Inspections, Compliance, Enforcement, and Criminal Investigations
8-3 - RESPONSIBILITY
Alerts to potential emergencies are nearly an everyday occurrence at FDA. The agency's permanent organizational structure is designed, in part, to accommodate both large and small emergencies. In an emergency situation, it is important that individual assignments and responsibilities be consistent with normal functions and duties as outlined in unit functional statements and position descriptions.
The EOC is a focal point for the review of preliminary information about potential emergencies and assists in the early recognition of incidents, outbreaks and potential acts of terrorism. Primary responsibility for monitoring emergency alert information and coordinating investigations and scientific evaluations rests with the EOC, HFA-615. Any emergencies involving highly transmissible diseases that would include SARS, avian flu, WNV (West Nile Virus), malaria, etc., chemical, biological or radiological emergencies, contact the EOC at 866-300-4374 or fax to 301-847-8544.
This procedure includes mechanisms for monitoring investigations leading to an understanding that an emergency exists. It is expected that the involved centers and district offices will establish the coordination units discussed in this procedure during the course of an investigation as the situation warrants. In some instances, a formal declaration of an emergency may be required to activate the appropriate emergency coordinating units within the agency. On other occasions, a formal declaration of an emergency may not be required because all coordination units are already functioning.
If there is disagreement between any offices or uncertainty regarding whether or not FDA should initiate emergency action under this procedure, the issue should immediately (by telephone) be referred to the Office of Crisis Management/EOC (8-6 3). The Director, Office of Crisis Management along with the Associate Commissioner for Regulatory Affairs or designee, in consultation with ORO and the involved centers, will decide whether to implement the procedure and will notify the appropriate offices.