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SMG 1269.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF COUNTER-TERRORISM AND EMERGENCY COORDINATION

Effective Date: 05/09/2006

[PDF Version]

1. OFFICE OF COUNTER-TERRORISM AND EMERGENCY COORDINATION (DBNL).

A. Provides scientific and regulatory leadership within the Center for Drug Evaluation and Research (CDER) for the drug development initiatives relating to terror and military counter-terrorism measures. Fosters and facilitates the special drug development issues relating to counter-terrorism (CT) and force protection, such as animal models, and the development and labeling of drugs for chemical, biological, radiological and nuclear threat agents.

B. Provides consultation for the evaluation for safety and effectiveness for the approval of new drug applications (NDAs) or biological license applications (BLAs) for CT and military use indications regulated by other offices of the center, and the evaluation of supplements that propose changes in the conditions upon which NDA approvals or BLA licensures are based.

C. Facilitates development of policy and procedures governing the review and evaluation of drug investigations and NDAs and BLAs for CT and military use indications regulated by the center.

D. Coordinates and performs consulting medical and scientific evaluations of submission of generic drugs, and over-the-counter drug products for CT and military use indications regulated by other offices in the center.

E. In consultation with the relevant offices or centers, represents the Agency as liaison with external agencies, other federal and state programs, advisory and professional groups, and academic institutions.

F. Provides scientific and regulatory leadership within CDER for activities related to interventions which may be used in a public health emergency (e.g., pandemic influenza, and disasters) or to counteract the effects of a terrorist event. Provides CDER with Emergency Preparedness Training Tools and assists in the design, education and implementation of an emergency plan for responding to terrorism or a public health emergency.

G. Interacts with organizations within CDER, Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), and the Office of the Commissioner; coordinates drug issues with external government agencies, such as Center for Disease Control (CDC) the Department of Defense (DOD), the Department of Homeland Security (DHS), National Institues of Health, and Health and Human Services’ (HHS) Office of Public Health Preparedness. Provides scientific and educational resources for counter-terrorism and emergency risk communication involving other Food and Drug Administration (FDA) scientists, the CDC, DOD, and other health care agencies.

H. Identifies ares of unmet medical need related to medical countermeasures (i.e., whether drugs are approved and/or labeled for the specific intended use).

I. In collaboration with CDER’s Drug Shortage Team, assists in assuring the availability of vitally important drugs used to counteract/treat the effects of chemical, biological, radiological or nuclear threat agents or public health emergencies (e.g., pandemic influenza, and disasters).

J. Serves as CDER’s point of contact (POC) for all interactions with the Strategic National Stockpile (SNS), as well as state, local, and other stockpiles.

K. Serves as initial POC for CDER for all incidents involving CDER-regulated products conveyed through FDA’s Office of Emergency Operations (OEO). Serves as coordinator for inter-office meetings intended to identify, address, and mitigate the emergency safety issue(s) associated with CDER-regulated products.

I. Responsible for the CDER Situation Room (CSR), including appropriate and adequate staffing when the CSR has been activated in response to an incident of national significance affecting CDER-regulated products, at the request of the Center Director or the Commissioner. Provides leadership in support of CDER’s role in emergency response exercises (e.g., TOPOFF).

M. Assigns an Incident Commander form the Office of Counter-Terrorism and Emergency Coordination (OCTEC) staff to coordinate Center responses for any incident of national significance requiring activation of the CSR, or of sufficient complexity so as to justify coordination by OCTEC.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Director, Center for Drug Evaluation and Research on May 9, 2006.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial05/09/2006N/aOC/OO/OM/OMPSteven Galson, Director, Center for Drug Evaluation and Research