Project Bioshield Act Of 2003

Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack medical counter-measures. The Project BioShield Act (PBA) became law in 2004 to address this need. Contents of this report: (1) Intro.; (2) The PBA: Expedited Procedures; Market Guarantee; Emergency Use of Unapproved Products; Reporting Requirements; (3) Appropriations; (4) Acquisitions; (5) BioShield and the Biodefense Advanced R&D Authority; (6) Policy Issues: Diversion of BioShield Funds to Other Purposes: Transfers for CBRN Countermeasure R&D; Transfer for Pandemic Influenza Preparedness; Changing the Counter-measure Development and Acquisition Process; Stockpile Management; Broad-Spectrum Countermeasures. Illus.

Contents: (1) Introduction; (2) The Project BioShield Act: Expedited Procedures; Market Guarantee; Emergency Use of Unapproved Products; Reporting Requirements; (3) Appropriations; (4) Acquisitions; (5) Policy Issues; Diversion of Appropriations for Other Purposes; Transfer of Account to HHS; Stockpile Replenishment; Broad Spectrum Countermeasures; The Biomedical Advanced Research and Development Authority. Charts and tables.

This report formally transmits the briefing in response to section 247d-6c of title 42 of the United States Code. The statute required the Comptroller General to examine the Department of Health and Human Services' (HHS) support for the development and procurement of and authority for the emergency use of medical countermeasures to address chemical, biological, radiological, and nuclear threats to public health, and provide the results to the congressional committees by July 21, 2009. HHS determines priorities for medical countermeasure procurement based on those chemical, biological, radiological, and nuclear agents that have been identified by the Department of Homeland Security (DHS) as posing a material threat to the U.S. population that could affect national security. Tables.

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. 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 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.