FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Title IV, Section 301, as amended, Public Law 78-410; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, 42 U.S.C. 241.

OBJECTIVES:

To assist public and private nonprofit institutions and individuals to establish, expand, and improve biomedical research and research training in allergic and immunologic diseases and related areas to assist public, private, and commercial institutions to conduct developmental research; to produce and test research materials; and to provide research services as required by the agency for research progress in allergic and immunologic diseases. NIAID's Allergy, Immunology and Transplantation Research concerns the immune system as it functions in the maintenance of health and as it malfunctions in the production of diseases. Because of this dual focus, the program encompasses both basic research and clinical research. Small Business Innovation Research (SBIR) program expands and improves private sector participation in biomedical research. The SBIR Program intends to increase and facilitate 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. The Small Business Technology Transfer (STTR) program stimulates and fosters 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. Research Career Development Awards support the development of scientists during the formative stages of their careers Individual National Research Service Awards (NRSAs) are made directly to approved applicants for research training in specified biomedical shortage areas. In addition, Institutional National Research Service Awards are made to enable institutions to select and make awards to individuals to receive training under the aegis of their institutional program.

TYPES OF ASSISTANCE:

Project Grants. Place Cursor Here for Definition

USES AND USE RESTRICTIONS:

Beginning with fiscal year 1998, the direct costs awarded in the first year to a research project grant resulting from a competing renewal application will be limited to no more than a 20 percent increase over the direct costs awarded in the last non-competing year of that grant. Research grants provide funds for salaries, equipment, supplies, and travel. They also afford the collateral benefits of enriching the training experience of research workers. Grantees are expected to be judicious in using these funds. The application for a research grant sets forth specific terms and conditions and requires the signatures of the principal investigator and an official authorized to sign for the institution. Scientists and institutions are under an obligation to expend grant funds prudently for the purposes stated in the application and award document. For Research Career Development Awards (RCDAs) the scientists must demonstrate an outstanding research potential for independent research in the sciences related to transplantation, immunology, allergies, and immunological diseases. For National Research Service Awards (NRSAs), each individual who receives NRSA support 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 which 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 the Phase II application.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   Universities, colleges, hospitals, laboratories, and other public or private nonprofit domestic institutions, including State and local units of government, and individuals are eligible to make application for grant support of research by a named principal investigator or a research career development candidate. For-profit organizations are also eligible, with the exception of NRSA. Individual NRSA 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 NRSA awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral candidates 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). SBIR 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 being 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. 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.

Beneficiary Eligibility:   Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation:   Research grant applicants must define the objectives, methodology, and facilities for the program, and must present the program director's competence and scientific interest. 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. Applicants for individual NRSAs must include their academic record, research experience, citizenship, institute sponsorship, and the proposed area and plan of training in their applications. The applicant for an institution must specify the objectives, methodology, and resources for the research training program, the qualifications experience of directing staff, the criteria to be used in selecting individuals for award, and a detailed budget justification for the amount of grant funds requested. 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 by HHS Regulations 45 CFR, Part 74, Subpart Q.

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

Application Procedure:   Use Form PHS-398 (Rev. May 1995) to apply for new, renewal, and supplemental research grants. Application forms and information concerning current areas of science being supported are 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- 7910. Telephone: (301) 435-0714. Fax: (301) 480-0525. E-mail: asknih@od.nih.gov. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for this program. 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. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" homepage 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:   All accepted applications are reviewed for scientific merit by an appropriate initial review group and a national advisory council. If recommended for approval and a decision to make an award is made, a formal award notice will be sent to the applicant and applicant institution. 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 Non-AIDS research applications: February 1, June 1 and October 1. For Renewal and Supplemental Non-AIDS research grant applications: March 1, July 1, and November 1. For all AIDS research grant applications: January 2, May 1, September 1. Research Career Development Award programs: February 1, June 1, October 1. Individual NRSAs: April 5, August 5, and December 5. Institutional NRSA: September 10. SBIR/STTR: April 1, August 1 and December 1.

Range of Approval/Disapproval Time:   From 8 to 9 months. SBIR/STTR: 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. Final decisions on unresolved appeals are made with the advice of the National Advisory Allergy and Infectious Diseases Council.

Renewals:   Renewals of research grant support are by competitive application and review. The competitive application may request support for a segmental period of up to 5 years.

ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:   This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance:   Research grant project periods average 4 years; they may not be extended beyond 7 years. (Project periods are generally composed of 1-year 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:   Annual progress reports and financial status reports are required.

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 government 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.

FINANCIAL INFORMATION:

Account Identification:   75-0885-0-1-552.

Obligations:   (Grants) FY 01 $392,796,000; FY 02 est $432,665,000; and FY 03 est $546,339,000. (SBIR) FY 01 $6,417,000; FY 02 est $7,424,000; and FY 03 est $12,781,000. (STTR) FY 01 $616,000; FY 02 est $631,000; and FY 03 est $768,000.

Range and Average of Financial Assistance:  
From $2,500 to $6,395,901 and the average $426,165.

In fiscal year 2001, a total of 1,377 grant awards were made to establish, expand, and promote research and research training in basic immunobiology and immunochemistry; hypersensitivity and inflammation; asthma and allergic diseases; the immune system and its disorders; immunopathology, transplantation biology immunogenetics and lymphocyte biology; and the support of research centers for the study of asthma and allergic diseases, immunodermatology, and immunological diseases. A total of 17 SBIR Phase I, 9 SBIR Phase II, 3 STTR Phase I, and 1 Phase II Awards were made in fiscal year 2001. An estimated 1,403 and 1,585 total awards will be made in fiscal years 2002 and 2003 respectively.

REGULATIONS, GUIDELINES, AND LITERATURE:

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:   Not applicable.

Headquarters Office:   Donna C. Perry 5601 Fishers Lane Room 5E48, Bethesda, Maryland 20892 Email: dp94y@nih.gov Phone: 240-669-5429

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

EXAMPLES OF FUNDED PROJECTS:

(1) Immunobiology and immunochemistry studies: (a) investigate the biology and chemistry of the immune system and its products; and (b) projects in lymphocyte biology supporting multi-disciplinary efforts in immunobiology, cell biology, genetics, biochemistry and immunochemistry with the goal of developing the capability to intervene and manipulate the immune system in health and disease. Particular focus is given to Acquired Immune Deficiency Syndrome. (2) Research in genetics and transplantation biology: (a) encompasses a broad approach to clarify how genes and gene products affect the immune response system, the goal being to understand the genetic and immunologic mechanisms involved in organ transplantation and in resistance or susceptibility to disease. (3) Studies in asthma and allergic diseases: (a) involve the etiology, pathogenesis, diagnosis, prevention, and treatment of both naturally occurring and acquired allergic diseases; and (b) asthma studies include both primary and predisposing factors. (4) Research in immunologic diseases: (a) investigates the underlying mechanisms of disease, as well as applications of basic knowledge to the etiology, prevention, and management of immunologic disorders; and (b) utilizes either of two disciplinary approaches - clinical immunology or immunopathology.

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.