The Office of Crisis Management (OCM) serves as the FDA's focal point for coordinating emergency and crisis response activities involving FDA-regulated products or in situations when FDA regulated products need to be utilized or deployed. It coordinates intra-agency and inter-agency activities related to crisis management, and emergency preparedness and response.
Mark R. Russo, Acting Director, Office of Crisis Management
Andrei Perlloni, Acting Director, Office of Emergency Operations
Improved public health evidenced by reduced risk of illness and injury as a result of effective preparedness activities and coordination of emergency incidents involving FDA-regulated products.
- Coordinating incidents involving injury or illness related to FDA-regulated products, including biologics, drugs, devices, tobacco, and certain foods/feed.
- Maintaining 24/7 capability to intake, assess, and assign calls to the FDA After-Hours Emergency Call Center.
- Managing the National Consumer Complaint System by observing trends, developing guidelines for common consumer complaint issues, and monitoring reports of problems received with FDA-regulated products that could be indicative of potential emergencies.
- Coordinating with internal and external organizations to ensure that international notifications pertaining to potential problems with FDA-regulated products are processed in a consistent and timely manner.
- Ongoing development and further deployment of FDA's Emergency Operations Network Incident Management System.
- Improving FDA's Geographic Information System mapping capabilities to strengthen the agency's preparedness and overall immediate response efforts.
- Coordinating National Incident Management System Incident Command System training for emergency response employees.
- Updating the FDA Emergency Operations Plan (FDA EOP) to reflect the Office of the Commissioner's organizational structural changes and the creation of new national level directives, strategies, frameworks, and guidance.
- Leading and coordinating the agency's planning and participation in multiple national and regional exercises, such as the National Exercise Program Capstone Exercise 2014 (NEPCE 2014), which examined the Federal government's ability to during simulated natural and manmade disasters.
Major Functions and Descriptions
Focal Point for Coordination and Response - for the Food and Drug Administration (FDA) in emergency and crisis situations involving FDA regulated products or in situations in which FDA regulated products are needed to be utilized or deployed.
Emergency and Crisis Management - assists in the development and management, emergency and crisis management policies and programs for FDA to ensure that a structure exists to respond rapidly to an emergency or crisis situation.
Emergency Coordinator - Serves as agency emergency coordinator to HHS Office of the Assistant Secretary for Preparedness and Response (OASPR) and as liaison to HHS Secretary's Office of Security and Strategic Information (OSSI). Provides OASPR situational awareness of all FDA-related emergencies and ensures that FDA's emergency operations procedures are in alignment with national and HHS procedures.
International Capability and Readiness - Participates in international initiatives to ensure FDA's capability and readiness to work with foreign counterparts in responding to international emergencies involving or impacting FDA-regulated products and to share information with international counterparts during such emergencies.
Emergency Operations Network Incident Management System -manages the FDA Emergency Operations Network Incident Management System (EON IMS), a system for capturing large amounts of near real time information about emergencies related to FDA-regulated products for use by senior agency decision makers in assessing and managing response activities. Provide offices and centers geographical information system maps created by EON IMS's GIS mapping component for use in strategic planning of agency emergency response activities.
Emergency Operations Plans - Develops and updates agency emergency operations plans and incident specific annexes, ensuring their alignment and compliance with the National Response Framework and its Emergency Support Functions and the National Incident Management System.
Exercises for Emergency Operations Plans - Plans and conducts agency exercises to test emergency operations plans. Plans and coordinates FDA's participation in emergency exercises sponsored by other Departments and agencies, including national and international level exercises.
Emergency Call Center - Oversees the FDA Emergency Call Center which provides after normal hours service for responding to public inquiries and reports related to FDA-regulated products as well as surge capacity service for managing increased volumes of inquiries due to an event involving an FDA-regulated product.
Emergency Operations Center - Manages FDA's Emergency Operations Center (EOC), activating the EOC with augmented staffing from relevant centers and offices to monitor emergency situations, triage complaints and alerts, issue mission assignments to organizational components, coordinate overall agency response operations, and communicate with external partners requesting technical and material support. FDA's EOC serves as the central point of contact with the Department of Homeland Security's National Operations Center, Health and Human Services Secretary's Operation Center, Centers for Disease Control and Prevention Emergency Operations Center, U.S. Department of Agriculture/ Food Safety and Inspection Service Situation Room, and other Federal EOCs as appropriate.
Evaluation of Emergency Responses - Coordinates agency evaluation of emergency responses and crisis situations to determine appropriate internal and external referral for further action and recommended changes in agency procedures.
Office of Emergency Operations
The Office of Emergency Operations serves as the FDA's central emergency coordination point with FDA Field Offices, Headquarters, and Centers.
OEO provides interagency coordination and response to adverse events, foodborne illnesses, injuries, product tampering and man-made and natural disasters.
- Assists in the development of emergency operations plans and incident specific annexes and the design, implementation, and presentation of associated training and exercise programs.
- Represents the Agency at federal, state, local and foreign government meetings and workgroups on emergency preparedness and response.
- Provides nationwide, 24-hour, seven-day-a-week emergency response system.
- Manages the National Consumer Complaint System.