NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NCI’s mission is to conduct and support research, training, health information dissemination, and other programs with respect to 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, and 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 application from each other partnering institutions are required. The program aims to achieve a stronger national cancer program and address challenges in cancer and cancer disparities research, education, and outreach, as well as their impact on underserved populations.

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

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

2) increase the number of students and investigators from underrepresented populations engaged in cancer research;

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 activities that benefit the surrounding underserved communities.

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 is dependent upon 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 homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that 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 advancements in scientific research, information, educational and research opportunities are not equally available to all.

This program encourages institutions to diversify their student and faculty populations and thus to enhance the participation of individuals currently underrepresented in the biomedical, clinical, behavioral and social sciences research enterprise, as described in NOT-OD-15-053.

A disproportionate burden of cancer exists among many population groups, including African Americans, American Indians and 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 2016 shows that Non-Hispanic Black has higher overall cancer incidence and death rates compared to Non-Hispanic White, while Hispanic/Latino and Asian and Pacific Islander indicate higher incidence and death rates in cancers of the liver and intrahepatic bile duct (Incidence and Death Rates for Selected Cancers by Site, Race, and Ethnicity, US, 2008-2012). Additionally, trends in cancer mortality rates showed that greater progress in cancer control was achieved for White populations compared with American Indian/Alaska Native populations over the last 2 decades. These same population groups where cancer health disparities exist are also significantly underrepresented in the U.S. biomedical research and health care workforce, which contributes to and exacerbates the cancer health disparities. The 2004 report from the Sullivan Commission indicated that African Americans, Hispanics and Native Americans together make up 25% of the U.S. population, but only 6% of physicians, 8% of registered nurses and 5% of dentists (Sullivan_Report_ES.pdf). With at least 90% of the U.S. population growth between 2010 and 2050 expected to come from underrepresented groups (Workforce Diversity), the issue of workforce diversity is more urgent than ever. A cancer research workforce that reflects the communities being served, supported in an environment that nurtures their success, is essential to creating an environment that is truly conducive to advancing cancer and cancer health disparities research, and in turn, cancer health equity.

While ISUPSs have enhanced the education of underrepresented population groups, they often lack the research infrastructure and resources to support a highly competitive cancer research program. Many ISUPSs are limited in achieving sufficient numbers of senior scientific leaders in cancer research, have limited resources to maintain a state-of-the-art research environment, and have a limited group of scientists with success in obtaining independent NIH funding. Through collaboration with the CCs, the CPACHE Program aims to enhance research infrastructure, capabilities, and resources at ISUPSs, by strengthening cancer research faculty, augmenting cancer research education, and improving institutional capacity to support and manage external research grant proposals and awards.

The NCI-designated Cancer Centers are recognized for their outstanding resources and the depth and breadth of their cancer research programs in basic, clinical, translational and/or population science, as well as effective cancer training programs. Cancer Center investigators are highly successful in obtaining research funding from NCI and other agencies. However, there has been limited focus on cancer health disparities research, 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, participation of underrepresented and underserved populations has been a longstanding problem. These underrepresented and underserved groups comprise more than 30% of the U.S. population, but only less than 18% of Phase I-III cancer clinical trial participants and 17% of FDA clinical trial participants in 185 studies of new molecular entities over a 5-year period. 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 provides the CCs with unparalleled access to patients and scientists from these populations, and opportunities to observe whether concordance between researchers and clinical subjects increases participation in clinical trials and improves satisfaction and compliance with clinical regimens. The CPACHE Program further aims to increase cancer health disparities research at the CCs.

CPACHE as a Partnership Program

The CPACHE Program is about building and sustaining 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: The PD(s)/PI(s) are preferred to be mid-to-senior-level scientists who have records of obtaining grants 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 outreach. These activities combined are expected to lead to vigorous efforts aimed at securing 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 application, new or competing renewal, should propose at least two Full Research Projects and at least one Pilot Research Project.

3. Planning and Evaluation Core: Partnership awardees will be required to conduct (as a continuous process) planning and evaluation of partnership activities and monitoring of trainees.

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

5. Outreach Core: It is expected that both partnering institutions will engage in outreach efforts that would benefit communities with cancer health disparities. Such efforts are strongly encouraged to be connected to cancer-relevant outreach research (e.g., through pilot projects or research development activities) conducted by the partnership.

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 partner institutions, and/or specifically enhance research focused on cancer health disparities issues.

It is expected that all activities should be planned to eventually 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 competitive research capacity of ISUPSs;
• Produce more competitive grant applications from underrepresented scientists;
• Enhance research in cancer health disparities at CCs;
• Increase involvement and effectiveness of Cancer Centers in cancer health disparities research;
• Increase the role of CC on augmenting education related to underserved populations;
• Develop more effective outreach and education initiatives that will have an impact on the underserved populations and individuals from underrepresented backgrounds;
• Identify and share innovative methods and approaches that strengthen and sustain each partnership.

Each partnership must have a common Internal Advisory Committee (IAC) shared across the partner institutions. The IAC will be composed of qualified faculty members from the partner institutions, and must have equal numerical representation of members from each partner institution. Each partnership is also required to have a Program Steering Committee (PSC), who will serve as the primary advisory board of the partnership program. The PSC will be composed of qualified external members with the appropriate scientific expertise.

Success of the CPACHE Program will be assessed based on several tangible metrics including, but not limited to, at the ISUPSs, increased infrastructure support, faculty/student recruitment and retention in cancer research, and cancer research-relevant curriculum developed and sustained; at the CCs, increased cancer health disparities research projects and funding, and cancer health disparities courses or curriculum developed and sustained. In addition, for both ISUPSs and CCs, indicators of success will include an increase in the number of underrepresented students and investigators in cancer research, an increase in the number of peer-reviewed publications, an increase in cancer-related grants submitted and awarded, as well as an increased number of cancer-related education and awareness outreach activities to underserved communities and development of community partnerships. The CPACHE Program may promote participation of underrepresented and underserved individuals in cancer clinical trials and bio-specimen donation via the development and implementation of innovative methodologies. In addition to these metrics, each partnership is encouraged to identify metrics unique to their program when designing their approaches.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Each partnership must include both types of institutions: 1) institutions serving underserved health disparity population and underrepresented students (ISUPSs); and 2) NCI-designated Cancer Centers (CCs). Partnerships involving more than two institutions require NCI approval before submitting the application.

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.

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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

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

This FOA supports linked applications. Multiple PDs/PIs are allowed on any single application. Because the FOA already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.

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.

Specific to this FOA:

• The PD(s)/PI(s) are preferred to be mid-to-senior-level scientists who have records of obtaining grants 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, both contact PDs/PIs should also be reciprocally listed as PD(s)/PI(s) on the linked application from the partner institution.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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

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

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

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

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

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter 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:

H. Nelson Aguila, D.V.M.
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 240-276-6170
Fax: 240-276-7862
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administrative Core)	12
Full Research Proj (Use for Full Research Project)	12
Pilot Res Project (Use for Pilot Research Project)	6
Plan and Eval Core (Use for Planning and Evaluation Core)	12
Res Edu Core (Use for Research Education Core)	12
Outreach Core	12
Shared Resource Core	6

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

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

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

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

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

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

Complete entire form.

Descriptive Title of Applicant's Project: To allow NIH to identify the set of two collaborative U54 applications, the titles for each application in the set must have the following format: a 1/2 or "2/2" indicator + identical title. Titles may not exceed 200 characters in length, including the tag (i.e., 1/2 or 2/2) at the beginning of the title.

Cover Letter: The Cover Letter is one pdf file only. Therefore, it must include the information requested below on the collaborative applications from the ISUPSs and CCs. The following collaborative information is required in the Cover Letter: a listing of BOTH applications that are a part of the set of collaborative U54 applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag (i.e., 1/2 or "2/2"), and 3) the Applicant Institution. Each partnering institution should submit an identical listing. For renewal applications only, the Cover Letter should include concurrence of the Program Steering Committee (PSC) for the submission of a renewal application, with the signature of the PSC Chair.

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

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.

Facilities and Other Resources: Provide a description of resources available for the partnership. This description should include allocation of space and facilities, and 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 the institutional research environment will 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 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 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 a ISUPS must include a statement providing justification for the ISUPS designation and signed by the institution official.

Enter primary site only.

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

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

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

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

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

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

Specific Aims: State the objectives of the collaboration. Outline the overall goals relevant to providing support for investigators at both the 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 the ways in which 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 a research education programs that the partnership believes can be achieved during the award period;
• A projected time-line for achieving each objective; and
• Other areas of opportunity that the partnership will consider as the relationship between the partners 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, and imaging), precision medicine, and/or therapeutic clinical trials accrual of underserved populations. Research may be focused on pediatric, adolescent, and young adult cancers. 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. Optimally, 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 early stage investigators.

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; 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), number of participants (students or postdocs, etc.), level of education of participants, where the participants are, modes of tracking of participants, etc., resulting from the U54 award. Discuss how recommendations of the Program Steering Committee, Internal Advisory Committee and institutional leadership (if any) have influenced the initiation, modification, or discontinuation of any project or shared resources. The use of tabular format to summarize all grants, publications resulting from 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. Document that this partnership was derived from careful planning and priority setting processes that were based on each partner's strengths/weaknesses. Describe the outcomes of the planning process that are particularly relevant to the proposed 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: Include here only the publications and accepted manuscripts that resulted 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 leadership of both institutions (e.g., President, Center Director, Dean) to show support of 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 will be wholly dedicated to cancer research under the partnership. The letters should clearly explain how the partner institutions would monitor these efforts and specific steps and procedures to ensure achieving 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);
• Statement of the activities that each faculty listed as Key Personnel is being released from (e.g., teaching, clinical, administrative duties), including a statement as to whether the costs of this released time are shared or not between the institutions and the comprehensive partnership program;
• Statement that details provisions for recruitment of new faculty members;
• Statement that details provisions to leverage funds for 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, with the following modification:

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

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 (Overall)

When involving NIH-defined human subjects research, clinical research, and/or 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: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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

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 a biennial CPACHE workshop), equipment, and supplies to support an administrative structure.

Effort Commitments: 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, with "in-kind" effort. Specifically, a minimum of 1.2 months effort per year is expected for the contact PD/PI from the ISUPS and Cancer Center with a maximum of 3 months effort per year. 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 cost 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.

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

Specific Aims: Succinctly describe the list of 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 efforts in cancer research, research education and outreach. 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 in terms of the qualifications and leadership experience as well as characterize the potential of partnership leaders to integrate the proposed efforts and to 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, administrative duties, will be adjusted or eliminated to allow the faculty members to spend adequate time on the partnership activities).
• Administrative Management: Describe specific functions of the core to provide the necessary day-to-day administrative support, coordination, and logistical services needed 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 Program Steering Committee (PSC; External Activities) and Internal Advisory Committee (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:
• How the recruitment of a specific 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 will 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 type of desirable expertise that the partnership plans to recruit over the 5-year period of this award; and

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, and 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:

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

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 (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Full Research Proj.

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)

For each Research Project, complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project, starting with "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 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) (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 attachment 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/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.
• Please note that Projects Leads and Project 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 (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.

For projects involving clinical trials, funds may be budgeted for data and safety monitoring, if justified.

Full project cannot exceed $275,000 in direct costs per year or continue for longer than 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. Note that 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 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; and
• Approach

Projects Involving Outreach Research. Hypothesis-driven projects in outreach research are encouraged. For example, they may lead to identify, develop, test, evaluate and/or refine 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: 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:

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

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 (Full Research Project)

When involving NIH-defined human subjects research, clinical research, and/or 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Pilot Res 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)

For each Research Project, complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project, starting with "Project 1:", "Project 2:", etc.
• 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, prior to using additional attachment 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.
• 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. Please note that Projects Leads and Project 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 (Pilot Research Project)

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

Budgets for Pilot 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 rationale and specific aims of the Pilot Research Project and explain how it fits into the goals and organizing framework of the partnership.

Research Strategy: A Pilot Research Project may be proposed for research in any area of cancer-related basic, clinical, translational, prevention, control, behavioral, population, and/or outreach 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 identify, develop, test, evaluate and/or refine 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: 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:

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

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 (Pilot Research Project)

When involving NIH-defined human subjects research, clinical research, and/or 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type 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.

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, and external activities, which should include the once per year Program Steering Committee (PSC) meeting;
• Consultant costs and travel costs; and
• Cost items such as special seminar series, inviting experts to make presentations that relate to the objectives of the partnership 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, evaluation and tracking of 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 to follow-up the projects that were supported and evaluate 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 will be required to 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 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).

• Internal Activities: List the names of the IAC members and outline each internal planning and evaluation activity (e.g., IAC meetings, regular forums and 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 method of communication. In instances where there is a problem of distance between partners, applicants are encouraged to consider other methods of communication including e-mail, teleconferences, and videoconferences.) 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 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 objectives of the partnership 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 recruitment of faculty will be implemented.
• 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 partner 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 types of expertise desired and include the names and biosketches of the proposed members 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:

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

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 NIH-defined human subjects research, clinical research, and/or 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

This core supports joint research education programs between the partner institutions. Such programs should be designed to link the faculty, Early Stage Investigators and students of the partner institutions in a manner that will facilitate productive and sustained long-term effective partnerships. The goal of this core is to support creative educational activities that serve the partnership objectives in the following areas:

• Research Experiences
• Curriculum Development (optional)

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

SF424 (R&R) Cover (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 be different from the partner 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 attachment 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 or not salaries are reimbursed) should be identified as senior/key persons. These would include co-Leader(s), if applicable, and other Research Education Core staff.

Program Faculty whose role is to mentor, develop, 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.
• 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 cancer research areas and scientific disciplines encompassed by the Core. Include a brief description of the level(s) (i.e., high school, undergraduate, predoctoral, and postdoctoral) and duration of the proposed research education experience, the projected number of participating individuals and their anticipated levels of experience. If applicable, also 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 occurring 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 are encouraged. Mentors from both sites are encouraged to participate in the proposed activities. Research Experiences and Curriculum Development (if applicable) activities should be linked. Individual Training & Development Plan (IDP) is strongly encouraged for all participants.

Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the research education program is intended, including the education and career level(s) of the participants, 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 any activities designed to develop specific technical skills or other skills essential for the proposed research experience.

Core Leads: Describe arrangements for 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. 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 be used to oversee and monitor the core.

Program Faculty: Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women 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 are engaged. Also, describe experiences relevant to the program and the proposed education and career stage(s) of participating faculty. Describe the criteria used to appoint and remove faculty and to evaluate their participation.

Program Participants: Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation 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.

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. 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, in addition, 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 is encouraged to specify baseline metrics (e.g., numbers, educational levels, and demographic 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 to provide suggestions for improvements. Specified evaluation metrics should be tied to the goals of the program.

Letters of Support: Evidence of institutional commitment to the research educational 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:

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

Dissemination Plan. 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 NIH-defined human subjects research, clinical research, and/or 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

SF424 (R&R) Cover (Outreach 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 Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Outreach 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 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 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 appropriate 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 Core)

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

Partnership applicants that will employ CHEs should describe the specific role(s) of the CHE on the outreach research and on the outreach activities related to the overall goals of the U54 partnership application. CHEs can be hired on a full-time basis or an "as-needed" basis consistent with the proposed outreach research projects and activities; 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 Core)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component. This section should be identical for both the ISUPS and CC applications.

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

Research Strategy: Cancer outreach in the context of this FOA is a joint effort between partner institutions, and must include efforts to effectively reach individuals and physicians and should lead to increased use of specific medical procedures that may result in decreasing cancer health disparities. For example, they may lead to identify, develop, test, evaluate and/or refine 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 recruitment and retention of 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 efforts are strongly encouraged to be connected to cancer-relevant outreach 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 prevention, early detection, and treatment of cancer;
• Working with community organizations to develop programs that encourage life-style changes important for cancer prevention and 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 the electronic information systems that 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 FOA; they must be described under Full Research Project or Pilot Research Project components, as appropriate, NOT in this Outreach Core component.

If a Community Health Education (CHE) is included, his/her main role is to be integrated on the outreach research projects and on the outreach activities assisting the core leads of the partnership grants in the planning and implementation of activities within the Cancer Outreach Research and Core Program. The plans for the U54 CHE may include collaborating with her/his counterpart of the NCI’s National Outreach Network, if applicable.

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

Dissemination Plan. A specific plan must be provided in each application to disseminate nationally any findings resulting from or materials developed under the auspices of the Outreach Core.

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

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 Core)

When involving NIH-defined human subjects research, clinical research, and/or 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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

Complete only the following fields:

• Applicant Information
• 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.).

Resources proposed can either augment existing Cancer Center capabilities or constitute entirely new resources, provided they are tailored to the common objectives and priorities of the partnership. Resources can be in either of the partner institutions (or in 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 partner institutions, and/or specifically enhance research focused on cancer health disparities issues. Shared infrastructure can be placed in either institution or in 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:

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

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 NIH-defined human subjects research, clinical research, and/or 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, you must include 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.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

In addition, for applications proposing 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?

Specific to this FOA: Does the proposed comprehensive partnership address an important cancer and/or cancer health disparities problem? Will the proposed partnership be likely to have a significant effect on 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 members of the participating community? Will the implementation of the partnership result in a sustainable cancer research capability for the ISUPS? Will the implementation of the partnership result in the successful research education of more competitive underrepresented cancer researchers? Will the implementation of the partnership enhance the ability of the Cancer Center to more directly and successfully address the disproportionate cancer burden in racial and ethnic groups and socio-economically disadvantaged populations?

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 proposing 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?

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?

In addition, for applications proposing 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?

Specific to this FOA: Is the study design being proposed already in existence but being applied to new underserved populations? Is the proposed design culturally tailored for the community of interest?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?

In addition, for applications proposing 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?

Specific to this FOA: Are the plans for pilot and full research projects as well as research education and outreach programs well-described and appropriate for the goals of the partnership? Does the applicant present strong arguments for the proposed study design as the best balance of scientific rigor, implementation constraints and ethical sensitivities of partners?

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?

In addition, for applications proposing 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?

Specific to this FOA: How well do the proposed efforts and support take advantage of the available infrastructure and existing resources to help establish the proposed partnership? Is there evidence of sufficient institutional support for the proposed partnership across the participating institutions? Does the applicant indicate the degree and the extent to which both academic and community partners have collaborated in the past? Does the applicant describe the way in which community partners will be included? Is the environment conducive for new, less experienced investigators?

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.

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

• 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 partner 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 (Merit Descriptor)

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 letters of commitment support the priorities and objectives proposed for the partnership?
• Are the resources (e.g., discretionary resources, space, faculty positions, protected time for research, etc.) committed to the partnership, adequate?
• Is the institutional investment/commitment in new, early stage or less experienced investigators adequate?

b. Administrative Core

• Is there evidence of administrative integration of the proposed partnership?
• 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 terms of providing scientific and administrative leadership needed to achieve the objectives of the partnership?
• Does the application provide a strong justification for selecting their Contact 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 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 a 5-year period?

Projects in Required Target Areas (Merit Descriptor for Each Project)

a. Full Research Projects

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

Research Education Core (Merit Descriptor)

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

Outreach Core (Merit Descriptor)

• Do the Core leaders have prior experience in recruiting and developing students and scientists?
• What are the merit and importance of proposed programs?
• What is the potential for the proposed programs to become self-sustaining?
• What is the methodology for evaluating the outcomes of the proposed programs?

Planning and Evaluation Core (Merit Descriptor)

• Are the plans for the continued development of additional projects/programs adequate?
• Are the qualifications and experience of each member of the Internal Advisory Committee adequate?
• Are the design and quality of each of the internal planning and evaluation processes adequate?
• Are the qualifications and experience of each member of the Program Steering Committee adequate?
• Is the plan for using the Program Steering Committee effective?
• Are the process and criteria for identifying and implementing the resource and infrastructure needs adequate?

Additional Review Criteria

Study Timeline

Specific to applications proposing 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)?

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

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

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

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

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

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

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.

Not Applicable.

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

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

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

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

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:

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

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

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

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

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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

PD(s)/PI(s) Commitments. Awardees must be committed to making the research tools and research 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 all a 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 months effort per year is expected for the contact PD/PI from the ISUPS and Cancer Center with a maximum of 3 months effort per year. 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). There must be a common Internal Advisory Committee (IAC), shared across the partner institutions. IAC will be responsible for internal planning and evaluation activities of the partnership. The IAC will be made up of 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 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 ex-officio member. All PD(s)PI(s) from both institutions will select members of the IAC, as needed 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 objectives of the partnership and their 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 partner institutions. 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 Program Steering Committee (PSC). Upon receiving the Notice of Award, the contact PD(s)/PI(s) will convene a teleconference of the Program Steering Committee (see 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 that are to be evaluated to the PSC at least 4 weeks before the meeting. The PSC chair will make assignments for other PSC members based on their expertise and experience. All members at the PSC will prepare the first draft of their recommendations, in the form of a written annual report. The PSC report should be a critical assessment of 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 commitment of the leadership to the partnerships and the faculty members involved. No later than 3 weeks after the adjournment of the meeting, the final draft of PSC report must be submitted to the NCI Program Director (PD). The NCI PD will have one week to comment or suggest any changes on the report, after one week the final draft will be returned to the PSC Chair. The PSC Chair will submit the final report to the contact PD(s)/PI(s). The contact PD(s)/PI(s) must submit the PSC report to the leadership of their partner institutions (i.e., to the Cancer Center 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 Non-Competing Continuation Application 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 to ensure that the necessary interactions are taking place. These meetings may be in the form of phone teleconferencing, videoconferencing, and/or web conferencing as well as face-to-face meetings.

Workshops. The contact PD(s)/PI(s) and senior administrators for the program (e.g., Program Managers) must attend a Biennial Workshop for sharing information and strategies. NCI will convene a Planning Committee to develop an agenda for the workshop.

Reports. Each partner awardee 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 Research Performance Progress Report (RPPR).

Approval of Changes. If the institutional leadership (i.e., Cancer Center 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 rationale for replacement.

Internal Evaluation of the Comprehensive Partnership Program. The IAC is responsible for the internal evaluation of the partnership 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, awardees 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, it is highly encouraged that an Individual Development Plan (IDP) is included for the investigator. The same process will apply to additional programs and/or activities that are proposed for development in the education and outreach cores during the award.

Concepts/applications for these additional projects will be prioritized by the IAC. Depending on the priority, the IAC will be expected to recommend either: (1) funding of the project as requested; or (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. Final decisions will be the responsibility of the PSC and NCI Program.

• Evaluation of Ongoing Pilot, Full Projects and Project Concepts under Development. The IAC will also perform an evaluation of existing pre-pilot, pilot, and full projects. This evaluation may be once a year or more frequently as deemed necessary by the PSC.

The following recommendations are possible: (1) convert either pre-pilot to pilot and/or pilot to 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 evaluate the Administrative, Research Education and Outreach Cores on an ongoing basis. The IAC will make recommendations and provide guidance for workshops, retreats, focus groups, and other forums to identify areas of new opportunity as well as for strengthening, stabilizing, and merging existing projects or programs. In addition, the committee will also evaluate and recommend other key partnership activities such as the recruitment of new investigators and research associates, and the establishment of 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), the cores as well as other activities will be forwarded to the Program Steering Committee (PSC, see below) for concurrence. If the IAC recommendations change the scope of the partnership objectives, those recommendations must be reviewed and approved by the PSC. The contact PD(s)/PI(s) must make minutes of the IAC meetings conducted throughout the year available to the PSC.

Sharing Experiences. Successful partnerships are expected to participate in sharing their approaches and experiences with other NCI-supported Centers, Networks, and other institutions.

Participation in program evaluation. All PD(s)/PI(s) of the partnerships program are expected to participate 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 objectivity and credibility of the evaluation findings and recommendations. However, CRCHD Program Officers will remain responsible for the scientific management, annual progress report review of each grant and evaluation of the partnership program. CRCHD, with feedback from PIs, will develop program-specific logic model which will include appropriate performance measures, program outputs and outcomes which will be used to identify the core data elements required for monitoring and evaluating the program overall. If the evaluation is conducted by an independent contractor, the contractor shall work in collaboration and seek the input of the PD(s)/PI(s) and NCI program officials in developing the program logic models and in specifying the core data elements.

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 the adjustment of projects/programs or approaches as warranted;
• Provide review and comments on all major transitional changes of an individual partner's activities prior to implementation to assure consistency with the goals of this FOA;
• 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 the dissemination of experiences and approaches among awardees of the partnership program as well as other NCI-designated Cancer Centers 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 time-line for achieving the objectives of the FOA;
• 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, projects/programs, and faculty recruits to ensure that they fall within the bounds of the areas prioritized for development and stabilization;
• Select members of the Workshop Planning Committee to organize a biennial 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 dominant role and prime responsibility for the activity resides with the awardees for the project although 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 NCI waiver per the NCI procedures for management of conflict of interest if such participation is deemed necessary.

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCI Program Official and Project Scientist may be the same person.

Areas of Joint Responsibility include:

The awardee institutions and the NCI staff members will work together to establish the Program Steering Committee (PSC) and then will participate in its activities.

PSC will serve as the primary advisory board of the U54 comprehensive partnership program. Based on continuing evaluation of the program, PSC will be responsible for making recommendations regarding: (a) establishing priorities; (b) changing directions; and (c) identifying areas of new opportunities.

Composition and organization 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. Changes in the composition of the PSC must be approved by the NCI Program staff.

• 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. Changes in the composition of the PSC must be approved by the NCI Program staff.
• Each full member of 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, who will be one of the PSC voting members.
• Subcommittees with additional ad hoc advisors may be established by the PSC as necessary to meet its planning, priority setting and evaluation responsibilities.
• The PSC will meet once per year.

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);
• Attend the annual PSC meeting, preferentially in person.
• Making recommendations for establishing priorities;
• Making recommendations for changing direction and identifying areas of new opportunities to accomplish mutual objectives more successfully; and
• Making recommendation regarding individual projects (pilot/full) and cores based on the progress during the prior funding period.

Awardees, 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 Program Response to the PSC report section in the Non-Competing Grant Progress Report.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

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

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

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

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

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

Carol Perry
National Cancer Institute (NCI)
Telephone 240-276-6282
Email: [email protected]

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

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