Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this Funding Opportunity Announcement (FOA) is to invite Cooperative Agreement (U24) applications that propose to establish and maintain an "Oncology Models Forum". Despite the growing adoption of pre-clinical mouse and human-in-mouse models for translational cancer research, NCI-supported investigators have no comprehensive resource for information to guide generating, validating, and credentialing new models, informing their practical uses, advancing modeling technologies, or providing catalogs of available models resources, programs, and services. The Forum to be supported under this FOA will be expected to fill this gap. The Forum focus is anticipated to be on effective, reliable use of mice, mouse models, and human-in-mouse models in translational cancer research, and other mouse modeling needs that the scientific community identifies.

To address these goals, the Forum will be based on an online infrastructure using an existing platform, NCIP Hub. This platform can support, for example, real-time collaborations using shared mouse model and human molecular and genomic datasets and appropriate tools for cross-species analyses, and radiology image files and pathology whole slide images and software for image analysis and annotation, as well as developing and deploying educational materials and videos. The NCI will assist the Forum awardees to leverage and enhance the community-building, research collaboration, and education capabilities of NCIP Hub.

The increasing use of experimental mouse and other animal models figures prominently in the conduct of basic and translational cancer research. As a result of NCI support, there is an extensive repertoire of available models, including cell lines, cell-line xenografts, patient-derived tumor xenografts (PDXs), and genetically engineered mouse models (GEMMs), and a wide range of validated translational applications. There are also increasing numbers of information resources about mouse models, their relevance to human biology and disease, how they are applied for translational research, and good operating practices for their appropriate use. With the exception of the NCI-Mouse Models of Human Cancers Consortium, NCI efforts in these areas have been largely independent of an organizing focus. Over 15 years, the Consortium refined the techniques of mouse germ-line alterations to suit cancer-specific requirements, and then formulated the tactics to substantiate the relevance of a model’s biology to human disease and to credential the model’s clinical course with the appropriate standard-of-care therapy.

The Consortium also served the important role of coordinating and disseminating information on the generation, validation, and application of GEMMs. The NCI-Mouse Models of Human Cancers Consortium ends in 2014. Given the current state of the field, NCI support for a centralized program for generation of mouse cancer models is not essential. However, there is a growing need for a comprehensive resource that would facilitate continued evolution of the field and improve various facets of mouse model generation and translational use.

As a successor to the NCI-Mouse Models of Human Cancers Consortium, the Oncology Models Forum could create many opportunities to build on prior successes by promoting the generation or discovery of mouse models that meet emerging requirements, the evolution of validation and credentialing standards for new models, pioneering approaches to modeling, and clarity for how experimental mouse models can be used efficiently and effectively for translational research purposes. The Forum could also pursue collaboration or partnering opportunities with other programs supported by the NCI, the NIH, the private sector, and internationally that would enhance the effective impact of mouse modeling science on oncology.

The three major goals for the Oncology Models Forum are as follows.

The first goal is to develop, deploy, and regularly refresh the knowledge base about mouse models. Included in the information may be the range of validated animal oncology models and their appropriate translational purposes, the available resources and tactics for animal modeling and for model validation and credentialing, and good operating practices and standards for appropriate, reproducible, and judicious translational use of oncology mouse and human-in-mouse models.

The second goal is to initiate, facilitate, and organize interactions among experts and other involved investigators at various levels. This goal covers such activities as organizing an annual meeting, several in-person focus groups annually, and Internet-enabled roundtables. These activities may, for example, portray the state-of-the-science for oncology mouse models, capture evolving needs for models and modeling, assess emerging opportunities for their broad importance to the oncology community, and identify other model or modeling resources on which the translational research community may be able to capitalize.

The third goal is to tailor the software platform capability of NCIP Hub as needed to sustain community-wide and cross-institutional research collaborations that require large-scale human and mouse data, or radiology and pathology images, or bioinformatics, data analysis tools, and databases that fuel cross-species comparisons and analyses.

The following are a few examples of potential objectives to consider for the proposed Oncology Models Forum that could benefit translational, clinical, and epidemiological cancer research.

Promote, facilitate, and support collaborations among modelers, model users, and informaticians to evolve the information standards and tools to support effective incorporation of mouse model data into clinical decision-making;

• Host an easy-to-query, extensive information resource to assist in appropriate choices of mouse models;
• Capture viewpoints of all cancer research and clinical community sectors to expand the NCI-MMHCC initiated project on good operating practices and procedures for translational use of mouse models;
• Foster oncology community debate about standards for methods and publications to document outcomes of pre-clinical and co-clinical investigations that employ mouse models;
• Collect, or link to collections of, annotated mouse model and relevant human specimen whole slide images (WSI) from various sites and annotation tools that enable users to compare their images with others without down-loading very large WSI images;
• Facilitate cross-community development of suitable standards for use of candidate biomarkers from mouse models by imaging scientists to develop in vivo biomarkers or novel imaging techniques;
• Promote interactions among oncologists, cancer researchers, and immunologists to explore emerging opportunities in immuno-oncology;
• Serve as a "nucleating" site for focus groups that pertain to organ-site specific modeling needs, particular research topics, gaps in mouse model types, modeling technology development, and other areas of interest to the oncology community;
• Forge links to international cancer or other human disease mouse modeling efforts.

Not appropriate for this FOA are projects that include:

• Hypothesis-driven mechanistic cancer research that involves mouse models;
• Development of a bioinformatics platform to support the Forum (other than enhancements to NCIP Hub).

This FOA versus Alternative Opportunities and Additional Resources

The Oncology Models Forum is not intended to provide funds for the many acknowledged and emerging needs of the translational community for mouse modeling and models. As listed below, there are two related FOAs that are suitable for research projects that relate to the mission of the Oncology Models Forum or use the NCIP Hub resource and whose outcomes will enrich and extend the Forum resources.

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

PAR-14-240, "Collaborative Research Projects to Enhance Applicability of Mouse Models for Translational Research (Collaborative R01)"

In addition, the NCI supports the Informatics Technology for Cancer Research (ITCR) Initiative, whose central mission is to promote research-driven informatics technology development. There are many facets of comparative oncology research that require new informatics tools; 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)"

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 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.

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.

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 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:

Cheryl L. Marks, PhD
Division of Cancer Biology
National Cancer Institute
9609 Medical Center Drive, Room 6W438
Bethesda, MD 20892-9747 (for regular mail)
Rockville, MD 20850 (for express delivery)
Telephone: 240-276-6217
Email: marksc@mail.nih.gov

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

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.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

Other Attachments: Applicants may provide additional materials supportive of their application.

In particular, applicants must include here any documentation (other than letters of support) of the oncology community's interest in the needs that the Forum applicants propose to fill. This documentation may include, for example, a survey of the greater cancer research community, published opinions/recommendations of investigators in the field, or some other means of assessing translational mouse models requirements.

Note that the filename provided for each attachment will be used for the bookmark in the application image. For the attachment containing documentation of community needs, use filename "Needs".

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

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional instructions apply.

Applicants should budget for the full costs of organizing, convening, traveling and housing speakers, and covering other expenses of the annual meeting (to be held in the NCI Shady Grove conference center), two Forum workshops (to be held at a site chosen by the awardees), and webinars. Applicants should also budget funds for travel for the PI(s)/PD(s) and two additional senior team members to the annual Forum meeting and the two Forum workshops.

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

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

Research Strategy: Research Strategy must consist of the following subsections A-E described below.

A. Building Research Communities.

B. Oncology Community Needs

C Development of Knowledge Base

D. Plans for Annual Meetings

E. Plans for Workshops and Webinars

Subsection A. Building Research Communities. Briefly outline skills and prior experience in promoting interactions among members of related and unrelated research communities, and providing leadership in team building and other community collaboration or outreach activities that might be useful for bringing to fruition a research resource based on community needs.

Subsection B. Oncology Community Needs. Summarize the needs of the oncology community that the proposed Oncology Model Forum intends to fill. Note that these needs must be supported by appropriate documentation (see SF424(R&R) Other Project Information above).

Applicants must also describe how, during the project period of the Forum, they will assess emerging opportunities to improve mouse models for, or extend the range of, translational applications.

Subsection C Development of Knowledge Base. Describe plans to develop, deploy, and regularly refresh the knowledge base about animal models. The possible elements of this resource may include information about the range of validated animal oncology models and their appropriate translational purposes, the available resources and tactics for animal modeling and for model validation and credentialing, and good operating practices and standards for appropriate, reproducible, and judicious translational use of oncology mouse and human-in-mouse models.

The Oncology Models Forum applicants are encouraged to propose enrichments to the NCIP Hub resource as an open forum for oncology mouse modeling, and as a nexus for informing the cancer research community about emerging translational models' needs.

Subsection D. Plans for Annual Meetings. Describe your overall vision and any specific plans for the annual meetings of the Oncology Models Forum. The annual meetings are intended to present a cross-section of advances in translational mouse modeling and models' applications. In addition to Oncology Models Forum awardees, the annual meetings will be attended by investigators supported by the companion R01 FOAs. Provide sufficient opportunities for investigators to debate controversial issues, additional requirements for translational mouse models, and set respective priorities. At the annual meetings, the Forum awardees are expected to present progress of their implementation of the Forum site to meet the oncology community needs that they documented in the application and new emerging needs that they document by a continuing process.

Subsection E. Plans for Workshops and Webinars. Describe your vision and plans for several special workshops annually and webinars to discuss emerging topics and issues in oncology mouse modeling that require community engagement and input. These workshops may convene animal models experts and appropriate experts from other sectors of the cancer research community to depict the state-of-the-art in some aspect of animal modeling, introduce new opportunities for improvements to existing models and modeling methods, explore unmet needs for models, or advance novel translational uses of mouse models.

Note: NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. Applicants are encouraged to consult the Portal and address the use of NIH-supported CDEs in their plans for Oncology Model Forum.

Letters of Support: In addition to standard items, provide letters from investigators that document their interests/needs in specific aspects that you are planning to incorporate in the Oncology Model Forum. These letters could be from collaborators, potential users of the resource, or other individuals with interest and needs related to translational mouse models. The letters should provide details on the nature of the proposed interactions or collaborations, and/or describe how the new resource that you propose could benefit their research.

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.

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

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

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.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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: Are the community needs to be addressed by the Forum properly documented and adequate? How will successful completion of the aims influence the scope or quality of applications of mouse models by the translational research community?

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?

Specific to this FOA: How strong are the investigators' background and leadership experience in managing research teams and/or facilitating the building of community-based resources?

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?

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

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 research.

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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 National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U24 award. Specific responsibilities include:
• The PD(s)/PI(s) will implement procedures to solicit input and feedback from the user community and integrate those ideas into the Forum program plan;
• The PD(s)/PI(s) will be actively engaged in outreach activities targeting the user community, the cancer research community in particular;
• The PD(s)/PI(s) will participate in all Forum program activities, including its annual meetings and workshops;
• The PD(s)/PI(s) will seek opportunities of collaboration with other NCI and NIH networks, consortia, and research resources as conduits to the expertise of the continuum of research activities in oncology;
• The PD(s)/PI(s) will oversee and cooperate with the NCI staff members on the planning and preparation of the annual meetings of the Oncology Model Forum.
• The PD(s)/PI(s) will be expected to work closely with the substantially involved NCI Program staff members.

Awardees will collaborate with NCI Program staff member on planning, arranging, and convening annual meetings of the Oncology Models Forum.

The awardees will establish a continuous process to reassess the originally identified investigators needs and any relevant emerging community needs and adjust the Forum site accordingly.

Awardees will be expected to report during the annual Forum Meetings on the progress in the implementation of the originally identified investigators needs and new emerging needs into Forum site.

Awardees will be expected to assist expeditiously investigators who would like to use the Oncology Models Forum site within the NCIP Hub platform. It is expected that the investigators who will request access (and will need to be accommodated) will include, at a minimum, all the awardees of the companion R01 FOAs.

Awardees (in coordination with NCI staff members) will be expected to respond to requests from other NCI or relevant NIH consortia or networks for focus group space in the Forum's NCIP Hub resource and accommodate these requests if possible.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NCI Program staff members, acting as Project Scientists, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Specifically, the NCI Project Scientists will:

• Coordinate and facilitate interactions and collaborations among the components of the Forum program;
• Serve as the liaison between individual projects and other components of the Forum program, including any advisory committee(s) that the NCI may appoint;
• Coordinate with the awardees the requests from other NCI or relevant NIH consortia or networks for focus group space in the Forum's NCIP Hub resource;
• Provide technical assistance and advice to the awardees as appropriate;
• Assist in avoiding unwarranted duplication of effort with other NCI, NIH, and international oncology models projects;
• Ensure that the awardees of this FOA provide reasonable and expeditious access to the NCIP Hub platform to awardees of FOAs that are related to this FOA as well as NCI and relevant NIH consortia and networks;
• Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met. Specifically, the NCI Project Scientist may recommend withholding of support, suspension, or termination of a Cooperative Agreement award for lack of adherence to required policies and/or procedures;
• Participate in organizing annual meetings, special workshops, and webinars of the Forum;
• Develop working groups and trans-project efforts as needed.

NCI staff members who are substantially involved in the program activities will not attend peer review meetings of renewal and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI Program staff member acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. The Program Official may also have substantial programmatic involvement (as a Project Scientist) and may be the same person as Project Scientist. In that case, the individual involved will not attend peer review meetings, or will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Areas of Joint Responsibility include:

Given that the NCI staff members will assist the awardees in various areas, frequent and regular interactions are anticipated between NCI Project Scientist(s) and the PD(s)/PI(s) of the Oncology model Forum. For example, the awardees and the NCI staff members will collaborate on planning, preparing, and convening the annual Forum meeting. They will also work jointly on other forms of facilitating access to Forum and interactions among interested investigators, including fostering inter-project collaborations.

The NCI Project Scientist and the PD/PI of the Oncology Models Forum will jointly represent the program and participate in appropriate initiative-wide activities.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
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: 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Cheryl L. Marks, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6217
Email: marksc@mail.nih.gov

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
E-mail: ncirefof@dea.nci.nih.gov

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

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.