Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress. Updated April 22, 2011

摘要

In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to encourage the private sector to develop medical countermeasures against 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) advance appropriated $5.593 billion for FY2004 to FY2013 for CBRN countermeasures acquisition through Project BioShield. Through FY2011, subsequent Congresses have removed $1.461 billion from this account through rescissions and transfers, more than 25% of the advance appropriation.