BREAST CANCER RESEARCH PROGRAMS IN NCI-DESIGNATED CANCER CENTERS NIH GUIDE, Volume 22, Number 43, November 26, 1993 RFA AVAILABLE: CA/ES/AG-94-005 P.T. 34 Keywords: 0715036 Biomedical Research, Multidiscipl 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 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE This 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). 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 an 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 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. Two different levels of eligibility are as follows: 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. An Institution may apply for both of these expansion components, but must provide separate applications for each. The maximum period of support will be four years. (see FUNDS AVAILABLE) 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. The P20 Planning and Development Grant will support: (1) the partial salary of the Program Development Director; (2) funds for special retreats and meetings; (3) developmental funds for recruitment of new scientists; (4) developmental funds for pilot projects; and (5) expansion of an existing shared resource or development of a new shared resource. FUNDS AVAILABLE Approximately $4.9 million is anticipated for availability in Fiscal Year 1994 to fund applications submitted in response to this RFA. Up to eight awards for the development of new breast cancer programs could be made for approximately $400,000 total costs 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. The 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 is limited to not more than 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 Breast cancer is the most common cancer among U.S. females and the incidence of breast cancer has increased at a rate of approximately two percent per year since 1980. This RFA is to encourage research that draws from expertise in many disciplines to focus on the problem of breast cancer in the basic, clinical and prevention and control research arenas, 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. This RFA is designed to provide a significant part of the developmental resources necessary to establish the program in order to encourage qualified institutions to make the long term commitment necessary to sustain the program as a ongoing part of the Cancer Center. The goal of this RFA is to establish a solid, broad-based infrastructure for the conduct and continued development of breast cancer research. The planning effort should result in an integrated, interactive research capability with a significant base of externally funded, peer reviewed research projects, focused on the problem of breast cancer. 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. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES Clinical research conducted under this RFA is likely to accrue women predominantly. However, applicants should also ensure that special attention is given to the inclusion of minorities in study populations. If minorities are not included in the study population for any clinical study, a specific justification for the exclusion from the study must be provided. Applications without such documentation will not be accepted for review. 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 a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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 The research grant application form PHS 398 (rev. 9/91) is to be used in applying for the P20 Planning Grant. 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and the program administrators listed under INQUIRIES. Supplemental instructions for preparing the application are provided in the RFA. The receipt date for applications under this RFA is February 17, 1994. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed initially for completeness and responsiveness. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications will be assessed on: (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 be based on how well the cancer center is expected to 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. The specific criteria that will be used by the peer review group in its evaluation of each application are outlined in the RFA. Only highly meritorious applications will be funded. The earliest anticipated date of award is September 30, 1994. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and 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. .
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