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Thursday, March 10, 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 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 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) advanceappropriated $5.593 billion for FY2004 to FY2013 for CBRN countermeasures acquisition through Project BioShield. Subsequent Congresses have removed $1.176 billion from this account through rescissions and transfers, more than 20% of the advance appropriation. The transfers from this account supported countermeasure advanced development, pandemic influenza preparedness and response, and basic research. The Full-Year Continuing Appropriations Act, 2011 (H.R. 1), as passed by the House, would transfer an additional $188 million out of this account for advanced countermeasure development. The President’s FY2012 budget requests a transfer of $765 million out of this account to support countermeasure advanced development and to establish a medical countermeasure strategic investment corporation.

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 the findings of an HHS review.

Date of Report: March 3, 2011
Number of Pages: 21
Order Number: R41033
Price: $29.95

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