SMG 1114.6

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE CHIEF SCIENTIST

OFFICE OF COUNTER-TERRORISM AND EMERGING THREATS

Effective Date: 07/08/2011

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1.  OFFICE OF COUNTER-TERRORISM AND EMERGING THREATS (DAEG)

A. Provides leadership and coordination of FDA’s medical countermeasure initiative including being the focal point for coordination with the Government’s PHEMCE

B. Develops and implements a comprehensive counterterrorism strategy for FDA to identify and address gaps in current efforts to safeguard medical products from adulteration or disruption of supplies during public health emergencies

C. Develops and coordinates the implementation of crosscutting policies to facilitate the availability of safe and effective medical countermeasures against chemical, biological, radiological, and nuclear agents and other emerging threats

D. Provides policy leadership for FDA’s Emergency Use Authorization (EUA) activities for terrorism and during public health emergencies

E. Develops and coordinates the implementation of comprehensive FDA plans and strategies for pandemic influenza preparedness and other emerging threats, in collaboration with the Centers and Offices and with external partners

F. Provides policy leadership by promoting the goals and needs for counter-terrorism and other emerging threats in the Agency budgeting and priority-setting processes

G. Coordinates the portfolio of FDA counter-terrorism and pandemic influenza policy and planning initiatives and serves as the point of entry to the Agency on counter-terrorism and emerging threats policy and planning matters

H. On behalf of the Office of the Commissioner, facilitates intra- and inter-agency communications on counterterrorism policy and pandemic influenza preparedness

2.  AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office were approved by the Secretary of Health and Human Services, effective July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/23/2007	N/a	OC/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
Revision	07/08/2011	N/a	OO/OM	Secretary of the Department of Health and Human Services