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 112 th Congress is considering several Project BioShield-related policy questions. One question is whether the Project BioShield acquisition mechanism has sufficiently improved national preparedness relative to its costs to merit extension. If so, congressional policymakers may consider whether changes to the funding levels or how Congress provides Project BioShield funds would improve the program's efficiency or performance. Additionally, congressional policymakers are considering whether the federal government sufficiently plans and coordinates its CBRN countermeasure efforts from basic research to distribution. Finally, Congress is considering whether changes to the emergency use authority will improve preparedness and planning. This report will provide a brief overview of the authorities established by the Project BioShield Act of 2004, discuss the availability of Project BioShield appropriations, identify the medical countermeasures obtained through Project BioShield, review the relationship between Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA), review policy issues and options faced by congressional policymakers, and review current Project BioShield-related legislation. Instead, it authorized the appropriation of up to $5.593 billion for procuring countermeasures from FY2004 through FY2013. The Department of Homeland Security Appropriations Act, 2004 ( P.L. The Project BioShield Act specified that the funds in this DHS "Biodefense Countermeasures" account are only for the procurement of CBRN countermeasures using the Project BioShield authorities and may not be used for other purposes, such as countermeasure development grants or program administration. The HHS has used Project BioShield to acquire countermeasures against only a few CBRN threats: anthrax, smallpox, botulinum toxin, and radiological and nuclear threat agents. Policy Issues and Options for Congress

As discussed above, the federal government has successfully used the Project BioShield Act authorities to contribute to national preparedness for a CBRN attack and pandemic influenza. The 112 th Congress is considering whether to reauthorize and modify the Project BioShield acquisition mechanism, whether to change the countermeasure development and acquisition process, and whether to modify the authority to allow the emergency use of unapproved medical countermeasures. Additionally, all of these products expire. 2405 , H.R. Subsequent Congresses have rescinded or transferred more than one-third of the advance appropriation for other purposes. 2356 , H.R. 6672 , and S. 1855 . 2405 and S. 1855 , H.R.
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. As the expiration of some of these authorities approaches, Congress is considering whether these authorities have sufficiently contributed to national preparedness to merit extension.
The Project BioShield Act provides three main authorities: (1) guaranteeing a federal market for new CBRN medical countermeasures, (2) permitting emergency use of countermeasures that are either unapproved or have not been approved for the intended emergency use, and (3) relaxing regulatory requirements for some CBRN terrorism-related spending. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS obligated approximately $2.625 billion to guarantee a government market for countermeasures against anthrax, botulism, radiation exposure, and smallpox. The HHS allowed the emergency use of several unapproved products, including during the 2009 H1N1 influenza pandemic. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development.
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 for FY2004-FY2013. Subsequent Congresses have removed $2.078 billion from this account through rescissions and transfers, more than one-third of the advance appropriation. The transfers from this account supported CBRN medical countermeasure advanced development, pandemic influenza preparedness and response, and basic biomedical research.
Since passing 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 112th Congress is considering several Project BioShield-related policy questions. One question is whether the Project BioShield acquisition mechanism merits extension based on its relative cost and contribution to national preparedness. If so, congressional policymakers may consider whether changes to the funding levels or how Congress provides Project BioShield funds would improve the program's efficiency or performance. Additionally, congressional policymakers are considering whether the federal government sufficiently plans and coordinates its CBRN countermeasure efforts from basic research to distribution. Finally, Congress is considering whether changes to the emergency use authority will improve preparedness and planning.
Four bills in the 112th Congress address some of these Project BioShield-related issues, H.R. 2356, H.R. 2405, H.R. 6672, and S. 1855.