SBIR / STTR #ed6db6b2-d74e-4838-9223-ce72f4895688

NIH SBIR/STTR Commercialization Readiness Pilot (CRP) Program Solicitation

The National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services, is inviting applications for the SBIR/STTR Commercialization Readiness Pilot (CRP) Program. - Government Buyer: - U.S. Department of Health and Human Services - National Institutes of Health (NIH) - Eligible Applicants: - U.S. small businesses with a prior NIH SBIR or STTR Phase II award (including Phase IIB Strategic Breakthrough awardees) - Products/Services Requested: - Later-stage research and development (R&D) services - Technical assistance for commercialization, including: - Regulatory strategy - Intellectual property (IP) strategy - Manufacturing technical assistance - Market research - Independent replication of studies - Optimization of manufacturing methods - Clinical studies and trials (with restrictions for certain NIH components) - Project oversight - Unique/Notable Requirements: - Significant outsourcing of work is allowed, but applicants must maintain substantial oversight - Filing fees and FDA submission fees are not covered - No separate Technical and Business Assistance (TABA) funding is available - Clinical trial proposals are restricted for certain NIH institutes and centers (NHLBI, NHGRI, NIAID, NIAMS, NIBIB, NIDCR, NIDDK, NIEHS, NCATS, ORIP) - No specific OEMs or vendors are named, as the solicitation is for R&D and technical assistance services, not products

Description

This funding opportunity supports later-stage research, development, and technical assistance for NIH SBIR or STTR Phase II recipients. It targets R&D requiring significant outsourcing during an active or ended Phase II award, with applicants required to have a prior NIH Phase II award. Eligible activities include regulatory strategy, intellectual property strategy, manufacturing assistance, market research, clinical studies, and project oversight. The program does not cover filing or FDA submission fees and excludes certain clinical trial proposals from specific NIH institutes.

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