In 2004, Congress passed the Project BioShield Act ( P.L. 108-276 ) to encourage the development of CBRN medical countermeasures. In response to perceived problems with Project BioShield countermeasure procurement, the 109 th Congress created the Biomedical Advanced Research and Development Authority (BARDA) and the position of Assistant Secretary for Preparedness and Response in the Department of Health and Human Services (HHS) through the Pandemic and All-Hazards Preparedness Act (PAHPA, P.L. 109-417 ). The Consolidated Appropriations Act, 2014 ( P.L. 113-76 ) provided $255 million for Project BioShield procurements to remain available until expended. The Project BioShield Act provides the federal government with authorities related to the development, acquisition, and use of medical countermeasures against CBRN attacks. Project BioShield creates a government-market guarantee by permitting the HHS Secretary to obligate funds to purchase countermeasures while they still need up to 10 more years of development. Another provision of the act establishes a process through which the HHS Secretary may temporarily allow the emergency use of countermeasures that lack Food and Drug Administration (FDA) approval. This authority is not limited to products acquired through Project BioShield. These allowances are known as emergency use authorizations (EUAs). The Department of Homeland Security Appropriations Act, 2004 ( P.L. 108-90 ) appropriated $5.593 billion "to secure medical countermeasures against biological terror attacks" into the DHS "Biodefense Countermeasures" account. Of the $5.6 billion FY2004-FY2013 advance appropriation, Congress rescinded or transferred approximately $2.3 billion and HHS obligated the remaining approximately $3.3 billion for CBRN medical countermeasures. For FY2015, the President requests $415 million for Project BioShield acquisitions. Congress has also transferred funds from this account for various purposes. The HHS awarded Project BioShield contracts for 12 medical countermeasures against the CBRN threats anthrax, smallpox, botulinum toxin, radiological and nuclear threat agents, and nerve agents. PAHPRA

The 113 th Congress reauthorized and modified key Project BioShield–related authorities through the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA, P.L. This law extended the Project BioShield procurement program, changed some aspects of the countermeasure development and acquisition process, and modified some authorities relating to the use of unapproved countermeasures. The switch to annual appropriations may complicate HHS's long-term countermeasure development and acquisition planning. 113-5 ) allows the HHS Secretary to transfer up to $1.4 billion of FY2014 through FY2018 Project BioShield appropriations to BARDA for countermeasure advanced development.
In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. However, the government still lacks countermeasures against many of the CBRN terrorism agents determined by the government to pose the greatest threat. Congress is likely to consider whether modifications of these authorities or new authorities would help address remaining gaps.
The authority generally referred to as Project BioShield allows the government to guarantee a market for CBRN medical countermeasures. Under this provision, the Secretary of Health and Human Services (HHS) may obligate funds to purchase countermeasures that still need up to 10 more years of development. Since 2004, HHS has obligated approximately $3.309 billion to guarantee a government market for countermeasures against anthrax, smallpox, botulism, radiation, and nerve agents.
Another provision of the Project BioShield Act established a process through which the HHS Secretary may temporarily allow the emergency use of countermeasures that lack Food and Drug Administration (FDA) approval. The HHS has used this authority to allow the emergency use of unapproved products several times.
The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance appropriated $5.593 billion to acquire CBRN countermeasures through Project BioShield between FY2004 and FY2013. Subsequent Congresses rescinded or transferred $2.291 billion, more than one-third, from this advance appropriation. The transfers from this account supported CBRN medical countermeasure advanced development, pandemic influenza preparedness and response, and basic biomedical research. The Consolidated Appropriations Act, 2014 (P.L. 113-76) provides $255 million for Project BioShield procurements to remain available until expended. For FY2015, the President requests $415 million.
Since passage of the Project BioShield Act, Congress has considered additional measures to further encourage countermeasure development. The Pandemic and All-Hazards Preparedness Act (P.L. 109-417) created the Biomedical Advanced Research and Development Authority (BARDA) in HHS and modified the Project BioShield procurement process. Among other duties, BARDA oversees all of HHS's Project BioShield procurements. The Pandemic and All-Hazards Preparedness Reauthorization Act (P.L. 113-5) authorized Project BioShield appropriations of $2.8 billion for FY2014 through FY2018 and modified some Project BioShield-related authorities.
The 113th Congress may also consider modifying the amount and manner by which it funds Project BioShield procurements. Additionally, Congress may consider whether HHS is optimally using its CBRN-related authorities to close remaining countermeasure gaps and appropriately planning for long-term costs associated with maintaining a countermeasure stockpile.