§300hh–10a Public Health Emergency Medical Countermeasures Enterprise

Summary

Create the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The Assistant Secretary for Preparedness and Response and the Director of the Office of Pandemic Preparedness and Response Policy must serve as co-chairs. Members must include leaders from HHS (such as CDC, NIH, and FDA), the Departments of Defense, Homeland Security, Agriculture, and Veterans Affairs, the Director of National Intelligence, the Office of Pandemic Preparedness and Response Policy, and other federal agencies the Secretary chooses (for example BARDA, the Strategic National Stockpile, NIAID, and the Office of Public Health Preparedness and Response). The PHEMCE must recommend to the Secretary what to research, develop, buy, stockpile, deploy, distribute, and use for medical countermeasures (as defined in section 247d–6b(c)). Those recommendations must be based on U.S. health security needs and informed, when possible, by the National Health Security Strategy (section 300hh–1), Strategic National Stockpile needs (section 247d–6b), and threat assessments including chemical, biological, radiological, nuclear, and emerging infectious diseases. If members disagree, the Secretary will decide. The PHEMCE must also find gaps and challenges (including regulatory ones), help align purchases with those needs, help plan logistics and use of countermeasures under section 247d–6b(a), provide input for the strategy and plan under section 300hh–10(d), and seek feedback from State, local, Tribal, and territorial public health officials when appropriate.