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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.
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.
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.
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.
Project BioShield Act: HHS Has Supported Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats
The Project BioShield Act of 2004 (BioShield Act) increased the fed. gov¿ts. ability to procure needed countermeasures to address threats from chemical, biological, radiological, and nuclear agents. Under the BioShield Act, HHS was provided with new contracting authorities (increased simplified acquisition and micropurchase thresholds, and expanded abilities to use procedures other than open competition and personal services contracts) and was authorized to use $5.6 billion in a Special Reserve Fund to procure countermeasures. This report reviewed: (1) how HHS has used its purchasing and contracting authorities; and (2) the extent to which HHS has internal controls in place to manage and ensure the appropriate use of its new authorities.

Crossing the Valley of Death

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Bioterrorism and Public Health Preparedness

Published: 2005

Total Pages: 72


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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. However, the government still lacks countermeasures against many of the CBRN terrorism agents determined by the government to pose the greatest threat. Congress is likely to consider whether modifications of these authorities or new authorities would help address remaining gaps.