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Tuesday, June 29, 2010

Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress

Frank Gottron
Specialist in Science and Technology Policy

Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available medical 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 personnel 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 contracts and grants related to CBRN countermeasure research and development. The HHS 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 CBRN countermeasures acquisition through Project BioShield. Subsequent Congresses have rescinded or transferred to other accounts approximately 19% of the advance appropriation. In FY2004 and FY2005, Congress removed a total of approximately $25 million from this account through rescissions included in the Consolidated Appropriations Act, 2004 (P.L. 108-199) and the Consolidated Appropriations Act, 2005 (P.L. 108-447). In the Omnibus Appropriations Act, 2009 (P.L. 111-8), Congress transferred $412 million from this account to support countermeasure advanced research and development and pandemic influenza preparedness and response. The Consolidated Appropriations Act, 2010 (P.L. 111-117) transferred $609 million from this account to support basic research and advanced countermeasure development. P.L. 111-117 also transferred the remaining Project BioShield funds from DHS to HHS. For FY2011, President Obama has requested the transfer of at least $476 million from this account to support countermeasure advanced development. 

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, BARDA oversees all of HHS' Project BioShield activities. The Pandemic and All-Hazard Preparedness Act also modified the Project BioShield procurement process. Some stakeholders question whether these changes have sufficiently improved countermeasure development and procurement. The Administration is considering implementing additional changes to the countermeasure research, development, and acquisition process. 

The 111th 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.

Date of Report: June 23, 2010
Number of Pages: 17
Order Number: R41033
Price: $29.95

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