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| 93.849 KIDNEY DISEASES, UROLOGY AND HEMATOLOGY RESEARCH |
| FEDERAL AGENCY |
| NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| AUTHORIZATION |
| Public Health Service Act, Sections 301, 405, 428, 431, 487, 491, 493, 495 and 498, as amended, Public Laws 78-410, 78-440, 99-158, 100-607, and 106-554, as amended, 42 U.S.C. 241; 42 U.S.C. 285c-5; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564. |
| OBJECTIVES |
| 1) To encourage basic and clinical research and research training to improve understanding of the mechanisms underlying diseases in the nephrologic, urologic, and hematologic systems; to promote the development of improved diagnostic tools and therapies for these diseases. Supported nephrologic research includes studies of the development, physiology, and cell biology of the kidney, pathophysiology of the kidney, genetics of kidney disorders, immune mechanisms of kidney disease, kidney disease as a complication of diabetes, effects of drugs, nephrotoxins and environmental toxins on the kidney, and mechanisms of kidney injury repair. Of special interest is improved diagnosis, prevention and treatment of chronic kidney disease and endstage renal disease, and improved approaches to maintenance dialysis therapies. Supported urological research includes basic studies of lower urinary tract cell biology, development, physiology, and pathophysiology, and clinical studies of bladder dysfunction, incontinence, pyelonephritis, interstitial cystitis, benign prostatic hyperplasia, and vesicoureteral reflux. The development of novel diagnostic tools and improved therapies, including tissue engineering strategies, for urologic disorders is a priority. Hematologic research emphasizes basic biomedical research on hematopoietic cell differentiation, metabolism of iron overload and deficiency, and the structure, biosynthesis and genetic regulation of hemoglobin as well as research on the etiology, pathogenesis, and therapeutic modalities for the anemias of chronic renal failure and other chronic diseases,. 2) To foster, via National Research Service Award (NRSA) and other training mechanisms, the training and career development of scientists interested in pursuing research in the above areas. 3) Small Business Innovation Research (SBIR) program: to increase small business participation in research in the areas described above, to increase private sector commercialization of innovations derived from Federal research and development, and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. 4) Small Business Technology Transfer (STTR) program: to stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions, to foster technology transfer between small business concerns and research institutions, to increase private sector commercialization of innovations derived from Federal research and development, and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. |
| TYPES OF ASSISTANCE |
| Project Grants. |
| USES AND USE RESTRICTIONS |
| Project Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives. Ruth L. Kirschstein National Research Service Awards (NRSAs) are made directly to individuals for research training in specified biomedical shortage areas. In addition, grants may be made to institutions to enable them to make Kirschstein National Research Service Awards to individuals selected by them. Each individual who receives a Kirschstein National Research Service Award is obligated upon termination of the award to comply with certain service and payback provisions. Small Business Innovation Research Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercial products or processes. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application. |
| Applicant Eligibility |
| Project Grants: Individuals and public and private institutions, both nonprofit and for-profit, who propose to establish, expand, and improve research activities in health sciences and related fields. Ruth L. Kirschstein National Research Service Awards: Individuals must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Nonprofit domestic organizations may apply for the Kirschstein Institutional National Research Service grant. Small Business Innovation Research and Small Business Technology Transfer grants can be awarded only to domestic small businesses that meet the following criteria: (1) Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit. (2) Is (a) at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51 percent owned and controlled by another for-profit business concern that is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States. (3) Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 CFR Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. STTR grants which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. |
| Beneficiary Eligibility |
| Project Grants: Although no degree of education is either specified or required, nearly all successful applicants have doctoral degrees in one of the sciences or professions. Kirschstein National Research Service Awards: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree. |
| Credentials/Documentation |
| As required in application form. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant forms PHS SF424 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS SF424 are used to apply for STTR Phase I and Phase II, respectively. |
| Preapplication Coordination |
| Not applicable. This program is excluded from coverage under E.O. 12372. |
| Application Procedure |
| Project Grants: Applications for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. Applications may not be submitted in paper format. A registration process through Grants.gov is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. Two steps are required for on time submission: 1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date. 2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for this program by those applicants that are State or local units of government. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. |
| Award Procedure |
| Following review by the appropriate Study Section and Council, the successful applicant is notified by the National Institute of Diabetes and Digestive and Kidney Diseases through a Notice of Grant Award. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research. |
| Deadlines |
| New Applications: February 1, June 1, and October 1. Competing continuation and supplemental applications: March 1, July 1, and November 1. Individual NRSA applications: April 5, August 5, and December 5. Institutional NRSAs: January 10, May 10, and September 10. Small Business Innovation Research: April 1, August 1, and December 1. Small Business Technology Transfer Program (STTR): April 1, August 1 and December 1. |
| Range of Approval/Disapproval Time |
| Project Grants: From 6 to 9 months. National Research Service Awards: From 6 to 9 months. SBIR/STTR applications: About 7-1/2 months. |
| Appeals |
| A principal investigator may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.html. |
| Renewals |
| Project Grants: Renewals are determined by competitive applications and review. Extensions considered upon request. National Research Service Individual Awards: Awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years. |
| Formula and Matching Requirements |
| None. |
| Length and Time Phasing of Assistance |
| Project Grants: Award may be recommended for up to 5 years. Awards are usually made for 12-month budget periods. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. |
| Reports |
| Expenditures and other financial information must be retained for 3 years from the day on which the grantee submits the last financial status report for the report period. |
| Audits |
| In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials. |
| Records |
| Project Grants: financial records, including documents supporting accounting records and substantive charges to each grant, must be maintained until at least 3 years after the end of the project or until audit is completed. National Research Service Awards: documentation of expenditures and other fiscal records must be kept readily available for examination by authorized Government personnel and must be maintained for 3 years following the submission of the annual expenditures report for that year. |
| Account Identification |
| 75-0884-0-1-552. |
| Obligations |
| Project Grants: FY 07 $363,606,378; FY 08 est. $364,923,468; and FY 09 est. $364,344,697. (NRSAs) FY 07 $15,434,668; FY 08 est. $15,757,635; and FY 09 est. $15,881,654. (SBIRs) FY 07 $12,679,881; FY 08 est. $12,714,682; and FY 09 est. $12,682,345. |
| Range and Average of Financial Assistance |
| Project Grants: $5,916 to $3,900,000; $323,781. National Research Services Awards: $7,000 to $518,868; $220,495. SBIR Phase I, approximately $50,000; Phase II, not to exceed $500,000. |
| PROGRAM ACCOMPLISHMENTS |
| Project Grants: In fiscal year 2007, 1,123 awards were made; in fiscal year 2008, 1,091 awards are estimated; and in fiscal year 2009, 1,107 awards are estimated. National Research Service Awards: In fiscal year 2007, 70 awards and 290 trainees were funded; in fiscal year 2008, 70 awards and 339 trainees are estimated; and in fiscal year 2009, 70 awards and 339 trainees are estimated. Small Business Innovation Research Awards: In fiscal year 2007, 32 awards were made; in fiscal year 2008, 32 awards are estimated; and in fiscal year 2009, 32 awards are estimated. |
| REGULATIONS, GUIDELINES, AND LITERATURE |
| Project Gants: 42 CFR 74; 45 CFR 92. Administration Policy Directive No. 65 01 (47 FR 52966 et seq. (1982), as amended by Policy Directive No. 65 01.1 (48 FR 38794 et seq. (1983)). Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications. |
| Regional or Local Office |
| None. |
| Headquarters Office |
| Program Contact: Dr. Robert Star, Acting Director, Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, 2 Democracy Plaza, Room 645, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 496-6325. Small Business Innovation Research Grants Contact: Helen Ling, Senior Grants Management Specialist, Grants Management Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 732, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8857. Grants Management Contact: Robert A. Pike, Chief Grants Management Officer, Grants Management Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 731, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8854. Use the same numbers for FTS. |
| Web Site Address |
| http://www.niddk.nih.gov |
| RELATED PROGRAMS |
| None. |
| EXAMPLES OF FUNDED PROJECTS |
| (1) Functional Structure of Renal Tubule; (2) Pathogenesis of Experimental Glomenolonephritis; Pathology of Recovery from Acute Renal Failure; (3) Urinary Stone Prevention; and (4) In vitro Studies of Hematopoietic Regulation. Small Business Innovation Research grant: Laser Fragmentation of Urinary Calculi. |
| CRITERIA FOR SELECTING PROPOSALS |
| The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. |
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General Services Administration Office of Chief Acquisition Officer Regulatory and Federal Assistance Division (VIR) |
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