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 the National Cancer Institute (NCI) Outstanding Investigator Award is to provide long-term support and increased flexibility for investigators with outstanding records of research accomplishments to continue or to embark upon a research program of unusual potential in cancer. Candidates for the OIA must be nominated by their applicant organization. Special features of the OIA include 7-year project periods; the expectation that the OIA PD/PI commit at least 6 person months effort to the OIA; the expectation of clear and substantial Institutional commitment to the PD/PI, for example, providing 20% of salary support; and that PD/PIs will be expected to renegotiate their time and effort on all other grant support, including NIH grants, in order to accommodate the OIA level of effort. It is expected that the OIA will replace current NCI funding on individual research grants. If an OIA is awarded, the NCI will only consider funding two additional research project grants to the Outstanding Investigator while the OIA is active. This limit includes single PD/PI, multiple PD/PI and multi-project grants where the OIA Investigator is the PD/PI. The NCI will not approve a change of PD/PI on an existing NCI grant to avoid the OIA requirements. An OIA investigator who was awarded two additional NCI grants (as PD/PI) in the last OIA project period will not be awarded another NCI grant, in addition to the OIA (R35), while those grants remain active.

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 from 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• 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 Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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) 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.
• o 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 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.

Additional Individual Eligibility Requirements:

1) Applications must be submitted by Institutions who have nominated a Program Director/Principal Investigator (PD/PI) with outstanding cancer research accomplishments during the last 5 consecutive calendar years.

2)The Institution-nominated PD/PI must have been a PD/PI or Project Leader of a research project (on a NIH-defined multi-project grant e.g., P01, P50, U54) excluding cores, on an eligible NCI research grant(s) continuously since September 2016. Continuous funding is defined as receiving a Notice of Award as PD/PI for an eligible NCI funded research grant in each Federal Fiscal Year beginning in FY 2016 onward. Continuous funding does not include grants in a funded or unfunded extension. Eligible NCI research grant mechanisms are defined as R01, R15, R33, R35, R37, P01, P50, U01, U54, UM1, U19, U10, DP1, and DP2.

3) Due to the nature of this award, applicants are required to devote at least 6 person months effort to the OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment may apply but must reduce those other commitments to accept the award.

4) PDs/PIs with effort on other grant support will be expected to provide, as part of the Just-in-Time information, a detailed explanation describing how effort on his/her other grants will be adjusted, if necessary, to permit 6 person months on the OIA.

5) PD/PIs will need to renegotiate their time and effort on other grant support, if necessary, in order to accommodate the OIA level of effort.

In addition, grantee Institutions are expected to:

1) Provide clear and continuing substantial commitment to the PD/PI, for example providing at least 20% salary support for the duration of the award.

2) For New (Type 1) applications: agree to relinquish the PD/PI's existing NCI funded single PD/PI and single project research grants to allow them to be consolidated into the OIA.

For Renewal (Type 2) application(s): PD/ PIs will not be required to relinquish NCI grants awarded after the current OIA was funded; PD/PI’s will be limited to a total of two NCI-funded grants (as PD/PI) in addition to the OIA, in compliance with NCI OIA administrative policy NOT-CA-21-044. Any institution that is considering submitting a renewal application early is strongly encouraged to contact NCI Program to discuss prior to submission.

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.

To prevent a potential lapse in funding, a PD/PI may submit a competitive R01 application and an OIA application in parallel. Should both applications be meritorious and considered for funding, the PD/PI may be permitted to accept only one of the awards pending negotiation with IC staff.

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 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, 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.

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:

Christine Siemon
National Cancer Institute (NCI)
Telephone: 240-276-6266
Email: siemonc@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.

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: Do not use. Specific Aims are not allowed.

Research Strategy: Upload the Research Strategy as a single attachment and organize the Research Strategy using the instructions provided below. Start each section of the document with the appropriate section heading:

Type 1 (New Applications) should address:

1) Evidence of PD/PI programmatic contributions: Explain how you will leverage and translate the seminal past contributions of your cancer research program (novel ideas; accomplishments; experience; sustained productivity; etc.) into the new approaches proposed for your future research program. Discuss the reasons and the likelihood that your research program is likely to continue to make novel and important contributions to cancer research.

2) Research Program description: What is the broad scientific question or challenge in cancer research that will be addressed and why is this important? Summarize the basis of the proposed research program.

3) Overview of future research program: Describe in broad terms the research vision, strategies, and potential outcomes over the next seven years. Describe how your goals derive from your existing program past contributions or the current state-of-the-science. If the planned research differs from your past or current work, explain if the new direction relates to your current research activities and describe your ability to pursue the new approaches and your rationale for the changes, such as the development of new strategies and/or the posing of new hypotheses.

Limited preliminary data should be included only if they are critical for assessing the feasibility of the new avenues of research.

The research strategy is expected to evolve over the next seven years. Therefore, rather than a detailed experimental plan, a description of the general approaches to be taken and the broad research hypotheses and questions to be addressed should be provided.

Type 2 (Renewal Applications) should address:

1) Evidence of PD/PI programmatic contributions: Explain the pioneering approaches and success in achieving that led to groundbreaking or paradigm-shifting concepts in cancer research during the current OIA project period. Include how the accomplishments of the highest quality and innovation have influenced cancer research.

2) Research Program description: Describe how the success of goals carried out in the current OIA project period reflect a fundamental new insight into the potential solution of a problem and/or development of exceptionally novel approaches. Summarize the basis of the proposed research program based on the current OIA project period.

3) Overview of future research program: Discuss the reasons and the likelihood that your research program is likely to continue to make novel and important contributions to cancer research.

If the planned research differs from your current OIA project period, explain how the new direction relates to your current research activities and describe your ability to pursue the new approaches and your rationale for the changes, such as the development of new strategies and/or the posing of new hypotheses.

Limited preliminary data should be included only if they are critical for assessing the feasibility of the new avenues of research.

The research strategy is expected to evolve over the next seven years. Therefore, rather than a detailed experimental plan, a description of the general approaches to be taken and the broad research hypotheses and questions to be addressed should be provided.

Letters of Support: Institutions must include a Letter of Nomination for the applicant being proposed for the Outstanding Investigator Award. The Letter of Nomination should be signed by the person at the institution who has the authority to evaluate and endorse the outstanding cancer research accomplishments of the nominee (e.g.: Dean, Center Director, etc.) and commit the institution to all the requirements of the application and award. Applications that are missing a Letter of Nomination will not be reviewed.

In two pages or less, the Letter of Nomination should describe:

1) The selection process used by the Institution to nominate the PD/PI for the OIA;

2) A brief statement of the PD/PI's demonstrated outstanding cancer research accomplishments and productivity for at least the past five years and the potential for the PD/PI's cancer research accomplishments, productivity and influence to continue at the same high caliber level;

3) The PD/PI's commitment of at least 6 person-months effort to the OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment may apply but must reduce those other commitments to accept the award; and,

4) A clear and continuing substantial institutional commitment to the PD/PI beyond the normal level extended by the Institution to faculty, for example, providing 20% salary support for the duration of the award.

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.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

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

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.

It is anticipated that the terms of award will include, but not be limited to, the following:

1) Carryover of an unobligated balance from one budget period to another budget period will require Grants Management Officer prior approval. Carryovers will only be considered under exceptional circumstances.

2) Awards funded under this FOA will not be provided the authority to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Award, as outlined in the NIH Standard Award Terms and Conditions. All extensions, including the first extension, will require NIH prior approval.

3) Awards are excluded from SNAP annual financial reporting is required.

4) All funds must be expended within the approved project period.

5) Change of PD/PI will not be allowed under the OIA.

6) Change of grantee institution will be allowable, with NCI prior approval, if the receiving institution agrees to all of the required OIA terms.

7) It is expected that the OIA will replace all funded NCI single project/single PD/PI grants that currently support up to 6 person months of the PD/PIs effort. The level of effort on NCI single project/single PD/PI grants will be based on the level of effort proposed in the competing year of that affected grant. NCI-funded multiple PD/PI and multiple project grants as well as other NIH funding will be excluded; however, effort on those grants will need to be accommodated outside the 6 person month effort required on the OIA.

8) It is expected that the PD/PI will renegotiate effort on other grant support, if necessary, to permit 6 person months effort to the OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment must reduce those other commitments to accommodate the OIA time and effort.

9) Evidence of a clear and substantial institutional commitment to the PD/PI (e.g., 20% salary support for the duration of the award).

10) Future applications submitted after the OIA is awarded will not be folded into this award. However, the 6 person months level of effort on the OIA must be maintained for the entire 7-year project period and cannot be renegotiated.

11) NCI will only consider funding two additional research awards on which the Outstanding Investigator is a named PD/PI. Research awards include single PD/PI, multiple PD/PI, multi-project grants, and Cancer Center (P30) grants, as well as Cancer Grand Challenges (CGC) awards where the OIA recipient is the CGC Team Lead. Other non-PD/PI roles, such as Project Leader or Co-Investigator are not considered in the two additional research awards. The NCI will not approve a change of PD/PI on an existing NCI grant to avoid the OIA requirements.

12) Specific to renewal (Type 2) applicants: An OIA investigator who was awarded two additional NCI research awards during the prior OIA project period will not be awarded another NCI grant or CGC award while those research awards are active. In addition, those research awards do not need to be relinquished when the renewal OIA (R35) is awarded.

13) Any grant that was relinquished at the time the OIA was awarded should not be submitted for renewal and will not be considered for funding by NCI.

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 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 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 Center for Scientific Review and the National Cancer Institute, NIH. Applications that are incomplete and/or non-compliant will not be reviewed.

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

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.

For this particular announcement, note the following:

The Outstanding Investigator Award (R35) is based on the accomplishments of the applicant. It is meant to support the cancer research program of individual scientists of exceptional creativity, demonstrated outstanding research accomplishments, and seminal past contributions in cancer research.

For this FOA, the research strategy is expected to evolve over the seven-year award period. Applicants should describe a general research strategy, providing an overview of the broad research questions/scientific questions they plan to address, a general description of possible strategies, and a description of how their past scientific accomplishments will inform this research. Experimental details, extensive preliminary data, and specific aims should not be included unless critical to assessing the feasibility of the new avenues of research.

Accordingly, reviewers will emphasize the following:

For Type 1 (New) Applications:

1) Evidence of important previous contributions made by the PD/PI to their field (outstanding research quality; continuous record of publications in peer-reviewed journals; landmark publications, honors and awards received; etc.);

2) PD/PI's demonstrated outstanding cancer research accomplishments of the highest quality for at least the past five years (beginning in Federal Fiscal Year 2016 onward);

3) Potential for the PD/PI's impact on cancer research and influence to continue at the same high caliber level;

4) Substantial institutional commitment to the PD/PI (e.g., 20% salary support for the duration of the award);

For Type 2 (Renewal) Applications:

1) Evidence of important contributions made by the PD/PI to their field as a result of the current OIA funding (outstanding research quality; continuous record of publications in peer-reviewed journals; landmark publications, honors and awards received; etc.);

2) PD/PI's demonstrated outstanding cancer research accomplishments of the highest quality during the current OIA project period;

3) Potential for the PD/PI's continued impact on cancer research and influence to continue at the same high caliber level;

4) Substantial institutional commitment to the PD/PI (e.g., 20% salary support for the duration of the award);

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.

Do the proposed research goals address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the goals of the research are achieved, how will scientific knowledge, technical capability, and/or clinical practice be affected? How will successful completion of the goals change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Evaluate the broad scientific challenge in cancer research that will be addressed, and why this is important. Evaluate the pioneering approaches that, if successful, might lead to groundbreaking or paradigm-shifting results to cancer research. Evaluate the proposed goals for providing impetus for others working in related areas. As appropriate, evaluate how the success of goals carried out in the current OIA project period reflect a fundamental new insight into the potential solution of a problem and/or development of exceptionally novel approaches.

Is the PD/PI well suited to the proposed research goals in terms of important contributions to his/her field (outstanding research quality; continuous record of publications in peer-reviewed journals; landmark publications, honors and awards received; etc)

Specific to this FOA: During at least the past five years, how has the PD/PI demonstrated outstanding accomplishments of the highest quality, innovation and influence in cancer research? How has the PD/PI contributed to important knowledge in cancer research? If applicable, how has the PD/PI demonstrated imagination, energy, and sensitivity to serendipitous findings in the past? Is his/her influence likely to continue at the same high caliber level in the future? Does the application indicate appropriate commitment of time and effort for the proposed work? Evaluate how the PD/PI's research has influenced that of others.

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?

Specific to this FOA: Has the PD/PI provided evidence of the proposed research program's novelty in cancer research? What PD/PI's insights have driven cancer research in new directions? Do the stated goals reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally novel approaches and/or from the posing of radically unconventional hypotheses?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the goals of the project? Has the investigator included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Has the investigator 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? Has the investigator presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA: In what way is the PD/PI's past work seminal? Evaluate the PD/PI's hypothesis and broad plans for research over the years of the award. How do the proposed goals facilitate future planned research? Evaluate the likelihood that the PD/PI will continue at the frontiers of research.

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 individuals of all ages (including children and older adults), 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?

Specific to this FOA: Evaluate the adequacy of the substantial institutional commitment to the PD/PI. Does the application indicate a level of institutional commitment of support for the PD/PI beyond the normal level extended by the Institution to faculty?

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 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 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 individuals of all ages (including children and older adults) 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.

For Resubmissions, the committee will evaluate the application as now presented.

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

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.

Not Applicable

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.
• Institutional commitment to the OIA applicant
• Level of existing total funding from NIH

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 recipient’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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 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.

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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Christine Siemon
National Cancer Institute (NCI)
Telephone: 240-276-6266
Email:siemonc@nih.gov

Shamala Srinivas, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6442
Email: shamala@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@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.