Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NATIONAL CANCER INSTITUTE (NCI)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title
Cancer Advancement through Partnerships in Research and Infrastructure (CAPRI) (U54 Clinical Trial Optional)
Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type
Reissue of PAR-22-249
Related Notices
  • Check for any recent Notices of NIH Policy Changes that may impact application requirements.
  • January 23, 2026 - NIH Pause on New Submissions to the NIH Human Embryonic Stem Cell Registry and Request for Information on Reducing Reliance on Human Embryonic Stem Cells in NIH-Supported Research. See Notice, NOT-OD-26-031.
Funding Opportunity Number (FON)
PAR-28-062
Companion Notice of Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.399
Notice of Funding Opportunity Purpose

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that invites applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered for funding. This funding opportunity seeks to support the Cancer Advancement through Partnerships in Research and Infrastructure (CAPRI). The CAPRI Program establishes and strengthens comprehensive, mutually beneficial and meaningful partnerships between Resource Limited Institutions (RLIs) and NCI-designated Cancer Centers (CCs) to accelerate collaborative and innovative cancer. The Program achieves this by strategically building institutional capacity, advancing research capabilities, enhancing the impact of innovative cancer research, cultivating the next generation of Early-Stage Investigators and trainees, and implementing coordinated outreach and education initiatives that extend the benefits of research to all populations nationwide.

Funding Opportunity Goal(s)

To reduce cancer risk, incidence, morbidity, and mortality and enhance quality of life in cancer survivors through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results through dissemination and diffusion strategies. 

Key Dates

Posted Date
August 31, 2026
Open Date (Earliest Submission Date)
December 25, 2026
The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
January 25, 2027 * January 25, 2027 * Not Applicable July 2027 October 2027 December 2027

All applications are due by 5:00 PM local time of applicant organization. 

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

Expiration Date
January 26, 2027
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The NCI conducts and supports research, training, health information dissemination, and other programs concerning cancer. This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that invites applications from eligible organizations to apply (please see Section III. Eligibility for additional information). In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered for funding. This funding opportunity seeks to support the Cancer Advancement through Partnerships in Research and Infrastructure (CAPRI) Program. The purpose of the CAPRI Program is to establish and strengthen comprehensive and mutually beneficial partnerships between Resource Limited Institutions (RLIs) and NCI-designated Cancer Centers (CCs) to accelerate collaborative and innovative cancer. Through strategic capacity building, CAPRI supports the development and expansion of sustainable research programs at partnering institutions, enhances the quality and competitiveness of cancer research programs, and promotes the integration of complementary expertise and resources across institutions. Joint research projects conducted primarily at RLIs may span any area of cancer research and are intended to strengthen institutional research capacity and scientific productivity. The program further advances the career development of Early-Stage Investigators (ESIs) and trainees to cultivate a robust cancer research workforce and supports coordinated outreach and education activities that align with and reinforce the partnership's research objectives. Collectively, these efforts are designed to generate impactful cancer research discoveries and extend their benefits nationwide.

Through its emphasis on scientific excellence, collaborative research, and community-focused engagement, this funding opportunity advances workforce development, and national efforts to reduce the burden of cancer and improve health outcomes. In doing so, CAPRI aligns with broader Administration priorities, including the Make America Healthy Again (MAHA) initiative, by strengthening the nation's research enterprise and accelerating progress toward improved health and well-being for all populations across the United States.

The institutions in each partnership are expected to work collaboratively to:

  • Strengthening cancer research capacity at Resource Limited Institutions (RLIs) by developing cancer research, enhancing institutional research infrastructure and competitiveness, and promoting the career development of ESIs and trainees.
  • Developing and implementing coordinated cancer-related outreach and education initiatives that are integrated with the partnership's research priorities and extending the benefits of scientific advances to communities nationwide.

To underscore their commitment to the partnership, linked applications from each partnering institution are required.

Background

A disproportionate burden of cancer exists among many population groups and geographic regions. Therefore, expanding our cancer knowledge across populations is critical to control this devastating disease. There is a critical need to expand biomedical research capacity and opportunities at RLIs, particularly in regions with low NIH participation. Strengthening RLIs is key to broadening the national cancer research enterprise, fostering innovation, and building sustainable, competitive research programs. Through structured collaboration with CCs, the CAPRI Program accelerates the development of research infrastructure and scientific capacity at RLIs, expands access to specialized expertise and shared resources, and positions these institutions to compete for external funding and lead impactful cancer research initiatives.

CCs are distinguished by rigorous programs across basic, clinical, translational, and population sciences, along with strong leadership and workforce development. Partnerships with RLIs extend the reach of their research, and enhance engagement with broader communities. These collaborations create mutual benefits: RLIs build research capacity and develop investigators, while CCs expand the reach and impact of their research. Together, they serve as a national model for advancing innovation and addressing complex cancer challenges.

For this funding announcement, to qualify as an RLI, institutions must:

  • Have received less than $50 million on average in annual NIH RPG funds within the three years before the time of application, and 
  • Award degrees in biomedical, health professions/health-related sciences, including social and behavioral sciences. 

CAPRI as a Partnership Program

The CAPRI Program builds capacity through collaborative partnerships that leverage the strengths of RLIs and CCs. Joint research, shared resources, and coordinated training strengthen research environments and expand cancer programs at RLIs. These collaborations provide access to advanced technologies, expertise, mentorship, and training for ESIs, supporting sustainable programs and improving competitiveness for external funding. Overall, CAPRI enhances scientific capacity, advances cancer research, and supports long-term workforce growth. The CAPRI Program supports ESIs and trainees through mentorship, research training, and professional development within the partnerships. Participation in collaborative research provides experience in multidisciplinary settings and builds skills in study design, data analysis, communication, and grant writing. These structured opportunities prepare investigators to compete for external funding and strengthen the national cancer research workforce.

CAPRI supports innovative research projects that leverage the complementary strengths of RLIs and CCs to build capacity and productivity. Joint research projects conducted primarily at RLIs may span all areas of cancer research.Partnerships are encouraged to address the needs of their catchment populations across the lifespan and may include basic, clinical, translational, prevention, behavioral, and population research, as well as emerging technologies, precision medicine, clinical trials, and outreach efforts, all of which align with NCI's priorities.  Hypothesis-driven outreach research projects are also appropriate, including those aimed at increasing high-quality, clinically annotated biospecimens from populations representative of the partnering institutions' catchment area.  The goal is to generate preliminary data to support competitive R01-level applications and strengthen research capacity at RLIs.

CAPRI is designed to promote improved health outcomes for all Americans while advancing research focused on populations that experience a disproportionate burden of cancer. These efforts will also strengthen research capacity and support evidence-based approaches to improve cancer outcomes nationwide.

Research support: This partnership program provides support for cancer research infrastructure and not to exceed three years support for research projects.

Research Team: The PD(s)/PI(s) are expected to be mid-to-senior-level scientists with records of obtaining grant support and serving as role models and mentors.  A less experienced investigator can be one of multiple PDs/PIs if there is an appropriate institutional investment in this investigator and a demonstrable collaboration (active or planned) with a more experienced PD/PI.

Community outreach and engagement are integral to CAPRI and its key function involves supporting the partnership's research efforts. Partnerships will implement coordinated outreach and education initiatives to strengthen community connections, raise awareness of cancer prevention and care, and support participation in research. These efforts help translate scientific discoveries into practical strategies while ensuring research remains responsive to community needs.

Each partnership program is expected to include:

1. Administrative Core: will provide day-to-day administrative support for the partnership, ensuring bidirectional and integral collaborations across institutions.

2. Full and Pilot Research Projects: each new or competing renewal application should propose at least one Full Research Project and one Pilot Research Project.

3. Planning and Evaluation Core: provides continuous process, outcomes, and impact planning and evaluation of partnership activities. 

4. Outreach and Engagement Core: provides support and is aligned with the partnership's cancer research and includes bidirectional activities to develop and share targeted educational materials with surrounding communities.

5. Shared Resources: applicants may propose the development of resources/infrastructure that augments the cancer research capability of the RLIs, the collaborative research of both partnering institutions, and/or enhance cancer research.

It is expected that all activities should be planned to:

  • Increase the participation of the RLIs in the nation's cancer research and research education enterprise.
  • Increase the competitive research capacity of RLIs.
  • Increase competitive grant applications from scientists supported by the partnership.
  • Increase the involvement and effectiveness of CCs in cancer research.
  • Develop effective and meaningful outreach, engagement, and education initiatives that will impact the surrounding communities.
  • Identify and share innovative methods and approaches that strengthen and sustain each partnership.

Through integrated efforts in collaborative research, capacity building, workforce development, and community engagement, the CAPRI Program aims to strengthen partnerships between RLIs and CCs and advance the national cancer research enterprise. 

Internal Evaluation

Each partnership must have an Internal Advisory Committee (IAC). The IAC is shared across the partnering institutions and will have an equal numerical composition of qualified faculty members from the partnering institutions (See Section VI Terms and Conditions of Award). The IAC is responsible for the internal evaluation of the partnership's activities. 

  • Evaluation of additional pilot and full projects, and programs. Beyond the specific projects in the application, recipients will be required to develop additional pilot and/or full research projects to provide continuity of research activities. When a project co-leader (investigator from the RLI or CC participating as PD(s)/PI(s) of a joint pilot/full project) is an ESI, it is recommended to include an Individual Development Plan. 
  • The IAC will prioritize these additional projects and will recommend either: (1) funding as requested; (2) funding as a pre-pilot project for 1-year; or (3) not funding due to low scientific merit, low relevance to partnership goals and objectives, low potential to generate publishable data, and/or low potential to give rise to a competitive grant application. Proposed programs will be recommended for funding or not. 

IAC will evaluate ongoing and proposed pilots, full projects, and project concepts under development.  This evaluation may occur once a year or as needed.  The following scenarios are possible: (1) convert pre-pilot to pilot, (2) pilot to a full project, or (3) terminate funding of pilot and/or full project.  

  • The IAC will continuously evaluate the Administrative, and Outreach and Engagement Cores. The IAC will make recommendations and guidance to develop workshops, retreats, focus groups, and other forums to identify areas of new opportunity and strengthen, stabilize, and merge existing projects or programs.
  •  The IAC will also evaluate and recommend other key partnership activities, and establish resources and infrastructure based on their merit and potential to effectively achieve high-priority goals and objectives.
  • The IAC will forward evaluations and recommendations for projects, cores, and other activities to the PSC for concurrence. If the IAC recommendations change the scope of the partnership objectives, those recommendations must be reviewed and approved by the PSC and NCI. The minutes of the IAC meetings must be available to the PSC and be part of the required report one month before the PSC meeting.

External Evaluation, Scientific Feedback, and Guidance

The Program Steering Committee (PSC) is an external committee of investigators from non-partnering institutions (See Section VI. Terms and Conditions of Award), provides annual evaluation, scientific feedback, and guidance. It reviews progress, assesses ongoing and proposed projects, and collaborates with NCI on final decisions. The PSC meets annually, ideally in person, to conduct a comprehensive evaluation.

Assessing Program Outcomes

The success of the CAPRI Program will be assessed based on metrics directly linked to the partnership's objectives. Moreover, each partnership should develop logic models for the overall partnership and each core. Metrics will include, but not limited to, increased infrastructure support at the RLIs and faculty conducting cancer research. Metrics at the CCs will include, but not be limited to, increased cancer research.In addition, an increased number of cancer-related education and awareness outreach and engagement activities to surrounding communities, and the development of community partnerships. The Program may promote the participation of individuals from all populations in cancer clinical trials and bio-specimen donation by developing and implementing innovative methodologies. Partnerships are encouraged to leverage CRCHD's community outreach toolkits and the U54 Outreach Evaluation Toolkit developed by the U54 Evaluation Task Force Evaluators. Each partnership should also identify metrics tailored to their specific goals.  

Non-Responsive Applications

Applicants are encouraged to contact the NOFO scientific/research contact before submission to discuss whether their application is responsive.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
New
Renewal
Resubmission

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

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

Award Budget

Application budgets are limited to $1.3 million in direct costs per year for partnerships of two institutions and $1.8 million in direct costs per year for partnerships of three institutions.

Award Project Period

The maximum period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions - Includes all types

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

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)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Faith-based or Community-based Organizations
  • Regional Organizations

Each partnership must include both types of institutions: 1) RLIs, and 2) NCI-designated Cancer Center (CC). Partnerships involving more than two institutions require NCI approval before applying.

RLIs with medical schools or with more focused education and research programs (e.g., Master's and PhD programs), as well as those that offer only Baccalaureate degrees and Tribal Colleges, may all participate in this initiative. 

 For this funding announcement, to qualify as an RLI, institutions must:

  • Have received less than $50 million on average in annual NIH funds within the three years before the time of application, and
  • Award degrees in biomedical and health professions/health-related sciences, including social and behavioral sciences.  

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM) – 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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. 

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. 

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 How to Apply - Application Guide.

This NOFO supports linked applications. Multiple PDs/PIs are allowed on any single application.

Specific to this NOFO:

  • The PD(s)/PI(s) are preferred to be mid-to-senior-level scientists with records of obtaining grant support and will serve as role models and mentors to the partnership participants. However, a less-experienced investigator can be one of multiple PDs/PIs if there is an appropriate institutional investment in this investigator and a demonstrable collaboration with an experienced PD/PI.
  • To underscore their commitment to the partnership, contact PDs/PIs should also be reciprocally listed as PD(s)/PI(s) on the linked application from the partnering institution.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Please note that specifically for this NOFO, the NCI will support only one U54 partnership for each institution.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 12 Required 1 1
Admin Core Admin Core 6 Required 1 1
Full Research Project Project 12 Required 1 1
Pilot Research Project Pilot Project 6 Required 1 1
Planning and Evaluation Core 1 - Plan Eval 6 Required 1 1
Outreach and Engagement Core 3 - Outreach 6 Required 1 1
Opportunity-Specific Shared Resource Core 6 Optional 0 NA

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type 'Overall'.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Follow standard instructions.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Provide overall goals/abstract/summary for the entire partnership application.

Project Narrative: In the "Project Narrative," state the relevance of the research to the partnership objectives and, in lay language, the relevance of the partnership's research to public health.

Facilities and Other Resources:

Describe resources available for the partnership. This description should  include the allocation of space and facilities, provisions for capital improvements, etc., for new projects/programs of the partnership.

Institutional Investment in the Success of Less-Experienced Investigators: For each Early-Stage Investigator (ESI) or other less-experienced investigators involved as PDs/PIs or leads/co-leads on the application components, describe institutional investment in the success of the investigator. Specifically, the elements covered by the "Institutional Investments" should be well-matched to the individual investigator's research objectives and the ability to compete for independent peer review funding.

Given these general objectives for "Institutional Investments," document the following aspects:

  • How will the institutional environment facilitate the investigator's research efforts with key faculty members and other investigators capable of productive collaboration with the candidate?
  • Assurances that the investigator will be provided with the protected time required to develop the research project and the investigator's career as an independent scientist.
  • Appropriate office and laboratory space, equipment, and other resources and facilities for the investigator to conduct the proposed research activities.
  • Availability and characteristics of senior colleagues, who are proposed to support the investigator and/or other staff, whose support may be helpful for the investigator's research and career goals.  It is expected that the person designated for the support role will be named a co-leader on the research project. If more than one faculty is proposed for support, the respective areas of expertise and responsibility should be described.

Other Attachments: The following "Other Attachments" must be included with the overall component to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

Performance Assessment: Renewal applications must include the assessment of their U54 partnerships by their respective Program Steering Committees (PSCs).

RLI Statement: Any institution applying as an RLI must include a statement signed by an institution's official certifying it is eligible as an RLI in the application.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: State the objectives of the collaboration. Outline the overall goals relevant to providing support for investigators at both the RLI and CC to conduct cancer research and other related activities. Specific Aims must be identical for both collaborative applications.   

Research Strategy: The application from each site must contain a research strategy that describes the aspects of the project that are common to all sites in the collaboration. All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site." 

Outline the following aspects:

  • The general rationale and the mutual benefits that the partner institutions expect to derive from the partnership. 
  • The immediate priorities of the partnership.
  • Overall goal and specific objectives in cancer research, and cancer outreach programs that the partnership will achieve during the award period.
  • A projected timeline for achieving each objective; and
  • Other areas of opportunity that the partnership will consider as the relationship between the partnering institutions evolves. 
  • Scientific and Administrative Leadership;
  • Overview of research activities; and
  • Integration of research activities with other components.

Note (and address accordingly) the following expectations for the partnership research and other activities:

  • Research projects, in general, may be in any area of basic, clinical, translational, prevention, control, behavioral, and/or population research. These projects are encouraged to include (as appropriate) translational research, emerging fields and technologies, precision medicine, and/or therapeutic clinical trials accrual. Research may focus on cancers affecting pediatric, adolescent, young adult, or aged populations. Hypothesis-driven outreach research projects are also appropriate, including those aimed at increasing high-quality, clinically annotated biospecimens from surrounding populations.
  • Joint research projects conducted primarily at RLI may be in any area of cancer research. 

  • Educational activities and outreach activities are also encouraged.

In outlining the plans for all these activities, explain how these collective efforts will be aimed at securing competitively funded extramural research awards. Specify your target expectations (e.g., R01, P50 awards, or projects on P01 or their equivalents). Small grants are also desirable, as a step in the career advancement of ESI.

Progress Report (for Renewal Applications only): Summarize the accomplishments and progress during the current funding period for specific partnership components (Administrative Core; Research Projects/Programs; Outreach Core; Shared Resources; and Evaluation Activities) in the context of the goals described in the original U54 application. For example, applicants may present a chronological history of their partnerships, discuss barriers faced, and indicate how these obstacles were resolved. Mention significant administrative changes that took place, name faculty members supported by the U54 award, and list grants (including the funding organization and type of award), the number of students or postdocs participating in research projects, where the participants are, etc., resulting from the U54 award. Discuss how recommendations of the PSC, IAC, and leadership have influenced the partnership activities. It is strongly recommended that a table be included summarizing all grants and publications resulting from the funded pilot, full projects, and programs.  

Planning Activities (for new applications only): Provide documentation that this partnership was derived from careful planning and priority-setting processes based on each partnering institution's strengths/weaknesses. Describe the outcomes of the planning process relevant to the proposed partnership in response to this NOFO.

In chronological order, present each process used in planning and setting the priorities and objectives for this application. Briefly describe the nature of each planning activity, its purpose, the individuals who participated from both institutions, and its outcome.

Progress Report Publication List (for Renewal Applications): Include only the publications and accepted manuscripts from projects conducted during the current funding period. Mark each listed publication that results from the different projects within the partnership.   

Letters of Support: Each application must include Letters of Support from the respective leadership of each institution (e.g., President, Cancer Center Director, Dean) to show support for the partnership and commitment to additional resources necessary to ensure that these partnerships will have the maximum sustainability. Specifically, institutional leaders are expected to provide detailed statements of the long-term commitment and list the specific resources, space, investigators' protected time, etc. Identify the number of investigators dedicated to cancer research under the partnership. 

Letters of Support should include the following specific items:

  • A statement detailing the effort and commitment of the designated PD(s)/PI(s).
  • A statement of the activities that each faculty member listed as Key Personnel is being released from (e.g., teaching, clinical, administrative duties);
  • A statement detailing provisions to leverage funds for the long-term sustenance of the U54-supported activities. 

When the PD/PI from the RLI or CC does not have experience as a PD/PI on a peer-reviewed grant, there must be a Letter of Support from a senior member (e.g., Department Chair, Dean, Cancer Center Director) of the RLI or CC indicating his/her qualifications and the willingness to guide and mentor the inexperienced PD/PI and support her/his research and academic development.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

  • A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type 'Admin Core.'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Title: Descriptive Title of Applicant's Project (use "Administrative Core")
  • Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Administrative Core)

Follow standard instructions.

Research & Related Other Project Information (Administrative 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) (Administrative 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 attachments for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

  • In the PD/PI 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 who are working on 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.
  • The contact PD/PI must be designated as the Administrative Core lead, and other PDs/PIs as co-leads.

Budget (Administrative Core)

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

Administrative costs (new applications may have higher administrative costs in the early stage of development and lower in the late stages) for managing the planning effort, such as salaries for Administrative Core key personnel, travel for key personnel (e.g., costs related to attendance at an annual CAPRIworkshop), equipment, and supplies to support an administrative structure.

Effort Commitments: Individuals designated as PD(s)/PI(s) are expected to be committed to the partnership for effective leadership. U54 CAPRIapplications are multiple PI-based, according to the requirements that the PD/PI from the RLI must be listed as PD/PI on the CC U54 application and vice versa, with "in-kind" effort. Specifically, a minimum of 1.2 person-months (with a maximum of 3 person-months) effort per year is expected for the contact PD/PI from the RLI and Cancer Center. In each institution, for all the other PD(s)/PI(s) combined, the total effort per year is limited to 6 months for the RLI and 4.8 months for the CC.

Budget Justification: Justify all the costs associated with this core. Administrative Core will provide funding for managing the partnership, such as: salaries for key personnel, equipment, and supplies to support an administrative structure.

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 (Administrative Core) 

Introduction to Application: F or Resubmission applications only. 

Specific Aims: Succinctly describe the specific objectives and goals of the Administrative Core. 

Research Strategy: The Administrative Core must have the appropriate organizational structure to support the partnership's cancer research, research education, and community outreach and engagement efforts. To achieve this, there must be effective planning, communication, and continuous evaluation of partnership activities.

The applications must describe the administrative structure of the partnership to concisely address the following:

  • Leadership and Team: Briefly describe the leadership structure. Explain how the designated PD(s)/PI(s) were chosen. For each PD/PI, applicants must specify and document that the expected commitment can be met and that current duties, will be adjusted or eliminated to allow the faculty members to spend adequate time on the partnership activities.
  • Administrative Management: Describe specific core functions to provide the necessary day-to-day administrative support, coordination, and logistical services to make this partnership function effectively. This role might include organizing communication across the partnership, meetings, workshops, and retreats; documenting the results of activities, etc.
  • External and Internal Advisory Activities: The PSC (external activities) and IAC (internal activities). Briefly describe the roles of the PSC and IAC (see Planning and Evaluation Core). 

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 of the application.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

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 Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials, follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed Onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

 Full Research Project

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 (Full Research Project)

Complete only the following fields:

  • Applicant Information
  • Descriptive Title of Applicant's Project (use "Project 1")
  • Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Full Research Project)

Follow standard instructions.

Research & Related Other Project Information (Full Research Project)

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 Summary/Abstract: Provide an abstract/summary of the proposed Research Project

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) (Full Research Project)

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 attachments for additional entries.

Research & Related Senior/Key Person Profile (Full Research Project)

  • 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.
  • For projects with multiple leads, in the Project Director/Project Investigator section of the form, use Project Role of 'Other (Specify)' and designate the role under 'Other Project Role Category' as 'Project Co-Lead' and provide a valid eRA Commons ID in the Credential.
  • In the additional Senior/Key Profiles section, list Senior/Key persons 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 (Full Research Project)

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. A Full Research Project cannot exceed $275,000 in direct costs per year or continue for over 3 years.

PHS 398 Research Plan (Full Research Project)

Introduction to Application:  For Resubmission applications only. 

Specific Aims: Outline the rationale and specific aims of the Research Project and explain how it fits the goals of the partnership.

Research Strategy: A Full Research Project may be proposed for research in any area of cancer-related basic, clinical, translational, prevention, control, behavioral, population, and/or outreach research. Full Research Projects are expected to be well-developed and supported by sufficient preliminary data.

Joint research projects conducted primarily at RLIs may be in any area of cancer research.

Address these requirements, organizing the Research Strategy in the following subsections:

  • Significance
  • Innovation
  • Preliminary data, and
  • Approach

Projects Involving Outreach and Engagement Research. Hypothesis-driven projects in outreach and engagement research are encouraged. The projects may lead to identifying, developing, testing, evaluating, and/or refining strategies to disseminate and implement evidence-based practices (e.g., behavioral interventions; prevention, early detection, and diagnosis) into public health, clinical practice, and community settings.

The proposed provisions should not duplicate review and monitoring systems already in place at the institution. For any cancer treatment protocol supported directly or indirectly by the U54, early stopping rules and procedures to detect and monitor adverse drug reactions must be provided in the application or, in the case of protocols after funding a U54, to the NCI Program Director.

Letters of Support: Include letters of support as appropriate. 

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component of the application. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

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

PHS Human Subjects and Clinical Trials Information (Full Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials, follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Pilot Research Project

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

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

SF424 (R&R) Cover (Pilot Research Project)

Complete only the following fields:

  • Applicant Information
  • Descriptive Title of Applicant's Project (Starting with "Pilot Project 1") 
  • Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Pilot Research Project)

Follow standard instructions.

Research & Related Other Project Information (Pilot Research Project)

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 Summary/Abstract: Provide an abstract/summary of the proposed research project, including how it fits the goals of the partnership. This text may be different for each of the linked applications.

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) (Pilot Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites before using additional attachments for additional entries.

Research & Related Senior/Key Person Profile (Pilot Research Project)

  • 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 who are working on the component.
  • For projects with multiple leads, in the Project Director/Principal Investigator section of the form, use Project Role of 'Other (Specify)' and designate the role under 'Other Project Role Category' as 'Project Co-Lead' and provide a valid eRA Commons ID in the Credential field.
  • 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 (Pilot Research Project)

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

Budgets for Pilot Research Projects cannot exceed $120,000 per project in direct costs per year for up to 3 years.

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 (Pilot Research Project)

Introduction to Application:  For Resubmission applications only.

Specific Aims: Outline the Specific Aims of the proposed Research Project and explain how these aims contribute to the overall goals of the U54 partnership.

Research Strategy: A Pilot Research Project may be proposed for research in any cancer-related basic, clinical, translational, prevention, control, behavioral, population, and/or outreach and engagement research. Note that preliminary data are not required, but Pilot Research Projects are expected to be well-based on information available from various sources.

Joint research projects conducted primarily at RLIs may be in any area of cancer research.

Address these requirements, organizing the Research Strategy in the following subsections:

  • Significance
  • Innovation
  • Preliminary data, if any, and
  • Approach

Projects Involving Outreach Research. Hypothesis-driven projects are encouraged. The projects may lead to identifying, developing, testing, evaluating and/or refining strategies to disseminate and implement evidence-based practices into public health, clinical practice, and community settings.

The proposed provisions should not duplicate review and monitoring systems already in place at the institution. For any cancer treatment protocol supported directly or indirectly by the U54, early stopping rules and procedures to detect and monitor adverse drug reactions must be provided in the application, or in the case of protocols after funding a U54, to the NCI Program Director.

Letters of Support: Include letters of support as appropriate. 

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component of the application. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

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 Human Subjects and Clinical Trials Information (Pilot Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials, follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Planning and Evaluation Core

When preparing your application in ASSIST, use Component Type 'Core 1 – Plan and Eval Core'

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

SF424 (R&R) Cover (Planning and Evaluation Core)

Complete only the following fields:

  • Applicant Information
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Planning and Evaluation Core)

Follow standard instructions.

Research & Related Other Project Information (Planning and Evaluation 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) (Planning and Evaluation 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 attachments for additional entries.

Research & Related Senior/Key Person Profile (Planning and Evaluation Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons who are working on the component.
  • Biographical Sketch: Include only one 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 (Planning and Evaluation 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.

The budget for this section may include such as:

  • Internal activities include IAC meetings, workshops, retreats, seminars, and consultants, as well as external activities such as the annual PSC meetings.
  • Consultant costs and travel costs; and
  • Cost items include inviting experts to make presentations that relate to the partnership's objectives, serving as ad hoc advisors in areas under development, or being external reviewers for research projects.

PHS 398 Research Plan (Planning and Evaluation Core)

Introduction to Application:  For Resubmission applications only.  

Specific Aims: Applicants must incorporate appropriate strategies to ensure that planning, monitoring, evaluating, and tracking partnership activities will be continuously ongoing. The development and use of a logic model is strongly suggested. The documented outcomes of those processes will constitute the basis for initiating or terminating the investment of resources. Applications must also describe the process for follow-up on the supported projects and evaluating the strategy for soliciting, evaluating, funding, and assessing new research projects. Awardees must develop one additional pilot and one full research project to provide continuity of research activities.

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

  • Internal Activities: List the names of the IAC members and outline each internal planning and evaluation activity in which the objectives are identified, activities are described, and participating individuals from the institutions are named. Outline how the progress of the partnership will be reported to institutional leaders.
  • Solicitation and Evaluation of Additional Research Projects: Outline the strategy for soliciting, evaluating, funding, and assessing additional research projects (beyond the specific projects described in the application). Describe the review and evaluation process for initiating and closing research projects and programs based on their merit and potential for achieving the partnership's objectives and their actual progress. This process must also be used to determine which resources and infrastructure needs of the partnership will be established and implemented. Partnerships can use ad hoc reviewers to assess new projects when appropriate. These ad hoc reviewers must be from outside the partnering institutions and can be compensated at the rate NIH compensates reviewers participating in study sections.
  • External Activities: Outline steps to ensure that the PSC provides unbiased, rigorous, and expert evaluation of progress. PSC is also expected to recommend improvements based on the objectives and priorities of the implementation plan of the partnership and provide insights and advice for taking advantage of new objectives and initiatives as they emerge during the grant period. The PSC members must not belong to the partnering institutions.  The current PSC membership may be reconstituted when a competing renewal application is being prepared for submission to the NCI. In such cases, the applicants should describe the desired expertise types and include the proposed members' names and biosketches in the applications.

Letters of Support: Attach letters of support relevant to the Planning and Evaluation Core.

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component of the application. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Planning and Evaluation Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Outreach and Engagement Core

When preparing your application in ASSIST, use Component Type 'Core 3 -Outreach '

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

SF424 (R&R) Cover (Outreach and Engagement Core)

Complete only the following fields:

  • Applicant Information
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Outreach and Engagement Core)

Follow standard instructions.

Research & Related Other Project Information (Outreach and Engagement 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 Summary/Abstract: Describe the overall goals of the Core. 

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) (Outreach and Engagement 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 attachments for additional entries.

Research & Related Senior/Key Person Profile (Outreach and Engagement 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 who are working in the component.
  • In cases where a Community Health Educator (CHE) is engaged, he/she must have experience in community engagement, communication, cancer control, program planning, and evaluation. Include only one 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 (Outreach and Engagement Core)

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

Partnership applicants that will employ CHEs should describe specific roles in the outreach research and outreach and engagement activities related to the overall goals of the U54 partnership application. CHEs can be hired full-time or on an "as-needed" basis consistent with the proposed outreach research projects and activities; the budget must be justified.

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 (Outreach and Engagement Core)

Introduction to Application:  For Resubmission applications only. 

Specific Aims: Summarize specific goals, outreach, and engagement activities to be accomplished.

Research Strategy: Cancer outreach and engagement in the context of this NOFO is a joint effort between partnering institutions and must include efforts to effectively engage individuals, communities, physicians, etc., to enhance bidirectional communication that should lead to, for example, increased use of specific medical procedures that may decrease cancer. These activities may also lead to identifying, developing, testing, evaluating, and/or refining strategies to disseminate and implement evidence-based practices into public health, clinical practice, and community settings. In addition, outreach efforts directed at recruiting and retaining individuals from surrounding populations into prevention, early detection, and therapeutic clinical trials, as well as participation in biospecimens donation research, are strongly encouraged. The proposed outreach and engagement efforts are strongly encouraged to be connected to cancer-relevant research conducted by the partnership.

Partnership activities targeted at surrounding communities may include (but are not limited to):

  • Utilizing church networks to reach and educate communities about the prevention, early detection, and treatment of cancer.
  • Working with community organizations to develop programs encouraging lifestyle changes important for cancer prevention, early detection, and diagnosis.
  • Developing continuing education programs for community health care providers to facilitate state-of-the-art care and advice to their patients.
  • Training communities to use electronic information systems to help them make informed decisions about their health. 

Note: Hypothesis-driven outreach research projects are encouraged and allowed for this NOFO; they must be described under Full or Pilot Research Project components, as appropriate, NOT in this Outreach and Engagement Core component.

If a CHE is included, his/her main role is to be integrated into the research projects and the outreach and engagement activities, assisting the core leads of the partnership grants in the planning and implementation of activities within the Cancer Outreach and Engagement Core and partnership research program. The plans for the CHE may include collaborating with other relevant NCI/NIH networks if applicable.

Letters of Support: Attach letter(s) of support relevant to the Outreach and Engagement Core.

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component of the application. 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:

Plan for dissemination of results: A specific plan must be provided in each application to disseminate any findings resulting from or materials developed under the auspices of the Outreach and Engagement Core.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Outreach and Engagement Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Outreach and Engagement Core)

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

Shared Resource Core

When preparing your application in ASSIST, use Component Type "Shared Resource Core"

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

Any new shared resource proposed must not overlap with or duplicate any existing resource at the applicants' institutions. However, enhancements to an existing shared resource may be proposed.

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

Complete only the following fields:

  • Applicant Information
  • Descriptive Title of Applicant's Project, starting with "Core 1:", "Core 2:"
  • Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Shared Resource Core)

Follow standard instructions.

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 Summary/Abstract: Provide an abstract/summary for the proposed Shared Resource Core, including which Research Projects will be supported by the Core.

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 attachments 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 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
  • For cores with multiple leads, in the PD/PI section of the form, use Project Role of 'Other (Specify)' and designate the role under 'Other Project Role Category' as 'Core Co-Lead' and provide a valid eRA Commons ID in the Credential field. Please note that Core Leads and Core Co-Leads may be physical scientists and/or cancer researchers.
  • In the additional Senior/Key Profiles section, list senior/key persons who are working on 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)

Introduction to Application: For Resubmission applications only.

Specific Aims: Outline the specific aims of the Shared Resource Core and how it serves the common objectives and priorities of the partnership.

Research Strategy: Describe resources/infrastructure proposed for development. The proposed resources can either augment existing RLI or CC capabilities or constitute entirely new ones, provided they are tailored to the common objectives and priorities of the partnership. Resources can be in either of the partnering institutions (or both institutions), but must be available to both partners.

These resources are expected to augment the cancer research capability of the RLI, the collaborative research of the partnering institutions, and/or specifically enhance research focused on cancer. The description must contain the following information:

  • Title of the resource/infrastructure to be developed.
  • The scope of expertise available, including the level of skills of technical personnel, if applicable, who will be responsible for the day-to-day operation (and who may not be included under Senior/Key Persons).
  • The key characteristics of resource/infrastructure and anticipated benefits for the partnership, and
  • Justification for the location of the resource(s).

Letters of Support: Attach appropriate letters relevant to the core.

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component of the application. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

  • Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Shared Resource Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Shared Resource Core)

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - 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. 

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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? Is the prior research that serves as the key support for the proposed project rigorous? 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 NOFO: Does  this partnership have a potential effect on changes in knowledge, opinion, and practices among participating community members?  Does the partnership increase RLI's sustainable cancer research capability? 

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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 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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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

Specific to this NOFO: How appropriate has the proposed design been tailored for the community of interest?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 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 project 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 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, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: How well does the partnership describe the plans for research projects, outreach, and engagement? How appropriate are the goals of the partnership? 

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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

Specific to this NOFO: How well does the proposal use the available infrastructure and existing resources to help establish or sustain the proposed partnership. How adequate is the proposed partnership's institutional support across the participating institutions? How will the environment be conducive to the participation of new, less-experienced investigators?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Overall

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.

Additional Review Criteria - Overall

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.

Prior Performance in Planning Phase (New applications) or Progress (Renewal applications) 

  • What is the evidence that the partnering institutions have collaborated and have concrete plans to establish a sustainable partnership? (New Applications only)
  • What is the evidence of productive collaborations between the partnering institutions during the previous funding period? (Renewals only)
  • To what extent has the partnership achieved its goals during the previous funding period? (Renewals only)
  • To what extent have the partnership's projects/programs led to new funding for the partnership's institutions? (Renewals only)
  • How sufficient is the partnership's progress to ensure the likelihood of success in the next funding period? (Renewals only)

Overall Evaluation and Partnership Integration 

a. Commitment from the Institutional Leadership

  • To what degree do the commitment letters support the priorities and objectives proposed for the partnership?
  • How adequate are the resources committed to the partnership?
  • How appropriate is the institutional investment/commitment to new, Early-Stage, or less-experienced investigators?

b. Administrative Core

  • What is the evidence of administrative integration of the proposed partnership?
  • How adequate are the proposed organizational and administrative structures to attain the priorities and objectives of the partnership?

c. Scientific and Administrative Leadership

  • How strong are the qualifications and experience of the PD(s)/PI(s), project leaders, and other key personnel from the participating institutions to provide scientific and administrative leadership needed to achieve the partnership's objectives?
  • How strong is the justification for selecting the PIs and the process of replacing them if needed?

d. Scientific Integration

  • What is the evidence of integration for the proposed partnership?
  • What is the evidence of coordination, interrelationships, synergy, and mutual benefits between institutions?
  • To what extent are the research projects and cores integrated into the overall goals of the partnership?
  • What is the likelihood for the priorities and objectives to be achieved within 5 years?

Projects in Required Target Areas

a. Pilot and Full Research Projects

  • How appropriate are the Co-Leaders' qualifications and the institutional environment's quality?
  • How are the proposed projects of significance and scientifically meritorious?
  • What is the potential for the pilot projects to lead to a full project and for the pilot and full project to evolve into an NIH or other funding agency, independent, competitive, and fundable project within 3 years?

Outreach and Engagement Core 

  • How experienced are the core leaders  working with communities?
  • How likely is it for the proposed programs to become self-sustaining?

Planning and Evaluation Core 

  • How appropriate is the methodology for evaluating the outcomes and impact of the proposed programs? 
  • How adequate are the plans for developing additional projects/programs?
  • How adequate are the qualifications and experience of each member of the Internal Advisory Committee (IAC)?
  • How adequate are the qualifications and experience of each member of the Program Steering Committee (PSC), if named?
  • How adequate are the process and criteria for identifying and implementing the resource and infrastructure needs?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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 Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, 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 will receive a written critique.

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.

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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  • ongoing and consistent access to HHS owned or operated information or operational technology systems; and
  • receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

  • Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
    • Identify:
      • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
    • Protect:
      • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
      • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
      • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
      • Regularly backup sensitive data and test backups.
    • Detect:
      • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
    • Respond:
      • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
      • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
    • Recover:
      • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

  • Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
  • Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
  • NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 
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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 reside with the recipients of the project. However, specific tasks and activities may be shared among the recipients and NIH as defined below.

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

PD(s)/PI(s) Commitments. Recipients must be committed to making the research tools and materials they develop available to the cancer research community. For effective leadership, individuals designated as PD(s)/PI(s) are expected to be committed to the partnership (see Section IV. Administrative Core). U54 CAPRI applications are multiple PI-based, according to the requirements that the PD/PI from the RLI must be listed as PD/PI on the CC U54 application and vice versa. 

Internal Advisory Committee (IAC). The IAC will oversee the partnership's internal planning and evaluation activities (See Section I. Internal evaluation). The IAC will comprise the PD(s)/PI(s) and other key personnel, as appropriate. Other (non-contact) PD(s)/PI(s) (if applicable) can also be members of the IAC. The IAC must have an equal numerical representation of members from the partnering institutions. In addition, the Program Manager will serve as an ex officio member. As needed, all PD(s)PI(s) from both institutions will select members of the IAC from among the qualified faculty members of the partnering institutions. The contact PD(s)/PI(s) will convene the initial meeting of the IAC to select a Chair of the committee. The PD(s)/PI(s) cannot be the Chair of the IAC. There will be no NCI representatives as members of the IAC.

The IAC will be responsible for establishing a process for reviewing and evaluating the initiation and closure of all pre-pilot, pilot, and full projects based on their merit and potential for achieving the partnership's objectives, as well as actual progress. The IAC will also review the Cores and other activities of the partnership. The expertise of the IAC members should be relevant to the objectives and goals of the partnership. If the committee lacks the scientific expertise to evaluate pilot/full projects/ programs, the IAC may seek ad hoc reviewers from within or outside.

The IAC evaluations and recommendations will be sent to the Program Steering Committee for concurrence. The IAC should meet regularly, but not less than quarterly.

Program Steering Committee (PSC). Upon receiving the Notice of Award, the contact PD(s)/PI(s) will convene a teleconference of the PSC to select a chair, schedule the first PSC meeting, and develop an agenda. The contact PD(s)/PI(s) must distribute all materials to be evaluated to the PSC at least 4 weeks before the meeting. The PSC chair will assign other PSC members based on their expertise. The contact PD(s)/PI(s) must submit the PSC report to the leadership of their institutions and to the IAC Chair, who will distribute the report to the IAC members. The contact PD(s)/PI(s) must use the recommendations in the report to guide and direct the development of the U54 program. The PSC report and the response to the report from the PDs/PIs must be included as part of the Research Performance Progress Report (RPPR). 

Partnership Meetings. Each partnership should plan to meet at least monthly to discuss the progress and direction of its activities and ensure that necessary interactions occur. These meetings may be virtual or face-to-face. 

Workshops. The contact PD(s)/PI(s) and Program Manager must attend an Annual Program Workshop to share information and strategies. NCI will convene a Planning Committee to develop an agenda for the workshop.

Reports. Each partnering institution will submit annual progress reports (including the PSC annual meeting report and program response) to the NCI that describe activities and accomplishments during the previous funding period as part of the RPPR.

Approval of Changes. If the institutional leadership (i.e., CC Director or RLI President) changes during the award, new letters of commitment must be sent to NCI no later than 90 days after the change. The PSC and NCI must approve any change of PI(s) and project and/or program leaders. Documentation should include institutional support letters and a rationale for replacement.

Sharing Experiences. Partnerships are expected to share their approaches and experiences with other partnerships, CCs, networks, and institutions.

Participation in program evaluation. All PD(s)/PI(s) of the partnerships program are expected to participate in and facilitate a national evaluation of the program. This evaluation might be conducted by an independent organization contracted by the NCI. Conducting the national evaluation under contract guarantees the objectivity and credibility of the evaluation findings and recommendations. However, NCI Program Officers will remain responsible for the scientific management, annual progress report reviews of each grant, and programmatic assessment of the partnership program. NCI, with feedback from PIs, will develop a program-specific logic model that includes appropriate performance measures, program outputs, and outcomes. This model will be used to identify the core data elements required for monitoring and evaluating the program overall. If an independent contractor conducts the evaluation, the contractor shall collaborate with and seek input from the PD(s)/PI(s) and NCI program officials in developing the program logic models and specifying the core data elements.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding 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:

  • Serve as a participating, non-voting member of the PSC.
  • Work with investigators and partners to facilitate collaborations and access to resources provided by NCI, NIH, and other agencies as appropriate.
  • Interact with each partner, and contribute to adjusting projects/programs or approaches as warranted.
  • Provide review and comments on all significant transitional changes to assure consistency with the goals of this NOFO.
  • Coordinate activities with other ongoing projects supported by NCI to avoid duplication of efforts.
  • Facilitate the dissemination of experiences and approaches among the partnership program and other CCs and NCI-supported networks.
  • Help in reprogramming efforts when projects/programs do not progress relative to the timeline for achieving the objectives of the NOFO.
  • Assist the PSC in the concurrence of new/replacement pilot and full projects/programs.
  • Monitor the fulfillment of institutional commitments and resources available to the partnership program.
  • Recommend the approval of new Contact PD(s)/PI(s), Co-leaders of projects/programs, if needed.
  • Select the Workshop Planning Committee members to organize an annual workshop.
  • Call additional meetings/workshops to address emerging areas of high priority to the NCI. 

The activity's dominant role and prime responsibility reside with the project's recipients. However, specific tasks and activities in carrying out the projects/programs will be shared among the recipients and the NCI Project Scientist.

The NCI Project Scientist will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, the NCI Project Scientist will seek a waiver, following procedures for managing conflicts of interest, if deemed necessary.

Additionally, an NCI Program Director acting as the Program Official will be responsible for the award's normal scientific and programmatic stewardship and will be named in the award notice.  

Areas of Joint Responsibility include:

The recipient institutions and the NCI staff members will work together to establish the PSC and participate in its activities.

The PSC in each partnership will serve as the primary external advisory board responsible for the yearly evaluation of the program and for making recommendations to recipient institutions regarding (a) establishing priorities, (b) changing directions, and (c) identifying areas of new opportunities. All members of the PSC will prepare a written annual report. The PSC report should critically assess the partnership and its activities, including recommendations to terminate specific research projects or programs. The PSC report should be prepared with reasonable detail, identifying weaknesses and recommending ways to correct them. The PSC should pay close attention to the leadership's commitment to the partnerships and the faculty members. The PSC Chair will submit the final report to the contact PD(s)/PI(s). The PIs of the partnership will have 30 days to respond to the PSC report recommendations.

The composition, organization, and role of PSC will be as follows:

The contact PD(s)/PI(s) will coordinate the nominations, with feedback from other PD(s)/PI(s), and periodically review PSC members for additions and replacements.

  • PSC must include a minimum of four and up to six (for a pair) or a minimum of six and up to nine (for a triad) external advisors with the scientific expertise necessary to provide advice relative to the partnership's objectives. The NCI Program Official must approve changes in the composition of the PSC.
  • A quorum for a PSC meeting is four PSC members for dyads and six PSC members for a triad. The PSC meeting cannot take place without a quorum.
  • Each full member of the PSC will have one vote.
  • The contact PD(s) or PI(s) of each partnership component and the NCI Project Scientist will participate as non-voting members.
  • The PSC voting members will select the chairperson, who must be one of the PSC voting members.
  • The PSC may establish subcommittees with additional ad hoc advisors as necessary to meet its planning, priority setting, and evaluation responsibilities.
  • The PSC will meet once per year, preferably in person.

The activities of the PSC will include:

  • Critical assessment of the overall progress of the partnership on an annual basis (or more frequently if necessary).
  • Making recommendations for establishing priorities.
  • Making recommendations for changing direction and identifying areas of new opportunities to accomplish mutual objectives more successfully; and
  • Make recommendations regarding individual projects (pilot/full), programs, and cores based on the progress during the prior funding period.

Recipients, in general, will be expected to accept and implement the recommendations by the PSC. In those situations where the recommendations are not feasible to implement, the contact PD(s) or PI(s) must provide a thorough explanation and rationale in the RPPR.

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 and composed of: 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 recipient. This special dispute resolution procedure does not alter the recipient'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.

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

4. Reporting

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Scientific/Research Contact(s)

NCI CRCHD Program Inbox
National Cancer Institute (NCI)
Email: nci-crchd@mail.nih.gov
Telephone: 240-276-6170

Peer Review Contact(s)

Center for Scientific Review (CSR)
E-mail: NOFOReviewContract@csr.nih.gov 

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.