology/tool/capability meets appropriate performance measures. The performance measures to be assessed should provide sufficient and objective proof that the novel technology/tool/capability is ready for adoption by targeted end-users and will offer genuine potential for transformative impact on the targeted area.

NCI convened the BRP in 2016 to recommend areas of scientific opportunity for the NCI to pursue aligned with the mission of the Beau Biden Cancer Moonshot^SM Initiative. Specifically, BRP was charged with making recommendations focused on areas in which a coordinated effort can profoundly accelerate the pace of progress in the fight against cancer, and specifically not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation for Development of New Enabling Cancer Technologies. The technology advancements identified in the BRP report were considered critical to enabling researchers and physicians to develop and select effective, individualized therapy strategies for a diverse set of patients, including racial and ethnic minorities and other underserved populations. The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer Moonshot^SM Initiative, including support for this FOA.

Scientific Scope. Applications submitted in response to this FOA must focus on one of the areas of scientific priority A-D listed below.

Priority Area A: Enhanced experimental and analytical capabilities addressing complexities of cancer development.

Applications focused on this area are expected to propose broadly enabling new capabilities for identification and tracking of cancer relevant cellular and/or molecular features and interactions across various scales and levels of complexity to more fully characterize the disease.

Examples of directions of interest for this area include (but are not limited to):

• Establishment of new techniques to identify and analyze the complex networks of genes, proteins, inflammatory/immune signatures, and/or biochemical pathways regulating different cell types within tumors;
• Development of tools (experimental and/or informatics) to integrate such data with relevant data from other sources (e.g., across diverse populations of patients, for different cancer types, etc.) and to provide, as appropriate, user-interaction capabilities for visualization, secondary analysis, etc.

Priority Area B: New capabilities for advancing precise clinical diagnosis of cancer patients.

Applications focused on this area are expected to propose new diagnostic tools (e.g., new molecular assays, imaging, etc.) with demonstrably unique and potentially transformative detection capabilities for a variety of biological features (e.g. molecular or cellular analytes, cell and tissue morphology, as appropriate).

Examples of directions of interest for this area include (but are not limited to):

• New diagnostic capabilities to overcome challenges associated with the complexity of diagnosing various populations, disparities in access to care, and/or optimized diagnosis of individual patients or patient sub-populations (e.g., to identify more advanced biomarker signatures based on integration of various sources of data and information, like molecular assays, images, and clinical records);
• New approaches/technologies involving, as appropriate, a combination of direct experimental measurements, various types of imaging, and/or integrative information/data analyses;

Priority Area C: Novel predictive ex vivo and/or in silico modeling approaches to accelerate cancer research and development of personalized therapies.

Applications focused on this area are expected to evaluate the efficacy of new modeling approaches that are demonstrably superior to currently available approaches in terms of ability to facilitate and accelerate preclinical research and various personalized medicine approaches, such as development of personalized treatment strategies. Applications must be focused on either in silico and/or ex vivo systems, including organoids and tissue slice platforms. In vivo modeling approaches are beyond the scope of this FOA.

Examples of directions of interest for this area include (but are not limited to):

• Testing/validation of new predictive models that could take advantage of various new technologies to accelerate the development of new anticancer therapies;
• Testing/validation of models or model-based approaches that could facilitate clinical treatment decisions (e.g., the use of both patient-derived cultures with advanced computational methods that allow for evaluation of personalized therapeutic approaches within clinically relevant timeframes);
• Testing/validation of new models of non-malignant tissues such as liver, heart or intestine for predictive toxicology (e.g., both efficacy and toxicity platforms could be used synergistically to personalize estimates of a therapeutic index).

Priority Area D: New technologies/approaches to improve biospecimen and data quality.

Scientific Scope: Applications focused on this area are expected to propose new standards (including materials, data sets, protocols, assays, etc.) to assure sufficient integrity of data and/or quality of tested biospecimens to allow comparison across clinical and/or large-scale basic research studies (e.g. comparing and/or using data across federated databases). Applications that offer the potential to overcome challenges with collecting samples from various populations (especially under-served populations) are of particular interest for this Area.

Examples of directions of interest for this area include (but are not limited to):

• Development of standardized processes for use of emerging technologies, biospecimen handling protocols, or treatment protocols and their implementation to improve accessibility;
• Development of standardized next-generation sequencing panels to impose quality control measures for patient profiling (e.g. validated tumor and germline gene panels, or panels to investigate the immunogenome);
• Development of comprehensive quality control/quality assurance measures such as standardized data collection protocols, data quality control standards, and/or structures that enhance comparison and integration of data across different studies.

Note: For each priority, projects may be focused either on:

• Integration of multiple technologies/tools/capabilities in a novel, unique way resulting in transformative, enabling characteristics (e.g., a novel combination of experimental approaches with new data analysis approaches); or
• Advancement of a single technology/tool/capability that offers transformative potential.

Path to implementation. Whereas it is expected that the technology/tool/capability will be "ready for implementation" by the end of project period, this FOA will not support activities beyond that stage. Nevertheless, applicants must briefly describe any additional steps (and corresponding benchmarks) that will be needed to ensure implementation and adoption of the technology/tool/capability by the target end-user community beyond the timeframe and scope of the award. This element includes, for example, defining any scaling up efforts, anticipated mode of dissemination (freely shared vs. commercialization), plans for possible future partnerships and intellectual property issues (especially if commercialization is considered the ultimate goal), etc.

The following types of projects will be considered non-responsive. (Non-responsive applications will not be reviewed.)

• Projects primarily focused on pursuit of a biological or clinical hypothesis for which the novelty of the project resides in the biological or clinical question and NOT in the novel technical capability being developed;
• Projects that fail to identify and justify the transformative/enabling potential (specific for the area of focus) of the technology/tool/capability proposed;
• Projects proposing new clinical trials;
• Projects proposing the development of preclinical experimental models that are not derived from human tissues;
• Projects employing established techniques to enhance the applicability of mammalian models for translational research (see Alternative Funding Opportunities below);
• Projects proposing early-stage exploratory development of new technologies and approaches that would not be ready for implementation and adoption by the targeted research community by the end of the project period; or
• Projects without clearly-defined technical validation activities and path to implementation readiness.

Alternative Funding Opportunities. Various projects not suitable for this FOA may be appropriate for other existing funding opportunities. For example:

• Projects focused on early-stage novel technologies for new molecular and cellular analysis capabilities or sample preparation or management (or advanced technologies beyond the scope of this FOA) may be responsive to FOAs associated with the Innovative Molecular Analysis Technologies (IMAT) program.
• Projects focused on developing novel bioinformatic approaches and novel software development associated with data analysis and visualization or bioinformatics research focused on developing data management and integration systems may be responsive to FOAs associated with the Informatics Technologies for Cancer Research (ITCR) program.

In addition, prospective applicants are also encouraged to explore other areas of priority identified for Cancer Moonshot and various recently-issued NCI FOAs that are addressing those priorities. Some of the specific aspects addressed include early detection capabilities, especially involving liquid biopsy approaches, as well as patient-derived xenograft (PDX) animal models for pre-clinical screening.

Applicants are encouraged to reach out to the Scientific/Research Contact listed in Section VII below to ensure appropriate alignment of projects with available funding opportunities.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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)

Governments

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

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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. 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 NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Tony Dickherber
Office of the Director
National Cancer Institute
Telephone: 301-547-9980
Email: dickherberaj@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed. Additional instruction:

Descriptive Title of Applicant’s Project: The title used must identify which of the four Priority Areas listed in Section I are being targeted. Therefore, each title proper should be preceded, as applicable, with either "Area A:" or " Area B:" or " Area C:" or " Area D:".

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Define Specific Aims of the project, including the key steps to validation. List the major performs measures/benchmarks to attain.

Research Strategy:

Use the standard Research Strategy subsections (Significance, Innovation, and Approach) to describe the proposed project. In addition to standard/typical elements, this description should also address all the specific aspects listed below.

Sub-Section Significance

Under a subheading "Priority Area Relevance and Transformative Potential", address the following aspects:

• Justify the relevance of the proposed project to a Priority Area targeted. For example, explain how the technology/tool/capability proposed addresses an unmet need for that Area. Discuss the expected outcomes in the context of how the project may contribute to the overall goals of the MoonshotSM Initiative.
• Justify the anticipated translational potential by indicating how the proposed project is expected to advance cancer research and/or clinical oncology in the selected Priority Area.
• Describe the hurdles restricting progress in the targeted area using available approaches and technologies, indicating how the proposed technology may overcome those.
• Describe the hurdles to utility and adoption of the proposed capability, indicating how the proposed research strategy may overcome those.

Under a sub-heading "Preliminary Data", address the following aspects:

• Describe the current state of development of the technology/tool/capability proposed. For application to be responsive, this description should offer a clear, rigorous evidence for the feasibility of the proposed approach and attaining the stage suitable for advanced development aimed at implementation.
• Preliminary studies on which the application is predicated should amount to a successfully completed phase I development (e.g., in terms of demonstrating the general utility of the concept, building a prototype, testing technology/tool in "real life samples, and/or other benchmarks as appropriate).
• For projects proposing a novel combination/integration of several approaches (e.g., experimental approaches in conjunction with integrative data analyses), provide appropriate preliminary data for the components as well as the entire combined approach.

Sub-Section Approach

Under a sub-heading "Technical Validation", address the following aspects:

• Explain clearly and precisely how the entire project and the individual elements of the proposed technology/tool/capability will be validated for the attainment of the intended qualities.
• Describe specific, objectively assessable (and quantifiable, as appropriate) Performance Measures for technical validation of the new technologies/tools-enabled capability to be achieved. Performance Measures should be clearly defined, scientifically justified, and quantitative whenever applicable.
• Performance Measures should address, as appropriate for the project, such aspects as:
• Statistical power analysis to support accuracy and precision of performance and also to define the number of specimens needed
• The means by which each of the proposed Performance Measures will be assessed.
• Explanation on how the proposed Performance Measures will provide the means for objectively assessing progress towards Specific Aims of the project. (Note: for some Specific Aims, it may be sufficient to define a single Performance Measure but other Specific Aims may require multiple Performance Measures).
• "Strategic" Performance Measures that could substantiate the expectations of the potential transformative/enabling impact that the new technology might have on cancer research or clinical oncology.
• While addressing Potential Pitfalls and Alternative Approaches, explain intended strategy(-ies) in case of inability to attain some critical performance benchmarks.

Other validation-related aspects to describe if applicable to your project:

• Plan for clinical validation of the assay within the intended clinical context of use, using appropriate clinical biospecimens
• Note 1: if appropriate for the validation, applicants are encouraged to plan for inclusion of specimens from diverse patient populations.
• Note 2: If applicable, include plans to accrue specimens to perform clinical validation of the technology/tool/capability, including identification of the clinical resource or trial that will provide specimens, documentation of appropriate availability and pre-approvals to get specimens (i.e. indication that the repository holder identifies availability of specimens and that there is an appropriate process to get the specimens with reasonable certainty). There is a strong preference to using already collected specimens or those coming from existing clinical trials to mitigate the challenges associated with new specimen accrual.
• Access to clinical specimens for testing/validating the proposed technology/tool/capability, including:
• Identification of the clinical resource or trial that will provide specimens (see Letters of Support below for the required documentation of appropriate availability and pre-approvals to get specimens).

Under a sub-heading "Path to Implementation", address the following aspects:

• General timeline for development during the project period as well as well as a stage of readiness for the implementation to be attained by the end of the project period.
• An outline of subsequent timeline to ultimate implementation.
• If applicable to your project, include:
• Plans to address regulatory requirements that might be needed either during the project period (e.g., experimental device status) and/or beyond (e.g., future clinical trials).
• Briefly address the intended steps/approaches during the project period and beyond to facilitate/promote/encourage adoption of the new technology/tool/ capability to be developed.

Letters of Support: As applicable, provide letters of collaborators/biorepository holders, documenting the availability of biospecimens for the proposed studies. Such letters should identify the characteristics and numbers of specimens that already are available and/or will be available with reasonable certainty.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Resource Sharing Plans are expected for this FOA, and should be cohesive with the description under "Path to Implementation", including strategies intended beyond the period of the award.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. 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

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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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 NCI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: How relevant is the proposed project to the targeted Area, e.g., in terms of addressing an unmet need? How strong is the potential of the proposed technology/tool/capability to transform cancer research or clinical oncology? What is the likelihood that the new technology/tool/capability proposed will be readily adopted by cancer research or clinical oncology? Is the proposed project feasible and sufficiently supported by pilot studies, proof-of-concept data, etc.?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA: How sufficient are the plans for technical validation of the proposed technology/tool/capability? Are the proposed performance measures appropriate and well justified? Will these performance measures allow one to objectively determine whether or not the projects goals have been accomplished? Are the long-term plans towards implementation well thought out and realistic?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will 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 six categories of research that are exempt under 45 CFR Part 46, the committee will 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.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment 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. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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:

• 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.
• Will receive a written critique.

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

Applications will be assigned 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 National Cancer Advisory 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. Funding priority may be given to those applications that are determined by peer review to be particularly responsive to the areas of unmet need described in the BRP final report, particularly with regards to those applications more likely to deliver new enabling capabilities by the end of the project period.

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.

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that 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 FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

A final progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Tony Dickherber, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-547-9980
Email: dickherberaj@mail.nih.gov

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

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 45 CFR Part 75.