kristoff@GENBANK.BIO.NET (Dave Kristofferson) (04/25/91)
$$XID RFA CA9115 CA-91-15 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: CA-91-15 PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS P.T. 04; K.W. 0715035, 0745027, 0795003, 0403004 National Cancer Institute Letter of Intent Receipt Date: July 15, 1991 Application Receipt Date: August 28, 1991 I. INTRODUCTION The Cancer Centers Branch (CCB) of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) of the National Cancer Institute (NCI) announces the availability of planning and development grants for the purpose of assisting eligible institutions to develop the organizational capability that will lead to the formation and/or development of cancer research centers of excellence. The goal of this Request for Applications (RFA) initiative is to encourage the development of clinical and consortium 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. 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 from the NCI. 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 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, D.C. 20402-9325 (telephone 202-783-3238). II. BACKGROUND INFORMATION The Cancer Centers Program was developed in the late 1960's and was formally authorized by the National Cancer Act of 1971. The language of the legislation 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." 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; and 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, contracts, and other funding sources, the Cancer Center Support Grant (CCSG) and the related Consortium Cancer Center Support Grant (CCCSG) undergirds these research activities by providing core support through partial funding of shared research resources that provide cost-effective access to essential services (e.g., animal facilities) and to sophisticated equipment, state-of-the-art technology, and expert services. The CCSG also supports central administrative expenses, partial salary support for the center's senior leadership and investigators, 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 (July, 1988)", and for the Consortium Cancer Center Support Grant in "Guidelines: Consortium Cancer Center Support Grants (October, 1987)". Both documents are available from the Cancer Centers Branch, DCBDC, NCI. A CCSG or CCCSG applicant must have a minimum amount of peer-reviewed cancer research support (currently $750,000 for a CCSG and $300,000 for a CCCSG in annual direct costs) to be eligible to apply for a center grant. In the years 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 reflecting both the U.S. population density and the locations of medical research centers. Nonetheless, there are medical institutions existing in currently underrepresented 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 and that may have prevented some institutions from exploring the possibility of forming a new cancer center or consortium cancer center. This RFA is designed to encourage qualified institutions to make the investment necessary to establish a cancer center. Detailed planning and development is crucial to the formation of a new clinical or consortium cancer center. 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(s) through a process of sometimes complex negotiations. 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 the parent institution(s). In addition, specific central research resources must be identified for inclusion or development as part of the cancer center. Finally, the parent institution(s) 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) a clear cancer research focus and intent, (b) coordination of interdisciplinary and translational research activities, (c) appropriate and adequate organization and facilities, (d) a qualified director with adequate authority over appointments, space, equipment, and identifiable clinical research facilities to ensure smooth and effective coordination, and (e) an adequate commitment of the parent institution(s) that recognizes the center as a major organizational element of the institution. The response to this RFA will help the NCI expand the cancer centers program to underrepresented geographic areas and their populations that are not currently served by NCI- designated cancer centers. 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 centers of excellence. III. GOALS AND SCOPE The primary goal of this RFA is to help applicant institutions develop the organizational capability that will lead to the formation and/or development of new centers of cancer research excellence that will benefit currently underrepresented geographic areas in the United States. To allow wider availability of up-to-date cancer care research and/or control research activities, this announcement is directed to potential applicants for clinical or consortium cancer centers rather than basic research centers. It is anticipated that applicant institutions will have a sufficient base of peer-reviewed research and initial organizational capability such that a three-year planning and development grant is both justifiable and likely to lead to the creation of a new cancer research center. It is also 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 or CCCSG application. IV. THE PLANNING AND DEVELOPMENT PROCESS A. DEFINITION OF THE PLANNING AND DEVELOPMENT EFFORT The first phase of the planning process involves the definition of the goals and objectives for the new or proposed cancer center that will provide the base on which the organizational structure, financing, and facilities can be developed. The development of objectives should take into account the following considerations: The overall objectives or purposes of the parent institution(s). The development of a cancer research center of excellence must agree with and support the long-term goals and objectives of parent institution(s) and their leadership. The specialized needs of the institution's geographic area and its populations. The special needs of the center's region or service population must be strongly considered in the development of research activities as well as in the education, outreach, and service programs of the center. The effect that 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 across traditional academic departments and disciplines. Consideration of the administration and organization of the center and its relationship with the parent institution(s) are as necessary to the planning mission as are scientific, clinical, and technical considerations. For example, the center, to be effective, should have its own administrative identity within the parent institution. 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 to the new center is needed to develop practical goals and objectives. Definition of the research activities to be included in the new center. The nature of the research activities must be defined in terms of the utilization and expansion of ongoing research activities at the parent institution(s) and the inauguration of new projects. The usual structural elements of the cancer research activities at a center include multidisciplinary research programs, shared resources for peer-reviewed research, and administrative support services. The relevance of the center to the mission of the NCI. The relevance of the proposed cancer research center to other programs of the NCI must be evaluated and incorporated into the objectives for the center. The work being performed by others. An institution planning or developing a cancer center must evaluate existing local, regional, and national programs relative to the unique and important contributions of its own programs to the region. B. ELEMENTS OF A PLANNING AND DEVELOPMENT EFFORT The following elements are essential in the planning and subsequent development of a cancer center: Planning director: A senior level person competent in 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 current or proposed founding director of the new center. Planning and advisory committees: An internal planning committee must assist the planning director. Committee members must be selected from within the institution(s) that is(are) developing the center. Additional members from the community must also be selected where appropriate. This committee must evaluate scientific, medical, institutional, and regional considerations and must make sure that all available resources are considered in the planning process. It may be advisable for all elements of the institution(s) affected by the center to be represented on this committee. In addition, an external advisory group, consisting of senior individuals who are familiar with the functions and organization of NCI-designated cancer centers, must be convened periodically to give the planning director knowledgeable advice on the development of a cancer research center as well as unbiased and independent assessments of the new center's progress to date and its objectives and plans for the future. Research program definition and implementation. The cancer research programs that will comprise the cancer center must be defined in terms of relevance to the cancer problem, productiveness, membership in the center (present and future), peer-reviewed grant/contract research base, space needs and utilization, and availability of patient resources. The research programs must be multidisciplinary in nature and may focus on basic, clinical, and prevention investigations. They should build on the current strengths of the institution. This definition and its subsequent implementation must also include consideration of local, regional, and national needs. Shared resources that will support the peer-reviewed research projects of the center programs will also need to be defined. Definition of the relationship of research activities to patient care, educational, and other outreach activities of the center: The relationship between the center's research activities and the patient care, educational (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. V. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) grant-in-aid. The exploratory grant mechanism, designated P20, will be used. 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. However, if the NCI determines that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. Approximately $750,000 in total costs per year will be committed specifically to fund applications submitted in response to this RFA. 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 should not exceed three years. The earliest feasible start date for the initial awards will be August 1, 1992. 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. VI. ELIGIBILITY REQUIREMENTS Applicant institutions must intend to develop clinical or consortium cancer centers. Eligible institutions must come from states that do not currently have an NCI-designated Comprehensive, Clinical, or Consortium Cancer Center, and are located outside of a reasonable distance from an existing Comprehensive, Clinical, or Consortium 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. At this time, the Cancer Centers Branch defines peer-reviewed cancer research projects as NCI research grants and contracts, American Cancer Society research project grants, and other NIH and the National Science Foundation (NSF) research grants that meet the NCI referral guidelines as cancer-related research. Questions concerning the NCI referral guidelines should be addressed to the individual noted in Section X of this announcement. Eligible institutions should require approximately three years of support under a planning and development grant to develop the institutional capability to form and or develop a cancer research center of excellence. Institutions that already have an established organizational capability as a cancer center and a sufficient peer-reviewed cancer research base are not eligible under this program. Potential applicants are strongly advised to contact NCI program staff of the Cancer Centers Branch to discuss eligibility prior to preparing an application (See section XI below). VII. METHOD OF APPLYING A. APPLICATION PREPARATION The most recent revision of the research grant application form PHS 398 (revised 10/88) must be used in applying for these grants. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892; and from the NCI Program Director named below. Complete information about the proposed planning and development effort must be submitted with the application. Follow the instructions for 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 section VIII.B below. The narrative portions of the application, sections I, II, III described below, must be limited to fifty pages of text. 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 contain the following elements: BASIC INFORMATION: FACE PAGE: Identify the application as being in response to this RFA by checking YES on item 2 of page 1 of the form PHS 398 and entering the title and number of this RFA. The RFA label available in the PHS 398 kit must be affixed 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. List the planning director as the Principal Investigator of the application. The planning director should be the primary author of the application. The face page is page 1 of the application; all succeeding pages should be numbered consecutively. ABSTRACT AND LIST OF KEY PERSONNEL IN THE PLANNING EFFORT: Page 2 of form PHS 398 should contain an brief abstract of the proposed planning and development effort including the name of the parent institution(s), goals of the proposed center, the elements of the proposed planning effort, and the impact the center's development will have on its geographic area. List key personnel including the planning director and other senior level faculty and administrators who will be involved in the planning process in a major way. TABLE OF CONTENTS: Page 3 of form PHS 398 must be used to present a table of contents for the application. ITEMIZED FIRST YEAR BUDGET AND COMPOSITE 3 YEAR BUDGET WITH JUSTIFICATIONS: Present a detailed, composite budget for all requested support for the first year on page 4 of the form PHS 398. Estimate the required budget for future years on page 5. Future year increases should be limited to 4 percent. If collaborative efforts involving other institutions or organizations are planned and will use funds awarded under this grant, itemize all costs associated with such other institution participation, including any applicable indirect costs on a separate budget page and enter the total under the "Consortium Contracted Costs" budget category of the budget on page 4. (See "Policy for Establishing Consortium Grants," NIH Guide for Grants and Contracts Vol. 14, No. 7, June 21, 1985.) If developmental funds are requested ($35,000/yr maximum), it must be entered in the composite budget on page 4 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. Detailed justifications for each budget item must be provided on page 5 and on continuation pages as needed. See VII.B, "Allowable Budget Items" below. It is estimated that the average first-year budget for planning and development grants should not exceed $175,000, direct costs. 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. Describe the new or developing 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(s) 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 (see Section III below). The potential relevance of the new center to other programs funded by the NCI or that could be implemented in its region must also 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 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. (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. These advisory groups will have central, although very different, roles in the development of the center. Thus, it is important 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(s) and other affiliations (e.g., Veterans Administration hospital staff). 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(s) 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 four 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. (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) a cancer research focus, (b) interdisciplinary coordination, (c) appropriate organizational capability and facilities, (d) center director with adequate authority, and (e) institutional commitment; 3. identify multidisciplinary basic and clinical research programs for inclusion in the center; 4. identify appropriate staff from the parent institution(s) for center membership and areas where additional recruitment is necessary; 5. identify shared research resources for inclusion or development by the center; 6. develop appropriate long-term relationships with parent institution(s) and with departments and/or centers within the institution(s); 7. develop affiliations with other institutions. If a consortium center is planned, describe plans for sharing the responsibilities and benefits of the new center. SECTION II. THE PARENT INSTITUTION'S RESEARCH BASE, ENVIRONMENT, AND RECOURCES: (A) Current cancer research activities and publications. Discuss whether all peer-reviewed cancer research projects located at the parent institution(s) (listed in Section IV.B below) will be associated with the cancer center. If not, please explain. Describe plans to expand the peer-reviewed grant/contract base. (B) Description of the parent institution(s). Discuss the environment of the parent institution(s) and its suitability for attracting appropriate staff. Describe the institutional officials who will be associated with and support the proposed center and the planning effort, the experience of the institution(s) with developing similar centers or programs, and the effect that the new cancer center will have on other programs and centers at the institution(s). 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(s) to the new center and 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. If a consortium center is planned, describe how the responsibility for developing and sustaining the new center will be divided among the consortium partners. 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. (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. Provide a list of currently active, peer-reviewed, cancer research grants and contracts at the parent institution(s). At this time, the Cancer Centers Branch defines peer-reviewed cancer research projects as NCI research grants and contracts, American Cancer Society research project grants, and other NIH and NSF research grants that meet the NCI referral guidelines as cancer-related research. Leukemia Society of America faculty salary support grants may also be listed. 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. (C) Bibliography. Provide a bibliography of cancer research publications from the parent institution(s) during the previous three years. (D) Letters or statements from senior officials of the parent institution(s) documenting their support for the proposed planning and development process. These document(s) must include a description of substantive actions by the parent institution(s) to promote the development of a center, e.g., the commitment of space and funds to the project as well as providing substantive authority to the planning director. 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). The purchase of equipment is discouraged. In addition, developmental funds may be requested up to a maximum level of $35,000/year. These developmental funds may be used by the planning director to help recruit new scientific staff to the center or to help develop peer- review quality, new cancer research projects or new shared resources for the peer-reviewed research projects of 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. C. APPLICATION SUBMISSION Before submitting the application, affix the RFA label in the 10/88 revision of application form PHS 398 to the bottom of the face page. Failure to use this label could result in delayed processing of your 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 2 of the face page of the application form. Submit a signed, typewritten original of the application (without appendices), including Checklist, and four (4) signed, exact photocopies, in one package to the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, send two (2) additional copies of the application to: REFERRAL OFFICER Division of Extramural Activities National Cancer Institute Room 838, Westwood Building 5333 Westbard Avenue Bethesda, MD 20892 Appendix materials should be retained by the applicant until specifically requested by NCI staff. Six copies of the appendices will be requested. Applications must be received by August 28, 1991. 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 a research 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. VIII. REVIEW PROCEDURES AND CRITERIA A. REVIEW PROCEDURES Upon receipt, applications will be reviewed initially for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and eligibility criteria stated in the RFA is an NCI program staff function. Applications will be judged to determine how well they meet the goals and objectives of the program as described in the RFA. Applications that are judged non-responsive will be returned to the applicant. Questions concerning the relevance of proposed work to the RFA should be directed to program staff as described in the INQUIRIES Section XI below. If the number of applications received is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those applications that are clearly not competitive. The NCI will withdraw from further competition those applications judged as noncompetitive and will notify the applicant and institutional business official. Those applications judged to be responsive and competitive will be further evaluated according to the review criteria stated below by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be performed by the National Cancer Advisory Board. This Board considers the special needs of the Institute and the priorities of the National Cancer Program. B. 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; 3) the potential of the proposed center to enhance the level of cancer research in its region and, ultimately, to enhance the impact of research on the quality of patient care, prevention, control, and related activities in its geographic area. Peer reviewers will be asked to specifically comment in these three areas. An unacceptable evaluation in any one of these review categories can be grounds for disapproval 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. THE TECHNICAL MERIT OF THE PROPOSED PLANNING AND DEVELOPMENT PROCESS. 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 existing NCI-designated clinical/consortium centers; 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, but not limited to: 1. Adequacy of the peer-reviewed cancer research base; 2. Progress toward implementing the essential characteristics of a cancer center: interdisciplinary coordination, appropriate organizational capabilities and facilities, center director with adequate authority, and institutional commitment; progress toward and potential for developing an appropriate cancer research focus; 3. Identification at the parent institution of senior investigators in basic, clinical, prevention, and control research who will be important for developing multidisciplinary cancer research programs; identification of shared resources that will be important for multidisciplinary research programs for inclusion or development in the center; 4. Plans to develop appropriate long-term relationships with senior leadership/administration of the parent institution(s) and with other departments and centers within the institution(s); 5. For consortium centers, the plans to develop appropriate formal relationships with clear commitments and division of responsibilities among consortium partners and the center; 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 or CCCSG award. INSTITUTIONAL COMMITMENT AND ENVIRONMENT: a. Adequacy of the institutions' 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; 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; assess the track record of the institution in developing similar programs in other fields, if any; discuss the potential for adequate continuity of institutional commitment for the center; and assess the potential effect of the new cancer center on other programs within the institution; e. If a consortium center is planned, the effectiveness of the relationships among the current member institutions and with regard to the proposed functions within the consortium; the adequacy of the demonstrated commitment of the component institutions to the planning effort. 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. 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 for its community and region; b. Proposed role and potential impact of the new cancer center in its geographic area; 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; 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 and, thus, competitive for a CCSG award. The review group will recommend an appropriate budget for each approved application. Requests for equipment and commercial consultants are discouraged and, if present in an application, such requests will be highly scrutinized. IX. NEGOTIATION, AWARD, AND REPORTING REQUIREMENTS 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, PHS form 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 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. X. LETTER OF INTENT 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. Prospective applicants are requested to submit, by July 15, 1991, 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. 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: Dr. Alan A. Schreier Program Director Cancer Centers Branch Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 308 Bethesda, MD 20892 Telephone: (301) 496-8531 XI. 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 above. 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 listed below. Ms. Francis Cohen Grants Specialist Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 42 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 100-607) 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.