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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 Partnerships to Reduce Cancer Health Disparities (U54)

Announcement Type
This is a reissue of RFA-CA-10-503.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-CA-11-001

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: October 14, 2010
Letters of Intent Receipt Date(s): December 6, 2010
Application Receipt Dates(s): January 6, 2011
Peer Review Date(s): May-June, 2011
Council Review Date(s): August, 2011
Earliest Anticipated Start Date: September 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 7, 2011

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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 applications for cooperative agreement (U54) awards for Comprehensive Partnerships between:

(1) Institutions serving racial/ethnic and/or underserved communities with cancer health disparities and

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

These partnerships are designed to develop a stronger national cancer program aimed at understanding the reasons behind the significant cancer disparities and impact on racial and ethnic, and socio-economically disadvantaged and/or underserved populations.

Presently, the program supports several fully implemented partnerships (U54 awards). In addition, the program has funded several awards for the planning/developing phase (supported by U56 awards).

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

1. Extend the support for the best of the partnerships that are currently supported (including a no-cost extension status) by a U54 Comprehensive Partnerships award; and

2. Elevate to the full Comprehensive Partnership status the best partnerships supported in the past or currently by the planning/developing phase U56 awards.

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

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

Interested eligible partnerships must submit linked applications in response to this FOA that would maintain the institutional composition/configuration of the partnership as in their preceding linked U54 or U56 awards (although institutions previously involved on subcontractual basis may be considered for full partnership status, if warranted by their contributions to the partnership).

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

The NCI-sponsored partnership program is a potentially powerful vehicle that can help institutions serving racial/ethnic and/or underserved communities with cancer health disparities and Cancer Centers to integrate and take maximum advantage of their expertise and experience to work together in areas of mutual benefit. For example, both types of institutions may benefit from a broader range of resources and technical expertise. The institutions serving racial/ethnic and/or underserved communities with cancer health disparities will gain exposure to state-of-the-art technology and access to information services available at the Cancer Center. Reciprocally, the Cancer Center will gain a greater diversity of students, faculty members, and researchers participating in cancer-related activities and increased access to racial/ ethnic and underserved patients for cancer and health disparities related 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 Americans populations. Increasing disparity is seen in patterns of prostate cancer among African American males compared with White males, in the southeastern United States (U.S.), particularly in rural areas (http://statecancerprofiles.cancer.gov/). Clearly, more research is needed to better understand and overcome these and other cancer health disparities in 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 (HHS) 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/).

Institutions serving racial/ethnic and/or underserved communities with cancer health disparities represent a rich source of potential clinical subjects, and talent with appropriate cultural sensitivity and perspectives needed to conduct research on cancer health disparities and high quality educational programs for persons interested in serving racial/ ethnic and the underserved populations. However, these institutions have to overcome difficulties in developing and sustaining independent programs in biomedical research. One factor contributing to these difficulties is a paucity of scientists from underrepresented groups who are successful in pursuing biomedical research careers. Despite various initiatives, progress has been slow in increasing the pool of scientists from underrepresented groups who are competitive for National Institutes of Health (NIH) research grants. More specifically, a substantial increase is needed in the pool of well-trained scientists from underrepresented groups who can conduct independent cancer research. While many scientists may have an interest in cancer health disparities, the cultural perspectives of scientists from these communities are essential to properly and successfully conduct research on the disproportionate burden of cancer in racial, ethnic, and socio-economically disadvantaged populations. Moreover, the institutions funded under this FOA provide unparalleled access to patients and scientists from these populations, and opportunities to observe whether concordance between researchers and clinical subjects improves participation, satisfaction, and compliance with clinical regimens. The NCI-designated Cancer Centers are geographically dispersed, research-intensive institutions with well-organized programs for training cancer scientists. They are the major organized units supported by the NCI to: conduct cancer research; sponsor cancer-related research training in the basic, clinical, translational, and population sciences; 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 and socio-economically disadvantaged groups; (2) training scientists from underrepresented groups; (3) reaching out to and partnering with different racial, ethnic and underserved populations in their communities; and (4) bringing the benefits of advances in cancer research to these populations.

Specific Requirements and Research Objectives

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

The Program will also support (but not indefinitely) cancer research projects, training, outreach, and education programs (see 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. All the program activities must be planned to eventually reach the sustainability of the partnership in terms of the ability to compete successfully for peer-reviewed research grants and to conduct quality research resulting in peer-reviewed publications.

Career and professional development activities must be provided for less experienced investigators, 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 (i.e., no R01, P01, etc., awards, but small awards [e.g., R03, R21] and training [K awards] do not count). The proposed plan of action for the career and professional development as well as mentorship must be integrated into every target area of the U54 cooperative agreement application (i.e., cancer research, training, outreach, and education) as well as administration.

Appropriate career development plans must be proposed for individual researchers from both institutions, for example for scientists designated to serve as 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 expected to be, typically, individuals at the associate or full professor levels. In addition to relevant research experience, mentors must have an appreciation and understanding of the cultural, socioeconomic, and research backgrounds of the junior investigators to be mentored. When appropriate, experienced senior faculty members within institutions serving racial/ethnic and/or underserved communities with cancer health disparities, 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 Comprehensive Partnership application should provide compensation for mentors, co-mentors, and/or consultants. The mentoring approach applies also to less experienced senior faculty members from the institution serving racial/ethnic and/or underserved communities with cancer health disparities.

Target Areas

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

1) Cancer Research (required component). For Type 1 applications, at least two pilot projects and one full project must be included. For Type 2 applications, at least one pilot project and two full projects must be included. Research projects may be in any area of basic, clinical, translational, prevention, control, behavioral, and/or population research. Partnership investigators are encouraged to develop research proposals in translational research as defined by the Translational Research Working Group of the NCI (go to http://www.cancer.gov/trwg/), emerging technologies, such as nanotechnology, proteomics, genomics, and imaging, and research focusing on pediatric, adolescent, and young adult cancers. Specific requirements regarding the topic of research projects are different for each institution:

All these efforts must be aimed at eventually securing competitively funded extramural awards (e.g., R01 awards, projects on P01 or P50 awards or their equivalents). Small grants (such as R03 and R21 awards) are also desirable but rather as a step in the career development of junior investigators.

2) Cancer Training (required component). Joint training programs that link the faculty and students of the partner institutions are among the most productive ways to sustain long-term effective partnerships. These programs must emphasize two aspects: (a) the training of underrepresented investigators; and (b) the recognition and understanding of the issues and problems associated with cancer disparities in racial, ethnic, and socio-economically disadvantaged populations. The NCI particularly encourages training of underrepresented scientists in basic, clinical, translational, behavioral, and population research, i.e., in the field of studies that depend largely on the cultural sensitivities of the investigators for success. Training programs in translational research, emerging technologies (nanotechnology, genomics, proteomics, and imaging) are a priority for NCI as there is a huge deficit of underrepresented scientists engaged in these research areas. 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, R25 mechanisms) as well as applications for individual pre-doctoral fellowships (F31), career development awards (e.g., K01, K07, K08, K23, K22) and research supplements for trainees.

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. Research studies may include focus groups and needs assessments. 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 Comprehensive Partnership Program may help communities develop activities such as:

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

Individuals to be designated CHEs must have appropriate training and knowledge of the NCI programs and experience in communications, comprehensive cancer control, training, program planning, and evaluation. The CHE will work with the community and NCI’s National Outreach Network (http://cis.nci.nih.gov/nciotreach.html) to identify, develop, and disseminate health promotion/cancer education materials, important NCI messages, etc. Partnership applicants should anticipate that approximately 50% of the workload of CHEs will be devoted to NCI activities and the remaining 50% to the Partnership cancer outreach research activities including planning and evaluation.

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

4) Cancer Education (required component if curriculum development is an inherent part of the training program; other activities are optional). Cancer education programs could focus on any effort to augment existing curricula or create new curricula in the partner institutions. This new curricula may apprise and culturally sensitize graduate and postdoctoral students in research, medicine, and public health of the need to reduce the disproportionate cancer burden in racial and ethnic 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 (e.g., an R25) and, to institutional commitments to implement these curricula as inherent components of the educational systems.

OTHER REQUIRED COMPONENTS:

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

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

In addition, the resources allocated for the Planning and Evaluation Core must include the costs for activities of the Internal Advisory Committee (IAC), key personnel, and ad hoc committee members, as well as external activities (e.g., per diem costs for travel and consultant costs for Program Steering Committee [PSC] members, consultant costs for focus groups). To ensure the integration of the partnership, applications from both of its components must specify appropriate commitment (percent effort) of 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.

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

Section II. Award Information

1. Mechanism of Support

This 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; and

2. New (Type 1) linked applications for U54 Comprehensive Partnership awards from the U56 of awardees seeking the full Comprehensive Partnership status.

2. Funds Available

The estimated amount of funds available for support of four or five applications (two partnerships) awarded as a result of this announcement is $6.25 million for fiscal year 2011. Future year amounts will depend on annual appropriations.

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

The U54 awardees submitting Type 2 applications and U56 awardees submitting Type 1 applications will compete for the same pool of awards (which will be significantly smaller than the number of applications).

Combined Direct Costs Limit, the direct costs budgeted in the applications from both partner institutions 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.

In addition, each partnership must plan for one full time Community Health Educator (CHE) position (can be split between two individuals on part time positions, if desirable). Regardless of the number of individuals designated as CHEs, the budget allocation for the CHE position must not exceed $125,000 total costs per year. This amount includes salary, travel to NCI once a year for a training workshop, and travel between the U54 partner institutions.

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

The following organizations/institutions are eligible to apply:

Only institutions that have been involved in the partnerships currently referred to as Comprehensive Partnerships to Reduce Cancer Health Disparities are eligible to apply in response to this FOA if the following provisions are met. Eligible institutions must be either: (a) currently supported by U54 awards (including those on no cost extension); or (b) supported in the past or currently by U56 planning awards (including those on no cost extension). In addition to primary awardee institutions on these awards, institutions that have contributed substantially to their partnerships under subcontractual basis are also eligible to apply as a third full partner (although such partnership expansion is subject to NCI concurrence, see below).

Each partnership must include both types of institutions: 1) an institution serving racial/ethnic and/or underserved communities with cancer health disparities and 2) an NCI-designated Cancer Center. In addition to such dyad partnerships, eligible partnerships may also involve three institutions (e.g., triads defined as two institutions serving racial/ethnic and/or underserved communities with cancer health disparities and one Cancer Center or two Cancer Center and one institution serving racial/ethnic and/or underserved communities with cancer health disparities). Triad partnerships may apply in response to this announcement only when approved by the NCI prior to submission.

Institutions serving racial/ethnic and/or underserved communities with cancer health disparities with medical schools, or with more focused education and research programs (e.g., Masters and Ph.D. programs), as well as those 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 programs.

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://grants.nih.gov/grants/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. 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 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 the collaborating institution. A significant commitment of the leadership to the program is required. The lead PI from the institution serving racial/ethnic and/or underserved communities with cancer health disparities must commit a minimum of 1.2 month-effort to the partnership activities, although a commitment level of 3 month-effort is expected if there are no other PIs from these institutions in the partnership. The lead PI from the Cancer Center must commit a minimum of 1.2 month-effort regardless of the number of PIs from the Cancer Center 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

Number of Applications. Each eligible institution may submit only one U54 application in response to this FOA.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Thus, resubmission of A2 applications to this FOA is possible only for those applicants whose A0 submission was assigned to a council not later than August 2009.

Renewals. Renewal applications are permitted in response to this FOA but only for partnerships supported by U54 awards. (However, all applications from eligible current or past U56 awardees must be submitted as new applications).

3.A. Special Requirements and Provisions

1) No overlap with current partnership (U54 or U56) awards allowed. The NCI will issue Comprehensive Partnership awards only to institutions for which the prior qualifying U54 or U56 awards have expired. Therefore, partnerships supported by U54 awards cannot submit a renewal (Type 2) application unless their program is in its final year of funding. Likewise, partnerships supported by U56 awards must refrain from submitting new U54 applications unless their support has already expired or is in the final year of the project period. This policy will be strictly enforced.

2) Partnership Structure

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

4) Projects/Programs.

5) Letters-of-Commitment. Each application must include written "Letters-of-Commitment" from the respective leadership of both institutions that are supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum 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 partner institutions 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 across the partner institutions. 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, the CHE, and other key personnel, as appropriate. The IAC must have equal numerical representation from the institutions. In addition, the Program Managers (i.e., 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). There will be no NCI representatives as members of the IAC. The expertise of the IAC members should be relevant to the objectives and goals of the partnership. If the committee lacks the scientific expertise to evaluate pilot/full projects/ programs, ad hoc reviewers from either within or outside the partnering institutions may be added to the IAC. The responsibilities of the IAC are as follows.

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

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

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

The following recommendations are possible: (1) convert either pre-pilot to pilot and/or pilot to full project/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.

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

The IAC may employ the expertise of the CHE to evaluate new and ongoing activities within the cancer outreach program. 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) Program Steering Committee (PSC). 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.

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

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 partner institutions. 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 institutions serving racial/ethnic and/or underserved communities with cancer health disparities, the collaborative research between these institutions and the Cancer Center, and/or specifically support and enhance research focused on issues pertaining to racial/ ethnic and socioeconomically disadvantaged groups. Resources proposed either can augment existing Cancer Center capabilities or they can constitute entirely new resources, as long as they are tailored to the common objectives and priorities of the partnership. Resources can be located either of the partner institution (or in both institutions) but must be available to both partners.

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

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

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 current 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) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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.

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, the section of the Research Plan 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(s): December 6, 2010
Application Receipt Dates(s): January 6, 2011
Peer Review Date(s): May-June, 2011
Council Review Date(s): August, 2011
Earliest Anticipated Start Date: September 2011

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: [email protected]

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
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: [email protected]

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. Applications which were submitted previously in response to one of the preceding U54 FOAs but were unfunded should be prepared as a RESUBMISSION applications.

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

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

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

Face Page (PHS 398 Form Page 1). The title of the partnership (Item 1) should be the same for both linked applications. The title should be unique to specific partnership (do not repeat the title of this FOA) and should include the suffix (1 of 2) or (2 of 2) to allow for the identification of the linked applications from each partner institution, respectively [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 remaining Key Personnel for this application alphabetically. Finally, list the members of the IAC and PSC.

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

A. Overall Objectives and Partnership Integration;

B. Leadership and Administrative Core;

C. Projects and Programs in Required Target Areas;

D. Career Development Plans;

E. Development of Shared Resources Cores; and

F. Planning and Evaluation Core.

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

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

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

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

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

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

This section must be identical for both U54 applications.

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

1) Overall Objectives. Outline the following aspects:

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

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

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

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

4) Progress Report (for renewal Type 2 applications only): Summarize the accomplishments and progress during the current funding period. Address progress accomplished for specific Partnership components (Administrative Core, and recruitment; Research Projects/Programs; Career Development; Shared Resources; and Evaluation Activities) in the context of the goals described in the original U54 application. For example, applicants may present a chronological history of their partnerships, discuss barriers faced, and indicate how these obstacles were resolved. Mention major administrative changes that took place, name all new faculty members supported by the U54 award, and list the publications, grants, 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. Appropriate tables may be included in the Appendix.

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

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

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

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

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

It is preferred that individuals designated as the lead 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 must be provided in Section 3D (see below). 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.

Recruitment Plans. Describe recruitment plans of the Partnership.

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

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

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

Describe the number of individuals (and type of desirable expertise) that the partnership plans to recruit over the 5-year period of this award; and

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

Justification for all the cost associated with this core must be provided. Administrative Core will provide funding for managing the partnership, such as salaries for PIs and other key personnel such as Program Managers (i.e., 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.

Section 3.C. Projects and Programs in Required Target Areas (page limits depend on the number and types of proposed components see details below)

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

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

Each partnership application must include at least three projects/programs. Type 1 applications must include at least one full project/program and two pilot projects/programs. Type 2 applications are expected to include 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.

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

1) 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.

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

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

Describe how this pilot project/program relates to the overall priorities of the partnership and the target area(s). Include any preliminary data (if available). Projects without preliminary data are expected to provide scientific rationale based on appropriate supporting literature. Describe, as appropriate for the nature of the project/program, experimental methods/study design, or the training, outreach and/or education plans and objectives. For example, include the identification of the target pool (students population), and/or the method of program evaluation and tracking. Describe the role played by each of the co-investigators/mentors. Identify which aspects of the pilot project/program will be conducted primarily at the institutions serving racial/ethnic and/or underserved communities with cancer health disparities and which at the Cancer Center. Research projects conducted primarily at the institutions serving racial/ethnic and/or underserved communities with cancer health disparities may be in any area of cancer research, but research projects conducted primarily at the Cancer Center must specifically address cancer health disparities research.

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

2) 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.

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

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

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

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

Section 6. Protection of Human Subjects

Section 7. Inclusion of Women and Minorities

Section 8. Targeted/Planned Enrollment Table;

Section 9. Protection of Children; and

Section 10. Vertebrate Animals.

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

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

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

Section 3.D. Career Development and Mentoring Plan (if needed)(up to 12 pages per section The Candidate in each plan plus other required administrative items)

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

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

a) Candidate’s Background

b) Career Goals and Objectives: Scientific Biography

c) Career Development/Training Activities during Award Period

d) Training in the Responsible Conduct of Research

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

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

Section 3.E. Developmental Core (up to 6 pages)

Section E must be different for each of the linked applications.

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

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

This section must be identical for each of the linked applications and should address the following. Describe the following:

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

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD 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. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

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 should 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

Review 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 linked applications submitted in response to this FOA will be reviewed together and will receive the same impact/priority score.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact.

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

Scored Review Criteria.

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

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

In addition, specific to this FOA: Does the proposed Comprehensive Partnership address an important cancer and health disparities problem? Will the proposed partnership have a significant effect on the broader field of health disparities? What is the potential effect of this partnership on changes in knowledge, opinion, and practices among members of the participating community? Will the proposed training and education activities have an effect on the community?

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

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

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

In addition, specific to this FOA: Does the intervention use a creative study design? Is the intervention being proposed already in existence but being applied to new racial/ethnic or underserved populations? Will the proposed intervention be culturally tailored for the community of interest? Will plans be made available and flexible enough to incorporate modified interventions, if found to be beneficial?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA: Are the plans for full research project and pilot educational project adequately described and appropriate for the goals of the particular partnership? Does the applicant present strong arguments for the proposed study design as the best possible balance of scientific rigor, implementation constraints and ethical sensitivities of partners? Are the potential limitations of the study design and approach adequately addressed? Is there an adequate plan for facilitating dissemination and translation of study findings with other partnerships? Is the career development and mentoring plan well detailed for the training program?

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

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

Additional Review Criteria

The following additional criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

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

2) Overall Evaluation and the Partnership Integration

a. Commitment from the Institutional Leadership:

b. Scientific and Administrative Leadership:

c. Scientific Integration:

d. Administrative Core

3) Projects and Programs in Required Target Areas

a. Pilot Projects and Programs.

b. Full Projects and Programs.

4) Career Development Plans

5) Resources/Infrastructure Development

6) Planning and Evaluation Core

As applicable, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

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

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

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

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

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. Revisions are not allowed for this FOA.

Additional Review Considerations

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

Applications from Foreign Organizations. Applications from foreign organizations are not allowed for this FOA.

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

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

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. Principal Investigator Rights and Responsibilities

The Principal Investigator 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 institution serving racial/ethnic and/or underserved communities with cancer health disparities 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:

Minimal PI Commitments. Awardees must be committed to making the research tools and research materials they develop available to the cancer research community. The awardees must ensure a significant effort commitment of the program leadership. Specifically, lead PI from the institution serving racial/ethnic and/or underserved communities with cancer health disparities must commit a minimum of 1.2 month-effort to the partnership activities, although a commitment level of 3 months-effort is expected if there are no other PIs from that side of the partnership. 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.

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

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

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

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

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

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

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

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

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

An NIH Project Scientist [or Project Coordinator, or Project Collaborator, or Intramural Scientist ] will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

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

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

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

2.A.3. Collaborative Responsibilities

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

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

Composition and organization of PSC will be as follows.

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

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

2.A.4. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS 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: [email protected]

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: [email protected]

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: [email protected]

3. Financial or Grants Management Contacts:

Ms. Barbara Liesenfeld
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243
Rockville, Maryland 20852-7150
Telephone: (301) 496-3265
Fax: (301) 496-8601
Email: [email protected]V

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.

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-09-116.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.

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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