Within HHS, several offices and agencies have specific responsibilities for  public health preparedness and response. 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. 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. HHS Has Established Timelines and Milestones for Key PHEMCE Priorities but Has Not Yet Provided Previously Recommended Anticipated Spending Estimates for Priority Countermeasures

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. 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). HHS has also identified deliverables and milestones for some of the  priority activities, threat-based approaches, and capabilities, and  assigned them more specific timelines. PHEMCE partners have tied each deliverable to a  specific milestone or set of milestones, which delineate the steps  necessary to complete the deliverable. Examples of deliverables, milestones, and more  specific timelines for PHEMCE priorities include the following:
For the priority activity that states that ASPR is to lead PHEMCE in  developing or updating medical countermeasure requirements for  certain CBRN threats by the end of fiscal year 2014, ASPR has  identified the requirements for each specific threat—such as  requirements for countermeasures for mustard gas and other blister  agents—as the individual deliverables for this activity. The blister  agents requirement deliverable has four associated milestones that  reflect the various activities of a PHEMCE working group to develop  the requirements and the levels of PHEMCE and HHS approval  needed, culminating in the approval by the ASPR Assistant Secretary  by September 2013. For the remaining 12 priority activities, 15 priority threat-based  approaches, and 6 priority capabilities, HHS has not established specific  deliverables with milestones and timelines other than the overall  completion of the priority within the specified near- or midterm time frame. According to HHS officials, during these monthly meetings,  PHEMCE participants discuss their progress in completing deliverables,  potential barriers to completion, and any options to help mitigate these  barriers. As of September  2013 (the most recent information available):
PHEMCE partners reported completing five deliverables for the 21  priority activities. We previously recommended  that HHS provide more specific information on anticipated  countermeasure spending when it updated its 2007 plan. However, the plan does not include any estimates of how  much of these funds HHS may spend to develop or procure specific  priority countermeasures. HHS officials told us that while PHEMCE has  developed spending estimates for internal planning, they are hesitant to  provide these estimates to manufacturers because they do not want to  create the expectation that the estimates would reflect any final contract  amounts. However, the nature and format of the  spending estimates that would be included in the plan had not been  determined. As we stated in our previous recommendation, information  on anticipated spending would allow HHS’s industry partners to suitably  target research and development to fulfill PHEMCE’s countermeasure  priorities, especially in tighter budget climates. PAHPRA’s requirement for HHS to include spending estimates  for each medical countermeasure priority in future PHEMCE  implementation plans is consistent with our 2011 recommendation. Appendix I: HHS Spending on Advanced Research, Development, and Procurement of Medical Countermeasures

The Department of Health and Human Services (HHS) spent  approximately $3.6 billion in advanced research, development, and  procurement of chemical, biological, radiological, and nuclear (CBRN)  and pandemic influenza medical countermeasures from fiscal year 2010  through fiscal year 2013. GAO-10-204.
Why GAO Did This Study

Public health emergencies--the 2001 anthrax attacks, the 2009 H1N1 influenza pandemic, and others--have raised concerns about national vulnerability to threats from chemical, biological, radiological, and nuclear agents and new infectious diseases. There are some medical countermeasures--drugs, vaccines, and medical devices such as diagnostics--available to prevent, diagnose, or mitigate the public health impact of these agents and diseases, and development continues. HHS leads federal efforts to develop and procure countermeasures through the interagency PHEMCE. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 mandated GAO to examine HHS's and PHEMCE's planning documents for medical countermeasure development and procurement needs and priorities.
This report examines the extent to which HHS developed timelines, milestones, and spending estimates for PHEMCE priorities. GAO reviewed relevant laws; analyzed HHS's 2012 PHEMCE Strategy and Implementation Plan, HHS's tools for tracking the implementation of PHEMCE activities, and data on countermeasure spending from fiscal years 2010 through 2013; and interviewed HHS officials.

What GAO Found

The Department of Health and Human Services (HHS) has established timelines and milestones for the 72 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) priorities--33 activities, 25 threat-based approaches, and 14 capabilities--that HHS selected as key to fulfilling PHEMCE strategic goals. However, HHS has not made spending estimates for its medical countermeasure development or procurement priorities (priority countermeasures) publicly available. In the PHEMCE implementation plan, HHS has grouped the 72 PHEMCE priorities into 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). For 21 priority activities, 10 priority threat-based approaches, and 8 priority capabilities, HHS and PHEMCE have identified specific deliverables, each tied to a milestone or set of milestones that delineate the steps necessary to complete deliverables, and established more specific timelines for completion of deliverables and milestones. For example, HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR) is to lead the development of medical countermeasure requirements, which outline countermeasure quantity, type, and desired characteristics. Deliverables are the threat-specific requirements, such as for antidotes for mustard gas and other blister agents. Milestones for mustard gas antidote requirements reflect the PHEMCE activities to develop the requirements and the necessary approvals; the milestones are tied to interim timelines and culminate in approval by the ASPR Assistant Secretary by September 2013. HHS has not established specific deliverables, milestones, or timelines for the remaining 12 priority activities, 15 priority threat-based approaches, and 6 priority capabilities other than their overall completion within the specified near- or midterm time frame. HHS monitors progress in completing deliverables and milestones for the priorities monthly, with PHEMCE partners meeting to discuss potential barriers to completing deliverables or meeting milestones and possible options to mitigate these barriers. As of September 2013 (the most recent information available), HHS reported that PHEMCE partners have completed 10 deliverables for the 72 priorities, resulting in completion of 5 priorities. GAO did not examine the status of the priorities that did not have specific deliverables, timelines, and milestones.
HHS has developed spending estimates for priority countermeasures for internal planning purposes but has not made them publicly available. In 2011, GAO recommended that HHS provide more specific anticipated spending information in an updated plan to assist with long-term planning. HHS's 2012 plan contains information on how countermeasures may be funded, such as through advanced development funds, but does not include estimates of how much PHEMCE may spend to develop specific countermeasures. HHS officials said they are hesitant to provide estimates because they do not want to create the expectation that estimates would reflect final contract amounts. However, consistent with our prior recommendation and Pandemic and All-Hazards Preparedness Reauthorization Act requirements, HHS plans to include spending estimates in the next iteration of the plan, anticipated in September 2014, but has not determined the nature and format of the estimates that would be included. Providing estimates would allow HHS's industry partners to suitably target research and development to fulfill countermeasure priorities, especially in tighter budget climates.

What GAO Recommends

Although GAO is not making any new recommendations, based on prior work GAO is continuing to emphasize its 2011 recommendation that HHS make more specific anticipated spending information available to countermeasure developers. In its comments, HHS discussed its efforts to develop spending estimates.