RFA-CA-01-002: COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP

Department of Health
and Human Services (HHS)

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COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP Release Date: April 25, 2000 RFA: CA-01-002 National Cancer Institute Office of Research on Minority Health Letter of Intent: June 8, 2000 Application Receipt Date: July 26, 2000 PURPOSE The National Cancer Institute (NCI) and the NIH Office of Research on Minority Health (ORMH) invite cooperative agreement applications (i.e., U54s) for the establishment of Comprehensive Minority Institution/Cancer Center Partnerships (CMI/CCP) between Minority-Serving Institutions (MSIs) and NCI-designated Cancer Centers. 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. The long-range goals of the partnerships are to increase the cancer research capabilities at the MSIs; to increase the number of minority scientists engaged in cancer research and other related cancer activities; and to improve the effectiveness of NCI-designated Cancer Centers in developing and sustaining activities focused on the disproportionate incidence, mortality and morbidity in minority populations in the region the cancer center serves. To achieve these goals, CMI/CCP activities are expected to lead to the development of long-term comprehensive partnerships that will strengthen competitive cancer research, research training and career development, education and outreach capabilities at MSIs and in Cancer Centers. The purpose of this request for application (RFA) is to solicit cooperative agreements (U54s) that would implement comprehensive partnerships between MSIs and NCI-designated Cancer Centers (or groups of centers) that will achieve goals that are of clear mutual benefit. The comprehensive partnership must be predominantly focused on cancer research and one or more of the following target areas: cancer research training and career development, education or outreach programs to minority communities. The partnership application must be based on extensive planning and priority setting activities, whether supported by a CMI/CCP U20 cooperative planning grant or not. CMI/CCP U54 applicants are expected to achieve the following objectives in whole or in part: 1. Build and stabilize the independent and collaborative, competitive research and research training projects and programs at MSIs; 2. Create stable, long-term collaborative relationships between MSIs and NCI-designated Cancer Centers (or groups of centers) in the areas of cancer research, research training and career development, education and/or 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 Cancer Center research, education and outreach activities specifically designed to benefit racial and/or ethnic minority populations in the region the Cancer Center serves; 4. Export successful approaches in addressing disproportionate cancer incidence and mortality rates in minority populations to other NCI Cancer centers, as well as to other key networks supported by the NCI (e.g., Cancer Genetics Network, Clinical Cooperative Groups, Early Detection Research Network, and the Special Populations Network). 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, Comprehensive Minority Institution/Cancer Center Partnership, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications will only be accepted from MSIs, 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. Minority-Serving Institutions are 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. A list of the eligible Minority-Serving Institutions can be found at the following website address: http://www.sciencewise.com/. A list of NCI-designated Cancer Centers can be found at the following website address: http://www.nci.nih.gov/cancercenters/ Each partnership must be submitted as two applications, one from the MSI and one from the Cancer Center (or group of Cancer Centers), but with separate, complementary budgets to achieve priorities, common goals and objectives. Each Principal Investigator must be listed as a Co-Investigator on the complementary application (See below for further instructions). Each applicant should specify the Co-Investigator and partnering institution in a cover letter. The Principal Investigators must be U.S. citizens, non-citizen alien nationals, or permanent residents of the United States. Each MSI and Cancer Center is limited to participate in no more than ONE Comprehensive Minority/Institution Cancer Center Partnership (U54) application. 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. The U54 is a cooperative agreement, an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activities. Under a cooperative agreement, the NIH's purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient in a partner role. NCI/ORMH staff will work cooperatively with the award recipients in a partner role and do not assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the activities to be funded under the cooperative agreements awarded for this Program are discussed below under "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. If the NCI does not continue the program, awardees will be able to submit grant applications through existing investigator-initiated grant programs. 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 will provide support for: 1. An Administrative Core activity (not to exceed 20% of the total direct costs) for a. Salaries of key personnel b. Equipment and supplies to support an administrative structure 2. Planning and Evaluation Core activities that may include the costs for a. Travel for key personnel b. Travel and per diem for Program Steering Committee members c. Workshops, seminars, retreats and other forums to strengthen, stabilize and consolidate interactions and cooperation between the MSI and the Cancer Center in areas of existing high priority; to merge existing cancer programs of the MSI and the Cancer Center to consolidate collaborations; and to identify new areas of opportunity and high priority as the partnership evolves. 3. Developmental Core Funds for: a. Pilot research projects or pilot programs in research training and career development, education and outreach (not to exceed $100,000 in direct costs per year per project/program or a duration of three years). b. Up to three Full Projects/Programs per year in research, research training and career development, outreach and education may be funded (not to exceed $250,000 in direct costs per year per project/program or a duration of three years) in areas prioritized for development and stabilization through subsequent competitive funding (e.g., R01, K12, P01, SPORES, 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 and start new projects 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. Support for research assistants and research associates in various stages of their career development as independent scientists. e. Start-up packages for newly recruited investigators in areas prioritized for development and stabilization. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI/ORMH anticipate making two (one pair) 5-year awards and plan to set aside an estimated total of $2.5 million (including direct costs and costs for facilities and administration) for the initial year's funding of the program. An annual budget in the range of $1 million - 1.5 million in direct costs is suggested. Third party sub-contractual F & A costs will not be counted toward the maximum combined direct costs of $1.5 million. Applications exceeding the $1.5 million in 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/ORMH, 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/ORMH will make a commitment for funding a partnership for the full term of the award. The anticipated award date is March 1, 2001. OBJECTIVES Background: Twenty-eight years have passed since the War on Cancer was initiated, and during this period, the disparities in cancer incidence and mortality in underserved racial and ethnic minorities have continued to rise. The incidence of large bowel and lung cancers in Alaska Native and African American men and women is higher than that of other ethnic groups. Five-year survival rates by selective sites among racial or ethnic groups in the U.S., for example in Native American, African American, Hawaiian, and Hispanic Americans, are lower than those of Japanese and White Americans. The cancer mortality rates for lung, trachea, bronchus, and pleura for minority males and females differ widely when measured by state economic area. Examples of geographical differences are seen in a pattern of excessive prostate cancer among African American males in the Southeastern U.S., particularly in rural areas. High rates of esophageal cancer in the District of Columbia and in the Coastal area of South Carolina appear to be related to alcohol consumption, tobacco use and dietary deficiencies. More research is needed that specifically addresses these disparities if they are to be eliminated. Information about cancer incidence and mortality rates in different racial and ethnic U.S. populations can be obtained at the following website address: http://www.nci.nih.gov/atlas Minority-Serving Institutions (MSIs) [e.g., Minority Medical Schools, Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribal Colleges] 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, MSIs 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 by the community and the NIH, 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 incidence and mortality rates 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 engage in extensive outreach and education programs designed to reduce cancer incidence and mortality in the communities they serve. Cancer centers 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. The low level of involvement of MSIs in cancer research and lack of significant training of minority scientists in cancer research represent 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 potentials for identifying and training minority students and faculty in areas of cancer research have not been fully explored. One untried and potentially powerful approach for addressing these difficult issues is to create collaborations and partnerships between MSI's and NCI Cancer Centers that integrate and take maximum advantage of their respective expertise and experience. MSIs and Cancer Centers can help each other get better and collaborate in areas that neither could do as well alone. Through long-term comprehensive partnerships that are mutually beneficial to MSIs and NCI-designated Cancer Centers, the objectives of NCI and ORMH are to increase the participation of MSIs in the nation's cancer research and research training enterprise; to increase the involvement and effectiveness of the cancer centers in research and research training relating to minorities; and to develop more effective research, outreach and education programs that will have an impact on minority populations. Within this objective, four broad areas are targeted for development: 1. Cancer Research: Cancer research projects must be the most significant component of a Comprehensive Minority Institution Cancer Center Partnership. Joint 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 NCI-designated 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 and control. 2. Cancer Research Training and Career Development: Cancer research training and career development programs can be in any of the research areas above but 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 incidence and mortality disparities in minority population. The need to train minority scientists in clinical research and population research is a recognized deficit in many areas of cancer research 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(s). For example, new research 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 a MSI might be linked formally to doctoral training programs in Cancer Centers. Clinical research training might also include the use of current methodologies for national and international electronic communication on diagnosis and treatment of cancer. 3. Cancer Education: Cancer education programs could focus on any efforts to augment existing or create new curricula in the MSI and/or the Cancer Center that would apprise and culturally sensitize graduate students and postdoctoral students in research, medicine and public health of the need to reduce disproportionate cancer incidence and mortality in racial and ethnic minority populations. A successful effort may result in an R25 education grant and later to institutional commitments to make these curricula an inherent component of their educational systems. 4. Cancer Outreach: Outreach programs may be defined as proactive effort 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 to develop community education 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 MSI Cancer Center Partnership could help communities develop activities such as the following: (a) utilize church networks to reach and educate the citizens of minority communities about prevention, early detection and treatment of cancer; (b) work 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) develop continuing education programs for community health care providers to ensure that they are providing state-of-the-art care and advice to their patients; (d) train communities to use and link these communities to the electronic information systems that can educate individuals about cancer and help them make informed decisions about their health. SPECIAL REQUIREMENTS AND PROVISIONS OF COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIPS (CMI/CCP) 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 participating in no more than ONE U54 Comprehensive Minority Institution Cancer Center Partnership application. 2. Of the four areas being targeted by this initiative (i.e., cancer research, cancer research training and career development, cancer education and outreach), cancer research must be the major component. 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), recruitment of new faculty, space and facilities, capital improvements, etc. 4. The CMI/CCP activity must be submitted as a clear partnership between the MSI and the Cancer Center. This must be done by submitting two applications, one from the MSI and one from the NCI Cancer Center (or Cancer Centers). The Principal Investigator of the MSI grant must be the Co-Investigator of the Center grant and visa 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 grants should demonstrate how the MSI and the Cancer Center requests complement each other in achieving these priorities and objectives. 5. The two applications must clearly outline the mutual benefits to be gained by the MSI and the Cancer Center (or Centers) as a result of the partnership. 6. The total direct costs of the two applications together cannot exceed $1.5 million. 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 devoted to Administrative Core expenses. 8. In using Developmental Funds to support Pilot or Full research projects or Pilot or Full programs (research training and career development, education or outreach), each activity must be co-led by individuals from both the MSI and the Cancer Center. 9. Cancer research training programs must be joint programs designed to function seamlessly across institutional boundaries and to share trainees, faculty and mentors. 10. Research projects supported by the U54 and primarily conducted at the MSI can be any research area relevant to cancer but research primarily conducted at the NCI-designated Cancer Center must be focused on cancer disparity in minority populations. 11. There must be a common planning and evaluation component shared between the MSI and the Cancer Center(s) proposals: a. A Program Steering Committee with NCI/ORMH staff as a voting member(s) must meet once-a-year to evaluate progress and make recommendations for mid- course corrections as needed. The progress 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. b. The partnerships must have a process in place for reviewing internal proposals for Pilot and Full projects/programs, recruitment of new investigators and establishment of infrastructure on the basis of their merit and potential to contribute effectively to achieving high priority goals and objectives and this process must serve as the basis for distributing Developmental Funds. The rationale for using all Developmental Funds would have to be based on careful planning and evaluation activities conducted by the U54 CMI/CCP program. 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., R01; R25; SPORES; T32; P01; K12). No full project/program can exceed $250,000 in direct costs or continue for a duration longer than 3 years c. Other internal planning and evaluation methods for assuring progress of the partnership. 12. Any new project/program and shared resources for development must not overlap in purpose and intent with existing projects/programs and shared resources funded by the NCI Cancer Center Support Grant, National Center for Research Resources Infrastructure Grants, National Institute of General Medical Sciences Minority Biomedical Research Support Grant 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. 13. All recipients of U54 CMI/CCP Awards will be expected to participate in an annual meeting sponsored by the Comprehensive Minority Biomedical Branch (CMBB) of the NCI. Travel for this purpose must be included in the grant applications from the both MSI and the Cancer Center institutions. 14. Successful Partnerships are expected to participate in exporting their approaches to other NCI Centers and Networks and MSIs. 15. Once a U54 CMI/CCP grant is funded, specific guidelines for Non-Competing Renewal applications will be provided to the grantees. 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/ORMH Program staff. 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 directions of its activities and to insure that the necessary interactions are taking place. For partnerships including members from other institutions, plans to extend meetings via teleconferencing, videoconferencing or web conferencing (for more frequent meetings) 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 Meeting to be organized by NCI staff in Washington D.C. In addition, the Co-Investigators will be voting members of the Program Steering Committee which meets once a year. e. Each partner will submit annual progress reports to the NCI that describe 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 drawn 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.ott.nih.gov/policy/rt_guide_final.html. Procedures must be described, which 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 Program staff consists of the NCI Program Director and an additional representative from the ORMH. The NCI/ORMH Program staff will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants (which includes evaluating progress), as described below. The NCI/ORMH staff will have substantial involvement in identifying new areas of opportunity, recommend making mid- course corrections on an annual basis and generally ensuring that the U54 CMI/CCP remains focused on the intent of this initiative. NCI/ORMH staff will be involved in the following ways: a. Serve as full participating and voting member(s) 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, ORMH, industry, private foundations and federal funding agencies. d. Ensure that activities proposed for the 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. Will assist the Program Steering Committee in the evaluation of new pilot and full projects/programs when requested as replacements for ongoing activities. l. Terminate or curtail 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. m. Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success. n. Prior approval of new faculty recruits to ensure that he/she falls within the bounds of the areas prioritized for development and stabilization. o. Organize and make final decisions on the 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. p. Call additional meetings/workshops of the participants to address emerging areas of high priority to the NCI and ORMH and/or the problems of high cancer incidence and mortality in minority populations. The dominant role and prime responsibility for the activity reside 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/ORMH Staff. 3. Collaborative Responsibilities of Program Steering Committee A Program Steering Committee (PSC) must be composed of the Co-Principal Investigators of each partnership, no more than two NCI/ORMH Program Staff, and up to six external advisors with the scientific expertise necessary to provide appropriate advice relative to the objectives of the U54 CMI/CCP. The Co-Principal Investigators and the six external advisors are responsible for providing the most objective advice. The PSC will meet once a year and serve as the primary advisory board of the U54 CMI/CCP Program and will have the responsibility to make recommendations for establishing priorities, changing directions 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 used by the Principal Investigators in guiding and directing the development of the U54 CMI/CCP program. The Principal Investigators from the MSI and the Cancer Center and the NCI/ORMH Program staff will have one vote. The chairperson, who will be someone other than the Principal Investigators and NCI/ORMH staffs, will be selected by the PSC. Subcommittees with additional ad hoc advisors can 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 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/ORMH may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the External Steering Committee (with the NCI/ORMH member not voting), a second member selected by NCI/ORMH, 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. 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 subpopulations must be included in all NIH-supported biomedical research projects involving human subjects, unless clear and compelling rationale and justification is provided that the 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as subjects in Clinical Research", which have been published in the federal register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contract, Volume 23, Number 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted and supported by the NIH, unless that are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type I) 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html PREAPPLICATION MEETING The NCI/CMBB and the ORMH strongly encourage all potential applicants to attend a pre-application technical assistance workshop (TAW) on May, 12-13, 2000 in New Orleans, LA. Since this is an entirely 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://deainfo.nci.nih.gov/cmbs/index.htm. These results will be posted by July 1, 2000. In addition, NCI encourages pre-application consultations with individual partnerships either as telephone conference calls 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 at by email at kimesb@mail.nih.gov or by phone at (301) 496-8537. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit by June 8, 2000, a letter of intent (LOI) that includes a descriptive title of the proposed CMI/CCP U54 partnership, address, and telephone number of the Co-Investigators, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which application may be submitted. 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 allow NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the program staff members listed under INQUIRIES by the letter of intent receipt date. APPLICATION PROCEDURES The following procedures apply to both the MSI application and the NCI Cancer Center(s) application: Applications are to be submitted using the Form PHS 398 (rev. 4/98) using the SUPPLEMENTAL INSTRUCTIONS provided below and at http://deainfo.nci.nih.gov/cmbs/index.htm on or before July 26, 2000. A Form PHS 398 application kit is available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Phone: (301) 710-0267; FAX: (301) 480-0525; Email: grantsinfo@nih.gov. Forms are also available on the following NIH website: http://grants.nih.gov/grants/funding/phs398/phs398.html NOTE: The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application and title "U54 CMI/CCP" must be typed on line 2 of the face page of the application form and the YES box must be marked. Type the RFA number on the label. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for the review. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. A cover letter must be attached to the application clearly defining the MSI or Cancer Center partner; this will allow the NCI to assemble the two applications as one package for peer review. Submit signed, typewritten originals of the of the cover letters, MSI application and the NCI-designated 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: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) As noted above the instructions for the Form PHS 398 do not entirely apply to the submission of a U54 CMI/CCP grant application. Accordingly, NCI strongly recommends that you follow the SUPPLEMENTAL INSTRUCTIONS below which have been adapted to accommodate the Form PHS 398 and the special needs of this U54 CMI/CCP RFA. These instructions include all of the information needed by peer reviewers of your applications. SUPPLEMENTAL INSTRUCTIONS 1. Face Page: Use page AA as instructed in the Form PHS 398. On line 1 provide a title that is representative of your partnership. This title should be the same for both the MSI application and the Cancer Center institution's application. For line 2 enter the title "U54 CMI/CCP " and the number beginning with RFA....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 page 2 of the Form PHS 398 and follow the instructions provided in the Form PHS 398. 3. Table of Contents: Organize the Table of Contents exactly as described below: Content Page Number Face Page Description, Performance Sites and Key Personnel Table of Contents Detailed Budget for Initial Budget Period: a. Administrative Core b. Planning and Evaluation Core c. Developmental Core Budget for Entire Proposed Period of Support a. Administrative Core b. Planning and Evaluation Core c. Developmental Core Budgets Pertaining to Consortium/Contractual Arrangements (e.g., more than one MSI/Cancer Center is involved) Biographical Sketches of Principal Investigator and the Co-Investigator (not to exceed two pages for each individual) Biographical Sketches of Key Professional Personnel of the MSI or Cancer Center (not to exceed two pages for each individual) Biographical Sketches of Program Steering Committee Members (not to exceed two pages for each individual) List of the participating members of the MSI or the Cancer Center Other Support of Principal Investigator, Co-Investigator and Key Personnel Resources Implementation Plan for the Partnership: a. Background and Objectives b. "Letter of Commitment" from the Institution or Cancer Center c. Chronological review of Planning and Priority-setting processes d. Scientific and Administrative Leadership e. Administrative Core f. Planning and Evaluation 1) Internal Processes 2) Program Steering Committee g. Proposed Pilot projects/programs to be supported with Developmental Funds h. Proposed Full projects/programs to be supported with Developmental Funds i. Proposed resources and infrastructure to be supported with Developmental Funds j. Proposed Recruitment to be supported with Development Funds k. Human Subjects l. Vertebrate Animals m. Consortium/Contractual Arrangements n. Intellectual Property o. Checklist 4. Detailed Budget for Initial Budget Period: Use DD (Form page 4) of the Form PHS 398 application kit. Separately break out the budget into three sections using different Page 4s as follows: a) Administrative Core; b) Planning and Evaluation Core; and c) Developmental Core. a) For the Administrative Core, denote the costs for personnel, supplies, travel etc. needed to provide administrative oversight, coordination and cohesion of the partnership. b) For Planning and Evaluation Core, delineate the costs separately for Internal processes (e.g., workshops, retreats, committees, seminar series, ad hoc consultants) and the Program Steering Committee. Internal processes should include the process for evaluating and prioritizing the use of developmental funds and the process for deciding which areas using developmental funds should continue or be discontinued. 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 who make presentations to partnership participants that relate to the objectives of the partnership and then serve as an ad hoc advisor in areas under development. c) For the Developmental Core, separately delineate the funds being requested for all Pilot projects/programs, Full Projects/programs, resources 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 page EE (Form page 5) of the Form PHS 398, break out the total budgets separately for Administration, Planning and Evaluation and Developmental Funds. Provide justifications for costs in future years only when there are specific items requested in future years that exceed standard cost-of-living increases. 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, the MSI or Cancer Center would have to serve as the primary grantee and subcontract costs would go to the other MSI or Cancer Center involved. 7. Biographical Sketches of the Principal Investigator and the Co-Investigator (not to exceed two pages). Use Form FF (Form page 6) of the Form PHS 398 and follow the instructions in the application kit. 8. Biographical Sketches of Key Professional Personnel of the MSI or Cancer Center (not to exceed two pages for each individual). Use Form FF as above. 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. 9. Biographical Sketches (not to exceed two pages for each individual) of Program Steering Committee Members other than the Principal Investigators of the MSI and Cancer Center and NCI/ORMH staff. Use form FF as above. 10. List all participating faculty/members of the MCI or the Cancer Center alphabetically by name. Include for each individual their degree, department affiliation or equivalent, and research or other interest (e.g., research area, training, education, or outreach). 11. Other Support: Use Page GG of the Form PHS 398 kit for the Principal Investigator, Co-Investigator and all other key professional personnel noted in item 8 above. 12. Resources: Using Page HH, follow the instructions in the Form PHS 398 application kit. 13. IMPLEMENTATION PLAN FOR THE PARTNERSHIP a. Background and Objectives: This section should be the same for both the MSI and the Cancer Center U54 applications. It should (1) discuss the general rationale for 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 research, research training, education and/or 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 and potential of the partners to work together evolves. b. Letter of Commitment: The MSI institutional leadership (e.g., Dean, President) and the Cancer Center leadership (e.g., Center Director, Dean) 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 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 Planning and Priority-setting Process: This section should be the same for both U54 CMI/CCP applications. This section is to provide to the reviewers of your application a clear indication that this partnership was derived from a careful planning and priority-setting process based on each partner's strengths and weakness 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: Briefly describe how the Principal and Co-Investigators were chosen in terms of their 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: (no more than 10 pages) Describe the leadership and specific functions of the administrative core to provide the necessary regular day-to-day oversight, coordination, support, and logistics 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: This section must be the same for each U54 application: 1) Internal Planning and Evaluation Activities: Document each internal planning and evaluation activity (e.g., steering committees, regular forums and seminars, workshops, retreats etc.) and include the individuals from the MSI and the Cancer Center who will be involved. This should include how the progress of the partnership will be reported to institutional leaders and the Cancer Center Director 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) Program Steering Committee: Not including the Co- Principal Investigators and the NCI/ORMH staff, 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 PARTS g., h., i., and j. 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. Proposed Pilot Projects/Programs: Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 in direct costs per year or continue for longer than three years, should be provided in the following format: 1. Title 2. Names of the Co-Leaders from the MSI and the Cancer Center 3. One paragraph abstract stating the objectives of the project/program 4. One paragraph describing how this pilot project/program relates to the overall priorities and objectives of the partnership as described in the Background and Objectives section above. 5. Detailed budget page for initial budget period using page DD from the Form PHS 398. 6. Biographical Sketches of Co-Leaders 7. Proposal (no more than two pages) 8. Describe what aspects of the pilot project/program will be conducted at the MSI and the Cancer Center 9. Human Subjects** **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 16 and 17 and 27-33 of the Form PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on pages 17 and 18 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 CMI/CCP, 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 CMI/CCP, to the NCI program director. h. Proposed Full Projects/Programs: Full Projects/Programs proposed for funding, which cannot exceed $250,000 in direct costs per year or continue for longer than three years, should be prepared in the following format: 1. Title 2. Names of the Co-Leaders from the MSI and the Cancer Center 3. One paragraph abstract describing the purpose and objective of the project/program 4. One paragraph describing how the project/program relates to the overall priorities and objectives of the partnership as described in the Background and Objectives section above. 5. Detailed budget for initial budget period using Page DD from the Form PHS 398. 6. Biographical Sketches of Co-Leaders 7. Proposal prepared in the same detail as any research, training or education grant proposal following the specific instructions, page limitations (no more than 25 pages) and guidelines provided in the Form PHS 398. **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 16 and 17 and 27-33 of the Form PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on pages 17 and 18 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 CMI/CCP, 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 CMI/CCP, to the NCI program director. i. Proposed 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: 1. Title 2. Co-Leaders from the MSI and Cancer Center who lead the activity 3. The experience of key technical personnel, if applicable, who will be responsible for the day-to-day operation. 4. Detailed budget for the initial budget period using page DD from the Form PHS 398 5. Budget for entire propose period of support using page EE from the Form PHS 398 6. Biographical Sketches of Co-Leaders 7. Description of the resource/infrastructure and how it will further the priorities and objectives of the partnership (no more than one page) 8. Commitment of space for the resource. 9. Justification for the location of the resource at the MSI, the Cancer Center or both. j. Recruitment: 1. Individuals who are known: a. Provide the Biographical sketch of the individual b. Describe how the individual fulfills the priorities and objectives of the partnership as described in the Background and Objectives section above c. Describe the nature of the position that provides the necessary stability (e.g., tenure track) and resources (e.g., space) to promote success. d. 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. 2. 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. 3. Budget: The budget can provide salary and start-up packages for new recruitment. Provide a five year budget plan that relates to the costs expected to be incurred by this grant in years 1 through 5 using page EE of the Form PHS 398 for recruitment and plans to incorporate these individuals into the permanent faculty of the MSI and/or the faculty/membership of the Cancer Center. k. Annual External Evaluation of Progress: This planning activity is required to use a Program Steering Committee (PSC) shared by the MSI and the Cancer Center to evaluate annual progress. An NIH or NCI staff person must be voting members of this committee. Each year a written report must be submitted to the NCI that summarizes the PSC’s evaluation and its recommendations for improvement. This section will be the same for the MSI and the Cancer Center grant applications. Describe the expertise of the individual external advisors and the rationale for their selection as a group that can effectively evaluate this activity relative to its objectives and provide recommendations for mid- course corrections as necessary. l. Human Subjects: Follow the directions and instructions provided in the Form PHS 398 application kit. m. Vertebrate Animals: Follow the directions and instructions provided in the Form PHS 398 application kit. n. Intellectual Property - See instruction in the Form PHS 398 application kit. 14. Checklist - See instruction in the Form PHS 398 application kit. 15. Appendix Materials REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR 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 application without further consideration. Applications that are complete and responsive to the RFA will be evaluated by the 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 application 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 receive a written critique but only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board (NCAB). Both 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 can 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. 1. General Features: a. Strength of the evidence that MSI and the Cancer Center established priorities and objectives for implementation after a careful and thorough planning process and that they worked closely together in the preparation of these applications. b. Strength of the evidence that the MSI and the Cancer Center have clearly identified the mutual benefits to be gained from this partnership. c. Feasibility of achieving the priorities and objectives for this partnership within the five-year grant period. d. Degree to which this implementation plan, if fully successful, will result in a stable cancer research capability for the MSI and/or result in the significant, successful training of more minority cancer researchers. e. Degree to which this implementation plan, if fully successful, will enhance the ability of the Cancer Center through research and/or training and education and/or outreach to more directly and successfully address the disproportionate incidence and mortality rates in minority populations. Those applications satisfying the criteria listed under General Features will be evaluated according to the following criteria. Each criterion includes additional guidance to reviewers. 2. Scientific and Administrative Leadership: The adequacy of the qualifications and experience of the Co-Investigators from the MSI and the Cancer Center to provide strong programmatic (e.g., scientific) and administrative leadership. 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. 3. Letters of Commitment from the MSI and the NCI-designated Cancer Center: The degree to which the letters of commitment from the MSI and the Cancer Center address and fully support the priorities and objectives of the implementation plan of the partnership. 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. Adequacy of the plans to remain responsible and accountable for monitoring and sustaining the priorities and objectives of this partnership. If applicable, 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. 4. Administrative Core: The quality of an appropriate organizational and administrative structure for effective attainment of U54 CMI/CCP 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 logistic services, contractual agreements, (if applicable), and internal communication among investigators. The qualifications, experience and commitment of Co-Investigators and key personnel in the services provided by the administrative core unit, as well as their ability to devote the required time and effort in providing services. The appropriateness of the use of the administrative core services by the budgeted activities and projects/programs. 5. Planning and Evaluation Activities: The adequacy of the design of and quality of each of the internal planning and evaluation processes proposed to achieve the objectives and priorities of the implementation plan. 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. The appropriateness and adequacy of the specific faculty and others identified who will participate together in each aspect of the planning and evaluation effort. 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. 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. 6. Method of Evaluating and Prioritizing the Use of Developmental Funds: 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. The adequacy of the criteria used for selecting pilot/full projects, pilot/full programs, recruitment etc. for funding based on their merit and their potential to meet the proposed priorities and objectives of the partnership. The adequacy of the evidence based on any specific pilot/full projects, pilot/full programs, recruitment, etc. proposed for support with Developmental Funds that the process for allocating developmental funds works effectively. 7. Proposed Pilot Projects/Programs: The qualifications of the Co-Leaders from the MSI and the Cancer Center to develop the project/program. The merit of the Pilot Project/Program, and the degree to which it contributes to the priorities and objectives of the partnership. Potential to develop into a Full project/program in three years or less. The options will be either to recommend support at the recommended budget levels or to recommend no support because it has either: a) low merit; b) low relevance to the objectives of the partnership and/or c) low potential to develop into a Full project/program. 8. Proposed Full Projects/Programs: The qualifications of the Co-Leaders to conduct the project/program as proposed. The merit of the Project/Program and the degree to which the project will fulfill the priorities and objectives of the partnership. The potential to become a competitively funded project (e.g., R01, T32, R25) in three years or less. The options will be either to recommend support at recommended budget levels or to recommend no support because it has either: a) low merit; b) low relevance to the objectives of the partnership; and/or c) low potential to become funded through competitive peer review. 9. Proposed Resources/Infrastructure: (if applicable) The degree to which the proposed resource/infrastructure proposed will contribute to the overall priorities and objectives of the implementation plan. 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 and potential future funded grants. The qualifications of key personnel to operate the resource/infrastructure activity, and the merit of the resource as proposed. The options will be either to recommend support either at the recommended budget levels, 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: a) low merit; and/or b) low relevance to the objectives and priorities of the partnership. 10. Proposed Recruitment: (if applicable) The quality of each specific individual recruitment proposed relative to background and ability to contribute substantially to strengthening areas of high priority to the implementation plan. 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. 11. Evaluation of Progress by Program Steering Committee: The adequacy of the expertise and qualifications of each of the Program Steering Committee members to provide appropriate evaluation and advice and recommendations for making mid-course corrections based on the objective of this planning effort. The adequacy of the plan for using the Program Steering Committee effectively. 12. Intellectual Property: (if applicable) 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. 13. Other Considerations: The initial review group will also examine: the appropriateness of the proposed budgets and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. Overall Evaluation and Scoring of Application: 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 extent to which the MSI and Cancer Center applications together satisfy the General Features above (i.e., overall intent of this initiative). 2. Taken together, the quality of the individual sub-components as proposed in the MSI and Cancer Center U54 CMI/CCP applications. AWARD CRITERIA Each set of two applications from an MSI and a Cancer Center will compete for funds with all other partnerships in response to this RFA. Applications recommended by the NCAB will be considered for award based upon (a) scientific and technical merit as determined by peer reviewers; (b) the program priorities of the NCI and the ORMH; and (c) availability of funds. SCHEDULE Preapplication Meeting Date: May 12-13, 2000 Letter of Intent Receipt Date: June 8, 2000 Application Receipt Date: July 26, 2000 Peer Review: October/November, 2000 Review by NCAB: February, 2001 Earliest Anticipated Award Date: March 1, 2001 NON-COMPETING CONTINUATION APPLICATION For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Application or Progress Reports each year. INQUIRIES Written, telephone, fax and e-mail inquiries concerning this RFA are encouraged especially during the planning phase of these applications. Below is a listing of program (i.e., scientific management), grants administration (i.e. fiscal management) and review (i.e., management of peer review process) staff of the National Cancer Institute who are available to for inquiries: Direct inquiries regarding scientific or programmatic issue to: Sanya A. Springfield, Ph.D. Chief, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 700 Bethesda, MD 20892-8347 Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: springfs@mail.nih.gov Or Brian Kimes, Ph.D. Director, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 700 Bethesda, MD 20892-8347 Telephone: (301) 496-8537 Fax: (301) 402-0181 Email: kimesb@mail.nih.gov Direct inquiries regarding fiscal or budget matters to: Ms. Barbara Fisher Grants Management Specialists National Cancer Institute 6120 Executive Blvd. EPS/243 Bethesda, MD 20892 Telephone (301) 496-8626 Email: Bf18m@nih.gov. Direct inquiries regarding review matters to: Ms Toby Friedberg Referral Officer Division of Extramural Activities 6116 Executive Boulevard, Room 8062, MSC 8239 Rockville, MD 20852 (express service) Bethesda, MD 20892-8239 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398, Cancer Research Manpower. 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 and Federal Regulations 42 CFR Parts 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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