From owner-sci-resources@net.bio.net Wed Dec 01 22:00:00 1993 Path: biosci!lhc!biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 43, pt. 3, 26 November 1993 Message-ID: Date: 29 Nov 93 19:40:22 GMT Sender: kristoff@net.bio.net Lines: 1020 Approved: biosci-moderator@net.bio.net $$XID RFA SAG94005 CA/ES/AG-94-005 P1O1 ******************************** BREAST CANCER RESEARCH PROGRAMS IN NCI-DESIGNATED CANCER CENTERS NIH GUIDE, Volume 22, Number 43, November 26, 1993 RFA NUMBER: CA/ES/AG-94-005 P.T. 34; K.W. 0715036, 0710030 National Cancer Institute National Institute of Environmental Health Sciences National Institute on Aging Letter of Intent Receipt Date: January 12, 1994 Application Receipt Date: February 17, 1994 PURPOSE This Request for Applications (RFA) is sponsored by the Cancer Centers Branch, Division of Cancer Biology, Diagnosis and Centers (DCBDC) of the National Cancer Institute (NCI); the Chemical Exposures and Molecular Biology Branch, Division of Extramural Research and Training of the National Institute of Environmental Health Sciences (NIEHS); and the Extramural Research Programs of the National Institute on Aging (NIA). The co-sponsoring Institutes announce the availability of planning and development grants for the purpose of developing and establishing broad, multidisciplinary research programs in breast cancer within existing NCI-designated cancer centers (i.e., those institutions currently awarded a Cancer Center Support Grant, P30). A research "program" as defined by the Cancer Centers Support Grant (CCSG) Guidelines consists of an interactive, collaborative group of funded investigators who share common scientific interests and goals and a leader who provides intellectual stimulation and guidance to the program, giving it cohesion, focus, and direction. The primary purpose of this RFA is to encourage Cancer Centers that do not currently have a formal breast cancer research "program" to develop and establish the research infrastructure for this kind of organized, interactive activity within the center. A secondary purpose is to encourage cancer centers with established breast cancer research programs to expand their competitive research base by focusing on breast cancer in the elderly and/or on environmental factors affecting the incidence, morbidity, and mortality of breast cancer. In the primary area, emphasis should be placed on developing "programs" that will involve a broad array of research approaches in basic, clinical, and prevention and control research and that will have the potential for medical application and impact on reducing the incidence and mortality of breast cancer on a local, regional, and/or national level. In the secondary area, the center should already have a strong, broadly-based research "program" in place with potential for medical application, and emphasis should be placed on expanding the existing "program" to take advantage of research opportunities related to the elderly and/or to environmental factors. Under both purposes, the sponsoring Institutes will be particularly receptive to applications that include or involve a focus on the problem of breast cancer in underserved minority populations and populations of women that have disproportionately high death rates due to breast cancer. Upon completion of these planning and development grants, it is anticipated that recipient institutions will either have a formal breast cancer research "program" in place or an expanded "program" addressing breast cancer in the elderly and/or environmental factors contributing to breast cancer. It is also expected that those "programs" will be sustained in the future through the same types of competitive funding sources that support other established programs in the Cancer Center. 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, Breast Cancer Research Programs in NCI-designated 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 Only institutions that are current recipients of Cancer Center Support Grants (CCSG) (P30) awards from the NCI are eligible to apply for a planning and development grant in response to this RFA. However, within existing NCI-designated cancer centers, there are two different levels of eligibility as described below. Depending on the stage of their current research efforts in breast cancer, institutions may apply for either of the following options: Option A 1. Eligibility. Cancer Centers that currently have neither: (a) an existing breast cancer research "program" or substantial breast cancer research activity equivalent to a program that is part of the CCSG-supported Cancer Center; or (b) a Specialized Program of Research Excellence (SPORE) (P50) grant in breast cancer. 2. Purpose/Funds. These institutions may apply for up to $400,000 in total costs per year for up to four years for the purpose of developing a broadly based research program in breast cancer (see FUNDS AVAILABLE). Option B 1. Eligibility. Cancer Centers that currently already have either: (a) an existing research "program" or substantial breast cancer research activity equivalent to a "program" that is part of the CCSG-supported Cancer Center; or (b) a Specialized Program of Research Excellence (SPORE) (P50) grant in breast cancer. 2. Purpose/Funds. These institutions may apply for up to $150,000 in total costs per year to develop research activities focused on breast cancer in elderly women or on environmental factors influencing breast cancer. Although the same Institution may apply for both of these areas of emphasis at $150,000 total costs each, a separate application must be submitted for each component since different co-sponsoring Institutes are involved in this initiative. A Cancer Center could therefore potentially be provided with one award for up to $150,000 for an expansion component for breast cancer in elderly women, and another award for up to $150,000 for an expansion component on the environmental factors in breast cancer. The priorities of this initiative will remain within the two areas noted above. However, situations may exist that do not fit either of the above options, but that may have a substantial impact in reducing incidence and mortality of breast cancer and therefore may be of extreme importance to the NCI's efforts to expand research in breast cancer. Potential applicants are strongly advised to contact NCI program staff listed under INQUIRIES to discuss these kinds of special situations and resolve eligibility requirements in writing before submitting a letter of intent. MECHANISM OF SUPPORT This RFA is a one-time solicitation. 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. 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 (rev. October 1, 1990) and this RFA. It should be noted that a Cancer Center with an existing breast cancer program could potentially be awarded a grant for one expansion subcomponent for up to $150,000 total costs for developing a focus on breast cancer in elderly women and awarded another grant for an expansion subcomponent for $150,000 total costs for developing a focus on the influence of environmental factors on breast cancer. The P20 Planning and Development Grant will support the following budgetary items: 1. The partial salary of the Program Development Director. 2. Funds for special retreats and meetings for the purpose of breast cancer program development and to stimulate cross-disciplinary collaborations among investigators, particularly those bridging basic science with clinical research. 3. Developmental funds for recruitment of new scientists to the institution who wish to engage in breast cancer research and can strengthen and/or broaden the program. 4. Developmental funds for pilot projects that will stimulate collaborative research using innovative approaches to breast cancer issues. These funds may be used to support projects in basic, clinical, and prevention and control research, and can be used as a means of stimulating cross-disciplinary collaborations, particularly those that have the potential for moving basic research discoveries into patient and population research settings. The funds for pilot projects can be used to develop the initial findings necessary for submitting a full research application (e.g., R01) for competitive funding. Pilot project funds are therefore important to the development of a new program with a competitively supported research base. 5. Expansion of an existing shared resource or development of a new shared resource will be considered for support with funds from this RFA. However, it should be noted that since the specific aim of this RFA is to develop highly focussed breast cancer research programs with a significant base of funded, peer reviewed research projects, the funds provided through this RFA are expected to be used primarily to support retreats, new recruitments, and pilot projects to achieve the objective. In the event that a new resource or expanded resource is needed, a request for support will be considered for funding through this RFA only if a strong justification is presented and evidence is provided that the resource meets the standards of any shared resource as defined in CCSG Guidelines (Sections I-IV, pgs. 25-26, 38; Section V, pgs 18-19). Note that establishment of a new shared resource devoted exclusively to a single program is not consistent with CCSG Guidelines. The applicant is advised to consult with NCI staff before including a request in the application for expansion of an existing shared resources or the establishment of a new resource. FUNDS AVAILABLE Approximately $4.9 million is anticipated for availability in Fiscal Year 1994 to fund applications submitted in response to this RFA. With these funds, up to eight awards for the development of new breast cancer programs could be made of approximately $400,000 total costs per year each for a total cumulative cost of up to $3.1 million per year. For those Centers applying for expansion of their existing programs, up to 12 subcomponents could be awarded at $150,000 total costs each per year at a total cumulative cost of $1.8 million per year. This funding level is dependent on the receipt of a sufficient number of applications of high merit; the sponsoring Institutes could fund more or fewer grants than the numbers estimated above depending on the scientific merit of the applications received. The total project period for applications submitted in response to the present RFA may not exceed four years. The earliest possible start date for the initial awards will be September 30, 1994. Although this program is provided for in the financial plans of the NCI, NIEHS and NIA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Breast cancer is the most common cancer among U.S. females and is the second leading cause of cancer death among women. Since 1980, the incidence of breast cancer has increased dramatically in both pre- and post-menopausal women at a rate of approximately two percent per year. During this time, the scientific information base for breast cancer has expanded significantly; however, application of this base to clinical and preventive activities has not been commensurate. There is a clear need to encourage research that draws from expertise in many disciplines to focus on the problem of breast cancer in the basic and clinical research arenas, in cancer prevention and control research, and in research that bridges basic science with clinical research. Significant scientific and clinical expertise in breast cancer exists in many of the NCI-designated Cancer Centers throughout the country. Cancer Centers have well-established interactive research environments, and they have the leadership, space, equipment, structure and resources already available to take advantage of new research directions as opportunities arise. A concerted effort to mobilize this expertise through this planning effort could accelerate advances in management of the breast cancer and, ultimately, in the prevention of this disease. Although some of the NCI-designated Cancer Centers already have developed formal "programs" in Breast Cancer and/or are recipients of a Breast Cancer SPORE, many others have no clearly definable, separate and distinct formal program in breast cancer. Yet it is known that these institutions have the research interests and expertise within the Cancer Center and the parent institution to form such a highly focused program. The planning and development of a formal cancer center research program requires a significant investment on the part of the Cancer Center and of the parent institution. This RFA is designed to provide a significant part of the developmental resources necessary to establish the program to encourage qualified institutions to make the long term commitment necessary to sustain the program as a ongoing part of the Cancer Center. The functions of the Cancer Center Support Grant and the definitions of and requirements for formal cancer research "programs," are described in "Guidelines: Cancer Center Support Grants." This document is available from the NCI program staff listed under INQUIRIES. B. Rationale for this RFA The rationale for this RFA is to establish a solid, broad-based infrastructure for the conduct and continued development of breast cancer research, allowing for incorporation of several disciplines and creative exploration of new approaches to this disease. The goal of the RFA is to provide the initial resources to develop and establish in NCI-designated cancer centers an integrated, interactive research capability with a significant base of externally funded, peer reviewed research projects, focused on the problem of breast cancer. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Since any clinical research conducted under this RFA is most likely to accrue women predominantly, the following statements deal only with the inclusion of minorities in clinical research studies. NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of racial/ethnic group. In addition, racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human subjects. If the required information is not contained within the application, the application will be returned. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research in defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from racial/ethnic minorities when it is important to apply results of the study broadly, and this should be stressed by applicants. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by January 12, 1994, a letter of intent that includes a descriptive title of the proposed application; the name, address, and telephone number of the Principal Investigator; the names of other key personnel; the participating institution(s); and the number and title of the RFA in response to which the application may be submitted. Although an LOI is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains is helpful in planning for the review. The letter of intent allows Institute staff to estimate the potential review workload, to establish the peer review group as soon as possible, and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Margaret E. Holmes at the address listed under INQUIRIES. APPLICATION PROCEDURES A. Application Preparation 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, Bethesda, MD 20892, telephone 301/594-7248; and from the Institute Program Directors listed under INQUIRIES. Although form PHS 398 was developed for investigator originated research applications, the instructions in this application kit should be followed where appropriate. The application must be a complete document that includes all essential information about the proposed planning and development effort necessary for its evaluation. In preparing the written application, the applicant should examine the review criteria provided in the REVIEW CONSIDERATIONS section. These criteria will be used to evaluate the written application. The narrative portion of the application is limited to no more than fifty pages of text. Although additional explanatory material may be submitted in appendices, this method of presentation should not be used to bypass the page limitations in the narrative section since appendices are sent only to selected reviewers. The application generally should contain the following elements and supporting documents in the order noted below: 1. Face Page 2. Abstract 3. Table of Contents 4. Narrative Description of the plan for development of the program. This section should address the elements noted in part B below and should not exceed 50 pages. 5. Overall and Individual Budgets and Justifications. An individual budget should be submitted for each budget category requested: (a) leadership salary, (b) retreats and meetings, (c) recruitment of new investigators, (d) support of pilot projects, and (e) expansion or development of shared resources. 6. Supporting documents: a. Biographical sketches of the Program Development Director and other key personnel (use form PHS 398 format). b. Research Grants and Contracts. Provide a list of currently active funded cancer research grants and contracts that constitute the initial research base of the new program. The projects should be listed in two groups: peer reviewed funded projects and non-peer reviewed, funded projects. Each entry for a research project on the list should include the Principal Investigator, his/her percent effort on the project, funding agency, (if NIH, identify as "NIH/[Institute Sponsor]) I.D. number, title of the project, total grant period, and current annual direct costs and current annual total costs (direct plus indirect). c. Bibliography. Provide a list of publications of the Principal Investigator and the proposed members of the program during the previous three years; highlight those that are relevant to breast cancer research. d. Letters or documents from senior officials of the parent institution documenting their support for the proposed planning and development process. B. Application Special Requirements The goal of the planning and development process should be to establish a broad, multidisciplinary, interactive "program" in breast cancer research that meets all of the requirements for a research "program" of a Cancer Center. The definition and requirements for a formal "program" are described in the CCSG guidelines, Sections I-IV, pages 15-16 and Section V, pages 9-11. In addition to the appropriate standard requirements of the form PHS 398, the narrative portion of the P20 grant application (i.e., part 4 of the general format provided in this section above) must describe the planning process in detail addressing each item below depending upon whether Eligibility Option A or B is being pursued: 1. Assignment of a qualified Program Development Director. The proposed Program Development Director should have adequate standing within the Cancer Center and within the Institution to effectively develop and coordinate the program. Either the existing breast cancer program leader or a senior level person with the appropriate scientific and administrative competence should 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, although less time may be needed for expanding a program (Option B) than developing a new one (Option A). The Program Development Director will be the Principal Investigator (PI) of the planning and development grant. 2. Definition of the new research program or expanded research effort and its potential for full development. The application must demonstrate that the Cancer Center has a sufficient number of investigators interested in and working in the area of breast cancer who can serve as the nucleus of a research group. In addition, the Center must have a reasonable number of funded breast cancer "related" research projects upon which to build, since the ultimate goal is to build a significant research base that will form the substance of a research "program" as per CCSG guidelines. In addition to the "Other Sources of Support" included as part of form PHS 398, these projects should be listed specifically in the application using the format of Summary #2 of the Standard Cancer Center Information summaries and include the following information: PI, funding agency or organization, full grant number, full project period, project title, current annual direct costs, current annual direct plus indirect costs. The application should demonstrate how this group and the funded research projects will form the initial directions for the program and provide the impetus for its further development. The application should describe how the full development of the program or the additional research development related to breast cancer in the elderly or to environmental factors affecting breast cancer is envisioned; i.e., what will be the final form of the program that constitutes the objective of this planning process. Under Option A, the application should discuss any components of the plan that will address breast cancer in younger women where the outcome of the disease is frequently very serious. The application should also discuss the new program's potential for impacting on breast cancer in underserved minority populations and populations of women that have disproportionately high mortality rates due to breast cancer. For Option B, the application should discuss the existing program's potential for impacting on breast cancer among younger women, as well as how the existing program and the expanded components have the potential for impacting on breast cancer in underserved populations and in populations of women that have disproportionately high mortality rates due to breast cancer. 3. The development plan and use of planning grant resources. The application should demonstrate the plans for the development of a research theme for the program and how the program will be built into a focused, cohesive, well funded, multidisciplinary, interactive, and productive program in breast cancer research. The application should describe the means by which a significant research base will be built, how new investigators will be recruited to the program, and how development funds will be used to the best advantage for pilot projects in building toward a fully funded research base. The P20 planning grant provides funds in areas that can be used flexibly for development of a program as follows: (a) retreats, (b) pilot projects and (c) new recruitments. The application should provide a detailed plan by which the requested funds in the above categories will be used in a balanced way over the requested grant period to achieve the objectives. The P20 planning grant can also provide support for establishment of new or specific expansion of existing shared resources where there is a strong justification for doing so (See Item 5 under MECHANISM OF SUPPORT. If expanding an existing shared resource, all budgetary and scientific aspects of the resource currently supported by the CCSG should be provided in the application. 4. Availability of patient resources for the clinical research components of the program. Regardless of the type of Cancer Center applying for funds under this grant mechanism, the relationship between the Cancer Center's breast cancer research effort and the potential for application to clinical research and patient populations must be clearly defined. Mechanisms of information transfer, collaboration and "translation" should be developed so that the promising results of cancer research performed at the center and elsewhere can be further developed and/or tested for their efficacy in cancer patients. For Cancer Centers that have a clinical capability as part of the CCSG-supported research effort, the application should describe these linkages relative to the patient population in the Center's own geographic area in addition to any collaborative efforts that may involve patients located elsewhere. 5. Identification of needs for space and shared facilities. The application should describe the space that will be provided for the conduct of research in the new or expanded program and the existing shared resources of the Cancer Center that will be utilized by the funded research projects of the program. The application should outline any requirements for new or specific expansions of existing shared resources, noting in the later case all current sources of support (i.e., CCSG or other). 6. Description of the decision making processes. An internal planning committee should assist the Program Development Director. Committee members must be selected from within the institution that is developing the program. This committee should evaluate all scientific considerations and should ensure that all available resources are considered in the planning process. External advisors may also assist in the planning process through the CCSG's external advisory committee or through ad hoc advisors invited to the Cancer Center to review the current status and potential of the breast cancer program as part of CCSG planning and evaluation activities. The application should describe the internal decision making processes that are used to develop the content and format of the program and should also address the process for prioritizing and distributing resources among: (1) retreats and meetings, (2) recruitment of new investigators; (3) pilot projects. Any internal processes that deal with identifying needs for and prioritizing uses of CCSG-supported shared resources should also be described. 7. Commitment of the Institution. The application should demonstrate adequate commitment by the parent institution that recognizes the breast cancer program as a major research focus of the Cancer Center. Any present or potential contribution by the Institution for the specific development of the breast cancer program in terms of facilities, staff, administrative resources, and financial resources should be described. 8. Plan to interface with other breast cancer interests in the Institution. The application should include any plans by which the breast cancer research effort will interface with other centers and research groups in the Institution. For example, investigators from a Center on Aging (supported by the National Institute on Aging) could form a collaborative effort with Cancer Center members to focus on the special problems of breast cancer in elderly women. Research groups or centers with interests in environmental health science (e.g., such as those supported by the National Institute of Environmental Health Sciences) might form a collaborative effort with the Cancer Center to study environmental factors influencing breast cancer. This section is particularly important for those applications from Cancer Centers that already have a formal research program in breast cancer, and are applying for one or both of the subcomponents as described in ELIGIBILITY REQUIREMENTS section under Option B of this RFA. Option B applicants will be expected to have made significant efforts to develop collaborative research programs with NIA or NIEHS centers at the same institutions and/or with any group of investigators at the same institution who can contribute to a special focus on cancer in the elderly and/or environmental factors of the disease. C. Application Submission The RFA label available in the application form PHS 398 (rev. 9/91) 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. In addition, the RFA number and title must be 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 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 Bethesda, MD 20892 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 February 17, 1994. Applications received after that date will be returned to the applicant institution. 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 or essentially identical applications will not be allowed, nor will such applications be reviewed by different review committees. A previously reviewed application may be submitted in response to this RFA; however, such applications must be submitted as revised or amended applications in accordance with the form PHS 398 guidelines. REVIEW CONSIDERATIONS A. Review Procedure 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 may be directed to program staff listed under INQUIRIES. If the number of applications received is large relative 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, the National Advisory Council on Aging, or the National Advisory Environmental Health Sciences Council, whichever is appropriate for the application submitted. These Boards/Councils consider the special needs and research priorities of the respective Institute. B. Review Criteria Applications will be assessed in three general areas: (1) the technical merit of the proposed plans and all scientific elements critical to the development of a strong research program; (2) the contributions of other resources from the cancer center and the institution to the successful development of a research program; and (3) the potential of the cancer center to develop a successful, broad-based, interactive research program with clinical application capability over the period of the planning process. The final priority score will reflect the reviewers' overall assessment of how well the cancer center will build upon its current research capabilities to establish or expand a breast cancer research program with a competitively funded research base that is multidisciplinary, interactive, and collaborative and that has the potential for generating results that may have effective applications. Below are the specific criteria that will be used by the peer review group in its evaluation of each application. 1. OPTION A Option A: Technical Merit a. Evaluate the qualifications of the Principal Investigator/Program Development Director in terms of research experience directly relevant to breast cancer and leadership capabilities. Evaluate the time commitment of the Program Development Director to effectively lead this effort within the cancer center. b. Evaluate the potential effectiveness of the Program Development Director's internal planning committee and staff in assisting the director in planning the program; the appropriateness of the proposed membership and stated functions of this internal planning group; the potential of listed key personnel to become key investigators in the research program. Evaluate the adequacy of the decision making processes, particularly with respect to planning the program research directions, gaining the cooperation of investigators from within the institution, recruiting new investigators from outside the institution, allocating developmental funds for pilot projects, and defining needs for and prioritizing use of CCSG-supported shared resources. c. Assess the adequacy of the proposed development plan, including the applicant's approach to: development of a research theme with attention to cohesion and focus, vision for the future of the program, and the methods to be used by which to build the research program. Assess the specific ongoing research activities (i.e., both peer-reviewed, funded activities and other activities sponsored by the institution) in breast cancer as a foundation upon which to build a strong research "program" in the cancer center. d. Evaluate the areas of research that need strengthening and how well the recruitment of identified individuals within the institution and new investigators from outside the institution to the "program" will serve to create a strong, new multidisciplinary, interactive research group. e. Evaluate the priorities of the Cancer Center in terms of recruitment of new outside scientists to the institution for the specific purpose of creating a broad-based research program with new collaborative, interdisciplinary and translational research potential. f. Evaluate the proposed research projects to be supported through pilot funds in terms of their innovativeness and likelihood of advancing the knowledge base in breast cancer and furthering the potential of the center to improve its overall research capability and its potential to bridge research from basic to clinical investigation and medical application. g. Assess the adequacy of the Cancer Center's access to breast cancer patients and how it proposes to take better advantage of this resource for clinical research and/or collaborations with clinical investigators. h. Assess how well the Cancer Center has studied its regional populations for possible new studies in prevention and control research. i. Evaluate the adequacy of space and other institutional resources to be dedicated to the development of the program. j. Assess the overall use of combined institutional resources (and CCSG-supported shared resources) and the funds requested in this grant application (i.e., funds for retreats, funds for recruitment, funds for pilot projects) in achieving objectives. k. Evaluate the reasonableness and importance to breast cancer research of any proposal for expanding an existing shared resource or developing a new resource. Evaluate the request in terms of its consistency with CCSG Guidelines Sections I-IV, pgs. 25-26, 38; and Section V, pg. 18-19. Option A: Other Resources of the Cancer Center and the Institution a. Evaluate how effectively the existing administrative, leadership, and planning and evaluation elements of the Cancer Center (e.g., senior leaders, internal advisory groups, external advisory groups) will enhance the Program Planning Director's ability to build a new breast cancer program that is fully integrated into the overall research environment of the Cancer Center. b. Evaluate any other resources that will be provided by the institution (e.g., space, discretionary funds) specifically for the purpose of developing a new breast cancer research "program" and the potential contribution to the eventual short- and long-term success of this effort. Option A: Potential a. Based on the track record of the Cancer Center for building "programs" of similar complexity in the past, evaluate whether or not this Cancer Center exhibits the kind of environment that has developed, fostered, and sustained "programs" that are interdisciplinary, interactive, collaborative and translational in nature. b. Based on the stage of development of the breast cancer research in this Cancer Center, the Program Development Director's scientific and administrative leadership qualities, the commitment of the Cancer Center and the Institution to enhance the planning and development process, and the real potential of the overall plan to develop a cadre of peer-reviewed funded investigators capable of sustaining this "program" or the expanded areas indefinitely, evaluate whether or not there is a high probability that this effort will be successful. Option A: Final Evaluation a. Recommend a period of time for support (not to exceed four years) and dollars for each year approved. Cancer Centers that have already begun a developmental effort and are further along in development of a breast cancer research program may require less time and/or total support than cancer centers that are just initiating the development process. b. Recommend a priority score rating that represents the reviewers' best relative assessment for the Cancer Center's ability to develop a new multidisciplinary, interactive, potentially translational "program" with an adequate competitively peer reviewed, funded research base within the time recommended. 2. OPTION B Option B: Technical Merit a. Evaluate the qualifications of the Principal Investigator/Program Development Director in terms of research experience directly relevant to breast cancer and leadership capabilities. Evaluate the time commitment (if the program development director is currently a CCSG supported Program Leader, then the "additional" time commitment) needed to expand the existing breast cancer research "program" to include breast cancer in elderly women and/or the influence of environmental factors in breast cancer. b. Evaluate the potential effectiveness of the Program Development Director's internal planning committee and staff in assisting the director in planning the program; the appropriateness of the proposed membership and stated functions of this internal planning group; the potential of listed key personnel to become key investigators in the research program. Evaluate the adequacy of the decision making processes, particularly with respect to planning the program research directions, recruiting new investigators, allocating developmental funds for pilot projects, and defining needs for and prioritizing use of CCSG-supported shared resources. c. Assess the adequacy of the proposed development plan, including the applicant's approach to: development of a research theme with attention to cohesion and focus, vision for the future of the program, and the methods to be used by which to build the research program. Assess the specific ongoing research activities (i.e., both peer-reviewed, funded activities and other activities sponsored by the institution) in breast cancer as a foundation upon which to expand the existing "program". d. Evaluate the areas of research that need strengthening and how well the recruitment of identified individuals within the institution to the "program" will serve to create a strong, new multidisciplinary, interactive research group. e. Evaluate the degree to which the applicant has engaged other Centers that may be present in the institution that have the relevant areas of scientific interest, i.e., centers on research in elderly, and/or centers on environmental health issues. If no Centers focussed on these areas are supported at the same institution, then evaluate to what degree groups of investigators supported with grants from NIA or NIEHS and interested in these research areas are brought to cooperate with the development of the breast cancer research program in these areas. Determine how effectively these centers or groups have been identified who can contribute to a broad-based breast cancer research "program." f. Evaluate the priorities of the Cancer Center in terms of recruitment of new outside scientists to the institution for the specific purpose of expanding the existing "program". g. Evaluate the proposed research projects to be supported through pilot funds in terms of their innovativeness and likelihood of advancing the knowledge base in breast cancer and furthering the potential of the center to improve its overall research capability and its translational research capability. h. Assess the adequacy of the Cancer Center's access to breast cancer patients and how it proposes to take better advantage of this resource for clinical research and/or collaborations with clinical investigators. i. Assess how well the cancer center has developed information about the regional populations and how well it has identified specific populations that are appropriate for the conduct of the cancer prevention and control research described in the application and/or that lend themselves to the development of new cancer prevention and control research studies. j. Evaluate the adequacy of space and other institutional resources to be dedicated to the expansion of the program. k. Assess the overall use of combined institutional resources (and CCSG-supported shared resources) and the funds requested in this grant application (i.e., funds for retreats, funds for recruitment, funds for pilot projects) in achieving objectives. l. Evaluate the reasonableness and importance to breast cancer research of any proposal for expanding existing shared resources or developing new resources. Option B: Other Resources of the Cancer Center and the Institution a. Evaluate how effectively the existing administrative, leadership, and planning and evaluation elements of the Cancer Center (e.g., senior leaders, internal advisory groups, external advisory groups) will enhance the PI's ability to build an expanded breast cancer program in the areas noted above. b. Evaluate any other resources that will be provided by the institution (e.g., space, discretionary funds) specifically for the purpose of expanding the existing program and their potential contribution to the eventual short- and long-term success of this effort. Option B: Potential a. Based on the scientific opportunities and track record of the Cancer Center in developing new research areas, evaluate whether or not this center likely to develop a strong research effort in one or both: breast cancer in elderly women, environmental factors in breast cancer. b. Based on the stage of development of the breast cancer research in this Cancer Center, the Program Development Director's scientific and administrative leadership qualities, the commitment of the Cancer Center and the Institution to enhance the planning and development process, and the real potential of the overall plan to develop a cadre of peer-reviewed funded investigators capable of sustaining the expanded areas indefinitely, evaluate whether or not there is a high probability that this effort will be successful? Option B: Final Evaluation a. Recommend a period of time (not to exceed four years) and dollars for each year approved. Cancer Centers with more well-developed breast cancer research in the special areas noted above may require less time and/or total support than cancer centers that are less well developed. b. Recommend a priority score rating that represents the reviewers' best relative assessment for the cancer center's ability to build upon the existing breast cancer "program" in order to develop a significant expansion of the competitively peer-reviewed funded research base in the special areas noted above within the time recommended. AWARD CRITERIA The earliest anticipated date of award is September 30, 1994. The following factors will be considered in making funding decisions: (1) the scientific merit of the proposed project as determined by peer review; (2) availability of funds; and (3) program balance among research areas of the RFA. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to: Margaret E. Holmes, Ph.D. Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 502 Bethesda, MD 20892 Telephone: (301) 496-8531 FAX: (301) 402-0181 William Suk, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0797 FAX: (919) 541-2843 Rosemary Yancik, Ph.D. Assistant Director for Liaison and Applied Research National Institute on Aging Building 31, Room 5C05 Bethesda, MD 20892 Telephone: (301) 496-5278 FAX: (301) 496-2793 Direct inquiries regarding fiscal matters to: Ms. Crystal Elliot Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 19 Mr. David Mineo Grants Management Branch National Institute of Environmental Health Sciences Building 2, Mail Drop 2-01 P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7628 Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.397, Cancer Centers Support. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100-607) and administered under PHS grants 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. From owner-sci-resources@net.bio.net Tue Dec 07 22:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: No NIH Guide on 12/2, 12/24, and 12/31 Message-ID: Date: 8 Dec 93 00:50:39 GMT Sender: kristoff@net.bio.net Lines: 4 Approved: biosci-moderator@net.bio.net $$MAIL BEGIN *********************************************************** There was no NIH Guide and E-Guide for the week of 12/2/93, and will be none for the weeks of 12/24/93 & 12/31/93. $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Mon Dec 27 22:00:00 1993 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 5 December 1993 Date: 27 Dec 1993 20:08:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 105 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2fobfh$45b@net.bio.net> NNTP-Posting-Host: net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Press Release Title: PR 93-83 NEW ALLIANCES TO ENCOURAGE MINORITY PARTICIPATION IN SCIENCE, ENGINEERING, AND MATHEMATICS File size (bytes): 4934 STIS Filename: pr9383 Title: PR 93-85 LASER/CHEMICAL TECHNIQUE COULD DETECT BREAST DISEASE File size (bytes): 4092 STIS Filename: pr9385 Title: PR 93-86 SKIN CANCER INCIDENCE, ULTRAVIOLET RADIATION BENCHMARKS SET File size (bytes): 4725 STIS Filename: pr9386 Title: PR 93-87 DEEPEST OZONE HOLE MATCHED BY RECORD ULTRAVIOLET RADIATION File size (bytes): 3712 STIS Filename: pr9387 Title: PR 93-88 NATIONAL SCIENCE BOARD APPROVES CREATION OF NATIONAL NANOFABRICATION USERS NETWORK File size (bytes): 3953 STIS Filename: pr9388 Title: PR 93-89 DISEASE RESISTANCE GENE CLONED FROM TOMATO PLANT File size (bytes): 2948 STIS Filename: pr9389 Document Type: Program Guideline Title: NSF 93-162 -- Small Business Technology Transfer (STTR) File size (bytes): 84405 STIS Filename: nsf93162 Title: NSF 93-166 Academic Reasearch Infastructure Facilities Modernization Brochure File size (bytes): 20906 STIS Filename: nsf93166 Document Type: Recruit Title: Director, Division of Chemistry, Directorate for Mathematical and Physical Sciences File size (bytes): 7989 STIS Filename: vep941 Title: Chemist (Program Director) File size (bytes): 4682 STIS Filename: vex943 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 112844 STIS Filename: phnalpha ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnalpha, the text of your message should be as follows: get phnalpha Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnalpha, you would enter: ftp> get phnalpha WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Dec 27 22:00:00 1993 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 26 December 1993 Date: 27 Dec 1993 20:19:39 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 71 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2foc4r$4nq@net.bio.net> NNTP-Posting-Host: net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Recruit Title: Deputy Director, Division of Molecular and Cellular Biosciences File size (bytes): 7450 STIS Filename: vep947 Title: Geneticist (Program Director) File size (bytes): 3760 STIS Filename: vex947 Title: Biological Science Administrator (Program Director) File size (bytes): 3861 STIS Filename: vex948 Title: Biological Science Administrator (Program Director) File size (bytes): 3815 STIS Filename: vex949 Title: Senior Program Assistant (Office Automation) File size (bytes): 5009 STIS Filename: vgs9426 Document Type: SRS Data Brief Title: NSF 93-324 Academic R&D Spending Increased in FY 1992 File size (bytes): 5690 STIS Filename: nsf93324 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf93324, the text of your message should be as follows: get nsf93324 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf93324, you would enter: ftp> get nsf93324 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Dec 27 22:00:00 1993 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 19 December 1993 Date: 27 Dec 1993 20:14:23 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 67 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2fobqv$4d6@net.bio.net> NNTP-Posting-Host: net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: FY94 RIA Notice File size (bytes): 2266 STIS Filename: ciseria Title: FY94 RIA Notice File size (bytes): 2264 STIS Filename: engria Document Type: SRS Data Brief Title: DB 93-324 Academic R&D Spending Increased in FY 1992 File size (bytes): 5688 STIS Filename: db93324 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113153 STIS Filename: phnalpha ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnalpha, the text of your message should be as follows: get phnalpha Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnalpha, you would enter: ftp> get phnalpha WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Dec 27 22:00:00 1993 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 12 December 1993 Date: 27 Dec 1993 20:12:30 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 115 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2fobne$4c8@net.bio.net> NNTP-Posting-Host: net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Recruit Title: Director, Division of Physics File size (bytes): 7635 STIS Filename: vep945 Title: Deputy Director, Division of Social, Behavioral and Economic Research File size (bytes): 7697 STIS Filename: vep946 Title: Sociologist (Program Director) File size (bytes): 4426 STIS Filename: vex944 Title: Secretary (Office Automation) File size (bytes): 5120 STIS Filename: vgs9420 Title: Information Management Supervisor (Branch Chief) File size (bytes): 6802 STIS Filename: vgs9421 Title: IPA (Computer Manager) File size (bytes): 3894 STIS Filename: vipadas Document Type: Report Title: ASSESSMENT OF THE NATIONAL SCIENCE FOUNDATION'S 1988-90 UNDERGRADUATE FACULTY ENHANCEMENT PROGRAM File size (bytes): 29317 STIS Filename: nsf93122 Title: ASSESSMENT OF THE NSF 1988-90 UNDERGRADUATE FACULTY ENHANCEMENT PROGRAM (INTERPRETIVE OVERVIEW) File size (bytes): 23740 STIS Filename: nsf93123 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 885 STIS Filename: cmpublic Title: NSF Advisory Committee Meetings File size (bytes): 885 STIS Filename: cmpublic Document Type: EPS Title: The NSF Electronic Proposal Submission Project File size (bytes): 5231 STIS Filename: epsflyer Title: NSF Electronic Proposal Submission Project (EPS) Information File size (bytes): 16020 STIS Filename: epsinfo Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113052 STIS Filename: phnalpha Title: NSF Alpha Telephone Directory File size (bytes): 113052 STIS Filename: phnalpha ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnalpha, the text of your message should be as follows: get phnalpha Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnalpha, you would enter: ftp> get phnalpha WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet).