Full Text DK-96-001 KIDNEY RESEARCH CENTERS NIH GUIDE, Volume 24, Number 33, September 22, 1995 RFA: DK-96-001 P.T. 04 Keywords: 0715133 0705048 Biomedical Research, Multidiscipl Biology, Cellular Biology, Molecular National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: May 23, 1996 Application Receipt Date: July 23, 1996 PURPOSE This Request for Applications (RFA) invites investigators to submit research applications for the George M. O'Brien Research Centers Program. The emphases for this program are twofold: (1) to attract new scientific expertise into the study of the basic mechanisms of kidney diseases and disorders; and (2) to encourage multidisciplinary research focused on the causes of these diseases. 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. It is the express intent of this RFA 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. Interinstitutional collaborative research arrangements are also appropriate and encouraged. Coordination for such arrangements must be evident and clearly meaningful and appropriate for the research proposed. 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, Kidney Research Centers, is related to the priority area of chronic debilitating diseases. 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. This RFA is a one-time solicitation. The total requested project period for an application submitted in response to this RFA may not exceed five years. The earliest anticipated award date is May 1, 1997. FUNDS AVAILABLE The NIDDK expects to award up to five center grants (P50) for research into kidney disorders in fiscal year 1997. The anticipated awards are for five years and are contingent upon the availability of appropriated funds. The total amount of available funds to support this program is anticipated to be no more than $3.16 million 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. Five competing continuation applications are anticipated in response to this RFA. The budget for the first year of a competing continuation application may be increased by 10 percent above the direct cost budget of the last issued noncompetitive (Type 5) award. In all cases, budgets are not to exceed the $750,000 total cost cap. RESEARCH OBJECTIVES Kidney diseases and disorders place a substantial burden on individuals and on society in the United States. They threaten the health, well-being, and longevity of millions of Americans. Chronic renal failure, for example, accounted for an estimated $3.7 billion of direct hospital and physician costs in 1990. Although considerable progress has been made in understanding the basic physiology and pathophysiology of the normal renal 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, renal dialysis and transplantation are life saving procedures. 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 multi disciplinary 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 kidney diseases such as: immunologically mediated diseases; diabetes mellitus and other endocrine and metabolic disorders; primary renal hypertension; genetic abnormalities; and nephrotoxins and toxic cell injury. 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 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. 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 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 May 23, 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.37F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7515 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD 20892-7762, telephone 301/710-0267, email: girg@drgpo.drg.nih.gov. Applications must include the following items: o A Table of Contents o A Rationale for the Proposed Center and a Statement of Objectives o Institutional Environment and Resources o Organization and Administrative Structure of the Center o Specific Managerial Responsibilities for the Center o Travel funds in the proposed budget for an annual meeting of Center Directors; o A description of the method for the replacement of the Center Director (should the need arise); o A description of the proposed research projects; o A description of the proposed cores; o A description of the procedure to be used for the addition/deletion of cores and projects during the proposed period of operation; o A description of the administrative relationship of the Center to the applicant institution. 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: 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 be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Applications must be received by July 23, 1996. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed for completeness and responsiveness. Incomplete and/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 staff function. Unsolicited material received after July 23, 1996 will not be accepted. 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 Advisory Board. The review criteria for individual research projects include: o The scientific, technical or medical significance and originality of the proposed research; o The feasibility and adequacy of the experimental design; o The qualifications and research experience of the proposed personnel; o The availability of resources necessary for the research; o The appropriateness of the budget and timetable in relation to the scope of 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 review criteria for scientific cores include: o The appropriateness and utility of the core to the proposed Center; o Each core unit must provide facilities or services to at least two research projects recommended for approval; o The quality of the proposed facilities or services including administrative arrangements for utilizing the core; o The qualifications, experience, and commitment of the personnel involved in the core; o The appropriateness of the budget. The review criteria for the overall Center program include: o The scientific merit of the program as a whole; o The significance of the overall goals of the Center; o The cohesiveness and multi disciplinary scope of the Center and the coordination and interrelationship of the projects and cores to the common theme of the Center; o The leadership, scientific expertise, and commitment of the proposed Center Director. Administrative Considerations o The institutional environment for and resources available to Center investigators; o The institutional commitment to the proposed Center; o 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; o The appropriateness of the budget in relation to the proposed activities of the Center; o The adequacy of addressing the protection of human subjects, animal welfare, and biohazard issues. 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 kidney 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 multi disciplinary 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, also of uniformly high scientific merit, 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 earliest anticipated date of award is May 1, 1997. 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. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. 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, Room 6AS-19 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: bainr@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters 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@ep.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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