Full Text CA-95-016 NATIONAL ACTION PLAN ON BREAST CANCER INNOVATIVE SMALL GRANT PROGRAM NIH GUIDE, Volume 24, Number 13, April 7, 1995 RFA: CA-95-016 P.T. 34 Keywords: 0715036 Biomedical Research, Multidiscipl National Cancer Institute Application Receipt Date: June 14, 1995 PURPOSE The National Action Plan on Breast Cancer (NAPBC) is a public-private partnership created to eliminate the epidemic of breast cancer. The Public Health Service's Office on Women's Health, which coordinates the implementation of the NAPBC, and the National Cancer Institute (NCI) invite applications for Small Grants (R03) in breast cancer research and outreach activities to address several priority areas in the NAPBC. This program is designed to support the implementation of six high priority areas for breast cancer that were derived from the "Proceedings of the Secretary's Conference to Establish a National Action Plan on Breast Cancer." These six activity areas are: information dissemination, national biological resource bank, consumer involvement, breast cancer etiology, clinical trials accessibility, and breast cancer susceptibility genes issues. One goal of this initiative is to provide support for novel, creative pilot research and outreach projects that, if successful, will yield exceptionally important new information on breast cancer. A second goal is to support developmental, exploratory, or pilot projects that could serve as the basis for more comprehensive well-defined future research and outreach project applications in the area of breast cancer. Funds to support this Small Grant program will be administered through the NCI. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), National Action Plan on Breast Cancer Innovative Small Grant Program, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Since this RFA concerns the National Action Plan on Breast Cancer, foreign or domestic applications with an international component are not eligible. Applications from minority and women investigators are encouraged. Small grant research support may NOT be used to supplement research projects currently supported by Federal or non-Federal funds. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) small research grant (R03) as its funding mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the present RFA may not exceed two years. Total direct costs up to $50,000 per year are allowed. The anticipated award date is September 30, 1995. Awards and level of support depend on receipt of applications of sufficient scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. This RFA is a one-time solicitation for new applications. Future unsolicited applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $3,000,000 in total costs per year for two years will be committed to fund applications submitted in response to this RFA. It is anticipated that approximately 40 awards will be made. RESEARCH OBJECTIVES Background Breast cancer, the most commonly diagnosed cancer and the second leading cause of cancer deaths among American women, has been identified as a public health priority in the United States. Breast cancer represents 32 percent of all cancers in women, and the lifetime risk of developing breast cancer today is one in every eight women, up from one in every twenty women just two decades ago. In October 1993, President Clinton was formally presented with a petition signed by 2.6 million people calling for the establishment of a comprehensive strategy to end the breast cancer epidemic. In response, HHS Secretary Shalala convened the "Secretary's Conference to Establish a National Action Plan on Breast Cancer" in December 1993. The conference was a unique undertaking that brought together for the first time 300 individuals, including advocates, consumers, clinicians, scientists, government officials, educators, members of Congress, the media, and others to develop a comprehensive plan for fighting breast cancer. The "Proceedings of the Secretary's Conference to Establish a National Action Plan on Breast Cancer" provides a framework and plan for activities in three major areas: the delivery of health care, the conduct of research, and the enactment of policy. The document represents a statement of national opportunities upon which to build and strengthen knowledge, resources, and commitment in the prevention, diagnosis, treatment, care and, ultimately, elimination of breast cancer as a threat to American women. The Public Health Service's Office on Women's Health is responsible for the coordination of the implementation of the NAPBC. A strong emphasis of the NAPBC is on the continued creation of public/private partnerships among consumers, health care professionals, scientists, private industry, Congress, the media, and Federal and state government agencies. In June 1994, the Conference Co-Chairs Coordinating Group met with government representatives and set six major priorities for FY 1995 described below. The NAPBC encourages Small Grant applications (R03) for the conduct of research or outreach projects related to the following six priority developmental, exploratory, or pilot areas: information dissemination, national biological resource bank, consumer involvement, breast cancer etiology, clinical trials accessibility, and breast cancer susceptibility genes issues. Applicants are encouraged to address the needs of women who may have been generally underserved in research and outreach activities. Applicants must address one or more of the six priority areas below. Within each priority area, examples of issues that may be addressed include, but are not limited to, the following: INFORMATION DISSEMINATION: Develop innovative tools and approaches for the Information Superhighway to disseminate information to and facilitate communication between scientists, consumers and practitioners about breast cancer, breast cancer clinical trials, and breast health using state-of-the-art information technologies such as computer systems, interactive videos, CD-ROM, etc. NATIONAL BIOLOGICAL RESOURCE BANK: Develop exploratory projects that would lead to the establishment of biological resource banks to ensure a national resource of biological materials for several areas of breast cancer research. Examples of possible topics include, but are not limited to, expansion of the number of samples in existing tissue banks, feasibility studies of the inclusion of other biological tissues (cell lines, lymphocytes, etc.) in biological banks, development of new technologies to facilitate the collection of pertinent background data on samples, and cooperative participation in the National Biological Resource Bank activities to increase the availability of samples to investigators across the country. In addition, studies to investigate the ethics of using biological specimens in research are of interest. CONSUMER INVOLVEMENT: Ensure consumer involvement at all levels in the development and implementation of public health and service delivery programs, research studies, and outreach efforts. Involve advocacy groups and women with breast cancer in setting research priorities and in patient education. BREAST CANCER ETIOLOGY: Foster pilot projects to expand the scope of biomedical, epidemiological, and behavioral research activities related to the etiology of breast cancer. Priority areas for pilot projects include the development and testing of exploratory procedures, survey instruments, screening tests, etc. that may prove useful to evaluate: the effects of radiation and electromagnetic fields, chemicals, hormones, lifestyle factors, viruses, and gene- environment interactions. CLINICAL TRIALS ACCESSIBILITY: Identify barriers to participation in clinical trials. Pilot strategies to overcome presumed barriers through outreach to consumers and clinicians, through better understanding of the decision making process for women and their physicians, through reduction of economic constraints, etc. Such pilot projects would lead to the goal of making clinical trials more widely accessible to women with breast cancer and women who are at risk for breast cancer. BREAST CANCER SUSCEPTIBILITY GENES ISSUES: Address the health needs and ethical, legal, and policy issues of individuals carrying breast cancer susceptibility genes. Recommend and pilot interventions for consumers, health care providers, and at-risk patient groups which will lead to the development of a comprehensive plan for these groups. Special consideration will be given to the following: o Implementing partnerships with private sector groups and/or o Including breast cancer consumer/advocacy groups in the design, conduct and evaluation of clinical/outreach/research strategies and o Testing new, innovative designs for ongoing outreach or research studies. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 4928 of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. 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 301-710-0267; and from the NAPBC program staff listed under INQUIRIES. The RFA label available in the PHS 398 application form 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 and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/overnight mail service) At the time of submission, two additional copies of the application must also be sent to: Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Bethesda, MD 20852 (for courier/overnight mail service) Applications must be received by June 14, 1995. If an application is received after that date, it will be returned. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already 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. SPECIAL INSTRUCTIONS FOR THE COMPLETION OF APPLICATION FORM PHS 398 NIH has recently been designated a "re-invention laboratory" by the Public Health Service. One component of our efforts to streamline NIH operations is to simplify the grant application and review process. Therefore, an experiment is being conducted to determine ways to reduce the administrative burden in applying for an NIH grant without compromising those elements needed by the initial scientific peer review group to assess the scientific merit of the application and the reasonableness of the proposed budget. In responding to the RFA, the following are specific instructions for sections of the PHS 398 (rev. 9/91) application form that must be completed DIFFERENTLY from usual. Some sections are modified and other sections do not need to be completed for the submission of the application, but WILL be requested if the application receives a priority score in the fundable range. For all other items in the application, follow the instructions on pages 9-32 of the PHS 398 booklet. Face Page (Form AA), Item 10, Inventions and Patents - Do not complete. See items 3-4, page 8 of these instructions. Detailed Budget Page for Initial Budget Period (Form DD, page 4) - Total direct costs may not exceed $50,000 per year. Enter direct costs only for the following: o Personnel, Patient Care Costs, Alterations-renovations - Complete these sections as instructed in the PHS 398 booklet. o Consultant Costs - Itemize only if proposed consultant costs exceed $10,000 or if a consultant is identified as key personnel. o Equipment - Itemize only individual items in excess of $10,000. o Supplies - Itemize (a) all animal costs and (b) any individual supply item that costs more that $10,000. If animals are involved, state their unit purchase and care costs. Enter total animal costs and supply costs on separate lines. o Travel and Other Expenses - Itemize any individual expense that exceeds $5,000. Budget for Entire Proposed Project Period (Form EE, page 5) - Do not complete this page. The future year will be automatically escalated on the direct costs proposed for the first year (minus one time costs for equipment) by four percent, not to exceed $50,000 direct costs per year, unless unusual increases of or decreases in future years are being requested. Biographical Sketch (Form FF, page 6) - For each KEY person only, provide no more than a two-page biographical sketch. o Name, Position, Title, Education - Complete these sections as instructed in the PHS 398 booklet. o Research and Professional Experience - Identify research background and experience relevant to the research proposed. Specifically, provide: 1. a list of previous research positions that are felt to be of significance or relevance for the review of the proposed research 2. complete references, titles, and authors on all peer-reviewed publications representative of research career or pertinent to the research proposed 3. the title and funding source of all active research grants or contracts on which are principal investigator, co-investigator, or project leader. Indicate current percent effort for each award. 4. the title and length of service on any peer review group, national advisory council, or program advisory committee Resources and Environment (Form HH, page 8) - Complete items(s) only if proposed research requires specialized resources unique for the proposed research. C. Specific Instructions-Research Plan (Booklet, pages 19-24) - Items 1-4 may not exceed 16 pages in total. Item 1, Specific Aims - In one page or less, list in priority order, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. Item 2, Background and Significance - In five pages or less, use this section to describe (a) how the proposed research will contribute to meeting the goals and objectives of the RFA; and (b) explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. Items 3-4 - In ten pages or less, complete as instructed on pages 20- 21 of the PHS booklet with the modification that ONLY five publications, manuscripts submitted or accepted for publication, patent, or invention reports can be included in the Appendix (see page 4). Members of previous review panels advise that an investigator should use this section to address the following: o preliminary studies pertinent to the application o rationale for each particular set of experiments o general methods that will be utilized; provide specific details ONLY for those techniques that are unique or where a significant departure from a generally accepted technique is important for reviewers to know o outcome measures that will be used to assess the success or failure of each set of experiments o plans for the rigorous management and verification of research data o plans for the early detection of and protection against adverse effects on human subjects o potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. Items 5-6 - Complete as described on pages 22-23. Item 7, Consultants/Collaborators - Biographical sketches should conform to the brief format described previously for Form FF. Item 8, Consortium, Contractual Arrangements - In one page or less, provide a brief explanation of the programmatic, fiscal and administrative arrangements made with collaborating organizations. D. Specific Instructions-Appendix (Booklet, page 24) - Only five publications, manuscripts, submitted or accepted for publication, patents, invention reports should be provided. Other than this change, complete as instructed. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and by the staff of the NCI and the Public Health Service's Office on Women's Health working on the NAPBC for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NAPBC staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. The review group will assess the scientific merit of the studies using the following review criteria: o originality of proposed project; o scientific and technical significance of the proposed study; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o research training and qualifications of the Principal Investigator and staff in the area of the proposed project; o availability and quality of the resources necessary to perform the project; o quality of data verification and management plans; and o appropriateness of the proposed budget and length of project in relation to the proposed research. o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will be considered for award based upon (a) scientific and technical merit; (b) availability of funds; and (c) programmatic priorities. Preference will also be given to investigators who are new to this research area. Application Receipt Date: June 14, 1995 Anticipated Award Date: September 30, 1995 INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues about the six priority areas of the NAPBC to: Susan J. Blumenthal, M.D., M.P.A. Deputy Assistant Secretary for Health (Women's Health) Co-Chair, The National Action Plan on Breast Cancer ATTN: Suzanne G. Haynes, Ph.D. Office on Women's Health, USPHS Hubert Humphrey Building, Room 730-B 200 Independence Avenue, S.W. Washington, DC 20201 Telephone: (202) 690-7650 FAX: (202) 690-7172 Direct inquiries regarding fiscal matters to: William G. Wells Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 6120 Executive Boulevard Bethesda, MD 20892-7150 Telephone: (301) 496-7800, Extension 250 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, Cancer Cause and Prevention Research; No. 93.394, Cancer Detection and Diagnosis Research; No. 93.395, Cancer Treatment Research; No. 93.396, Cancer Biology Research; and No. 93.399, Cancer Control. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations of 42 CFR Part 52, 45 CFR Part 74, and 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. .
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