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U.S. Department of Health and Human Services

About FDA

FDA Broad Agency Announcement (BAA) or Program for Extramural Regulatory Science and Innovation (PERSI)

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: During FY13, 15 new contracts were awarded and currently 18 active contracts are in place for regulatory science research.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Renew BAA

5/23/2014

Completed 5/23/2014

B. Complete FY14 3rd quarter full proposal reviews and monitor the progress of the executed awards

6/30/2014

Not Yet Started

C. Complete FY14 4th quarter full proposal reviews and monitor the progress of the executed awards

9/30/2014

Not Yet Started

D. Complete FY15 1st quarter full proposal reviews and monitor the progress of the executed awards

12/31/2014

Not Yet Started

E. Complete FY15 2nd quarter full proposal reviews and monitor the progress of the executed awards

3/31/2015

Not Yet Started

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.