Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Outstanding Investigator Award (R35)

Activity Code

R35 Outstanding Investigator Award (OIA)

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-14-267

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393, 93.394, 93.395, 93.396, 93.399

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites grant applications for the Outstanding Investigator Award (R35) in any area of cancer research.

The objective of the National Cancer Institute (NCI) Outstanding Investigator Award (OIA) is to provide long-term support to experienced investigators with outstanding records of cancer research productivity who propose to conduct exceptional research. The OIA is intended to allow investigators the opportunity to take greater risks, be more adventurous in their lines of inquiry, or take the time to develop new techniques. The OIA would allow an Institution to submit an application nominating an established Program Director/Principal Investigator (PD/PI) for a 7-year grant.

It is expected that the OIA would provide extended funding stability and encourage investigators to embark on projects of unusual potential in cancer research. The research projects should break new ground or extend previous discoveries toward new directions or applications that may lead to a breakthrough that will advance biomedical, behavioral, or clinical cancer research.

Key Dates
Posted Date

June 27, 2014

Open Date (Earliest Submission Date)

September 20, 2014

Letter of Intent Due Date(s)

September 20, 2014 

Application Due Date(s)

October 20, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

January 7, 2015

Scientific Merit Review

March 2015

Advisory Council Review

May 2015

Earliest Start Date

July 2015

Expiration Date

January 8, 2015

Due Dates for E.O. 12372

Not Applicable

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.


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Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

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 embark upon projects of unusual potential in cancer research. Candidates for the OIA must be nominated by the applicant organization. Special features of the OIA include 7-year project periods; the expectation that the OIA PD/PI commit at least 50% of his or her time and effort to the OIA; the expectation of clear and continuing Institutional commitment to the PD/PI, for example, of at least 20% of salary support; and that PD/PIs will be expected to renegotiate their time and effort on other NIH grants in order to accommodate the OIA level of effort.  It is expected that the OIA will replace current NCI funding on individual grants.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets (direct costs exclusive of third party facilities and administrative costs) may not exceed $600,000 per year and must reflect the actual needs of the proposed project.  

Award Project Period

The total project period may not exceed 7 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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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
Foreign Institutions

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 not allowed.

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.

Additional 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 past 5 years.
  • The Institution-nominated PD/PI must have been a PD/PI on an NCI grant for the last 5 consecutive years.
  • Due to the nature of this award, the PD/PI will be expected to commit a major portion (at least 50%) of their research activities to the OIA. Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. 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 on the OIA. 
  • PD/PIs will need to renegotiate their time and effort on other NIH grants in order to accommodate the OIA level of effort.

In addition, grantee Institutions are expected to: 1) provide clear and continuing commitment to the PD/PI, for example including at least 20% salary support for the duration of the award; 2) agree to relinquish the PD/PI's existing individual NCI awards to allow them to be consolidated into the OIA.

Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

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

Page Limitations

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

  • The Biographical Sketch for each Senior/Key Person is limited to 5 pages.
  • The Research Strategy is limited to 12 pages.
Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketch: The NIH is conducting a pilot of proposed changes to the SF424 (R&R) Biographical Sketch. The most important change replaces the request for applicants to provide a list of up to fifteen peer-reviewed publications (original section C) with instructions to  describe up to five contributions to science, depending on length of post-graduate experience (see section C below). The format of these contributions is described below. The instructions also explain how to include mention of other work closely related to the subject of the grant application. The modified Biographical Sketch Format page is available at http://grants.nih.gov/grants/funding/424/index.htm#format.

Following the education section of the Biographical Sketch, complete sections A, B, C and D as indicated below:

NOTE: Applicants must follow the formats and instructions below.

A. Personal Statement: Briefly describe why you are well-suited for your role in the project described in this application. The relevant factors may include aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and your past performance in this or related fields (you may mention specific contributions to science that are not included in Section C).  Also, you may identify up to four peer reviewed publications that specifically highlight your experience and qualifications for this project, provided that those publications do not appear in Section C.  If you wish to explain impediments to your past productivity, you may include a description of factors such as family care responsibilities, illness, disability, and active duty military service.

B. Positions and Honors:  List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee.

C. Contributions to Science:  Briefly describe up to five of your most significant contributions to science.   For each contribution, indicate the historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology; and your specific role in the described work.   For each of these contributions, reference up to four peer-reviewed publications that are relevant to that contribution.   The description of each contribution should be no longer than one half page including any figures.  Please also provide a link to a full list of your published work as found in a publicly available digital data base such as PubMed, myBibliography, or SciENcv all of which are maintained by the National Library of Medicine.

D. Research Support:  List both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs.

All other components of the Biographical Sketch remain as described in the SF424 (R&R) Instruction Guide.

R&R Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Specific Aims are not required and should not be submitted.

Research Strategy: Describe your vision for addressing a major biomedical or behavioral problem or challenge in cancer research, the importance of this problem or challenge, and your qualifications to engage in groundbreaking cancer research. Research strategy is expected to evolve during the tenure of the grant. The statement should include the following sections in the order given with the headings as shown below:

Scientific Area/Cancer Relevance: The proposed science should be of high priority and long term relevance to the mission the NCI.

Describe in broad terms plans for research over the years including the tools and strategies to be used. The presentation must be clear and particularly compelling. Preliminary data are not required but may be included. The research strategy is expected to evolve and therefore fewer details are needed in the scientific plan.

Describe the area of cancer research that you plan to pursue over the next several years and how those plans build on your existing program. Discuss novel hypotheses and/or approaches that will be pursued and how they have evolved from your past studies. Discuss how the research, if successful, would affect current understanding of the problem you are addressing. 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. Provide cogent justifications within the context of existing knowledge for the proposed directions of your research plan.

Evidence of PD/PI programmatic contributions, beyond what is outlined in the biosketch:

  • Discuss your programmatic contributions to your own or related fields of cancer research, how they have affected progress in that field(s) and evidence that your program has exerted leadership in the development of novel concepts, technologies, or research strategies
  • 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.

Letters of Support: Institutions must include a Letter of Nomination for the applicant being proposed for the Outstanding Investigator 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 significant commitment, for example, of at least 50% of his/her research effort  activities supported by the OIA. Effort expended toward teaching, administrative, and/or clinical duties should not be included in this calculation; and,

4) a clear and continuing institutional commitment to the PD/PI, for example, at least 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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

Section V. Application Review Information
1. Criteria

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 FOA, 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.

Overall Impact

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).

Scored Review Criteria

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 novel 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: What is the scientific challenge in cancer research that will be addressed, and why is this important? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to groundbreaking or paradigm-shifting results to cancer research? Will achievement of the proposed goals provide impetus for others working in related areas?

Investigator(s)   

Is the PD/PI well suited to the proposed goals? Has the PD/PI demonstrated an ongoing record of accomplishments that have advanced his/her field(s)?

Specific to this FOA: Has the PD/PI made important contributions to the field (outstanding research quality; continuous record of publications in peer-reviewed journals; landmark publications, honors and awards received; etc.). Has the PD/PI demonstrated outstanding research productivity of the highest quality for at least the past five years? What is the potential for the PD/PI’s research productivity and influence to continue at the same high caliber level? Does the application indicate appropriate commitment of time and effort for the proposed work?

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: Has the PD/PI provided evidence of the research program’s novelty and significance in cancer research? Has the PD/PI's past research contributed to cancer research? If the goals differ from past or current work, how do the new goals derive from current research direction? 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? How has the PD/PI demonstrated imagination, energy, and sensitivity to serendipitous findings in the past?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the goals 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?

Specific to this FOA: How do the proposed goals facilitate future planned research? Evaluate how the PD/PI has previously developed experimental approaches critical to the progress of his/her area of research. 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. 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 children, justified in terms of the scientific goals and research strategy proposed?

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: Evaluate the adequacy of the institutional commitment to the PD/PI. Does the application indicate appropriate institutional commitment of support for the proposed work?

Additional Review Criteria

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.

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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.

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

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.

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

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.

Applications from Foreign Organizations

Not Applicable

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 goals.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • 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.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

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.

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 current NCI funding on individual PD/PI grants . Renegotiation of current NCI funds will be expected.  Multiple PD/PI grants will be excluded.

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.

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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement. In keeping with the goals of the OIA, annual progress reports should include, in addition to standard reporting requirements, a description of how the line of inquiry has been of high risk or of unusual potential.

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.

Section VII. Agency Contacts

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

Application Submission Contacts

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

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)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.

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