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; 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.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) 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

This Funding Opportunity Announcement (FOA) invites applications for cooperative agreement (U54) awards to support Comprehensive Partnerships between:

(1) Institutions serving underserved health disparity populations and underrepresented students (ISUPS); and,

(2) NCI-designated Cancer Centers (CC).

The cancer health disparities research activities are aimed at understanding the reasons behind the disproportionate cancer burdens and their impacts on underserved communities and socio-economically disadvantaged populations.

Presently, the NCI supports several comprehensive partnerships (U54 awards) through this program. In addition, a few institutions of this program were funded through the Exploratory Grants--Cooperative Agreements (U56).

This Funding Opportunity Announcement (FOA) targets past and current awardees of the Comprehensive Partnership program (supported by either U54 or U56 awards) and similar partnerships with the intention to:

1. Extend the support for the best of the partnerships that are currently supported (including a no-cost extension status) by a U54 Comprehensive Partnerships award;
2. Elevate to the full Comprehensive Partnership status the best partnerships supported in the past by the planning/developing phase U56 awards; and
3. Provide opportunities for similar partnerships that have completed their planning phases to apply for Comprehensive Partnership status.

Applications from those partner institutions currently in the last year of support of the U54 Comprehensive Partnership awards are to be submitted as renewal (Type 2) applications.

Applications from those partner institutions that were supported through the U56 Exploratory Grants--Cooperative Agreements awards are to be submitted as new (Type 1) applications.

Applications from similar partnership that have completed the planning stage are to be submitted as new (Type 1) applications.

Interested eligible partnerships must submit linked applications in response to this FOA that would maintain the institutional composition/configuration of the partnership as in their preceding linked U54 or U56 awards.

The partnership program is expected to promote a stronger national cancer research effort aimed at developing cancer research capacity at ISUPS as well as understanding the reasons behind cancer health disparities and their impact on underserved and socio-economically disadvantaged populations. Specifically, the program aims to overcome two major obstacles to progress in this area namely: (1) insufficient research enrichment opportunities for scientists in underserved communities engaged in cancer research; and (2) the low level of involvement of leading cancer research and healthcare institutions.

The NCI-sponsored partnership program is a powerful vehicle that can help ISUPS and CCs to integrate and take maximum advantage of their respective expertise and experience to work together in areas of mutual benefit. For example, both types of institutions may benefit from a broader range of resources and technical expertise. The ISUPS will gain exposure to state-of-the-art technology and access to information services available at the CCs. Reciprocally, the CCs will gain a greater diversity of students, faculty members, and investigators participating in cancer research-related activities and increased access to underserved patients for cancer and health disparities - related clinical trials while understanding the sensitivity of information collected and respecting the cultural norms of all patients.

Health Disparities in Underserved Populations. The disparities in cancer incidence, morbidity, and mortality in underserved populations, including racial and ethnic populations and socio-economically disadvantaged groups have continued to rise over several decades, despite the significant progress in other aspects of cancer research. For example, the five-year relative survival is lower for African Americans than whites for most cancers at each stage of diagnosis. However, Hispanics have higher incidence and mortality rates for cancers of the stomach, liver, uterine cervix, and gallbladder, reflecting greater exposure to cancer-causing infectious agents, lower rates of screening for cervical cancer, differences in lifestyle and dietary patterns, and possibly genetic factors. In addition, cancer incidence and death rates are lower in other racial and ethnic groups than in whites and African Americans for all cancer sites combined and for the four most common cancer sites. However, incidence and death rates for cancers related to infectious agents, such as uterine cervix, stomach, and liver, are generally higher in underserved health disparity populations than in whites. Stomach and liver cancer incidence and death rates are twice as high in Asian Americans/Pacific Islanders as in whites, reflecting an increased prevalence of chronic infection with Helicobacter pylori and hepatitis B virus in this population. Kidney cancer incidence and death rates are the highest among American Indians/Alaska Natives, which may reflect the high prevalence of obesity and smoking in this population. The extent to which these disparities reflect unequal access to health care versus other factors remains an active area of research. Overall, progress in reducing cancer death rates has been made, although more can and should be done to accelerate this progress through ensuring equitable access to cancer prevention, early detection, and state-of-the-art treatment strategies.

Need for Critical Research Workforce Mass in Health Disparities. Institutions serving underserved health disparity populations and underrepresented students represent a rich source of potential clinical subjects, and talent with cultural sensitivity and perspectives that may contribute to the conduct of research on cancer health disparities and high quality educational programs for persons interested in serving racial/ethnic groups and the underserved populations. However, investigators at these institutions have to overcome difficulties in developing and sustaining independent programs in biomedical research. Notably, the NIH has commissioned and supported a number of studies in recent years to address and examine the unacceptable status and many factors that contribute to the lack of diversity of the biomedical and behavioral research workforce. Despite various initiatives, progress has been slow in increasing the pool of scientists from underrepresented groups who are competitive for NIH research grants.

A significant enhancement in the pool of well-trained scientists from underrepresented backgrounds who can conduct independent competitive cancer research is needed. While many scientists may have an interest in elucidating the factors leading to cancer health disparities, the cultural perspectives of scientists from these communities are also essential to successfully conduct research on the disproportionate burden of cancer in underserved and socio-economically disadvantaged populations. Moreover, the institutions funded through this FOA provide unparalleled access to patients and scientists from these populations, and opportunities to observe whether concordance between researchers and clinical subjects improves participation, satisfaction, and compliance with clinical regimens. The NCI-designated Cancer Centers are geographically dispersed, research-intensive institutions with well-organized programs for educating cancer scientists. They are the major organized units supported by the NCI to: conduct cancer research; sponsor cancer-related research education in the basic, clinical, translational, and population sciences; as well as develop and sustain educational and outreach programs that benefit their communities. In recent years, CCs have begun to play greater roles in facilitating:

(1) research pertinent to cancer in underserved and socio-economically disadvantaged groups;

(2) research education for scientists from underrepresented backgrounds;

(3) engaging and partnering with underserved and socio-economically disadvantaged groups; and

(4) disseminating the benefits of advances in cancer research to diverse groups within their communities.

Since the inception of CPACHE, participating institutions have been making significant contributions to the activities of the CCs in these areas but much remains to be accomplished.

The Comprehensive Partnership Program is about building and sustaining excellence. 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.).

The focus of the Partnership is on cancer research and outreach. Other areas include activities facilitating cancer research, such as research enrichment activities and education. All of these activities combined are expected to lead to vigorous efforts aimed at securing independent peer-reviewed funding from NIH and other funding agencies.

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

1) Increase the participation of the institutions serving underserved health disparity populations and underrepresented students (ISUPS) in the nation’s cancer research and research education enterprise;

2) Produce more competitive grant applications from minority scientists;

3) Increase competitive research capacity of ISUPS;

4) Increase involvement and effectiveness of Cancer Centers in research and education related to underserved populations;

5) Develop more effective outreach and education initiatives that will have an impact on the underserved populations and individuals from underrepresented backgrounds;

6) Enhance research in cancer health disparities at Cancer Centers.

The U54 linked award applications must be focused on cancer research but appropriate supporting activities on research education and outreach are also required.

1. 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. The numbers of such projects that are required are somewhat different for the renewal of the U54 Comprehensive Partnership award versus new U54 application submitted by the U56 planning grant awardees (see Section IV. Content and Form of Application Submission).

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

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

4. Research Education Core: This core supports joint research education programs between the partner institutions. Such programs link the faculty and students of the partner institutions. The goal of this core is to support educational activities that complement and/or enhance the education of a workforce to meet the nation’s biomedical, behavioral and clinical research needs. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

• Research Experiences

These programs must emphasize the following: (a) the research enrichment of students and early stage investigators underrepresented in biomedical and cancer research; and (b) cancer health disparities and cultural issues and problems associated with cancer disparities in underserved health disparity populations. The NCI particularly encourages the development of scientists underrepresented in basic, clinical, translational, behavioral, and population research, i.e., in the field of studies that depend largely on the cultural sensitivities of the investigators for success..

5. Outreach Core: It is expected that both partnering institutions will engage in outreach efforts that would benefit communities with cancer health disparities. Optimally such efforts may be connected to cancer-relevant outreach research (e.g., through pilot projects or research development activities).

6. Planning and Evaluation Core: Partnership awardees will be required to conduct (as a continuous process) planning, evaluation and tracking of partnership activities. Applicants must incorporate appropriate strategy to ensure that planning, evaluation and tracking will be constantly ongoing, and that the outcomes of those processes will constitute the basis for initiating (and terminating, if needed) the investment of resources into developmental projects, programs, resources, and recruitments. For example, applications must outline the strategy for soliciting, evaluating, funding, and assessing of additional research projects (beyond the specific projects described in the application). Thus, awardees will be required to develop additional pilot and/or full research projects to provide continuity of research activities.

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) an institution serving underserved health disparity populations and underrepresented students (ISUPS); and 2) an NCI-designated Cancer Center (CC). In addition to such dyad partnerships, eligible partnerships may also involve three institutions (e.g., triads defined as two institutions serving underserved health disparity populations and underrepresented students (ISUPS) and one Cancer Center (CC) or two Cancer Centers and one ISUPS). Only existing partnerships are eligible to apply as triad in response to this announcement.

ISUPS 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.

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

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

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

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

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

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Specific to this FOA:

1) No overlap with current partnership (U54) awards allowed. The NCI will issue Comprehensive Partnership awards only to institutions for which the prior qualifying U54 or U56 awards have expired. Therefore, an institution with an active U54 partnership award cannot submit a renewal (Type 2) application unless the grant is in its final year of funding.

2) Partnership Structure. Each U54 application must reflect a clearly documented existing partnership between the partnering institutions.

• For each partnership, separate applications must be submitted, i.e., one from each partner institution.
• Applications from eligible institutions must be linked in the same institutional configurations as in the original qualifying awards.
• The PD(s)/PI(s) are generally 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 ISUPS can be designated as one of multiple PDs/PIs, provided that there is an appropriate institutional investment in this investigator, and that this individual will work collaboratively with a more experienced PD/PI.
• The contact PDs/PIs on the ISUPS application must be an ISUPS PD/PI, and the contact PD/PI for the CC must be a CC 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.
• The overall priorities and objectives for implementation of the linked applications must be the same, but the actual activities and budgets of the individual applications should demonstrate how the partner institutions requests differ and complement each other in achieving these priorities and objectives.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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

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

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

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

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

The letter of intent should be sent to:

Peter O. Ogunbiyi, DVM, Ph.D.
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 240-276-6176
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
Core Use for: Shared Resource Core Outreach Core Planning and Evaluation Core	12
Project (use for Full Research Projects)	12
Pilot Res Project (use for Pilot Research Projects)	6
Res Edu Core (use for Research Education Core)	12

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

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

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
• Full Research Project: minimum of 2 for renewal applications from U54 awardees and a minimum of one for new applications from planning grant U56 awardees;
• Pilot Research Project: one required for renewal application from U54 awardees and two for new applications from planning grant U56 awardees;
• Shared Resources Core: optional; maximum of 3
• Outreach Core: required
• Planning and Evaluation Core: required
• Research Education Core: required

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 ISUPS 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.

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, 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 in order 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: Both New and Renewal applicants must provide the assessment of their U56 and U54 partnerships by their respective Program Steering Committees (PSCs).

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 replacement may be needed when the partnership PD/PI is no longer willing or able to lead the program or leaves the institution. The selected PD/PI must be approved by the partnership PSC and NCI.

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

Specific Aims: State the objectives of the collaboration. Outline the overall goals relevant to providing support for investigators at both the 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 Overall research strategy should be identical for both ISUPS and the CC partnership applications. Although the overall objectives of the two applications must be the same, the actual activities proposed for the two applications should demonstrate how the ISUPS and the CC requests both differ and complement each other in achieving their common objectives.

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 program 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.

In addition, describe:

• 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). Research may be focused on pediatric, adolescent, and young adult cancers. Hypothesis-driven outreach research projects may also be appropriate.
• 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.
• Other areas of encouraged activities include: educational/dissemination activities, outreach activities and outreach research (especially aimed at increased high quality, clinically annotated biospecimens from underserved populations, which is a critical endeavor to stimulate research studies addressing the biological and genetic factors associated with cancer health disparities).

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 rather as a step in the career development 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, and recruitment; Research Projects/Programs; Career Development; 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 students, tracking of students, 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 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 U56 planning process that are particularly relevant to the proposed full-fledged partnership under the U54 mechanism.

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: The publications and accepted manuscripts, which have resulted from projects conducted during the current funding period, should be included here. Using an asterisk, mark each listed publication that results from formal collaborations among different projects within the Partnership. For publicly available citations, PMC submission identification numbers (PMCID), if required, should accompany the full reference. Copies of these publications should not be included as appendix material.

Letters of Support: Each application must include written "Letters-of-Commitment/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 Native Americans are involved, a Letter of Commitment from the Tribal Nation Leader is required.

These "Letters-of-Commitment/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 the purpose of long-term sustenance of the U54-supported activities.
• 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;
• 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.

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 submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

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

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

When 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 Summary/Abstract: Describe the overall goals and strategies for the Administrative 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

List all performance sites that apply to the specific component.

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

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

It is preferred that individual designated as the contact PD/PI be an established investigator with active competitive research support, such as R01 grants or equivalent peer-reviewed funding.

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

Administrative costs (which may be higher 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 PACHE 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. Specifically, if the multiple PD(s)/PI(s) option is not used, the PD/PI from the ISUPS is expected to commit a maximum of 3 months effort per year and the Cancer Center PD/PI is expected to commit at least 1.2 months effort per year but not more than 3 months effort per year. If the multiple PD(s)/PI(s) option is used, 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 efforts per year is limited to 6 months for the ISUPS and 4.2 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 and Revision applications, 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. In order 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 succinctly 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 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 such 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).

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 submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

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

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

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

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

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

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

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

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 and Revision applications, 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 Studies; and
• Approach

Projects Involving Outreach Research. Hypothesis-driven projects are encouraged that may lead to increased use of and access to beneficial medical procedures, such as primary prevention measures, e.g., smoking cessation and cancer vaccines, or early detection procedures, such as mammography, PAP smear, colorectal cancer screening, etc. Research studies may include focus groups and needs assessments.

Protection of Human Subjects:

Projects Involving Clinical Trials. Research projects involving clinical trials must include a data and safety monitoring plan as described in the SF424 Application Guide instructions.

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 subsequent to funding of a U54, to the NCI Program Director.

Letters of Support: Each application must include written "Letters-of-Commitment" from the respective leadership of both institutions (e.g., President, Center Director, Dean) to show support of the partnership and commitment of 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 Native Americans are involved, a Letter of Commitment from the Tribal Nation Leader is also required.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

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

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

Planned Enrollment Report (Full Research Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Full Research Project)

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

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 and Revision applications, 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.

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 Studies; and
• Approach

Projects Involving Outreach Research. Hypothesis-driven projects are encouraged that may lead to increased use of and access to beneficial medical procedures, such as primary prevention measures, e.g., smoking cessation and cancer vaccines, or early detection procedures, such as mammography, PAP smear, colorectal cancer screening, etc. Research studies may include focus groups and needs assessments.

Protection of Human Subjects:

Projects Involving Clinical Trials. Research projects involving clinical trials must include a data and safety monitoring plan as described in the SF424 Application Guide instructions.

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 subsequent to funding of a U54, to the NCI Program Director.

Letters of Support: Each application must include written "Letters-of-Commitment" from the respective leadership of both institutions (e.g., President, Center Director, Dean) to show support of the partnership and commitment of 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 Native Americans are involved, a Letter of Commitment from the Tribal Nation Leader is also required.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

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

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

Planned Enrollment Report (Pilot Research Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Research Project)

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

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

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

Shared resources are optional but limited to a maximum of 3 per partnership.

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.

In general, a shared resource should serve at least two projects.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Core(s) 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 and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Outline the specific aims of the Shared Resource Core and describe which projects will be supported by the Core.

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 either can augment existing Cancer Center capabilities or they can constitute entirely new resources, as long as they are tailored to the common objectives and priorities of the partnership. Resources can be located 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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

Planned Enrollment Report (Shared Resource Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Shared Resource Core)

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

When preparing your application in ASSIST, use Component Type Core

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

SF424 (R&R) Cover (Outreach Core)

Complete only the following fields:

• Applicant (Co-Leads) Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s (Co-Leads') Outreach Core Name
• 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.
• Individuals to be designated Community Health Educators (CHEs) must have appropriate training and knowledge of the NCI programs and experience in community engagement, communication, comprehensive cancer control, program planning, and evaluation. 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 (Outreach Core)

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

Partnership applicants should anticipate that approximately 6 person months of the workload of CHEs will be devoted to NCI activities and the remaining 6 person months to the Partnership cancer outreach research activities including planning and evaluation.

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 and Revision applications, 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. Examples include primary prevention measures, e.g., smoking cessation and cancer vaccines, or early detection procedures, such as mammography, PAP smear, colorectal cancer screening, etc.

In addition, recruitment and retention of individuals from underserved health disparity populations into clinical trials such as prevention, early detection, or treatment trials are encouraged.

Possible Partnership actions to help underserved communities may include (but are not limited to) Partnership activities such as:

• Utilizing church networks to reach and educate the citizens of 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 that emphasizes the importance of early detection and diagnosis;
• Developing continuing education programs for community health care providers to ensure that they are able to offer 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 utilize the electronic information systems that can educate individuals about cancer and help them make informed decisions about their health.

Note: Although hypothesis-driven outreach research projects are allowed (and encouraged) for this FOA, they must be described under Full Research Project or Pilot Research Project components, as appropriate, NOT in this Outreach Core component.

Community Health Educator. Applicants must include in their plans, facilitate and implement the following activities of the CHE:

• The CHE will work with the community and NCI’s National Outreach Network to identify, develop, and disseminate health promotion/cancer education materials, important NCI messages, etc.
• It is expected that certain activities under the Cancer Outreach Core will be guided and coordinated by the NCI. For this purpose, the partnership application must include plans for one properly trained individual designated as Community Health Educator (CHE), who will function between the two institutions. The CHE will assist the core leads of the partnership grants in the planning and implementation of activities within the Cancer Outreach Program. The CHE will also work with the community and the NCI’s National Outreach Network on NCI-coordinated agenda. These will include identification, development, and dissemination of health promotion/cancer education materials, important NCI messages (e.g., disease prevention, etc.

The plans must also take into account that the CHE will be involved in the following NCI-coordinated activities within the Cancer Outreach Core by:

• Increasing awareness and adoption of NCI recommendations on cancer prevention, early detection, and treatments through dissemination of information and education materials;
• Participating in an annual NCI training and ad hoc training activities;
• Assisting in message development and cancer content for culturally competent study brochures and educational materials;
• Disseminating relevant NCI messages, materials, programs, and research opportunities; and
• Coordinating review, evaluation, and dissemination of select culturally competent, evidence-based materials developed by awardees and others to assess and demonstrate their effectiveness.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report (Outreach Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Outreach Core)

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

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

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

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s (Co-Leads") Core
• Proposed Core 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 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 (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.

PHS 398 Research Plan (Planning and Evaluation Core)

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

Specific Aims: Partnership awardees are required to conduct as a continuous process planning, evaluation and tracking of partnership activities. Applicants must incorporate appropriate strategy to ensure that planning, evaluation and tracking will be constantly ongoing, and that the outcomes of those processes will constitute the basis for initiating (and terminating, if needed) the investment of resources into developmental projects, programs, resources, and recruitments. For example, applications must outline the strategy for soliciting, evaluating, funding, and assessing additional research projects (beyond the specific projects described in the application). Thus, awardees will be required to develop additional pilot and/or full research projects to provide continuity of research activities.

Research Strategy: This section must be identical for each of the linked applications. Specific aspects to be addressed in this section are indicated below.

• 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 IAC 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 course of 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 new 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: Each application must include written "Letters-of-Commitment" from the respective leadership of both institutions that are supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum sustainability. Complete and specific descriptions of these additional resources in the "Letters-of-Commitment" should include the following items:

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

Planned Enrollment Report (Planning and Evaluation Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Planning and Evaluation Core)

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

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 educational activities that complement and/or enhance the training of a workforce to meet the nation s biomedical, behavioral and clinical research needs. To accomplish the stated over-arching goal, this FOA will support creative educational activities in the following areas:

• Research Experiences; and

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 (Outreach 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.

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 and Revision applications, an Introduction to Application is allowed for the Research Education Core.

Specific Aims: Describe the 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.

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

Program Plan: While the proposed research education program may complement ongoing research education occurring at the applicant institution, the proposed educational experiences must be distinct from those research education programs currently receiving federal support. When research education programs are on going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research education supported by the training program. The description should include the educational and/or career level(s) of the planned 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 trainees. 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 Program Director/Principal 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, as a joint activity between the ISUPS and the CC, 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 as well as experiences relevant to the program and the proposed education and career stage(s) of program participants. 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 award. The application must 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. Wherever 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 Plans: 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 Guide.

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 research education program. .

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

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: https://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.

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 NOT-OD-13-030.

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

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

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

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Does the proposed Comprehensive Partnership address an important cancer and health disparities problem? Will the proposed partnership have a significant effect on the broader field of 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 and/or result in the significant, 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 New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Does the investigator(s) have prior adequate training and experience in designing and implementing new research education programs that are culturally appropriate interventions?

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

Specific to this FOA: Is the study design being proposed already in existence but being applied to new underserved populations? Will the proposed design be culturally tailored for the community of interest? Will plans be made available and flexible enough for modification, if found to be beneficial?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Are the plans for pilot and full research projects as well as outreach and educational programs adequately described and appropriate for the goals of the particular partnership? Does the applicant present strong arguments for the proposed study design as the best possible 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?

Specific to this FOA: How well do all the proposed efforts take advantage of the available infrastructure and existing resources of 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 and early stage 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)

• Is there evidence of productive collaborations between the partner institutions during the current or past funding period? Has the applicants partnership achieved the goals for the current or past funding period?
• Have the partnership projects/program led to new funding for the partnership institutions?
• Is the performance/progress of the partnership sufficient to ensure the likelihood of success in the next funding period?

Overall Evaluation and the Partnership Integration

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 in less experienced investigators adequate?

b. Administrative Core

• Is there sufficient evidence of administrative integration of the proposed partnership?
• Is the proposed quality of the 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?

c. Scientific and Administrative Leadership:

• How strong are the qualifications and experience of the Contact 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?
• What is the quality of the recruitment plan and the potential of individual recruitment proposed to contribute substantially to the program?
• Is the proposed 5-year faculty recruitment (Early Stage Investigators) appropriate and strategically adequate?

d. Scientific Integration:

• Is there sufficient evidence of administrative 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/ and core components coherent and sufficient as joint efforts?
• How well do these components (taken together) address the priorities and objectives of the Comprehensive Partnership Program as related to required target areas of research, education and outreach?
• Can these priorities and objectives be achieved within a 5-year period?

Projects in Required Target Areas

a. Pilot Research Projects

• 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 an NIH or other funding agency competing application in 3 years or less?

b. Full Research Projects

• What is the relationship of the project to the objectives of the partnership as well as other programs in the partner institutions?
• What is the potential for a Partnership project to evolve into an independently competitive and fundable project?

Research Education Core

• Do the applicant and other team members have appropriate prior experience in recruiting and developing students and post-doctoral fellows?
• What are the levels of merit and importance of proposed programs?

Outreach Core

• What are the merit and importance of proposed programs?
• What is the potential for the proposed programs to become self-sustaining?
• What are the plans for measuring the success of the proposed programs?

Planning and Evaluation Core

• 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?

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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) Genome Wide Association Studies (GWAS)/Genomic Data Sharing Plan .

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

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

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

Minimal 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. The awardees must ensure a significant effort commitment of the program leadership. Specifically, contact PD(s)/PI(s) from the ISUPS must commit a minimum of 1.2 month-effort to the partnership activities, although a commitment level of 3 months-effort is expected if there are no other PD(s)/PI(s) from that side of the partnership. Contact PD(s)/PI(s) from the Cancer Center must commit a minimum of 1.2 month-effort regardless of the number of PD(s)/ PI(s) from the CC side of the partnership.

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. The contact 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 IAC 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, ad hoc reviewers from within or outside the partner institutions may be added to the IAC. 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 2 weeks after the adjournment of the meeting, the final PSC report must be submitted 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 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. Unwillingness or a consistent inability of a PD/PI to attend this workshop may be the basis for administrative action including termination of the award.

Workshops. The contact PD(s)/PI(s) and senior administrators for the program (e.g., Program Managers) must attend a Biennial Workshop for the purpose of sharing information and strategies. A Planning Committee will be convened by the NCI to develop an agenda for the workshop (see Section III. 3.A.12).

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 course of the award, new letters of commitment must be sent to NCI no later than 90 days after the change. Any change of PI(s) and project and/or program leaders must be approved by the PSC and NCI. 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 in the course of 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, the project must be accompanied by a Career Development and Mentoring Plan (CDMP) as required for projects directly proposed in the application. The same process will apply to additional programs and/or activities that are proposed for development in the training and outreach cores during the course of the award. Each plan must be placed in the Career Development and Mentoring Plan (CDMP) section.

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.

• 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 assistance in reviewing and commenting 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 of 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 of 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 as a whole, 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 according to 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) (contact PD(s)/PI(s), if multiple PD(s)/PI(s) option is used) will nominate the members of the PSC, except the NCI Project Scientist, 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 in order 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);
  • 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 generally will be expected to accept and implement policies approved by the PSC and its programmatic recommendations. 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.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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

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

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

eRA 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

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)
Telephone: 301-945-7573
Email: [email protected]

Carmen P. Moten, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone Number: 240-276-6181
Email: [email protected].

John Ojeifo, M.D., Ph.D.
National Cancer Institute (NCI)
Telephone Number: 240-276-6186
Email: [email protected]

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

Aida Vasquez
National Cancer Institute (NCI)
Telephone Number: 240-276-6319
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 Parts 74 and 92.