In 2004, Congress passed the Project BioShield Act ( P.L. 108-276 ) to encourage the development of CBRN medical countermeasures. The 108 th Congress also appropriated $5.6 billion to acquire countermeasures through Project BioShield for FY2004 to FY2013. 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 ( P.L. 109-417 ). These include whether to continue diverting Project BioShield acquisition funding to other purposes; whether to change the countermeasure development and acquisition process; how to replace stockpiled countermeasures as they expire; and whether to alter federal efforts to encourage the development of broad-spectrum countermeasures. The first provision provides HHS expedited procedures for CBRN terrorism-related spending, including procuring products, hiring experts, and awarding research grants. Reporting Requirements

The Project BioShield Act of 2004 requires the HHS Secretary to report annually to Congress on the use of some of the authorities granted by this law. The Department of Homeland Security Appropriations Act, 2004 ( P.L. Congress has also transferred funds from this account for purposes other than CBRN countermeasure procurement. Thus, excluding the canceled VaxGen contract, HHS has obligated approximately $2.56 billion to date. In response to perceived problems with Project BioShield countermeasure procurement, the 109 th Congress created the Biomedical Advanced Research and Development Authority (BARDA) in HHS through the Pandemic and All-Hazards Preparedness Act ( P.L. Policy Issues

Congress continues to address several Project BioShield-related policy issues. Subsequent Congresses have rescinded or transferred more than 25% of the advance appropriation. The President's FY2012 budget requests the transfer of up to $765 million to fund BARDA activities and an independent medical countermeasure strategic investment corporation. This pattern of annual transfers from the Project BioShield special reserve fund to support countermeasure research and development activities may affect future CBRN countermeasure development and procurement activities. Transfers Unrelated to CBRN Countermeasure Research and Development

Two of the transfers out of the Project BioShield special reserve fund supported programs not directly related to medical countermeasures to CBRN agents. Changing the Countermeasure Development and Acquisition Process

Project BioShield represents just one piece of the federal effort to research, develop, and acquire countermeasures for civilian use.
In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. Although some countermeasures have been acquired through this law, Congress continues to address several Project BioShield-related policy issues. These include whether to continue diverting Project BioShield acquisition funding to other purposes; whether to change the countermeasure development and acquisition process; how to replace stockpiled countermeasures as they expire; and whether to alter federal efforts to encourage the development of broad-spectrum countermeasures.
This law provides three main authorities: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development. The HHS used the authority to guarantee a government market to obligate approximately $2.5 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times, including during the 2009 H1N1 influenza pandemic.
The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance-appropriated $5.593 billion for FY2004 to FY2013 for CBRN countermeasures acquisition through Project BioShield. Through FY2011, subsequent Congresses have removed $1.461 billion from this account through rescissions and transfers, more than 25% of the advance appropriation. The transfers from this account supported CBRN medical countermeasure advanced development, pandemic influenza preparedness and response, and basic biomedical research. The President's FY2012 budget requests a transfer of $765 million out of this account to support CBRN countermeasure advanced development and to establish a CBRN countermeasure strategic investment corporation.
Since passing the Project BioShield Act, subsequent Congresses have considered additional measures to further encourage countermeasure development. The 109th Congress created the Biomedical Advanced Research and Development Authority (BARDA) in HHS through the Pandemic and All-Hazard Preparedness Act (P.L. 109-417). Among other duties, BARDA oversees all of HHS's Project BioShield procurements. The Pandemic and All-Hazard Preparedness Act also modified the Project BioShield procurement process. Some stakeholders question whether these changes have sufficiently improved federal countermeasure development and procurement. The Administration plans to improve the countermeasure research, development, and acquisition process based on the findings of a 2010 HHS review.