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Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)

National Institutes of Health

Note: This is a Forecasted Opportunity.

The Small Business Innovation Research (SBIR) Program is an important National Institutes of Health (NIH) funding mechanism used to develop innovative solutions that address public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. NHLBI anticipates issuing a notice of funding opportunity (NOFO) that will invite small businesses to submit SBIR grant applications to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR (Small Business Technology Transfer) Phase II awards and which will require eventual Federal regulatory approval/clearance.

The purpose of this anticipated NOFO and the resulting Phase IIB Small Market SBIR awards is to assist applicants in pursuing the milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners.

Phase IIB Small Market RFAs are specifically designed to support products that address rare diseases or products that are targeted at young pediatric populations. This intended NOFO will specifically be intended to benefit clinical practice by accelerating the commercialization of novel products that require ultimate approval/clearance by the FDA. Competitive preference and funding priority is expected to be given to applications deemed likely to result in a clinically-relevant commercial product, as indicated by the applicant's ability to secure independent third-party investor funds.

Estimated Post Date:

Nov 26, 2024

Estimated Application Due Date:

Feb 25, 2025

Specialties

Engineering and Physical Sciences

Medical - Basic Science

Medical - Translational

Medical

Medical - Clinical Science

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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