SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required)

Background
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The NOFO aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts.

Grant Details
The grant aims to provide support for technical assistance and later stage research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R&D throughout the award. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

Eligibility Requirements
Only United States small business concerns (SBCs) that have had an active NIH SBIR or STTR Phase II or Phase IIB contract, grant or cooperative agreement from NIH within the last 36 months 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 outlined in the document.

Period of Performance
The maximum project period allowed is 3 years.

Grant Value
Budgets up to $3,945,657 total funding support may be requested except for specific budget limitations associated with certain Institutes/Centers.