Since 2004, Congress has authorized over $8 billion for medical countermeasure procurement. The Project BioShield Act of 2004 authorized the appropriation of $5.6 billion from fiscal year 2004 through fiscal year 2013 for the Project BioShield Special Reserve Fund, and funds totaling this amount were appropriated. The act facilitated the creation of a government countermeasure market by authorizing the government to commit to making the Special Reserve Fund available to purchase certain medical countermeasures, including those countermeasures that may not be FDA-approved, cleared, or licensed. In 2013, PAHPRA authorized an additional $2.8 billion to be available from fiscal year 2014 through fiscal year 2018 for these activities,funding has not yet been appropriated for these years. In addition to the but Special Reserve Fund, Congress has also made funding available through annual and supplemental appropriations to respond to influenza pandemics, including developing vaccines and other drugs. HHS is the primary federal department responsible for public health emergency planning and response, including medical countermeasure development, procurement, and distribution. HHS also coordinates with other federal departments, such as DHS, through PHEMCE. Within HHS, several offices and agencies have specific responsibilities for public health preparedness and response. HHS’s ASPR leads PHEMCE and the federal medical and public health response to public health emergencies, including strategic planning, medical countermeasure prioritization, and support for developing, procuring, and planning for the effective use of medical countermeasures. Within ASPR, BARDA—established by the Pandemic and All-Hazards Preparedness Act of 2006—oversees and supports advanced development and procurement of some medical countermeasures into the SNS. NIH conducts and funds basic and applied research and early development needed to develop new or enhanced medical countermeasures and related medical tools for CBRN and infectious disease threats. CDC maintains the SNS, including purchasing commercially available products as necessary, and supports state and local public health departments’ efforts to detect and respond to public health emergencies, including providing guidance and recommendations for the mass dispensing and use of medical countermeasures from the SNS. FDA assesses the safety and effectiveness of medical countermeasures; regulates their development; approves, clears, or licenses them; and conducts postmarket surveillance as part of its overall role to assess the safety and effectiveness of medical products. FDA also provides technical assistance to help ensure that product development meets FDA’s regulatory requirements and provides technical support for the development of regulatory science tools. FDA may authorize the emergency use of medical products that have not yet been approved, cleared, or licensed or were approved, cleared, or licensed only for other uses. DHS develops material threat assessments (MTA), in coordination with HHS, to assess the threat posed by given CBRN agents or classes of agents and the potential number of human exposures in plausible, high- consequence scenarios. DHS uses the MTAs to determine which CBRN agents pose a material threat sufficient to affect national security and to provide HHS with a basis for determining needed countermeasures for those agents. DHS also develops terrorism risk assessments (TRA) to assess the relative risks posed by CBRN agents based on variable threats, vulnerabilities, and consequences. HHS’s PHEMCE is responsible for establishing civilian medical countermeasure priorities for CBRN and emerging infectious disease threats, including influenza; coordinating federal efforts to research, develop, and procure medical countermeasures to enhance preparedness and response for public health threats; and developing policies, plans, and guidance for the use of countermeasure products in a public health emergency. PHEMCE is composed of officials from ASPR, including BARDA; CDC; FDA; NIH; and other federal departments, including the Departments of Agriculture, Defense, Homeland Security, and Veterans Affairs. HHS and PHEMCE establish federal medical countermeasure development and procurement priorities through a multistep process. This process includes assessing the threat posed by CBRN agents and the potential consequences they pose to public health, determining medical countermeasure requirements—the type of countermeasure (vaccines, drugs, or medical devices such as diagnostics), the amount needed, and characteristics of the countermeasures (such as formulations, dosing, and packaging)—for these agents, evaluating public health response capability, and developing and procuring countermeasures against these CBRN agents. (See fig. 1.) The 2012 PHEMCE Strategy lays out the four PHEMCE strategic goals and their underlying objectives for building HHS’s countermeasure capabilities to respond to a public health emergency. The 2012 PHEMCE Implementation Plan updates the 2007 implementation plan and describes the activities that HHS and its interagency partners plan to conduct to achieve the four strategic goals and their associated objectives, the medical countermeasures HHS wants to develop and procure, and the capabilities HHS wants to build to support countermeasure development and procurement. The plan also includes 72 items that HHS selected as key priorities for fulfilling PHEMCE’s strategic goals within the next 5 years, which the agency placed into three categories. For the purposes of this report we refer to the items in these categories as “priority activities,” “priority threat-based approaches,” and “priority capabilities.” The 33 priority activities reflect activities that support PHEMCE’s overall mission and include pursuits such as developing systems to track countermeasure activities across all PHEMCE partners, enhancing national laboratory capabilities, and developing guidance documents and information for the public on using medical countermeasures in an emergency. (See table 1 for examples of PHEMCE priority activities by strategic goal.) In addition to the 33 priority activities, the 25 items identified as priorities for threat-based approaches are intended to directly address threats such as anthrax or smallpox. These priorities include pursuits such as publishing updated clinical guidance for anthrax countermeasures; developing and qualifying with FDA animal models to test the safety and efficacy of medical countermeasures for certain biological, radiological, and nuclear threats; and developing new plans for the distribution and dispensing of pandemic influenza antivirals. The remaining 14 items identified as priority capabilities reflect what HHS refers to as crosscutting capabilities. The priority capabilities are a mix of programs or technological applications that may, for example, support the development of countermeasures for a range of existing CBRN threats or for any new threats that may emerge in the future, or build infrastructure to provide countermeasure developers assistance with advanced development and manufacturing services. The priority capabilities include such pursuits as initiating a research program to fill gaps in knowledge in the area of patient decontamination in a chemical incident and establishing a network of facilities to support the filling and finishing of vaccines and other countermeasures. In addition to the 72 items HHS selected as key priorities for fulfilling PHEMCE’s strategic goals, the implementation plan also identifies the medical countermeasures that constitute HHS’s priorities for development and procurement to fulfill strategic goal 1, which we refer to as “priority countermeasures” for the purposes of this report. (See table 2.) Many of the threat-specific countermeasures for which PHEMCE set procurement priorities in 2007 continue to be priorities for development and procurement in the 2012 plan, such as anthrax vaccine, smallpox antivirals, chemical agent antidotes, and diagnostic devices for radiological and nuclear agents. The 2012 plan also includes pandemic influenza countermeasures and nonpharmaceutical countermeasures, such as ventilators, as priorities, whereas the 2007 plan focused on CBRN medical countermeasures only. HHS has established timelines and milestones for the 72 priority activities, threat-based approaches, and capabilities identified in the 2012 PHEMCE Implementation Plan as key to fulfilling PHEMCE’s strategic goals. However, while HHS has developed spending estimates for its priority medical countermeasures for internal planning purposes, it has not made these estimates publicly available, as we previously recommended in 2011. HHS has established timelines and milestones for the 72 items it selected as key priorities for fulfilling PHEMCE’s strategic goals. Leading practices for program management call for establishing time frames and milestones as part of a plan to ensure that organizations achieve intended results.In the implementation plan, HHS has assigned each of the 33 priority activities, the 25 priority threat-based approaches, and the 14 priority capabilities to one of three time frames for completion—near-term (fiscal years 2012 through 2014), midterm (fiscal years 2015 through 2017), and long-term (fiscal year 2018 and beyond). In addition, HHS has placed PHEMCE’s priority countermeasures into these time frames. All but 2 of the 33 priority activities, and all of the priority threat-based approaches and capabilities, are slated for completion in either the near term or the midterm. HHS has also identified deliverables and milestones for some of the priority activities, threat-based approaches, and capabilities, and assigned them more specific timelines. For 21 of the 33 priority activities, 10 of the 25 priority threat-based approaches, and 8 of the 14 priority capabilities, HHS and the PHEMCE agency or office responsible for carrying out the activity have identified specific deliverables intended to complete them. PHEMCE partners have tied each deliverable to a specific milestone or set of milestones, which delineate the steps necessary to complete the deliverable. In addition, the deliverables and milestones may have more specific timelines, such as an actual month or year of expected completion within the broader multiyear near- or midterm time frame.