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| 93.848 DIGESTIVE DISEASES AND NUTRITION 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, 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. |
| OBJECTIVES |
| The Division of Digestive Diseases and Nutrition, NIDDK, is responsible for managing programs in basic and clinical research, training and career development in digestive diseases, liver diseases, nutrition and obesity. The Division provides grant support using a variety of NIH mechanisms, including investigator initiated awards, cooperative agreements and contracts. In addition, the Division provides resource support through Digestive Diseases, Nutrition, and Obesity/Nutrition Research Centers. Current program areas of interest are the following, for which additional detail can be found on the corresponding topics on our web site: 1.)Digestive Diseases Programs; Acquired Immunodeficiency Syndrome(AIDS), Gastrointestinal Motility, Gastrointestinal Mucosa and Immunology, Gastrointestinal Neuroendocrinology, Gastrointestinal Transport and Absorption, Clinical Trials in Digestive Diseases, Digestive Diseases Research Core Centers(DDRCCs), Pancreas 2.) Liver Disease Research Programs; Liver and Biliary, Clinical Trials in Liver Disease, HALT-C, NASH Clinical Research Network, Biliary Atresia Clinical Research Consortium, Adult-to-Adult Living Donor Liver Transplantation Cohort Study, Hepatotoxicity Network 3.) Obesity and Nutrition Research Programs; Obesity and Eating Disorders, Obesity Prevention and Treatment, Look AHEAD: Action for Health in Diabetes, Obesity/Nutrition Research Centers (ONRC), Longitudinal Assessment of Bariatric Surgery (LABS), Genetics and Genomics of Obesity, Clinical Trials in Nutrition, Clinical Obesity and Nutrition Program, Nutritional Epidemiology Program, Nutrient Metabolism, Clinical Nutrition Research Units (CNRU), Conferences,Training 4.) Epidemiology and Clinical Trials Programs; Clinical Trials in Digestive Diseases, Clinical Trials in Liver Diseases, Clinical Trials in Nutrition, Digestive Diseases and Nutrition Epidemiology and Data Systems 5.) Small Business programs in Digestive Diseases, Liver, Nutrition and Obesity research; Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR). |
| 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% 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 |
| 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 (SBIR): 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. SBIR and STTR: About 7-1/2 months. National Research Service Awards: From 6 to 9 months. |
| Appeals |
| 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. |
| Renewals |
| Project 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. |
| Formula and Matching Requirements |
| This program has no statutory formula or matching requirements. |
| Length and Time Phasing of Assistance |
| Project 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. |
| Reports |
| Project 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. |
| 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 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. |
| Records |
| 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. |
| Account Identification |
| 75-0884-0-1-552. |
| Obligations |
| Project Grants: FY 07 $387,023,105; FY 08 est. $388,425,017; and FY 09 est. $387,808,973. (NRSAs) FY 07 $17,786,713; FY 08 est. $18,158,896; and FY 09 est. $18,301,814. (SBIRs) FY 07 $10,453,045; FY 08 est. $10,481,734; FY 09 est. $10,455,076. |
| Range and Average of Financial Assistance |
| Research grants: $4,926 to $1,791,309; $328,264. National Research Services Awards: $7,850 to $508,850; $202,122. SBIR: Phase I, approximately $50,000; Phase II, not to exceed $500,000. |
| PROGRAM ACCOMPLISHMENTS |
| Project Grants: In fiscal year 2007, 1,179 awards were made; in fiscal year 2008, 1,146 awards are estimated; and in fiscal year 2009, 1,162 awards are estimated. National Research Service Awards: In fiscal year 2007, 88 awards and 312 trainees were made; in fiscal year 2008, 88 awards and 364 trainees are estimated; and in fiscal year 2009, 88 awards and 364 trainees are estimated. Small Business Innovation Research Awards: In fiscal year 2007, 29 awards were made; in fiscal year 2008, 29 awards are estimated, and in fiscal year 2009, 29 awards are estimated. |
| REGULATIONS, GUIDELINES, AND LITERATURE |
| Project 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. |
| Regional or Local Office |
| Not applicable. |
| Headquarters Office |
| Program Contact: Project Grants: Dr. Stephen James, Director, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 677, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-7680. Small Business Innovation Research Grants and Small Business Technology Transfer Grants Contact: Mrs. 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: Mr. 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 |
| Pathogenesis of Gastroesophageal reflux disease (GERD). Genetics of inflammatory bowel disease. Inflammation in IBD. Prevention of weight gain. Treatment of non-alcoholic steatohepatitis (NASH). Long-term treatment of hepatitis C. |
| CRITERIA FOR SELECTING PROPOSALS |
| 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. |
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General Services Administration Office of Chief Acquisition Officer Regulatory and Federal Assistance Division (VIR) |
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