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, and 106-554; 42 U.S.C. 241, 42 U.S.C. 285c-2; 42 U.S.C. 285c-5, 42 U.S.C. 288, as amended; Small Business Research and Development Enhancement Act of 1992; Public Law 102-564.

OBJECTIVES:

To encourage basic and clinical biomedical research and research training for a greater understanding of diabetes and the underlying mechanisms that cause diabetes and related complications. Fundamental and clinical studies include the etiology, pathogenesis, prevention, diagnosis and treatment of diabetes mellitus and its complications. In endocrine research, to encourage biomedical research for a greater understanding of the normal and abnormal function of the pituitary, thyroid, parathyroid, adrenal, pineal, thymus glands, as well as the action of hormones, hormone biosynthesis, secretion, metabolism, binding to protein carriers and subsequent release, and the kinetics of binding. In metabolic research, to encourage basic studies on fundamental metabolic processes of diseases such as membrane structure, function, and transport phenomena enzyme biosynthesis; and basic and clinical studies on the etiology, pathogenesis, prevention, and treatment of inherited metabolic disorders (such as cystic fibrosis) as an example to support extramural 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.

TYPES OF ASSISTANCE:

Project Grants. Place Cursor Here for Definition

USES AND USE RESTRICTIONS:

Research Grants provide funds for salaries, equipment, supplies, travel, 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 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 Phase II application.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   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: 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 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. or 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 research is 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.

Beneficiary Eligibility:   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.

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 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.

Pre-application Coordination:   Not applicable. This program is excluded from coverage under E.O. 12372.

Application Procedure:   Research Grants: Form PHS-398 (Rev. May 1995) 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. 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: a2y@cu.nih.gov. 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.

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 renewal applications and supplements: 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:   Research grants: From 6 to 9 months. SBIR/STTR applications: 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 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:   Research grants: Renewals by competitive application and review. National Research Service Individual 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.

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.

POST ASSISTANCE REQUIREMENTS:

Reports:   Research grants: Annual and terminal progress reports, annual reports of inventions, financial status reports, 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 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 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:   Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last financial status report for the report period. 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 financial status report for that year.

FINANCIAL INFORMATION:

Account Identification:   75-0884-0-1-552.

Obligations:   (Grants) FY 01 $454,135,000; FY 02 est $510,390,000; and FY 03 est $553,893,000. (NRSAs) FY 01 $16,513,000; FY 02 est $20,787,000; and FY 03 est $21,618,000.

Range and Average of Financial Assistance:  
Project Grants: Range of $1,000 to $37,000,000; $456,000 average
NRSAs: Range of $3,000 to $700,000; $127,000 average
SBIR: Range of $5,000 to $1,400,000; $453,000 average.

Research Grants: In fiscal year 2001, 1,389 awards were made; in fiscal year 2002, 1,474 awards are estimated, and in fiscal year 2003, 1,599 awards are estimated. National Research Service Awards: in fiscal year 2001, 145 awards and 438 trainees were made; in fiscal year 2002, 138 awards and 445 trainees are estimated, and in fiscal year 2003, 138 awards and 415 trainees are estimated. Small Business Innovation Research Awards: In fiscal year 2001, 44 awards were made; in fiscal year 2002, 55 awards are estimated, and in fiscal year 2003, 54 awards are estimated.

REGULATIONS, GUIDELINES, AND LITERATURE:

Research Grants: 42 CFR 52; 42 CFR 66; 45 CFR 74. 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.

INFORMATION CONTACTS:

Regional or Local Office:  
None. Project Grants: Dr. Judith Fradkin, Director, Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 6037, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 496-7349; 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 6029, 6707 Democracy Blvd., Telephone: (301) 594-7680; Dr. Robert Star, Director, Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 6119, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 496-6325. Grants Management Contact: Mr. Robert 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 7333, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8854. Use the same numbers for FTS.

Headquarters Office:   Michelle Shorter 31 Center Drive, Room 9A34, Bethesda, Maryland 20892 Email: Shorterm@mail.nih.gov Phone: 3015948842

Web Site Address:  
http://www2.niddk.nih.gov

EXAMPLES OF FUNDED PROJECTS:

(1) Genetic Control of Diabetes Pathogenesis; (2) Factors Involved in Insulin Homeostasis; (3) Mode of Action of Steroid Hormones; (4) Regulation of Lipogenesis and VLDL Synthesis/Assembly; and (5) Endocrine Sweat Gland Function and Cystic Fibrosis. Small Business Innovation Research grants: Implantable Glucose Sensor.

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.