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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

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

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

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

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

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

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Keren Witkin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6250
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Core (Use for Shared Resource Cores)	6
Project (Use for Research Projects)	12

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Research Projects: required; 3 minimum; 4 maximum.
• Administrative Core: required; maximum of 1.
• Shared Resource Core(s): optional; maximum of 3.

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Specific Aims should be the overall vision and goals for the FusOnC2 Center. These Aims should be overarching and at a high level and distinct from the aims of the individual components.

Research Strategy: The Center Overview should present a concise overall vision and plan for the proposed FusOnC2 Center. Applications should clearly identify the specific fusion oncoprotein (or related family of fusion oncoproteins) being targeted and should describe the applicant’s proposed comprehensive, multi-disciplinary approach. Applications should demonstrate that a Center mechanism is essential to accomplishing the proposed studies. Additional items to be addressed include:

• Center Organization. The Overall component should include a concise description of the structure of the Center including the organizing framework. This description should explain: (1) how the components of the Center, including key personnel, will interact to form a multidisciplinary team; (2) why each component is essential for addressing the organizing framework of the Center; (3) how the individual projects together create a FusOnC2 Center that spans the continuum from basic biological mechanisms of fusion oncoproteins to targeted therapeutic development: and 4) how the organization of the components into a Center will create an entity that is greater than the sum of its parts in terms of generating advances in understanding fusion oncoproteins in childhood cancers and using this knowledge for therapeutic development.
• Center Integration. Applications should explicitly discuss the integration of work proposed in the application. While the Research Projects make up the foundation of the FusOnC2 Centers, applicants are encouraged to describe cross-cutting elements in this Overall component. Applications should demonstrate that use of the research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities, and research resources that a research Center can uniquely provide.
• Center Expertise. The Overall component should demonstrate that the Center will include the necessary expertise and support the team science environment needs to complete the proposed multidisciplinary work, and should confirm that ongoing communication and sharing of data and resources will occur within the Center.
• Research Projects. Briefly describe each project, including its scientific integration with the proposed organizing framework and a rationale for how each project will help, within the funded period, generate sufficient results to drive the development of new knowledge on fusion-driven pediatric cancers and novel therapeutic strategies based on the proposed organizing framework.
• Shared Resource Cores. Briefly describe any Shared Resource Cores, including the projects supported by the Core.
• Health Disparities. The BRP recommendations outline a set of opportunities that, if implemented, will transform our understanding of cancer and result in new opportunities to more effectively prevent and treat the disease, which can reduce the burden of cancer in all Americans and the health disparities that currently exist. Racial/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates. If applicable to the type of research project being proposed, the Research Strategy must address how health disparity populations or data will be integrated into the proposed studies.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Addressing the Cancer Moonshot Public Access and Data Sharing Policy: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer MoonshotSM Initiative that requires applicants to submit a Public Access and Data Sharing Plan that (1) describes their proposed process for making resulting Publications and, to the extent possible, the Underlying Primary Data immediately and broadly available to the public upon publication; (2) if applicable, provides a justification to NCI if such sharing is not possible. NCI will give competitive preference and funding priority to applications that comply with the strategy described here. The data sharing plan will become a term and condition of award.

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.

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

The Administrative Core Leader is strongly encouraged to propose and budget for a Center Administrator to manage day-to-day operations.

The budget should include funds to support travel for Center and FusOnC2 Consortium activities, including but not limited to supporting the participation of PD(s)/PI(s) in an initial FusOnC2 Consortium Kick-off meeting and supporting the participation of the PD(s)/PI(s) and other Center members in an Annual Investigators' Meeting. FusOnC2 Centers are encouraged to include early career scientists in the Consortium activities and should include budget to travel at least one graduate student or postdoctoral fellow to the Annual Investigators Meeting.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Succinctly describe the strategies and goals for managing the FusOnC2 Center and connecting the Center to the broader collaborative research consortium.

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support the multidisciplinary research teams, foster synergy and integration of the Center, and support planning and evaluation activities. The Administrative Core will support and coordinate project administration within the individual Center and coordinate participation in the FusOnC2 Consortium s Steering Committee (SC).

Applications must describe the administrative structure to support the proposed FusOnC2 Center, including but not limited, to:

Management and Communication Plan. The application should describe the plans for management and integration of Center activities and communication and evaluation of progress across the Center. The plan should describe the leadership and communication strategies to manage and track progress of the multiple projects and sites that make up the Center. The plan should include a description of the Center leadership structure and should concisely describe oversight mechanisms that will be used by the Center PD(s)/PI(s). The plan should describe any provisions for the mentoring and development of new investigators. If internal/external advisory groups are proposed, list the membership or areas of expertise for each group and describe their roles.

Annual Meeting and Other Consortium Activities. Provide a brief description of strategies for connecting and integrating the Center with the FusOnC2 Consortium. Funded Centers are expected to participate in an Annual Investigators meetings to present results and to communicate with other FusOnC2 Consortium investigators. The Center PD(s)/PI(s) are expected to attend the Annual Meeting and participating faculty, postdoctoral associates, graduate students, and other Center members are all encouraged to attend. The Center PD/PI (contact PD/PI for applications with multiple PDs/PIs) is expected to participate in the Program’s Steering Committee. The FusOnC2 Centers are also encouraged to organize and participate in other FusOnC2 Consortium meetings and workshops, organize collaborative activities, promote Trans-Consortium collaborations, and organize and participate in scientific and programmatic working groups.

Outreach plan. Applicants should provide a plan that describes how outreach will be conducted to promote the training and career development of researchers in the Center at all career stages, educate the biomedical community on fusion-driven childhood cancers, and disseminate advances and capabilities of the FusOnC2 Center to the broader cancer research community. The proposed activities should relate to and integrate with the organizing framework of the Center. Potential activities include, but are not limited to, conferences, workshops, seminar series, training events, personnel exchanges, and development of a Center website.

Center and Program Evaluation. The Administrative Core should coordinate participation in Center program evaluation activities, including progress reports, site visits, and providing additional communication and materials to the NCI as needed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource Sharing Plan.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Administrative Core)

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

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Projects)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Projects)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Projects)

Specific Aims: This section should include the specific aims of the Research Project and provide a rationale and description of how it fits into organizing framework of the FusOnC2 Center.

Research Strategy: This section should describe the overall strategy for the Research Project and provide a concise discussion of how the Project is integrated within the FusOnc2 Center.

Describe the research strategy using the standard sub-sections of Research Strategy (Significance, Innovation, and Approach) defined in the SF424 Application Guide with additional guidance as defined below.

Project Timeline: A timeline (Gantt chart) including milestones is required. Milestones are intermediate steps towards the completion of concrete goals, that create go/no-go decision points in the project and must include clear and quantitative criteria for success. Yearly quantitative milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. Milestones and the timeline must be provided in a separate heading at the end of the Approach section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource Sharing Plan.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

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

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Shared Resource Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Shared Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resource Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Shared Resource Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Shared Resource Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Shared Resource Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Shared Resource Core)

Specific Aims: This section should include the specific aims of the Shared Resource Core and describe which projects will be supported by the Core.

Research Strategy: The optional Shared Resource Core may be physical or virtual infrastructures providing a resource that supports other FusOnC2 Center components in their activities. Each Shared Resource Core is expected to support two or more Research Projects and the services and resources provided to other Center components should be clearly defined. Issues to be addressed include, but are not limited to: value of the Core services to the Center and Research Projects, integration between the Core and Projects, quality control, procedures for prioritizing Projects to use the Core and allocating resources, cost effectiveness, and increased efficiency. Training in complex techniques and methods should be described if they are functions of the proposed Core. These shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource Sharing Plan.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Shared Resource Core)

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

It is anticipated that the terms of award will include, but not be limited to, the following:

In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the National Cancer Institute (NCI) will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act. In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.

Investigators will be expected to coordinate with and leverage technology from related NCI-sponsored informatics initiatives, in collaboration with NCI program staff. These initiatives include: 1) The NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research; 2) The NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications Involving the NIH Intramural Research Program

For FusOnC2 Center applications that include NIH intramural research subprojects, the intramural resource level will be included in the total cost of the overall application. The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses (refer to NIH Grants Policy Statement, Section 17.6 for allowable and unallowable costs). Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as research collaborators or consultants in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The involvement of Intramural scientists needs to be consistent with NIH Policy, https://oir.nih.gov/sourcebook/ethical-conduct.

The participation of an intramural scientist is independent of and unrelated to the role of the Project Scientist as described in the Terms and Conditions of Award.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, please note the following:

Reviewers will provide an overall impact score for the entire FusOnC2 Center (Overall Component) and for each individual Research Project. In addition, assigned reviewers will provide individual "criterion scores" for the Overall criteria and for the Research Projects criteria, but not for the other components.

The Administrative Core and optional Shared Resource Cores will be evaluated, but each will receive only one overall adjectival (not numerical) rating.

For the evaluation of the FusOnC2 Center application, the Research Projects will be emphasized as the scientific base of each Center, with additional components enhancing and integrating the overall research program.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the FusOnC2 Center 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 FusOnC2 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the FusOnC2 Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the Center? If the aims of the FusOnC2 Center 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 for this FOA: Are the organizational framework, vision, and scientific focus of the proposed FusOnC2 Center designed to enable a unique understanding of fusion oncoproteins in childhood cancers and make progress towards targeted therapeutics? Are the FusOnC2 Center components and the investigator team well integrated to collectively support the overarching goal of the Center and the vision of the FusOnC2 Consortium Program?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the FusOnC2 Center? If Early Stage Investigators or those 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 Center 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 for this FOA: Are the backgrounds, expertise, and commitments of the PD(s)/PI(s) and other key persons sufficient for the proposed scope of activities and in line with the overall goals of the FusOnC2 Consortium? How well do the proposed collaborations between the FusOnC2 Center PD(s)/PI(s) and other key persons integrate to achieve the overarching research goals? Is the proposed research team sufficiently multi-disciplinary to achieve a comprehensive approach that spans from basic biological mechanisms to therapeutic development?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific for this FOA: Does the proposed FusOnC2 Center explore innovative biological concepts to improve understanding of the mechanisms by which fusion oncoproteins drive pediatric cancers and to identify and develop novel therapeutic strategies for pediatric cancers driven by fusion oncoproteins?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the FusOnC2 Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the FusOnC2 Center 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?

Specific for this FOA: How well does the proposed FusOnC2 Center take advantage of multidisciplinary approaches for a comprehensive study that includes both biological mechanisms of oncogenesis driven by fusion oncoproteins and development of novel therapeutic strategies? Are effective mechanisms in place to foster strong collaborative interactions and promote cross-fertilization among investigators and participating institutions? Are mechanisms for facilitating sharing of samples and resources well planned or in place as appropriate and consistent with achieving the goals of this program? Does the application contain acceptable plans for addressing the Cancer Moonshot Public Access and Data Sharing Policy?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific for this FOA: Will the scientific environment at the participating institutions stimulate trans-disciplinary research collaborations? Do multi-institutional teams take advantage of the distinctive strengths available through multi-institutional collaborations, where appropriate?

As applicable for the FusOnC2 Center 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.

Integration

Will the proposed FusOnC2 Center be a truly integrated entity, rather than a collection of unrelated research projects and support services? How well does the FusOnC2 Center organization promote scientific and administrative integration, synergy and a cohesive research program? Do the applicants state their willingness to collaborate and share data, models, software, and other resources within the FusOnC2 Center and across the Consortium? Is there evidence of ongoing productive interactions among participating investigators/institutions?

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed FusOnC2 Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not applicable.

Not applicable.

Not applicable.

As applicable for the FusOnC2 Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not applicable.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

In addition to the above criteria, the following components of the FusOnC2 Center application will be evaluated and will be considered in the determination of the overall impact score for the whole application.

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

Significance

Does the proposed research project address an important problem related to the mechanism of action of fusion oncoproteins in childhood cancers and/or apply mechanistic knowledge to development of targeted therapeutics? Is there a strong scientific premise for the project? If the aims and milestones of the project are achieved, how will scientific knowledge be advanced?

Investigators

Are the investigators appropriately trained and well suited to carry out this work? Is the project proposed appropriate to the experience and expertise of the project leader and other researchers and team members?

Innovation

Does the proposed project employ novel concepts, novel multi-disciplinary approaches, and/or novel methods to solve the problem stated in the study? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies, theories, and/or technologies?

Approach

Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Does the applicant acknowledge potential problem areas and consider alternatives, as appropriate?

Environment

Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments benefit from unique features of the scientific environment or employ useful collaborative arrangements?

Reviewers will provide only one overall adjectival impact score for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:

Significance

Does the proposed Administrative Core address the needs of the FusOnC2 Center that it will coordinate and serve? Is the scope of activities proposed for the Administrative Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the FusOnC2 Center?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Administrative Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the FusOnC2 Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research program of the FusOnC2 Center? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program of the FusOnC2 Center? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Center, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy for the Administrative Core adequately establish feasibility and manage the risks associated with the activities of the Center? Are a appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Environment

Will the institutional environment in which the Administrative Core will operate contribute to the probability of success in facilitating the research of the FusOnC2 Center it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Administrative Core proposed? Will the Administrative Core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Organizational Framework and Integration

Will the Administrative Core be able to effectively coordinate the efforts of the participating institutions in the FusOnC2 Center, as well as coordinate with the entire FusOnC2 Consortium?

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will provide only one overall adjectival impact score for each optional Shared Resources Core (criterion scoring is not used for this component).

Reviewers will consider the following aspects while determining scientific and technical merit of this component:

How well matched is the proposed Shared Resource Core to the needs of the overall FusOnC2 Center? Are the services of the Shared Resource Core critical to the goals of more than one Research Project? Are the qualifications, experience, and effort commitment of the Shared Resources Core Director(s) and other key personnel adequate and appropriate for providing the proposed facilities or services? Will the proposed Shared Resource Core provide cost effective services to the FusOnC2 Center, prevent duplication, and/or increase efficiency?

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

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 Part 75, 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:

• Planning and conducting the operations defined by the terms and conditions of the cooperative agreement award. This includes determining research approaches, designing protocols, setting project milestones in consultation with NCI staff, and ensuring scientific rigor.
• Conducting the scientific research in the project, reporting progress and milestones or objectives to NCI staff, and reporting results to the scientific community.
• Assuming responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research and administrative functions supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
• Participating in a cooperative, interactive, and collaborative manner with NCI staff, other FusOnC2 Consortium investigators, and one another to maximize impact of the FusOnC2 Consortium and meet Program goals and objectives. This includes becoming a member of the FusOnC2 Consortium Steering Committee (SC), as described below.
• Maintaining the confidentiality of the information developed or handled by the FusOnC2 Consortium, including, without limitation, unpublished data, protocols, data analysis, confidential exchanges between members of the FusOnC2 Consortium, as well as any confidential information received by third party collaborators.
• Facilitating the public release and dissemination of results, data, reagents, models, technologies and other products generated through this award broadly and in a timely manner. The PD/PI is expected to share data and resources generated through this award in accordance with the approved plan for making quality-assured data and materials available to the scientific community and the NIH as written in the final version of the grant application, and consistent with sharing policies and recommendations developed and approved by the SC, NIH sharing policies, the Cancer Moonshot Public Access and Data Sharing Policy, and the goals of the FOA.
• Ensuring that any industry collaborations are governed by an appropriate research collaboration agreement with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH policies and procedures and any policies and procedures developed by the SC.
• Operating in accordance with processes and goals as delineated in the Funding Opportunity Announcement, and in accordance with processes, goals, and policies established by the FusOnC2 SC.
• Attending an initial face-to-face Kickoff Meeting of the FusOnC2 Consortium PDs/PIs, followed by at least one FusOnC2 Consortium investigator meeting annually.
• Adherence to a Consortium Communication Plan: A consensus Communication Plan will be drafted by the SC during the Kickoff Meeting of the FusOnC2 Consortium. This plan will clearly spell out interactive requirements that all FusOnC2 Consortium investigators are expected to follow, including:
• Participation in regular conference calls with fellow FusOnC2 Consortium colleagues through contribution to various sub-committees and working groups.
• Participation and presentation of findings at the FusOnC2 Consortium Annual Investigator Meeting.
• Coordination of efforts with other members of the FusOnC2 Consortium.
• Jointly publishing FusOnC2 Consortium collaboration in a timely manner.
• In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the National Cancer Institute (NCI) will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act. In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.
• If the project involves human subjects and/or NIH-defined clinical research, then the institution must comply with OHRP and FDA regulations concerning protection of human subjects.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• The NCI will designate program staff, including a Program Officer and a Grants Management Specialist to provide stewardship and administrative oversight of the cooperative agreement. The Program Officer and Grants Management Specialist will be named in the Notice of Grant Award.
• An NCI Project Scientist, separate from the Program Officer, will be substantially involved in the management of the awards above and beyond the normal stewardship of an NIH Program Official. Among other activities, the NCI Project Scientist will serve as a resource for the research teams in making them aware of other ongoing NCI activities that may be relevant to the study, including drug development capabilities available through NCI to which the teams may have access. The Project Scientist will also manage the use of any opportunity pool of funds through NCI that may be available for collaborations either within the Consortium or for researchers external to the Consortium to collaborate with Consortium members.
• The NCI Project Scientist and Program Officer will review the scientific progress of FusOnC2 projects, and review all projects for compliance with sharing and operating policies developed by the FusOnC2 Consortium SC and the NCI. Based on this review, the Project Scientist in conjunction with the Program Officer may recommend to the NCI to continue funding, or to withhold or restrict support for the grantee for lack of progress or failure to adhere to FusOnC2 Consortium or NIH policies. Review of progress may include regular communications between the PD/PI and NCI staff, site visits, or fiscal review. The NCI also retains the option of organizing periodic external review of progress of the work supported by the FusOnC2 award.
• The NIH reserves the right to terminate any FusOnC2 award in the event of (1) A substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application, (2) A failure to meet the FusOnC2 Consortium policies and procedures, (3) Substantive changes in the management of the FusOnC2 award that are not in keeping with the objectives of the FOA and/or (4) failure to make substantial progress towards milestones keeping in mind the agreed upon go/no-go decisions.

Areas of Joint Responsibility include:

The FusOnC2 Consortium Steering Committee (SC)

• Close interaction among the participating investigators will be required, as well as significant involvement from the NCI, to develop Consortium policies and meet Program goals. The SC will be the principal governing body of the FusOnC2 Consortium. The awardee agrees to the role and authority of the FusOnC2 Consortium SC that is responsible for governance of FusOnC2 Consortium activities.
• PD(s)/PI(s) of each FusOnC2 Center and the NCI Project Scientists for each grant will serve on the SC. The SC will be tasked with establishing guidelines and agreements with regard to Consortium-specific scientific, strategic and administrative issues. Other designated NIH program staff, FusOnC2 Center staff, or external experts approved by NCI staff may attend the SC meetings on a regular or ad-hoc basis.
• The FusOnC2 Consortium SC will be constituted at the FusOnC2 Consortium Kickoff Meeting, and will meet regularly (monthly or quarterly), including at least once in-person during the annual FusOnC2 Consortium Investigators Meeting. Operating procedures for the SC will be established at the Consortium Kickoff Meeting.
• The first meeting of the FusOnC2 Consortium SC will be chaired by an NCI representative. Following that initial meeting, a Chairperson for the FusOnC2 Consortium SC will be chosen by the SC, with NCI approval. The Chairperson is responsible for coordinating the FusOnC2 Consortium activities, preparing meeting agendas, and chairing FusOnC2 Consortium SC meetings. At the end of one year of service, with NCI concurrence, the SC may ask the Chairperson to serve a second one-year term, or choose a replacement for that role. NCI staff may also choose to replace the FusOnC2 Consortium SC Chair at any time based on poor job performance or failure to follow the relevant procedures and guidelines.
• All major scientific and policy decisions will be determined by voting policies as established by the FusOnC2 Consortium SC. Specific activities of the FusOnC2 Consortium SC will include, but are not limited to:
• Developing collaborative protocols;
• Identifying impediments to success and developing strategies to overcome them;
• Developing shared tools for disseminating information about the FusOnC2 Consortium;
• Discussing important issues relevant to fusion oncoproteins in pediatric cancer.
• Helping with the planning of major events, such as the Annual Investigators Meeting;
• Identifying opportunities for sharing techniques, materials, information and tools developed within each individual FusOnC2 Center;
• Facilitating communication and fostering collaboration across the FusOnC2 Consortium;
• Reviewing progress of the FusOnC2 Consortium towards meeting the overall Consortium goals;
• Developing publication policies to facilitate collaborations and co-publications by Consortium members;
• Ensuring that the FusOnC2 Consortium leverages existing NCI resources and programs;
• Making recommendations on the possible use of any opportunity pool of funds that may be available for collaborations either within the Consortium, or between Consortium members and other members of the scientific community;
• Evaluating collaborative activities and providing feedback to the NCI Program Staff.
• Discussing implementation of recommendations or suggestions from the NCI and any external consultants and planning a timely implementation strategy.
• Subcommittees and/or working groups of the FusOnC2 Consortium SC may be constituted following recommendation and approval by the FusOnC2 Consortium SC to help with scientific planning activities, development of FusOnC2 Consortium policies, etc.
• NCI Project Scientists involved with the management of the FusOnC2 Consortium will help the SC develop and draft sharing and operating policies that are in accordance with NIH guidelines.
• PD/PIs of the FusOnC2 Centers will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the FusOnC2 Consortium SC.

FusOnC2 Consortium External Scientific Consultants (ESCs)

• 2-4 independent external experts will be appointed by NCI as External Scientific Consultants (ESCs). The ESCs will meet at least once a year in conjunction with a meeting of the FusOnC2 Consortium. The ESCs may also meet by phone or web at others times of the year, as needed. The ESCs will provide input and advice to NCI on adjustments and future directions for the FusOnC2 Consortium activities. Annually, the ESCs will provide assessments to the NCI of the progress of the FusOnC2 Consortium and will present recommendations regarding any changes in the Program as necessary. This could include reviewing and evaluating the progress of the entire FusOnC2 Consortium or individual awardees as well as recommending changes in priorities for the Program based on scientific advances within and outside of the Consortium. The ESCs will be senior, scientific experts who are not directly involved in the activities of the FusOnC2 Consortium. NCI staff may attend executive meetings with the ESCs. All members of the ESC will be given the opportunity to listen to SC meetings and to attend the annual FusOnC2 Consortium Investigator meetings.

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 members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Keren Witkin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6250
Email: [email protected]

Malcolm Smith, M.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6087
Email: [email protected]

Charles Morrow, M.D., Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9850
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.