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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)
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Service Source Final Application Due Date Funding Available Match Required
Health Care Federal
HHS
02-25-2025 $21.0 M No Match
Required
  • Service
  • Source
  • Final Application Due Date
  • Funding Available
  • Match Required
Status
  • Past
  • Current
  • Forecasted
  • N/A
  • $3,500,000
  • Award Floor
  • Award Ceiling
    • Opportunity Type Discretionary
    • CFDA N/A
    Description

    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. The NHLBI and NCATS intend to publish a NOFO that will utilize the R44 activity code. The reissue of this NOFO is expected to occur in Fall 2024 with an expected application due date of February 25, 2025. This Notice is being provided to allow potential applicants sufficient time to develop responsive proposals and consider the requirements that are integral to this initiative.

    Eligibility
    • IHE
    • Local Government
    • Non-Profit
    • Other
    • State Government
    • Tribal Government
    Key Date(s)
    • September 26, 2024: Forecasted Date
    • November 26, 2024: Estimated Post Date
    • February 25, 2025: Estimated Application Due Date
    • December 01, 2025: Estimated Project Start Date
    • December 01, 2025: Estimated Award Date
    Contact Information

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