FDA Emergency Operations Plan (Version 3.0)

The FDA Emergency Operations Plan (Version 3.0) is a national cross-sectoral plan of the United States of America. Its main objectives are to serve as the single, overarching FDA-wide operational plan to address the full spectrum of natural and technological hazards and terrorist threats and the “umbrella plan” into which all supporting agency emergency plans, procedural documents, and other guidance integrate; define the FDA emergency operating structure and assigns essential tasks to all FDA organizational components involved in prevention, protection, mitigation, response, and recovery efforts; provides mechanisms for vertical and horizontal command, control, coordination, and communications; and integrates FDA emergency response operations into the Federal coordinating structure and ensures consistency with nationally recognized incident management policy and guidance.
More specifically, the Plan provides for concept of operations; emergency authorities; emergency operations phases; prevention, protection, and mitigation; surveillance, detection, and alert; consumer product protection; medical countermeasures; increased surveillance of FDA-regulated medical products; response; gain and maintain situational; alert and notification; assessment and monitoring; activation and deployment of resources and capabilities; authority to change operational levels; conditions for operational level change; coordination of response actions; FDA field response; mission assignments in support of state and local response; medical countermeasures: EUA and expanded access; characteristics of potential foodborne agents; chemical agents; biological agents; oversight of select agents and toxins by HHS/CDC and USDA/ANIMALAND plant health inspection service; domestic and international traceback/traceforward; nuclear/radiological annex to the FDA emergency operations plan; and pandemic influenza annex to the FDA emergency operations plan.