Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov/)

Title: Comprehensive Minority Institution/Cancer Center Partnership (Limited Competition U54)

Announcement Type
This is a reissue of RFA-CA-08-001.

Request For Applications (RFA) Number: RFA-CA-09-501

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.397, 93.399, 93.398

Key Dates
Release Date: December 31, 2008
Letters of Intent Receipt Date: February 17, 2009
Application Receipt Date: March 17, 2009
Peer Review Date(s): June/July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 18, 2009

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Cancer Institute (NCI) solicits cooperative agreement U54 “linked award” applications for the implementation of Comprehensive Minority Institution/Cancer Center Partnerships (MI/CCPs) between Minority-Serving Institutions (MSIs) and NCI-designated Cancer Centers (or groups of Centers). These partnerships will develop a stronger national cancer program aimed at understanding the reasons behind the significant cancer disparities and impact on racial and ethnic minority and socio-economically disadvantaged populations.

 This Funding Opportunity Announcement (FOA) uses the U54 mechanism and is designed as a limited competition re-issuance of RFA-CA-08-001 intended for:

(a)     Extending the support under the U54 mechanism for the best of the MI/CCPs that are currently funded under RFA-CA-08-001; and

(b)     Elevating to the full MI/CCP status the best partnerships currently in the planning/developing phase (that are currently supported by U56 awards under “Cooperative Planning Grant for Comprehensive Minority Institution/ Cancer Center Partnership”, latest FOA reissuance RFA-CA-06-012).

Interested partnerships must submit linked applications in response to this FOA that would maintain the composition/configuration of MSI/CC as in their current linked U54 or U56 awards.

Definition of Minority Serving Institution. MSIs are institutions at which students of minority groups that are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders) comprise a significant proportion of the enrollments AND at which there have been documented records of commitment to the special encouragement of minority faculty, students, and investigators.

The lack of significant training opportunities for underserved scientists in cancer research and the low level of involvement of MSIs in competitive cancer research represent two major obstacles to developing a stronger national cancer research effort aimed at understanding the reasons behind cancer health disparities and its impact on racial and ethnic minority and socio-economically disadvantaged populations. The NCI-sponsored partnership program is a potentially powerful vehicle that can help MSIs and Cancer Centers integrate and take maximum advantage of their expertise and experience to work together in areas of mutual benefit.  For example, both the MSI and Cancer Center may benefit from a broader range of resources and technical expertise. The MSI partner 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 and researchers participating in cancer related activities and increased access to minority and underserved patients for clinical trials.

Background

The disparities in cancer incidence, morbidity, and mortality in racial and ethnic minority populations and among the socio-economically disadvantaged have continued to rise over several decades, despite the significant progress in other aspects of the “War on Cancer”. 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://www.nci.nih.gov/atlasplus/). Clearly, more research is needed to better understand and overcome these and other cancer health disparities in the near future (http://www.healthypeople.gov/default.htm ). This overarching goal is an important element of the priority recommendations for U.S. Department of Health and Human Services (DHHS) to lead the Nation in eliminating cancer health disparities (Making Cancer Health Disparities History), http://www.hhs.gov/chdprg  and The NCI Strategic Plan (http://strategicplan.nci.nih.gov/).

Conducting high quality educational programs oriented on minorities and the underserved, MSIs represent a rich source of talent with appropriate cultural sensitivity and perspectives needed to conduct research on cancer health disparities. However, MSIs have to overcome difficulties in developing and sustaining independent programs in biomedical research. One factor contributing to these difficulties is a paucity of minority scientists successful in pursuing biomedical research careers. Despite various initiatives, progress has been slow in increasing the number of minority scientists who are competitive for National Institutes of Health (NIH) research grants. More specifically, a substantial increase is needed in the number of well-trained minority and underserved scientists who can conduct independent cancer research. Cultural perspectives of such scientists are essential to properly and successfully conduct research on the disproportionate burden of cancer in racial and ethnic minority and socio-economically disadvantaged populations.

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, and population sciences; provide information services; and develop and sustain educational and outreach programs that benefit their communities. Yet, Cancer Centers can (and should) play a greater role in facilitating (1) research pertinent to cancer in racial and ethnic minorities and socio-economically disadvantaged groups; (2) training minority scientists; (3) reaching out to and partnering with different racial, ethnic minority populations in their communities; and finally, (4) bringing the benefits of advances in cancer research to these populations.

Scope

The MI/CCP program is about building and sustaining excellence. The MI/CCP program will serve as a nurturing environment and “incubator” to allow for the development of new projects/programs. The MI/CCP 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 below the list of broad target areas for development). The emerging projects/programs are expected to lead to competing grant applications to NIH or equivalent sources of research funding. The overall goal of all the MI/CCP activities must be to eventually generate peer-reviewed competitively funded grants.

Career and professional development activities must be provided for less experienced investigators from the MSI and Cancer Center, in particular junior investigators, and post-doctoral scientists involved in the partnerships. For the purpose of this FOA, a junior investigator is any scientist or faculty member with no prior independent research funding from NIH or equivalent agencies. 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 (cancer research, training, outreach, and education) as well as administration.

Appropriate career development plans must be proposed for individual researchers from the MSI and Cancer Center, for example for scientists designated to serve as PIs. The objective of this endeavor is to increase the chances that junior 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, typically, expected to be 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 junior investigators to be mentored. When appropriate, experienced senior faculty members within MSIs, but outside the junior investigator's research area, may be chosen as mentors, co-mentors or consultants.  The mentor(s) and the junior 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 MI/CCP application should provide compensation for mentors, co-mentors, and/or consultants. The mentoring approach applies also to less experienced senior faculty members from the MSIs.

Target Areas

The U54 MI/CCP linked award applications must address three target areas: Cancer Research, Cancer Training and Cancer Outreach. The fourth target area, Cancer Education, is optional.

1) Cancer Research (required component). For Type 1 applicants at least 2 pilot projects and 1 full project are expected to be described. For Type 2 applicants, at least 1 pilot project and 2 full projects are expected. Research projects may be in any area of basic, clinical, translational, prevention, control, behavioral, or population research. MI/CCP investigators are encouraged to develop research proposals in emerging technologies, such as nanotechnology, proteomics, genomics, and imaging. Specific requirements regarding the topic of research projects are different for MSIs and Cancer Centers:

All these efforts must be aimed at eventually securing competitively funded extramural awards (e.g., NIH R03, R21, and R01 awards, projects on P01 or P50 awards or their equivalents).

2) Cancer Training (required component).  Joint training programs that link the faculty and students of the MSI and the Cancer Center are among the most productive ways to sustain long-term effective partnerships. These programs must emphasize two aspects: (a) the training of minority investigators and (b) the recognition and understanding (by minority and non-minority trainees alike) of the issues and problems associated with cancer disparities in racial and ethnic minority and socio-economically disadvantaged populations. The NCI particularly encourages training of minority 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 emerging technologies (nanotechnology, genomics, proteomics and imaging) are a priority for NCI as there is a huge deficit of minority scientists engaged in these research areas. Examples of appropriate training activities include (but are not limited to) the following:

Successful training programs may lead to the submission of competitive training grant applications (e.g., for T32, K12, R25T mechanisms) as well as applications for individual pre-doctoral fellowships (F31), career development awards (e.g., K01, K08, K23, K22) and research supplements for trainees.

3) Cancer Outreach (required component). Cancer outreach programs in the context of this FOA are hypothesis-driven research programs to increase the 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 or prostate specific antigen testing. These programs must effectively reach individuals and physicians and should increase the use of these procedures. In addition, recruitment and retention of racial and ethnic minorities and socio-economically disadvantaged populations into clinical trials such as prevention, early detection or treatment trials is encouraged. Specifically, the U54 MI/CCP program may help communities develop activities such as:

4) Cancer Education (optional component): Cancer education programs could focus on any effort to augment existing curricula or create new curricula in the MSI and/or the Cancer Center. 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 racial and ethnic minority and socio-economically disadvantaged populations. A successful completion of the designing phase of new curriculum may result in the submission of competitive NCI education grant application (for examples for the R25E mechanism) and to institutional commitments to implement these curricula as inherent components of the educational systems.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This limited competition funding opportunity will use the NIH cooperative agreement specialized center (U54) award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". 

Reflecting the two categories of eligible applicants, the FOA solicits:

  1. U54 competing renewal (Type 2) linked applications (from the current MI/CCP U54 awardees); and

  2. New (Type 1) linked applications for U54 MI/CCP awards from the current U56 awardees seeking the full MI/CCP status.

2. Funds Available

The estimated amount of funds available for support of 4-5 applications (two partnerships) awarded as a result of this announcement is $5.0 million for fiscal year 2009. Future year amounts will depend on annual appropriations.

An applicant may request a project period of up to 5 years.

Both MI/CCP U54 awardees submitting Type 2 applications and current U56 awardees submitting Type 1 applications will compete together for the same single pool of awards (which will be significantly smaller than the number of eligible applicant teams (and the expected number of applications). Therefore, even though this FOA is formally a limited competition, it involves a bona fide open competition within the defined, restricted pool of qualifying applicants.

Combined Direct Costs Limit. The direct costs budgeted in the applications from the MSI and the Cancer Center together cannot exceed $2.0 million per year per pair and $2.5 million per year per triad of linked applications. If there is a third/fourth party subcontract, only the direct costs of the subcontract will count against the limit of $2.0 or $2.5 million. Future years may include cost of living adjustments of 3 percent over the maximum direct cost budget limit for each institution in the partnership.

The U54 MI/CCP awards will provide support for the following required cores:

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

2) Planning and Evaluation Core. Planning and evaluation should be constantly ongoing, and the outcomes of those processes will constitute the basis for initiating and terminating the investment of resources into developmental projects, programs, resources, and recruitments. These resource allocations may 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 lead PIs 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.

3) Developmental Core. This core will cover costs of pilot and/or fully developed programs/projects that each partnership is required to propose in their applications (at least three project/programs must be proposed, of which at least one must be a full project), resources, and recruitment:

Funds for Developmental Core funds would have to be justified based on the documentation of prior planning and evaluation processes.

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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

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

1.A. Eligible Institutions

Given additional restrictions specified below, the following organizations/institutions are eligible to apply:

Only institutions that are current MI/CCP U54 awardees or U56 awardees under cooperative planning grant for MI/CCP are eligible to compete for awards under this limited competition FOA.

Applications will only be accepted from MSIs, as defined in the Purpose section (e.g., Historically Black Colleges and Universities [HBCUs], Hispanic-Serving Institutions [HSIs] and Tribal Institutions [e.g., Colleges]) either in the United States or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers (or groups of centers) that wish to develop comprehensive partnerships.

Each partnership must include both types of institutions. Three or more institutions (e.g. triads, groups of Cancer Centers) may apply in response to this announcement only when approved by the NCI prior to submission.

MSIs with medical schools, MSIs with more focused education and research programs (e.g., Masters and Ph.D. programs), as well as MSIs that offer only baccalaureate degrees and Tribal Colleges may all participate in this initiative.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

If the multiple PIs option is used, it is expected that one PI from each partnering institution will be designated “lead” PI” to facilitate effort of coordination with collaborating institution. A significant commitment of the leadership to the program is required. The lead PI from the MSI must commit a minimum of 10 percent of effort to the partnership activities, although a commitment level of 25% of effort is expected if there are no other PIs from the MSI side of the partnership. The lead PI from the Cancer Center must commit a minimum of 10 percent of effort regardless of the number of PIs from the CC side of the partnership.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Current MI/CCP U54 awardees may submit only a renewal (Type 2) application. Current U56 planning grant awardees may submit only a new (Type 1) application.

3.A. Special Requirements and Provisions

1) Number of permissible applications and concurrent awards. Each MSI and Cancer Center is limited to applying for no more than ONE Comprehensive Minority Institution/Cancer Center Partnership (U54) award. No institution can have two MI/CCP Cooperative Agreement awards simultaneously. The NCI will not issue an award to institutions with overlapping awards from the MI/CCP program. Therefore, institutions that are currently funded with a MI/CCP U54 or U56 cooperative agreement and are in a budget period prior to the 5th year of funding cannot submit an application under this FOA. Specifically, U54 awardees cannot submit a competing continuation (Type 2) application until their program is in its final year of funding. This policy will be strictly enforced.

2) Partnership Structure. Each U54 MI/CCP program application must be submitted as a clearly documented partnership between the MSI and the Cancer Center. All these partnerships must maintain the composition/configuration of MSI/CC as in their current linked U54 or U56 awards. For each partnership, two separate applications must be submitted: one from the MSI and one from the Cancer Center. Each application may have multiple PIs but one PI from each partnering institution is expected to be designated “lead/contact PI”. The PIs must be mid-to-senior-level scientists who have established records of obtaining competitively-funded grants who will serve as role models and mentors to the partnership participants. The lead/contact PIs must commit a minimum of 10 percent effort to the partnership. If a lead PI is not an established, competitively funded investigator, the other more experienced lead PI must work with him/her to develop a career and professional development plan that sets a high priority on working toward the goal of his/her becoming a well-rounded, competitively funded PI within 2-3 years.

To underscore their commitment to the partnership, both lead PIs should also be reciprocally listed as PIs on the linked application from the partnering institution. Thus, the lead PI on the application from the MSI should be listed as a PI on the linked application from the Cancer Center and the lead PI on the application from the Cancer Center should be listed as a PI on the linked application from the MSI.

The overall priorities and objectives for implementation of the two applications must be the same, but the actual activities and budgets of the two applications should demonstrate how the MSI and the Cancer Center requests both differ and complement each other in achieving these priorities and objectives.

Three-way (triad) partnerships that have been previously approved by the NCI (and are current U54 or U56 awardees) may respond to this FOA by submitting three linked applications.

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/Programs.

5) Letters-of-Commitment. Each application must include written "Letters-of-Commitment" from the respective MSI leadership and the Cancer Center leadership that are supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. 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 MSI and the Cancer Center must not only complement each other, but also clearly outline the mutual benefits to be gained as a result of the partnership.

7) Internal Advisory Committee. There must be a common Internal Advisory Committee (IAC) shared between the applications from the MSI and the Cancer Center(s). IAC will be organized and will be responsible for internal planning and evaluation activities as outlined below:

The IAC will be made up of the PIs and other key personnel, as appropriate, from both the MSI and the Cancer Center. The IAC must have equal numerical representation from the MSI and the Cancer Center. In addition, the Program Managers (key personnel that assist the lead PIs in coordinating and organizing day-to-day activities of the partnership) of each partnership will serve as ex-officio member(s). (The NCI Project Scientist will not be a member 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 partnering institutions may be added to the IAC. The responsibilities of the IAC are:

The IAC will prioritize the applications and may recommend funding of the project/program at the requested level or 1-year funding as a pre-pilot project/program. The IAC could also recommend that the program/project not receive funding due to 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.

The following recommendations are possible: (1) convert either pre-pilot to pilot and/or pilot to full project/program, or (2) terminate funding of pilot/full project/program 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.

The IAC evaluations and recommendations for new pilot and full projects/programs, ongoing pre-pilot, pilot, and full projects/programs and 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 PIs must make minutes of the IAC meetings conducted throughout the year available to the PSC.

8) External Evaluation:

Program Steering Committee. The PIs (lead PIs, if multiple PIs option is used) 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.

National Evaluation. The evaluation being performed by the IAC and the PSC are local evaluations of their specific MI/CCP partnership. All MI/CCP partnerships will be required to participate in a national program evaluation. The national evaluation will be contracted out by NCI to assess the effectiveness / success of the overall MI/CCP program in achieving the goals and objectives enumerated in this FOA. For example, the national evaluation will assess the extent to which the MI/CCP is fostering better collaboration between MSI and Cancer Centers; the extent to which the MI/CCP helps new investigators to become more competitive in securing NIH grant awards; increase in access of underserved populations to beneficial cancer diagnosis and treatment, etc.

9) Project Leadership and Budgetary Limitations. In using Developmental Core funds to support pilot/full projects/programs, each activity must be co-led by individuals from both the MSI and the Cancer Center. No pilot project/program can exceed $120,000 in direct costs per year or continue for more than 3 years and no full project/program 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/programs will become full projects/programs and that full projects/programs 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.

10) Nature of Projects/Resources for Development. Any new project/program 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 programs). Resources should augment the research capability of the MSI, the collaborative research between the MSI and the Cancer Center, and/or specifically support and enhance research focused on minority issues. 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 either at the MSI or at the Cancer Center or divided but shared between the MSI and the Cancer Center.

11) Sharing Experiences. Successful Partnerships are expected to participate in sharing their approaches and experiences with other NCI Centers, Networks, and MSIs.

12) MI/CCP Workshop. The recipients of U54 MI/CCP awards must participate in a biennial MI/CCP Workshop for sharing information and strategies. A Planning Committee composed of selected funded MI/CCP 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 the MSI and the Cancer Center.

13) Studies Involving Native Americans (if applicable). If an application includes participation of Native American (American Indian) or similar defined populations, a formal letter-of-support from the Tribal Nation Leader or equivalent must be included.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5939.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

The standard PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html) and the standard PHS 398 Forms should be followed unless specific exceptions and/or additional requirements are noted below.

Face Page (PHS 398 Form Page 1). The title of the partnership (Item 1) should be the same for both the MSI and the Cancer Center 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 linked applications from MSI and Cancer Center, respectively [triad application should use analogous suffixes “(1 of 3)”, “(2 of 3)” and “(3 of 3)”.

Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS 398 Form Page 2). List the lead PI first followed by the other PIs (the lead PI on the partnering application should be included as one of the PIs). Then list all Key Personnel for the Administrative Core, Planning and Evaluation Core, Developmental Core (all pilot/full projects/programs) and Resources in this application alphabetically. Finally, list the members of the IAC and PSC.

Detailed Budget for Initial Budget Period of Support (PHS 398 Form Page 4). In addition to the standard Detailed Initial Budget for the entire application, use separate PHS 398 Form Page 4 sheets to provide detailed initial budget individually for each core:

Budget for Entire Proposed Period of Support (PHS 398 Form Page 5). In addition to the standard Budget for Entire Proposed Period of Support for the entire application, use separate PHS 398 Form Page 5 sheets to provide individual budgets for each core for entire proposed period of support:

Use PHS 398 Form Page 5 for the entire application (and continuation sheets, if needed) to provide budget justification. Provide justifications for costs in future years when there are specific items requested that exceed standard cost-of-living increases.

Budgets Pertaining to Consortium/Contractual Arrangements. Follow the PHS 398 instructions to complete this information if your application (either the MSI 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 and the other one will be involved under a subcontract.

Biographical Sketches. Follow the PHS 398 instructions and use the PHS 398 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).

RESEARCH PLAN

To match the unique needs of the MI/CCP application, the standard items 2-5 of the PHS 398 Research Plan (previously known as Sections A-D) are replaced by new Sections N1-N8. The standard page limit of 25 pages for items 2-5 is replaced by a new limit of 30 pages to be apportioned as needed for these new Sections N1-N8.

Other sections of the PHS 398 Research Plan (items 6-17) in the main body of the application are not modified and should be completed as per the standard instructions.

On the top of this limit for the main body of the application, additional page allocation is allowed for the specific components (pilot and full projects/programs, career development plans; and resources/infrastructure development plans) whose numbers may vary from application to application. These additional limits are specified below in the guidelines to Section N8, Developmental Core.

Applicants are encouraged to use the minimum number of pages necessary to clearly and succinctly describe each element in the Research Plan following the organization as described below.

New Section N1. Overall Objectives and Partnership Integration (2-3 pages suggested). This section should be identical for both the MSI and the Cancer Center U54 applications. In this section, applicants should: (1) discuss the general rationale and the mutual benefits that the MSI and the Cancer Center expect to derive from the partnership and the ways in which the MSI and the Cancer Center believe they can help each other develop stronger cancer programs; (2) outline the immediate priorities of the partnership derived from a careful planning process that relates to mutual benefits; (3) present focused objectives in the areas of cancer research, cancer training and career development, cancer outreach and cancer education that the partnership believes can be achieved during the grant period for each priority; (4) present a projected time-line for achieving each objective; and (5) discuss other areas of opportunity that the partnership will consider as the relationship between the partners evolves.

New Section N2. Letters-of-Commitment (2-3 pages suggested). This section should be different for the MSI and Cancer Center applications. The MSI institutional leadership (e.g., President, Dean) and the Cancer Center leadership (e.g., Center Director, Dean), respectively, should include a detailed statement of their long-term commitment by noting the specific resources that will be dedicated to the priorities of this partnership as outlined in the Background and Objectives (Section 1 above). These resources could be in the form of (i) protected/release time for faculty to participate in and focus on the objectives of this partnership; (ii) faculty appointments that will be made available in those areas where recruitment will be needed; (iii) space that will be dedicated to this effort; (iv) discretionary resources that will be made available to the Principal and Co-Investigators; and (v) purchase of sophisticated equipment for critical infrastructure needs. The leadership must specify the percent effort (a minimum of 25 percent [MSI] or 10 percent [Cancer Center] if no multiple PI option is used and a minimum of 10% effort for the Lead/contact PIs from the MSI and Cancer Center if the multiple PI option is used with a maximum of 25% effort in each institution for all the other PIs combined) that will be freed up for each lead PI and must specify what current duties, (e.g., teaching, clinical duties, administrative duties) will be eliminated to allow the faculty member(s) to spend adequate time on the MI/CCP. In addition, the institution should specify how these duties will be accommodated by others in the institution or by additional recruitments. The institution must clearly demonstrate that it will be completely committed to a certain number of positions that will be dedicated to cancer research. The letters should also clearly explain how the MSI and the Cancer Center leadership would be responsible and accountable for following the progress of this effort and doing what is needed to sustain it.

New Section N3. Chronological Review of the Prior Planning and Priority-setting Processes (for new Type 1 applications only, up to 5-7 pages suggested). This section should be identical for both the MSI and Cancer Center applications and limited to five pages. The description must clearly 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. This section can be used to describe the outcomes of the U56 converting to a U54.

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 opportunity, workshops of MSI faculty and Cancer Center members, retreats of MSI faculty and Cancer Center members), its purpose, the individuals that participated from the MSI and the Cancer Center, and its outcome.

New Section N4. Progress Report (for competing continuation Type 2 applications only, up to 5 pages suggested). This section must be identical for both the MSI and Cancer Center applications. Competing continuation applications should summarize in this section the accomplishments and achievements reached during the expiring funding period. It is suggested to report all progress by cores (administrative, planning and evaluation and developmental) as well as specific progress pertinent to resources and recruitment. For example, applicants may present a chronological history of their partnerships and discuss barriers faced and how these obstacles were resolved. Include any administrative changes that took place, name all new faculty supported by the U54 award and their current position and funding, name all the pilot/full projects and programs and list the publications, grants, number 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.

New Section N5. Scientific and Administrative Leadership (2-3 pages suggested). This section must be different for each of the linked applications. Without duplicating the standard PHS 398 Item 14 (Multiple PD/PI Leadership Plan), briefly describe how the PIs were chosen in terms of the qualifications and experience to provide leadership and cohesion for this effort and to promote collaboration and cooperation in achieving the common objectives as outlined in the Background and Objectives section above.

It is preferred that individuals designated as the lead PIs are established investigators with active competitive research support, such as R01 grants or equivalent peer-reviewed funding. If the lead PI 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 (collated after Section N5) should outline the activities and actions through which this individual could become a well-rounded and competitive scientist, including a specific objective of securing (as a PI) a mainstream NIH-funded research grant (e.g., R01, sub-project on a P01 grant) or equivalent funding. The plan description should follow the format of applications for Career Development Awards (K Awards), by providing the following information 1. The Candidate; 2. Statements by Sponsor, Co-Sponsor(s),* Consultant(s),* and Contributor(s); and 3. Environment and Institutional Commitment to Candidate (http://grants.nih.gov/grants/funding/phs398/phs398.html). Only the first sub-section The Candidate is subject to the page limit of 10 pages (on the top of the overall page limit for the entire application Research Plan).

In addition to the information on the PIs, 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.

New Section N6. Administrative Core (up to 10 pages suggested). This section must be different for each of the linked applications. Describe the leadership and specific functions of the administrative core to provide the necessary day-to-day oversight, coordination, support, and logistical services needed to make this partnership function effectively. This role might include organizing meetings, workshops, and retreats; documenting the results of activities; and providing critical secretarial services, etc.

New Section N7. Planning and Evaluation Core (up to 5 pages suggested). This section must be identical for each of the linked applications and should address the following.

New Section N8. Developmental Core (suggested up to 2-3 pages to cover the overall summary and recruitment plans, if any, which count towards the overall page limit). Additional page allocation for other components is specified below. Section N8 must be different for each of the linked applications.

The use of developmental funds should be flexible and responsive to the planning and priority setting activities of the MSI and the Cancer Center during the course of the grant. Each partnership must include at least three projects/programs. Type 1 applications must describe at least one full project/program and two pilot projects/programs. Type 2 applications are expected to describe two full projects/programs and at least one pilot project/program. Although there is no upper limit, it is suggested that there will be no more than four (combined) pilot and full projects/programs proposed.  Joint pilot project/programs must focus on each of the required target areas (cancer research, training and outreach).

With these general stipulations, Section N8 of each application should contain an appropriate mix of the following elements:

a. Recruitment Plans.

b. Proposed Pilot Projects/Programs (including career development plans when needed).

c. Proposed Full Projects/Programs (including career development plans when needed).

d. Proposed Resources/Infrastructure development.

Note 1: On the top of the overall page limit, there is additional page allocation for individual components to be addressed in new Section N8:

Note 2: Individual projects/programs proposed in this section (both pilot and full projects) are 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/programs will follow the format of the standard PHS 398 Research Plan, including the unmodified items 2-5 (respectively: Specific Aims; Background and Significance; Preliminary studies; and Research Design and Methods).  Only these items 2-5 are subject to the following page limits.

Provide a brief overall summary (e.g., a list) of the applicable items in these categories A-D. Next, describe each category in detail following the guidelines below.

A. Recruitment Plans. For the already identified individuals who are anticipated to be recruited:

For recruitment plans where specific names of individuals are not yet known: Describe the number of individuals (and type of desirable expertise) that the partnership plans to recruit over the 5 year period of this award. Explain how such recruitments will strengthen capabilities in critical areas defined by the priorities of the partnership (e.g., epidemiology, prostate cancer, breast cancer, behavioral research, outcomes research, community outreach, molecular genetics).

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

NOTE: Special requirements pertain to all NIH-supported biomedical or behavioral research projects involving human subjects and/or vertebrate animals (see information for Sections 8-12 in PHS 398 instructions). Funds should be budgeted as needed to comply with these requirements. When direct or indirect support for clinical trials is requested, plans for data and safety monitoring, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application. (In case of clinical trial protocols subsequent to funding of a U54 award, such plans must be submitted in advance to the NCI Program Director/Program Official responsible for the stewardship of the award.)

C. Proposed Full Projects/Programs.  Full Projects/Programs 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/programs with the following differences.

NOTE: Special requirements pertain to all NIH-supported biomedical or behavioral research projects involving human subjects and/or vertebrate animals (see information for Sections 8-12 in PHS 398 instructions). Funds should be budgeted as needed to comply with these requirements. When direct or indirect support for clinical trials is requested, plans for data and safety monitoring, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application. (In case of clinical trial protocols subsequent to funding of a U54 award, such plans must be submitted in advance to the NCI Program Director/Program Official responsible for the stewardship of the award.)

d. Resources/Infrastructure Development (not to exceed 5 pages). The description of Resources and Infrastructure (e.g., tissue resource, clinical trial accrual core, clinical research management core, special equipment) proposed for development by the partnership should contain the following information:

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs  

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new item of the research plan (item 14), entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date: February 17, 2009
Application Receipt Date: March 17, 2009
Peer Review Date(s): June/July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

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
6116 Executive Boulevard, Suite 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7344
Fax: (301) 435-9225
Email: aguilah@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
E-Mail: ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)


6. Other Submission Requirements and Information

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only, and include five identical CDs in the same package with the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)p

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The linked applications submitted in response to this FOA will be reviewed together and will receive one overall impact score.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.  

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.

1) Performance/Progress (Type 2 applications only):

2) Overall Evaluation of the Partnership Integration:

a. Letters of Commitment from the Leadership of the MSI and the Cancer Center: 

b. Scientific and Administrative Leadership:

c. Administrative and Scientific Integration

3) Administrative Core: Is the proposed quality of the organizational and administrative structures adequate for the effective attainment of U54 priorities and objectives? Are the qualifications, experience and time commitment of all key personnel, adequate? Is the use of the administrative core services by the budgeted activities and projects/programs appropriate?

4) Planning and Evaluation Core:  Are the qualifications and experience of each member of the Internal Advisory Committee adequate? Is the design and quality of each of the internal planning and evaluation processes adequate? Is the plan for using the Program Steering Committee effective? Are the process and criteria for identifying and implementing the resource and infrastructure needs adequate? Is the proposed 5-year recruitment appropriate and strategically adequate?

5) Developmental Core: 

a. Pilot Projects and Programs (i.e. research, training, and outreach).

b. Full Projects and Programs (i.e. research, training, and outreach).

c. Resources/Infrastructure Development:

d. Recruitment Plans:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, 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.

2. A.1. Awardees and Principal Investigators Rights and Responsibilities

The Principal Investigators will have the primary responsibility for: the partnership program as a whole, including research design and conduct, data collection, data quality control, data analysis, and interpretation and preparation of publications, as well as collaborations with awardees in other partnerships.

The lead PIs from both the MSI and Cancer Center components of the partnership program will be together responsible for constituting, overseeing, and participating in a partnership.

Specific responsibilities of awardee institutions and PIs will include the following:

The awardees must adhere to the NIH Data Sharing Policies as indicated in this FOA.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

The NCI Program Director acting as Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Specifically, Project Scientist will:

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.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.


2.A.3. Collaborative Responsibilities

Both, 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 MSI/CCP Program. Based on continuing evaluation of the MSI/CCP 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 PIs must provide a thorough explanation and rationale in the Program Response to the PSC report section in the Non-Competing Grant Progress Report.

2.A.4. Arbitration Process

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 arbitration. An Arbitration 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

H. Nelson Aguila, D.V.M.
Diversity Training Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Blvd., Suite 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7344
Fax: (301) 435-9225
Email: aguilah@mail.nih.gov

Peter Ogunbiyi, D.V.M., Ph.D.
Diversity Training Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Blvd., Suite 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7344
Fax: (301) 435-9225
Email: ogunbiyp@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Penny Williams
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, Suite 243
Rockville, Maryland 20852
Telephone: (301) 496-3197
Fax: (301) 496-8601
Email: plwilliams@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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