The National Institutes of Health (NIH), in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Advancing Translational Sciences (NCATS), is reissuing the Small Business Innovation Research (SBIR) Phase IIB Small Market Awards to support the commercialization of technologies addressing rare diseases or young pediatric populations (ages 0-12 years). These awards aim to bridge the funding gap that small businesses face between SBIR Phase II completion and commercialization, with an emphasis on overcoming challenges in small-market products. This funding opportunity seeks to encourage partnerships with third-party investors and strategic partners, including patient advocacy organizations, to advance the development of these critical products.

The program targets projects that align with the NHLBI mission and address rare diseases, as defined by the Orphan Drug Act (affecting fewer than 200,000 people in the U.S.), Humanitarian Use Devices (benefiting fewer than 4,000 individuals annually), or medical needs in young pediatric populations. Eligible projects must have already progressed through SBIR or STTR Phase II funding and demonstrated significant development milestones. Applicants must present plans for regulatory approval and commercialization, including engagement with Federal agencies like the FDA, and highlight collaborations with NCATS for innovations accelerating translational science.

Funding supports diverse development activities, including preclinical and clinical validation, regulatory submissions, and commercialization strategies. Projects may pertain to therapeutics, diagnostics, and medical devices targeting cardiovascular, lung, blood disorders, and sleep conditions in rare or pediatric populations. Examples include diagnostics for rare arrhythmias, devices for neonatal care, and treatments for conditions like cystic fibrosis or Sickle Cell Disease. NCATS may co-fund projects that align with its mission to streamline translational processes and accelerate treatments for multiple rare diseases.

Eligibility is restricted to U.S.-based small business concerns (SBCs) with no more than 500 employees. Applications must demonstrate prior SBIR/STTR Phase II funding and propose a continuation of these efforts. Foreign entities are not eligible, but foreign components may be allowed. Applicants are encouraged to leverage additional Federal programs like Orphan Drug designation or FDA incentives and engage with patient advocacy groups or similar stakeholders for strategic support.

The award provides up to $3.5 million in total funding over three years, with annual funding typically capped at $1,166,667. An additional $50,000 for Technical and Business Assistance (TABA) can be requested outside the budget cap. Projects must secure independent third-party investment equal to at least one-third of the requested NHLBI funding. Applications must include a detailed commercialization plan addressing long-term financial and regulatory strategies.

Key deadlines include a first submission date of January 26, 2025, with annual deadlines through February 26, 2027. Applications must comply with updated NIH forms (FORMS-I) and adhere strictly to the NIH Grants Policy Statement. Review criteria include scientific merit, potential for commercialization, alignment with NHLBI priorities, and feasibility of achieving regulatory and financial goals. Applicants are strongly encouraged to contact NHLBI and NCATS program officers for guidance and ensure their project aligns with programmatic goals.