Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Research Answers to NCI’s Provocative Questions (R21)
Activity Code	R21 Exploratory/Developmental Grant
Announcement Type	New
Related Notices	September 21, 2012 - Selection of Appropriate Funding Opportunity under the National Cancer Institute (NCI) Initiative Research Answers to NCI’s Provocative Questions See Notice NOT-CA-12-014. September 21, 2012 - This RFA has been reissued as RFA-CA-12-016. September 21, 2012 - This RFA has been reissued as RFA-CA-12-018. September 21, 2012 - This RFA has been reissued as RFA-CA-12-020. September 21, 2012 - This RFA has been reissued as RFA-CA-12-022.
Funding Opportunity Announcement (FOA) Number	RFA-CA-11-012
Companion FOA	RFA-CA-11-011, R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.394, 93.395, 93.396
FOA Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to support research projects designed to use sound and innovative research strategies to solve specific problems and paradoxes in cancer research identified by the National Cancer Institute (NCI) as the NCIs "Provocative Questions" (PQs). These Provocative Questions are not intended to represent the full range of NCI's priorities in cancer research. Rather, they are meant to challenge cancer researchers to think about and elucidate specific problems in key areas of cancer research that are deemed important but have not received sufficient attention. Some of these PQs stem from intriguing but older, neglected observations that have never been adequately explored. Other PQs are built on more recent findings that are perplexing or paradoxical, revealing important gaps in current knowledge. Finally, some PQs reflect problems that traditionally have been thought to be intractable but that now may be open to investigations using new strategies and recent technical advances. Each research project proposed in response to this FOA must be focused on solving one particular research problem defined by one specific PQ selected from the list of Provocative Questions. This program covers two FOAs of identical scientific scope. This FOA solicits applications for the NIH R21 funding mechanism. The companion FOA (RFA-CA-11-011) is a parallel announcement for the NIH R01 mechanism.

Posted Date	August 25, 2011
Open Date (Earliest Submission Date)	October 14, 2011
Letter of Intent Due Date	October 14, 2011
Application Due Date(s)	November 14, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	March/April 2012
Advisory Council Review	May 2012
Earliest Start Date(s)	July 2012
Expiration Date	November 15, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support new research projects designed to use sound and innovative strategies to solve specific problems and paradoxes in cancer research identified by the National Cancer Institute (NCI) as the NCI’s Provocative Questions" ( PQs ).

This program covers two parallel Funding Opportunity Announcements (FOAs) of identical scientific scope. This FOA solicits applications for exploratory/developmental research projects using the NIH R21 funding mechanism. The companion FOA, RFA-CA-11-011, is a parallel announcement for well-developed projects using the NIH R01 mechanism.

To be responsive to this FOA, each applicant team must specifically address a particular scientific problems identified as one of the NCI’s Provocative Questions" listed in this FOA (and further defined at http://provocativequestions.nci.nih.gov/).

Background

Progress in cancer research depends on identifying important outstanding questions in the field and designing appropriate experiments to answer them. The best research questions often illuminate the key issues that underlie a problem, suggest potential approaches to attack the question, and even hint at the promise of the final results. Over the past year, the NCI has sponsored several workshops to identify, articulate, and prioritize particularly compelling but understudied problems in cancer research to create a list of Provocative Questions . PQs come from various fields relevant to cancer research, but all are framed to inspire interested scientists to conceive new approaches or feasible solutions.

It is important to note that these Provocative Questions are not intended to represent the full range of NCI's priorities in cancer research. Rather, they are meant to challenge cancer researchers to think about and elucidate specific problems in key areas of cancer research that are deemed important but have not received sufficient attention.

Types of the NCI "Provocative Questions". Most PQs fall broadly into three categories. The first type of questions brings ignored or neglected cancer-relevant problems back into focus. These problems typically relate to intriguing older observations or issues that cancer researchers may have taken for granted but for which satisfactory, rigorous research answers are still lacking.

A second class of PQs is built on more recent findings that are perplexing or paradoxical, revealing important gaps in current knowledge. Research answers to this type of PQs have the potential to re-shape several of our current key conceptions about cancer.

Finally, a third class of PQs reflects problems that used to be perceived as particularly difficult to explore but became open to investigations because of recent scientific discoveries and technical advances.

List of the NCI’s Provocative Questions (for full details see http://provocativequestions.nci.nih.gov/). Each application must address one and only one specific PQ, exactly as defined in this FOA.

PQ1. How does obesity contribute to cancer risk?

PQ2. What environmental factors change the risk of various cancers when people move from one geographic region to another?

PQ3. Are there ways to objectively ascertain exposure to cancer risk using modern measurement technologies?

PQ4. Why don't more people alter behaviors known to increase the risk of cancers?

PQ5. Given the evidence that some drugs commonly and chronically used for other indications, such as an anti-inflammatory drug, can protect against cancer incidence and mortality, can we determine the mechanism by which any of these drugs work?

PQ6. What are the molecular and cellular mechanisms by which patients with certain chronic diseases have increased or decreased risks for developing cancer, and can these connections be exploited to develop novel preventive or therapeutic strategies?

PQ7. How does the life span of an organism affect the molecular mechanisms of cancer development and can we use our deepening knowledge of aging to enhance prevention or treatment of cancer?

PQ8. Why do certain mutational events promote cancer phenotypes in some tissues and not in others?

PQ9. As genomic sequencing methods continue to identify large numbers of novel cancer mutations, how can we identify the mutations in a given tumor that are most critical to the maintenance of its oncogenic phenotype?

PQ10. As we improve methods to identify epigenetic changes that occur during tumor development, can we develop approaches to discriminate between driver and passenger epigenetic events?

PQ11. How do changes in RNA processing contribute to tumor development?

PQ12. Given the recent discovery of the link between a polyomavirus and Merkel cell cancer, what other cancers are caused by novel infectious agents and what are the mechanisms of tumor induction?

PQ13. Can tumors be detected when they are two to three orders of magnitude smaller than those currently detected with in vivo imaging modalities?

PQ14. Are there definable properties of a non-malignant lesion that predict the likelihood of progression to invasive or metastatic disease?

PQ15. Why do second, independent cancers occur at higher rates in patients who have survived a primary cancer than in a cancer-na ve population?

PQ16. How do we determine the clinical significance of finding cells from a primary tumor at another site?

PQ17. Since current methods to assess potential cancer treatments are cumbersome, expensive, and often inaccurate, can we develop other methods to rapidly test interventions for cancer treatment or prevention?

PQ18. Are there new technologies to inhibit traditionally undruggable target molecules, such as transcription factors, that are required for the oncogenic phenotype?

PQ19. Why are some disseminated cancers cured by chemotherapy alone?

PQ20. Given the recent successes in cancer immunotherapy, can biomarkers or signatures be identified that can serve as predictors or surrogates of therapeutic efficacy?

PQ21. Given the appearance of resistance in response to cell killing therapies, can we extend survival by using approaches that keep tumors static?

PQ22. Why do many cancer cells die when suddenly deprived of a protein encoded by an oncogene?

PQ23. Can we determine why some tumors evolve to aggressive malignancy after years of indolence?

PQ24. Given the difficulty of studying metastasis, can we develop new approaches, such as engineered tissue grafts, to investigate the biology of tumor spread?

Specific Requirements

Scientific Scope. The collective scientific scope of this FOA is defined by the list of Provocative Questions . These PQs define research areas appropriate for this FOA. They should NOT be construed as examples of specific topics. The scientific scope of each individual application must clearly and distinctly correspond to one (and only one) of the PQs listed above. Within an area defined by a given PQ, applicants may propose and pursue any topic they deem relevant as a "research answer" to that PQ. It is essential, however, that applicants visit Provocative Question web site (http://provocativequestions.nci.nih.gov/) for additional information for each PQ pertaining to context, background, feasibility, and expectations of needs to be accomplished for a successful solving of these problems.

Note: Applicants who fail to choose a specific PQ from this list, address more than one PQ within a single application, and/or re-write the PQ will have their applications rejected without review as non-responsive.

Applicants wishing to address more than one of the Provocative Questions may still do so by submitting separate applications.

Individual Goals and Approaches. Within the research area defined by a specific Provocative Question chosen, the overarching goal of the proposed research project must be an attempt to provide comprehensive and thorough research answers to the problem or portions of the problem presented by that question.

Within this general required framework, specific strategies, priority directions, and other details of study design and execution are left to the discretion, originality, and creativity of the applicants. The creativity and originality (combined with scientific rigor) are particularly important, given that the areas identified by the individual Provocative Questions are, generally, understudied. Therefore, the applicants have the full freedom to identify the most promising direction(s) to address the selected Provocative Question , formulate Specific Aims, choose optimal experimental approaches, and adapt appropriate specific benchmarks as measures of accomplishing the overarching goal of the project. It is expected that these specific benchmarks will be consistent with Implications of Success identified for each of the NCI-defined Provocative Questions .

Original Rigorous Concepts. In general, the R21 funding mechanism is used for pilot, exploratory, research projects. For such projects, preliminary data are not required, although may be included if available. It is realized that for the areas of the Provocative Questions , there could be gaps in background information and original preliminary data may be particularly scarce or hard to get beforehand. The intention of this FOA is, by definition, to exploit understudied areas. Therefore, the emphasis of this R21 FOA is on concepts to be explored, i.e. the power of the ideas behind the proposed research. These concepts and ideas must be original but also rigorous in terms of integrating to the best extent possible the available incomplete information for a given area from various sources.

NOTE: Applicants may notice some similarities between this Provocative Questions FOA and another NIH Program on which NCI participates: Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) (recent FOA: http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-11-003.html). Both programs emphasize originality, creativity, and potential for high impact on the field. However, there are important differences. The scientific scope of the EUREKA program is open to all areas relevant to participating Institutes. By contrast, the scientific scope of this FOA is strictly defined by the areas of Provocative Questions . Unless the proposed project is entirely focused on one particular PQ (and other requirements specified in this FOA are met as well), projects proposed previously for the EUREKA program will be non-responsive to this FOA.

The National Institutes of Health (NIH) Exploratory/Developmental Grant (R21) funding opportunity supports the development of new research activities in categorical program areas. The R21 mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NCI appropriations, and the submission of a sufficient number of meritorious applications. NCI intends to fund an estimate of approximately 12 awards, corresponding to a total of up to $5 - $7.5 million, for fiscal year 2012. Future year amounts will depend on annual appropriations.
Award Budget	The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Application budgets must reflect actual needs of the proposed project.
Award Project Period	The total project period may not exceed 2 years.

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

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

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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PDs/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons accounts are affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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, 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 NCI staff to estimate the potential review workload and plan the review.

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

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

Note: Project Title must include the PQ number that is being addressed (at the end in parenthesis).

The letter of intent should be sent to:

Jerry S.H. Lee, Ph.D.
Health Sciences Director
Office of the Director
National Cancer Institute
31 Center Drive, Room 10A33
Bethesda, MD 20892
Telephone: (301) 496-1045
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

Note: All application titles must include the PQ number on which the application is based (insert PQ number at the end of the title in parenthesis).

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

• In Specific Aims, address the expected overall impact of the project outcomes in terms of breadth and magnitude on cancer research.
• The Research Strategy section must contain (within the standard page limits) the following element:
  • Provocative Question (PQ) Choice and Challenge Statement. Identify one (and only one) specific PQ that is being addressed in the proposed project and briefly describe how you propose to provide an answer to the PQ selected. How original is the concept/hypothesis/strategy proposed to solve the problem defined by the selected PQ? What aspects make the proposed approach novel, different, and/or better from previous attempts? Why is testing the proposed concept/hypothesis and/or solving the problem important for the field defined by that particular PQ?

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and for responsiveness by the National Cancer Institute, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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:

It is essential that research projects proposed in response to this FOA meet the expectations in terms of exceptional creativity and originality in addressing the selected PQ. To be viewed as meritorious, the proposed research projects, as designed, must be likely to yield far- or broad-reaching advances in the understanding of the research problem defined by the selected PQ. Thus, strength of the applications will be judged in main part on the power of the ideas behind the proposed research.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Reviewers will provide an overall impact/priority 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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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: Is the proposed research creative and original to the degree expected by the goals of this FOA? To what extent is this research project, as designed, likely to yield far- or broad-reaching advances in our understanding for the selected PQ?

Investigator(s)

Are the PD/PIs, 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?

Innovation

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: Does the proposed project address the selected PQ in a new and fresh way? Does it provide opportunity for novel findings that would be informative as answers for the selected PQ? For high risk projects, is the potential for benefit justifiably high?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Is the experimental design optimized enough to ensure generation of important information for the selected PQ? If negative results are obtained, how likely is it that these results will be informative for our understanding of the selected PQ? Do the applicants propose a conceptually original and rigorous strategy to solve the problem defined by the selected PQ?

Environment

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: Do the environment and/or resources provide novel or enhanced opportunity to investigate the selected PQ?

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

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/priority score.

Applications from Foreign Organizations

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.

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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. Review assignments 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 will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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.

Note: No appeals will be permitted for applications submitted in response to this FOA.

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.

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Jerry S.H. Lee, Ph.D.
Health Sciences Director
Office of the Director
National Cancer Institute
Telephone: 301-496-1045
Email: [email protected]

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected].

Crystal Wolfrey
National Cancer Institute
Telephone: 301-496-8634
e-mail: [email protected]

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 Parts 74 and 92.