Required Application Instructions

It is critical that applicants follow the 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 productivity 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 50% (6 calendar months) of their total effort to the direct conduct of biomedical research to the OIA (Applicants with administrative responsibilities or other duties inconsistent with this time commitment, excluding clinical or patient responsibilities, may apply but must reduce those other commitments to accept the award); 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.

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
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

Applications that do not meet the eligibility requirements will not be reviewed.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

Additional Individual Eligibility Requirements:

• Applications must be submitted by Institutions who have nominated a Program Director/Principal Investigator (PD/PI) with outstanding cancer research productivity for at least the last 5 consecutive calendar years.
• The Institution-nominated PD/PI must have been a PD/PI or Project Leader of a research project (excluding cores) on an eligible NCI research grant(s) continuously since September 2010. The continuous support cannot include supplements or no cost extensions. Examples of eligible research grant mechanisms are R01, R37, P01, P50, U01, U54, DP1, DP2, and DP5.
• Due to the nature of this award, applicants are required to devote at least 50% (6 calendar months) of their total effort to the direct conduct of biomedical research (excluding patient and clinical responsibilities) to the OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment, excluding clinical or patient responsibilities, may apply but must reduce those other commitments to accept the award.
• PDs/PIs with effort on other NIH grants will be expected to provide, as part of the Just-in-Time information, a detailed explanation describing how effort on his/her other NIH grants will be adjusted, if necessary, to permit 50% effort (6 calendar months) on the OIA.
• PD/PIs will need to renegotiate their time and effort on other grants, including NIH grants, 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) agree to relinquish the PD/PI's existing individual NCI research grants to allow them to be consolidated into the OIA.

Individuals are NOT eligible for the Outstanding Investigator Award if:

• Their only continuous NCI support since September 2010 is as a PD/PI is on Research Training and Fellowships (T & F series) and Career Development Awards (K series).
• Their only continuous NCI support as a PD/PI is on a R03, R15, R21, P30 Project Leader, R13, SBIR/STTR, Clinical Trials grant.

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).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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, address, and telephone number of the PD/PI
• Names of other key personnel
• Participating institution
• Number and title of this funding opportunity

The letter of intent should be sent to:

Christine Siemon
National Cancer Institute (NCI)
Telephone: 240-276-6180
Email: siemonc@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 6 pages.

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.

While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 7 years of support.

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

Not Applicable

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 required.

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:

1) Evidence of PD/PI programmatic contributions: Explain how you will leverage and translate the seminal 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 based on past accomplishments.

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 build on your existing program and past contributions or the current state-of-the-science. If the planned research differs from your past or current work, 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 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 productivity 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 productivity for at least the past five years and the potential for the PD/PI’s cancer research productivity and influence to continue at the same high caliber level;

3) The PD/PI's commitment of at least 50% (6 calendar months) of their total effort, excluding clinical and patient responsibilities, to the direct conduct of biomedical research. Applicants with administrative responsibilities or other duties inconsistent with this time commitment, excluding clinical or patient responsibilities, 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, 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.

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 Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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

4) Change of grantee institution will be allowable if the receiving institution agrees to all of the required OIA terms.

5) It is expected that the OIA will replace all funded NCI single project/single PD/PI grants that currently support up to 50% of the PD/PIs effort. 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 six-month calendar (50%) effort required on the OIA.

6) It is expected that the PD/PI will renegotiate effort on other NIH grants, if necessary, to permit 50% (6 calendar months) of their total effort to the direct conduct of biomedical research (excluding patient and clinical responsibilities) on the OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment, excluding clinical or patient responsibilities, must reduce those other commitments to accommodate the OIA time and effort.

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

8) Future grant support, including NCI support, will not be folded into this award. However, the 50% level of effort to the direct conduct of biomedical research (excluding patient and clinical responsibilities) on the OIA must be maintained for the entire 7-year project period and cannot be renegotiated.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.

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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this particular announcement, note the following:

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

For this FOA, the research strategy is expected to evolve over the next seven years. Applicants should describe a general research strategy, providing an overview of the broad research questions/scientific questions they currently 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 are not expected.

Accordingly, reviewers will consider the following:

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 productivity of the highest quality for at least the past five years (since September 2010)

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

4) Evidence of OIA required commitment of 50% (6 calendar months) of their total effort to the direct conduct of biomedical research (excluding patient and clinical responsibilities)

5) Substantial institutional commitment to the PD/PI (e.g., at least 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? If the goals of the research are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? 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 is this important. Evaluate the pioneering, and possibly high-risk, 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.

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.)? During at least the past five years, has the PD/PI demonstrated outstanding productivity of the highest quality, innovation and influence 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?

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 and significance 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 proposed research? Are potential problems, alternative strategies, and benchmarks for success presented? If the research goals are in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Specific to this FOA: How has the PD/PI contributed to important and reliable data to cancer research? In what way is the PD/PI’s work seminal in nature? Evaluate how the PD/PI's research has influenced his/her own work and that of others. Evaluate the PD/PI’s 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 research goals involve 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?

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 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 the 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 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.

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.

Information regarding the disposition of applications is available 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.

2) The first and any subsequent no-cost extension will require Grants Management Officer prior approval.

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

4) Change of grantee institution will be allowable if the receiving institution agrees to all of the required OIA terms.

5) It is expected that the OIA will replace all funded NCI single project/single PI grants that currently support up to 50% of the PD/PIs effort. 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 six-month calendar (50%) effort required on the OIA.

6) It is expected that the PD/PI will renegotiate effort on other NIH grants, if necessary, to permit 50% effort to the OIA.

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

8) Future grant support, including NCI support, will not be folded into this award.

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.

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.

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

eRA Commons Help Desk (Questions regarding 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)
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Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Christine Siemon
National Cancer Institute (NCI)
Telephone: 240-276-6180
Email: siemonc@mail.nih.gov

Christopher Hatch, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6454
Email: hatchc@mail.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.