Full Text DK-96-005 THE REGULATION OF PROSTATE GROWTH NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: DK-96-005 P.T. 34 Keywords: Urogenital System Growth Factors 0705048 National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Aging Letter of Intent Receipt Date: July 15, 1996 Application Receipt Date: August 8, 1996 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute on Aging solicit research project grant (R01), First Independent Research Support and Transition (FIRST) (R29) award, and Interactive Research Project Grant (IRPG) applications for the support of basic research studies that use human tissue and cells to focus on the molecular mechanisms of the regulation of normal prostate growth, the factors involved in the re- initiation of normal growth in adult men, and abnormal, non-malignant prostate growth and disorders. The intent of this solicitation is to increase the diversity of approaches to the study of prostate growth regulation and related abnormalities by encouraging investigators from diverse research areas to apply their expertise in this area. 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, The Regulation of Prostate Growth, is related to the priority area of disease and aging. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. Competing renewal applications are not eligible for this solicitation. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01), Investigator-Initiated Interactive Research Project Grant (IRPG) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed five years. FIRST Awards must be for five years and the total direct cost award for the five year period may not exceed $350,000. A maximum of three years can be requested for foreign awards. The maximum dollar request is limited to $160,000 in direct costs for the initial budget period for R01s and the individual IRPGs. However, the lead IRPG may include a request for up to an additional $50,000 Direct Costs for shared resources. (Special instructions for preparing applications for IRPGs must be requested from the program officials listed under INQUIRIES). The anticipated award date will be April 1, 1997. FUNDS AVAILABLE For FY 1997, $2,500,000 will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that 12 to 14 awards will be made by the NIDDK. In addition, the NIA will fund up to two high quality applications related to molecular and cellular mechanisms of prostate growth in middle aged and older men. However, these funding level are dependent upon the receipt of a sufficient number of applications of high scientific merit. In order to help meet NIDDK and NIA goals or managing the costs of biomedical research, applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plans of the NIDDK and NIA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background: Normal and abnormal prostate growth contribute to two major prostate diseases: benign prostatic hyperplasia (BPH) and prostate cancer (PCa). Other prostate abnormalities result in the development of chronic prostatitis. The factors involved in the initiation and regulation of prostate growth have been inadequately characterized and many new factors remain to be described. There are also many other areas of prostate abnormality which are poorly investigated. Of particular importance are the immunologic mechanisms of the prostate and the interrelationship between benign prostate enlargement and urinary bladder abnormalities. A large amount of the current knowledge about these diseases has been extrapolated from research studies on animals and animal cell lines. The number of studies which focus on well characterized human tissue are very limited. If progress is to be made in effectively treating and preventing prostate disease, the basic molecular mechanisms which regulate prostate growth must be characterized in normal prostate tissue and in well characterized abnormal prostate tissue. Innovative molecular approaches to the study of cellular growth and immunology are being utilized effectively by investigators in fields as diverse as oncology, wound healing, morphogenesis, and pharmacogenetics. All too often these investigators focus on one specific organ system or disease problem and are not encouraged to apply their knowledge to a related phenomenon in a different tissue. Areas for investigation: The major emphasis of this RFA is the solicitation of new and innovative approaches to study of prostate growth and chronic prostate inflammation using well characterized human tissue. (Well characterized tissue is tissue for which both a pathological diagnosis, e.g. normal, prostatitis, hyperplasia, chronic prostatitis, and, if possible, the concurrent clinical parameters, are identified.) If animal tissue is used in the study design, it cannot be the major focus of the study but used as a mechanism to develop or amplify studies on human tissue. Topics that are be within the scope of this RFA include, but are not limited to: o research studies on prostate stem cells, o common regulatory factors found in various prostate diseases such as prostatitis, BPH and PCa, o the role of cytokines, interleukins, etc. in prostate growth regulation, o the regulation of prostate apoptosis, o cell/cell interactions and prostate growth o enzymatic factors involved in the regulation of prostate growth, o molecular genetics of prostate growth regulation, o the role of neuroendocrine cells and neuroendocrine factors in prostate growth regulation, o fetal imprinting and adult prostate growth regulation. o the effect of diabetes mellitus on prostate growth regulation. o comparison of growth regulation in tissues from persons of diverse ethnic/racial origins, o the molecular effects of prostate enlargement and/or outflow obstruction in gene expression in bladder and prostate, o the immune defense mechanisms of the human prostate and urethra, o effects of bacterial agents on the molecular immunology of the prostate, o exocrine, paracrine and other regulator mechanisms of prostate growth, o genetic differences in growth initiation in prostate tissue from persons of diverse ethnic origins. o age-related changes in prostate growth bioregulatory factors, and prostate cell sensitivity to these factors, o molecular, cellular, and genetic mechanisms that lead to initiation and sustenance of prostate growth in middle aged men. Applications solely to study malignant prostate growth and its regulation are not within the scope of this RFA. However, applications that use malignant tissue for comparative study with benign hyperplasia, chronic prostatitis, normal cells, or models are acceptable for application. Program project grant applications (P01) will not be accepted in response to this RFA. Special Requirements: NIDDK BPH Clinical Trial Investigators: Investigators funded by either the Pilot or Full-Scale NIDDK BPH Clinical Trial may utilize the tissue collected by the study and stored at the diagnostic center. Applicants must include with their application a letter from the NIDDK Project Officer stating that they are eligible to use this tissue bank. Applicants should include in their budget any special shipping or preparation costs which will be incurred by the diagnostic center and additional travel funds to the NIH for two research planning meetings during the first grant period. FIRST Award Applicants: Must adhere to the R29 Administrative Guidelines (revised February 1994) for eligibility, budget and period of award. FIRST Award applications (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award applications submitted without the required reference letters will be considered incomplete. Foreign Institutions are not eligible for FIRST Awards. 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 sub-populations must be included in all NIH supported biomedical and behavioral research 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 492B 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. Because this solicitation is limited to prostate tissue, a statement regarding the inclusion of women in the study is not necessary. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS Volume 23, Number 11, March 18, 1994. Investigators may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by July 15, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities 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 a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. 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 title and number must be typed on line 2 of the face page of the application form and the YES box must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must also be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by August 8, 1996. If an application is received after that date, it will be returned to the applicant without review. 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review criteria o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration 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. o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. o in addition, the reviewers will be asked to address the new and innovative character of the application; applicants should ensure that those factors are delineated in the application. AWARD CRITERIA The anticipated date of award is April 1, 1997. Funding decisions will be made based on the scientific and technical merit as reflected in the priority score, availability of funds, and programmatic priorities. Compliance with the intent and purpose of the RFA will also be considered in funding decisions. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301)-480-3510 Email: Ralph_Bain@nih.gov Leroy M. Nyberg, Jr., Ph.D., M.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301)-480-3510 Email: Leroy_Nyberg@nih.gov Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@gw.nia.nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Trude Hilliard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8859 FAX: (301) 480-3504 Email: MccainT@ep.niddk.nih.gov Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, Md 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: pikeb@gw.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK) and 93.866 (NIA). 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 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. 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 case, any portion of a facility) in which regular or routine 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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