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

Limited Competition: Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE) (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-CA-11-001

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-12-055

Companion FOA

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, 93.398

FOA Purpose

The National Cancer Institute (NCI) invites cooperative agreement (U54) applications for the implementation of Comprehensive Partnerships between institutions serving communities with cancer health disparities and NCI-designated Cancer Centers (or groups of Centers). The purpose of this limited competition funding opportunity announcement (FOA) is to foster and support intensive collaborations among investigators at institutions that serve communities with cancer health disparities in order to develop stronger national cancer programs aimed at understanding the reasons behind the significant cancer disparities and related impacts on these populations. This FOA is intended for: (1) supporting active Comprehensive Partnerships under the U54 mechanism; and (2) elevating the most promising partnerships currently in the planning phase (U56 awards) to the comprehensive status.

Key Dates
Posted Date

December 9, 2011

Letter of Intent Due Date

December 27, 2011; December 28, 2012; December 28, 2013

Application Due Date(s)

January 27, 2012; January 28, 2013, January 28, 2014  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2012; June/July 2013; June/July 2014  

Advisory Council Review

August 2012; August 2013; August2014

Earliest Start Date(s)

September 2012; September 2013; September 2014

Expiration Date

January 29, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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 applications for cooperative agreement (U54) awards to support Comprehensive Partnerships between:

(1)   Institutions serving communities with disproportionately high cancer health disparities;

and,

(2)   NCI-designated Cancer Centers.

These partnerships are designed to develop some cancer activities aimed at understanding the reasons behind the significant cancer disparities and impacts on underserved communities and socio-economically disadvantaged populations.

Presently, the NCI supports several comprehensive partnerships (U54 awards) through this program. In addition, the program has funded several awards for the planning/developing phase (U56 awards).

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

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

Applications from those partner institutions that have been supported through the U56 Cooperative Planning Partnership awards are to be submitted as new (Type 1) applications.

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

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

The NCI-sponsored partnership program is a powerful vehicle that can help institutions serving underserved communities with cancer health disparities and Cancer Centers to integrate and take maximum advantage of their respective expertise and experience to work together in areas of mutual benefit. For example, both types of institutions may benefit from a broader range of resources and technical expertise. The institutions that serve communities with cancer health disparities will gain exposure to state-of-the-art technology and access to information services available at the Cancer Center. Reciprocally, the Cancer Center will gain a greater diversity of students, faculty members, and researchers participating in cancer research-related activities and increased access to underserved patients for cancer and health disparities - related clinical trials.

Background

The disparities in cancer incidence, morbidity, and mortality in underserved populations, including racial and ethnic minority 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 survival rates 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) (Making Cancer Health Disparities History; http://www.hhs.gov/chdprg/pdf/chdprg.pdf) .

Institutions serving underserved communities with cancer health disparities represent a rich source of potential clinical subjects, and talent with appropriate cultural sensitivity and perspectives needed to conduct research on cancer health disparities and high quality educational programs for persons interested in serving racial/ethnic and the underserved populations. However, investigators at these institutions have to overcome difficulties in developing and sustaining independent programs in biomedical research. Despite various initiatives, progress has been slow in increasing the pool of scientists from underrepresented groups who are competitive for National Institutes of Health (NIH) research grants (http://www.sciencemag.org/content/333/6045/1015.full).

A significant increase is needed in the number of well-trained scientists from underrepresented groups who can conduct independent competitive cancer research. While many scientists may have an interest in elucidating the factors leading to cancer health disparities, the cultural perspectives of scientists from these communities are essential to properly and successfully conduct research on the disproportionate burden of cancer in underserved and socio-economically disadvantaged populations. Moreover, the institutions funded through this FOA provide unparalleled access to patients and scientists from these populations, and opportunities to observe whether concordance between researchers and clinical subjects improves participation, satisfaction, and compliance with clinical regimens. The NCI-designated Cancer Centers are geographically dispersed, research-intensive institutions with well-organized programs for 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; as well as develop and sustain educational and outreach programs that benefit their communities. Yet, Cancer Centers can (and should) play a greater role in facilitating:

Specific Requirements and Research Objectives

The Comprehensive Partnership Program is about building and sustaining excellence. The Program will serve as a nurturing environment and “incubator” to allow for the development of new projects/programs. The Comprehensive Partnership Program provides long-term support for cancer research infrastructure (e.g., key personnel recruitment, equipment, clinical accrual cores, tissue cores, etc.).

The Program will also support (but not indefinitely) cancer research projects, training, outreach, and education programs (see the list of broad target areas for development below). The emerging projects/programs are expected to lead to competing grant applications to NIH or equivalent sources of research funding.

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

1.    Compete successfully for peer-reviewed research grants; and,

2.    Conduct quality research resulting in peer-reviewed publications.

Career and professional development activities must be provided for less experienced investigators, in particular early stage investigators, and post-doctoral scientists involved in the partnerships. For the purpose of this FOA, an early stage investigator is a Program Director/Principal Investigator who is a New Investigator within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) with no prior independent research funding from NIH or equivalent agencies (i.e., R01, P01, etc., awards; small awards [e.g., R03, R21] and training [K awards] do not count). The proposed plan of action for the career and professional development as well as mentorship must be integrated into every target area of the U54 cooperative agreement application (i.e., cancer research, training, outreach, and education) as well as administration.

Appropriate career development plans must be proposed for individual researchers from both institutions, for example for scientists designated to serve as PD(s)/PI(s). The objective of this endeavor is to increase the chances that early stage investigators develop the research skills and abilities needed to work in a collaborative and competitive environment and will eventually become successful independent cancer researchers. The career plan should identify mentor(s) who will be responsible for career and professional development of these individuals. Mentorship should involve senior faculty member(s) with research competence and/or experience appropriate for the role. Mentors are expected to be, typically, individuals at the associate or full professor levels. In addition to relevant research experience, mentors must have an appreciation and understanding of the cultural, socioeconomic, and research backgrounds of the early stage investigators to be mentored. When appropriate, experienced senior faculty members within institutions serving underserved communities with cancer health disparities, but outside the early stage investigator's research area, may be chosen as mentors, co-mentors, or consultants. The mentor(s) and the early stage investigator are expected to closely interact during the development and execution of a tailored career development plan similar to the model used in NIH career development awards (K Awards). The mentoring process should include defining the expected outcomes in a way clear to both mentors and mentees. The career development plan should ensure that mentors are available to provide appropriate guidance throughout the duration of the program. The Comprehensive Partnership application may provide compensation for mentors, co-mentors, and/or consultants. The mentoring approach applies also to less experienced senior faculty members from the institution serving underserved communities with cancer health disparities.

Target Areas

The U54 linked award applications must address three target areas: Cancer Research; Cancer Training; and Cancer Outreach. A fourth target area, Cancer Education, must be addressed for those training programs where curriculum development is an inherent part of the training activity. Other activities related to Cancer Education are optional.

1) Cancer Research (required component). For Type 1 applications, at least two pilot projects and one full project must be included. For Type 2 applications, at least one pilot project and two full projects must be included. Research projects may be in any area of basic, clinical, translational, prevention, control, behavioral, and/or population 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. NCI is interested on developing educational, outreach and research projects leading to increase biospecimen collection from underserved populations, a critical endeavor to potentially elucidate the biologicaland 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. These projects may focus, for example, on general areas of environmental carcinogenesis, cancer biology, molecular epidemiology, and/or behavioral issues related to cancer prevention, treatment, and control. Joint research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in underserved and/or socio-economically disadvantaged populations. All these efforts must be aimed at eventually securing competitively funded extramural awards (e.g., R01 awards, projects on P01 or P50 awards or their equivalents). Small grants (such as R03 and R21 awards) are also desirable but rather as a step in the career development of early stage investigators.

2) Cancer Training (required component). Training programs that link the faculty and students of the partner institutions are among the most productive ways to sustain long-term effective partnerships. These programs must 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, i.e., in the field of studies that depend largely on the cultural sensitivities of the investigators for success. Training programs 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 Outreach (required component). Cancer outreach in the context of this FOA is a joint effort between partner institutions and must include hypothesis-driven research projects that may lead to increased use of and access to beneficial medical procedures, such as primary prevention measures, e.g., smoking cessation and cancer vaccines, or early detection procedures, such as mammography, PAP smear, colorectal cancer screening, etc. Research studies may include focus groups and needs assessments. These efforts must effectively reach individuals and physicians and should lead to increased use of medical procedures that may result in decreasing cancer health disparities. In addition, recruitment and retention of underserved and socio-economically disadvantaged populations into clinical trials such as prevention, early detection, or treatment trials is encouraged.

4) Cancer Education (required component if curriculum development is an inherent part of the training program; other activities are optional). Cancer education could focus on any effort to augment existing curricula or create new curricula in the partner institutions. This new curricula may apprise and culturally sensitize graduate and postdoctoral students in research, medicine, and public health of the need to reduce the disproportionate cancer burden in underserved  and socio-economically disadvantaged populations. A successful completion of the design phase of new curriculum may result in the submission of a competitive NCI education grant (e.g., an R25) application  and to institutional commitments leading to implementation of these curricula as  components of their education programs.

OTHER REQUIRED COMPONENTS:

Administrative Core: Each partnering institution must establish an Administrative Core that will provide the day-to-day administrative support for the partnership. The Administrative Core will provide funding for managing the partnership, such as: salaries for PD(s)/PI(s) and other key personnel, e.g.,  Program Managers (key personnel that assist the lead PD(s)/PI(s) in coordinating and organizing day-to-day activities of the partnership); equipment and supplies to support an administrative structure.

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

In addition, the resources allocated for the Planning and Evaluation Core must include the costs for activities of the Internal Advisory Committee (IAC), key personnel, and ad hoc committee members, as well as external activities (e.g., per diem costs for travel and consultant costs for Program Steering Committee [PSC] members, consultant costs for focus groups). To ensure the integration of the partnership, applications from both of its components must specify appropriate commitment (percent effort) of PD(s)/PI(s) to the activities of the IAC. They may also include costs associated with the identification and conduct of strategic planning sessions, workshops, seminars, retreats, and other forums to strengthen, stabilize, and consolidate interactions and cooperation in areas of existing high priority.

Developmental Core: Pilot and full projects that each partnership is required to propose in the application are included in this core. The core will cover costs of all pilot and full projects proposed. Appropriate funds for additional projects to be developed, based on IAC and PSC recommendations, must be included in the budget for this core.

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

Section II. Award Information
Funding Instrument

Cooperative Agreement.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the PHS398 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.

Award Budget

Application budgets are limited to $2.75 million total cost for dyads and $3.25 million total cost for triads.

Award Project Period

The maximum period is 5 years

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

Only institutions that have been involved in the partnerships currently referred to as “Comprehensive Partnerships to Reduce Cancer Health Disparities” are eligible to apply in response to this limited competition FOA if the following provisions are met. Eligible institutions must be either: (a) currently supported by U54 awards (including those on no cost extension); or (b) supported in the past or currently by U56 planning awards (including those on no cost extension).

Each partnership must include both types of institutions: 1) an institution serving underserved communities with cancer health disparities; and 2) an NCI-designated Cancer Center. In addition to such “dyad” partnerships, eligible partnerships may also involve three institutions (e.g., triads defined as two institutions serving underserved communities with cancer health disparities and one Cancer Center or two Cancer Center and one institution serving underserved communities with cancer health disparities). Only existing triad partnerships may apply in response to this announcement.

Institutions serving underserved communities with cancer health disparities with medical schools, or with more focused education and research programs (e.g., Masters and PhD programs), as well as those that offer only baccalaureate degrees and Tribal Colleges may all participate in this initiative.

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 PHS398 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 Director(s)/Principal Investigator(s) (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 least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PIs, visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

For further information on multiple PD(s)/PI(s), please see http://grants.nih.gov/grants/multi_pi

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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications (NOT-OD-09-003) from the PHS398 Application Guide.

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

2) Partnership Structure

3) Targeted Areas. Among the four areas targeted by this initiative, cancer research, cancer training, and cancer outreach are required components that must be addressed in all the applications.

4) Projects.

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

6) Benefits of the Partnership. The linked applications from the partner institutions must not only complement each other, but also should clearly outline the mutual benefits gained and to be gained as a result of the partnership.

7) Internal Advisory Committee. There must be a common Internal Advisory Committee (IAC), shared across the partner institutions. IAC  will be responsible for internal planning and evaluation activities as outlined below:

The IAC will be made up of the PD(s)/PI(s) and other key personnel, as appropriate. The IAC must have equal numerical representation of members from the institutions. In addition, the Program Manager (i.e., key personnel that assist the lead PD(s)/PI(s) in coordinating and organizing day-to-day activities of the partnership) of each partnership will serve as ex-officio member. The PD(s)/PI(s) cannot be the Chair of the IAC. There will be no NCI representatives as members of the IAC. The expertise of the IAC members should be relevant to the objectives and goals of the partnership. If the committee lacks the scientific expertise to evaluate pilot/full projects/ programs, ad hoc reviewers from either within or outside the partner institutions may be added to the IAC. The responsibilities of the IAC are as follows.

Evaluation of Additional Pilot Projects, Full Projects, and Programs (to be developed and in the course of the award). Beyond the specific projects described in the application, awardees will be required to develop additional pilot and/or full research projects to provide continuity of research activities (see details in Section VI.2.A. A. Cooperative Agreement Terms and Conditions of Award). When a project co-leader (investigator from the institution serving underserved communities with cancer health disparities or Cancer Center participating as PD(s)/PI(s) of a joint pilot/full project) is an early stage investigator, the pilot, full project must be accompanied by a career development and mentoring plan as required for projects directly proposed in the application. The same process will apply to additional programs and/or activities that are proposed for development in the training and outreach cores during the course of the award.

Concepts/applications for these additional projects will be prioritized by the IAC. Depending on the priority, the IAC will be expected to recommend either: (1) funding of the project as requested; or (2) funding as a pre-pilot project for 1-year; or (3) not funding the proposed project due to low scientific merit, low relevance to partnership goals and objectives, low potential to generate publishable data, and/or low potential to give rise to a competitive grant application. Proposed programs will be recommended for funding or not funding.

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

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

Evaluation of Cores and Other Activities. The IAC will evaluate the Administrative, Training and Career Development, and Outreach Cores on an ongoing basis. The IAC will make recommendations and provide guidance for workshops, retreats, focus groups, and other forums to identify areas of new opportunity as well as for strengthening, stabilizing, and merging existing projects or programs. In addition, the committee will also evaluate and recommend other key partnership activities such as the recruitment of new investigators and research associates, and the establishment of resources and infrastructure based on their merit and potential to contribute effectively to achieving high priority goals and objectives.

The IAC evaluations and recommendations for new projects (pilot/full), ongoing projects (pre-pilot/pilot/full), the cores as well as other activities will be forwarded to the Program Steering Committee (PSC, see below) for concurrence. If the IAC recommendations change the scope of the partnership objectives, those recommendations must be reviewed and approved by the PSC. The Lead PD(s)/PI(s) must make minutes of the IAC meetings conducted throughout the year available to the PSC.

8) Program Steering Committee (PSC). The PD(s)/PI(s) will nominate the members of the PSC, except the NCI Project Scientist. Changes in the composition of the PSC must be approved by the NCI Program staff. The activities of the PSC will include:

Both Type 1 and Type 2 applicants must provide in their applications the assessment of their U56 and U54 partnerships by their respective PSCs.

9) External Evaluation of the Comprehensive Partnership Program. In addition to evaluations of individual partnerships by their IAC and PSC, all partnerships will be expected to participate in periodic external evaluation of the entire Comprehensive Partnership Program. This external evaluation will assess, for example, the extents to which the Partnership Program: fosters better collaboration between institutions; helps new investigators to become more competitive in securing NIH grant awards; increases access of members of underserved populations to beneficial cancer diagnoses and treatments, assess the number of grants submitted, funded, peer review publications.

10) Core/Project Leadership and Budgetary Limitations. In using Core funds to support pilot/full projects and programs, each activity must be co-led by individuals from both partner institutions. No pilot project can exceed $120,000 in direct costs per year or continue for more than 3 years and no full project can exceed $275,000 in direct costs per year or continue for longer than 3 years. Any extension beyond 3 years must be approved by the IAC, PSC, and NCI. The expectation is that successful pilot projects will become full projects and that full projects will become competitively funded grants (e.g., R03, R21, R01, R25T, R25E, P50, T32, P01, and K12). Third/fourth party facilities and administrative costs are in addition to the direct costs requested. Activities of the Cores can be supported for the period of the grant, usually 5 years.

11) Nature of Projects/Resources for Development. Any new project and shared resources for development must represent totally new activities that do not overlap in purpose or intent with existing grants and shared resources (e.g., P30, P50, P60, National Center for Research Resources' Infrastructure Grants, National Institute of General Medical Sciences Minority Biomedical Research Support Grants [S06, SC1, SC2, SC3], or any other peer-reviewed funded grant and/or cooperative agreement). Resources should augment the research capability of the institutions serving underserved communities with cancer health disparities, the collaborative research between these institutions and the Cancer Center, and/or specifically support and enhance research focused on issues pertaining to underserved and socioeconomically disadvantaged groups. Resources proposed either can augment existing Cancer Center capabilities or they can constitute entirely new resources, as long as they are tailored to the common objectives and priorities of the partnership. Resources can be located in either of the partner institutions (or in both institutions) but must be available to both partners.

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

13) Partnership Investigators Workshop. The recipients of U54 Comprehensive Partnership awards must participate in a biennial Workshop for sharing information and strategies. A Planning Committee composed of selected funded Comprehensive Partnership investigators will be convened by the NCI to develop an agenda for the workshop. Travel expenses for this purpose must be included in the applications from each of the partner institution.

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 PHS398 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:

H. Nelson Aguila, D.V.M.
Diversity Training Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 6W102
Bethesda, MD 20892-9746 (for regular mail)
Rockville, MD 20850 (for express delivery)
Telephone: 240-276-6161
E-mail: aguilah@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 (NCI)
9609 Medical Center Drive, Room 7W412
Bethesda, Maryland 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 PHS398 Application Guide must be followed, with the following requirements:

Introduction (required for a resubmission application) is limited to 1 page.

Specific Aims is limited to 1 page.

Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to:

Please see description of these sections below):

For the applications submitted in response to this FOA, the standard PHS 398 instructions for application preparation are altered as follows:

Face Page (PHS 398 Form Page 1). The title of the partnership (Item 1) should be the same for both linked applications. The title should be unique to specific partnership (do not repeat the title of this FOA) and should include the suffix “(1 of 2)” or “(2 of 2)” to allow for the identification of the linked applications from each partner institution, respectively.

Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS 398 Form Page 2). List the lead PD(s)/PI(s) first followed by the other PD(s)/PI(s) (the lead PD(s)/PI(s) on the partnering application should be included as one of the PD(s)/PI(s)). Then list all remaining Key Personnel for this application alphabetically. Finally, list the members of the IAC and PSC.

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to replace standard sub-sections of Section 3 “Research Strategy” of the PHS 398 Research Plan with the following new sub-sections A-G:

Budget (PHS 398 Form Pages 4 and 5): Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5).

Use additional Form Pages 4 and 5 to provide detailed separate budget information (first-year and cumulative budgets for the entire project period) for the individual application components.

Specifically provide:

Budgets Pertaining to Consortium/Contractual Arrangements. Follow the PHS 398 instructions to complete this information if your application involves a consortium between the primary applicant institution and another institution.

RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:

Other sections of the PHS398 Research Plan remain unmodified and should be completed following standard instructions.

Section 3.A. Overall Objectives and Partnership Integration (up to 12 pages)

This section must be identical for both U54 applications.

In this section, applicants should address the following items (under separate subheadings):

1) Overall Objectives. Outline the following aspects:

2) Institutional commitment of the partner institutions. Summarize the commitments of partnering institutions. The following types of institutional commitment are expected to be considered:

Institutional commitments must also be properly documented by respective letters attached in Section 14 Letters of Support. For example, the institutional leaders (e.g., President, Center Director, Dean) are expected to provide detailed statements of the long-term commitment and list the specific resources, space, protected time, etc. These statements should also identify a specific number of positions that will be wholly dedicated to cancer research under the partnership. The letters should clearly explain how the partner institutions would monitor these efforts and specific steps and procedures to ensure achieving the planned goals.

3) Prior Planning Activities (for new Type 1 applications only): Provide a chronological review of the prior planning and priority-setting processes. Document that this partnership was derived from careful planning and priority-setting processes that were based on each partner's strengths/weaknesses and potential to help each other become stronger in relevant targeted areas. Describe the outcomes of the U56 planning process that are particularly relevant to the proposed full-fledged partnership under the U54 mechanism.

In chronological order, present each process used in planning and setting the priorities and objectives for this application. Briefly describe the nature of each planning activity completed (e.g., meetings of higher institutional officials, planning committees, steering committees in areas of common interest , workshops, retreats), its purpose, the individuals that participated from both institutions, and its outcome.

4) Progress Report (for renewal Type 2 applications only): Summarize the accomplishments and progress during the current funding period. Address progress accomplished for specific Partnership components (Administrative Core, and recruitment; Research Projects/Programs; Career Development; Shared Resources; and Evaluation Activities) in the context of the goals described in the original U54 application. For example, applicants may present a chronological history of their partnerships, discuss barriers faced, and indicate how these obstacles were resolved. Mention major administrative changes that took place, name all new faculty members supported by the U54 award, and list the publications, grants (including the organization that funds the award and type of award), number of students, tracking of students, etc., resulting from the U54 award. The use of tabular format to summarize all grants, publications resulting from funded pilot and full projects and programs is recommended, and must be included within page limitations.

Section 3.B. Administrative Core , which includes Scientific and Administrative Leadership (up to 12 pages).

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

Within the 12 page limit for the entire Section 3B, describe specific functions of the administrative core to provide the necessary day-to-day administrative support, coordination, and logistical services needed to make this partnership function effectively. This role might include: organizing communication across Partnership, meetings, workshops, and retreats; documenting the results of activities; and providing critical secretarial services, etc.

Justification for all the cost associated with this core must be provided. Administrative Core will provide funding for managing the partnership, such as: salaries for PD(s)/PI(s) and other key personnel such as Program Managers (i.e., key personnel that assist the lead PD(s)/PI(s) in coordinating and organizing day-to-day activities of the partnership); equipment; and supplies to support an administrative structure.

1) Leadership and Team. Without duplicating the information in the standard PHS 398 Section 12 (Multiple PD(s)/PI(s) Leadership Plan), briefly describe the leadership structure. Explain how the designated PD(s)/PI(s) were chosen in terms of the qualifications and leadership experience as well as characterize the potential of Partnership leaders to integrate the proposed efforts and to promote collaboration and cooperation in achieving the common objectives.

Expected Effort Commitments. To provide effective leadership, it is expected that individuals designated as PD(s)/PI(s) will be meaningfully committed to the partnership. Specifically, if the multiple PD(s)/PI(s) option is not used, the PD(s)/PI(s) from the institution serving underserved communities with cancer health disparities is expected to commit a minimum of 3 months effort per year and the Cancer Center PD(s)/PI(s) is expected to commit at least 1.2 months effort per year. If the multiple PD(s)/PI(s) option is used, a minimum of 1.2 months effort per year is expected for the Lead PD(s)/PI(s) from the institutions serving or underserved communities with cancer health disparities and Cancer Center with a maximum of 3 months effort per year in each institution for all the other PD(s)/PI(s) combined.

For each designated lead PD/PI, applicants must specify and document that the expected commitment can be met (for example, what current duties, e.g., teaching, clinical duties, administrative duties, will be eliminated to allow the faculty members to spend adequate time on the partnership activities).

It is preferred that individuals designated as the lead PD(s)/PI(s) are established investigators with active competitive research support, such as R01 grants or equivalent peer-reviewed funding. If the lead PD(s)/PI(s) is not an established and competitively funded investigator, the partnership application must include a 2-3 year professional development plan for that individual. The plan must be provided in Section 3D (see below). In addition to the information on the PD(s)/PI(s), provide analogous information on any other mid-to-high level investigators who are anticipated to play a significant role in determining the success of this partnership.

2) Recruitment Plans. Describe recruitment plans of the Partnership.

For the already identified individuals who are anticipated to be recruited address the following aspects:

Note: Include these individuals in the list of Key Personnel and attach their biographical sketches.

For recruitment plans where specific names of individuals are not yet known:

Section 3. C. Planning and Evaluation Core (up to 6 pages)

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

Note: Budget for this section may include such items as:

Section 3.D. Developmental Core - Pilot and Full Projects in Required Target Areas (page limits depend on the number and types of proposed components – see details below)

This section may be different for each of the linked applications.

Joint projects must focus on the required target areas (cancer research and outreach). The proposed projects should be responsive to the planning and priority setting activities of the partner institutions during the course of the funding period.

Each partnership application must include at least three projects. Type 1 applications must include at least one full project and two pilot projects. Type 2 applications are expected to include two full projects and at least one pilot project. Although there is no upper limit, it is suggested that there will be no more than four (combined) pilot and full projects proposed.

Note: Individual projects proposed in this section (both pilot and full projects) are to be structured similar to sub-project on a multi-project PHS 398 grant and contain elements that do not count towards page limits. Research Plans for these individual pilot and full projects will follow the format of the standard PHS 398 instructions and the Research Strategy section as described below. Within Research Plans, Section “Research Strategy” is limited to 6 and 12 pages for pilot and full projects respectively.

1) Proposed Pilot Projects. Pilot Projects proposed for funding cannot exceed $120,000 per project in direct costs per year for up to 3 years. The description of these projects should be provided in the following format.

Title Page including: the title of project, names of co-leaders from both partner institutions, and brief abstract stating the objectives (specific aims) of the project.

NOTE: Identify any needs for career development plan for the less experienced Project co-leaders (respective Career Development Plans are to be included in Section 3E, see below);

Research Strategy (up to 6 pages) to include the following items:

Describe how this pilot project relates to the overall priorities of the partnership and the target area(s). Include any preliminary data (if available). Projects without preliminary data are expected to provide scientific rationale based on appropriate supporting literature. Describe, as appropriate for the nature of the project, experimental methods/study design, or education plans and objectives. Identify which aspects of the pilot project will be conducted primarily at the institutions serving underserved communities with cancer health disparities and which at the Cancer Center. Research projects conducted primarily at the institutions serving underserved communities with cancer health disparities may be in any area of cancer research, but research projects conducted primarily at the Cancer Center must specifically address cancer health disparities research.

Note: Other Sections of PHS 398 Research Plan (Sections 4-15) must also be completed (but are excluded from page limitations). In particular, Research Plan sections pertaining to human subjects and vertebrate animals must be strictly followed. See note below. Respective information must also be included (in cumulative fashion) in Sections 4-15 for the entire partnership application.

2) Proposed Full Projects. Full Projects proposed for funding cannot exceed $275,000 per project/program in direct costs per year for up to 3 years. The description of these projects should follow the same format as the description of pilot projects with the following differences.

NOTE: Identify any needs for career development plans for less experienced Project co-leaders (respective Career Development Plans are to be included in Section 3E, see below);

Title Page including: the title of project, names of co-leaders from each institution, and brief abstract stating the objectives (specific aims) of the project.

Research Strategy (up to 12 pages) to include the following items:

Note: Well-developed project and sufficient preliminary data are needed for full projects.

Other Sections of PHS 398 Research Plan (Sections 4-15) must also be completed (but are excluded from page limitations). In particular, Research Plan sections pertaining to human subjects and vertebrate animals must be strictly followed. See note below. Respective information must also be included (in cumulative fashion) in Sections 4-15 for the entire partnership application.

NOTE 1 for both Pilot and Full projects. PHS398 Instructions to Research Plan, sections pertaining to human subjects and/or vertebrate animals (listed below), must be strictly followed and appropriate documentation (described in PHS398 instructions) attached as required.

Research components involving clinical trials must include a data and safety monitoring plan as described in the PHS instructions. Funds should be budgeted for these activities and should be justified. The proposed provisions should not duplicate review and monitoring systems already in place at the institution. For any cancer treatment protocol supported directly or indirectly by the Comprehensive Partnership U54, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols subsequent to funding of a U54, to the NCI Program Director.

Relevant information from Sections 4-15 for each project must also be included (in cumulative fashion) in corresponding Sections 4-15 for the entire application.

NOTE 2: Beyond the specific projects described in this section of the application, applicants must plan for the development of additional projects (see details in Section C, Planning and Evaluation Core)

Section 3.E. Training/Career Development and Education Core

Training and education programs and activities are limited to 12 pages each within this core.

Training and mentoring of post-doctoral fellows, early stage investigators and students from underserved populations will be supported through this core. Joint training programs, as stated in Section I under target areas, must include core co-leaders from partner institutions. Partnerships proposing Cancer Education programs with new curricula will develop such programs in this core.

Examples of appropriate training activities include (but are not limited to) the following:

Successful training programs should lead to the submission of competitive training grant applications (e.g., T32, K12, R25 mechanisms) as well as applications for individual pre-doctoral fellowships (F31), career development awards (e.g., K01, K07, K08, K23, K22) and research supplements for trainees.

Successful education programs should result in the development of instutionalized curricula that enhance education and research capacity of partner institutions.

1) Career Development and Mentoring Plan (if needed)(up to 12 pages per section “The Candidate” in each plan plus other required administrative items)

As indicated in the earlier sections, career development and mentoring plans must be provided for the less experienced co-leaders and directors of individual projects/programs. The plan description must follow the format similar to applications for Career Development Awards (K Awards), by providing the following information

The Candidate (limit of 12 pages for items A-D);

a) Candidate’s Background

b) Career Goals and Objectives: Scientific Biography

c) Career Development/Training Activities during Award Period

d) Training in the Responsible Conduct of Research

Formal/administrative Items Required for Each Career Development Plan (not page limited):

NOTE: (1) All NIH-supported biomedical or behavioral research projects involving human subjects must address the respective requirements under the Research Plan, Section E, Human Subjects, following the PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described under the Research Plan, Section F, Vertebrate Animals of the Form PHS 398 instructions; and (3) Research components involving clinical trials must include a data and safety monitoring plan as described in the PHS 398 instructions. Funds should be budgeted for these activities and should be justified. The proposed provisions should not duplicate review and monitoring systems already in place at the institution. For any cancer treatment protocol supported directly or indirectly by the U54, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols subsequent to funding of a U54, to the NCI Program Director.

Section 3.F. Outreach Core (up to 12 pages)

Joint cancer outreach programs can be proposed in this section. Specifically, the U54 Comprehensive Partnership may help underserved communities develop activities such as:

It is expected that certain activities under the Cancer Outreach Core will be guided and coordinated by the NCI. For this purpose, the partnership application must include plans for one properly trained individual designated as “Community Health Educator” (CHE). The CHE will assist the PD(s)/PI(s) in the planning and implementation of activities within the Cancer Outreach Program. The CHE will contribute to the planning and evaluation of outreach activities and research of the partnership. The CHE will also work with the community and the NCI’s National Outreach Network on NCI-coordinated agenda (for details, see Section IV.6. Other Submission Requirements)

Individuals to be designated CHEs must have appropriate training and knowledge of the NCI programs and experience in communications, comprehensive cancer control, training, program planning, and evaluation. The CHE will work with the community and NCI’s National Outreach Network to identify, develop, and disseminate health promotion/cancer education materials, important NCI messages, etc. Partnership applicants should anticipate that approximately 6 person months of the workload of CHEs will be devoted to NCI activities and the remaining 6 person months to the Partnership cancer outreach research activities including planning and evaluation. Please refer to http://grants.nih.gov/grants/policy/person_months_faqs.htm for definition of “person months”.

The CHE will be involved in the following NCI-coordinated activities within the Cancer Outreach Core by:

Section 3.G. Shared Resources (up to 6 pages)

This Section G must be different for each of the linked applications.

In this section, describe resources/Infrastructure proposed for development (e.g., tissue resource, clinical trial accrual core, clinical research management core, special equipment, etc). These resources are expected to augment the cancer research capability of the institutions serving racial/ethnic and/or underserved communities with cancer health disparities, the collaborative research of the partner institutions, and/or specifically enhance research focused on cancer health disparities issues. Shared infrastructure can be placed in either institution or in both locations. The description must contain the following information:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

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 PHS398 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 PHS398 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 PHS398 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.

6. 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.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the partnership address an important problem or a critical barrier to progress in the field? If the aims of the partnership 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 Comprehensive Partnership address an important cancer and health disparities problem? Will the proposed partnership have a significant effect on the broader field of health disparities? What is the potential effect of this partnership on changes in knowledge, opinion, and practices among members of the participating community? Will the proposed training and education activities have an effect on the community?    

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the partnership? 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(s)/PI(s), 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 the investigator(s) have prior adequate training and experience in designing and implementing new training programs that are culturally appropriate interventions? Do the applicant 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 community 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? 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 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 plans for pilot and full research projects as well as outreach and educational programs adequately described and appropriate for the goals of the particular partnership? Does the applicant present strong arguments for the proposed study design as the best possible balance of scientific rigor, implementation constraints and ethical sensitivities of partners? Are the potential limitations of the study design and approach adequately addressed? Is there an adequate plan for facilitating dissemination and translation of study findings with other partnerships? Is the career development and mentoring plan well detailed for the training program?   

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

Additional Review Criteria - Overall

As applicable for the partnership proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

1)Prior Performance in Planning Phase (Type 1 applications) or Progress (Type 2 applications)

2) Overall Evaluation and the Partnership Integration

a. Commitment from the Institutional Leadership:

b. Administrative Core

c. Scientific and Administrative Leadership:

d. Scientific Integration:

3) Projects in Required Target Areas

a. Pilot Projects

b. Full Projects

4) Career Development Plans

5) Training and Outreach Cores

6) Resources/Infrastructure Development

7) Planning and Evaluation Core

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  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, 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

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

Revisions

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

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority 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) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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 National Cancer Advisory 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(s)/PI(s) 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

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

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

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

Minimal PD(s)/PI(s) Commitments. Awardees must be committed to making the research tools and research materials they develop available to the cancer research community. The awardees must ensure a significant effort commitment of the program leadership. Specifically, lead PD(s)/PI(s) from the institution serving underserved communities with cancer health disparities must commit a minimum of 1.2 month-effort to the partnership activities, although a commitment level of 3 months-effort is expected if there are no other PD(s)/PI(s) from that side of the partnership. Lead PD(s)/PI(s) from the Cancer Center must commit a minimum of 10 percent of effort regardless of the number of PD(s)/ PI(s) from the CC side of the partnership.

Internal Advisory Committee (IAC). IAC will be responsible for internal planning and evaluation activities. Other (non-lead) PD(s)/PI(s) (if applicable) will also be members of the IAC. The lead PD(s)PI(s) from both institutions will select members of the IAC, as needed from among the qualified faculty members of the institutions participating in the partnership program. The lead PD(s)/PI(s) will convene the initial meeting of the IAC to select a Chair of the committee. The IAC will be responsible for establishing a process for IAC review and evaluation for initiating and closing all pre-pilot, pilot, and full projects based on their merit and potential for achieving the objectives of the partnership and their actual progress. The IAC will also review the Cores and other activities  of the partnership. The IAC evaluations and recommendations will be forwarded to the Program Steering Committee for concurrence. The IAC should meet regularly but not less than quarterly.

Participation in the activities of Program Steering Committee (PSC). Upon receiving the Notice of Award, the lead PD(s)/PI(s) will convene a teleconference of the Program Steering Committee (see section on “Joint Responsibilities” for details) to select a chair, determine the date/time of the first PSC meeting and identify the most critical elements for an effective agenda. Once a meeting date is determined, the lead PD(s)/PI(s) must distribute all materials that are to be evaluated to the PSC at least 4 weeks before the meeting. The PSC chair will make assignments for other PSC members based on their expertise and experience. All members at the PSC will prepare the first draft of their recommendations, in the form of a written annual report. The PSC report should be a critical assessment of the partnership and its activities including recommendations to terminate specific research pilot projects or full studies. The PSC report should be prepared with reasonable detail, identifying weaknesses and recommending ways to correct them. The PSC should pay close attention to the commitment of the leadership to the partnerships and the faculty members involved. No later than 2 weeks after the adjournment of the meeting, the final PSC report must be submitted to the Lead PD(s)/PI(s). The lead PD(s)/PI(s) must submit the PSC report to the leadership of their partner institutions (i.e., to the Cancer Center Director and Institution's President). The Lead PD(s)/PI(s) must use the recommendations in the report to guide and direct the development of the U54 program. The PSC report must be included as part of the Non-Competing Continuation Application submitted to the NCI each year. Awardees will respond to the advice and recommendations of the PSC report and this response must also be included in the Non-Competing Grant Progress Report (PHS 2590).

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

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

Reports. Each partner awardee will submit annual progress reports (including the PSC annual meeting report and program response) to the NCI that describes activities and accomplishments during the previous funding period as part of the Non-Competing Grant Progress Report (PHS 2590).

Approval of Changes. If the institutional leadership (i.e., Cancer Center director or Institution's President) changes during the course of the award, new letters of commitment must be sent to NCI no later than 90 days after the change. Any change of PI(s) and project and/or program leaders must be approved by the PSC and NCI. Documentation should include institutional support letters and rationale for replacement.

Developing and evaluating additional Pilot and Full Projects in the course of the award. Awardees will be required to develop additional pilot and/or full research projects to provide continuity of research activities. Before funds are allocated for such additional projects, each of them must be evaluated for scientific merit, relevance to the partnership objectives, potential to generate publishable data for peer-reviewed journals, and potential of the pilot, full project to lead to a competitive grant application to be submitted to NCI/NIH or other equivalent funding agencies. Project review should be patterned on the NIH system, including individual reviewers preparing detailed written critiques and assigning numerical scores. When a project co-leader (investigator from the institutions serving racial/ethnic and/or underserved communities with cancer health disparities or Cancer Center participating as PI of a joint pilot/full project) is a junior investigator, the pilot, full project must be accompanied by a career development and mentoring plan.

Participation in program evaluation. All PD(s)/PI(s) of the partnerships program are expected to participate and facilitate a national program evaluation that might be conducted by an independent evaluation organization contracted by the NCI. Conducting the national evaluation under contract ensures objectivity and credibility of the evaluation findings and recommendations. The contractor shall seek the input and cooperation of the PD(s)/PI(s) and NCI program officials in developing the program logic models and in specifying the core data elements. However, the contractor shall still conduct an objective/independent evaluation of the overall program. Each partnership shall submit/transmit a set of core data sets to the national program evaluator (at least semi-annually or periodically as deemed feasible by the NCI and the PD(s)/PI(s)). The data sets will include both quantitative and qualitative data necessary to adequately conduct a comprehensive cross-site evaluation of the national multi-site Comprehensive Partnership Program. Data from local evaluations shall be provided to the national evaluation contractor to supplement data submitted for the national evaluation.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the projects/programs will be shared among the awardees and the NCI Project Scientist.

The NCI Project Scientist will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, the NCI Project Scientist will seek NCI waiver according to the NCI procedures for management of conflict of interest if such participation is deemed necessary.

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCI Program Official and Project Scientist may be the same person. In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

Areas of Joint Responsibility include:

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

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

Composition and organization of PSC will be as follows.

Awardees generally will be expected to accept and implement policies approved by the PSC and its programmatic recommendations. In those situations when the recommendations are not feasible to implement, the lead PD(s)/PI(s) must provide a thorough explanation and rationale in the Program Response to the PSC report section in the Non-Competing Grant Progress Report.

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

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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)

H. Nelson Aguila, D.V.M.
Center to Reduce Cancer Health Disparities
National Cancer Institute (NCI)
Telephone: 240-276-6161
Email: aguilah@mail.nih.gov

Peter O. Ogunbiyi, D.V.M, Ph.D.
Center to Reduce Cancer Health Disparities
National Cancer Institute (NCI)
Telephone: 240-276-6170
E-mail: po43t@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Sy L. Shackleford
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6321
E-mail: shacklefords@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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