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 and regulatory leadership within CDER for the drug development initiatives relating to counter-terrorism measures, medical countermeasures, and coordination of emergency activities for the Center.
What We Do
- Facilitate the development and availability of safe and effective medical countermeasures for chemical, biological, radiological and nuclear threat
- Coordinate CDER emergency operations and responses pertaining to drugs and biological therapeutics
- Coordinate CDER activities related to emergency situations involving CDER-regulated products or facilities
- Facilitate, coordinate and maintain the Animal Model Qualification Program (AMQP)
- Work with Emergency Use Authorization (EUA)
- Work with Animal Rule
Office Leadership
- Office Director: Rosemary Roberts, M.D.
- Deputy Director: Brad Leissa, M.D.
- Associate Director for Regulatory Affairs: Joanne Holmes
Links to Useful Tools
- Animal Model Qualification Program (AMQP)
- Emergency Use Authorization (EUA) of Medical Products
- Animal Rule Guidance (Guidance)
Contact Us
Office of Counter-Terrorism and Emergency Coordination
Hillandale Building, 2nd Floor
10001 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-2210 or 2190
Fax: 301-431-6356
You should contact us for early discussion about Medical Countermeasure (MCM) development, animal model qualification or other areas of interest. Based on the issue of interest you may want to contact:
- Medical Countermeasure Development – Susan McDermott MD, 301-796-1121 Susan.McDermott@fda.hhs.gov
- Animal Model Qualification – Joel Beren, DVM, 301-796-2965 Joel.Beren@fda.hhs.gov or Jerry Davis, DVM, 301-796-3784 Jerry.Davis@fda.hhs.gov
- Strategic National Stockpile – Brad Leissa, MD, 301-796-1693 Brad.Leissa@fda.hhs.gov
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