CENTERS OF EXCELLENCE IN PEDIATRIC NEPHROLOGY Release Date: February 12, 2001 RFA: RFA-DK-01-016 (This RFA has been reissued, see RFA-DK-06-011) National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: May 11, 2001 Application Receipt Date: June 22, 2001 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, invites grant applications for Specialized Centers of Research (P50) in pediatric nephrology. The purpose of the research center is to attract a partnership of interdisciplinary research among investigators with scientific expertise who will use complementary and integrated approaches into the study of kidney diseases endemic to the pediatric population. In approaching the study of these disease processes it is anticipated that extensive collaboration will be required among individuals in the clinical and basic sciences, including cell biology, molecular biology, immunology, virology, genetics, epidemiology, biochemistry, physiology and pathology. Studies designed to foster and extend the development of new approaches into the causes, early diagnoses, improved treatment, and where possible, prevention of these diseases and disorders are appropriate. The emphases for this program are several-fold (1) to continue to attract new scientific expertise into the study of the basic mechanisms of kidney diseases and disorders among infants, children, and adolescents, (2) to encourage multidisciplinary research focused on the causes of these diseases, 3) to explore new basic areas that may have clinical research application and 4) to design *Developmental Research (DR)/Pilot and Feasibility (P&F) studies of two years duration, which are anticipated will lead to new and innovative approaches to study kidney disease amongst the pediatric population, and the eventual submission of competitive investigator-initiated R01 research grant applications. Individual institutions with research capabilities relating to diseases of the kidney in the pediatric population 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. 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 must not exceed five years. The earliest anticipated award date is April 1, 2002. *Generally DR/P&F proposals are expected to have little preliminary data and are reviewed based on the development of hypotheses and supporting literature. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), CENTERS OF EXCELLENCE IN PEDIATRIC NEPHROLOGY is related to the priority area of Maternal, Infant and Child Health, Chronic Kidney Disease, Diabetes, Disability and Secondary Conditions and Educational and Community-Based Programs. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit 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 P50 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be considered eligible, applicant organizations must have: (1) a statement of institutional commitment that addresses how the institution will incorporate the Centers of Excellence in Pediatric Nephrology high within its institutional priorities, (2) a qualified principal investigator who is a scientific leader in the field, (3) independent investigators who are successful in obtaining peer-reviewed research support (R01, P01, U01, or equivalent) who together collectively represent experience in both laboratory and clinical research, and utilize a balance and diversity of research approaches, 4) research subprojects, representing a balance and diversity of research approaches, (5) developmental/pilot & feasibility programs, and (6) appropriate shared resources to support the proposed research of the Centers of Excellence in Pediatric Nephrology. Although an application must be submitted by a single applicant institution, subcontracted collaborative scientific arrangements with scientists from other institutions may be included if these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the applicant institution. Criteria for designating an investigator as a center grant participant should be defined. Subsets of participants based on degree of participation or other measures are acceptable. Each center is encouraged to develop guidelines for center participation by investigators. Support will not be provided for applications with research activities focused exclusively on basic research, or clinical research or trials, or epidemiological research. NIDDK program staff listed under INQUIRIES should be consulted if there are questions regarding any of the above eligibility requirements for exclusion. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Specialized Center (P50) award mechanism. This mechanism supports the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary approach on a specific kidney disease process or biomedical problem. These grants differ from traditional program project (P01) grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for multidisciplinary research subprojects, support is also provided for pilot research projects, specialized resources, and shared core facilities. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five (5) years. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. Applicants from institutions which 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. In such a case, 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. The anticipated award date is April 1, 2002. FUNDS AVAILABLE The NIDDK intends to fund two (2) new and/or competing continuation center grants in response to this RFA. Two competing continuation applications are anticipated in response to this RFA. Both new and renewal applicants may request a project period of up to five (5) years and a budget for up to $700,000 direct costs per year (not to exceed $3.5 million for five years). However, the direct cost cap can be exceeded with the inclusion of Facilities and Administrative (F&A) Costs (previously referred to as indirect costs ) for consortia subcontracts to other participating institutions. The budgets of these consortia subcontracts may also include the regular cost-of-living increases (currently 3% per year). For renewal applications, budgets requested for research subprojects and core facilities are limited to 20% budget growth over the most recent non-competing budget. Both new and renewal applications must include budgets of at least $120,000 annually for Developmental Research/Pilot and Feasibility (P&F) projects. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds in FY 2002 and the receipt of a sufficient number of applications of outstanding scientific and technical merit. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES Background Kidney disease is a major cause of illness and death in infants, children and adolescents, who make up approximately 25 percent of the United States population. Of this population, both incident and prevalent rates have increased moderately since 1990, with rates continuing to be highest in 15-19 age group, with particularly high rates -- three times those of Caucasian Americans -- in African American children of both genders. It is estimated that 14,000 have kidney disease, 5,000 have kidney failure and are on dialysis or have a kidney transplant, of these about 60 percent are 12 years of age or younger. As a consequence the financial cost to the American taxpayer is enormous. Developmental disorders of the kidney account for about one-third of all childhood cases. Investigators are beginning to perform molecular and genetic analyses to link specific gene products to normal kidney growth and development and human kidney diseases. For example in congenital nephritic syndrome, a glomerular disease characterized by massive amounts of protein in urine and progressive renal failure in infants, researchers have recently identified mutations in glomerular protein called nephrin. This disorder often progresses so that dialysis or renal transplantation is often required during infancy. Other disorders in the very young patient include renal dysplasia(s) and hypoplasia(s), cystic malformations, PKD, tubulointerstitial diseases and congenital structural abnormalities i.e., obstructive uropathy, vesicoureteral reflux and the resulting reflux nephropathy. Older children often develop end-stage renal failure from conditions such as immune complex disease, hereditary nephropathy, focal segmental glomerulosclerosis, IgA nephropathy, and the hemolytic uremic syndrome. The basic cellular and molecular mechanisms of the majority of these disorders are poorly understood. Progression often occurs even when the primary disease process has been thought to be adequately treated and the disorder appears to have become inactive. Several diseases that lead to chronic renal disease and end-stage renal disease (ESRD) in adults often have their origin in childhood, a notable example is diabetes and hypertension. Up to one third of children who develop Type 1 (insulin-dependent) diabetes will develop ESRD in their twenties or thirties. Strategies to prevent kidney disease ideally should begin in childhood or late adolescence, and therefore, a great need exists to better understand the pathogenesis of these conditions, with the ultimate aim of prevention of complications and/or the development of improved therapies. In kidney disease, children face special growth and developmental challenges and strategies to address this are another urgent need. Representative, but not all-inclusive areas of research appropriate for investigation include: (1) studies of renal disorders of genetic and congenital origin that may lead to progressive loss of renal function or cause severe metabolic imbalances in children, including hyperoxaluria, and which include the use of gene targeting and transgenic technologies in addressing Bartter s, Gitelman’s and Liddle’s syndromes during development, and congenital nephrogenic diabetes insipidus, (2) further identification and study of genes and gene mutations and molecular events involved in renal and urogenital morphogenesis and differentiation, (3) studies of events involved in cellular signaling in renal morphogenesis in health and disease, including the definition of events involved in cellular communication and mechanisms by which growing cells influence and are influenced by extracellular matrix, (4) immune-mediated disorders, including such diseases as post- infectious glomerulonephritis, human immunodeficiency virus (HIV), immunoglobulin A (IgA) nephropathy, Goodpasture’s syndrome, and Wegner’s granulomatosis, (5) studies to understand the molecular mechanisms underlying the renal hypertension in infants and children, (6) studies addressing the short and long-term effects of anti-hypertensive agents in infants and children, (7) identification of risk factors and predisposing factors contributing to renal disease progression in infants and children, (8) studies addressing the etiology, pathophysiology, and treatment strategies for end-stage renal disease in infants and young children, including determinants of abnormal growth and development, the development of animal models to quantitate the contribution of selective variables in growth retardation in chronic renal failure, the effects of exogenous recombinant hormones, and the role of uremia in protein synthesis in young growing infants, 9) cellular and molecular studies underlying the development and progression of glomerulonephritis in children, including the molecular changes affecting the glomeruli, alterations of the basement membrane, mechanisms leading to proteinuria, and the biochemistry of the nephron during pathological states. Other The Specialized Center (P50) must be an identifiable unit within a single university medical center or within a consortium of cooperating institutions with a university affiliation. The overall goal of a P50 Center is to bring together, in a cooperative, multidisciplinary and integrative manner, basic science and clinical investigators to enrich the effectiveness of research into causes, treatment and cure of kidney disease in infants, children and adolescents. Interrelated, basic research subprojects, each with high scientific merit and clear research objectives have provided the traditional framework of the Centers of Excellence in Pediatric Nephrology program. In the aggregate, the subprojects should continue to be directed to the development of fundamental knowledge leading to the understanding of childhood kidney disease processes and the design of curative or preventive strategies. However, a new dimension to the centers program is the requirement to include Research Development/Pilot and Feasibility (P&F) project(s) as integral components of the centers concept (described below). Core facilities that will benefit the overall centers program are likely components of a center (described below). SPECIAL REQUIREMENTS Other then the customary requests for support of research subprojects and cores (e.g., administrative, animal, etc.), the following new program should be included in the submissions for this RFA for Centers of Excellence in Pediatric Nephrology. Developmental Research (DR)/Pilot & Feasibility (P&F) Projects A DR/P&F program may be included which will provide modest support for innovative initiatives with the potential to advance progress in understanding cellular and molecular mechanisms that cause kidney diseases of the pediatric population. This program is directed toward both new and established investigators who wish to explore the feasibility of a novel approach to a problem in this area. Investigators eligible for DR/P&F funding fall into three general categories: (1) new investigators without current or past NIH support as a principal investigator, and whose current or previous support from other sources has been modest, (2) established investigators with limited previous work on the kidney who wish to apply their expertise to a problem in this area, and (3) established renal investigators who propose testing innovative ideas that represent a clear departure from their ongoing research directions. It is anticipated that the majority of the recipients of DR/P&F funding will be from the first category. Each DR/P&F study award is intended to provide a modest amount of support, not to exceed $60,000 per year direct costs, for duration not to exceed two years, which will allow an investigator the opportunity to develop sufficient preliminary data to provide the basis for an application for independent research support. DR/P&F study support is not intended for large projects by established investigators, which otherwise would be submitted as separate research grant applications. DR/P&F funds also are not intended to support or supplement ongoing funded research of an investigator. Each DR/P&F study proposal should state clearly the justification for eligibility of the investigator under one of the above three criteria. A proposed DR/P&F study should present a testable hypothesis and clearly delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed. The DR/P&F studies should be submitted for review generally in the format of NIH research project applications (R01), but with a 15-page limitation. Within this structure, it is imperative for each applicant institution to establish a mechanism to oversee the ongoing use of funds for the proposed DR/P&F program. This mechanism must include the use of appropriate consultants (described below) for review from the scientific community external to the center. These same consultants may, if desired, review and assess other activities of the center and may constitute the external advisory group to the center. The projects selected to receive these funds are to be described by the Director in the DR/P&F section of the application. Enrichment and Educational Program The center proposal may budget for and provide limited support for an enrichment program, whose description and budget may be included within the administrative core. It may provide support for visiting scientists, seminars, and research forums. Limited travel support is allowable for center investigators to travel to present scientific findings, learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. In all cases, the enrichment program should further the overall aims and objectives of the center as well as of the scientific cores. Annual Kidney Center Workshop Centers of Excellence in Pediatric Nephrology investigators may be expected to participate in an annual workshop organized by the DKUHD- NIDDK to share positive and negative results with other kidney research centers (O Brien Kidney and PKD), share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations that will maximize the impact of the research on reducing incidence and mortality, and improving survival. Travel funds for the Principal Investigator and selected center investigators and collaborators may be budgeted for this purpose. 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 are provided indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 or 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 of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by May 11, 2001 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 plan the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 655 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) 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 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. 4/98) 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. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and 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: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 655 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Applications must be received by the application receipt date listed in the heading of the RFA. If an application is received after that date, it will be returned to the applicant without review. Supplemental documents containing significant revision or additions will not be accepted, unless the Scientific Review Administrator notifies applicants. The Center for Scientific Review (CSR) 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 CSR 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, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 the review criteria stated below. 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, generally the top half of the applications under review, 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 The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Do these studies address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o adequacy of plans to include both genders, 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. o the reasonableness of the proposed budget and duration to the proposed research. o the adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. o the adequacy of the proposed plan to share data. Schedule Letter of Intent Receipt Date: May 11, 2001 Application Receipt Date: June 22, 2001 Peer Review Date: October-November 2001 Council Review: February 13-14, 2002 Earliest Anticipated Start Date: April 1, 2002 Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Specific criteria to be used in the evaluation of grant applications are listed below. a. Individual Research Subprojects: Within the Centers of Excellence in Pediatric Nephrology concept of research to be performed, reviewers will evaluate each research subproject using the five criteria listed below. Each criterion will be addressed and considered by the reviewers in assigning the overall score project merit: a.1. Significance: The importance of the research objective to pediatric kidney disease and its likelihood of completion within the subproject period. Do these studies address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? a.2. Approach: The adequacy of the experimental design and methods to achieve the research objectives. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? a.3. Innovation: Originality and novelty of the experimental design as it relates to the proposed research. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the subproject challenge existing paradigms or develop new methodologies or technologies? a.4. Investigators: The qualifications of the investigators to conduct the proposed subproject research and the appropriateness of the time commitments of each investigator to the conduct of the subproject. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? a.5. Environment: The scientific environment in which the investigations will be done, and the unique features, if any, of the environment to support the proposed work. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed subproject research budget and duration, the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. b. Shared Resources (Cores) b.1. adequacy of the proposed plan to maintain appropriate cores and potential for the distribution of reagents, tissues, transgenic animals within and outside the Centers of Excellence in Pediatric Nephrology, b.2. degree to which plans indicate that shared resources effectively and efficiently support (or will support) the subproject and P&F research of the Centers of Excellence in Pediatric Nephrology in a manner that cannot be supported through available national resources, b.3. adequacy of the justification for each specialized resource relative to its essential need for the conduct of Centers of Excellence in Pediatric Nephrology subproject research or pilot projects, b.4. adequacy of qualifications and performance (if applicable) of managers of resources, b.5. appropriateness of the requested budgets to conduct each resource operation. c. Developmental Research Program/Pilot & Feasibility Projects c.1. adequacy of the process and/or track record for attracting new ideas for pilot studies within and outside of the Centers of Excellence in Pediatric Nephrology institution. c.2. adequacy of the proposed process and/or track record for continuously reviewing and funding a spectrum of pilot projects (e.g., research, technology development, resources) for their quality and importance to research that will have an impact on human renal disease. c.3. general quality of the pilot projects provided by the Centers of Excellence in Pediatric Nephrology to demonstrate the effectiveness of the process of including pilot projects, c.4. established mechanism within the institution to solicit DR/P&F proposals and to oversee the use of funds for the proposed DR/P&F program. This mechanism must include the use of appropriate consultants for review from the scientific community external to the center. c.5. appropriateness of the budget relative to the needs and demonstrated capabilities of the Centers of Excellence in Pediatric Nephrology. d. Overall Program Organization and Capability: d.1. scientific qualifications and involvement of the Centers of Excellence in Pediatric Nephrology Principal Investigator, as well as his/her demonstrated scientific and administrative leadership capabilities, adequacy of the time commitment of the Principal Investigator, d.2. adequacy of the planning and evaluation process to include: determining research productivity of existing projects and resources, discontinuing activities of low productivity, initiating new activities in response to important research opportunities, establishing collaborations, and the use of external advisors, d.3. adequacy of access to patients and populations for conducting current and projected therapeutic, prevention, detection and control research, d.4. degree to which the organization and leadership of the Centers of Excellence in Pediatric Nephrology promote and facilitate scientific interactions between subprojects, pilot projects, etc., and effective use of the Centers of Excellence in Pediatric Nephrology infrastructure (e.g., shared resources) in the conduct of research, d.5. effectiveness of and/or plans for promoting interdisciplinary scientific interaction, d.6. adequacy of tangible institutional commitments that will enable and facilitate the research objectives of the Centers of Excellence in Pediatric Nephrology (e.g., special facilities, recruitments, discretionary resources such as dollars and space), d.7. Interactions with Other Centers of Excellence in Pediatric Nephrology e. Interactions with other Centers of Excellence in Pediatric Nephrology e.1. adequacy of plans (new application) or progress (competing renewal applications) to promote and maintain communication and integration of scientific projects of mutual interest with other Centers of Excellence in Pediatric Nephrology, e.2. willingness to interact with other Centers of Excellence in Pediatric Nephrology and with the NIDDK in sharing information, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o Adequacy of plans to include both genders, 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 o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the subproject and P&F proposed research in the application. o The adequacy of the proposed plan to share data. AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit as determined by peer review, o Availability of funds, o Programmatic priorities. 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: M. James Scherbenske, Ph.D., Renal Physiology/Cell Biology and Kidney Centers and SBIR Program Director DKUHD/NIDDK 6707 Democracy Blvd, Room 613 Bethesda, MD 20892-5458 Telephone: (301) 594-7719 FAX: (301)480-3510 E-mail: js255f@nih.gov Direct inquiries regarding fiscal matters to: Mrs. Mary K. Rosenberg Grants Management Branch DEA-NIDDK, NIH 6707 Democracy Blvd, Room 638 Bethesda, MD 20892 Telephone: (301) 594-8891 FAX: (301) 480-3504 E-Mail: RosenbergM@extra.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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