42 U.S.C. § 300hh–10a — Public Health Emergency Medical Countermeasures Enterprise

(a) In general. The Secretary must create the Public Health Emergency Medical Countermeasures Enterprise, called PHEMCE. The Assistant Secretary for Preparedness and Response and the Director of the Office of Pandemic Preparedness and Response Policy both serve as its co-chairs. (b) Members. PHEMCE must include these people or their designees: the Assistant Secretary for Preparedness and Response; the Director of the CDC; the Director of the NIH; the Commissioner of Food and Drugs; the Secretary of Defense; the Secretary of Homeland Security; the Secretary of Agriculture; the Secretary of Veterans Affairs; the Director of National Intelligence; the Director of the Office of Pandemic Preparedness and Response Policy; and, if the Secretary decides it is appropriate, representatives from other federal agencies, such as the Directors of BARDA, the Strategic National Stockpile, the National Institute of Allergy and Infectious Diseases, or the Office of Public Health Preparedness and Response. (c) Functions. (1) PHEMCE must: (A) make recommendations to the Secretary on research, development, buying, stockpiling, deploying, and using countermeasures, ranking them by the country's health security needs, and informed by the National Health Security Strategy, Strategic National Stockpile needs, and current national security threat assessments; if members can't agree on a recommendation, the Secretary makes the final call; (B) identify gaps and challenges — including regulatory ones — in countermeasure-related preparedness, and help line up countermeasure buying with the needs found under (A); (C) help the Secretary build strategies for moving, distributing, giving out, and using countermeasures, which may apply to the Strategic National Stockpile; and (D) advise on building the strategy and implementation plan required under section 300hh–10(d). (2) While doing the work in (B) and (C), PHEMCE must ask for and consider input from state, local, tribal, and territorial public health departments and officials, as appropriate.