National Heart, Lung, and Blood Institute – Small Business
Program Funding
Annual program obligations reported to SAM.gov.
Program Objective
The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, blood, and sleep conditions and enhance the health of all individuals so that they can live longer and more fulfilling lives. Small Business Innovation Research (SBIR) program: To stimulate technological innovation; use small business to meet Federal research and development needs; foster and encourage participation in innovation and entrepreneurship by emerging and undercapitalized small business concerns; and increase private-sector commercialization of innovations derived from Federal research and development funding. Small Business Technology Transfer (STTR) program: To stimulate technological innovation; foster technology transfer through cooperative R&D between small businesses and research institutions, and increase private sector commercialization of innovations derived from federal R&D.
Eligibility
Eligible Applicants
- Local
- Nonprofit Organization
- Unrestricted by Individual Type
- For-Profit Organization
- Not-for-Profit Organization
Local (includes State-designated Indian Tribes; excludes institutions of higher education and hospitals), Public nonprofit institution/organization (includes institutions of higher education and hospitals), Individual/Family, Small business (less than 500 employees), Private nonprofit institution/organization (includes institutions of higher education and hospitals). Any nonprofit organization engaged in biomedical research and institutions or companies organized for profit may apply for almost any kind of grant. SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, or owned by another small business that itself is independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees including affiliates). 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. SBIR projects must be performed at least 67% by the applicant small business in Phase I and at least 50% of the project in Phase II. 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.
Beneficiaries
- Unrestricted by Individual Type
- For-Profit Organization
- Nonprofit Organization
- Health Professional
- Education Professional
Any nonprofit or for-profit organization, company or institution engaged in biomedical research. Only domestic for-profit small business firms may apply for SBIR and STTR programs.
How to Apply
Award Procedure
All accepted applications are evaluated by an appropriate initial review group (study section). All grant applications receive a final secondary review by the National Heart, Lung, and Blood Advisory Council. Staff inform applicants of the results of the review. If support is contemplated, staff initiate preparation of awards for grants. 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.
Decision Timeline
- Approval: > 180 Days
- Renewal interval: > 180 Days
Regular Grants: From 7 to 9 months. SBIR/STTR Grants: About 7-1/2 to 9 months.
Program details & compliance
Description
The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, blood, and sleep conditions and enhance the health of all individuals so that they can live longer and more fulfilling lives. Small Business Innovation Research (SBIR) program: To stimulate technological innovation; use small business to meet Federal research and development needs; foster and encourage participation in innovation and entrepreneurship by emerging and undercapitalized small business concerns; and increase private-sector commercialization of innovations derived from Federal research and development funding. Small Business Technology Transfer (STTR) program: To stimulate technological innovation; foster technology transfer through cooperative R&D between small businesses and research institutions, and increase private sector commercialization of innovations derived from federal R&D.
Mission Categories
Primary: Prevention and Control (includes Suicide Prevention)
Use of Funds
Allowed Uses
Grants may support stipends, research expenses, supplies, travel, childcare costs, and research training tuition as required to perform the research effort. SBIR Phase I awards (of approximately 6 to 24 months in duration) are to establish the scientific and technical merit of the proposed research effort, and feasibility of ideas that appear to have commercial potential. Direct to Phase II SBIR awards are for projects that have been developed beyond the feasibility phase using resources other than NIH Phase I awards that meet program needs and exhibit potential for commercial application. SBIR Phase IIB awards are for promising projects that require additional time and funding to advance to commercialization as well as ultimate approval or clearance by a Federal regulatory agency. The Phase IIB program promotes partnerships between previously funded SBIR or STTR Phase II awardees and third-party investors and/or strategic partners by encouraging matching contributions. STTR Phase I awards (normally of 6 to 24 months in duration) are to establish the scientific and technical merit of the proposed cooperative research effort between a small business and non-profit research institution, and feasibility of ideas that appear to have commercial potential. Phase II awards are for the continuation of research initiated in Phase I that meets particular program needs and exhibits potential for commercial application. Fast-Track is an option whereby Phase I and Phase II SBIR or STTR projects are submitted and reviewed concurrently with the aim of reducing or eliminating the funding gap between Phase I and Phase II. The SBIR/STTR Commercialization Readiness Pilot Program awards facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization phase by providing additional support for technical assistance and later stage research and development activities not typically supported through Phase II or Phase IIB grants or contracts including replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance or a combination of services. While the intent of the SBIR/STTR programs is commercialization (Phase III), only SBIR/STTR technical and business assistance (TABA) funds are allowed to be used for commercialization activities such as intellectual property protections; market and sales; market research; business development/product development/market plans; legal fees, travel and other costs including labor relating to license agreements and partnerships. The remaining SBIR/STTR funds are for research and development purposes only and exclude these commercialization activities.
Restrictions
Restrictions or limitations are imposed against the use of funds for entertainment, foreign travel, general-purpose equipment, alterations and renovations, and other items not regularly required for the performance of research.
Required Documentation
Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organization costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with DHHS Regulations 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, the applicant organization (small business concern) must present a research plan 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. SBIR and STTR applicants must use the SF424 Research and Related (R&R) application for electronic submission through grants.gov. Electronic submission of NIH Research Performance Progress Reports (RPPR) applies to non-competing continuations (e.g., second year of Phase II). OMB Circular No. A-87 applies to this program. 2 CFR 200, Subpart E - Cost Principles applies to this program. 2 CFR 200, Subpart E - Cost Principles applies to this program.
2 CFR 200, Subpart E - Cost Principles applies to this program.
Reporting & Compliance
Applicable 2 CFR 200 Subparts
- Subpart B — General Provisions
- Subpart C — Pre-Federal Award Requirements
- Subpart D — Post-Federal Award Requirements
- Subpart E — Cost Principles
- Subpart F — Audit Requirements