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Diabetes, Digestive, and Kidney Diseases Extramural Research

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This federal aid program is managed by:

National Institutes of Health, Department of Health and Human Services

Objectives:

(1) To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases. Specific programs areas of interest include the following: (a) For diabetes, endocrine, and metabolic diseases areas: Fundamental and clinical studies including the etiology, pathogenesis, prevention, diagnosis, treatment and cure of diabetes mellitus and its complications; Normal and abnormal function of the pituitary, thyroid, parathyroid, adrenal, and other hormone secreting glands; Hormonal regulation of bone, adipose tissue, and liver; on fundamental aspects of signal transduction, including the action of hormones, coregulators, and chromatin remodeling proteins; Hormone biosynthesis, secretion, metabolism, and binding; and on hormonal regulation of gene expression and the role(s) of selective receptor modulators as partial agonists or antagonists of hormone action; and Fundamental studies relevant to metabolic disorders including membrane structure, function, and transport phenomena and enzyme biosynthesis; and basic and clinical studies on the etiology, pathogenesis, prevention, and treatment of inherited metabolic disorders (such as cystic fibrosis). (b) For digestive disease and nutrition areas: Genetics and genomics of the GI tract and its diseases; Genetics and genomics of liver/pancreas and diseases; Genetics and genomics of nutrition; genetics and genomics of obesity; Bariatric surgery; Clinical nutrition research; Clinical obesity research; Complications of chronic liver disease; Fatty liver disease; Genetic liver disease; HIV and liver; Cell injury, repair, fibrosis and inflammation in the liver; Liver cancer; Liver transplantation; Pediatric liver disease; Viral hepatitis and infectious diseases; Gastrointestinal and nutrition effects of AIDS; Gastrointestinal mucosal and immunology; Gastrointestinal motility; Basic neurogastroenterology; Gastrointestinal development; Gastrointestinal epithelial biology; Gastrointestinal inflammation; Digestive diseases epidemiology and data systems; Nutritional epidemiology and data systems; Autoimmune liver disease; Bile, Bilirubin and cholestasis; Bioengineering and biotechnology related to digestive diseases, liver, nutrition and obesity; Cell and molecular biology of the liver; Developmental biology and regeneration; Drug-induced liver disease; Gallbladder disease and biliary diseases; Exocrine pancreas biology and diseases; Gastrointestinal neuroendocrinology; Gastrointestinal transport and absorption; Nutrient metabolism; Pediatric clinical obesity; Clinical trials in digestive diseases; Liver clinical trials; Obesity prevention and treatment; and Obesity and eating disorders. (c) For kidney, urologic and hematologic diseases areas: 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; Mechanisms of kidney injury repair; Improved diagnosis, prevention and treatment of chronic kidney disease and end-stage renal disease; Improved approaches to maintenance dialysis therapies; Basic studies of lower urinary tract cell biology, development, physiology, and pathophysiology; Clinical studies of bladder dysfunction, incontinence, pyelonephritis, interstitial cystitis, benign prostatic hyperplasia, urolithiasis, and vesicoureteral reflux; Development of novel diagnostic tools and improved therapies, including tissue engineering strategies, for urologic disorders;Research on hematopoietic cell differentiation; metabolism of iron overload and deficiency; Structure, biosynthesis and genetic regulation of hemoglobin; as well as Research on the etiology, pathogenesis, and therapeutic modalities for the anemia of inflammation and chronic diseases. (2) To encourage basic and clinical research training and career development of scientists during the early stages of their careers. The Ruth L. Kirschstein National Research Service Award (NRSA) funds basic and clinical research training, support for career development, and the transition from postdoctoral biomedical research training to independent research related to diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases. (3) To expand and improve the Small Business Innovation Research (SBIR) program. The SBIR Program aims to increase and facilitate private sector commercialization of innovations derived from Federal research and development; to enhance small business participation in 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) To utilize the Small Business Technology Transfer (STTR) program. The STTR Program intends 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.

Funding obligations:

(Project Grants) FY 09 $1,352,092,000; FY 10 est $1,427,399,000; FY 11 est $1,461,140,000 - NRSAs: FY 2009 Actual: $56,917,000; FY 2010 Estimate: $57,402,000; FY 2011 Estimate: $60,721,000 SBIRs: FY 2009 Actual: $46,625,000; FY 2010 Estimate: $47,752,000; FY 2011 Estimate: $48,183,000.

Uses and Use Restrictions:

Project Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives. NRSAs are made directly to individuals for research training in specified biomedical shortage areas, or, to institutions to enable them to make NRSAs to individuals selected by them. Each individual who receives a NRSA is obligated upon termination of the award to comply with certain service and payback provisions. SBIR 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.

Examples of Funded Projects:

Fiscal Year 2010: No Current Data Available Fiscal Year 2011: No Current Data Available Fiscal Year 2012: No Current Data Available

Program Accomplishments:

Fiscal Year 2010: No Current Data Available Fiscal Year 2011: Project Grants: In Fiscal Year 2011, 3,420 awards are estimated. NRSAs: In Fiscal Year 2011, 453 awards and 1,142 trainees are estimated. SBIR Awards: In Fiscal Year 2011, 124 awards are estimated. Fiscal Year 2012: No Current Data Available

Types of Assistance:

PROJECT GRANTS

Range and Average of Financial Assistance:

Project Grants: $1,000 to $24,854,886; $392,138 NRSAs: $4,200 to $581,147; $133,922 SBIR: Phase I awards approximately $100,000; Phase II awards not to exceed $750,000.

Length and Time Phasing of Assistance:

Project Grants: Awards are usually made for a 12-month period with recommendation of up to 4 years of additional support. 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. See the following for information on how assistance is awarded/released: The Notice of Award (NoA) is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual increments following the annual assessment of progress. This funding is also contingent on the availability of funds. The NoA includes all applicable terms of award either by reference or specific statements. It provides contact information for the assigned program officer and grants management specialist. The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees.

Applicant Eligibility:

Project Grants: Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both non-profit and for-profit, and individuals who propose to establish, expand, and improve research activities in health sciences and related fields. NRSAs: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. 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). 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. Nonprofit domestic organizations may apply for the Institutional NRSA. SBIR and STTR 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% 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% owned and controlled by another for-profit business concern that is at least 51% 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 C.F.R. 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:

Health professionals, graduate students, health professional students, scientists, and researchers, any nonprofit or for-profit organization, company, or institution engaged in biomedical research. 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. NRSAs: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.

Award Procedure:

Research Grant and Training Program applications are reviewed initially for scientific merit by an appropriate review panel, composed of scientific authorities, and by the National Diabetes and Digestive and Kidney Diseases Advisory Council composed of leaders in medical science, education, and public affairs. Approved applications will compete on a merit basis for available funds. The successful applicant is sent 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.

Contact Info for Headquarters Office:

Terra L. Robinson, 6707 Democracy Boulevard, Suite 714, Bethesda, Maryland 20892 Email: robinste@niddk.nih.gov Phone: (301) 496-9488.

Website Address:

http://www2.niddk.nih.gov

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