The purpose of the NHLBI SBIR Phase IIB Small Market Award is to provide support to Phase II SBIR awardees developing NHLBI mission-related technologies that address a rare disease or young pediatric populations. The goal of this FOA is to de-risk these technologies so that development can continue with private funding after NHLBI support ends; therefore, applicants must submit a Commercialization Plan, which should include details on any independent third-party funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will be equal to or greater than one-third of the NHLBI funds being requested throughout the project period. Projects proposed in response to this FOA must require eventual Federal regulatory approval/clearance, and may address preclinical and/or clinical stages of technology development. Clinical trials may be proposed as appropriate, but are not required.