FDA Emergency Response and 2017 Hurricane Season Andrei Nabakowski, PharmD Director, Office of Emergency Operations U.S. Food and Drug Administration www.fda.gov OEM | Office of Emergency Management
Disclosure I have no conflicts of interest or financial relationships with commercial interests to disclose. www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
Topics - Overview of USG Federal response - Describe FDA organizational structures in a response - FDA response activities in natural disasters www.fda.gov OEM | Office of Emergency Management
Federal Response Overview www.fda.gov OEM | Office of Emergency Management
U.S. Federal Response • The Department of Homeland Security (DHS) has general responsibility for U.S. federal disaster response. The Secretary of DHS reports to the President. • The Federal Emergency Management Agency (FEMA) is a component of DHS and coordinates disaster response and emergencies that overwhelm state and/or local resources. • Governors of U.S. states declare a state of emergency and request federal assistance, including a Presidential disaster declaration. www.fda.gov OEM | Office of Emergency Management
Collaboration www.fda.gov OEM | Office of Emergency Management
National Response Framework • Guide to how the Nation responds to disasters and emergencies • Describes roles, responsibilities, and coordinating structures • Scalable, flexible, adaptable • Includes individuals, communities, NGOs, private sector, local, tribal, state and federal government www.fda.gov OEM | Office of Emergency Management
NRF and the Private Sector Key private sector activities include: • Addressing the response needs of employees, infrastructure, and facilities. • Protecting information and maintaining the continuity of business operations. • Planning for, responding to, and recovering from incidents that impact their own infrastructure and facilities • Collaborating with emergency management personnel to determine what assistance may be required and how they can provide needed support. • Contributing to communication and information-sharing efforts during incidents. • Planning, training, and exercising their response capabilities. www.fda.gov OEM | Office of Emergency Management
National Level Incident Support Joint Field Office Field coordination of response activities Regional Response Coordination Center National Response Coordination Center www.fda.gov OEM | Office of Emergency Management
NRCC www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
Joint Field Office- Hurricane Maria www.fda.gov OEM | Office of Emergency Management
Emergency Support Functions Emergency Support Functions (ESFs) are organizational relationships outlined in the National Response Framework www.fda.gov OEM | Office of Emergency Management
Emergency Support Function #8 Responsibilities • Public Health and Medical needs assessments • Agriculture Safety and Security • Health Surveillance • Worker Health and Safety Medical Care- Personnel, Supplies and Public Health and Medical technical consults • • Equipment • Behavioral health care • Patient Evacuation • Vector Control • Patient Care • Potable Water and Wastewater Disposal • Safety and security of human drugs, • Victim Identification/ mortuary services biologicals, medical devices, and veterinary Animal Health/ veterinary care • drugs • Blood and Blood Products Food safety and Security • www.fda.gov OEM | Office of Emergency Management
ESF #8 – Public Health and Medical Services HHS coordinates the overall health and medical response to national-level incidents ESF #8: personnel and assets from HHS and Support Agencies: Department of Transportation Department of Agriculture Department of Defense Department of Veterans Affairs Agency for International Development Department of State Department of Energy Environmental Protection Agency General Services Administration Department of Homeland Security U.S. Postal Service Department of the Interior Department of Justice American Red Cross Department of Labor Department of Commerce www.fda.gov OEM | Office of Emergency Management
HHS Secretary’s Operations Center www.fda.gov OEM | Office of Emergency Management
Department of Health and Human Services Staff Staff Divisions Divisions Operating Divisions www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
U.S. Food and Drug Administration – The FDA protects the public health by ensuring the safety, effectiveness, & security of human & animal drugs, biological products, medical devices, foods, cosmetics, and also regulates tobacco products. – FDA regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
Food and Drug Administration Agency Organizational Chart Office of the Commissioner Office of Foods Office of Office of Medical Products and Veterinary Global Reg. & Tobacco Medicine Ops & Policy Office of Office of C enter for C enter for C enter for C enter for C enter for C enter International Regulatory F ood V eterinary B iologics D evices & D rug for Programs Affairs S afety & M edicine E valuation R adiological E valuation T obacco A pplied & H ealth & P roducts N utrition R esearch R esearch www.fda.gov OEM | Office of Emergency Management
FDA Field Locations and Previous Regions www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
www.fda.gov OEM | Office of Emergency Management
Example District • San Juan District Office – OBPO Division 1 (biologics) – OPQO Division 2 (drugs) – OBIMO Division 1 (bioresearch monitoring) – OMDRHO Division 2 (medical devices) – OHAFO Division 4 East (foods) – OEIO Division of Southeast Import www.fda.gov OEM | Office of Emergency Management
Office of Emergency Operations • The Office of Emergency Operations (OEO), within the Office of Emergency Management , serves as FDA’s focal point for emergency and incident coordination with FDA Headquarters offices, Product Centers, and ORA District Offices. • OEO responds to and provides interagency coordination for: – Adverse events – Some foodborne illnesses (in coordination with CORE) – Injuries – Product tampering – Manmade and natural disasters • Manages the National Consumer Complaint System • Assists in the development of emergency operations plans & procedures, and the implementation of related training and exercise programs. • 24/7 availability www.fda.gov OEM | Office of Emergency Management
FDA Emergency Operations Center www.fda.gov OEM | Office of Emergency Management
FDA Incident Management Group (IMG) • Coordinates FDA’s response across the Agency to ensure a unified Agency response. • Coordinates with Department of Health and Human Services (HHS) through the Secretary’s Operations Center (SOC) and Assistant Secretary for Preparedness and Response (ASPR) • Coordinates with interagency including Federal Emergency Management Agency and Department of Homeland Security • Ensures 24/7 coverage for the duration of a response • Serves as central repository for information about the response • Receive and respond to Requests for Information/Action • HHS Secretary • FDA Commissioner • External stakeholders, with the Joint Information Center www.fda.gov OEM | Office of Emergency Management
FDA Agency Executive Group www.fda.gov OEM | Office of Emergency Management
FDA Agency Incident Coordinator www.fda.gov OEM | Office of Emergency Management
Incident Command System www.fda.gov OEM | Office of Emergency Management
IMG Organization- 2017 Hurricane Response www.fda.gov OEM | Office of Emergency Management
Key: Harvey Maria Irma AEG Jose “Alert” “Stand-by” New Jersey DO. Philadelphia DO IMG BLT • Monitoring • GIS Provided IMT New England New York DO DO • GIS Provided • GIS provided SJN FLA ATL NOL DAL IMT IMT IMT IMT IMT Field IMT Status 9/22/17 (pm) FDA Incident Coordination Groups - 2017 Hurricanes NJS-2017
IMG Activation Activated August 28 th Joint Information Center Fully Staffed IMG & JIC activated September 11 th • In-place August 29 th • Staffing : 40+ • Initial Staffing: <20 • Participating organizations: • In-place September 13 th OEM, OEA, ORA, CFSAN, CVM, • Participating Organizations: OC, CORE, CDER, CBER, CDRH, OEM, CFSAN, CDER, ORA, OIMT CTP, OEXA/OMA, OFEMS, NCTR, OHR, OIMT, OSO Note: FDA OEO coordination prior to landfall and through IMG activation www.fda.gov OEM | Office of Emergency Management
Hurricane Harvey/Irma/Maria IMG www.fda.gov OEM | Office of Emergency Management
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