Declaration Regarding Emergency Use of Treatment for Uncontrolled Hemorrhage Due to Agents of Military Combat

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act. On June 7, 2018, Patrick M. Shanahan, Deputy Secretary of Defense, determined in accordance with the Federal Food, Drug and Cosmetic Act, as delegated by the Secretary of Defense, that there is a military emergency or significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with an agent or agents that may cause, or are otherwise associated with an imminently life-threatening and specific risk to those forces. More specifically, U.S. Forces are now deployed in multiple locations where they serve at heightened risk of an enemy attack with agents of military combat, including firearms, projectiles, and explosive devices, that may cause major and imminently life-threatening combat casualties involving uncontrolled hemorrhage. On the basis of this determination, on July 9, 2018 the Secretary declared that circumstances exist justifying the authorization of emergency use of Freeze Dried Plasma (FDP) to treat uncontrolled hemorrhage due to agents of military combat (e.g., firearms, projectiles, and explosive devices) in emergency situations when plasma is not available for use or its use is not practical, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.