Full Text CA-94-029 PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS NIH GUIDE, Volume 23, Number 31, August 19, 1994 RFA: CA-94-029 P.T. 34 Keywords: Cancer/Carcinogenesis Biomedical Research, Multidiscipl National Cancer Institute Letter of Intent Receipt Date: September 29, 1994 Application Receipt Date: November 29, 1994 PURPOSE The Cancer Centers Branch (CCB), Division of Cancer Biology, Diagnosis and Centers (DCBDC), National Cancer Institute (NCI) announces the availability of planning and development grants for cancer centers in underrepresented areas of the nation. This initiative provides applicant institutions with the opportunity to either initiate or continue their planning and development activities toward this goal. The overall intent of these grants is to further assist eligible institutions to develop the organizational capability that will lead to the formation and/or development of cancer research centers. The ultimate goal of this Request for Applications (RFA) initiative is to encourage the development of cancer research centers in geographic areas that are currently not served by existing NCI-designated clinical or comprehensive cancer centers. In addition to basic cancer research, these new centers should plan to emphasize clinical and prevention/control research that will ultimately impact on the populations in their regions, paying particular attention to minority, rural, and other underserved populations. It is anticipated that after completion of these planning and development grants, recipient institutions will be in a position to compete for Cancer Center Support Grants (CCSG) from the NCI. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Planning Grants for Prospective Cancer Centers, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by the following institutions: 1) Domestic medical research organizations, public and private such as universities, that fulfill the following requirements and that do not currently have a Cancer Center Support Grant (CCSG) (P30) Planning Grant for Prospective Cancer Centers and (P20); 2) Institutions that currently hold a P20 Planning Grant for Prospective Cancer Centers, but have not yet developed their research base to be eligible to apply for a CCSG. Applicant institutions must intend to develop cancer research centers that, define at a minimum, will have a strong basic research and clinical research foundation, and will develop or include prevention and control research in their long-term objectives. Eligible institutions must come from states that do not currently have an NCI-designated Comprehensive, Clinical, or Consortium Cancer Center. The NCI will also consider accepting applications from other institutions if they are located outside of the regional service area of an existing Comprehensive, or Clinical Cancer Center. In addition, eligible institutions must have three or more externally funded, peer-reviewed, cancer research project grants or contracts (e.g., R01, P01, N01, U01), or equivalent types of research projects. The Cancer Centers Branch in its 1992 "Guidelines for Cancer Center Support Grant," established the bases for identifying funded peer-reviewed cancer research projects. This is the standard that will be followed in determining eligibility of institutions to apply for a planning grant. Eligible institutions may request up to three years of support under a planning and development grant to develop the institutional capability to form a successful cancer research center of excellence. Institutions that already have a fully established organizational capability as a cancer center and a sufficient peer-reviewed cancer research base of $1.5 million dollars or greater in cancer specific research (See 1992 "Guidelines for Cancer Center Support Grants") are not eligible under this program. Potential applicants are strongly advised to contact NCI program staff listed under INQUIRIES , to discuss eligibility requirements prior to preparing an application. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory grant mechanism (P20). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in the RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH 90-50,000, revised October 1, 1990) This RFA is a one-time solicitation. The earliest feasible start date for the initial awards will be July 1, 1995. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. FUNDS AVAILABLE Approximately $750,000 in total costs per year will be committed specifically to fund applications submitted in response to this RFA, but no single institution may apply for more than $175,000 in direct costs (See Review Criteria). It is anticipated that three to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high merit. The total project period for applications submitted in response to the present RFA may not exceed three years. RESEARCH OBJECTIVES Background The Cancer Centers Program was developed in the late 1960s and was formally authorized by the National Cancer Act of 1971. The language of the Congress indicated that the NCI should develop an expanded Cancer Centers Program of both comprehensive and specialized types that would "be expected to perform fundamental research in clinical and basic science disciplines; take the lead in planning and coordinating organ site programs; develop the special competence of each individual center; serve as focal points for testing and evaluating outputs of the research and development efforts; and couple the output of the cancer research efforts to medical practice." In the last ten years, legislative language has repeatedly stressed the need for cancer centers to develop research compatibility in the area of prevention and control. The Cancer Centers Program of the NCI currently supports multidisciplinary cancer research centers in a variety of institutions through Cancer Center Support Grants using the P30 grant mechanism. These NCI-designated cancer centers are responsible for implementing a major portion of the National Cancer Program in all aspects of cancer research, including basic, clinical, control, and prevention. These research activities favorably impact on the cancer treatment, control, prevention, and other adjunct service functions that are associated with clinical and comprehensive cancer centers. NCI-designated Cancer Centers provide the national standards of excellence in cancer detection, diagnosis, treatment, rehabilitation, prevention, control, and continuing care. Additionally, they serve as major resources for health professionals and the public in their regions. Although the cancer research programs of NCI-designated Cancer Centers are independently funded through a variety of peer-reviewed grants and contracts from NIH and other funding sources, the Cancer Center Support Grant (CCSG) undergirds these research activities by providing core support through partial funding of shared research resources that provide cost-effective access to sophisticated equipment, state-of-the-art technologies, and essential services. The CCSG also supports central administrative expenses, partial salary support for the center's senior leadership and other key research personnel, the recruitment of key new members to the center, and the exploration of new research opportunities. These functions, as well as detailed application information, are described for the Cancer Center Support Grant in "Guidelines: Cancer Center Support Grants (1992)." This document is available from Cancer Centers Branch DCBDC/NCI. To be eligible to apply for a CCSG, a prospective applicant must have a minimum amount of peer reviewed cancer research. (currently, $1,500,000 in direct costs) Since the passage of the National Cancer Act, Congress has emphasized in legislative language the need for better geographic distribution of NCI-designated cancer centers around the U.S. A majority of funded NCI designated Comprehensive, Clinical, and Consortium Cancer Centers are located on the east and west coasts and around the Great Lakes, which reflects both the U.S. population density and the locations of medical research centers. Nonetheless, there are medical institutions existing in currently under-represented areas that have sufficient peer-reviewed cancer research and could provide the base for developing cancer research centers. However, the planning and development process requires a significant investment of institutional resources; this may have prevented some institutions from exploring the possibility of forming a new cancer center. This RFA, like the previous RFA (RFA CA-91-15) published in 1991, is designed to encourage qualified institutions to make the investment necessary to establish a cancer research center. Detailed planning and development is crucial to the formation of a new cancer research center with a broad range of research capabilities (i.e., basic, clinical, and prevention and control research). Since a new cancer center must be an entity that has its own distinct administrative identity and a measure of autonomy, it may need to be 'created' within the parent institution, which is often a complex process. The goals of the new center must be clearly defined. Space and personnel must be dedicated to the cancer center. The center must have distinct multidisciplinary and interdisciplinary cancer research programs. These programs may need to be developed and members recruited from within and outside the parent institution. In addition, specific central research resources must be identified for inclusion or development as part of the cancer center. Finally, the parent institution must give tangible support to the new center. These planning elements are based on the recognized essential characteristics of a cancer center as described in the CCSG guidelines mentioned above. The essential characteristics of cancer centers include: (a) adequate commitment of the parent institution that recognizes the center as a major organizational element of the institution; (b) appropriate and adequate organization; (c) availability and configuration of facilities devoted to the cancer center to facilitate the research and other activities of the center; (d) a qualified and effective director with adequate authority over appointments, space, equipment, and identifiable clinical research facilities to ensure smooth and effective coordination; (e) clear cancer research focus and intent; and (f) coordination of interdisciplinary and translational research activities. The intent of this RFA is to provide support to new institutions that need time and resources to develop their centers in order to meet the essential characteristics of an NCI-designated cancer center and/or to expand their research base. A successful implementation of this RFA will allow a larger proportion of the U.S. population to have direct access to the most up-to-date cancer research, education, and care through these regional research centers of excellence. Goals and Scope The primary goal of this RFA is to provide support to those institutions that wish to develop the organizational capability that will lead to the formation and/or development of new centers of cancer research excellence in underrepresented geographic areas in the United States. Applicants must demonstrate their potential and/or actual progress toward fulfilling the essential characteristics and obtaining the required research base. Ultimately, the development of these centers should provide wider access of regional populations to the benefits of state-of-the art clinical and prevention and control research. It is anticipated that these new centers, after completion of the planning and development effort, will be in a position to compete for NCI cancer center designation through submission of a CCSG application. The Planning and Development Process A. Definition of the planning and development effort The planning process involves identification of and the proposed methods for achieving, goals and objectives that together will provide the research capability, the organizational structure, financing, and facilities needed for the cancer center. These objectives should take into account the following considerations: 1. The identification of the special problems that need to be resolved in order to develop a competitive cancer research center. Plans and contingencies should be noted. 2. The overall objectives and purposes of the parent institution. The development of a cancer research center should be compatible with the long-term goals and objectives of the parent institution and its leadership. 3. The identification of the specialized needs of the institution's geographic area and its populations that can be addressed through research. The special needs of the center's region or service population, especially as they relate to cancer incidence, mortality, and survival must be strongly considered in the development of research programs. Research programs are included in a CCSG application. These same considerations influence the development of the education, outreach, and service programs of the center. Such programs are not included for support in a CCSG application, but are clearly a significant aspect of any cancer center desiring to have an impact on its region. 4. The effect that the establishment of a cancer-oriented center will have on the internal structure or organization of an institution. Cancer centers must actively promote multidisciplinary research and service activities which transcend and work effectively across traditional academic departments and disciplines. Consideration of the administration and organization of the center and its relationship to other organizational elements within the parent institution is critical to the planning process as are scientific, clinical, and technical considerations. For example, the center, to be effective, should have its own administrative identity within the parent institution and should have, at a minimum, equivalent status to academic departments. 5. The level of commitment and resources the parent institution can provide a new cancer center. The development of a cancer center requires substantial institutional investment in areas such as facilities, staff, administrative reorganizations, and financial resources. A realistic view of the potential resources that could be made available on a regular, stable basis to the new center is needed if the goals and objectives of the institution are to be achieved. 6. Definition of the interactive and translational research activities to be included in the new center is at the heart of the cancer center concept. Multidisciplinary research 'programs' must be defined in terms of the current research activities and new research activities that must be added to the center in order to give it greater balance and effectiveness. However, the center must also consider how it will capitalize on its unique capabilities and opportunities. The usual structural elements of the cancer research activities at a center include multi-disciplinary research 'programs,' shared resources for peer-reviewed research, and administrative support services. 7. The relevance of the center to the mission of the National Cancer Institute. All of the above must be considered with respect to how the planned activities of the cancer center are compatible with the mission of the NCI. B. Elements of a planning and development effort The following elements are essential in the planning and subsequent development of a cancer center: 1. Planning director. A senior level person competent in scientific administration must be assigned the responsibility for directing the planning and development effort. This person must devote a significant proportion of his/her time to this endeavor. The planning director will be the Principal Investigator of the planning and development grant. It is both customary and desirable that the planning director be the director of the new center. 2. Planning and advisory committees. An internal planning committee must assist the planning director. Committee members should be selected from within the institution that is developing the center. Additional members from the community can also be selected where appropriate. This committee is responsible for evaluating scientific, medical, institutional, and regional considerations and should ensure that all available resources and research opportunities are considered in the planning process. It may be advisable for all elements of the institution affected by the center to be represented on this committee. In addition, an external advisory group, consisting of senior individuals who can contribute to or are familiar with the functions and organization of NCI-designated cancer centers, should be convened periodically to give the planning director insightful advice on the development of a cancer research center as well as unbiased and independent assessments of the new center's progress in achieving its objectives and goals. 3. Research program definition and implementation. The cancer research programs that will comprise the cancer center should be defined in terms of their leadership, relevance to the cancer problem, productivity, individual membership (present and future), peer-reviewed grant/contract research base, space needs and utilization, and availability of patient resources for clinical research (if applicable). The research programs must be multidisciplinary in nature and may focus on basic, clinical, and prevention and control investigations. They should build on the current strengths of the institution. Their definition and its subsequent implementation must also include consideration of local, regional, and national needs. 4. Shared resources. It is important to identify and establish shared resources that will best support the peer-reviewed research projects of the center programs. 5. Definition of the relationship of research activities to patient care, education, and other outreach activities of the center. The relationship between the center's research activities and the patient care, education (both professional and lay), community outreach, and other activities of the center must be defined. Mechanisms must be developed so that the results of cancer research performed at the center and elsewhere can impact quickly and positively on the populations served by the center in its geographic area. Such translational activities are a fundamental aspect of a cancer center. 6. Description of the use of developmental funds. Developmental funds can serve to stimulate the planning and implementation of the center through careful allocation of "seed monies" or recruitment monies in areas of particular need or importance to the center. STUDY POPULATIONS 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 and behavioral research involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guide for Inclusion of Women and Minorities in Clinical Research", which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513), to correct typesetting errors in the earlier publication, and reprinted in the NIH Guide for Grants and Contracts on March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from the sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are requested to submit, by September 29, 1994, a letter of intent that includes a descriptive title of the proposed cancer center, the name, address, and telephone/fax number of the planning director, the names of other key personnel, the participating institutions, and the 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, it is requested in order to provide an indication of the number and scope of applications to be reviewed. This advance information provides you with an opportunity to work with NCI program staff with regard to the policies and guidelines of the Cancer Centers Program before you submit your application and ensures that the NCI review staff will have the lead time to assemble highly qualified group of peer-reviewers. Prospective applicants are strongly encouraged to contact the NCI staff listed below before the submission of a letter of intent and/or an application. Such contact is advantageous to the prospective applicant because it will start a dialogue with the NCI staff where issues such as eligibility requirements and application procedures may be discussed. The letter of intent is to be sent to J. Blanche O'Neill at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/710-0267; and from the NCI Program Director listed under INQUIRIES. Before submitting the application, affix the RFA label in the application form PHS 398 to the bottom of the face page. 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 number and title must by typed on line 2a of the face page of the application form. Submit a signed, typewritten original of the application (without appendices), including Checklist, and three signed, exact, clear, and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 (If hand-delivered or delivery service) Bethesda, MD 20892-7148 (If using U.S. Postal Service) It is important to send these copies at the same time the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the application will be reviewed in competition with other applications received on or before the designated receipt date. Appendix materials should be retained by the applicant until specifically requested by NCI staff. Five copies of the appendices will be requested. Applications must be received by November 29, 1994. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to another grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. Complete information about the proposed planning and development effort must be submitted with the application. Follow the instructions in form PHS 398 where appropriate. However, the form PHS 398 was developed for research grant applications. To provide the required information, the following supplemental instructions must be used to prepare the application. It is also advisable for the prospective applicant to examine the review criteria for these applications, described in the section "Review Criteria," below. The narrative portions of the application, sections I, II, III described below, must be limited to fifty pages of text or it will be returned without any further action. The application must be a complete document that includes all essential information necessary for its evaluation. Additional explanatory material may be submitted as appendices. There is no page limitation on appendices. However, appendices should not be used to bypass page limitations in the application because only selected reviewers will receive copies of the appendices. The application should be prepared using the standard PHS 398. List the planning director as the Principal Investigator of the application. The planning director should be the primary author of the application. The application should contain the following elements: Narrative Descriptions and Supporting Documents Include the following sections on the form PHS 398 continuation pages: Section I. THE NEW CENTER AND THE PROPOSED PLANNING AND DEVELOPMENT EFFORT: (A) Description of the current or planned cancer center. Discuss the institution's concept of a cancer center. List and discuss proposed short-term and long-term goals and objectives of the center. These goals must include cancer research objectives (such as basic, clinical, and/or prevention research) appropriate for the institution as well as goals designed to translate the results of the research into improved patient care, prevention, control, education/ information, and other activities of the center. This discussion must include references to the proposed relationship between the center's research activities and its goals for its community and geographic region, making special reference to opportunities related to minority and other special populations (see Section III below). The special significance of the new cancer center to the institution and its relationship to other existing centers or comparable entities should be addressed. Also, the relationship of the center to other existing programs funded by the NCI in its region should be discussed (see Section III for examples). (B) Description and discussion of progress to date toward attaining the goals and objectives of the center. Discuss the history of the new center and its current strengths. Describe the evolution of the relationship between the parent institution and the center. Describe the benefits the local community and region have received or will receive from the center. Discuss the level of progress that has been made toward achieving the short- and long-term goals of the center. Discuss whether the center is at a preliminary or advanced stage of development in terms of its eligibility to apply for a CCSG grant. (See 1992 "Guidelines for Cancer Center Support Grants"). (C) Description of the Planning Director and his/her responsibilities and authority to carry out the proposed planning and development process. Discuss the selection of this individual as planning director and his/her future role in the center. If the planning director is not the current center director or the director designate of a new center, discuss the status of the institution's search for a permanent director. The planning director is considered to be the pivotal person responsible for implementing the planning and development effort. It is essential that this section adequately present his/her scientific qualifications and administrative experience as well as the formal authorities of the planning director that will enable him/her to guide the formation and development of a new center during its formative stage. (D) Description of planning and advisory committees. List the membership of the internal planning committee and the center director's external advisory committee. Discuss the selections for the committees. Each of these advisory groups will have different, but important, roles in the development of the center. Thus, it is critical that their duties and responsibilities be clearly described in the application. (E) Description of other key personnel and their duties. Discuss the selection and duties of the key personnel for the planning effort. Describe the key personnel's current positions in the parent institution. Describe their role in the planning and development process and their current/future responsibilities in the cancer center. (F) Description of issues at the parent institution that will need to be resolved through the planning and development process. Discuss the major issues and obstacles that must be considered in the planning and development process. Examples of such issues are an adequate cancer research base and implementation of the six essential characteristics of a cancer center (see (H) below and/or the CCSG guidelines). (G) Describe how award of this planning and development grant to your institution will help resolve the issues listed in (F) above and aid in the development of the center. Describe how other institutional resources will be combined with the planning grant to achieve overall objectives. (H) Detailed description of the planning and development proposed. Include, where appropriate, discussions of plans to: 1. attain the necessary peer-reviewed cancer research base relative to the current research base; 2. implement the essential characteristics of cancer centers: a. institutional commitment, b. appropriate organizational capability c. appropriate facilities, d. center director with adequate authority, e. a cancer research focus and f. interdisciplinary coordination and collaboration; 3. identify multidisciplinary basic, clinical, and prevention and control research programs that are or would be included in the center; 4. identify appropriate staff from the parent institution for center membership and areas where additional recruitment is necessary; 5. identify shared research resources for inclusion or development by the center and the research capability of the center; 6. address the efforts needed to develop appropriate long-term, productive relationships with the parent institution and with departments and/or other centers within the institution. Section II. THE PARENT INSTITUTION'S RESEARCH BASE, ENVIRONMENT, AND RESOURCES: (A) Current cancer research activities and publications. Discuss whether all peer-reviewed cancer research projects located at the parent institution (listed in Section IV (B) below) will be associated with the cancer center. If not, explain. Describe plans to expand the peer-reviewed grant/contract base. (B) Description of the parent institution. Discuss the environment of the parent institution and its suitability for attracting appropriate research expertise. Describe the institutional officials who will be associated with and support the proposed center and the planning effort, the experience of the institution with developing similar centers or programs, and the effect that the new cancer center will have on other programs and centers at the institution. Include discussions of the history of cancer research activities, access to appropriate patient and client populations, special programs to include women and minorities in clinical trials, local referral patterns, community interactions, financial resources, appropriate current or proposed facilities, and organizational capabilities. (C) Description of the resources that will be allocated by the institution to the new center during and after the proposed planning and development effort. Discuss the space, personnel, administrative, financial, and other resources that have been allocated and are planned to be allocated to the new or developing center. For example, the applicant may describe institutional payment of part of the salaries of staff involved in the planning effort, seed money to help start new cancer research projects or new shared resources, and funds for the recruitment of new scientific and support staff for the center. Section III. THE IMPACT OF THE NEW CENTER ON ITS GEOGRAPHIC AREA AND ITS POPULATIONS: (A) Description of the parent institution's current relationship to and recognition within its geographic area. Discuss the resources related to cancer that the institution currently provides to its region. (B) Discussion of the need in the institution's geographic area for an NCI-designated cancer center. Discuss how the region is underserved from the perspective of the linkage of high quality cancer research with patient care, prevention, control, and other activities. Describe the potential impact of the new center on its region. Discuss how new research programs initiated through the center would ultimately benefit the populations in its area. Discuss special problems of the region as they relate to higher incidence and mortality rates of certain cancers and to special populations and minorities. Describe how the potential cancer center can address these problems through its research programs. (C) Description of the potential relevance of the new center to other programs of the NCI that already exist or could be implemented in its region. Examples of such programs are national cooperative groups, cancer information service (CIS), drug discovery groups, and the community clinical oncology program (CCOP). Section IV. ESSENTIAL SUPPORTING DOCUMENTS: (A) Biographical sketches of the planning director and other key personnel. Use forms provided in the form PHS 398. These sketches are limited to two pages. (B) Peer-Reviewed Research Grants and Contracts. This is a list of the research base of the center and additional to page GG of the PHS 398 form. List the currently active, peer-reviewed, research grants and contracts that will be included as the existing research base of the center at the parent institution. The Cancer Centers Branch has defined peer-reviewed cancer research projects in the 1992 "Guidelines for Cancer Center Support Grants." Each entry for a peer-reviewed research project on the list should include the Principal Investigator, his/her percent effort on the project, funding agency, I.D. number, title, total grant period, and current year's direct cost award. Other sources of support that contribute to the overall research capability of the center (e.g., cancer development awards, training grants) may be listed. This must be a separate listing. (C) Bibliography. Provide a bibliography of cancer research publications from the parent institution during the previous three years. (D) Letters or statements from senior officials of the parent institution documenting their support for the proposed planning and development process. These documents must include a description of substantive actions by the parent institution to promote the development of a center, e.g., the commitment of space and funds, recruitment packages, funds to the programs, as well as substantive authority to the planning director, who will provide scientific and administrative leadership during the planning period. B. Allowable Budget Items Allowable budget items for these planning and development grants are limited to a portion of the salaries of the planning director (Principal Investigator), key scientific personnel, administrative and clerical support personnel, travel and per diem expenses for outside advisors (the use of commercial consultants is discouraged), supplies, travel expenses for the planning director or other key personnel, and other justifiable operating expenses of the planning effort. The level of effort of personnel on this grant should reflect the commitment of the individual to the planning and development process although the salaries may be paid in part from other sources (these other sources must be described). In addition, developmental funds may be requested up to a maximum level of $35,000/year. If developmental funds are requested, it must be entered in the composite budget on page 4 of the PHS 398 form as a line item under other expenses. A detailed budget for the potential uses of developmental funds must be provided on a separate budget page and fully justified. These developmental funds may be used by the planning director to help recruit new scientific staff to the center, to support pilot studies that will help expand the peer-reviewed research base of the center, and to initiate new shared resources that will be needed by the center. Developmental funds may not be used for major equipment purchases. All budget items must be justified in terms of their support of the planning and development process. Budget requests for applications submitted under this RFA must not exceed $175,000 direct costs per year. In addition, unless otherwise noted, allowable costs and policies governing the research grant program of the NIH will prevail. Overlapping support between the planning and development grant and other NIH grants and contracts to the applicant institution will be administratively reviewed and, if appropriate, adjustments will be made to avoid duplication of funding. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG staff and responsiveness by NCI staff. Incomplete and 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 NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Questions concerning the relevance of proposed work to the RFA may be directed to program staff listed under INQUIRIES. The second level of review will be performed by the National Cancer Advisory Board. This Board considers the special needs of the NCI and the priorities of the National Cancer Program. Review Criteria Applications will be assessed in three general areas: (1) the technical merit of the proposed planning and development process; (2) the institutional commitment and environment; and (3) the potential of the proposed center to enhance its impact on the quality of patient care, prevention, control, and related activities in its geographic area. Peer- reviewers will be asked to specifically comment on these three areas. An unacceptable evaluation in any one of these review categories can be grounds for Not Recommended For Further Consideration of the application. The final priority scores will reflect the peer-reviewers' overall assessment based on their judgements of the three review areas. Below are the specific criteria that will be used by the peer-review group in the evaluation of these three major areas. 1. The technical merit of the proposed planning and development process. If the application is a renewal, the application should stress the progress that has been made during the past grant period, making specific reference to the previous summary statement as needed. If the application is new, emphasis should be placed on the potential for these investigators and the proposed activities to form a viable center. a. Clarity and appropriateness of the goals and objectives of the new or proposed cancer center; the extent to which the proposed concept of a cancer center is consistent with the concept of cancer centers as illustrated by the 1992 "Guidelines for Cancer Center Support Grants"; b. Extent to which the application appropriately defines the problems that need to be resolved to achieve the formation or development of a center of cancer research excellence; c. Extent to which the proposed detailed planning and development effort has clear and appropriate plans and is of adequate scope with regard to important issues including: (1) Adequacy of the peer-reviewed cancer research base; identification with the parent institution of independent investigators in basic, clinical, prevention, and control research who will be important in providing the leadership necessary to develop multidisciplinary cancer research programs; identification of shared resources that will be important for multidisciplinary research programs for inclusion or development in the center; (2) Progress toward implementing or the potential to implement the six essential characteristics of a cancer center: institutional commitment, organizational capabilities, adequate facilities, center director with adequate authority, progress toward and potential for developing an appropriate cancer research focus, and interdisciplinary coordination; (3) Progress and/or plans to develop the appropriate leadership, stable research infrastructure, and administrative capacity within the parent institution, paying special attention to the status of the cancer center relative to other organizational components (e.g., departments, other centers); d. Qualifications of the proposed planning director to lead the planning and development effort, his/her leadership experience and scientific background, and the adequacy of the director's authority from the institution with respect to recruitment, staff appointments and promotions, space allocation, fiscal and administrative responsibilities, and review and direction of the planning effort; e. Potential effectiveness of the planning director's external advisory committee in assisting the director in planning the center; the appropriateness of the proposed membership and stated functions of this advisory group; f. Appropriateness of the membership and stated functions of the proposed internal planning committee to assist the director in the planning and development effort; g. Qualifications and appropriateness of the key personnel designated to assist the planning director; the potential of listed key personnel to become senior leaders or major program leaders in the new center; h. Adequacy of the applicant's consideration and assessment of such factors as the utilization and need for space, staff recruitment, availability of patients for research, patient referral patterns in the community, and financial planning; i. Current level of progress of the new or proposed center toward realization of its objectives; if the applicant is at an advanced stage of development, consideration should be given to whether a planning and development grant is appropriate or whether the applicant should directly apply for a CCSG. 2. Institutional commitment and environment. If the application is a renewal, the applicants should stress the progress that has been made during the past grant period; making specific reference to the previous Summary Statement as needed. If the application is new, emphasis should be placed on the potential for these investigators and the proposed activities to form a viable center. a. Adequacy of the institution's commitment to cancer research; include an evaluation of the plans to expand the peer-reviewed cancer research grant/contract funding base through appropriate recruitment, encouragement of existing faculty, and other appropriate measures; b. Evidence for a substantial institutional commitment to the cancer center planning and development effort in terms of space, personnel, organizational, and financial resources that have been allocated to the effort; c. Adequacy of the administrative, organizational, and management capabilities and the facilities of the applicant institution; and d. Adequacy of the environment of the applicant institution with regard to its ability to recruit qualified scientists that will enhance the center's multidisciplinary research capability, the track record of the institution in developing similar programs in other fields, if any, the potential for adequate continuity of institutional commitment for the center, and the potential effect of the new cancer center on other programs within the institution. 3. The potential of the proposed center to enhance the level of cancer research in its region and, ultimately, to enhance the impact of that research on the quality of patient care, prevention and control, and related activities in its geographic area. If the application is a renewal, the applicants should stress the progress that has been made during the past grant period; making specific reference to the previous Summary Statement as needed. If the application is new, emphasis should be placed on the potential for these investigators and the proposed activities to form a viable center. a. Extent to which the institution's geographic area is underserved by high quality cancer research that is effectively linked to patient care, prevention, control, and other activities; the role in cancer already played by the institution within its community and region; b. Proposed role and potential impact of the new cancer center in its geographic area; a demonstrated understanding of the cancer incidence and mortality rates in the region, especially with regard to minorities and special populations; the adequacy of proposed mechanisms to move the results of research into improvements of cancer treatment, prevention, control, education, and other activities that will benefit the center's local community and region. c. Potential relevance of the new center to other NCI programs (e.g., national cooperative groups, cancer information service, and the community cancer oncology program) that already exist or could be implemented in its geographic area; d. Extent to which award of a planning and evaluation grant will enhance the ability of the institution to form and/or develop a cancer center that will benefit its region; In the overall evaluation, the appropriateness of the proposed multi-year planning and development effort to allow the new cancer center to reach a level of excellence that would be comparable to current NCI-designated cancer centers will be considered. The review group will recommend an appropriate budget for each rated application. Requests for equipment and commercial consultants are discouraged and, if present in an application, such requests will be highly scrutinized. AWARD CRITERIA The anticipated date of award is August 1, 1995. Grant applications recommended for approval by the National Cancer Advisory Board and selected for funding will be negotiated by the NCI staff with the applicant institution. A Notice of Grant Award will summarize the results of the negotiations. Award of funds for the approved future years of the grant will require the submission of a noncompeting continuation application, form PHS 2590 (rev. 10/88) at least two months prior to the anniversary date of the award. As with research grants, interim and terminal progress reports must be submitted to the NCI in accordance with the current PHS Grants Policy Statement. The interim progress reports will be a part of the non- competing continuation application and should include the following information: (a) a brief statement and critique of progress toward achieving originally stated objectives; (b) a description or listing of related issues, positive or negative, considered to be significant by the planning director; and (c) plans for the next funding period. Terminal progress reports must be submitted within 90 days after the end of the project and should include items (a) and (b) above. INQUIRIES Written and telephone inquiries concerning the objectives, scope, application procedures, and allowable budget items for this RFA and inquiries about whether specific applications would be responsive are encouraged and must be directed to the Cancer Centers Branch, NCI, program officer listed below. The Branch staff welcomes the opportunity to clarify any issues or questions from potential applicants. In addition, questions of a more administrative nature not directly related to the programmatic aspects of this RFA may be directed to the Grants Administration Branch official, also listed below. J. Blanche O'Neill Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 502 Bethesda, MD 20892 Telephone: (301) 496-8531 Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 282 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.397. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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