ENVIRONMENTAL FACTORS AND BREAST CANCER IN HIGH-RISK AREAS NIH GUIDE, Volume 22, Number 11, March 19, 1993 RFA AVAILABLE: CA/ES-93-024 P.T. 34 Keywords: Cancer/Carcinogenesis ENVIRONMENT Epidemiology Risk Factors/Analysis Occupational Health and Safety National Cancer Institute National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 16, 1993 Application Receipt Date: May 20, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Extramural Programs Branch, Division of Cancer Etiology, National Cancer Institute (NCI) and the Division of Extramural Research and Training, National Institute of Environmental Health Sciences (NIEHS) invites grant applications for innovative epidemiologic studies to better understand the etiology of breast cancer in high risk areas including Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. These studies are to be designed to take known risk factors into consideration and must focus on markers or indicators of environmental exposures that may influence geographic differences in rates and temporal changes in incidence and mortality. 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, Environmental Factors and Breast Cancer in High-Risk Areas, is related to the priority area of cancer. Potential applicants may obtain a copy of a "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 Applications may be submitted by domestic non-profit and for-profit institutions, public and private, such as colleges, universities, hospitals, research laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from or involving minority institutions, individuals, and women are encouraged. MECHANISM OF SUPPORT This RFA will be supported through the NIH research project grants (R01). Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. It is anticipated that the average award will be approximately $250,000 total costs. This RFA is a one-time solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. Competitive continuation applications will compete with cited applications and be reviewed by a Division of Research Grants study section. If the NCI and the NIEHS determine that there is a sufficient continuing program need, they may announce a request for renewal applications. FUNDS AVAILABLE Approximately $1.0 million per year in total costs for four years will be committed by the NCI to specifically fund applications which are submitted in response to this RFA. In addition, $250,000 will be committed by the NIEHS to fund at least one application. The expected range of number of awards is three to five. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NCI and the NIEHS, the award of grants pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES This RFA responds to the FY 1993 Senate Appropriations Subcommittee Report for NIH which specifies that "NCI is directed to conduct a study with four years of follow-up to determine the factors contributing to the high breast cancer mortality rates in Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. NCI is to develop a plan for conducting the study and provide it to the House and Senate Appropriations Committees, the House Committee on Energy and Human Resources and the Senate Committee on Labor and Human Resources by July 1, 1993. $1 million is provided to fund this study." This RFA encourages applications for epidemiologic studies of breast cancer that include assessment of markers or indicators of environmental or occupational exposures, and include persons residing in the high-risk areas of Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington, DC. These studies are to be designed to take known risk factors into consideration while focusing on environmental exposures that may account for geographic differences in rates, as well as temporal changes in incidence and mortality.Investigators must include innovative approaches to the quantitation of environmental and/or occupational exposures and the evaluation of biologic levels in exposed persons. Collaborations of multiple disciplines and research institutions are particularly encouraged. Whenever possible, research designs should make use of existing resources, such as specimen repositories. Investigators may propose studies for evaluating the mechanisms by which environmental, nutritional, or occupational exposures could act in the initiation or promotion of breast cancer, such as through effects on hormonal or metabolic pathways. Projects should be proposed as traditional R01s. Proposals may build upon ongoing research projects, utilizing already collected specimens or epidemiologic data. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are requested to submit by April 16, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel and participating institutions, 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in review. The letter of intent is to be sent to Dr. A.R. Patel at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The format and instructions applicable to regular research grant applications must be followed. Applications must be received by May 20, 1993. If an application is received after that date, it will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review criteria for RFAs are the same as those for unsolicited research grant applications. AWARD CRITERIA The earliest anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues, requests for the RFA, and address the letter of intent to: A.R. Patel, Ph.D. or Kumiko Iwamoto, M.D. Division of Cancer Etiology National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Suite 535 Rockville, MD 20892 Telephone: (301) 496-9600 Dr. William A. Suk 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 Direct inquiries regarding fiscal matters to: Ms. Katherine Schulze Grants Administration Branch National Cancer Institute 6120 Executive Boulevard Executive Plaza South, Suite 243 Rockville, MD 20892 Telephone: (301) 496-7800, ext. 16 Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393 and 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) 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 System Agency review. .
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