PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

Background
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America's Seed Fund, are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization.

National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their mission to improve health and save lives.

Grant Details
This Notice of Funding Opportunity (NOFO) issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I, Phase II, Fast-Track, and Phase IIB grant applications. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts.

An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. NIH Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases.

Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR and STTR Phase II to achieve commercialization. NIH Institutes and Centers (ICs) may allow small businesses who have been awarded a Phase II SBIR or STTR to submit a Phase IIB (second, sequential Phase II) SBIR or STTR application that will provide additional funding for Phase II SBIR or STTR projects.

Eligibility Requirements
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets specific criteria including being organized for profit, having a place of business located in the United States, operating primarily within the United States or making a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor, having not more than 500 employees, among other requirements.

Period of Performance
According to statutory guidelines, award periods normally may not exceed 1 year for Phase I and 2 years for Phase II.

Grant Value
Total funding support normally may not exceed $306,872 for Phase I awards and $2,045,816 for Phase II awards. Each participating component may also set their own budget limit higher or lower than these amounts.