Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Feasibility Studies to Build Collaborative Partnerships in Cancer Research (P20)

Activity Code

P20 Exploratory Grants

Announcement Type

Reissue of PAR-09-201

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-13-068

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393, 93.394, 93.395, 93.396, 93.397, 93.399

Funding Opportunity Purpose

The National Cancer Institute (NCI) invites NIH P20 grant applications for the implementation of collaborative partnership awards between Institutions serving communities with cancer health disparities and NCI-designated Cancer Centers (or groups of Centers).For the purpose of this funding opportunity announcement (FOA), "the Institutions" will refer to academic or other organizations serving communities with cancer health disparities. This FOA is designed to facilitate the planning and execution of focused collaborations in cancer-related research, training and career development, and education by supporting the creation of partnership frameworks and the conduct of pilot projects and pilot programs by investigators at the partnering institutions. A major goal of the NCI P20 partnership awards is to provide support for investigators at the Institutions to conduct cancer pilot projects and programs, which should allow awardees to obtain preliminary data that will lead to their submission of competitive grant applications for support by the NIH/NCI and/or other Federal/non-Federal sources of peer-reviewed funding.

Key Dates
Posted Date

December 21, 2012

Letter of Intent Due Date(s)

February 19, 2013; February 19, 2014; February 19, 2015

Application Due Date(s)

March 19, 2013; March 19, 2014; March 19, 2015

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2013; June/July 2014; June/July 2015

Advisory Council Review

September 2013; September 2014; September 2015

Earliest Start Date

October 2013; October 2014; October 2015

Expiration Date

(Now Expired January 16, 2014 per NOT-CA-14-027), Originally March 20, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The National Cancer Institute (NCI) invites P20 grant applications for the implementation of partnership awards between Institutions serving communities with cancer health disparities and NCI-designated Cancer Centers or other institutions with highly integrated cancer research efforts. For the purpose of this funding opportunity announcement (FOA), "the Institutions" will refer to academic or other organizations serving  communities with cancer health disparities. This FOA is designed to facilitate planning and implementation of focused collaborations in cancer-related research, training, and education. A major goal of the NCI P20 partnership awards is to provide support for investigators at the Institutions to conduct cancer pilot projects and programs, which should allow awardees to obtain preliminary data that will lead to their submission of competitive grant applications for support by the NIH/NCI and/or other Federal/non-Federal sources of peer-reviewed funding. Cancer Centers will gain increased access to underserved patients for cancer and health disparities-related clinical trials.

The NCI Feasibility Studies to Build Collaborative Partnerships in Cancer Research (P20) Program is one of two grant mechanisms that currently constitute the NCI Partnerships to Advance Cancer Health Equity (PACHE) Program (http://crchd.cancer.gov/research/pache-overview.html) to promote and build collaborative research, training and career development, and education efforts between the Institutions and the NCI-designated Cancer Centers or other institutions with highly integrated cancer research efforts as described below:

1) Collaborative pilot project(s) in any area of cancer-related basic, clinical, translational, prevention, control, behavioral, population and/or outreach research;

2) Collaborative cancer training and career development programs designed to train students and scientists;

3) Collaborative cancer education programs designed to augment existing or create new curricula in the partnering institutions that would apprise high school, undergraduate,  graduate students, and postdoctoral trainees about cancer research and/or cancer health disparities and to motivate them to pursue cancer research careers. A successful effort may result in the submission of a competitive NCI education grant application (R25E) and that later should yield to institutional commitments to make these curricula an inherent component of their educational systems.

The ultimate objective of the pilot projects and pilot programs proposed for the P20 partnership awards must be the submission of competitive applications to the NIH/NCI for funding by grant mechanisms such as:

Background

The disparities in cancer incidence, morbidity, and mortality in underserved populations, including racial and ethnic populations and socio-economically, disadvantaged populations have continued to rise over several decades, despite the significant progress in other aspects of cancer research. For example, the incidences of colon and lung cancers in Alaska Native and African American men and women are higher than that of other ethnic groups. The 5-year cancer survival rates (e.g., for persons with lung, ovarian, prostate, colon, or breast cancers) in the Native American, African American, Hawaiian, and Hispanic American populations are lower than in the Japanese and White American populations. Increasing disparity is seen in patterns of prostate cancer among African American males compared with White males in the southeastern United States (U.S.), particularly in rural areas (http://statecancerprofiles.cancer.gov/). Clearly, more research is needed to better understand and overcome these and other cancer health disparities. This overarching goal is an important element of The NCI Strategic Plan (http://strategicplan.nci.nih.gov/) and the priority recommendations for the U.S. Department of Health and Human Services (HHS) as presented in the report Making Cancer Health Disparities History (http://permanent.access.gpo.gov/gpo12674/2004chdprg.pdf).

Institutions serving health disparity populations embody a pool of faculty and investigators who are culturally competent, and have unique expertise  conducting research on cancer health disparities and to establish high quality educational programs for persons interested in serving racial/ethnic and the underserved populations. However, investigators at these Institutions have to overcome barriers (e.g., limited infrastructure and resources) in developing and sustaining independent programs in cancer and/or cancer health disparities research. The NCI-designated Cancer Centers are geographically dispersed, research-intensive institutions with well-organized programs for training cancer scientists. They are the major organized units supported by the NCI to: conduct cancer research; sponsor cancer-related research training in the basic, clinical, translational, and population sciences; provide informational services; and develop and sustain educational and/or outreach programs that benefit their communities. Yet, Cancer Centers can (and should) play a greater role in facilitating the following activities: 1) conducting research pertinent to cancer in underserved, isolated, and socio-economically disadvantaged groups; 2) training scientists in the care and treatment of individuals from health disparity populations;; 3) reaching out to and partnering with different underserved populations in their communities; and 4) bringing the benefits of advances in cancer research to their underserved communities and populations.

Specific Requirements and Research Objectives

The NCI Partnerships to Advance Cancer Health Equity (PACHE) Program aims to build and sustain excellence. The P20 Program serves as a nurturing environment to allow for the development of new pilot projects and programs, and obtain preliminary data that will lead to the submission of specific competitive NCI grant applications and/or other sources of peer-reviewed funding.

As part of the PACHE Program, the P20 Partnership grant supports collaborative efforts in three broad target areas: Cancer Research; Cancer Training; and Cancer Education. The partnership applications must propose at least two of the three target areas. Cancer Research must be one of the two selected areas.

1) Cancer Research. A joint pilot research project may be in any area of cancer-related basic, clinical, translational, prevention, control, behavioral, population, and/or outreach research.  Partnership investigators are encouraged to develop research applications in translational research as defined by the Translational Research Working Group of the NCI (go to http://www.cancer.gov/trwg/), emerging technologies, such as nanotechnology, proteomics, genomics, and imaging, and research focusing on pediatric, adolescent, and young adult cancers. The NCI encourages the development of research, educational, and outreach projects leading to increased biospecimen collection from underserved populations, a critical endeavor to potentially elucidate the biological and genetic factors associated with cancer health disparities. Joint research projects conducted primarily at the Institutions serving underserved communities with cancer health disparities may be in any area of cancer research. Joint research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in underserved and/or socio-economically disadvantaged populations.

2) Cancer Training. Training and career development programs are encouraged to emphasize two aspects: (a) the training of underrepresented investigators and students; and (b) the recognition and understanding of the issues and problems associated with cancer disparities in underserved and socio-economically disadvantaged populations. The NCI particularly encourages training of underrepresented scientists in basic, clinical, translational, behavioral, and population research on cancer. Training and career development programs relevant to cancer in translational research, behavioral research, emerging technologies (nanotechnology, genomics, proteomics, and imaging) are a priority for NCI as there is a huge deficit of underrepresented scientists engaged in these research areas.

3) Cancer Education. Cancer education programs can focus on any effort to augment existing or create new curricula in the Institution and/or the Cancer Center that would apprise and culturally sensitize students in research, medicine, and public health of the need to reduce the disproportionate cancer burden in underserved populations. The development of curriculums that focus on teaching students about emerging technologies (e.g., genomics, proteomics, and nanotechnology) and their use in cancer research are encouraged. A successful effort may result in the submission of a competitive NCI education grant application (R25) and that later should yield to institutional commitments to make these curricula an inherent component of their educational systems.

Planning for Evaluations of Partnerships

The Program Directors/Principal Investigators (PD(s)/PI(s)), in their applications, should plan for an evaluation of their partnership because the NIH may request information essential to an assessment of the effectiveness of this P20 program. Awardees may be contacted after the completion of this award for periodic updates on various aspects of high school, undergraduate, and graduate students' rates of graduation, entry into academic biomedical and behavioral science programs, publications Periodic updates may also be required of post-doctoral fellows and new/early stage investigators' employment histories, publications support from research grants or contracts

The overall evaluation of the program will be based on metrics that will include, but not be limited to, the following:

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission -- only resubmissions of applications submitted previously in response to this FOA are allowed.
Revision -- only revision applications for awards made in response to this FOA are allowed.

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Award Budget

The combined budget of direct costs for two equal and complementary partnership applications, one from the Institution and one from the Cancer Center, cannot exceed $275,000 in direct costs for the first year. Future years may include cost of living adjustments of 3 percent over the maximum direct cost budget limit for each Institution in the partnership.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

NOTE: The Pilot Projects are ONLY funded for up to 3 years and funding cannot exceed $120,000 direct cost per pilot project. The cost of each pilot project is INCLUDED in the overall budget limit of $275,000 direct cost. Future years may include cost of living adjustments of 3 percent over the (overall) maximum direct cost budget limit for each institution in the partnership. In addition, the pilot projects must include one investigator from each partnering institution.

The project period and budget requested should be appropriate to the stage of partnership development, and take into account that the planning and priority-setting stages are not as costly as the implementation stage.

Award Project Period

Applicants may apply for up to 4 years of support in applications submitted in response to this FOA.

Applicants requesting 4 years of support must clearly describe three stages of partnership development: a planning stage; a priority setting stage; and an implementation stage.

Applicants requesting 3 years or less of support should have already identified areas of potential collaboration through planning. The applications must include documentation of prior planning activities and must contain clear descriptions of a priority-setting stage and an implementation stage.

The project period and budget requested should be appropriate to the stage of partnership development, and take into account that the planning and priority-setting stages are not as costly as the implementation stage.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Governments

Each partnership must include both types of institutions: 1) an Institution serving communities with cancer health disparities; and 2) an NCI-designated Cancer Center (or groups of Centers).

Foreign Institutions

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.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. 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 PHS 398 Application Guide.     

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Number of concurrent applications/awards. The NCI PACHE Program includes the P20 grant mechanism and the U54 cooperative agreement mechanism (Comprehensive Partnerships to Advance Cancer Health Equity [CPACHE]; http://grants.nih.gov/grants/guide/pa-files/PAR-12-055.html).  Each Institution and Cancer Center may not have more than one P20 award and one U54 award simultaneously within the same partnering Institutions.  However, the partnering institutions can establish and apply for P20 partnerships with different partner institutions.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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


The letter of intent should be sent to:

Carmen P. Moten, Ph.D., M.P.H.
Diversity Training Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
9609 Medical Center Drive, Room 6W242
Bethesda, MD 20892-9746 (for regular mail)
Rockville, MD 20850 (for express delivery)
Telephone: 240-276-6181
E-mail: cmoten@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for Express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following additional limitations:

Supplemental Instruction for the Preparation of Multi-Component Applications

The following section supplements the instructions found in Form PHS 398 for preparing a multi-component grant application. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-component applications.  All applications must be submitted on Form PHS 398. 

The multi-component grant application should be assembled and paginated as one complete document in the following order:

Additional requirements and provisions of the supplemental instructions include:

Contact PD/PI: Each application may have multiple PDs/PIs but one PD/PI from each partnering Institution is expected to be the designated contact PD/PI. Even if there are no additional PDs/PIs from the same Institution, the contact PD/PI on the application from the Institution should be listed as PD/PI on the partnered application from the Cancer Center and the contact PD/PI on the application from the Cancer Center should be listed as PD/PI on the partnered application from the Institution.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Face Page for the Entire Application

The title of the partnership should be identical for both the Institution and the Cancer Center partnership applications. The title should be unique to the specific partnership (do not repeat the title of this funding opportunity announcement) and should include the suffix (1 of 2) or (2 of 2) for applications from the Institution and Cancer Center, respectively. Attach additional Form Page 1 sheets for each additional PD/PI.

Overview of the Partnership

The instructions listed below are only for those sections with information different from the Application Guide.

Face Page (Overview of the Partnership)

The Face Page of the 398 Form should not be used as a cover page for individual research projects and cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project 

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Overview of the Partnership)

Follow all instructions in the Application Guide, but note the following additional instructions:

Senior/Key Personnel: List the contact PD/PI first, followed by the other PD(s)/PI(s); the contact PD/PI on the partnership application should be included as one of the PD(s)/PI(s). Then list all Key Personnel for the Administrative Core and all Pilot Projects/Programs in the application in alphabetical order. Finally, list the members of the IAC.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Overview of the Partnership)

Use form pages as directed for the initial year and overall 5-year plan, with justifications, and do not repeat these elsewhere in the application. Include here budget lines for the each component, providing further budget details for each component in its own section on Budget.

In addition to the standard Budget for Entire Proposed Period of Support for the entire application, use separate PHS398 Form Page 5 sheets to provide individual budgets for each stage of the partnership (i.e., developmental costs) during the entire proposed period of support (i.e., separate budgets for the entire period of support for: (i) planning stage; (ii) priority-setting stage; and (iii) implementation stage). Use PHS398 Form Page 5 for the entire application (and continuation sheets, if needed) to provide budget justification. Provide specific justifications for costs for each year requested, and what is appropriate to the stage of development. The costs for each year would include administrative costs and developmental costs as needed within the $275,000 direct cost cap (together for both applications) and as described below:

1) Administrative costs (which may be higher in the early stage of development and lower in the late stages) for managing the planning effort, such as salaries for key personnel, travel for key personnel (e.g., costs related to attendance at a biennial PACHE workshop), equipment, and supplies to support an administrative structure.

2) Developmental costs for:

a) Initial Planning Stage, which should be focused on developing and organizing workshops, seminars, retreats, and other forms of communication to explore potential opportunities in cancer research, cancer training, or cancer education;

b) Priority-Setting Stage, which should be focused on selecting the areas of greatest promise for implementation as specific types of pilot projects or programsbased on merit and potential to result in a successful grant application. Pilot projects/programs cannot exceed $120,000 in direct costs per year, and may notexceed 3 years; and

c) Implementation Stage, which should be focused on implementing pilot research projects or pilot programs in training, education, or outreach for the explicit purpose of obtaining preliminary data for the submission of a specific grant application(s).

NOTE: Given that the PDs/PIs of P20 PACHE awards will be expected to participate in a biennial PACHE Workshop for sharing information and strategies, travel expenses for this purpose must be included in the grant applications from the Institution and the Cancer Center.

Budgets Pertaining to Consortium/Contractual Arrangements: Follow the PHS398 instructions to complete this information if the application (either the Institution application or Cancer Center application) involves a consortium of more than one Institution of its type. One of these Institutions will serve as the primary applicant Institution (the one formally submitting the application) whereas the other will be involved under a subcontract.

Biographical Sketches (Overview of the Partnership)

Follow the PHS398 instructions and use the PHS398 Biographical Sketch Format Page to provide biosketches (not to exceed four pages each) for all the individuals listed on Form Page 2 (collated in the same order).

Resources (Overview of the Partnership)

Follow all instructions in the PHS 398 Application Guide.

Research Plan (Overview of the Partnership)

Introduction to Resubmission Application, if applicable: This section should be identical for both the Institution and Cancer Center applications. Include a summary of the additions, deletions, and changes in the resubmission application, placing particular emphasis on responses to the criticisms and issues raised in the previous summary statement. In addition, include a chronological description of activities conducted since the original submission (e.g., meetings, research activities).  The important changes must be clearly marked in the text. Note: Resubmissions of applications previously submitted in response to this FOA are allowed. For more information, see the NIH Policy on Resubmission Applications from the PHS398 Application Guide. Revision applications can be submitted only for awards made in response to this FOA.

Research Strategy: This component should be identical for both the Institution and the Cancer Center partnership applications. Describe the characteristics of the Institution and the Cancer Center that will contribute to the planning effort. The description should clearly denote the nature of the interactions and deliberations that occurred between the Institution and the Cancer Center during the preparation of these applications (and identify the individuals involved). State the objectives of the collaboration.

Letters of Support: Each application must include written "Letters-of-Commitment" from the respective leadership of both institutions that are supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum sustainability. In addition, if Native Americans are involved, a Letter of Commitment from the Tribal Nation Leader is also required. Complete and specific descriptions of these additional resources in the “Letters of Support” should include the following items:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Partnership Plan

The instructions listed below are only for those sections with information different from the Application Guide.

Face Page (Partnership Plan)

The Face Page of the 398 Form should not be used as a cover page for individual research projects and cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Partnership Plan)

Follow all instructions in the PHS 398 Application Guide, providing relevant information about the Partnership Plan.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Partnership Plan)

Prepare a detailed budget and justification for the Partnership Plan using Form Pages 4 and 5 of the PHS 398.

Biographical Sketches (Partnership Plan)

Do not repeat the biographical sketches of participating investigators since this information will be included In the Overview of the Partnership section.

Resources (Partnership Plan)

Follow all instructions in the PHS 398 Application Guide, providing relevant information about resources available to execute the Partnership Plan.

Research Plan (Partnership Plan)

Introduction to Resubmission Application, if applicable: This section should be identical for both the Institution and Cancer Center applications. Include a summary of the additions, deletions, and changes in the resubmission application, placing particular emphasis on responses to the criticisms and issues raised in the previous summary statement. In addition, include a chronological description of activities conducted since the original submission (e.g., meetings, research activities). The important changes must be clearly marked in the text.

Research Strategy: 

This component should be identical for both the Institution and the Cancer Center partnership applications. Describe the characteristics of the Institution and the Cancer Center that will contribute to the planning effort.  The description should clearly denote the nature of the interactions and deliberations that occurred between the Institution and the Cancer Center during the preparation of these applications (and identify the individuals involved). State the objectives of the collaboration.

(i) Estimated Timeline for Initial Planning, Priority-Setting, and Implementation Stages. This section should be identical for both the Institution and the Cancer Center applications. Depending upon prior experience, interactions, and progress in planning, the two applications must clearly describe a collaborative planning process that includes the Planning, Priority-Setting, and Implementation Stages. PI(s)/PD(s) should include a chronological narrative or table listing the specific first year, second year, third year, and fourth year objectives that are expected to be achieved. For each objective, a brief statement should be made about the separate contributions of the Institution and the Cancer Center in order to achieve success. The intent of these P20 partnership awards is to provide support for cancer pilot projects and programs for up to 3 years to perform feasibility studies and obtain preliminary data that will lead to the submission of specific competitive grant applications for support by the NCI and/or other sources of peer-reviewed funding.

(ii) Initial Planning Stage. This section should be identical for both the Institution and the Cancer Center applications. The applicants should clearly describe the kinds of planning activities that the Institution and the Cancer Center will conduct to ensure a highly interactive and integrated effort between their faculty and scientists. The roles and activities of the Internal Advisory Committee (IAC) should be clearly described (see IAC below). The applicants should also relate each planning activity (e.g., workshop, retreat, executive meeting) to specific objectives (see Component 3 above) and name the specific faculty and interests (e.g., training, clinical oncology researchers, research in prostate cancer, establishing new curriculum in cancer health disparities, nutrition) involved in each activity.

(iii) Priority-Setting Stage. This section should be identical for both the Institution and the Cancer Center applications. In the Priority-Setting Stage, the participants must select the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application (the PD(s)/PI(s) from both partnering components should describe the process used by the IAC to evaluate new and ongoing pilot projects/programs). Clearly describe how the specific pilot projects/programs will be prioritized and selected for implementation based on their merit and greatest potential for success.

(iv) Implementation Stage. This section should be identical for both the Institution and the Cancer Center applications. The applicants must describe one (required) or up to three pilot project(s) and  a joint training or education program in any of the target areas (e.g., cancer research, training and career development, and education) to acquire preliminary data to submit a specific competitive grant application. NOTE: THE PARTNERSHIP APPLICATIONS MUST PROPOSE AT LEAST TWO OF THE THREE TARGET AREAS (CANCER RESEARCH, TRAINING AND CAREER DEVELOPMENT, AND EDUCATION). CANCER RESEARCH MUST BE ONE OF THE TWO SELECTED AREAS.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Pilot Projects/Program

Applicants may proposed up to three pilot projects/programs.

The description of each joint pilot project/program should be presented in the following format, following all instructions in the PHS 398 Application Guide, except where noted:

Face Page (Pilot Projects/Program)

The Face Page of the 398 Form should not be used as a cover page for individual research projects and cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual pilot project/program. 

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Pilot Projects/Program)

Follow all instructions in the Application Guide, but note the following additional instructions:

Senior/Key Personnel: Include names of co-leaders from the Institution and the Cancer Center.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Pilot Projects/Program)

Prepare a detailed budget and justification for the Partnership Plan using Form Pages 4 and 5 of the PHS 398.

Biographical Sketches (Pilot Projects/Program)

Include the biographical sketches of the co-leaders, even if already included among the biosketches for the entire application.

Resources (Pilot Projects/Program)

Follow all instructions in the PHS 398 Application Guide, providing relevant information about resources available to execute the Pilot Project/Program.

Research Plan (Pilot Projects/Program)

For the purpose of this FOA: A Pilot Project supports research in any area of cancer-related basic, clinical, translational, prevention, control, behavioral, population, and/or outreach research. A Pilot Program supports training/career development and/or education of high school, undergraduate, graduate students, postdoctoral trainees and investigators about issues and problems associated with cancer disparities and motivates them to pursue cancer research careers.

Introduction to Resubmission Application, if applicable: This section should be identical for both the Institution and Cancer Center applications. Include a summary of the additions, deletions, and changes in the resubmission application, placing particular emphasis on responses to the criticisms and issues raised in the previous summary statement. In addition, include a chronological description of activities conducted since the original submission (e.g., meetings, research activities). The important changes must be clearly marked in the text.

Research Strategy: Describe how this pilot project/program relates to the overall priorities of the partnership and the target area(s). Include any preliminary data (if available). Describe, as appropriate for the nature of the project/program, experimental methods/study design, or the training, and/or education plans and objectives. For example, for a training program include the identification of the target pool (students or racially/ethnically diverse population), and/or the method of program evaluation and tracking. Describe the role played by the Institution and Cancer Center co-investigators/mentors. Identify which aspects of the pilot project/program will be conducted primarily at the Institution and which will be conducted at the Cancer Center. Pilot projects conducted primarily at the Institution may be in any area of cancer research, but pilot projects conducted primarily at the Cancer Center must specifically address cancer health disparities research.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Career Development and Mentorship Plan

The instructions listed below are only for those sections with information different from the Application Guide.

Face Page (Career Development and Mentorship Plan)

The Face Page of the 398 Form should not be used as a cover page for individual research projects and cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual component of the application.  

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Career Development and Mentorship Plan)

Follow all instructions in the PHS 398 Application Guide, providing relevant information about the Partnership Plan.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Career Development and Mentorship Plan)

Prepare a detailed budget and justification for the Partnership Plan using Form Pages 4 and 5 of the PHS 398.

Biographical Sketches (Career Development and Mentorship Plan)

Do not repeat the biographical sketches of participating investigators since this information will be included In the Overview of the Partnership section.

Resources (Career Development and Mentorship Plan)

Follow all instructions in the PHS 398 Application Guide, providing relevant information about resources available to execute the Partnership Plan.

Research Plan (Career Development and Mentorship Plan)

Introduction to Resubmission Application, if applicable: This section should be identical for both the Institution and Cancer Center applications. Include a summary of the additions, deletions, and changes in the resubmission application, placing particular emphasis on responses to the criticisms and issues raised in the previous summary statement. In addition, include a chronological description of activities conducted since the original submission (e.g., meetings, research activities). The important changes must be clearly marked in the text.

Plan Description: The Career development and mentorship plan must be provided for less experienced investigators, in particular early stage investigators, and post-doctoral scientists involved in the partnerships. The plan description should follow the format of Institutional Career Development Awards (K Awards):

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following: The collaborative partnership applications submitted in response to this FOA will be reviewed together and will receive one (i.e., the same) overall impact/priority score.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the partnership and pilot project(s)/program(s) 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 partnership and pilot project(s)/program(s) proposed).

Scored Review Criteria

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 partnership or project/program that by its nature is not innovative may be essential to advance a field.

Significance

Does the partnership or project/program address an important problem or a critical barrier to progress in the field? If the aims of the partnership or project/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? 

In addition, specific to this FOA: Does the proposed partnership or project/program address an important cancer and health disparities problem? Will the proposed partnership or project have a significant effect on the broader field of health disparities? 

Investigator(s)

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

In addition, specific to this FOA: Does (Do) the investigator(s) have prior adequate training and experience in designing and implementing new training programs that are culturally appropriate interventions? Do the applicant(s) and other team members have prior experience in recruiting and training new and early stage investigators? 

Innovation

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

In addition, specific to this FOA: Does the application use a creative study design? Is the study design being proposed already in existence but being applied to new underserved populations?  Will the proposed design be culturally tailored for the population of interest? Will plans be made available and flexible enough for modification, if found to be beneficial?

Approach

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

If the partnership or project/program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA: Are the methods for the Initial Planning Stage that are proposed by the Institution and the Cancer Center to explore areas of research and training opportunities adequate to ensure highly interactive and integrated efforts between individual scientists and/or between faculty and scientists Is the duration of the initial planning stage needed to identify areas of potential collaboration adequate?  

Environment

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

In addition, specific to this FOA: What is the strength of the evidence that the researchers and faculty of the Institution and the Cancer Center worked closely together in the preparation of the application? To what degree do the letters-of-support from senior faculty and/or Institutional/Center leaders address the need for mentoring of inexperienced PDs/PIs or for specific Institutional/Center commitments to ensure the success of the collaboration?

Additional Review Criteria - Overall

As applicable for the partnership and pilot project(s)/program(s) 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

Inclusion of Women, Minorities, and Children 

When the proposed partnership or project/program involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, which can only be resubmissions of applications submitted previously in response to this FOA, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

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

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review 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:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects/Programs

Awardee-selected projects/programs that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Carmen P. Moten, Ph.D., M.P.H.
Diversity Training Branch
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 240-276-6181
E-mail: cmoten@mail.nih.gov

Peer Review Contact(s)

Referral Officer
Division of Extramural Activities
National Cancer Institute
Telephone: 240-276-6390
E-mail: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Brett Hodgkins
Office of Grants Administration
National Cancer Institute
Telephone: 240-276-6296
E-mail: hodgkinsb@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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