Volume 13, Number 7—July 2007
Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, United States
|Step||Required action||Responsible authority|
|1||Determination of an emergency justifying issuance of an EUA||Secretary of Homeland Security OR Secretary of Defense OR Secretary of Health and Human Services|
|2||Declaration of emergency||Secretary of Health and Human Services|
|3||Consultation (to the extent feasible) between the FDA, NIH, and CDC||FDA commissioner, NIH director, CDC director|
|4||Issuance of an EUA||FDA commissioner (under delegated authority from Secretary of Health and Human Services)|
*EUA, Emergency Use Authorization; FDA, US Food and Drug Administration; NIH, National Institutes of Health; CDC, Centers for Disease Control and Prevention.