Digestive Diseases and Nutrition Research
To encourage basic and clinical biomedical research and research training for a greater understanding of the basic and clinical studies on normal abnormal function of the enteric nervous system, on gastrointestinal hormones and peptides including their structure, biological actions, receptors, release and correlation with physiological events. Other studies include the action of drugs on gastrointestinal motility, intestinal obstruction, the biochemistry of contractile processes and diseases such as irritable bowel syndrome, colonic diverticular disease, swallowing disorder, and gastro esophageal reflux as well as studies on the process of food digestion in the gastrointestinal tract; the assembly of digestive enzymes; the growth and differentiation of gastrointestinal cells in normal and disease states; and studies on gastrointestinal diseases such as maldigestion and malabsorption syndromes, celiac sprue, diarrhea, inflammatory bowel disease, and gastric and duodenal ulcers. To encourage biomedical research and research training for a greater understanding of the normal function and the diseases of the liver and biliary tract including factors leading to liver cell injury, fibrosis, and death; basic and applied studies on liver transplantation; metabolism of bile acids and bilirubin; and factors controlling cholesterol levels in bile as well as disease research on inborn errors in bile metabolism hepatitis, and various liver diseases such as Wilson's disease, primary biliary cirrhosis, and others. To encourage biomedical research on the structure, function, and diseases of the exocrine pancreas. To encourage biomedical research and research training in obesity, anorexia, bulimia and other eating disorders, the metabolism of nutrients and other dietary components at the organ, cellular and subcellular levels in normal and diseased States. To extramurally support basic laboratory research and clinical investigations and provide postdoctoral biomedical research training for individuals interested in careers in health sciences and fields related to these programs. Small Business Innovation Research (SBIR) program. To expand and improve the SBIR Program; to increase private sector commercialization of innovations derived from Federal research and development; to increase 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. 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.
General information about this opportunity
Last Known Status
Deleted 08/20/2009 (Archived.)
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Type(s) of Assistance Offered
Research Grants: In fiscal year 2001, 882 awards were made; in fiscal year 2002, 936 awards are estimated; and in fiscal year 2003, 989 awards are estimated. National Research Service Awards: In fiscal year 2001, 92 awards and 278 trainees were made; in fiscal year 2002, 88 awards and 264 trainees are estimated; and in fiscal year 2003, 88 awards and 264 trainees are estimated. Small Business Innovation Research Awards: In fiscal year 2001, 39 awards were made; in fiscal year 2002, 45 awards are estimated, and in fiscal year 2003, 45 awards are estimated.
Public Health Service Act, Sections 301, 405, 428, 431, 487, 491, 493, 495, and 498, as amended, Public Laws 78-410, 99- 158, 100-607; 106-554, 42 U.S.C. 241, as amended; 42 U.S.C. 285c-2, 42 U.S.C. 285c-5, 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Who is eligible to apply/benefit from this assistance?
Research 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. National Research Service Awards: Individual National Research Service awardees 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 Institutional National Research Service grant. Small Business Innovation Research grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. 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. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which researches proposed and have no more than 500 employees) 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.
Research 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. National Research Service Awards: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.
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 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively.
What is the process for applying and being award this assistance?
Not applicable. This program is excluded from coverage under E.O. 12372.
Research Grants: Form PHS-398 (Rev. September 1991) with current instructions is available from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Telephone 301/435-0714, e-mail: ASKNIH@odrockml.od.nih.gov. Completed forms should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, MSC 7710, Federal Express should use the Zip Code 20817-7710. 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. National Research Service Awards: Applications form for individual or institutional National Research Service Awards and information concerning the areas of science being supported may be obtained from and submitted to the Office of Research Manpower, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Suite 1040, Bethesda, MD 20892-7710. 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. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor. Telephone: (301) 206-9385; FAX: (301) 206- 9722; E-mail: email@example.com. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.
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.
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 (SBIR): April 1, August 1, and December 1. Small Business Technology Transfer Program (STTR): April 1, August 1, and December 1.
Approval/Disapproval Decision Time
Research grants: From 6 to 9 months. SBIR and STTR: About 7-1/2 months. National Research Service Awards: From 6 to 9 months.
A principal investigator (P.I.) may question the substantive or procedure 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.
Research grants: renewals by competitive application and review. National Research Service Individual Awards: awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the predoctoral level for more than 5 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years.
How are proposals selected?
The major elements in evaluating proposals include assessment 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 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.
How may assistance be used?
Research Grants provide funds for services, equipment, supplies, training, and other expenses associated with scientific investigation relevant to program objectives. 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 National Research Service Awards to individuals selected by them. Each individual who receives a 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 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 Phase II application.
What are the requirements after being awarded this opportunity?
Research grants: Annual and terminal progress reports, annual reports of inventions, reports of expenditures and annual certification with respect to research involving human subjects are required. National Research Service Awards: Reports are required after termination of National Research Service Awards to ascertain compliance with service and payback provisions.
In accordance with the provisions of OMB Circular No. A- 133, (Revised, June 24, 1997), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal Awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for the year, except as noted in Circular No. A-133. For nongovernmental grant recipients, audits are to be carried out in accordance with the provisions set forth in OMB Circular No. A- 133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Other Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula or matching requirements.
Length and Time Phasing of Assistance
Research grant awards may be recommended for up to 5 years. Awards usually are 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.
Who do I contact about this opportunity?
Regional or Local Office
Program Contact: Research Grants: Dr. Jay Hoofnagle, Director, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 31 Center Drive MSC 2560, Bethesda, MD 20892-2560. Telephone: (301) 496-1333. Small Business Innovation Research Grants Contact: Mr. George Tucker, Acting Chief Grants Management Officer, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Democracy Plaza 2, Room 633, 6707 Democracy Plaza Blvd., Bethesda, MD 20892. Telephone: (301) 594-8833. Grants Management Contact: Mr. George Tucker, Acting Chief Grants Management Officer, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Democracy Plaza 2, Room 633, 6707 Democracy Plaza Blvd., Bethesda, MD 20892. Telephone: (301) 594-8853. Use the same numbers for FTS.
(Grants) FY 02 $288,275,000; FY 03 est $323,984,000; and FY 04 est $351,599,000. (NRSAs) FY 02 $12,479,000; FY 03 est $13,195,000; and FY 04 est $13,723,000.
Range and Average of Financial Assistance
Research grants: $26,547 to $1,438,500; $164,900. National Research Services Awards: $19,000 to $214,500; $71,775. SBIR: Phase I, approximately $50,000; Phase II, not to exceed $500,000.
Regulations, Guidelines and Literature
Research grants: 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.
Examples of Funded Projects
(1) Extrinsic Control of Gastrointestinal Motility, Biosynthesis of Gastrin; (2) Mechanism of Carbon Tetrachloride Hepatotoxity, Mechanism of Bile Secretion and Cholestasis; and (3) Clinical and Experimental Study of Obesity. Small Business Innovation Research grant: Remote In Vivo Gastrointestinal Analysis Using Optrodes.