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

Collaborative Research Projects to Enhance Applicability of Mouse Models for Translational Research (Collaborative R01)

Activity Code
Announcement Type

New

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-240

Companion Funding Opportunity

PAR-14-241 R01 Research Project Grant 

PAR-14-239 U24 Resource-Related Research Projects – Cooperative Agreements

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

93.396, 93.393, 93.394, 93.395  

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for collaborative R01 projects from multi-disciplinary teams to expand, improve, or transform the utility of mouse cancer and tumor models for translational research.  For a linked set of collaborative R01s, each site has its own Program Director(s)/Principal Investigator(s), and the program provides a mechanism for cross-site coordination and communication.  Collaborative studies are appropriate to address research questions beyond the capacity of a single-site investigation, particularly to accommodate collaborations among sites with diverse expertise, perspectives, and contributions.

The NCI supports many hypothesis-driven, mechanistic R01 projects that employ mice, or develop and use mouse cancer models or human-in-mouse tumor models for oncology research.  However, the NCI has not previously supported projects devoted to ensuring that mice and mouse models used for translational research questions are used appropriately and that the models provide reliable information for patient benefit.  Teams of applicants could propose demonstrations of how to overcome limitations of oncology mouse and human-in-mouse models, define new uses of models or mouse genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally.

Key Dates
Posted Date

May 30, 2014

Open Date (Earliest Submission Date)

July 3, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

August 3, 2014 then Standard dates apply, 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)

Not Applicable

Scientific Merit Review

October-November, 2014 then Standard dates apply

Advisory Council Review

January 2015 then Standard dates apply

Earliest Start Date

April 1, 2015 then Standard dates apply.

Expiration Date

May 8, 2017

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 this Funding Opportunity Announcement (FOA) is to invite applications for collaborative R01 projects from multi-disciplinary teams to expand, improve, or transform the utility of mouse cancer and tumor models for translational research.  For a linked set of collaborative R01s, each site has its own Program Director(s)/Principal Investigator(s), and the program provides a mechanism for cross-site coordination and communication.  Collaborative studies are appropriate to address research questions beyond the capacity of a single-site investigation, particularly to accommodate collaborations among sites with diverse expertise, perspectives, and contributions.

The NCI supports many hypothesis-driven, mechanistic R01 projects that employ mice, or develop and use mouse cancer models or human-in-mouse tumor models for oncology research.  However, the NCI has not previously supported projects devoted to ensuring that mice and mouse models used for translational research questions are used appropriately and that the models provide reliable information for patient benefit.  Teams of applicants could propose demonstrations of how to overcome limitations of oncology mouse and human-in-mouse models, define new uses of models or mouse genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally.

Background

Mouse and human-in-mouse models are integral components of basic cancer research.  Spurring this activity are rapidly evolving technology platforms to genotype, phenotype, and image animals; exquisitely sensitive methods to detect analytes of many kinds in small volumes of body fluids or specimens; large stores of human patient data for cross-species comparison; and a suite of bioinformatics tools that enable multi-scale integration of mouse model data with human data.  As a result, mouse models are increasingly applied translationally for interventions (therapy and prevention), genetics, and molecular signatures.  For each of these areas, there is need to address a variety of practical issues related to appropriate model use.  A few examples are defining which mouse models (cell line transplants, patient tumor-grafts (PDXs), genetically engineered mouse models (GEMMs), or standard transgenic or carcinogen-induced models) are appropriate for particular applications; designing and testing updated validation or credentialing criteria for newly generated mouse models; delineating and refining best practices for particular translational uses of mouse models; ascertaining the biological relevance of currently available mouse models to specific malignancies; testing novel approaches that enable mouse models to be suitable for previously unexplored translational opportunities; or, developing informatics tools and resources to empower integrated mouse model/human translational research.  Despite the significant level of NCI investment in using mice, in deriving mouse and human-in-mouse models, and in applying the models, there is no explicit funding opportunity to support projects that address the many practical issues that pertain to robust translational applications of mouse models.

Specific Research Objectives

The four major goals for this FOA are as follows. 

The first goal is for cross-disciplinary applicant teams to address the technical and experimental parameters that ensure effective translational use of mouse models.  Numerous publications illustrate that data from mouse and human-in-mouse models can inform the conduct and clarify the outcomes of clinical trials, and present new prospects for treating patients with resistant or recurrent disease.  Candidate biomarkers from mice can be informative for patients screening, and the genetics of mice can inform the genetics of human risk and response or resistance to therapy or preventive interventions.  The effectiveness of models depends in part on acquiring high-quality, robust experimental data.  Additionally, integral use of different kinds of models is crucial, the choices of which models to use are governed by the translational questions, and using more than one modeling approach is advisable to have confidence in the data that are applied to human research.  New efforts are required to demonstrate how the positive attributes of models can be built upon and integrated into oncology practice. 

The second goal is for applicants with differing expertise to identify and propose the means to address unmet translational requirements.  For example, novel tactics are clearly required to for metastasis models that support interventions testing, a pressing clinical need.  Another important question is what does testing combinations of several small-molecule drugs, or small molecule drugs and immune modulators in mouse models actually predict for individual, or populations of, patients.  Regularized procedures for performing effective pre-clinical testing of radiation with other modalities are needed.  Another important translational question is what are appropriate models and pre-clinical or co-clinical protocols to test alternative schedules, such as variations of chronotherapy or metronomic delivery.  The toxicities associated with cancer therapy, and relapse and recurrence are considerable clinical problems; effective strategies for co- and post-clinical use of mouse models are required to identify and test biomarkers of these confounding problems as they emerge.  Many mouse population genetics approaches that have translational value for questions that pertain to human risk assessment are under-utilized in oncology.  Cross-species discovery of the genetic and environmental bases of cancer susceptibility and resistance, progression of early cancer lesions to invasive tumors, propensity to metastasize, and response or resistance to therapy are a few testable approaches.

The third goal is for applicants to extend the range of cross-disciplinary insights and approaches that address translational oncology modeling needs, such as those cited above, and many others.  The NCI anticipates that applicant teams who respond to this FOA will have expertise in several oncology disciplines; these include basic, translational, clinical, prevention, epidemiology, or population research; generation and use of mouse cancer and tumor models and models of other, cancer-related diseases; small animal imaging science; computational science; informatics; multi-scale data analysis; and mouse genetics.  Where appropriate, applicant teams may incorporate basic, translational, clinical, and epidemiological expertise in normal biology or in cancer-related diseases.          

The fourth goal is for awardees to be active participants in the Oncology Models Forum (PAR-14-239).  If possible, applicants should propose to incorporate use of the Forum's NCIP Hub platform to facilitate collaborations that require sharing large amounts of data or images or developing informatics tools for cross-species comparisons, or facilitate distant collaborations.  Applicants who propose to use this platform will be expected to work collaboratively with the awardees of the Oncology Models Forum and the NCI to ensure that they take full advantage of the capabilities of the NCIP Hub resource.  Not all projects that are in response to this FOA will benefit from use of the NCIP Hub platform. Awardees of this FOA are required to attend the annual meetings of the Oncology Models Forum and participate in Forum workshops and webinars.       

Projects that are suitable for this FOA include but are not limited to the following: 

  • Test cross-species validation strategies for various mouse models, e.g, for specific organ systems;
  • Utilize experimental mouse genetics strategies to test novel ways to functionalize discoveries from cancer GWAS and population studies;
  • Use the Oncology Models Forum platform to develop and deploy standard practices and procedures for translational applications of specific organ system models;
  • Derive widely applicable tool strains for oncology modeling;
  • Develop modeling approaches to fill gaps for interventions testing, e.g., novel metastasis models that reflect human organ tropism;
  • Create radiology imaging mouse strains and use them to assess aspects of interventions testing, such as tracking response, or development of resistance, or onset of toxicities, or defining surrogates for efficacy;
  • Derive new unbiased tool strains for early detection or measuring activity of specific pathways or processes;
  • Nucleate interdisciplinary groups around common technical or scientific challenges which require new tool strains or mouse models or novel uses of models;
  • Optimize experimental approaches for applying models to test combinations of small molecule or biologic therapies or alternative delivery schedules;
  • Use the Oncology Models Forum platform to develop and deploy new analytical approaches that integrate mouse models data with patient data as clinical decision-making tools.
  • Evolve in the Oncology Models Forum platform the effective links to international cancer or other human disease mouse modeling efforts;
  • Develop the bioinformatics tools that enable integration of mouse and human data to support clinical decisions.          

Projects that are not appropriate for this FOA include: 

  • Applications requesting support for hypothesis-driven mechanistic cancer research that involves mouse models;
  • Applications that lack cross-disciplinary cooperation and collaboration.  

This FOA versus Alternative Opportunities and Additional Resources

There is another related FOA that is suitable for research projects whose goals are similar to the goals of this FOA but differ in scope.    

PAR-14-241, "Research Projects to Enhance Applicability of Mouse Models for Translational Research (R01)"    

In addition, the NCI supports the Informatics Technology for Cancer Research Initiative (ITCR), whose central mission is to promote research-driven informatics technology development.  There are many facets of comparative oncology research that require new informatics tools and resources; these FOAs are additional opportunities for support.  The FOAs cover various projects, and support technology development at different stages.  Investigators are allowed to submit multiple applications in response to these FOAs because they are scientifically distinct from one another.

PAR-13-294, "Advanced Development of Informatics Technology (U24)"

PAR-12-286, "Revisions for Early-Stage Development of Informatics Technology (R01)";

PAR-12-289, "Revisions for Early-Stage Development of Informatics Technology (U01)";

PAR-12-290, "Revisions for Early-Stage Development of Informatics Technology (P01)"; and,

PAR-12-288, "Early-Stage Development of Informatics Technology (U01)"

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
Resubmission (but only of applications originally submitted under this FOA)

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 are limited to $450,000 direct costs per year.

Award Project Period

Applicants may request support for up to 3 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
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA requires the use of the linked NIH Collaborative Research Project Grant (R01) award mechanism.  Multiple PDs/PIs are allowed on any single application and the policy for doing so is included in this FOA.  Because the collaborative R01 mechanism already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply.  PD(s)/PI(s) from each linked application should NOT be designated as multiple PDs/PIs on each application of a collaborative set.

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.

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.
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.

Page Limitations

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

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. The following additional

Instructions apply.

Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative R01s, the titles for each R01 in the set must have the following format:  a “1/N” indicator + Identical Title (e.g., “1/3”, where the 1/3 means this is site 1 of 3 sites in the set.  The other sites will be labeled 2/3, etc.)  Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.

Cover Letter Attachment: The Cover Letter is one pdf file only.  The following collaborative information is required in the Cover Letter:  a listing of all the applications that are a part of the set of collaborative R01s being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., “1/3”), and 3) the Applicant Institution.  Each site should submit an identical listing.

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. 

Modular or R&R Budget

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

Applicants are required to budget for travel for the PI(s)/PD(s) to the annual meetings of the Oncology Models Forum.

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:

The application from each site must contain a Research Strategy that clearly describes those aspects of the project that are common to all sites of the collaboration. All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site." In this subsection, PDs/PIs should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, (etc).

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. 

Foreign Institutions

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

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.

Post Submission Materials

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.

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 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?  

Investigator(s)   

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

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?   

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 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?   

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

Not Applicable

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

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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.

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.

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)

Cheryl L. Marks, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6217

Email: marksc@mail.nih.gov

Peer Review Contact(s)

Syed Quadri, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1211
Email: q3u@drgpo.drg.nih.gov

Financial/Grants Management Contact(s)

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: Hines@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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