COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP Release Date: March 28, 2002 (see reissue RFA-CA-05-021) RFA: CA-03-010 National Cancer Institute (NCI) (http://www.nci.nih.gov/) Letter of Intent Receipt Date: July 17, 2002 Application Receipt Date: August 14, 2002 This RFA is a reissue of RFA-CA-02-005, which was published in the NIH Guide on April 9, 2001. THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National Cancer Institute (NCI) invites cooperative agreement applications (i.e., U54) for the implementation of Comprehensive Minority Institution/Cancer Center Partnerships between Minority-Serving Institutions (MSIs) and NCI-designated Cancer Centers (or groups of Centers) in order to develop a stronger national cancer program aimed at understanding the reasons behind the significant cancer disparities and impact on minority populations. The lack of significant training opportunities for minority scientists in cancer research and the low level of involvement of MSIs in competitive cancer research have represented two major obstacles to developing a stronger national cancer research effort aimed at understanding the reasons behind the significant disparities of cancer impact on minority populations. The NCI has created a potentially powerful approach that can help MSIs and Cancer Centers integrate and take maximum advantage of their expertise and experience to work together in areas that are mutually beneficial. This new initiative, the Minority Institution/Cancer Center Partnership (MI/CCP) program, offers two cooperative agreement assistance mechanisms, a U56 and a U54. The Cooperative Planning Grant for Comprehensive Minority Institution/Cancer Center Partnership (U56) is to be used by those institutions that are in the initial stages of planning for a comprehensive partnership. The Comprehensive Minority Institution/Cancer Center Partnership (U54) is to be used by those institutions who have had considerable prior planning and evaluation and are ready to begin implementing a more broadly focused partnership having inter-institutional cancer research projects and/or cancer training and career development, education or outreach programs. The sole purpose of the MI/CCP program is to provide support for various collaborative activities that will lead to the submission of specific competitive grant applications traditionally supported by the NCI and other funding organizations. This initiative for a U54 Comprehensive Minority Institution/Cancer Center Partnership must be based on previous extensive planning and priority setting activities and must achieve goals that are of clear mutual benefit. Partners are expected to work toward the following objectives: 1. Build and stabilize the independent, competitive cancer research projects and cancer research training and career development programs at MSIs; 2. Create stable, long-term collaborative relationships between MSIs and Cancer Centers in the areas of cancer research, cancer training and career development, cancer education and/or cancer outreach that increase the emphasis on problems and issues relevant to the disproportionate cancer incidence and mortality in minority populations; 3. Improve the effectiveness of the Cancer Center research, training and career development, cancer education and cancer outreach activities specifically designed to benefit minority populations in the region the Cancer Center serves; 4. Export successful approaches in addressing disproportionate cancer burden in minority populations to other MSIs, Cancer Centers, and key networks supported by the NCI (e.g., Cancer Genetics Network, Clinical Cooperative Groups, Early Detection Research Network, and the Special Populations Network). OBJECTIVES Background Since the War on Cancer was initiated, the disparities in cancer incidence, morbidity and mortality in underserved racial and ethnic minorities have continued to rise. For example, the incidence of colon and lung cancers in Alaska Native and African-American men and women is higher than that of other ethnic groups; five-year survival rates in Native American, African American, Hawaiian, and Hispanic Americans are lower than those of Japanese and White Americans; and patterns of prostate cancer among African American males compared with White males, seen in the Southeastern U.S., particularly in rural areas still remain higher http://www.nci.nih.gov/atlasplus/. Clearly, more research is needed that specifically addresses these and other disparities if they are to be eliminated by 2010 (Presidents Initiative on Race and Health Disparities). Minority-Serving Institutions conduct high quality programs for educating minorities and they represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in cancer research. However, they have had difficulties developing and sustaining independent programs in biomedical research, and there is a paucity of minority scientists who are pursuing successful biomedical research careers. Despite various initiatives, progress in realizing a significant increase in the number of minority scientists who are competitive for NIH research grants has been slow. More specifically, there remains a serious shortage of well-trained minority scientists who can conduct independent cancer research, who can focus research efforts on the disproportionate burden of cancer in minority populations, and whose cultural perspectives are essential to the successful conduct of many forms of research involving minority patients and populations. The NCI-designated Cancer Centers are geographically dispersed, research intensive organizations with well-organized programs for training cancer scientists. They are the only organized units supported by the NCI that conduct research; sponsor research training in the basic, clinical and population sciences; provide information services; and develop and sustain educational and outreach programs that benefit their communities. Yet, the progress of Cancer Centers in focusing on research issues of particular importance to cancer in minorities, in training minority scientists, in reaching out to and partnering with different racial and ethnic minority populations in their communities, and in bringing the benefits of cancer research to these populations has been slow and often disappointing. Objectives and Scope The U54 MI/CCP grant offers four broad areas to target for development: 1. Cancer Research: Joint cancer research projects must be the most significant component of a U54 Comprehensive Minority Institution/Cancer Center Partnership. Joint pilot and full research projects may be in any area of basic, clinical, prevention, control, behavioral or population research. Research projects conducted primarily at the MSI may be in any area of cancer research, but research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in minority populations. Joint cancer research projects at MSIs might focus, for example, on general areas of environmental carcinogenesis, molecular epidemiology, and behavioral issues related to cancer prevention, treatment and control. The expectation is that successful pilot research projects will become full research projects and that full research projects will become competitively funded grants (e.g., R03, R01; project on a P01; project on a P50). 2. Cancer Training and Career Development: Cancer training and career development programs are highly encouraged and must focus on joint programs between MSI and Cancer Center(s) that place an emphasis on the training of minority scientists and on educating majority trainees to appreciate the issues and problems associated with cancer disparities in minority populations. The NCI particularly encourages training of minority scientists in clinical, behavioral and population research; there is a huge deficit of minority scientists engaged in these research areas, areas which are highly dependent for their success on the cultural sensitivity of the researchers. These training programs must represent true collaborations that function seamlessly across the institutional boundaries of the MSI and the Cancer Center. For example, new training programs might provide graduate students in MSIs the opportunity to fulfill their research requirements in Cancer Center laboratories using state-of-the-art equipment and mentoring by Cancer Center investigators; or masters programs in an MSI might be linked formally to doctoral training programs in Cancer Centers. Clinical research training programs at MSIs might also include rotations dealing with minority cultural issues for majority trainees and clinical training programs at the Cancer Center might offer the use of current methodologies for national and international electronic communication on diagnosis and treatment of cancer for minority trainees. Successful activities in this area may lead to the submission of a competitive training grant application (e.g. T32, K12, R25T). 3. Cancer Education: Cancer education programs could focus on any effort to augment existing or create new curricula in the MSI and/or the Cancer Center that would apprise and culturally sensitize graduate and postdoctoral students in research, medicine and public health of the need to reduce disproportionate cancer burden in minority populations. A successful effort may result in the submission of competitive NCI education grant application (R25E) and later to institutional commitments to make these curricula an inherent component of their educational systems. 4. Cancer Outreach: Cancer outreach programs may be defined as proactive efforts to help minority communities develop and manage their own culturally sensitive programs for educating their populations about cancer risk, early detection, screening, prevention, and treatment. MSIs and Cancer Centers would be expected to combine their expertise in working with minority leaders and organizations in the community to develop outreach programs that effectively reach individuals and physicians and that increase the recruitment and retention of racial and ethnic minorities into clinical trials and prevention protocols. The U54 MI/CCP could help communities develop activities such as: (a) utilizing church networks to reach and educate the citizens of minority communities about prevention, early detection and treatment of cancer; (b) working with civic organizations to develop programs that encourage life-style changes important for cancer prevention and that emphasize the importance of early detection and diagnosis; (c) developing continuing education programs for community health care providers to ensure that they are providing state- of-the-art care and advice to their patients; and (d) training communities to use and link their communities to the electronic information systems that can educate individuals about cancer and help them make informed decisions about their health. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) cooperative specialized center (U54) award mechanism. The U54 mechanism may support any part of a full range of research development from very basic to clinical. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April 1, 2003. The NIH U54 is a cooperative agreement award mechanism in which the Principal Investigator 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 "Cooperative Agreement Terms and Conditions of Award" This RFA is a one-time solicitation. If it is determined that there is a continuing program need, the NCI will either reissue this RFA for re- competition or invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review. The Principal Investigators on behalf of the institutions are responsible for the conduct of this activity with strong continuing commitments from the MSI and the Cancer Center enabling the success of the partnership. ALLOWABLE COSTS The U54 MI/CCP will provide support for: 1. Administrative costs (not to exceed 20% of the total direct costs per year per partnership) for managing the partnership, such as salaries for key personnel; equipment and supplies to support an administrative structure. 2. Planning and Evaluation should be constantly ongoing and the basis for initiating and terminating the investment of resources into developmental projects, programs, resources and recruitments below. This may include the costs for travel for internal and external activities (key personnel; travel and per diem for Program Steering Committee members), workshops, seminars, retreats and other forums to strengthen, stabilize and consolidate interactions and cooperation in areas of existing high priority; to merge existing cancer programs into consolidated collaborations; to identify new areas of opportunity and high priority as the partnership evolves; and for reviewing pilots/full projects/programs, recruitments and resources. 3. Developmental costs for: a. Pilot cancer research projects or pilot cancer training and career development, cancer education and/or cancer outreach programs(not to exceed $100,000 in direct costs per year per project/program of the partnership for no more than three years). These activities cannot be self-contained and must have the potential to become long-term efforts (i.e. full projects as in section b below or competitive grant applications) b. Up to three full projects/programs per year may be funded (not to exceed $250,000 in direct costs per year per project/program of the partnership for no longer than three years) in areas prioritized for development and stabilization through subsequent competitive funding (e.g., R01, K12, P01, P50, T32, R25). One of one, one of two, or two of three Full projects/programs must be focused primarily on research. The partnership would have the flexibility to discontinue projects/programs and start new projects/programs based on the regular evaluation of progress; the funding of Full projects/programs through other competitive sources; and identification of new opportunities through formalized planning, evaluation and priority setting activities. c. Resources and infrastructure (e.g., tissue resources) that augment the cancer research capability of the MSI, the collaborative research of the MSI and the Cancer Center, and/or specifically enhance research focused on minority issues. Shared infrastructure could be placed in either the MSI or the Center or in both locations. d. Start-up packages for newly recruited investigators in areas prioritized for development and stabilization. FUNDS AVAILABLE NCI anticipates making two (one pair) 5-year awards and intends to commit approximately $2.5 million (including direct costs and costs for facilities and administration) for the initial year's funding of the program. The maximum combined direct cost budget of the MSI and the cancer center together is $1.5 million. Third party sub-contractual facilities and administration costs will not be counted toward the maximum combined direct costs of $1.5 million. Applications exceeding the $1.5 million direct costs limit will be considered unresponsive to the RFA and will be returned without further consideration. Funding in response to this RFA is dependent upon the receipt of a sufficient number of meritorious applications. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. Awards are not renewable. The NCI will make a commitment for funding a partnership for the full term of the award. The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date is April 1, 2003. ELIGIBLE INSTITUTIONS Applications will only be accepted from Minority-Serving Institutions (MSIs) [e.g., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs) and Tribal Institutions (e.g., Colleges)] either in the United States or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers (or groups of centers) that wish to develop comprehensive partnerships. MSIs are defined as those in which students of minority groups, who are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders), comprise a significant proportion of the enrollments AND that have a track record of commitment to the special encouragement of minority faculty, students and investigators. Both MSIs with medical schools and MSIs with more focused education and research programs (e.g., Masters and Ph.D. Programs) are invited to participate in this initiative. MSIs that offer only baccalaureate degrees, and Tribal Colleges are also invited to participate in this initiative as sub- contractual partners in Minority Institution/Cancer Center Partnerships. A partial list of eligible Minority-Serving Institutions can be found at the following website address: http://www.sciencewise.com/. Other institutions that meet MSI qualifications may not be listed on the website but they are also eligible to apply. A list of NCI-designated Cancer Centers can be found at the following website address: http://www.nci.nih.gov/cancercenters/. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The Principal Investigators must be U.S. citizens, non-citizen alien nationals, or permanent residents of the United States. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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. SPECIAL REQUIREMENTS There are a number of Special Requirements and Provisions that each Comprehensive Minority Institution/Cancer Center Partnership must comply with: 1. Each MSI and Cancer Center is limited to applying for no more than ONE Comprehensive Minority Institution/Cancer Center Partnership application (either a U56 or a U54). 2. Of the four areas being targeted by this initiative, (i.e., cancer research, cancer training and career development, cancer education and cancer outreach) cancer research must represent 50 percent of the proposed activities. 3. There must be written "Letters of Commitment" from the MSI leadership and the Cancer Center leadership that are fully supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. Additional resources would include protected faculty time (i.e., release time with grant funds), provisions for recruitment of new faculty, space and facilities for new projects/programs, capital improvements, etc. 4. Each U54 MI/CCP activity must be submitted as a clear partnership between the MSI and the Cancer Center. This must be done by submitting two separate applications, one from the MSI and one from the Cancer Center. The Principal Investigator of the MSI grant application must be the Co-Investigator of the Cancer Center grant application and vice versa. The overall priorities and objectives for implementation of the two applications must be the same, but the actual activities and budgets of the two applications should demonstrate how the MSI and the Cancer Center requests both differ and complement each other in achieving these priorities and objectives. 5. The two applications must not only complement each other, but clearly outline the mutual benefits to be gained by the MSI and the Cancer Center as a result of the partnership. For example, both the MSI and Cancer Center benefit from a broader range of resources and approaches than are available at any one institution, however, the MSI will be exposed to state-of-the-art technology and have greater access to information services while the Cancer Center benefits by having a greater diversity of students, faculty and researchers participating in cancer related activities and more access to minority patients for clinical protocols. 6. The direct costs of the two applications together cannot exceed $1.5 million per year. If there is a third party subcontract, only the direct costs of the subcontract will count against this cap. 7. No more than 20% of the total direct costs of the partnership can be used for Administrative Core expenses. 8. There must be a common Planning and Evaluation Core shared between the MSI and the Cancer Center(s) proposals with: a. Internal Processes for workshops and other forums to identify areas of new opportunity as well as for strengthening, stabilizing and merging existing projects/programs. Internal processes must also have an evaluation and prioritization process in place for reviewing internal proposals for Pilot and Full projects/programs, recruitment of research associates, new investigators and establishment of resources and infrastructure on the basis of their merit and potential to contribute effectively to achieving high priority goals and objectives. b. External Processes, in which a Program Steering Committee evaluates overall progress on an annual basis, make recommendations for establishing priorities, changing direction and identifying areas of new opportunity to accomplish mutual objectives more successfully. The evaluation and recommendations must be in the form of a written report and must be included as part of the Non-Competing Continuation Application submitted to the NCI each year. The rationale for using Developmental Core funds would have to be based on these planning and evaluation processes. 9. In using Developmental Core funds to support pilot/full projects/programs, each activity must be co-lead by individuals from both the MSI and the Cancer Center. No pilot project/program can exceed $100,000 in direct costs per year of the partnership or continue for more than three years. No full project/program can exceed $250,000 in direct costs per year of the partnership or continue for longer than 3 years. 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; R01; R25T; R25E; P50; T32; P01; K12). Third party facilities and administrative costs are in addition to the direct costs requested. 10. Any new project/program and shared resources for development must be totally new activities that do not overlap in purpose or intent with existing grants and shared resources (e.g. P30; P50; National Center for Research Resources' Infrastructure Grants, National Institute of General Medical Sciences Minority Biomedical Research Support Grants or any other peer- reviewed funded programs). Resources should augment the research capability of the MSI, the collaborative research between the MSI and the Cancer Center, and/or specifically support and enhance research focused on minority issues. Resources can augment existing Cancer Center resources, or they can be entirely new resources, as long as they are tailored to the common objectives and priorities of the partnership. Resources can be located either at the MSI or the Cancer Center or divided but shared between the MSI and the Cancer Center. 11. Successful Partnerships are expected to participate in exporting their approaches to other NCI Centers, Networks and MSIs. 12. All recipients of U54 MI/CCP awards will be expected to participate in an annual MI/CCP Workshop for the purpose of sharing information and strategies sponsored by the Comprehensive Minority Biomedical Branch of the NCI. Travel expenses for this purpose must be included in the applications from the MSI and the Cancer Center. 13. If an application includes participation of Native American (American Indian) or similar populations, a formal letter of support for the study from the Tribal Nation Leader or equivalent must be included. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92 and administered under the NIH Grants Policy Statement. The administrative and funding instrument used for this program is a cooperative agreement (U54), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Coordinator. These are summarized below: 1. AWARDEE RIGHTS AND RESPONSIBILITIES a. Awardees will have primary responsibility for the project 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 other awardees. Awardees will retain primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the research tools and research materials they develop available to the cancer research community. b. Awardees agree to follow the advice and recommendations of the Program Steering Committee, whenever possible, in meeting the intent of this initiative. c. 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. For partnerships including members from other institutions, plan and extend meetings via teleconferencing, videoconferencing or web conferencing (for more frequent meeting), as well as face-to-face meetings (semiannually or quarterly) should be described. d. The Co-Investigators and other designated investigators will attend an Annual MI/CCP Workshop for the purpose of sharing information and strategies to be organized by NCI. In addition, the Co-Investigators will be voting members of the Program Steering Committee which meets once year. e. Each partner will submit annual progress reports (including the PSC annual meeting recommendation) to the NCI that describes activities and accomplishments during the previous funding period as part of the Non- Competing Continuation Renewal. f. Intellectual Property. Each applicant must provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Procedures must be described for resolution of legal problems should they arise. Your attention is directed to P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions were also published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 19, No. 23, June 22, 1990). All Awardees must adhere to the policy for distribution of unique research resources produced with PHS funding, published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 25, No. 23, July 12, 1996). The Guide can be accessed electronically at http://grants.nih.gov/grants/guide/index.html. All awardees must also adhere to the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 Federal Register 72090). The Principles and Guidelines can be accessed electronically at: http://www.nih.gov/od/ott/RTguide_final.htm. Procedures must be described, that address how awardees will approach such distribution/dissemination, including acknowledgment of the terms of any related technology licenses or sponsored research agreements which Institution may have. Awardees shall include the following terms concerning intellectual property rights, or provide an alternative plan. NCI acknowledges that some commercial collaborators that are members of applicant partners, or who provide agents to applicant partners, may require that Institution agree to grant to them certain intellectual property rights, as described by the terms below. If an Institution voluntarily agrees to the described terms, then they should appear in the Institution's partner application. NCI recognizes that Institutions' ability to access agents from commercial collaborators for this effort may be limited absent such a voluntary agreement, or a substantially similar independent agreement between Institution and commercial collaborators providing agents. However, in no event will the award of a cooperative agreement be dependent upon the described terms' being part of an Institution's partner application. Rather, Institution's partner application may provide Institution's own plan for accessing agents from commercial collaborators. In no event, however, will an award be made absent incorporation of either the terms below, or Institution's own plan. "Institution agrees to grant to commercial collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Institution Inventions for research purposes only; and (ii) a time-limited first option to negotiate an exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to sub-license, to all Institution Inventions on terms to be negotiated in good faith by the collaborator and Institution. The collaborator shall notify Institution, in writing, of its interest in obtaining such an exclusive license to any Institution Invention within six (6) months of the collaborator's receipt of notice of such Institution Invention(s). In the event that a collaborator fails to so notify Institution, or elects not to obtain an exclusive license, then the collaborator's option shall expire with respect to that Institution Invention, and Institution will be free to dispose of its interests in such Institution Invention in accordance with Institution's policies. If Institution and collaborator fail to reach agreement within ninety (90) days, (or such additional period as collaborator and Institution may agree) on the terms for an exclusive license for a particular Institution Invention, then for a period of six (6) months thereafter Institution shall not offer to license the Institution Invention to any third party on materially better terms than those last offered to collaborator without first offering such terms to collaborator, in which case collaborator shall have a period of thirty (30) days in which to accept or reject the offer. Institution agrees that notwithstanding anything contained herein to the contrary, any inventions, discoveries or innovations, whether patentable or not, which are not Subject Inventions as defined in 35 USC 201(e), arising out of any unauthorized use of the collaborator's agent and/or any modifications to the agent, shall be the property of the collaborator (hereinafter "Collaborator Inventions"). Institution will promptly notify the collaborator in writing of any such Collaborator Inventions and, at collaborator's request and expense, Institution will cause to be assigned to collaborator all right, title and interest in and to any such collaborator inventions and provide collaborator with assignment or other documents). Institution may also be conducting other research using the agent under the authority of a separate Material transfer Agreement (MTA) with the collaborator. Inventions arising thereunder shall be subject to the terms of the MTA, and not to this clause." g. Protection of Proprietary Data. The ability to publish new results in a timely and intellectually unconstrained manner is fundamental to the academic enterprise. This need must be balanced with the legitimate requirements of commercial collaborators to protect the proprietary or confidential information that they provide concerning their proprietary agents. Commercial collaborators also may require exclusive access to the raw and primary data generated in studies of their agents. Therefore, NCI urges that the following statement also be incorporated in Partner applications: "Raw and primary data may be provided exclusively to the NCI, industrial collaborators, and the FDA, as appropriate. This provision shall not affect the investigators' right to disseminate their research findings through publications or presentations." 2. NCI STAFF RESPONSIBILITIES The NCI Program Coordinator will be responsible for normal stewardship of the award and may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative. The NCI Program Coordinator will also: a. Serve as full participating and voting member of the Program Steering Committee. b. Work closely with individual investigators and partners to facilitate collaborations. c. Assist the partnership efforts by facilitating access to fiscal and intellectual resources provided by NCI, NIH, industry, private foundations and federal funding agencies. d. Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by Cancer Center Support Grants, Research Centers at Minority Institutions Infrastructure Grants, Minority Biomedical Research Support Grants or other peer reviewed funding mechanisms. e. Interact with each partner, coordinate approaches between partners, and contribute to the adjustment of projects/programs or approaches as warranted. f. Provide assistance in reviewing and commenting on all major transitional changes of an individual partner's activities prior to implementation to assure consistency with the goals of this RFA. g. Coordinate activities with other ongoing studies supported by NCI to avoid duplication of effort and encourage sharing and collaboration in the development of new clinically useful agents and methodologies. h. Coordinate access to other resources from NCI including NCI sponsored agents for pre-clinical and clinical testing, assistance in IND filing, etc. i. Link the approaches developed from these partnerships to each other and to other NCI Cancer Centers and NCI-supported networks to ensure that information is shared and utilized on the widest basis possible. j. Help reprogram efforts within the peer reviewed scope of work, including options to modify projects/programs when projects/programs are not making headway relative to the time-line for achieving the objectives of the RFA. k. Assist the Program Steering Committee in the evaluation of new pilot and full projects/programs when requested as replacements for ongoing activities. l. Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success. m. Recommend the approval of new faculty recruits to ensure that they fall within the bounds of the areas prioritized for development and stabilization. n. Organize and recommend an agenda for an annual workshop that engages all of the partnerships and other participants as needed. This meeting will be held for all funded investigators to share progress and research insights that may benefit all of the projects. o. Call additional meetings/workshops of the participants to address emerging areas of high priority to the NCI and/or the problems of high cancer incidence and mortality in minority populations. The dominant role and prime responsibility for the activity resides with the awardee(s) 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 Staff. 3. COLLABORATIVE RESPONSIBILITIES OF THE PROGRAM STEERING COMMITTEE A Program Steering Committee (PSC) must be composed of the Co-Principal Investigators of each partnership, NCI Program Coordinator, and up to six external advisors with the scientific expertise necessary to provide appropriate advice relative to the objectives of the U54 and for providing the most objective advice. The PSC will meet once a year and serve as the primary advisory board of the U54 Program and will have the responsibility of making recommendations for establishing priorities, changing direction and identifying areas of new opportunity based on continuing evaluation. The PSC's recommendations, in the form of a written annual report, are to be submitted to the leaders of the MSI and the Cancer Center and the NCI and are to be used by the Principal Investigators to guide and direct the development of the U54 program. The Principal Investigators and the NCI Program Coordinator will each have one vote. The chairperson, who will be someone other than the Principal Investigators or NCI staff, will be selected by the PSC. Subcommittees with additional ad hoc advisors may be established by the PSC as necessary in order to meet its planning, priority setting and evaluation responsibilities. Awardees generally will be expected to accept and implement the recommendations of the PSC; in those situations where the recommendations are not feasible to implement, the Co-Principal Investigators must provide a thorough explanation and rationale to the NCI. 4. ARBITRATION Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Program Steering Committee (with the NCI member not voting), a second member selected by NCI, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct your questions about scientific/research issues to: Sanya A. Springfield, Ph.D. Chief, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7013 Bethesda, MD 20892-8347 Rockville, MD 20852 (express courier) Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: springfs@mail.nih.gov Nelson Aguila, D.V.M. Program Director, CMBB, OCTR, ODDES, NCI 6116 Executive Blvd. Suite 7013 Bethesda, MD 20892-8347 Rockville, MD 20852 (express courier) Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: aguilah@mail.nih.gov Or Brian Kimes, Ph.D. Director, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7000 Bethesda, MD 20892-8347 Rockville, MD 20852 (express courier) Telephone: (301) 496-8537 Fax: (301) 402-0181 Email: kimesb@mail.nih.gov Direct inquiries regarding financial or grants management matters to: Ms. Barbara Fisher Grants Administration Branch 1003 West 7th Street Suite 300 Frederick, Maryland 21701 Telephone: (301) 846-1015 Fax: (301) 496-8601 Email: fisherb@mail.nih.gov Direct inquiries regarding review matters to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncidearefof@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed U54 partnership o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NCI staff to estimate the potential peer review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Sanya A. Springfield, Ph.D. Chief, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7013 Bethesda, MD 20892-8347 Rockville, MD 20852 Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: springfs@mail.nih.gov PREAPPLICATION TECHNICAL ASSISTANCE WORKSHOP The NCI strongly encourages all potential applicants to attend a pre- application Technical Assistance Workshop (TAW) on June 4-5, 2002. Since this is a new concept for the NCI and for the applicant population, it will give staff the opportunity to clarify any perceived ambiguities in the RFA and help applicants to present their strongest case for support. If one is unable to attend the technical assistance workshop, the results of the workshop can be accessed at the Web site http://minorityopportunities.nci.nih.gov. In addition, NCI encourages pre-application consultations with individual partnerships either as telephone conference calls, videoconference meetings, or as face to face meetings. In order to make these arrangements contact Dr. Sanya A. Springfield by email at springfs@mail.nih.gov or by phone at (301) 496-7344 or Dr. Brian Kimes by email at kimesb@mail.nih.gov or by phone at (301) 496-8537. SUBMITTING THE APPLICATION The following procedures apply to both the MSI and the Cancer Center applications: Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/01). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS 1. Face Page: Use Form Page 1 as instructed in the Form PHS 398 (rev. 5/01). On line 1 provide a title that is representative of your partnership. This title should be the same for both the MSI and the Cancer Center institution's applications. For line 2 enter the title "U54 MI/CCP " and the number of this RFA, RFA CA-03-010. Remember to affix the RFA label that comes with the Form PHS 398 to the bottom of the Face Page. 2. Description, Performance Sites and Key Personnel: Use Form Page 2 of the Form PHS 398 and list the Principal Investigator first and next the Co- Principal Investigator for the partnership application. Then list all Key Personnel for the Administrative Core, Planning and Evaluation Core and Developmental Core (all pilot/full projects/programs) and Resources inthis application alphabetically. Follow the instructions provided in the Form PHS 398. 3. Table of Contents: NOTE: The Table of Contents and Research Plan of the PHS 398 (rev. 5/01) application are not specifically tailored to the unique objectives of the MI/CCP application. Therefore organize the Table of Contents exactly as described below: Face Page Description, Performance Sites and Key Personnel Table of Contents Detailed Budget for Initial Budget Period: a. Total Initial Budget for all Cores b. Administrative Core c. Planning and Evaluation Core d. Developmental Core Budget for Entire Proposed Period of Support: a. Total Entire Budget for all Cores b. Administrative Core c. Planning and Evaluation Core d. Developmental Core Budgets Pertaining to Consortium/Contractual Arrangements List of all participating members Biographical Sketch(s) and Other Support: a. Principal Investigator b. Co-Investigator c. All Key Personnel in alphabetical order d. Program Steering Committee Members Resources Implementation Plan: (replaces Research Plan in PHS 398 application instructions) Introduction to Revised Application (if applicable) a. Background and Objectives b. "Letter of Commitment" from the MSI or Cancer Center c. Chronological Review of Planning and Priority-setting Processes d. Scientific and Administrative Leadership e. Administrative Core f. Planning and Evaluation Core: 1. Internal Processes 2. External Processes g. Development Core: 1. Pilot projects/programs 2. Full projects/programs 3. Resources and infrastructure 4. Recruitment(s) h. Human Subjects i. Vertebrate Animals j. Literature Cited k. Consortium/Contractual Arrangements l. Intellectual Property Appendix Checklist Personal Data 4. Detailed Budget for Initial Budget Period: Use Form Page 4 of the Form PHS 398 application kit. Separately break out the budget into three sections using different Form Page 4s as follows: a. Total Initial Budget for all Cores b. Administrative Core: Denote the costs for personnel, supplies, travel etc. needed to provide administrative oversight, coordination and cohesion of the partnership. c. Planning and Evaluation Core: Delineate the costs separately for: 1. Internal processes (e.g., workshops, retreats, committees, seminar series, and ad hoc consultants to strengthen, stabilize and merge existing programs and the process for evaluating and prioritizing the use of developmental funds and the process for deciding which areas using developmental funds should be continued or be discontinued. 2. External processes should include the Program Steering Committee, which must meet once a year and evaluate the progress of the partnership as a whole toward accomplishing its objectives and make recommendations for changing direction or strategy to accomplish mutual objectives more successfully. External processes could also include special seminar series inviting experts to make presentations to partnership participants that relate to the objectives of the partnership and then serve as ad hoc advisors in areas under development. d. Developmental Core: Separately delineate the funds being requested for all Pilot projects/programs, Full Projects/programs, resources, research associates and recruitment. Remember that individual Pilot projects/programs cannot exceed $100,000 in direct costs and Full projects/programs cannot exceed $250,000 in direct costs. 5. Budget for Entire Proposed Period of Support: Using Form Page 5 of the Form PHS 398, break out the total budgets separately for (provide justifications for costs in future years only when there are specific items requested in future years that exceed standard cost-of-living increases): a. Total Entire Budget for all Core b. Administration Core c. Planning and Evaluation Core d. Developmental Core Funds 6. Budgets Pertaining to Consortium/Contractual Arrangements: Use this category if more than one MSI or Cancer Center is being linked in the partnership. In either case, one of the MSIs or Cancer Centers would have to serve as the primary grantee and subcontract for the consortia involvement of the other MSI or Cancer Center. 7. List all participating faculty/members of the MSI or the Cancer Center alphabetically by last name. Include for each their degree, department affiliation or equivalent, and research or other interest (e.g., research area, training, education, or outreach). 8. Biographical Sketches and Other Support: Use Biographical Sketch Format Page and follow the instructions in the Form PHS 398 application kit for: a. Principal Investigator b. Co-Principal Investigator c. All Key Personnel of the MSI or Cancer Center: This section should include all professional individuals who serve in middle leadership roles. The biographical sketches of those Co-Leaders of Pilot projects/programs, Full projects/programs and resources, as well as any named individuals who are going to be recruited, should be provided in the appropriate sections of this application. d. Program Steering Committee Members 9. Resources: Using Resources Format Page, follow the instructions in the Form PHS 398 application kit. 10. Implementation Plan The Research Plan of the PHS 398 (rev. 5/01) application is not specifically tailored to the unique objectives of the MI/CCP application. Therefore, applicants should follow the outline below: Special Introduction for Revised Applications (if applicable): This section should be the same for both the MSI and Cancer Center applications and limited to three pages. Include a summary of the additions, deletions, and changes in the revised application, placing particular emphasis on responses to the criticisms and issues raised in the previous summary statement. Include a chronological description of activities conducted since the original submission (meetings, research activities, etc.). The changes in the full text must be clearly marked by appropriate bracketing, indenting, or changing the type setting, unless the changes are so extensive as to include most of the text. A. Background and Objectives: This section should be the same for both the MSI and the Cancer Center U54 applications and limited to two to three pages. It should (1) discuss the general rationale and the mutual benefits that the MSI and the Cancer Center expect to derive from the partnership and the ways in which the MSI and the Cancer Center believe they can help each other develop stronger cancer programs, (2) clearly outline the immediate priorities of the partnership derived from a careful planning process that relates to mutual benefits, (3) present focused objectives in the areas of cancer research, cancer training and career development, cancer education and/or cancer outreach that the partnership believes can be achieved during the grant period for each priority, (4) present a projected time-line for achieving each objective and (5) discuss other areas of opportunity that the partnership will consider as the relationship between the partners evolves. B. Letter of Commitment: This section should be different for the MSI and Cancer Center application and limited to two to three pages. The MSI institutional leadership (e.g., Dean, President) and the Cancer Center leadership (e.g., Center Director, Dean), respectively, should include a detailed statement of their long-term commitment by noting the specific resources that will be dedicated to the priorities of this partnership as outlined in the Background and Objectives section above. These resources could be in the form of protected time for faculty to participate in and focus on the objectives of this grant, faculty appointments that will be made available in those areas where recruitment will be needed, space that will be dedicated to this effort, discretionary resources that will be made available to the Principal and Co-Investigators and purchase of sophisticated equipment for critical infrastructure needs. The letter should clearly explain how the MSI and the Cancer Center leadership would be responsible and accountable for following the progress of this effort and doing what is needed to sustain it. C. Chronological Review of the Prior Planning and Priority-setting Processes: This section should be the same for both the MSI and Cancer Center applications and limited to five pages. It should provide a clear indication that this partnership was derived from careful planning and priority-setting processes based on each partner's strengths and weaknesses and potential to complement each other and help each other become stronger in areas of opportunity. In chronological order present each process used in planning for and setting the priorities and objectives for this application. Briefly describe the nature of each planning activity (e.g., meetings of higher institutional officials, planning committees, steering committees in areas of opportunity, workshops of MSI faculty and Cancer Center members, retreats of MSI faculty and Cancer Center members), its purpose, the individuals that participated from the MSI and the Cancer Center, and its outcome. D. Scientific and Administrative Leadership: This section should be different for each application and limited to two to three pages. Briefly describe how the Principal Investigator was chosen in terms of the qualifications and experience to provide leadership and cohesion for this effort and to promote collaboration and cooperation in achieving the common objectives as outlined in the Background and Objectives section above. Also, if there are other mid-level leaders who will play a significant role in determining the success of this partnership, provide the same information for them. E. Administrative Core: This section should be different for each application and limited to ten pages. Describe the leadership and specific functions of the administrative core to provide the necessary day-to-day oversight, coordination, support, and logistical services needed to make this partnership function effectively. This might include organizing meetings, workshops, and retreats; documenting the results of activities; providing critical secretarial services, etc. F. Planning and Evaluation Core This section must be the same for each application and limited to five pages. 1. Internal Processes: Document each internal planning and evaluation activity (e.g., regular forums and seminars, workshops, retreats etc.) in which the objectives (or issues to be addressed) are identified, activities described, and participating individuals from the MSI and the Cancer Center named. (Face-to-face informal meetings between collaborators have been found to be the most effective method of communication. In instances where there is a problem of distance between partners, applicants are encouraged to consider other methods of communication including e-mail, teleconferences, and videoconferences). This should include how the progress of the partnership will be reported to institutional leaders and must include a review and evaluation process for initiating and closing all pilot and full projects and programs based on their merit and potential for achieving the objectives of the partnership and their actual progress. This process must also be used to determine which resources and infrastructure needs of the partnership will be established and which kinds of recruitment of faculty will be implemented. 2. External Processes: Program Steering Committee: Excluding the Co-Principal Investigators and the NCI Program Coordinator, describe how each Program Steering Committee member was chosen to provide unbiased, rigorous, expert evaluation of progress, to provide recommendations for improvement based on the objectives and priorities of the implementation plan of the partnership and to provide insights and advice for taking advantage of new objectives and initiatives as they emerge during the course of the grant period. NOTE: THE USE OF DEVELOPMENTAL FUNDS IN PART G BELOW IS INTENDED TO BE VERY FLEXIBLE AND RESPONSIVE TO THE PLANNING AND PRIORITY SETTING ACTIVITIES OF THE MSI AND THE CANCER CENTER DURING THE COURSE OF THE GRANT G. Developmental Core This section should be different for each application. 1. Pilot Projects/Programs: Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 per project/program in direct costs per year of the partnership or continue for longer than three years, should be provided in the following format: Title Names of the Co-Leaders from the MSI and the Cancer Center One paragraph abstract stating the objectives of the project/program Specific Aims One paragraph describing how this pilot project/program relates to the overall priorities Detailed budget page for initial budget period using Form Page 4 of the Form PHS 398. Budget for entire proposed period of support using Form Page 5 from the Form PHS 398 Proposal (up to five pages), include experimental methods and design, and any preliminary data and the role played by the MSI and Cancer Center investigators in the collection of data. Describe which aspects of the pilot project/program will be conducted at the MSI/Cancer Center Human Subjects** Vertebrate Animals Literature Cited Consortium/Contractual Consultants **NOTE: (1) All NIH-supported biomedical or behavioral research projects involving human subjects must consider appropriate inclusion of Gender and Minorities and Children as noted on pages 17 - 27 the Form PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on page 27 of the Form PHS 398 instructions; (3) Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. 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, informed consent forms, 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 Coordinator. 2. Proposed Full Projects/Programs: Full Projects/Programs proposed for funding, which cannot exceed $250,000 per project/program in direct costs per year of the partnership or continue for longer than three years, should be prepared in the following format: Title Names of the Co-Leaders from the MSI and the Cancer Center One paragraph abstract describing the purpose and objective of the project/program Specific Aims One paragraph describing how the project/program relates to the overall priorities Detailed budget for initial budget period using Form Page 4 from the Form PHS 398. Budget for entire proposed period of support using Form Page 5 from the Form PHS 398) Proposal prepared in the same detail as any research (R01), training (T32) or education (R25) grant proposal following the specific instructions, page limitations (no more than 25 pages) and guidelines provided in the Form PHS 398. Describe which aspects of the full project/program will be conducted at the MSI/Cancer Center Human Subjects** Vertebrate Animals Literature Cited Consortium/Contractual Consultants **NOTE: (1) All NIH-supported biomedical or behavioral research projects involving human subjects must consider appropriate inclusion of Gender and Minorities and Children as noted on pages 17 – 27 of the Form PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on page 27 of the Form PHS 398 instructions; (3) Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. 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, informed consent forms, 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 Coordinator. 3. Resources/Infrastructure: Resources and Infrastructure needs (e.g., minority tissue resource, minority patient accrual core, clinical research management core) of the partnership should be presented in the following format: Title Co-Leaders from the MSI and Cancer Center who lead the activity The experience of key technical personnel, if applicable, who will be responsible for the day-to-day operation. Detailed budget for the initial budget period using Form Page 4 from the Form PHS 398 Budget for entire proposed period of support using Form Page 5 from the Form PHS 398 Biographical Sketches of Co-Leaders Description of the resource/infrastructure and how it will further the priorities Commitment of space for the resource(s). Justification for the location of the resource(s) at the MSI, the Cancer Center or both. 4. Recruitment to be supported with Developmental Funds: Individuals who are known: Provide the biographical sketch of the individual. Describe how the individual fulfills the priorities and objectives of the partnership as described in the Background and Objectives section above. Identify a mentor and describe a career development plan if the individual is a less experienced investigator. Describe the nature of the position that provides the necessary stability (e.g., tenure track) and resources (e.g., space) to promote success. Describe the location of the individual at the MSI or the Cancer Center and how this location will best achieve the needs of the partnership. Individuals who are planned for: Describe the number and expertise of the individuals that the partnership plans to recruit over the five-year period of this grant in order to strengthen its capabilities (e.g., epidemiology, prostate cancer, breast cancer, behavioral research, outcomes research, community outreach, molecular genetics) in those areas needed to fulfill its priorities and objectives. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: A cover letter must be attached to the application clearly defining the MSI or Cancer Center partner and the Co- Principal Investigator; this will allow the NCI to assemble the two applications as one package for peer review. Submit signed, typewritten originals of the cover letters, MSI application and the Cancer Center application with their checklists, and three signed photocopies to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 or Bethesda, MD 20817-7710 (for express/courier service) At the time of submission, two additional copies of the applications must be sent to: NCI Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice- files/NOT-CA-02-002.html). This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after the date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and responsiveness to ELIGIBILITY REQUIREMENTS and responsiveness to the SPECIAL REQUIREMENTS AND PROVISIONS OF COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIPS by the NCI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI. The initial review will first evaluate the applications for meeting the criteria in the General Features below. Those applications that meet the criteria in the General Features (intent of the RFA) will be further evaluated for scientific and technical merit in accordance with the other review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Those that receive a priority score will undergo a second level review by the National Cancer Advisory Board. The application from the MSI and the application from the Cancer Center will be reviewed together as ONE partnership. REVIEW CRITERIA: This initiative is quite broad in scope and may include objectives ranging from cancer research to cancer training, to cancer education to cancer outreach. Under these circumstances, the review criteria are not organized under the traditional headings of Significance, Approach, Environment, Investigator and Innovation typically used for NIH research grants. Reviewers will have to use considerable flexibility in determining the merit of a broad range of possibilities that can strengthen the research capabilities of minority institutions, expand training and career development opportunities for minority scientists and increase the effectiveness of cancer centers in developing programs with the potential to reduce disproportionate cancer incidence and mortality in minority populations. INDIVIDUAL SUBCOMPONENTS: (1) SCIENTIFIC AND ADMINISTRATIVE LEADERSHIP: a. The adequacy of the qualifications and experience of the Co- Investigators and other key personnel from the MSI and the Cancer Center to provide strong programmatic (e.g., scientific) and administrative leadership. b. If applicable, the adequacy of the qualifications and experience of other key personnel in both the MSI and the Cancer Center to successfully plan for and achieve the objectives of the implementation plan of the partnership. (2) LETTERS OF COMMITMENT FROM THE LEADERSHIP OF THE MSI AND THE CANCER CENTER: a. The degree to which the letters of commitment from the leadership of the MSI and the Cancer Center address and fully support the priorities and objectives of the implementation plan of the partnership. b. The level of authority of officials committing to this joint effort at the MSI and the Cancer Center that gives confidence that these commitments will be stable and long-lasting. c. Adequacy of the plans to remain responsible and accountable for monitoring and sustaining the priorities and objectives of this partnership. d. The adequacy of the resources (e.g., discretionary resources, space, faculty positions, protected time for research, etc.) that the MSI and the Cancer Center will provide to promote the successful achievement of the priorities and objectives of this partnership. (3) ADMINISTRATIVE CORE: a. The quality of an appropriate organizational and administrative structure for effective attainment of U54 priorities and objectives that considers arrangements for internal quality control of ongoing activities, the allocation of funds, day-to-day oversight and management, support and logistical services, contractual agreements, (if applicable), and internal communication among investigators. b. b. The qualifications, experience and time commitment of Co- Investigators and key personnel in the services provided by the administrative core unit. c. The appropriateness of the use of the administrative core services by the budgeted activities and projects/programs. (4) PLANNING AND EVALUATION CORE: a. The adequacy of the design and quality of each of the internal planning and evaluation processes proposed to achieve the objectives and priorities of the implementation plan. b. The adequacy of the review and evaluation process and criteria for initiating and closing pilot and full projects/programs based on their merit and potential for achieving the objectives of the partnership and on their actual progress. c. The appropriateness and adequacy of the specific faculty and others identified who will participate together in each aspect of the planning and evaluation effort. d. The adequacy of the qualifications and experience of each proposed member of the Program Steering Committee to evaluate and monitor the progress of the partnership in achieving its priorities and objectives, to recommend mid-course changes in approaches and tactics, and to help the partnership evaluate and take advantage of new opportunities. e. If applicable, the appropriateness and adequacy of the process and criteria for identifying and implementing the resource and infrastructure needs of the partnership, and the appropriateness and strategic adequacy of the actual and proposed recruitment over the five-year period of the grant to strengthen the partnership's capabilities in areas of high priority for implementation. f. The adequacy of the experience and qualifications of the individuals who take part in evaluating specific proposals (e.g., pilot/full projects, pilot/full programs, recruitment) for using Developmental funds. (5) DEVELOPMENTAL CORE: a. Evaluation Criteria for Pilot Projects/Programs: 1. The qualifications of the Co-Leaders from the MSI and the Cancer Center to develop the proposed project/program. 2. The merit of the proposed Pilot Project/Program, and the degree to which it contributes to the priorities and objectives of the partnership. 3. Potential to develop into a Full project/program in three years or less. The options will be either to score and recommend support at the recommended budget levels or to Not Recommend for Further Consideration (NRFC) because it has either: (1) low merit; (2) low relevance to the objectives of the partnership; (3) low potential to develop into a Full project/program within three years; and/or (4) low potential to become funded through competitive peer review. b. Evaluation Criteria for Full Research Projects 1. Significance: Does this study address an important problem consonant with thte objectives of the MI/CCP program? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field of cancer research and/or research on cancer disparities? 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Co-Leader: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The options will be either to score and recommend support at the recommended budget levels or to Not Recommend for Further Consideration (NRFC) because it has either: (1) low merit; (2) low relevance to the objectives of the partnership and/or (3) low potential to become funded through competitive peer review. c. Evaluation Criteria for Full Programs (i.e., training and career development, education, and/or outreach) 1. The qualifications of the Co-Leaders from the MSI and the Cancer Center to develop the proposed program. 2. The merit of the proposed Full Program, and the degree to which it contributes to the priorities and objectives of the partnership. 3. Potential to develop into a competitive rogram in three years or less. The options will be either to score and recommend support at the recommended budget levels or to Not Recommend for Further Consideration (NRFC) because it has either: (1) low merit; (2) low relevance to the objectives of the partnership; (3) low potential to become funded through competitive peer review. d. Evaluation Criteria for Resources/Infrastructure: (if applicable) 1. The degree to which the proposed resource/infrastructure proposed will contribute to the overall priorities and objectives of the implementation plan. 2. The degree to which the proposed resource/infrastructure will provide long-term stability to the activities of the partnership supported by current pilot and full projects/programs and potential future funded grants. 3. The qualifications of key personnel to operate the proposed resource/infrastructure activity, and the merit of the resource as proposed. The options will be either to recommend support at the budget levels recommended by review, or to recommend support with specific modifications in the operation of the resources, or to recommend no support and the development of a more appropriate resource because of either: (1) low merit; and/or (2) low relevance to the objectives and priorities of the partnership. e. Evaluation Criteria for Recruitment: (if applicable) 1. The quality of each specific individual recruitment proposed relative to background and ability of the individual to contribute substantially to strengthening areas of high priority to the implementation plan. 2. The quality of plans to recruit individuals with the kinds of qualifications that will satisfy the most important strategic needs in strengthening the future capability of the partnership to fulfill its priorities and objectives. (6) EVALUATION OF PROGRESS BY THE PROGRAM STEERING COMMITTEE: a. The adequacy of the plan for using the Program Steering Committee effectively. (7) INTELLECTUAL PROPERTY: (if applicable) a. The adequacy of the intellectual property plan (if applicable), including provision for sharing of research tools/materials, and the accession of agents from commercial collaborators. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. (include if appropriate) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: The overall degree of merit for the partnership, as reflected by one priority score that will be assigned to the MSI and the Cancer Center applications, will be determined considering the following: 1. The quality of the seven individual sub-components, additional and other review criteria as proposed in the MSI and Cancer Center U54 applications. 2. The extent to which the MSI and the Cancer Center applications together satisfy the following General Features (i.e., overall intent of this initiative): GENERAL FEATURES: 1. Have the MSI and the Cancer Center established priorities and objectives for implementation after a careful and thorough planning process and have they shown that they worked closely together in the preparation of these applications? 2. Have the MSI and the Cancer Center clearly identified the mutual benefits to be gained from this partnership? 3. Can the applicants achieve the priorities and objectives for this partnership within the five-year grant period? 4. If fully successful, will the implementation plan result in a stable cancer research capability for the MSI and/or result in the significant, successful training of more minority cancer researchers? 5. If fully successful, will the ability of the Cancer Center be enhanced through research and/or training and career development and education and/or outreach to more directly and successfully address the disproportionate cancer burden in minority populations? RECEIPT AND REVIEW SCHEDULE Preapplication Technical Assistance Workshop Date: June 4-5, 2002 Letter of Intent Receipt Date: July 17, 2002 Application Receipt Date: August 14, 2002 Peer Review: November/December, 2002 Review by NCAB: February, 2003 Earliest Anticipated Award Date: April 1, 2003 NON-COMPETING CONTINUATION APPLICATION For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Application. AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. The set of two applications from an MSI and a Cancer Center will compete for funds with all other partnerships in response to this RFA. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants/guide/notice- files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: 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 AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 that is available at 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research in now available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (HESC): Criteria for federal funding of research on HESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using HESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the HESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC 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 public 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 RFA 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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 RFA 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 No. 93.398, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and administered under NIH grants policies described at: http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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.


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