Public Health Emergency - Leading a Nation Prepared
In July 2006, HHS established the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The PHEMCE’s mission is to advance national preparedness against CBRN and EID threats, including pandemic influenza, by coordinating MCM-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 participate in a non-voting capacity, 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. The PHEMCE activities are organized and governed using the hierarchy shown in the figure below.
Enterprise Senior Council (ESC) – It is the mission of the ESC to provide, on behalf of the HHS Secretary, coordinated, strategic direction and policy oversight for HHS “end-to-end” MCM preparedness activities, defined as: requirements generation, research, early- and late-stage product development, procurement and stockpiling, utilization planning, and monitoring, evaluation, and assessment activities for all threats, including CBRN, pandemic influenza, and other EID. As the most senior level in the PHEMCE structure, the ESC will address strategic issues related to the prioritization of resources and the development of policies in accordance with national needs for MCMs. It will coordinate HHS efforts with the MCM-related activities of other departments/agencies.
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 of the CDC, the Director of the NIAID within the NIH, and the Commissioner of the 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.
Enterprise Executive Committee (EEC) – The EEC of the PHEMCE is the operational-level decision and coordination body for all of its policy and product-level issues. It provides the critical interface and organizing capability between the strategic focus of the ESC and the tactical-level efforts conducted within the subordinate IPT and Working Group (WG) levels (Figure 1). The EEC reports directly to, and receives guidance from, the ESC. The EEC will coordinate, and approve as delegated, end-to-end PHEMCE MCM activities related to requirement analyses, research, early- and late-stage product development, stockpiling, utilization planning, and monitoring, assessment and evaluation in support of MCM policy and strategy established and approved by the ESC. The EEC is responsible for vetting important programmatic, procurement, requirements, and portfolio actions and identifying solutions and recommended actions requiring approval at higher levels. Additionally, the EEC manages the work at the lower IPT and subgroup levels, directly manages the annual assessment of the SNS, and composes PHEMCE-level documents, such as the annual PHEMCE SIP and PHEMCE MYB.
Integrated Program Teams (IPT) – The IPTs are established by the PHEMCE EEC to provide a complete, end-to-end vision of MCMs for any of a variety of needs, such as against a well-defined threat type (e.g., anthrax, radiological/nuclear, etc.), a potential future threat (e.g., novel antimicrobial resistant organisms), for commodity areas that span a range of threats (e.g., diagnostics) or for major cross-cutting issues related to unaddressed population needs (e.g., at-risk populations). The IPT areas of consideration range from requirement-analysis to development and production, to stockpiling, delivery and dispensing to the end user, adverse event monitoring, communications, guidance and policy development, and evaluating MCM effectiveness and replacement needs. They report to the EEC.
Requirements Working Groups (WG) – The Requirements WGs are established by the EEC to assist the IPTs in determining which types of MCMs are needed for response to public health emergencies and other threats to national health security. The WGs provide their products to the appropriate IPT(s) for further development and/or passing along to the EEC.
Project Coordination Teams (PCT) – PCTs are established by the BARDA Director to support the development and administration of each MCM acquisition or advanced development program managed by BARDA.
Emerging Infectious Disease (EID) Working Group – The EID WG was established by the EEC to evaluate the public health risk posed by EIDs, excluding influenza, as charged by the EEC or ESC and to provide recommendations to the EEC regarding which pathogens, or pathogen classes, require PHEMCE response, and at what level.
Public Readiness and Emergency Preparedness (PREP) Act Working Group (WG) – The PREP Act WG was established by the ESC in 2012 to ensure that recommendation to the Secretary regarding PREP Act liability protections and declarations are conducted with a consistent, transparent, and reproducible process. Representation includes ASPR, OGC, ASFR, ASPE, ASL, CDC, FDA, HRSA and NIH.
Integrated Portfolio for CBRN Medical Countermeasures/Portfolio Advisory Committee (PAC) – The PAC seeks to maximize national preparedness to respond to CBRN threats by aligning HHS and DoD MCM development and related infrastructure resources. The PAC reports to the EEC. The activities of the PAC enhance intra- and inter-departmental collaboration in CBRN MCM development, establish a shared understanding of each agency’s programmatic requirements, and develop an integrated set of goals. The PAC is co-chaired by the BARDA and the Office of the Deputy Assistant Secretary of Defense for Chemical and Biological Defense.
Specific PHEMCE mission components – and organizations with lead responsibilities and capabilities in these areas – are depicted in the PHEMCE Mission Components, which shows the complex interconnectedness of the PHEMCE organizations and mission space.
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