PHEMCE Governance

In July 2006, HHS established the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The PHEMCE advances national preparedness against chemical, biological, radiological, and nuclear (CBRN) and emerging infectious disease (EID) threats, including pandemic influenza, by coordinating medical countermeasure related efforts within HHS and in cooperation with interagency PHEMCE partners. The forum for cooperation and overall mission fulfillment is the Enterprise Senior Council (ESC) and its supporting infrastructure. Structurally, the ESC is led by the Assistant Secretary for Preparedness and Response and comprised of the senior leadership of National Institute of Allergy and Infectious Disease (NIAID) within the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) with comparable senior level representatives from the Department of Defense (DoD) , the Department of Homeland Security (DHS), the Department of Veteran's Affairs (VA) , and the U.S. Department of Agriculture (USDA).  Additional HHS components including the Office of the General Counsel, Office of the Assistant Secretary for Health, Office of the Assistant Secretary for Legislation, and the Office of the Assistant Secretary for Planning and Evaluation participate in a non-voting capacity.  The PHEMCE activities are organized and governed using the hierarchy shown below.

 

 

The ESC's mission is to provide, on behalf of the HHS Secretary, coordinated, strategic direction and policy oversight for HHS “end-to-end” medical countermeasure preparedness activities, defined as requirements generation, research, early- and late-stage product development, procurement, and utilization planning activities for all threats including CBRN, pandemic influenza, and EID. The ESC is a consensus interagency body chaired by the HHS ASPR, as the HHS Secretary’s principal advisor on federal public health and medical preparedness and response for public health emergencies. The HHS principal members are the Director for the Centers for Disease Control and Prevention (CDC), the Director of the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH), and the Commissioner of the Food and Drug Administration (FDA). The principal interagency members are the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs, Office of the Under Secretary of Defense for Acquisition, Technology and Logistics from DoD; the Assistant Secretary for Health Affairs and Chief Medical Officer from DHS; the Assistant Secretary for Operations, Security and Preparedness from VA; and the Undersecretary for Food Safety from USDA. As the most senior level in the PHEMCE structure, this group approves major policies, product requirements, and large-scale procurement actions. It also oversees strategic reviews of the activities in each of the major threat portfolios (e.g., anthrax, smallpox, rad/nuc) and is the final reporting body for high priority actions identified as gaps in these reviews.

 

Enterprise Executive Committee (EEC) is an operational-level decision and coordination body for all policy and product-level issues in the Enterprise. The EEC is comprised of senior program managers across the partner agencies. It provides the critical interface and organizing capability between the strategic focus of the ESC and the tactical-level efforts conducted within the subordinate Integrated Program Teams (IPTs) and Working Groups (WGs). The EEC reports directly to, and receives guidance from, the ESC. The Executive Committee is co-chaired by two senior management officials appointed by the ASPR. The EEC is composed of senior staff from each PHEMCE agency selected by the ESC members. The EEC is responsible for assuring that important programmatic, procurement, requirements, and portfolio actions are fully vetted and that the solutions and recommended actions requiring approval at higher levels are well delineated for decisions. Additionally, the EEC manages the work at the lower IPT and subgroup levels, directly manages the annual assessment of the Strategic National Stockpile, and composes PHEMCE level documents, such as this Strategy and Implementation Plan.    

 

Integrated Program Teams (IPTs) provide an end-to-end vision of medical countermeasures against a particular threat type (e.g., anthrax, smallpox) or capability (e.g., diagnostics) that ranges from requirements-setting (specifically quantity and product characteristics) through to stockpiling, delivery and dispensing, and monitoring and evaluating medical countermeasure effectiveness. The IPTs develop strategies for addressing key cross-cutting issues, in consideration of available programmatic resources at the Federal, state, local, tribal and territorial levels. IPTs serve as subject matter expert communities of practice for interagency vetting and input on issues within their purview. They report to the EEC.

Thhe Biological, Chemical, Radiological/Nuclear, and Blood/Tissue MCM Requirements Working Groups are established by the EEC to determine which types of medical countermeasures, including blood and tissue, are needed for response to public health emergencies and other threats to national health security. The Working Groups report to the EEC.

 

Project Coordination Teams (PCTs)are established by the BARDA Director to support the development and administration of each medical countermeasure acquisition or advanced development program managed by BARDA.