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. This gap is increased by the barriers associated with technologies under development for small commercial markets, such as those focused on rare diseases or young pediatric populations. This Funding Opportunity Announcement (FOA) invites 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 that address rare diseases or young pediatric populations (aged 0-12 years and defined in Section IV, part 7), and will require eventual Federal regulatory approval/clearance. The goal of this FOA and the resulting Phase IIB awards is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between small business awardees and third-party investors and/or strategic partners, including patient advocacy organizations.

• Proposed projects MUST be relevant to the NHLBI?mission?(see B. Scientific/Technical Scope) and require ultimate approval/clearance by a Federal regulatory agency. NCATS intends to co-fund applications that meet the NCATS mission to develop innovations that reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process, to speed the development and delivery of new drugs, diagnostics, medical devices and behavioral interventions to patients. For a description of the NCATS SBIR/STTR research priorities, please refer to?http://ncats.nih.gov/smallbusiness/priorities?(http://ncats.nih.gov/smallbusiness/priorities.
• This FOA is specifically intended to benefit clinical practice by accelerating the commercialization of novel products

• that address a rare disease or young pediatric populations (aged 0-12 years and defined in Section IV, part 7). The primary indication of the product under development would:

• Address a rare disease as defined in the Orphan Drug Act Amendment of 1984 as any disease or condition that affects less than 200,000 persons in the United States; or
• Qualify as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year;
• OR be targeted at a young pediatric population, defined as including neonates (0-28 days), infants (<2 years), and/or children (2-12 years of age), as indicated in the?FDA Premarket Assessment of Pediatric Medical Devices.

This FOA will give competitive preference and funding priority to applications deemed likely to result in a commercial product as indicated by the applicant’s ability to secure independent third-party investor funds that equal or exceed one-third of the requested NHLBI funds (total costs) being requested for the entire project period of the Phase IIB Small Market Award.

Deadlines:

• Letter of Intent Due Date(s): January 28, 2022; January 28, 2023; January 28, 2024
• Application Due Date(s): Feb. 28, 2022; Feb. 28, 2023; Feb. 28, 2024

RFA-HL-23-008 Expiration Date February 29, 2024