Counter-Terrorism and Emergency Coordination Staff

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aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <hr> <p><p>The Counter-Terrorism and Emergency Coordination Staff (CTECS) 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. </p> <h4><b>What We Do</b></h4> <ul> <li>Coordinate Center activities related to emergency situations involving CDER-regulated products or facilities</li> <li>Provide consultation for consistent application of the Animal Rule to product development</li> <li>Provide consultation on the development and availability of safe, effective, and quality medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) threats and emerging infectious diseases</li> <li>Assist scientific researchers and drug sponsors early in MCMs drug development to prepare for formal regulatory meetings with CDER’s review divisions</li> <li>Interact with other federal partners, such as the Assistant Secretary for Preparedness and Response (DHHS/ASPR), Biomedical Advanced Research and Development Authority (DHHS/ASPR/BARDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Department of Defense (DoD), and the Department of Homeland Security (DHS), on emergency preparedness and response activities</li> <li>Provide policy expertise related to MCM priority review vouchers (PRV)</li> <li>Provide consultation on Emergency Use Authorization (EUA)</li> <li>Coordinate the Animal Model Qualification Program (AMQP)</li> <li>Serve as the after-hours contact for CDER emergency INDs</li> <li>Serve as the CDER point of contact for strategic stockpiles (e.g., CDC’s Strategic National Stockpile)</li> </ul> <h4><b>Useful Links</b></h4> <ul> <li><a href="/media/88625/download" target>Guidance for Industry:  Product Development Under the Animal Rule</a> (PDF - 2 MB)</li> <li><a href="/drugs/nda-and-bla-approval-reports/animal-rule-approvals" target>Animal Rule Approvals</a></li> <li><a href="/drugs/drug-development-tools-qualification-programs/animal-model-qualification-program" target>Animal Model Qualification Program (AMQP)</a></li> <li><a href="/medical-countermeasures-initiative" target>Medical Countermeasures Initiative (MCMi)</a></li> <li><a href="/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" target>Emergency Use Authorization (EUA)</a> </li> <li><a href="/expanded-access-compassionate-use-0" target>Expanded Access (Compassionate Use) </a></li> <li><a href="https://www.fda.gov/Drugs/EmergencyPreparedness/default.htm">Emergency Preparedness (Drugs)</a></li> </ul> <h4><b>Contact Us </b></h4> <p>Counter-Terrorism and Emergency Coordination Staff (CTECS)<br> 10001 New Hampshire Avenue<br> Silver Spring, MD 20993<br> Phone: 301-796-2210<br> Fax: 301-431-6356</p> <p>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:  </p> <ul> <li>Director: Rosemary Roberts, M.D., <a href="mailto:Rosemary.Roberts@fda.hhs.gov">Rosemary.Roberts@fda.hhs.gov</a></li> <li>Associate Director: Kelly Ngan, Pharm.D., MPH, <a href="mailto:Kelly.ngan@fda.hhs.gov">Kelly.ngan@fda.hhs.gov</a></li> <li>Associate Director for Regulatory Affairs: Andrea Gormley, Pharm.D., J.D., <a href="mailto:Andrea.Gormley@fda.hhs.gov">Andrea.Gormley@fda.hhs.gov</a></li> <li>CDER / Department of Defense Engagement: Brad Leissa, M.D., <a href="mailto:Brad.Leissa@fda.hhs.gov">Brad.Leissa@fda.hhs.gov</a></li> <li>Medical Countermeasure Development – Susan McDermott, M.D., <a href="mailto:Susan.McDermott@fda.hhs.gov">Susan.McDermott@fda.hhs.gov</a></li> <li>Animal Model Qualification Program – Susan McDermott, M.D., <a href="mailto:Susan.McDermott@fda.hhs.gov">Susan.McDermott@fda.hhs.gov</a></li> <li>Drug Emergencies, including emergency Investigational New Drug (IND) requests – call the Office of Emergency Operations (OEO) 24-hour, 7-days-a-week emergency response system, 301-796-8240/ 1-866-300-4374 (toll-free) or refer to <a href="https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm">FDA's Expanded Access (Compassionate Use) website</a>.</li> </ul> <p> </p> <p> </p> <br/> <br></p> <hr>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 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