UROLOGY RESEARCH CENTERS Release Date: July 16, 1998 RFA: DK-98-018 P.T. National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute Letter of Intent Receipt Date: October 20, 1998 Application Receipt Date: November 20, 1998 PURPOSE This Request for Applications (RFA) invites investigators to submit research grant applications for the George M. O'Brien Research Centers Program. The emphases for this program are to: (1) attract new scientific expertise into the study of the basic mechanisms of urological diseases and disorders; (2) encourage multidisciplinary research focused on the causes of these diseases and disorders; and (3) extend the development of innovative clinical and epidemiologic studies of the causes, therapy and possible prevention of urological diseases and disorders. In approaching the study of these disease processes, it is anticipated that extensive collaboration will be required between individuals in the clinical and basic sciences, including for example investigators with training and expertise in cell biology, molecular biology, immunology, genetics, epidemiology, biochemistry, physiology, and pathology. An intent of this RFA is to attract new investigators not currently active in this field and to explore new basic areas that may have clinical research applications. Individual institutions with both basic and clinical research capabilities are eligible to apply. Inter-institutional collaborative research arrangements are also appropriate and encouraged. Coordination for such arrangements must be evident and clearly meaningful and appropriate for the research proposed. The National Cancer Institute (NCI) plans to provide support for this initiative in the area of prostate cancer. Studies to be supported may include the full range from laboratory to clinical investigations encompassing biology, etiology, detection, diagnosis, treatment, prevention and control. Of particular interest is multidisciplinary research that links basic research to applied settings involving patients and populations. 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. 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 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT Support of this program will be through the NIH specialized center (P50) 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. FUNDS AVAILABLE The NIDDK and NCI expect to award one center grant (P50) for research into urologic disorders in fiscal year 1999. The anticipated award is for five years and is contingent upon the availability of appropriated funds. The total amount of available funds to support this program is anticipated to be no more than $725,000 per year. No applicant may request more than $750,000 in total costs including both direct and indirect costs) in the initial budget period. A standard escalation factor may be used for subsequent budget periods. The budget for the first year of a competing continuation application may be increased by 10% above the direct cost of the last issued noncompetitive (Type 5) award. In all cases, budgets are not to exceed the $725,000 total cost cap. RESEARCH OBJECTIVES Urologic diseases and disorders place a substantial burden on individuals and on society in the United States. Urinary tract infections had a direct hospital and physician cost of over $4 billion in 1990. Benign prostatic hyperplasia (over $2 billion), stone disease (over $1 billion), and bladder disorders (over $1 billion) are disorders whose costs exceed $1 billion annually. These diseases and disorders threaten the health, well-being, and longevity of millions of Americans. Although considerable progress has been made in understanding the basic physiology and pathophysiology of the normal urologic systems, there has been only limited progress in unraveling the mechanisms of those processes that lead to progressive deterioration in the function of these systems. Nevertheless, major progress has been made in the management of their clinical consequences. For example, the clinical management of benign prostatic hyperplasia has improved over the past several years. Unfortunately, these scientific and medical advances have not led to the means to prevent or reverse the consequences of these diseases and disorders; moreover, their incidence is steadily increasing. The proposed multidisciplinary research centers should help to provide an environment for investigators to apply the necessary and appropriate expertise to topical areas of research related to the pathogenesis of urologic diseases such as immunologically mediated diseases, diabetes mellitus and other endocrine and metabolic disorders, genetic abnormalities, bladder physiology and pathophysiology, and developmental and obstructive disorders. Prostate cancer is the most common cancer in U.S. males and is the second leading cause of cancer death in men. Mortality due to prostate cancer is two- fold higher in U.S black men than U.S. white men. Costs attributable to this disease exceed $1 billion annually. The disease results annually in a quarter of a million hospitalizations as well as more than 38,000 deaths. The report from the meeting "NCI Roundtable on Prostate Cancer: Future Research Directions" (Reported in Cancer Research, 51: 2498, 1991) contains information and recommendations defining areas of research that could advance the understanding and management of prostate cancer. Potential applicants requesting support for this area of research are urged to acquaint themselves with the report. Special Requirements Successful applicants are expected to attend a yearly meeting of Center Directors convened by the NIDDK. Funds to support travel to this meeting may be requested in the budget proposed for the center. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts Vol. 23, No. 11, March 18, 1994. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion or Children as Participants in Research Involving Human Subjects" published in the NIH Guide for Grants and Contracts, March 6, 1998. It is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by October 20, 1998, 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 and NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Ann Hagan, Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research, or may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301- 710-0267, email: GrantsInfo@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 marked. Submit a signed, typewritten original of the application, including the Checklist, plus three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW 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 be sent to: Dr. Ann Hagan, Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37F Bethesda, MD 20892-6600 Applications must be received by November 20, 1998. If an application is received after that date, it will be returned to the applicant without review. Applications should include the following: A Table of Contents. A Rationale for the Proposed Center and a Statement of Objectives. Institutional Environment and Resources. Organization and Administrative Structure of the Center. Specific Managerial Responsibilities for the Center. Travel funds in the proposed budget for an annual meeting of Center Directors. A description of the method for the replacement of the Center Director (should the need arise). A description of the proposed research projects. A description of the proposed cores. A description of the procedure to be used for the addition/deletion of cores and projects during the proposed period of operation. A description of the administrative relationship of the Center to the applicant institution. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed for completeness and responsiveness. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK and NCI staff function. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the NIDDK. In cases where the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition when they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Following this review, the applications will be given a secondary review by the NIDDK Advisory Council and the National Cancer Advisory Board unless not recommended for further consideration by the initial review group. The review criteria for individual research projects include: The scientific, technical or medical significance and originality of the proposed research. The feasibility and adequacy of the experimental design. The degree to which projects link basic and clinical research. The qualifications and research experience of the proposed personnel. The availability of resources necessary for the research. The appropriateness of the budget and timetable in relation to the cope of the proposed research. The review criteria for scientific cores include: The appropriateness and utility of the core to the proposed Center. The quality of the proposed facilities or services including administrative arrangements for utilizing the core. The qualifications, experience, and commitment of the personnel involved in the core. The appropriateness of the budget. Note: Each core unit must provide facilities or services to at least two research projects recommended for approval. The review criteria for the overall Center program include: The scientific merit of the program as a whole. The significance of the overall goals of the Center. The cohesiveness and multidisciplinary scope of the Center and the coordination and interrelationship of the projects and cores to the common theme of the Center. The leadership, scientific expertise, and commitment of the proposed Center Director. Administrative Considerations include: The institutional environment for and resources available to Center investigators. The institutional commitment to the proposed Center. The administrative leadership necessary to provide for the quality control of supported projects in the Center, the allocation of funds, and the ability to foster communication and cooperation among Center investigators. The appropriateness of the budget in relation to the proposed activities of the Center. The adequacy of addressing the protection of human subjects, animal welfare, and biohazard issues. Adequacy of plans to include both genders (if applicable), minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Competing Continuation Applications: Applicants must follow the NIDDK Program Project Grants Guidelines (July 1996) for preparation of the Grant Application, Chapter 4, Part B and Part C. Copies of the Guidelines are available from the Program Director listed under INQUIRIES. For the purposes of this RFA a distinction between a P50 grant and a P01 grant is made as follows: Research projects supported by the P50 center award are of uniformly high scientific merit, and are generally related to central issues in urologic diseases and disorders. Each project should be directed to the development of fundamental knowledge leading to understanding disease processes and the design of curative or preventative strategies. The P50 grant mechanism provides an opportunity to approach multidisciplinary basic research in a synergistic fashion. Close cooperation, communication, and collaboration among all center personnel of many professional disciplines are characteristics of a successful P50 center. In comparison, each research project of the P01 Program Project Grant must contribute to or be directly related to a clearly defined central unifying theme of the total research effort. The projects should demonstrate essential elements of unity and interdependence. AWARD CRITERIA The anticipated date of award is September 1, 1999. Factors that will be taken into consideration in making awards include the scientific merit of the proposed Center as determined by peer review and the availability of funds. Schedule Letter of Intent Receipt Date: October 20, 1998 Application Receipt Date: November 20, 1998 Initial Review: March 1999 Second Level Review: May 1999 Anticipated Date of Award: September 1, 1999 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding non-cancer programmatic issues may be directed to: Charles H. Rodgers, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-19J Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: rodgersc@extra.niddk.nih.gov Inquiries regarding cancer-related programmatic issues may be directed to: Jorge Gomez, M.D., Ph.D. Office of Centers, Training and Resources, ODDES National Cancer Institute Executive Plaza North, Suite 512 Bethesda, MD 20892 Telephone: (301) 496-8528 Email: jg1w@nih.gov Inquiries regarding fiscal matters may be directed to: Ms. Helen Ling Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8857 FAX: (301) 480-3504 Email: lingh@extra.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. 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 cases, 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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