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Project BioShield: Purposes and Authorities (CRS Report for Congress)

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Release Date Revised Aug. 12, 2009
Report Number RS21507
Report Type Report
Authors Frank Gottron, Specialist in Science and Technology Policy
Source Agency Congressional Research Service
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Summary:

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.
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