Part 1. Overview Information

Key Dates

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.

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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.
   
   



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The NCI conducts and supports research, training, health information dissemination, and other programs concerning cancer. This funding opportunity seeks to support the Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE) Program. The CPACHE Program develops and maintains comprehensive, long-term, mutually beneficial partnerships between institutions serving underserved health disparity populations and underrepresented students (ISUPSs) and NCI-designated Cancer Centers (CCs). To underscore their commitment to the partnership, linked applications from each partnering institution are required. The program aims to achieve a stronger national cancer program and address challenges in cancer and cancer disparities research, education, outreach, and cancer's impact on underserved populations.

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

1) increase the capacity of cancer research and cancer research education of the ISUPSs

2) promote the diversity of the cancer research workforce

3) improve the effectiveness of CCs in developing and sustaining research programs focused on cancer health disparities and increase the number of investigators and students conducting cancer health disparities research; and

4) develop and implement cancer-related outreach and education initiatives that benefit the surrounding underserved communities.

Background

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity, and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation depends on a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Many benefits flow from a diverse NIH-supported scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in and benefit from health research, and enhancing public trust.

Despite tremendous scientific research, information, and education advancements, opportunities are not equally available to all. NIH, including NCI through this program, encourages institutions to diversify their student and faculty populations through means consistent with applicable federal, state, and local law to enhance the participation of individuals from diverse backgrounds, including those from underrepresented groups (NOT-OD-20-031).

A disproportionate burden of cancer exists among many population groups, including African Americans/Blacks, American Indians, Alaska Natives, Hispanics or Latinos, Native Hawaiians, and other Pacific Islanders, individuals with disabilities, and individuals from socioeconomically disadvantaged backgrounds. For example, the American Cancer Society Cancer Facts & Figures (2022 Cancer Facts & Figures) shows that Non-Hispanic Black people have higher overall cancer incidence and death rates compared to Non-Hispanic Whites, while Hispanics/Latinos have cervical cancer incidence rates about 30% higher than Whites. Hispanics/Latinos and Asian/Pacific Islander populations have an incidence that is double for liver and stomach cancers compared to the White population. Additionally, the same report shows that the cancer incidence among American Indian/Alaska Native populations is higher than among Whites for lung, colorectal, and kidney cancers and cancers associated with infectious agents. The lack of diversity in the U.S. biomedical research and healthcare workforce is an important factor contributing to and exacerbating cancer health disparities (2022 AACR Cancer Disparities Progress Report). A cancer research workforce with investigators from diverse backgrounds and life experiences, supported in an environment that nurtures their success, is essential to creating an environment conducive to advancing cancer and cancer health disparities research and, in turn, cancer health equity.

ISUPSs often lack the research infrastructure and resources to support a highly competitive cancer research program. Therefore, ISUPSs are limited regarding the achievement of substantial numbers of senior scientific leaders in cancer research, especially those that have earned independent NIH funding. Additional challenges exist regarding the limited resources required to maintain a state-of-the-art research environment. Through collaboration with the CCs, the CPACHE Program aims to enhance research infrastructure, capabilities, and resources at ISUPSs, by strengthening the faculty conducting cancer research, augmenting cancer research education, and improving institutional capacity to increase cancer research and to support and manage external research grant proposals and awards.

The CCs are recognized for their outstanding resources and the depth and breadth of their cancer research programs in basic, clinical, translational, and population science, as well as effective cancer training programs. CC investigators are highly successful in obtaining research funding from the NCI and other federal and private agencies. However, there has been limited focus on research on cancer health disparities, and access to and interactions with underserved communities is often lacking. While thousands of patients are enrolled in cancer clinical trials at the CCs each year, the low participation of underserved populations has been a longstanding problem. The disproportionate clinical trial participation not only limits the generalizability of research findings but also undermines equity in the provision of cancer-related health care in the U.S. Through collaboration with the ISUPSs, the CPACHE Program aims to provide the CCs with unparalleled access to patients and scientists from these populations, and opportunities to promote improved satisfaction and compliance with clinical regimens. The CPACHE Program aims to increase cancer health disparities research at the CCs.

CPACHE as a Partnership Program

The CPACHE Program builds and sustains excellence through mutually beneficial partnerships between ISUPSs and CCs. The program serves as a nurturing environment and incubator to allow for the development of new projects/programs. This partnership program provides long-term support for cancer research infrastructure (e.g., key personnel recruitment, equipment, clinical accrual cores, tissue cores, etc.) and limited (not to exceed three years) support for pilot and full research projects.

Research Team: Although grants are awarded to institutions, not investigators, the PD(s)/PI(s) are preferred to be mid-to-senior-level scientists who have records of obtaining grant support and will serve as role models and mentors to the partnership participants. However, a less experienced investigator at an ISUPS can be designated as one of multiple PDs/PIs if there is an appropriate institutional investment in this investigator and a demonstrable collaboration (active or planned) of the less experienced investigator with a more-experienced PD/PI.

The partnership must target cancer research, cancer research education, and community outreach and engagement. These combined activities are expected to lead to vigorous efforts to increase the number of peer-reviewed publications and secure independent peer-reviewed funding from NIH and other funding agencies.

Each partnership program is expected to include:

1. Administrative Core: Each partnering institution must have an Administrative Core that will provide the day-to-day administrative support for the partnership.

2. Full and Pilot Research Projects: Each partnership must be centered on specific well-developed research projects (further referred to as "Full Research Projects") and pilot, exploratory projects. Each new or competing renewal application should propose at least two Full Research Projects and one Pilot Research Project.

3. Planning and Evaluation Core: Partnership recipient will be required to conduct (as a continuous process) planning and evaluation of partnership activities and tracking of outcomes and scholars supported by the partnership.

4. Research Education Core: This core supports joint research education programs between partnering institutions that offer research experiences, curriculum development, or both. Such programs link the faculty and students of the partnering institutions.

5. Outreach and Engagement Core: Both partnering institutions are expected to engage in community outreach efforts supporting cancer-relevant outreach research. In addition, the core also is expected to establish bidirectional activities leading to the dissemination or development of educational materials/activities for the proposed targeted outreach to the surrounding underserved communities.

6. Shared Resources: Applicants may propose the development of resources/infrastructure that augment the cancer research capability of the ISUPSs, the collaborative research of both partnering institutions and/or specifically enhance research focused on cancer health disparities issues.

It is expected that all activities should be planned to reach sustainability in terms of the ability to:

• Increase the participation of the ISUPSs in the nation’s cancer research and research education enterprise.
• Increase the competitive research capacity of ISUPSs.
• Encourage competitive grant applications from scientists from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031 , Notice of NIH’s Interest in Diversity), and scientists from underrepresented groups.
• Enhance research in cancer health disparities at CCs.
• Increase involvement and effectiveness of CCs in cancer health disparities research.
• Increase the role of CC in augmenting education related to underserved populations.
• Develop more effective outreach, engagement, and education initiatives that will impact the surrounding underserved communities.
• Identify and share innovative methods and approaches that strengthen and sustain each partnership.

Each partnership must have an Internal Advisory Committee (IAC) and a Program Steering Committee (PSC).

Internal Evaluation

The Internal Advisory Committee (IAC) is shared across the partnering institutions. The IAC will be composed of qualified faculty members from the partnering institutions and must have an equal numerical representation of members from each partnering institution (See Section VI. Terms and Conditions of Award), and is responsible for the internal evaluation of the partnership’s activities, including the research projects as follows:

• Evaluation of additional pilot projects, full projects, and programs (developed during the award). Beyond the specific projects described 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 ISUPS or CC participating as PD(s)/PI(s) of a joint pilot/full project) is an Early-Stage Investigator (ESI), it is highly encouraged that an Individual Development Plan (IDP) is included for the ESI. The same process will apply to additional programs and/or activities proposed for development in the education and outreach cores during the award.

The IAC will prioritize these additional projects. Depending on the priority, the IAC will be expected to recommend either: (1) funding the project as requested; (2) funding as a pre-pilot project for 1-year; or (3) not funding the proposed project 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 funding.

IAC will evaluate ongoing pilot, full projects, and project concepts under development. The IAC will also evaluate existing pre-pilot, pilot, and full projects. This evaluation may occur once a year or more frequently as deemed necessary.

The following scenarios are possible: (1) convert either pre-pilot to pilot and/or pilot to a full project; or (2) terminate funding of pilot and/or full project based on low scientific merit, low relevance to partnership goals and objectives, low potential to generate publishable data, and/or low potential to become a competitive grant application.

• Evaluation of cores and other activities. The IAC will continuously evaluate the Administrative, Research Education, 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.
• In addition, the IAC will also evaluate and recommend other key partnership activities, such as recruiting new investigators and establishing resources and infrastructure based on their merit and potential to contribute effectively to achieving high-priority goals and objectives.
• The IAC evaluations and recommendations for new projects (pilot/full), ongoing projects (pre-pilot/pilot/full), cores, and other activities will be forwarded 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 contact PD(s)/PI(s) must make minutes of the IAC meetings conducted throughout the year available to the PSC members and be part of the report required one month before the PSC meeting.

External Evaluation, Scientific Feedback, and Guidance

The Program Steering Committee (PSC) is an external advisory board of the partnership and will comprise investigators from non-partnering institutions (See Section VI. Terms and Conditions of Award). The role of the PSC is to assess the annual progress of the partnership and provide guidance and scientific feedback to the partnership. Final decisions on concepts and applications for additional projects will be the responsibility of the PSC and NCI Program. The PSC will provide external evaluation of ongoing pilot, full projects, and project concepts under development. The PSC must meet once a year, ideally in person, to review the partnership’s progress to date and provide a thorough assessment, including scientific evaluation and feedback.

Assessing Program Outcomes

The success of the CPACHE Program will be assessed based on several tangible metrics directly linked to the partnership’s objectives. Moreover, each partnership should develop logic models for the overall partnership and each cores. Metrics will include, but will not be limited to, at the ISUPSs, increased infrastructure support, faculty/student recruitment and retention in cancer research, and cancer research-relevant curriculum developed and sustained. Metrics at the CCs will include, but not limited to increased cancer health disparities research projects and funding and cancer health disparities courses or curricula developed and sustained. In addition, for both ISUPSs and CCs, indicators of success for the CPACHE Program will include an increase in the number of peer-reviewed publications, and an increase in cancer-related grants submitted and awarded. In addition, an increased number of cancer-related education and awareness outreach and engagement activities to underserved communities and the development of community partnerships. The CPACHE Program may promote the participation of underserved individuals in cancer clinical trials and bio-specimen donation by developing and implementing innovative methodologies. In addition to these metrics, each partnership is encouraged to identify metrics unique to its program when designing its approaches.

Non-Responsive Applications

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

• Applications that do not include either Administrative, Planning and Evaluation, Research Education, or Outreach and Engagement Cores.
• Applications that do not include at least two full research and one pilot research project .
• Applications that do not address all the three required areas: cancer research, cancer education, or cancer community outreach and engagement.
• Applications that do not include a partnership between an ISUPS and an NCI-designated Cancer Center.
• Applications with a budget over the cap of $1.7 million for dyads or $2.2 million for triads

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

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

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

Section II. Award Information

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

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

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

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

For this funding opportunity announcement, ISUPS are defined as institutions with a documented historical and current mission to serve underserved health disparity populations and underrepresented students.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences. For additional detail refer to https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html.

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

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

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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • 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. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

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

Specific to this FOA:

• Although grants are awarded to institutions, not investigators, the PD(s)/PI(s) are preferred to be mid-to-senior-level scientists who have records of obtaining grant support and will serve as role models and mentors to the partnership participants. However, a less-experienced investigator at an ISUPS can be designated as one of multiple PDs/PIs if there is an appropriate institutional investment in this investigator and a demonstrable collaboration (active or planned) of the less-experienced investigator with a more-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.

3. Additional Information on Eligibility

Number of Applications

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

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Sandra L. San Miguel-Majors, DrPH, M.S.
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 240-276- 5977
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

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

• Overall: required
• Administrative Core: required; maximum of 1.
• Shared Resources Core: optional; maximum of 3.
• Full Research Project: required; minimum of 2 and maximum of 3.
• Pilot Research Project: required; minimum of 1 and maximum of 3.
• Core 1 - Planning and Evaluation Core: required;? maximum of 1.
• Core 2 - Research Education Core: required; maximum of 1?.
• Core 3 - Outreach Core: required, maximum of 1.

Overall Component

When preparing the application, use Component Type Overall .

All instructions in the SF424 (R&R) 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)

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

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 of building research capacity at the ISUPS and cancer health disparities research at the CC 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 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 with efforts to promote and facilitate a broad range of scholarly activities, including the conduct of high-quality, rigorous research, peer-reviewed publications of research results in scientific journals (as well as their presentations at scientific meetings), 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 research 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 the protected time required for the development of the research project and other activities related to the development of the investigator's career as an independent scientist, e.g., clinic responsibilities, teaching, and administration.
• Appropriate office and laboratory space, equipment, and other resources and facilities for the investigator (including access to clinical and/or other research populations) to carry out the proposed research activities.
• Availability and characteristics of senior colleagues, who are proposed to provide collegial support to the investigator and/or other staff whose support may be helpful for the investigators' research and career goals. Since the CPACHE research activities are shared between the ISUPS and the CC, it is expected that the person designated for the collegial support role will be named a co-leader on the project or core led by the investigator. If more than one individual is proposed for collegial support, the respective areas of expertise and responsibility should be described.

Other Attachments: The following "Other Attachments" should 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.

Summary Information: Tables, graphs, figures, diagrams, and charts relevant to the Overall component.

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

ISUPS Statement: Any institution applying as an ISUPS must include a statement signed by the institution official certifying it is eligible as an ISUPS 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 applications and 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 ISUPS and CC to conduct cancer pilot and full projects 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 clearly describes those aspects of the project that are common to all sites of the collaboration. All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site." In this subsection, PDs/PIs should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, etc.

Outline the following aspects:

• The general rationale and the mutual benefits that the partner institutions expect to derive from the partnership (including how both institutions believe they can help each other develop stronger cancer programs);
• The immediate priorities of the partnership derived from a careful planning process that relates to mutual benefits;
• Overall goal and specific objectives in cancer research, cancer outreach, and research education program or programs that the partnership believes can be achieved 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 (such as nanotechnology, proteomics, genomics, imaging, etc.), precision medicine, and/or therapeutic clinical trials accrual of underserved populations. Research may focus on cancers affecting underserved pediatric, adolescent, young adult or aged populations. Hypothesis-driven outreach research projects are also appropriate, including those aimed at increased high-quality, clinically annotated biospecimens from underserved populations.
• Joint research projects conducted primarily at ISUPS may be in any area of cancer research. These projects may focus, for example, on general areas of environmental carcinogenesis, cancer biology, molecular epidemiology, and/or behavioral issues related to cancer prevention, treatment, and control.
• Joint research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in underserved and/or socio-economically disadvantaged populations.
• Educational activities and outreach activities are also encouraged.

In outlining the plans for all these activities, explain how these efforts collectively will be aimed at eventually securing competitively funded extramural research awards. Specify your target expectations (e.g., R01 awards, projects on P01 or P50 awards, or their equivalents). Small grants (such as R03 and R21 awards) are also desirable but 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. Address progress accomplished for specific partnership components (Administrative Core; Research Projects/Programs; Career Enhancement of trainees (students, postdoctoral, residents, ESIs, etc.); 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 major administrative changes that took place, name all new faculty members supported by the U54 award, and list grants (including the organization that funds the award and type of award), the number of participants (students or postdocs, etc.), level of education of participants, where the participants are, modes of tracking participants, etc., resulting from the U54 award. Discuss how recommendations of the PSC, IAC, and institutional leadership (if any) have influenced the initiation, modification, or discontinuation of any project or shared resources. A tabular format to summarize all grants and publications resulting from the funded pilot and full projects and programs is strongly recommended and must be included within page limitations.

Prior Planning Activities (for new applications only): Provide a chronological review of the prior planning and priority-setting processes. Please document 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 that are particularly relevant to the full-fledged partnership proposed in this FOA.

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 completed (e.g., meetings of higher institutional officials, planning committees, steering committees in areas of common interest, workshops, retreats), its purpose, the individuals that 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. Using an asterisk, mark each listed publication that results from formal collaborations among different projects within the partnership. Copies of these publications should not be included as Appendix material.

Letters of Support: Each application must include written "Letters of Support" from the respective leaderships 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, protected time, etc. These statements should also identify the specific number of positions that are wholly dedicated to cancer research under the partnership. The letters should clearly explain how the partnering institutions would monitor these efforts and specific steps and procedures to ensure they achieve the planned goals. In addition, if American Indians are involved, a Letter of Commitment from the Tribal Nation Leader is required.

"Letters of Support" should include the following specific items:

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

When the PD/PI from the ISUPS or CC is an individual with no prior experience as a PD/PI on a peer-reviewed grant, there must be a written "Letter of Support" from a senior member (e.g., Department Chair, Dean, Cancer Center Director) of the ISUPS or CC. In the letter, the senior member is expected to indicate his/her qualifications and the willingness to provide guidance to 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 SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the Data Management and Sharing Plan instructions. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 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 (Overall)

All instructions in the SF424 (R&R) 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
• Type of Applicant (optional)
• Title: Descriptive Title of Applicant's Project (use "Administrative Core")
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

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 attachment for additional entries.

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

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

Effort Commitments: Individuals designated as PD(s)/PI(s) are expected to be meaningfully committed to the partnership for effective leadership. U54 CPACHE applications are multiple PI based on the requirements that the PD/PI from the ISUPS 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) of effort per year is expected for the contact PD/PI from the ISUPS 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 ISUPS and 4.8 months for the CC.

Budget Justification: Justification for all the costs associated with this core must be provided. Administrative Core will provide funding for managing the partnership, such as: salaries for PD(s)/PI(s) and other key personnel such as Program Managers (i.e., key personnel that assist the lead PD(s)/PI(s) in coordinating and organizing day-to-day activities of the partnership); 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: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Succinctly describe the specific objectives and goals of the Administrative Core that will support and manage the partnership activities.

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 regarding the qualifications and leadership experience and characterize the potential of partnership leaders to integrate the proposed efforts and promote collaboration and cooperation in achieving the common objectives. For each PD/PI, applicants must specify and document that the expected commitment can be met (for example, what current duties, e.g., teaching, clinical duties, and administrative 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; and providing critical secretarial services, 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).
• Recruitment of Early-Stage Investigators (ESIs): Describe recruitment plans of ESIs by the partnership. For the already-identified individuals who are anticipated to be recruited, address the following aspects, consistent with applicable law:
  • How recruiting a specific prospective individual contributes to the proposed priorities and objectives of the partnership.
  • Institutional investment in the ESI.
  • Describe the nature of the position, documenting that the arrangement provides the necessary stability (e.g., tenure track) and resources (e.g., space) to promote success; and
  • Where the individual would be located and how this location serves the needs of the partnership.
• For recruitment plans where specific names of individuals are not yet known:
  • Describe the number of individuals and the type of desirable expertise that the partnership plans to recruit over the 5 years of this award; and

Additionally, explain how the recruitments will strengthen partnership capabilities in critical priority areas identified by the partnership leadership, IAC, and PSC (e.g., epidemiology, prostate cancer, breast cancer, behavioral research, outcomes research, community outreach, molecular genetics, etc.).

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.

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.

PHS Assignment Request Form (Administrative Core)

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
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (use "Project 1", "Project 2", etc.")
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Full Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

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 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, an Introduction to Application is allowed for each component.

Specific Aims: Outline the rationale and specific aims of the Research Project and explain how it fits into the goals and organizing framework 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 ISUPS may be in any area of cancer research.

Joint research projects conducted primarily at the CC must address cancer disparity in health disparity populations.

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. For example, they 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, diagnostic, treatment, and disease management interventions; quality improvement programs) 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 comprehensive partnership U54, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application or the case of protocols after funding a U54 to the NCI Program Director.

Letters of Support: Include letters of support as appropriate. If American Indians are involved, a Letter of Commitment from the Tribal Nation Leader is required.

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.

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.

PHS Assignment Request Form (Full Research Project)

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
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Starting with " Pilot Project 1" or " Pilot Project 2" or " Pilot Project 3)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

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 for the proposed Research Project, including how it fits within the organizing framework 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 that are working in 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, an Introduction to Application is allowed for each component.

Specific Aims: Outline the Specific Aims of the proposed Research Project and explain how these aims contribute to the overall goals and organizing framework 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 ISUPS may be in any area of cancer research.

Joint research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in health disparity populations.

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. For example, they 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, diagnostic, treatment, and disease management interventions; quality improvement programs) 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 comprehensive partnership U54, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols after funding of a U54, to the NCI Program Director.

Letters of Support: Include letters of support as appropriate. If American Indians are involved, a Letter of Commitment from the Tribal Nation Leader is required.

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:

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.

PHS Assignment Request Form (Pilot Research Project)

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

PHS 398 Cover Page Supplement (Planning and Evaluation Core)

Enter Human Embryonic Stem Cells in each relevant component.

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 attachment 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 that are working in 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 items as:

• Cost items for internal activities, IAC meetings, partnership workshops, retreats, committees, seminar series, and the use of ad hoc consultants such as evaluators, and external activities, which should include the once per year Program Steering Committee (PSC) meetings.
• Consultant costs and travel costs; and
• Cost items such as special seminar series, inviting experts to make presentations that relate to the partnership's objectives and/or to serve as ad hoc advisors in areas under development or external reviewers for full and pilot research projects.

PHS 398 Research Plan (Planning and Evaluation Core)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Applicants must incorporate appropriate strategies to ensure that planning, monitoring, evaluating, and tracking partnership activities will be continuously ongoing. The documented outcomes of those processes will constitute the basis for initiating or terminating the investment of resources into developmental projects, programs, resources, and recruitments. Applications must also describe the process of following up on the supported projects and evaluating their outcomes (peer review publications, grant submissions, research findings, etc.). For example, applications must outline the strategy for soliciting, evaluating, funding, and assessing new research projects (beyond the specific projects described in the application). Awardees must develop additional pilot and/or full research projects to provide continuity of research activities.

Research Strategy: The application from each site must contain a Research Strategy that clearly 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 analyses, (etc.).

• Internal Activities: List the names of the IAC members and outline each internal planning and evaluation activity (e.g., IAC meetings, regular forums, seminars, workshops, retreats, etc.) in which the objectives (or issues to be addressed) are identified, activities are described, and participating individuals from the institutions are named. (Face-to-face informal meetings between collaborators are among the most effective methods of communication. In instances where there is geographical distance between partners, applicants are encouraged to consider other methods of communication, including e-mail, teleconferences, and video-conferences.) 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 the progress of additional research projects (beyond the specific projects described in the application). Describe the review and evaluation process for initiating and closing all pilot and full 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 which kinds of faculty recruitment will be 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 compensate 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 that are being evaluated. 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 appropriate letters of support relevant to the 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:

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.

PHS Assignment Request Form (Planning and Evaluation Core)

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

Research Education Core

When preparing your application in ASSIST, use Component Type Core 2 - Res Edu '.

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

SF424 (R&R) Cover (Research Education Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Education Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Education 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: Summarize the objectives of the Research Education Core. Provide information regarding the research areas and scientific disciplines encompassed by the Core. Include a brief description of the level(s) (i.e., high school, undergraduate, predoctoral, postdoctoral) and duration of the proposed research education experience, the projected number of participating individuals, and their anticipated levels of experience. This section may differ from the partnering institution, similar and/or complementary.

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.

Facilities and Other Resources: Describe the institutional environment, including the availability of facilities and educational resources that can contribute to the planned Research Education Program.

Project/Performance Site Location(s) (Research Education 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 (Research Education 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 that are working in the core.
• 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.

The Research Education Core Leader and any other individuals whose contributions are critical to the development, management, and execution of the Core in a substantive, measurable way (whether salaries are reimbursed or not) should be identified as senior/key persons. These would include co-Leader(s), if applicable, and other Research Education Core staff.

Program Faculty who mentor, implement, direct, monitor, evaluate, consult, etc., in the proposed research education program should be listed as Key Personnel and provide a biographical sketch.

R&R Budget (Research Education Core)

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. This NOFO would allow including mentor costs, but it must be strongly justified, such as going above and beyond usual mentoring activities.
• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

PHS 398 Research Plan (Research Education Core)

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

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for the Research Education Core.

Specific Aims: Describe the core's cancer research areas and scientific disciplines. Include a brief description of the level(s) (i.e., high school, undergraduate, predoctoral, medical students and post-baccalaureate, postdoctoral, Early-Stage Investigators) and duration of the proposed research education experience, the projected number of participating individuals, and their anticipated levels of experience. If applicable, include a brief description of the planned curriculum development activities.

Research Strategy: The Research Strategy must include the following subsections.

Program Plan: The proposed educational experiences must be distinct from those research education programs currently receiving federal support; however, they may complement ongoing research education at the applicant institution. The applicant organization must distinguish between the activities in the proposed research education program and the research education supported by other training programs. The description should include the educational and/or career level(s) of the planned participants.

The proposed educational experiences must be joint efforts by the ISUPS and the CC, and participation at both sites is strongly encouraged and expected. Mentors from both sites are highly encouraged to participate in the proposed activities. Research Experiences and Curriculum Development (if applicable) activities should be linked. Individual Training & Development Plans (IDP) are strongly encouraged for all participants within the program's first month.

Provide an overview of the proposed program. Outline the program's objectives and the activities that will be used to meet these objectives. Describe for whom the research education program is intended, including the participants' education and career level(s), the academic and research background needed to pursue the proposed research enhancement, and, as appropriate, plans to accommodate differences in preparation among participants. Include information about planned courses, mentored research experiences, and activities designed to develop specific technical or other skills essential to the proposed research experience.

Core Leads: Describe arrangements for the administration of the program. Provide evidence that the Lead Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple leads, describe the complementary and integrated expertise of the leads, their leadership approach, and governance appropriate for the planned project. The Research Education Core is a joint activity between the ISUPS and the CC and must include co-leaders from both institutions. It is strongly recommended that the Core co-leaders are not the investigators in the multi-PI team. Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Core Leaders. Relate these strengths to the proposed management of the core. Describe the planned strategy and administrative structure to oversee and monitor the core.

Program Faculty: Researchers from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031 , Notice of NIH’s Interest in Diversity), are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Describe the complementary expertise and experiences of the proposed faculty, including active research and other scholarly activities in which the faculty is engaged. Also, describe experiences relevant to the program and participating faculty's proposed education and career stage(s).

Program Participants: Applications must describe the intended participants, the eligibility criteria, and/or specific educational background characteristics essential for participating in the proposed research education program. Identify the career levels for which the proposed program is planned. Provide details about the pool of expected participants (e.g., size, qualifications) and the sources of the applicant pool. NCI will use the information provided in a manner consistent with applicable law.

Plan for Instruction in the Responsible Conduct of Research: All applications with participants must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). For programs involving participants for more than 6 months, the plan must address the five required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program. For programs involving participants for 6 months or less, see the subsection on "Short-term training and research education programs" within the section on "Special Considerations by Type of Award" in NOT-OD-10-019. Renewal (Type 2) applications must also describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan: Applications must include a plan for evaluating the activities supported by the Research Education Core. The application should include baseline metrics (e.g., numbers, educational levels, and characteristics of participants, program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions), as well as measures to gauge the short- or long-term success of the research education award in achieving its objectives. When appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and provide suggestions for improvement. Specified evaluation metrics should be tied to the program's goals and listed in the application. The evaluation plan must include how the trainees will be tracked over time. NCI will use the information provided in a manner consistent with applicable law.

Letters of Support: Evidence of institutional commitment to the educational research program is required. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

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:

Plan for dissemination of results. A specific plan is expected to be provided in each application to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, consistent with achieving the goals of the program.

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 (Research Education 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 (Research Education Core)

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

PHS 398 Cover Page Supplement (Outreach and Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

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 Education & Outreach Unit.

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 attachment 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 that are working in the component.
• In cases where a Community Health Educator (CHE) is engaged, he/she must have training and knowledge, and experience in community engagement, communication, comprehensive 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 the CHE's specific role(s) 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, an Introduction to Application is allowed for each component.

Specific Aims: Summarize specific goals and 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 health disparities. These activities may also lead to identifying, developing, testing, evaluating, and/or refining strategies to disseminate and implement evidence-based practices (e.g., behavioral interventions; prevention, early detection, diagnostic, treatment, and disease management interventions; quality improvement programs) into public health, clinical practice, and community settings. In addition, outreach efforts directed at recruiting and retaining individuals from underserved health disparity populations into prevention, early detection, and therapeutic clinical trials, as well as participation in biospecimen 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 to underserved communities may include (but are not limited to):

• Utilizing church networks to reach and educate underserved 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.
• Promoting the development and delivery of health promotion and educational activities; and
• Training communities to use electronic information systems can educate individuals about cancer and 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 Research Project or Pilot Research Project components, as appropriate, NOT in this Outreach and Engagement Core component.

If a Community Health Education (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 U54 CHE may include collaborating with other relevant NCI/NIH networks if applicable.

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

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 Core.

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 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
• Type of Applicant (optional)
• 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)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resource Core)

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

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

Project 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 attachment for additional entries.

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

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

Budget (Shared Resource Core)

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

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

PHS 398 Research Plan (Shared Resource Core)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

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 (e.g., tissue resource, clinical trial accrual core, clinical research management core, special equipment, etc.). The proposed resources can either augment existing ISUPS 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 ISUPS, the collaborative research of the partnering institutions, and/or specifically enhance research focused on cancer health disparities issues. Shared infrastructure can be placed in either institution or both locations. 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 in terms of priorities of the partnership; and
• Justification for the location of the resource(s).

Letters of Support: Attach appropriate letters relevant to the 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:

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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 the SF424 (R&R) 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.

7. Other Submission Requirements and Information

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

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 the SF424 (R&R) Application Guide.

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

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 the 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.

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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: How well does the partnership proposal address cancer and/or cancer disparities? How meaningful will the proposed partnership impact the broader field of cancer and/or cancer health disparities? What is the potential effect of this partnership on changes in knowledge, opinion, and practices among participating community members? To what extent will the partnership increase sustainable cancer research capability for the ISUPS? How meaningful will the partnership increase the Cancer Center's ability to conduct cancer research, including outreach research, to address the disproportionate cancer burden in underserved and disadvantaged populations?

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: To what extent is the proposed study design already in existence applied to new, underserved populations? How appropriate has the proposed design been culturally 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/gender, 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, research education, and outreach and engagement, and in what ways are these plans appropriate for the goals of the partnership? What meaningful arguments does the applicant present that the proposed study design is the best balance of scientific rigor, implementation constraints, and ethical sensitivities of partners?

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, gender, 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/gender 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 is the proposal using 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 well does the applicant describe the collaboration with community partners? How well does the proposal describe the inclusion of community partners? How sufficient is the evidence provided that the environment will 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.

RFA/PAR only: Additional Review Criteria may be added. Use Heading" style with indent for the names of the criteria.

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

• Is there demonstrable evidence that the partnering institutions have a history of collaboration and concrete planning to establish a sustainable partnership? (New Applications only)
• Is there demonstrable evidence of productive collaborations between the partnering institutions during the previous funding period? (Renewals only)
• Has the partnership achieved the goals during the previous funding period? (Renewals only)
• Have the partnership projects/program led to new funding for the partnership institutions? (Renewals only)
• Is the performance/progress of the partnership sufficient to ensure the likelihood of success in the next funding period? (Renewals only)

Overall Evaluation and Partnership Integration (Adjectival Rating)

a. Commitment from the Institutional Leadership

• Is the level of authority of officials committing to this joint effort adequate on both sides of the partnership?
• To what degree do the commitment letters support the priorities and objectives proposed for the partnership?
• To what extent are the resources (e.g., discretionary resources, space, faculty positions, protected time for research, etc.) committed to the partnership adequate?
• How adequate is the institutional investment/commitment to new, Early-Stage, or less-experienced investigators?

b. Administrative Core

• Is there evidence of administrative integration of the proposed partnership?
• To what degree are the proposed organizational and administrative structures adequate for the effective attainment of the priorities and objectives of the partnership?
• Is the use of the administrative core services by the budgeted activities and projects/programs appropriate?
• Are the recruitment plan and the potential of individual recruitment proposed adequate?
• Is the proposed 5-year faculty recruitment (Early-Stage Investigators) appropriate and strategically adequate?

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 in providing scientific and administrative leadership needed to achieve the objectives of the partnership?
• Does the application provide a strong justification for selecting their PIs and the process to replace them if needed?

d. Scientific Integration

• Is there sufficient evidence of integration of the proposed partnership?
• Is there evidence of coordination, interrelationships, synergy, and mutual benefits between the investigators from both institutions?
• Are all the individual research projects integrated into the overall goals of the partnership?
• How well do the core components address the priorities and objectives of the proposed partnership application?
• Can these priorities and objectives be achieved within 5 years?

Projects in Required Target Areas (Adjectival Rating for Each Project)

a. Full Research Projects

• What is the relationship of the project to the objectives of the partnership?
• Are the Co-Leaders' qualifications and the institutional environment's quality adequate?
• What is the merit and significance of the proposed full projects?
• What is the potential for the full project to evolve into an NIH or other funding agency independent competitive and fundable project within 3 years?

b. Pilot Research Projects

• What is the project's relationship to the partnership's objectives?
• Are the Co-Leaders' qualifications and the institutional environment's quality adequate?
• What is the merit and significance of the proposed pilot project?
• What is the potential of the Pilot Project to lead to a full project or an NIH or other funding agency independent competitive and fundable project within 3 years?

Research Education Core (Adjectival Rating)

• Do the Core leaders have prior experience designing and implementing education programs?
• What are the merit and impact of the proposed programs?
• What is the potential for the proposed programs to become self-sustaining?
• What is the methodology for evaluating the outcomes and impact of the proposed programs?

Outreach and Engagement Core (Adjectival Rating)

• Do the Core leaders have prior experience in working with underserved communities?
• What are the merits and importance of the proposed programs?
• What is the potential for the proposed programs to become self-sustaining?
• What is the methodology for evaluating the outcomes and impact of the proposed programs?

Planning and Evaluation Core (Adjectival Rating)

• Are the plans for developing additional projects/programs adequate?
• Are the qualifications and experience of each member of the Internal Advisory Committee (IAC) adequate?
• Are the design and quality of each internal planning and evaluation process adequate?
• Are the qualifications and experience of each member of the Program Steering Committee (PSC) adequate?
• To what extent is the plan for leveraging the benefits of PSC effective?
• Are the process and criteria for identifying and implementing the resource and infrastructure needs adequate?

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 Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Renewals

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

Revisions

Not Applicable

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) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

3. Anticipated Announcement and Award Dates

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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: Grantee institutions 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).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

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 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 resides with the recipients of the project as a whole. 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 meaningfully committed to the partnership. U54 CPACHE applications are multiple PI based on the requirements that the PD/PI from the ISUPS must be listed as PD/PI on the CC U54 application and vice versa. Specifically, a minimum of 1.2 person-months (with a maximum of 3 person-months) of effort per year is expected for the contact PD/PI from the ISUPS 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 ISUPS and 4.8 months for the CC.

Internal Advisory Committee (IAC). A common IAC must be shared across the partnering institutions. 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 (i.e., key personnel that assist the contact PD(s)/PI(s) in coordinating and organizing day-to-day activities of the partnership) of each partnership 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 institutions participating in the partnership program. 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 review and evaluation for initiating and closing all pre-pilot, pilot, and full projects based on their merit and potential for achieving the partnership's objectives and 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 forwarded to the Program Steering Committee for concurrence. The IAC should meet regularly but not less than quarterly.

Participation in the activities of the Program Steering Committee (PSC). Upon receiving the Notice of Award, the contact PD(s)/PI(s) will convene a teleconference of the PSC (see the section on Joint Responsibilities for details) to select a chair, determine the date/time of the first PSC meeting and identify the most critical elements for an effective agenda. Once a meeting date is determined, 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 and experience. The contact PD(s)/PI(s) must submit the PSC report to the leadership of their partner institutions (i.e., to the CC Director and ISUPS President, 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) submitted to the NCI each year.

Partnership Meetings. Each partnership should plan regular meetings (no less than monthly) to discuss the progress and direction of its activities and ensure that the necessary interactions occur. These meetings may be in the form of phone teleconferencing, videoconferencing, and/or web conferencing, or face-to-face meetings.

Workshops. The contact PD(s)/PI(s) and senior administrators for the program (e.g., Program Managers) must attend an Annual 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 describes 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 ISUPS 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. Successful partnerships are expected to participate in sharing their approaches and experiences with other Partnerships, NCI-supported Centers, Networks, and other 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 ensures the objectivity and credibility of the evaluation findings and recommendations. However, CRCHD Program Officers will remain responsible for the scientific management, annual progress report reviews of each grant, and evaluation of the partnership program. CRCHD, with feedback from PIs, will develop a program-specific logic model which will include appropriate performance measures, program outputs, and outcomes that 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 and seek the input of the PD(s)/PI(s) and NCI program officials in developing the program logic models and specifying the core data elements.

Recipients(s) 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 has 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 closely with individual investigators and partners to facilitate collaborations.
• Assist the partnership efforts by facilitating access to fiscal and intellectual resources provided by NCI, NIH, and other agencies as appropriate.
• Interact with each partner, coordinate approaches between partners, and contribute to adjusting projects/programs or approaches as warranted.
• Provide review and comments on all major transitional changes of an individual partner's activities before implementation to assure consistency with the goals of this NOFO.
• Coordinate activities with other ongoing projects supported by NCI to avoid duplication of efforts.
• Coordinate access to other resources from NCI, including NCI-sponsored agents for pre-clinical and clinical testing, assistance in investigational new drug (IND) filing, etc.
• Facilitate disseminating experiences and approaches among awardees of the partnership program and other CCs and NCI-supported networks.
• Help reprogram efforts within the peer-reviewed scope of work, including options to modify projects/programs when projects/programs are not making headway relative to the timeline for achieving the objectives of the NOFO.
• Assist the IAC and PSC in the concurrence of new/replacement pilot and full projects/programs when requested for ongoing activities.
• 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 that engages all the partnerships and other participants as needed. This meeting will be held for selected funded investigators to share progress and research insights that may benefit all the projects; and
• Call additional meetings/workshops of the participants to address emerging areas of high priority to the NCI and/or the problems of high cancer incidence and mortality in underserved populations.

The activity's dominant role and prime responsibility reside with the project's awardees. However, specific tasks and activities in carrying out the projects/programs will be shared among the awardees 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 an NCI waiver per the NCI procedures for managing conflict of interest if such participation is 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 awardee institutions and the NCI staff members will work together to establish the Program Steering Committee (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 institutional program and responsible 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 the first draft of their recommendations in the form of a written annual report. The PSC report should critically assess the partnership and its activities, including recommendations to terminate specific research pilot projects or full studies. 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 PD(s)/PI(s) (if multiple PD(s)/PI(s) option is used, the contact PD(s)/PI(s) will coordinate the nominations from other PD(s)/PI(s)) will nominate the members of the PSC, and periodically review PSC members for additions and replacements.

• PSC must be composed of 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 appropriate objective advice relative to the objectives of the U54 partnership. The NCI Program Official must approve changes in the composition of the PSC.
• A quorum for a PSC meeting is four PSC members for a dyad and six PSC members for a triad. The PSC meeting cannot take place if there is no quorum.
• Each full member of the PSC will have one vote.
• The contact PD(s)/PI(s) of each partnership component and the NCI Project Scientist will be participating non-voting members.
• The PSC voting members will select the chairperson, 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:

• Evaluation of the overall progress of the partnership program 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, when the recommendations are not feasible to implement, the contact PD(s)/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

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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. 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Sandra L. San Miguel-Majors, DrPH, M.S.
National Cancer Institute (NCI)
Telephone: 240-276-5977
Email: [email protected]

Behrous Davani, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6170
Email: [email protected]

LeeAnn Bailey, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6170
Email: [email protected]

H. Nelson Aguila, D.V.M.
National Cancer Institute (NCI)
Telephone: 240-276-6170
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 202-276-5699
Email: [email protected]

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

All applications, regardless of the direct costs requested for any year, should address a Data Management and Sharing Plan.