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U.S. Department of Health and Human Services

About FDA

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Office of Counter-Terrorism and Emergency Coordination (OCTEC)

The Office of Counter-Terrorism and Emergency Coordination (OCTEC) provides scientific, regulatory and policy assistance within the Center for Drug Evaluation and Research (CDER) for drug development initiatives relating to medical countermeasures, and coordination of emergency activities involving CDER regulated products. 

 
What We Do
 
  • Facilitate the development and availability of safe, effective and quality medical countermeasures (MCM) for chemical, biological, radiological and nuclear threats.
  • Coordinate CDER operations and responses for emergencies involving drugs and biological therapeutics
  • Facilitate, coordinate, and manage the Animal Model Qualification Program (AMQP).
  • Liaise with other federal partners, such as the Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Department of Defense (DoD).
  • Help scientific researchers and drug sponsors early in MCM drug development prepare for formal regulatory meetings with CDER’s review divisions.
  • Provide policy expertise related to Emergency Use Authorization (EUA).
  • Facilitate CDER’s consistent application of the “Animal Rule.”
 
Useful Links
 
 
Contact Us
 
Office of Counter-Terrorism and Emergency Coordination
10001 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-2210
Fax: 301-431-6356
 
You may contact us for early discussion about MCM development, animal model qualification or other areas of interest. Based on the issue of interest, you may contact: