About FDA

Description: PERSI encourages participation by science and technology based firms and educational institutions in meeting FDA goals for innovative ideas and approaches for regulatory science. PERSI-BAA identifies innovative and promising technologies for advanced development across the FDA which focuses on nine regulatory science research areas: (1) Modernize Toxicology to Enhance Safety; (2) Stimulate Innovation in Clinical Evaluation and Personalized Medicine to Improve Product Development and Patient Outcomes; (3) Support New Approaches to Improve Product Manufacturing and Quality; (4) Ensure FDA Readiness to Evaluate Innovative Emerging Technologies; (5) Harness Diverse Data Through Information Sciences to Improve Health Outcomes; (6) Enable a Prevention Focused Food Safety System; (7) Facilitate Development of Medical Countermeasures to Protect US and Global Health and Security; (8) Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions; and (9) Strengthening the Global Product Safety Net. The BAA vehicle not only accelerates contract awards with flexible solicitation, but also reduces up-front planning and document reviews by creating unified advanced development solicitation. It provides flexibility to accommodate a range of contract awards (type, scope, number) in one vehicle which allows for market assessment of technologies. The BAA process starts with a quad chart/white paper review which will allow for a quick assessment of promising technologies from which to select full proposals. The second step includes establishing full review cycles of selected full proposals. After an extensive peer-review process, only a few proposals with the greatest importance to the FDA, are selected. PERSI-BAA is flexible and can be amended and modified anytime.

Accomplishment: The BAA program has sustained a consistent growth in the number of contract awards within FY14 and FY15. For example, FDA awarded 28 new projects in FY14 and 29 new projects in FY15. We completed 5 BAA projects in FY14 and 10 projects in FY15. Our FY16 awards are still in progress.