FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Sections 301, 437, and 487, as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, as amended; 42 U.S.C. 285d-2; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

OBJECTIVES:

To support research relevant to arthritis, musculoskeletal and skin diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports research training and basic and clinical investigations including epidemiology and clinical trials in each of the following program areas: The Arthritis Program supports research related to all forms of arthritis including rheumatoid arthritis, systemic connective tissue diseases, osteoarthritis, and metabolic and infectious types of arthritis. The Muscle Biology Program supports research on basic aspects of muscle physiology and disease and exercise physiology. The Musculoskeletal Diseases Program supports research relating to orthopaedic problems, osteoarthritis, bone diseases and bone metabolism, most specifically Osteoporosis and Paget's Disease, heritable disorders of connective tissue, and programs relating to the affects of mechanical forces on musculoskeletal disease, as well as exercise and sports medicine. The Skin Diseases Program supports all forms of research on skin diseases, in particular diseases of keratin, pigmentation, basement membranes, and heritable disorders. The Centers Program supports large programs in arthritis and musculoskeletal and skin diseases. 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. Individual National Research Service Awards (NRSAs) are made to individuals for research training in specified biomedical shortage areas. In addition, grants may be made 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. 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 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 on 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 private, for-profit or nonprofit 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 that 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:   Requirements are specified in the 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 2001) with current instructions is available from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892. 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. Application forms are also available on the NIH website at: http://grants.nih.gov/grants/forms.htm. National Research Services Awards: Completed application forms should be submitted to the Office of Research Manpower, Center for Scientific Review, Grants, National Institutes of Health, Bethesda, MD 20892. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at ww.nih.gov/grants/funding/sbir1/sbir.htmtm 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: phone: (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 Arthritis and Musculoskeletal and Skin 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 applications: March 1, July 1, and November 1. Individual NRSA Applications: April 5, August 5, and December 5 Institutional NRSA: January 10, May 10, and September 10. Small Business Innovation Research: April 15, August 15, and December 15. STTR: December 1, only.

Range of Approval/Disapproval Time:   Research 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 (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. Extension by request and administrative action. National Research Service Awards: 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 grants: 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 final progress reports. Also annual reports of inventions and financial status reports. Annual certification with respect to research involving human subjects. National Research Service Awards: Reports are required during and 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 Non-Profit 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 expenditure report for the report period.

FINANCIAL INFORMATION:

Account Identification:   75-0897-0-1-552.

Obligations:   Research Grants: FY 01 $312,222,000; FY 02 est $349,807,000; and FY 03 est $375,418,000. National Research Service Awards (NRSAs): FY 01 $10,821,000; FY 02 est $11,815,000; and FY 03 est $12,241,000.

Range and Average of Financial Assistance:  
Research Grants: $1,000 to $1,700,000; $340,271. National Research Service Awards: $7,850 to $463,441; $133,929. SBIR: Phase 1 awards -- approximately $206,432; Phase II awards --approximately $574,163. STTR: Phase 1 awards -- approximately $182,162; Phase II awards --approximately $207,860.

Research Grants: In fiscal year 2001, a total of 1,140 noncompeting and competing research grants were funded, including 44 SBIR and STTR awards. The estimate for fiscal year 2002 is 1,214 research grant awards, including 45 SBIR and STTR awards. The estimate for fiscal year 2003 is 1,255 grants, including 46 SBIR and STTR awards. National Research Service Awards: In fiscal year 2001, 114 awards and 271 trainees were funded. Estimates for fiscal years 2002 and fiscal year 2003 are 114 awards and 270 trainees each year.

REGULATIONS, GUIDELINES, AND LITERATURE:

Research Grants: 42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; 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:  
See Regional Agency Offices.

Headquarters Office:   Laura K. Moen, 6701 Democracy Boulevard, Ste 800, Bethesda, Maryland 20892 Email: moenl@mail.nih.gov Phone: (301) 451-6515.

Web Site Address:  
http://www.niams.nih.gov

EXAMPLES OF FUNDED PROJECTS:

(1) Tissue Injury Mechanisms - Systemic Lupus Erythematosus; (2) Regulation of Biosynthesis of Proteoglycan; (3) Function of Vitamin D Metabolites and Bone Disease; (4) Sarcoplasmic Reticulum Function and Reassembly; and (5) Biosynthesis of Keratin - Biosynthetic Studies. Small Business Innovation Research Grant: Development of Diagnostic Probes for Autoimmune Disease.

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.