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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.
In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. As the expiration of some of these authorities approaches, Congress is considering whether these authorities have sufficiently contributed to national preparedness to merit extension. The 112th Congress is considering several Project BioShield-related policy questions. One question is whether the Project BioShield acquisition mechanism has sufficiently improved national preparedness relative to its costs to merit extension. If so, congressional policymakers may consider whether changes to the funding levels or how Congress provides Project BioShield funds would improve the program's efficiency or performance. Additionally, congressional policymakers are considering whether the federal government sufficiently plans and coordinates its CBRN countermeasure efforts from basic research to distribution. Finally, Congress is considering whether changes to the emergency use authority will improve preparedness and planning.