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Friday, February 18, 2011

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

Frank Gottron
Specialist in Science and Technology Policy

In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to encourage the private sector to develop medical countermeasures to 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 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 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 to allow 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 Subsequent Congresses have rescinded or transferred to other accounts approximately 20% of the advance appropriation.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. The Continuing Appropriations and Surface Transportation Extensions Act, 2011 (P.L. 111-322) allows the transfer of approximately $130 million from this account for advanced countermeasure development.

Since passing the Project BioShield Act, subsequent Congresses have considered additional measures to further encourage countermeasure development. The 109
th 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 findings of an HHS review.

Date of Report: February 7, 2011
Number of Pages: 19
Order Number: R41033
Price: $29.95

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