GENERAL PROVISIONS FOR THE NATIONAL ACTION PLAN ON BREAST CANCEROMNIBUS PUBLIC HEALTH SERVICE (PHS) ADMINISTRATIVE SUPPLEMENTS NIH GUIDE, Volume 24, Number 14, April 14, 1995 P.T. Keywords: National Cancer Institute PROGRAM GOALS AND SCOPE 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, will offer approximately $2 million in FY 1995 for supplemental awards of up to $100,000 (direct costs) for a period of one year. These administrative supplements are offered to enable currently federally funded investigators to address one or more of six high priority areas for breast cancer research and outreach activities that were derived from the "Proceedings of the Secretary's Conference to Establish a National Action Plan on Breast Cancer," held in December 1993. Any currently funded investigator-initiated PHS research and outreach grants relevant to breast cancer is eligible for an administrative supplement under this announcement including those funded by any PHS entity, NIH Institute, Center or Division (ICD). Contracts are not eligible for this supplement program. Since this announcement concerns administrative supplements for the National Action Plan on Breast Cancer, foreign or domestic applications with an international component are not eligible. The six priority areas for administrative supplements are: information dissemination, national biological resource bank, consumer involvement, breast cancer etiology, clinical trials accessibility, and breast cancer susceptibility genes issues. Applicants must address one or more of the six priority areas below. Within each priority area, examples of issues which may be addressed are, but not limited to, the following: INFORMATION DISSEMINATION: Develop innovative tools, approaches and strategies 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 (e.g. computer systems, interactive videos, CD-ROM, and/or the Information Superhighway). NATIONAL BIOLOGICAL RESOURCE BANK: Establish biological resource banks to ensure a national resource of well characterized and documented biological materials for multiple areas of breast cancer research. Examples of possible topics include, but are not limited to, a survey of existing tissue banks, the inclusion of other biological tissues (cell lines, lymphocytes, etc.) in biological banks, use 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: Expand the scope and breadth of biomedical, epidemiological, and behavioral research activities related to the etiology of breast cancer. Priority areas for projects include the effects of radiation and electromagnetic fields, chemicals and hormones, lifestyle factors, viruses, and gene-environment interactions. CLINICAL TRIALS ACCESSIBILITY: Make clinical trials more widely accessible to women with breast cancer and women who are at risk for breast cancer. Identify barriers to participation in clinical trials and develop strategies to overcome these 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. BREAST CANCER SUSCEPTIBILITY GENES ISSUES: Address the health needs and ethical, legal, and policy issues of individuals carrying breast cancer susceptibility genes. Recommend and test interventions for consumers, health care providers, and at-risk patient groups, which will lead to the development of a comprehensive plan for these groups. It is especially important to note that all requests for supplements MUST be within the scope of the parent grant. The parent grant can deal with breast cancer, other cancers, other diseases, or any of the above six priority areas. Program directors for individual grants must be contacted for questions on the consistency of the proposed supplemental project's aims with the parent project. The parent award must have a minimum of one year remaining (end date no sooner than September 30, 1996) in the project from the time the supplement is awarded. This will ensure that results of the activities under the administrative supplement can be incorporated into a competing continuation application of the parent award at the discretion of the Principal Investigator. Direct costs of the supplement can represent no more than 25 percent of the current year total direct costs, not to exceed $100,000 direct cost maximum. APPLICATION PROCEDURES Principal Investigators requesting supplements (regardless of parent ICD) should use a standard PHS-398 (rev. 9/91) Face Page and Budget; no more than five single-spaced pages of text addressing specific aims, background and significance, research design and methods; and a list of pertinent references (not included in the five page limit). In addition, the following material is required: a copy of the official initial peer review comments for the parent grant (e.g. summary statement or the equivalent); the most current Notice of Grant award; biographical sketches (page FF of PHS-398 or equivalent) of all relevant project staff. All requests must be signed by the appropriate institutional officials as well as the Principal Investigator. Budget requests for less than $50,000 direct costs need only indicate personnel time and effort total dollars requested; budgets in excess of $50,000 must provide categorical listings as required in PHS Form 398 instructions. Investigators funded by PHS entities outside of the National Cancer Institute may be required to provide additional budgetary information or be subject to additional conditions or limitations consistent with the general policies and practices of the specific units holding the parent award. Individuals will be notified of such issues by their administrative contact if an award is contemplated. Submit by the receipt date of June 14, 1995 a signed, typewritten original of the request and 4 signed, exact copies, in one package to: National Action Plan on Breast Cancer 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 At the same time, an exact copy of the application MUST be submitted directly to the Program Director of the PHS funding component responsible for the funding of the parent grant. The name of the program director and awarding official should be on the notice of award for the parent grant that is sent directly to principal investigators and institutional business offices. If there is any question about who or where to send this copy, applicants should call the agency directly for the information prior to mailing the copy. A copy of this announcement should be included with your request for a supplement. Failure to do so may exclude the request from the competition. In case your program director is not familiar with the NAPBC competition, they should be referred to one of the individuals listed below for more information. EVALUATION AND FUNDING PROCEDURES Requests for Omnibus Administrative Supplements will be evaluated and ranked by a process involving representatives of Federal agencies including DHHS, outside consultants, and the PHS Office of Women's Health. The evaluation will be made against the following general criteria: originality of proposed activity, scientific and technical significance of the proposed study as related to the six high priority areas, appropriateness and adequacy of the experimental approach and methodology to carry out the activity, development of public and private partnerships, the potential of the project to develop successful programs during the one year supplement period (i.e. qualifications of project team, resources, data quality and management plans), and appropriateness of the proposed budget and activities to the parent award. Applicants are encouraged to address the needs of women who may have been generally underserved in research and outreach projects. Special consideration will be given to proposed activities that emphasize the following: o Implementing partnerships with public and private sector groups, o Including breast cancer consumer/advocacy groups in the design, conduct and evaluation of clinical/outreach/research strategies, o Testing new, innovative designs for ongoing research or outreach studies, The information and initial evaluation will be forwarded to appropriate PHS program directors for review to ensure that the proposed activities are compatible with and within the scope of the objectives and aims of the parent project. Requests will also be reviewed for the appropriateness of funds requested and for potential overlap with other current support. Applications must be submitted by June 14, 1995. Successful supplements will be funded no later than September 30, 1995. Approximately 20-30 supplements will be awarded from this program. The Public Health Service's Office on Women's Health coordinates the implementation of the NAPBC. Funding for the NAPBC is administered by the National Cancer Institute (NCI). Approved Administrative Supplements will be funded directly from the NCI (if the parent grant is a NCI grant); or through a co-funding or interagency agreement between NCI and other PHS entities. INQUIRIES For additional information about this initiative, interested and eligible investigators should contact: Susan J. Blumenthal, M.D., M.P.A. Deputy Assistant Secretary for Health (Women's Health) Co-Chair, National Action Plan on Breast Cancer ATTN: Suzanne G. Haynes, Ph.D. (etiology; consumer involvement) Cheryl L. Marks, Ph.D. (clinical trials; information dissemination) Debbie Saslow, Ph.D. (breast cancer susceptability genes; tissue bank) Office on Women's Health, USPHS Hubert Humphrey Building, Room 730-B 200 Independence Avenue, S.W. Washington, DC 20201 Telephone: (202) 401-9587 FAX: (202) 401-9590 or Susan M. Sieber, Ph.D. Deputy Director Division of Cancer Etiology National Cancer Institute Building 31, Room 11A03 Bethesda, MD 20892 Telephone: (301) 496-5946 FAX: (301) 496-1297 Direct inquiries regarding fiscal matters to: William G. Wells Section Chief 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 Since program directors in agencies outside of NCI may be unfamiliar with this program, they are encouraged to contact one of the above individuals for more information. .
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