SMG 1130.11

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE COUNSELOR TO THE COMMISSIONER

OFFICE OF CRISIS MANAGEMENT

Effective Date: 08/07/2009

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1. OFFICE OF CRISIS MANAGEMENT (DARA).

A. Serves as the first responder for 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.

B. Assists in the development and management of emergency and crisis management policies and programs for FDA to ensure that a structure exists to respond rapidly to an emergency or crisis situation.

C. 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.

D. 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.

E. 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. Provides Offices and Centers geographical information system (GIS) maps created by EON IMS’s GIS mapping component for use in strategic planning of Agency emergency response activities.

F. 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 (NRF) and the National Incident Management System (NIMS).

G. Plans and conducts Agency exercises to test emergency operations plans. Plans and coordinates FDA’s participation in emergency exercises sponsored by HHS and other Departments and agencies, including national and international level exercises.

H. Develops agency training goals and initiatives to ensure that agency emergency response staff and senior officials are informed of the operational requirements of the NRF, NIMS, national level exercise programs and other national emergency plans and preparedness efforts.

I. 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.

L. 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, HHS Secretary’s Operation Center, CDC Emergency Operations Center, USDA/FSIS Situation Room, and other Federal EOCs as appropriate.

M. 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.

N. Oversees and tests the Agency’s ability to communicate through the Government Electronic Telecommunications Service (GETS) which provides global telecommunications (secure voice, facsimile and data communications) capability for organizations that perform national security and emergency preparedness functions.

O. Oversees the work of the Office of Emergency Operations.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Secretary of Health and Human Services on August 7, 2009.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/23/2007	N/a	OC/OO/OM/OMP	Secretary of the Department of Health and Human Services
Revision	08/07/2009	N/a	OC/OA/OM/OBOHCP/OMP	Secretary of the Department of Health and Human Services