NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)

HHS-NIH11 RFA-HL-26-014
Posted: Nov 18, 2024 12:00:00 AM EST
Closes: 02/26/2027

Description

The Small Business Innovation Research (SBIR) Program is an important funding mechanism that the National Institutes of Health (NIH) uses 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. This Notice of Funding Opportunity (NOFO) invites SBIR grant applications from SBCs to support later-stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR Phase II awards and will require eventual Federal regulatory approval/clearance. The goal of this NOFO and the resulting Phase IIB 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.
Projects proposed under this NOFO MUST be relevant to the NHLBI mission (see B. Scientific/Technical Scope).
This NOFO is specifically intended to benefit clinical practice by accelerating the commercialization of novel products that require ultimate approval/clearance by a Federal regulatory agency.
This NOFO will give competitive preference and funding priority to applications deemed likely to result in a clinically-relevant commercial product as indicated by the applicants ability to secure independent third-party investor funds that equal or exceed the requested NHLBI funds (total costs).

Synopsis

The Small Business Innovation Research (SBIR) Program is an important funding mechanism that the National Institutes of Health (NIH) uses 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. This Notice of Funding Opportunity (NOFO) invites SBIR grant applications from SBCs to support later-stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR Phase II awards and will require eventual Federal regulatory approval/clearance. The goal of this NOFO and the resulting Phase IIB 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.
Projects proposed under this NOFO MUST be relevant to the NHLBI mission (see B. Scientific/Technical Scope).
This NOFO is specifically intended to benefit clinical practice by accelerating the commercialization of novel products that require ultimate approval/clearance by a Federal regulatory agency.
This NOFO will give competitive preference and funding priority to applications deemed likely to result in a clinically-relevant commercial product as indicated by the applicants ability to secure independent third-party investor funds that equal or exceed the requested NHLBI funds (total costs).

Eligibility

Eligible Applicants:
Small businesses
Other Eligible Applicants include the following:
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Funding Activity Categories

Health

CFDA Numbers

  • 93.233 - National Center on Sleep Disorders Research
  • 93.837 - Cardiovascular Diseases Research
  • 93.838 - Lung Diseases Research
  • 93.839 - Blood Diseases and Resources Research
  • 93.840 - Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

Contact Information

Agency: National Institutes of Health
Contact: National Institutes of Health
Phone: 301-402-2541
NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis
Opportunity Category: Discretionary
Version: 1
Last Updated: Nov 19, 2024 03:06:36 PM EST

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