FDA Emergency Response and 2017 Hurricane Season Andrei Nabakowski, - - PowerPoint PPT Presentation

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FDA Emergency Response and 2017 Hurricane Season Andrei Nabakowski, - - PowerPoint PPT Presentation

Mar 31, 2024 451 likes •1.03k views

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

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www.fda.gov OEM | Office of Emergency Management

FDA Emergency Response and 2017 Hurricane Season

Andrei Nabakowski, PharmD Director, Office of Emergency Operations U.S. Food and Drug Administration

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Disclosure

I have no conflicts of interest or financial relationships with commercial interests to disclose.

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Topics

  • Overview of USG Federal response
  • Describe FDA organizational structures in a

response

  • FDA response activities in natural disasters
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Federal Response Overview

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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.

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Collaboration

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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

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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.
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National Level Incident Support

Joint Field Office Field coordination of response activities Regional Response Coordination Center National Response Coordination Center

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NRCC

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Joint Field Office- Hurricane Maria

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Emergency Support Functions

  • Emergency Support Functions (ESFs) are organizational

relationships outlined in the National Response Framework

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Emergency Support Function #8 Responsibilities

  • Public Health and Medical needs assessments
  • Health Surveillance
  • Medical Care- Personnel, Supplies and

Equipment

  • Patient Evacuation
  • Patient Care
  • Safety and security of human drugs,

biologicals, medical devices, and veterinary drugs

  • Blood and Blood Products
  • Food safety and Security
  • Agriculture Safety and Security
  • Worker Health and Safety
  • Public Health and Medical technical consults
  • Behavioral health care
  • Vector Control
  • Potable Water and Wastewater Disposal
  • Victim Identification/ mortuary services
  • Animal Health/ veterinary care
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HHS coordinates the overall health and medical response to national-level incidents

ESF #8: personnel and assets from HHS and Support Agencies:

 Department of Agriculture  Department of Defense  Department of State  Department of Energy  Department of Homeland Security  Department of the Interior  Department of Justice  Department of Commerce  Department of Transportation  Department of Veterans Affairs  Agency for International Development  Environmental Protection Agency  General Services Administration  U.S. Postal Service  American Red Cross  Department of Labor

ESF #8 – Public Health and Medical Services

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HHS Secretary’s Operations Center

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Department of Health and Human Services

Operating Divisions Staff Divisions Staff Divisions

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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

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Office of the Commissioner

Center for Food Safety & Applied Nutrition Center for Veterinary Medicine

Office of Foods and Veterinary Medicine

Center for Drug Evaluation & Research Center for Biologics Evaluation & Research Center for Devices & Radiological Health Center for Tobacco Products

Office of Medical Products & Tobacco

Office of Regulatory Affairs

Office of Global Reg. Ops & Policy

Office of International Programs

Agency Organizational Chart

Food and Drug Administration

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FDA Field Locations and Previous Regions

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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

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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
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FDA Emergency Operations Center

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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
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FDA Agency Executive Group

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FDA Agency Incident Coordinator

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Incident Command System

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IMG Organization- 2017 Hurricane Response

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DAL IMT SJN IMT FLA IMT

IMG

AEG

Field IMT Status

9/22/17 (pm)

ATL IMT BLT IMT NOL IMT

New York DO New England DO New Jersey DO. Philadelphia DO

  • GIS Provided

“Stand-by” “Alert”

NJS-2017
  • GIS provided
  • GIS Provided
  • Monitoring

Key:

Harvey Maria Irma Jose

FDA Incident Coordination Groups - 2017 Hurricanes

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IMG Activation

Activated August 28th

  • In-place August 29th
  • Initial Staffing: <20
  • Participating Organizations:

OEM, CFSAN, CDER, ORA, OIMT

Joint Information Center activated September 11th

  • In-place September 13th

Fully Staffed IMG & JIC

  • Staffing : 40+
  • Participating organizations:

OEM, OEA, ORA, CFSAN, CVM, OC, CORE, CDER, CBER, CDRH, CTP, OEXA/OMA, OFEMS, NCTR, OHR, OIMT, OSO

Note: FDA OEO coordination prior to landfall and through IMG activation

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Hurricane Harvey/Irma/Maria IMG

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Hurricane Strength Info

  • Tropical Storm 39-73 mph
  • Category 1

74-95 mph Very dangerous winds, some damage

  • Category 2

96-110 mph Extremely dangerous, extensive damage

  • Category 3

111-129 mph Devastating damage

  • Category 4

130-156 mph Catastrophic damage

  • Category 5

>156 mph Catastrophic damage

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Hurricane Harvey

Texas landfall 8/25/17 as a Category 4 storm First major hurricane landfall in US since 2005 Slow moving, torrential rainfall and severe flooding

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Hurricane Irma

Very strong storm; tied record for longest lasting Category 5 storm in Atlantic basin Impacted both Puerto Rico 9/6/17 and Florida 9/10/17 Landfall in Florida as a Category 4 storm, the first Cat 4 since 2004 in the state

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Hurricane Maria

Landfall 9/20/17 as a high Category 4 storm Catastrophic damage from winds, torrential rains and flooding, as P.R. and USVI were still addressing damage from Irma Enormous damage to P.R. and USVI infrastructure including power outages, comms, transportation

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Photo of Puerto Rico damage: KALW Radio, San Francisco, CA

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Challenges

  • Widespread and sustained power outages
  • Communications
  • Roads/transportation
  • Generators, fuel, maintenance
  • Damage across all FDA regulated product areas
  • Duration of response
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Hurricane Maria

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Agency Areas of Focus

  • Personnel accountability and safety of FDA Staff
  • Status of FDA facilities and sites
  • Assessments of FDA regulated firms
  • Impact on products and availability
  • Communications with stakeholders
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FDA Personnel Accountability

Accountability of Florida (FL) as of XXXX

Location Employee Name Center Residence Location Building Name Accounted For (Yes/No) Evacuated (Yes/No) Property Sustained damage (Yes/No) Damage Details Returned to work

SAMPLE #1 Brown, Sally OC Anywhere, FL Yes No No n/a Yes SAMPLE #2 Brown, Charlie OC Somewhere, FL Yes No Yes Water in house No 100% 0.00% 50.00% 50%

FL Employee Listing

1 2 3 4 5 6 7 8

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FDA Facilities Assessment

2017 Hurricane Irma FDA Facility conditions

Location / Situation Own/Lease Open damage (Y/N) Electric (Yes/No Generator running (Yes/No) Running water (Yes/No) Damage Details Working Office / Telework Additional information

Arkansas 2017 Hurricane Irma Miami IMF PEV Boca Raton Fort Myers Jacksonville Tampa – Maitland Port Everglades Boca Raton International Mail Facility Jacksonville Tallahassee Resident Post Miami Lakes Resident Posts Florida District Office in Maitland

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Assessment of FDA regulated firms

Develop list of firms potentially impacted by the hurricane Prioritize and rank the firms impacted by the hurricane IMG perform final review of list and forward to the IMT IMT evaluate list and follow- up on high priority firms Final outcome

  • f the follow-

up reported to IMG

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FDA Joint Information Center (JIC)

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Wildfires in California

Large incidents, concurrent with other responses

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Alberto Beryl Chris Debby Ernesto Florence Gordon Helene Isaac Joyce Kirk Leslie Michael Nadine Oscar Patty Rafael Sara Tony Valerie William

2018 Hurricane Names

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QUESTIONS?

Andrei.Nabakowski@fda.hhs.gov