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

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

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

The purpose of this Funding Opportunity Announcement (FOA) is to support the planning and development of translational research programs focused upon cancer health disparities research. The P20 grants supported by this FOA are expected to expand into comprehensive translational research programs focused upon cancer health disparities and ultimately compete for P50 awards under the umbrella of the National Cancer Institute (NCI) "Specialized Programs of Research Excellence (SPOREs)".

Each P20 Program proposed must include the following components:

• Research Program (at least two translational research projects are required);
• Administrative Core;
• Shared Resource Facility (Biospecimen/Pathology Core is required); and
• Developmental Research Program.

The research supported through the P20 Program must be translational in nature and must focus upon knowledge of human biology with a translational human endpoint proposed. The proposed research theme for the P20 Program must be focused on addressing disparities in cancer incidence, prevalence, mortality, survivorship, and/or burden of cancer, or related health conditions, that are well documented among racial/ethnic minority populations. Projects may focus on a wide range of research areas including prevention, early detection, diagnosis, treatment, epidemiology and/or cancer control, and are expected to have clear translational potential to advance research findings to applications relevant for clinical practice and/or healthcare settings.

Cancer Health Disparities: Adverse differences in cancer incidence, prevalence, mortality, survivorship, and/or burden of cancer, or related health conditions, that exist among specific populations.

Racial/ethnic minority populations: Populations having the following racial or ethnic backgrounds: American Indian/Alaska Natives, Asians, African Americans, Native Hawaiians/Pacific Islanders, and Hispanic/Latinos.

Translational Research: Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer.

Complexities of Cancer Health Disparities. The causes of cancer health disparities are multifactorial, including differences in access to health care, diet and lifestyle, cultural barriers, environmental exposures, and ancestry-related biological/genetic factors. Furthermore, the interplay of these determinants is exceedingly complex, making this field of research remarkably challenging.

Role of SPOREs in NCI-supported Cancer Research, Including Cancer Health Disparities. SPOREs are multi-project, multi-disciplinary research programs that conduct translational research in various areas of cancer prevention, early detection, diagnosis, and treatment of human cancers. To date, there are no SPORE grants with an exclusive focus on cancer health disparities, as most currently funded SPOREs are organized around a single organ-specific cancer. However, in recent years, NCI has encouraged SPORE applications to expand beyond the organ site and focus upon highly related cancers, cancers driven by common pathways, or other cross-cutting themes (including cancer health disparities). Given the underrepresentation of translational research studies investigating cancer health disparities, the field may benefit from planning support to build the necessary infrastructure for competitive research programs. Establishing complex, multi-component research programs, such as a SPORE, may facilitate scientific advancements in better understanding and addressing cancer health disparities.

Overarching Goals. The main goal of this FOA is to promote the development of comprehensive translational research programs with distinct focus on, and primary relevance to, addressing cancer health disparities. Accordingly, each P20 Program proposed must be driven by this objective.

Proposed P20 Programs must be based on strong well-developed Research Projects, supported by appropriate infrastructure (see details below).

In addition, being a "planning and feasibility" grant, the proposed P20 Programs must have a clear potential for, and a defined path, to future expansion. Specifically, it is expected that the P20 awardees should be able to compete for a full P50 SPORE award, or a comparable program, by the end of the project period. For these reasons, applicants are strongly encouraged to familiarize themselves with the SPORE program, including its objectives, requirements, and modus operandi.

Focus on Health Disparities and Appropriate Cancer Types. All research activities of the proposed P20 Programs should be directly relevant to addressing cancer health disparities as defined in this FOA. Applicants are encouraged to focus upon cancer types for which health disparities are particularly well documented including cancers of the cervix, gastrointestinal systems, endometrium, head and neck, liver, lung, and kidney, as well as leukemia and myeloma. Although studies involving these cancers are strongly encouraged, other cancer types (except for breast and prostate cancers) can be included if a disparity is appropriately justified.

Note: Projects proposing studies of breast and prostate cancers will be non-responsive because these cancer types are well represented among current cancer health disparities focused NCI-supported awards.

Translational Potential. The proposed research must be translational in nature and be appropriate to support the Program goal of combining experimental/laboratory approaches with studies involving human specimens or other types of human-focused applied research (e.g., epidemiology, population studies, or clinical trials.) Laboratory/experimental research may involve any relevant cellular, molecular, structural, biochemical, and/or genetic approaches in vitro and/or in vivo.

The goals of such research may vary widely and may include, for example:

• Advancing a new tool, technology, therapeutic agent, etc., towards clinical implementation;
• Using human biospecimens to study new phenomena, discover and/or develop biomarkers, and/or optimize previous findings;
• Developing new hypotheses based on results from human studies; and/or
• Other aspects addressing cancer health disparities.

Human Endpoints. The unifying aspect for all studies under the P20 Program is the requirement for the inclusion of endpoints that are clearly oriented on humans and (with few exceptions specified below) derived from studies on human subjects and/or human clinical biospecimens. These endpoints are collectively referred to as "human endpoints". Examples of types of research that may serve as human endpoints are given below.

• Population, behavioral, or psychosocial studies, when these studies address mechanistic aspects of the biology of the disease;
• Discovery and development of biomarkers, only when measurements are made in human specimens, or directly in human subjects;
• Early phase clinical trials (Phase I and/or Phase II only) of new investigational drugs and biologics, experimental therapeutic procedures, medical devices, or combinations thereof;
• Early phase clinical trials (Phase I and/or Phase II only) of new combinations or new uses of the FDA-approved agents and devices; and
• Investigational new drug (IND)-directed toxicology studies* conducted following a pre-IND meeting with the FDA in which the plan proposed by the investigators is acceptable to the FDA.

Note: *IND-directed toxicology studies do not involve human beings, but as these studies are the last steps before clinical trials begin, they are considered programmatically appropriate as a human endpoint for SPORE translational projects.

While experiments using cell lines, xenografts, patient-derived xenografts (PDX), organoids, paired germline samples, or engineered tissues are encouraged, these studies alone are not sufficient to meet the human endpoint requirement and must be in combination with an acceptable human endpoint, as listed above.

Clinical trials, as broadly defined by NIH (https://grants.nih.gov/policy/clinical-trials/definition.htm ), are not required but may be proposed, if appropriate and feasible. Such clinical trials may serve as a "human endpoint" and are expected to be of early-stage trials with limited recruitment. It is expected that many P20 applications will not propose clinical trials but will propose to reach a human endpoint by using human specimens in the laboratory to expand upon observations made in the clinic. This is a process known as reverse translation. However, when biomarker studies are ready for clinical trials, P20s are encouraged to collaborate with trans-NCI clinical trial mechanisms to validate the biomarkers clinically.

Scientific Collaboration. The awarded P20 Programs will be encouraged to interact, when feasible, with SPORE awardees to facilitate their planning for the integration into the SPORE community. Although such collaborations are not required for projects proposed for the P20 Programs, applicants are encouraged to plan for and establish such collaborations during the project period.

Investigator Teams and Leadership. For the goals of the FOA, each proposed team must have considerable expertise in cancer health disparity research. The applicant teams should also be multidisciplinary with appropriate combinations of expertise in basic/experimental research and applied/clinical research. Depending on the specific research proposed, the teams must have already established capabilities to conduct translational research in the prevention, early detection, diagnosis, and/or treatment of human cancer.

It is required that at least two investigators from the leadership of the proposed P20 Program (PDs/PIs, Project or Core leaders) be independent investigators, who:

• Have active peer-reviewed research grants (e.g., R01, R21, P01, U01, U10, non-mentored K career development grants, American Cancer Society (ACS), U.S. Department of Defense (DOD), or equivalent) directly related to the cancer(s) being investigated, cancer health disparity-related research, and/or other relevant expertise; or
• Serve as overall chairpersons or site chairpersons on an active clinical trial (relevant to the proposed P20 scope) that is sponsored by the NCI Clinical Trials Network or committees.

Specialized Research Infrastructure, Collaborations, Networks, and Consortia. Proposed P20 Programs are expected to establish the critical research infrastructure needed to sustain the translational research projects proposed. If these programs reside in a Cancer Center, they should make use of the Cancer Center infrastructure and build upon it. The P20 Programs are expected to identify research questions that can best be accomplished through collaborations, networks, and consortia. One key component is the establishment of appropriate collaborations, as described in the SPORE PAR. While the potential source of these interactions within the P20 Programs is broad, including other academic and/or non-academic research groups (e.g., industry), the awarded P20 Programs will be encouraged to integrate within the SPORE community.

Participation in NCI-Sponsored Meetings and Workshops. P20 PDs/PIs, and selected investigators, are expected to participate in appropriate NCI-sponsored meetings, workshops, and other activities to share expertise and research results with other translational grantees funded by NCI. Goals of these meetings are to share materials, assess progress, identify new research opportunities and priorities, and establish collaborations (e.g., SPORE investigators) that will facilitate the reduction in incidence, morbidity, and mortality of cancer overall, as well as more specifically address cancer health disparities.

Each proposed P20 Program must have the following component structure (with the details provided below).

1) Research Projects. All applications must propose at least two research projects that should have the following characteristics:

• Each proposed project must meet the definition of translational research, as described above. The translational nature of the projects proposed may pertain to advancing any clinically relevant cancer area, including cancer early detection, prevention, diagnosis, and/or treatment. There is a programmatic preference to create a portfolio of awards that will cover a broad spectrum of translationally-relevant aspects.
• Each proposed project must align with the cross-cutting theme of addressing cancer health disparities.
• Each proposed project should be focused upon a cancer health disparity
• Each project must have a clear translational potential and should include a specific human endpoint to be addressed within the project period (as listed above). Projects proposing mainly studies in non-human models are allowed only if a human application/human endpoint is included in at least one of the proposed specific aims. When human biospecimens are the starting point for research projects, these biospecimens must be used to study the biological basis of observations made in humans.
• Projects proposing the development of new cancer-relevant interventions should include both a laboratory component and a human application that must be proposed within the project aims.
• Note: The term "intervention" includes any intervention, tool and/or method that is applicable to the prevention, early detection, diagnosis, prognosis, and/or treatment of cancer. These may include molecular assays, imaging techniques, drugs, biological agents, and/or other relevant methodologies.

2) Administrative Core. This core should provide all organizational, administrative, and scientific management of the P20 Program. The Administrative Core responsibilities include:

• Providing logistical support to facilitate interactions across components of P20 Program and between the P20 awardee and NCI, an External Advisory Board (EAB), an optional Internal Advisory Board (IAB), external collaborators, other P20 awardees, SPOREs, etc.
• Strategic planning to facilitate the P20 Program to apply for a full P50 SPORE by the end of the project period. This includes development of a transition plan and should include the following items:
• Planning activities for the development of additional Research Projects;
• Planning activities for establishing essential collaborations;
• Planning activities for the development of a Career Enhancement Program (CEP), discussed with the SPORE PAR, with recruitment strategy proposed;
• Planning activities for any anticipated shared resource cores; and
• Timeline and milestones for all planning activities.

3) Shared Resource Cores. P20 Program applications must include a Biospecimen/pathology Shared Resource Core and may include other Shared Resource Cores that will provide laboratory and/or clinical facilities, equipment, and/or services supporting at least two research projects and the developmental research program.

The Biospecimen/Pathology Core is expected to support Research Projects in terms of providing biospecimens, with an emphasis on collection of specimens from racial/ethnic minority populations (e.g., American Indian/Alaska Natives, Asians, African Americans, Native Hawaiians/Pacific Islanders, and Hispanic/Latinos).

4) Developmental Research Program (DRP). Each P20 Program must allocate a significant effort to support pilot projects that take maximum advantage of new research opportunities in cancer health disparity research. The pilot projects may be collaborative with other external research groups and may be for one or two years in length. High-risk/high payoff pilot projects are especially encouraged and do not need to reach a human endpoint during the project period.

Non-Responsive Applications

The following types of activities remain outside of the scope of this FOA and non-responsive to this FOA (non-responsive applications will not be reviewed).

• Applications lacking a cancer health disparity theme;
• Applications that do not have access to racial/ethnic minority and/or underserved populations/biospecimens that are the focus of the application;
• Applications proposing Research Projects focused upon breast and/or prostate cancers; and
• Applications that are not proposing translational research and/or does not include appropriate human endpoints (as defined above).

Pre-application Communications with NCI Staff. Prospective P20 applicants are encouraged to consult with the NCI scientific staff member(s) listed in Scientific/Research Contact(s).

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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.

Investigators who are designated as PDs/PIs on an active SPORE grant or on a pending SPORE application cannot be designated as PD/PI on this P20 application.

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).

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

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

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:

Tiffany Wallace, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5114
Fax: 240-276-7862
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administrative Core)	12
Project (Use for Research Projects)	12 (each Project)
Core (Use for Biospecimen/Pathology Core and Shared Resource(s) Core)	12 (each Core)
Dev Res Prog (Use for Developmental Research Program (DRP))	12

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Research Project: minimum of two required projects and no more than three
• Biospecimen/Pathology Core: required
• Shared Resources Core (other than Biospecimen/Pathology): maximum of two optional Cores
• Developmental Research Program (DRP): required

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions. Additional guidance applies

Project Narrative: In the "Project Narrative", the relevance of the P20 Program's research to cancer health disparities and public health should be clearly stated.

Other Attachments: Applicants must provide documentation specified below (uploaded as a separate PDF), using the indicated filename (which will serve as application bookmark).

Attachment 1. Access to patient populations (use filename Patient Populations).

In this attachment, provide documentation detailing sources of and access to relevant racial/ethnic minority and/or underserved populations for the proposed studies.

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.

The designations of individuals as Senior/Key persons as well as the information provided in respective biosketches must adhere to and address the following requirements:

• Investigators who are designated as PDs/PIs on an active SPORE grant or on a pending SPORE application cannot be designated as PD/PI on this P20 application. However, such investigators may have other roles (e.g., project or Core leader).
• It is required that at least two investigators from the leadership of the proposed P20 Program (PDs/PIs, Project or Core leaders) be independent investigators, who:
• Have active peer-reviewed research grants (e.g., R01, R21, P01, U01, U10, non-mentored K career development grants, American Cancer Society (ACS), U.S. Department of Defense (DOD), or equivalent) directly related to the cancer(s) being investigated, cancer health disparity-related research, and/or other relevant expertise; or
• Serve as overall chairpersons or site chairpersons on an active clinical trial (relevant to the proposed P20 scope) that is sponsored by the NCI Clinical Trials Network or committees.

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

Specific Aims: Succinctly list the specific objectives and goals of the P20 Program, as a whole, with an emphasis on how the proposed program will address cancer health disparities.

Research Strategy: Use the sub-sections A-D (defined below) to address, at a minimum, all the aspects identified.

Sub-section A. Significance, Translational Relevance, and Expansion Potential

• Explain the significance of the proposed translational goals, including the overarching problems or critical barriers to translational progress in the organ site(s) and cancer health disparities that the proposed P20 Program will address.
• Describe the expected outcomes(s) and significance of the P20 Program, including the impact that the proposed translational research will have on addressing cancer health disparities in the areas of prevention, early detection, diagnosis and/or treatment.
• Explain how the P20 Program, as a whole, is expected to contribute to scientific knowledge, technical capabilities, and/or clinical practice relevant to the targeted areas of prevention, detection, diagnosis or treatment of cancer, as relating to addressing cancer health disparities.
• Outline the vision and expectations of the proposed P20 Program to develop the necessary requirements (e.g., capabilities, expertise, infrastructure, etc.). to be competitive for a full SPORE award.

Sub-section B. Innovation:

• Highlight any aspects in which the overall P20 Program challenges and seeks to shift current translational research or clinical practice paradigms relating to cancer health disparities.
• Summarize novel theoretical concepts, approaches, methodologies, instrumentation, and/or intervention(s) to be developed, tested, or used in the projects and/or shared resources Cores, if applicable. Specify how these will be developed, refined and/or improved to accomplish the translational disparity research goals proposed.
• Summarize how the P20 Program as a whole will refine, improve, or provide new applications of theoretical concepts, approaches, methodologies, instrumentation, and/or intervention(s) in translational cancer research, specifically addressing cancer heath disparities.

Sub-section C. Approach

• Summarize the global strategies, methodologies, and analyses that will be used to accomplish the overall specific aims and objectives of the P20 Program.
• Address potential problems, alternative strategies and benchmarks for success in achieving the aims of the overall P20 Program, aligned with the cross-cutting theme of cancer health disparities.
• Discuss the collaboration of applied researchers (e.g., clinical researchers, epidemiologists) with basic investigators in the design and implementation of cancer health disparities translational research that is most likely to have an impact on human cancer. Without repeating information in biosketches, identify investigators, who meet the requirement for the requisite peer-reviewed funding or leadership role in NCI-supported clinical trials (as defined under Senior/Key Persons). Applications with teams not including at least two investigators meeting these requirements will be considered non-responsive (and will not be reviewed).

Sub-Section D. Cancer Patient Population:

• Describe plans for ensuring sufficiently high proportion of racial/ethnic minority populations and/or collected biospecimens.
• If the appropriate patient populations are not available at the applicant institution, summarize agreement(s)/commitment(s) established with a different institution(s) to provide adequate access to clinical specimens and/or patients.
• The plans should also be based on reasonable assurances that the patients and human specimens needed for the proposed translational research are readily available from the sources considered and applicants already have or will be granted access to them. (Note that supporting documentation for this Sub-section is requested under Other Attachments).

Letters of Support: Attach letters of support here that are relevant to the overall application. The letter of commitment from the host institution should describe the integration and synergies between the institutional resources and those of the overall P20 Program and its components. Specifically, institutional leaders are expected to provide detailed statements of the long-term commitment and list the specific resources, space, protected time, etc. The letter must be addressed to either the PD(s)/PI(s) or the NCI and must be signed by one of the institution's leaders. If the host institution is associated with an NCI-designated Cancer Center, a separate letter of commitment from the Cancer Center Director should describe the integration and synergies between the Cancer Center resources and those of the overall P20 Program.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Resource Sharing Plan should be provided only under the 'Overall' component but it should cover all the activities proposed for the entire P20 application.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

Project Narrative: State the relevance to the Administrative Core's activities to public health and cancer health disparities

Facilities and Other Resources:

If the P20 program will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The P20 contact PD/PI is expected to serve as the Lead of the Administrative Core.

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

PD/PI Effort Commitment. Any PD/PI (whether designated as contact or not) must commit a minimum of 1.2 person-months effort per year to the award. This commitment cannot be reduced in later years of the award. Note that this is a minimum effort level that should be increased as appropriate to meet the needs of the work.

The budget may include up to $50,000 to be used as discretionary funds to be utilized at the discretion of the PI(s)/PD(s) to support unanticipated research opportunities during the funding period.

Budgets should also include travel funds for the PD(s)/PI(s) and other senior investigators to attend NCI sponsored meetings/workshops and NCI-related activities, particularly those relevant to the SPOREs. Any costs related to EAB meetings should be included. Funds should not be requested for participation in grant review meetings, special emphasis panels, and other evaluation groups where reimbursement derives from other sources.

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

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

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

Research Strategy: Use the sub-sections A-C (defined below) to address, at a minimum, all the aspects identified.

Sub-Section A. Leadership and Program Administration:

• Outline the organization and function of the Administrative Core (a diagram showing the chain of authority is recommended;
• Identify senior investigator(s), who, if needed, may succeed a PD/PI, who no longer is able to lead the P20 Program;
• Outline the plans for specific administrative and scientific management activities anticipated; and
• Address other relevant aspects, such as: planned effort for coordination with participating institutions (if applicable); logistical support for the entire Program and its components, etc.

Sub-Section B. Integration of P20 Program with Host Institution:

• Describe how the P20 Program will integrate with and use existing institutional resources (e.g., use of clinical data and safety management systems, biostatistics Cores, etc.); and
• Explain how coordination and communication among the different projects and programs, shared resources Cores and participating institutions will be achieved at the overall program level.

Sub-Section C. Planning and Evaluation Activities:

• Discuss the planning and evaluation of P20 Program activities, e.g., role of the EAB/IAB in evaluating translational research productivity;
• Describe the proposed establishment of the required External Advisory Board and the recommended Internal Advisory Board (if proposed). If members of the Advisory Board(s) have already been selected, detail the areas of expertise of the individuals. If the board(s) have not yet been established, describe areas of expertise needed and the plan for establishing. Note: Inclusion of at least one member of a past or current SPORE on the EAB is strongly encouraged.
• Scientific Collaboration: Describe a plan for how collaborations will be initiated, it is encouraged to include at least one member of a past or current SPORE on the EAB facilitated, and/or implemented throughout the course of the P20 Program. If applicable, include details on the nature, logistics, agreements and/or any other pertinent aspects of the collaborations.
• Provide a transition plan detailing activities and plans to compete for a SPORE grant following the program period. The following should be included:
• Timelines, clearly articulated milestones, and assessment/evaluation strategies;
• Plans for future research projects, collaborations, programs (e.g. Career Enhancement Program that is required for SPOREs), and other potential shared resource cores;

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

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project, starting with "Project 1", then "Project 2"
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

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

Project Narrative: State the relevance to the Research Project's activities to public health, specifically highlighting the relevance to addressing cancer health disparities.

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

• The project must have at least one basic and one clinical/applied co-leader. In the PD/PI section of the form, use Project Role of Other (Specify) and designate the role under 'Other Project Role Category' as Basic or Clinical co-leader and provide a valid eRA Commons ID in the Credential field.
• For other co-leaders, in the additional Senior/Key Profiles section, use Project Role of Other (Specify) and provide the role under 'Other Project Role Category' as Basic or Clinical co-leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list other Senior/Key persons that are involved in the Research Project and provide a valid eRA Commons ID in the Credential field.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is involved in multiple components, the Biographical Sketch can be included only in one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

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

Each project must include both basic and applied/clinical scientist co-leaders who will use their combined expertise to design and implement the project. Each co-leader is expected to commit meaningful level of effort to the project (generally no less than 0.6 person-months). It is not necessary that the co-leaders commit equal amount to the project.

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

PHS 398 Research Plan (Research Project)

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

Specific Aims: State the specific aims of the Research Project and state concisely the translational goals and expected translational outcomes(s), including the impact on the human disease site(s) involved and/or the impact on addressing cancer health disparities.

Research Strategy: Address the following aspects using the sub-sections as defined:

Sub-Section A. Significance

• Define the cancer type(s) that a given project is focused on (which must NOT be breast or prostate cancer to be in line with the responsiveness criteria defined in Section I).
• Background and preliminary data: Discuss the preliminary studies, data, and/or without duplicating information in the biosketches, experience of the co-leaders of the project that are pertinent to the project. Ensure that the premise of the proposed aims are justified by the preliminary data presented.
• Explain the importance of the cancer health disparity being investigated including critical barriers that currently exist for conducting the translational research proposed.
• Explain how the proposed translational science project will improve scientific knowledge, technical capability, and/or clinical practice, particularly in respect to addressing cancer health disparities.
• Describe how the concepts, methods, technologies, treatments, services, or preventive interventions that drive cancer research, particularly research addressing cancer health disparities, will be changed if the proposed aims are achieved.

Sub-Section B. Innovation

• Explain how the project challenges and seeks to shift current translational research or clinical practice paradigms, in relation to cancer health disparities.
• Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s).
• Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions

Sub-Section C. Approach

• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted.
• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the specific aims and the overall aim of reaching a human endpoint. Detailed timelines are encouraged.
• If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work.
• Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.
• Describe access to patients and populations, including relevant racial/ethnic minority populations, adequate for conducting the proposed research projects?

Letters of Support: Attach appropriate letters specific to the project detailing the nature and extent of participation. The letter of commitment from the host institution should describe the integration and synergies between the institutional resources and those of the P20 project.

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

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

For applications proposing the optional clinical trials: A copy of a draft or Institutional Review Board (IRB)-approved clinical trial protocol, along with informed consent forms are required and must be included in the Appendix if the trial is already underway or is anticipated to begin within the first 2 years of an award. If the trial will be performed during the latter part of the grant term, submission of these items to NCI program staff is required prior to the initiation of the trial.

PHS Human Subjects and Clinical Trials Information (Research Project)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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 (Biospecimen/Pathology Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Biospecimen/Pathology Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biospecimen/Pathology 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: State the relevance to the Core's activities to public health and how it will benefit the proposed cancer health disparity research.

Facilities and Other Resources:

If the core will benefit from a funded institutional, local, state, or national resource/consortium, the funded resource should be described in the application.

Institutional Commitment: List the type(s) and provide details of institutional commitment provided to the core by the applicant institution that will facilitate the proposed research, if applicable.

Project /Performance Site Location(s) (Biospecimen/Pathology 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 (Biospecimen/Pathology Core)

• In the PD/PI section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the 'Credential' field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that have an involvement in the Core and provide a valid eRA Commons ID in the 'Credential' field.
• Include a single Biographical Sketch for each Senior/Key person involved in this component. When a Senior/Key person is involved in multiple components, it is only necessary to attach his/her biographical sketch to just one of the components.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biospecimen/Pathology Core)

Budget forms appropriate for the specific component will be included in the application package. Core Director(s) is expected to commit meaningful level of effort to the project (generally no less than 0.6 person-months). Capital equipment may be requested with strong justification and will be considered on case-by-case basis.

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 (Biospecimen/Pathology Core)

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

Specific Aims: Describe the goals of the Biospecimen/Pathology Core. Indicate which specific Research Projects will be served by the Core.

Research Strategy:

• Describe access to appropriate patients/and or biospecimens to support the Core. Specifically, detail the proportions of racial/ethnic populations represented.
• For freshly resected biospecimens, describe the plans for collecting and distributing human specimens, including site-specific tissues, fixed tissues, frozen tissues, paraffin blocks, slides, preserved cells, serum, plasma, urine, sputum samples, and other body fluids, as appropriate for the cancer site.
• Describe the plans for achieving detailed annotation on parameters of collection and preservation that are pertinent to the pre-analytic and analytic considerations of potential P20 Program studies as well as essential pathological, clinical, demographics (include racial/ethnicity data) and family history information needed for conducting a wide range of translational research activities.
• Describe the informatics that will be used for tracking specimens, as well as linkage to clinical and follow-up data sets. Address development, acquisition, storage, and usage of standardized reference specimens and materials, and any other services related to the analysis of specimens (e.g., tissue microdissection, immunohistochemistry) that will be provided.
• Describe and justify any research activities to improve Core services and how they will benefit the P20 Program.
• Provide a plan for prioritizing distribution of biospecimens to P20 scientists and others, both inside and outside the parent/consortium institution(s), based on the merit of the proposed translational cancer research projects.

Letters of Support: Attach appropriate letters relevant to the Core detailing the nature and extent of participation.

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

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

PHS Human Subjects and Clinical Trials Information (Biospecimen/Pathology Core)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

Only a Biospecimen/Pathology Core is required, however up to two other Shared Resource Cores may be proposed if appropriately justified.

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

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Shared Resources Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resources 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: State the relevance to the Core's activities to public health and how it will benefit the proposed cancer health disparity research.

Facilities and Other Resources:

If the core will benefit from a funded institutional, local, state, or national resource/consortium, the funded resource should be described in the application.

Institutional Commitment: List the type(s) and provide details of institutional commitment provided to the core by the applicant institution that will facilitate the proposed research, if applicable.

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

• In the PD/PI section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the 'Credential' field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that have an involvement in the Core and provide a valid eRA Commons ID in the 'Credential' field.
• Include a single Biographical Sketch for each Senior/Key person involved in this component. When a Senior/Key person is involved in multiple components, it is only necessary to attach his/her biographical sketch to just one of the components.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Shared Resources Core)

Budget forms appropriate for the specific component will be included in the application package. Core Director(s) is expected to commit meaningful level of effort to the project (generally no less than 0.6 person-months). Capital equipment may be requested with strong justification and will be considered on case-by-case basis.

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 Resources Core)

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

Specific Aims: Describe the goals of the Shared Resource Core. Indicate which specific Research Projects will be served by the Core.

Research Strategy:

• Justification for the Core, how the proposed services will facilitate accomplishment of the proposed goals for the P20 Program, and its role in supporting at least two projects. Examples of optional Shared Resources Cores include Animal, Clinical, Biostatistical, Bioinformatics, and Outreach Cores. [Note that such Cores may not duplicate resources already available at the participating institution(s) but may serve as a way to enhance the existing resource (e.g., to increase capacity/throughput)].
• For all Cores, describe services that will be provided, and state the rationale for centralizing them in the Core, rather than including them in individual projects.
• Provide data, results, experimental protocols, etc., that document the ability of the Core to provide the proposed services.
• Describe how the Shared Resource Core(s) proposed are distinct components that are supportive of future and/or current research projects.
• The proposed Core may include efforts aimed at improving/optimizing approaches and procedures (both experimental and/or bioinformatic) with the goal to enhance Core services offered.

Letters of Support: Attach appropriate letters relevant to each Core detailing the nature and extent of participation.

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

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

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

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application in ASSIST, use Component Type Dev Res Prog .

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

SF424 (R&R) Cover (Developmental Research Program)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title: "Developmental Research Program"
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Developmental Research Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental Research Program)

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: State the relevance to the DRP's activities to public health.

Facilities and Other Resources:

Institutional Commitment: List any institutional commitment provided for the DRP and describe how it will specifically facilitate the research proposed.

Project /Performance Site Location(s) (Developmental Research Program)

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 (Developmental Research Program)

• In the PD/PI section of the form, use Project Role of Other with Category of DRP Director and provide a valid eRA Commons ID in the 'Credential' field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that have an involvement in the DRP and provide a valid eRA Commons ID in the 'Credential' field.
• Include a single Biographical Sketch for each Senior/Key person involved in this component. When a Senior/Key person is involved in multiple components, it is only necessary to attach his/her biographical sketch to just one of the components.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Developmental Research Program)

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

The DRP, as a required component of this P20, must be maintained throughout the entire term of the grant. A budget of approximately $50,000 direct costs per year from P20 funds must be proposed and maintained for a DRP. Any contribution(s) made by the parent and/or consortium institutions should be detailed. DRP funds should be used for research activities only (to cover personnel costs and supplies). The funds should be listed in the Other Expenses category under the heading DRP Funds.

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 (Developmental Research Program)

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

Research Strategy: Clearly describe the process for solicitation of DRP projects and the institutional review process for funding pilot and/or collaborative projects that generate feasibility data. This program is intended to remain flexible and to support studies of 2 years or less. The expectation is that successful feasibility studies that have translational potential could evolve into full projects in applications for a SPORE, or other comparable funding opportunity.

Describe how the DRP will be organized within the P20 Program and the processes for reviewing and funding the pilot and collaborative projects. Applicants are encouraged to outline possible types of research, projected directions of the research, and/or characteristics/attributes expected for projected projects.

Letters of Support: Attach appropriate letters relevant to the DRP detailing the nature and extent of participation.

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

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

PHS Human Subjects and Clinical Trials Information (Developmental Research Program)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

For this FOA, note the following:

Reviewers will provide an overall impact score for the entire P20 application. In addition, assigned reviewers will provide individual "criterion scores" for the Overall criteria but not for the other components.

All other components of the Center [i.e., Administrative Core, Biospecimen/Pathology Core, optional Shared Resources Core(s), and Developmental Research Program] will be evaluated but each will receive only one overall adjectival (not numerical) rating.

For applications involving clinical trials:

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the P20 Program 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 P20 Program 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 P20 Program address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the P20 Program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA:

• What is the likelihood that the P20 Program, as proposed, will help advance cancer health disparities translational research?
• How is the P20 Program, as a whole, expected to contribute to scientific knowledge, technical capabilities, and/or clinical practice relevant to the prevention, detection, diagnosis or treatment of cancer, as related to addressing cancer health disparities?
• How well does the vision to develop a future SPORE (e.g., establishing capabilities, expertise, infrastructure, etc.) demonstrate the feasibility to compete for a full SPORE award at the end of the project period.

In addition, for applications involving clinical trials

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

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the P20 Program? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

• How appropriate is the collaboration of applied researchers (e.g., clinical researchers, epidemiologists) with basic investigators in the design and implementation of cancer health disparities translational research that is most likely to have an impact on human cancer?
• How strong is the team in terms of balanced representation of senior investigators across basic/laboratory researcher and applied/clinical research?

In addition, for applications involving clinical trials

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

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

In addition, for applications involving clinical trials

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the P20 Program? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the P20 Programinvolves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA:

• How adequate is the access to patients and populations, including relevant racial/ethnic minority populations, for conducting the projected therapeutic, prevention, detection, and/or control research projects proposed in the P20 Program?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

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

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

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

Data Management and Statistical Analysis

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

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 strong is the institutional commitment in terms of the potential to facilitate the P20 Program? Are the specific documented commitments sufficient (e.g., access to specific resources, space, protected time, etc.)?
• Does the P20 Program appropriately integrate with and use existing institutional resources? Is there evidence of, or plans for, coordination and communication across all component of the P20 Program and among all participating institutions at the overall P20 level?

In addition, for applications involving clinical trials

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

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

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

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

As applicable for the P20 Program 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.

Study Timeline

Specific to applications involving clinical trials

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

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

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

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

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

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

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

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

Not applicable.

Not Applicable.

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

Not applicable.

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

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

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

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

Review Criteria for Administrative Core

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

Leadership and Program Administration

• Are the scientific qualifications, involvement, leadership and time commitment of the PD(s)/PI(s) sufficient for the requirements of the proposed P20 Program?
• Are the plans for the overall data management and/or bioinformatics capabilities of the P20 Program, as they are related to institution and/or activities of other NIH/NCI initiatives, sufficient for the requirements of the proposed P20?
• Does the plan for the Administrative Core adequately address how the P20 Program will be managed administratively including the fiscal and data operations?
• Are the communication aspects of the P20 Program facilitated by this Core adequately addressed, particularly if there is more than one institution involved in the proposed research?

Integration of P20 Program with Institution

• How well does the proposed P20 Program integrate with and utilize existing institutional resources?
• At the overall program level, how adequate are the coordination and communication among the different projects and programs, shared resources Cores and participating institutions?

Planning and Evaluation Activities

• How adequate are the plans proposed for evaluating the translational research productivity of existing projects and Cores in relation to the requirements of the proposed P20 Program?
• How appropriate are the plans to develop and/or utilize an External Advisory Board (or optional Internal Advisory Board)?
• How well are the plans to initiate, facilitate, and/or implement scientific collaborations to support the P20 Program adequately addressed?
• How adequate is the transition plan in terms of detailing a well-constructed and feasible plan towards competing for a subsequent SPORE grant?

Review Criteria for Research Projects

Reviewers will provide only one overall adjectival rating for each Research Project (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component. Note: A project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

• How compelling is the premise and how well is the proposed project supported by the preliminary studies?
• How well does the project address an important translational research goal or barrier for cancer health disparities?
• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved, particularly in respect to addressing cancer health disparities?
• How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions that drive the field of disparities?

Investigators

• Are the Project co-leaders, collaborators, and other researchers well suited with complementary expertise to the project?
• Is there adequate evidence of co-leadership of the project by basic and applied/clinical investigators in the conception, design, and proposed implementation of the project?
• Do the Project co-leaders, collaborators, and/or other researchers have expertise in the field of cancer health disparities?

Innovation

• Are the proposed projects novel and/or seek to challenge current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions in the context of translational research and cancer health disparities?

Approach

• How well are the overall strategies, methodologies, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• How well are the cancer health disparity research questions defined and are the approaches appropriate for addressing these questions?
• How adequate is the access to patients and populations, including relevant racial/ethnic minority populations, and is it adequate for conducting the projected therapeutic, prevention, detection, and/or control research projects proposed in the P20 Program?
• How well are potential problems, alternative strategies, and benchmarks for success presented?
• How adequate is the timeline provided for successful completion of the human endpoint(s) proposed? Is the plan feasible?

Environment

• How adequate are the institutional support, equipment and other physical resources available to the investigators for the project proposed?
• How will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
• In the case of multiple institutions involved in a single project, how adequate is the plan for communication among investigators to achieve the goals of the grant?
• Is there evidence of effective use of P20 Cores?

Additional Review Criteria - Research Projects

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Review Criteria for Biospecimen/Pathology Core

Each Biospecimen/Pathology Core must provide essential functions or services for at least one project. Reviewers will assign a adjectival score based on the following criteria (these criteria do not receive separate scores).

• How well does the proposed plan detail access to appropriate patients/and or biospecimens to support the P20 Program? Specifically, how adequately are the racial/ethnic minority populations represented?
• How well does the proposed plan for this Core adequately address the development, annotation, and maintenance of a human cancer site-specific specimen resource, including linkage of specimens with pre-analytical parameters and pathological, clinical, and family history data that maximize their potential use in translational research?
• How adequately does the proposed plan address and prioritize the distribution of specimens within and outside the P20 Program?
• If applicable, does the proposed plan adequately address the performance of analyses on specimens (e.g., tissue microdissection, immunochemistry) and/or develop new technologies and methodologies that enhance or benefit activities of the P20 Program?
• How adequate is the informatics that will be used for tracking specimens, as well as linkage to clinical and follow-up data sets?
• Is there sufficient evidence of proficient personnel dedicated to the activities of specimen collection, annotation, quality control, storage, distribution, and analysis? Is there sufficient oversight of the collection of initial and follow-up clinical information, data entry, and maintenance of database and computer networks?
• Does the proposed plan give sufficient evidence that the activities of the Core are well integrated with those of the projects and that the investigators within the projects are working closely with those of the Core to meet P20 project objectives?
• Does the proposed plan adequately address if and how the investigators will obtain written informed consent for all prospectively collected tissues/specimens in a manner that will protect patient confidentiality and enable studies?

Review Criteria for Shared Resources Core(s) (optional)

Each Shared Resources Core must provide essential functions or services for at least one project. Reviewers will assign an adjectival score based on the following criteria (these criteria do not receive separate scores).

• How well matched is the proposed Shared Resources Core to the needs of the overall P20 Program?
• How will the proposed Core meaningfully enhance the P20 research program?
• How convincing is the justification that the services of the Shared Resources Core are essential to the goals of more than one Research Project?
• Are the qualifications, experience, and effort commitment of the Shared Resources Core Director(s) and other key personnel adequate and appropriate for providing the proposed facilities or services?
• Will the proposed Shared Resources Core provide cost-effective services to the Research Center, prevent duplication, and/or increase efficiency?

Review Criteria for the Developmental Research Program (DRP)

Reviewers will assign an adjectival score based on the following criteria (these criteria do not receive separate scores).

• Will the proposed plan for the DRP attract new ideas and pilot studies within and/or outside of the P20 institution(s)?
• How adequate is the plan for solicitation, review and funding of a spectrum of pilot projects, as well as for promoting pilot projects with translational research potential to full projects within the P20 Program?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the 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.

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

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. A programmatic preference will be given to applications addressing cancer health disparities for a range of cancer types to create a portfolio of awards that will cover a broad spectrum of translationally-relevant aspects.

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

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

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

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

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

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

When an award is made, it is the policy of NCI that meritorious projects reviewed as part of the P20 Program be funded as part of the P20 Program even though other funding may be available. Duplicate funding will not be awarded.

NCI program staff may administratively delete funding or reduce the duration of support for components of P20 Program that are judged by peer review to be less meritorious and/or nonessential to the conduct of the P20 Program.

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

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

Per NOT-OD-19-055, recipients must provide NIH with a certification that all non-exempt human subjects research has been reviewed and approved by an appropriate IRB. The date of final IRB approval is the date that all protocols in the proposed research application received IRB review and approval (i.e., the date of the last protocol approval). When human subjects research is anticipated within the period of the award but definite plans for involvement of human subjects cannot be described in the application or proposal (referred to as "delayed onset human subjects research"), prior to the involvement of human subjects in non-exempt research, the recipient must submit to the NIH awarding IC for prior approval (1) detailed information as required in the Human Subjects and Clinical Trials Information Form of the application, as well as the certification and date of final IRB approval.

Under no circumstances may NIH-supported non-exempt human subjects research be initiated prior to meeting the requirements for conducting an IRB review of protocols as well as obtaining the date of final IRB approval. NIH will not allow any funds to be used by recipients where a certification and an IRB approval date has not been provided to the funding IC.

Recipients are also reminded that any changes to study protocols that have been subject to peer review, as well as the addition of new study protocols, require the prior approval of the NIH awarding Institute or Center consistent with Section 8.1.2.5 of the NIHGPS. Such requirements are also generally described in the Funding Opportunity Announcement and/or the Notice of Award.

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

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

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In addition, information on NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards can be found at https://grants.nih.gov/grants/policy/harassment.htm

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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

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

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Tiffany Wallace, Ph.D
National Cancer Institute (NCI)
Telephone: 240-276-5114
Email: [email protected]

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

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

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

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