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 Funding Opportunity Announcement (FOA) 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 FOA 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.