The Project BioShield Act

To encourage the development of new CBRN countermeasures, President Bush proposed Project BioShield in his 2003 State of the Union address. This act has three main provisions. It provides the Department of Health and Human Services (HHS) expedited procedures for CBRN terrorism-related spending, including procuring products, hiring experts, and awarding research grants. All these awards supported research on medical countermeasures to be used following radiation exposure. The Pandemic and All-Hazard Preparedness Act ( P.L. HHS used some of these authorities when structuring each of the Project BioShield contracts discussed below (" Acquisitions "). The second report determined that HHS has used Project BioShield to support development and procurement of CBRN medical countermeasures. Instead, it authorized the appropriation of up to a total of $5.593 billion for countermeasures procurement from FY2004 through FY2013. The Department of Homeland Security Appropriations Act, 2004 ( P.L. 108-90 specified that $3.418 billion was available for obligation for FY2004 to FY2008. The Project BioShield Act specified that these funds are only for the procurement of CBRN countermeasures using the Project BioShield authorities and may not be used for other purposes, such as for grants to support countermeasure development or program administration. Congress removed $25 million from this account through rescissions in the Consolidated Appropriations Act, 2004 ( P.L. The Omnibus Appropriations Act, 2009 ( P.L. The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010 ( H.R. 3293 ) would make this transfer. Future targets for Project BioShield procurement include countermeasures against anthrax, viral hemorrhagic fevers, and radiation. In response to perceived problems with Project BioShield countermeasure procurement, the 109 th Congress created the Biodefense Advanced Research and Development Authority (BARDA) in HHS through the Pandemic and All-Hazards Preparedness Act ( P.L. 109-417 ). Policy Issues

The 111 th Congress faces several BioShield-related policy issues. These include: whether to grant the President's request to transfer the account from DHS to HHS; the diversion of BioShield funds for other purposes; how to replace stockpiled countermeasures as they expire; and whether this program has sufficiently encouraged the development of broad spectrum countermeasures. Transfer of Account to HHS

In the FY2010 budget request, President Obama has proposed transferring the entirety of the Project BioShield special reserve fund from DHS to HHS. Subsequent Congresses have removed approximately 8% of the advance appropriation through rescissions and transfers to other accounts. 3293 would transfer the requested $305 million to BARDA and $500 million to NIAID to support basic research. Transfer for Pandemic Influenza Preparedness

In FY2009, Congress transferred $137 million from the Project BioShield special reserve fund to HHS for pandemic influenza preparedness and response.
Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available countermeasures. In 2003, President Bush proposed Project BioShield to address this need. The Project BioShield Act became law in July 2004 (P.L. 108-276).
This law has three main provisions: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring and awarding research grants; (2) guaranteeing a federal government 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 grants relating to developing treatments for radiation exposure and used the authority to guarantee a government market to obligate approximately $2 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times, including allowing young children with H1N1 "swine" influenza to receive specific antiviral drugs.
The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance-appropriated $5.593 billion for FY2004 to FY2013 for Project BioShield. Subsequent Congresses have removed approximately 8% of the advance appropriation through rescissions and transfers to other accounts. In FY2004 and FY2005, Congress removed a total of approximately $25 million through rescissions. In the Omnibus Appropriations Act, 2009 (P.L. 111-8), Congress transferred $412 million to other programs supporting countermeasure advanced research and development and pandemic influenza preparedness and response. For FY2010, President Obama has proposed transferring an additional $305 million to support countermeasure advanced research and development and transferring the account from DHS to HHS. The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010 (H.R. 3293) would make both these requested transfers. This legislation would also make a transfer that was not in the President's request: $500 million out of the Project BioShield account to support basic research in HHS.
Since passing the Project BioShield Act, subsequent Congresses have considered additional measures to further encourage countermeasure development. The 109th Congress passed the Pandemic and All-Hazard Preparedness Act (P.L. 109-417) which created the Biomedical Advanced Research and Development Authority (BARDA) in HHS. Amongst other duties, this office oversees all of HHS' Project BioShield activities. The Pandemic and All-Hazard Preparedness Act also modified the Project BioShield procurement process. Questions remain regarding whether these changes have sufficiently improved countermeasure development and procurement.
The 111th Congress faces several challenging policy issues. Primary among them is assessing whether Project BioShield is successfully encouraging medical countermeasure development. A second issue is whether to allow additional diversions of the Project BioShield advance appropriation, a key element of the government's market guarantee, to support other activities. A third is whether to broaden Project BioShield's mandate beyond CBRN countermeasures in the face of other threats such as pandemic influenza.