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Published: 2004

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Few effective countermeasures currently exist to deal with chemical, biological, radiological, and nuclear terror agents. In early 2003, the Bush administration proposed Project BioShield to stimulate the development of such countermeasures and to procure them for the Strategic National Stockpile (SNS). Congress considered three bills that incorporated much of the administration's proposal: S. 15 (Gregg), H.R. 2122 (Tauzin), and S. 1504 (Gregg). H.R. 2122 passed the House on July 16, 2003. S. 15 passed the Senate on May 25, 2004 in an amended form similar to H.R. 2122. This version of S. 15 passed the House on July 14, 2004. President Bush signed S. 15 into law as the Project BioShield Act of 2004 (P.L. 108-276) on July 21, 2004. Although many of the details of Project BioShield changed during Congressional consideration, all the proposals shared similar key provisions. Each bill would have provided expedited hiring, procurement, and grant awarding procedures for bioterrorism-related products and services. Each bill would have provided a market guarantee for countermeasure producers by allowing the Secretary of Health and Human Services (HHS) to contract to procure countermeasures still in development. Thus, several years before a company plans to be able to deliver a countermeasure, the company would have been assured that if they successfully develop the countermeasure the government is obligated to purchase a set amount of it at a set price. Each bill would have authorized the HHS Secretary to allow the emergency use of countermeasures that lack Food and Drug Administration approval. Congress changed many important aspects of the Administration's proposal. The most important change related to the funding mechanism. The Administration requested a permanent, indefinite appropriation, to be spent at the President's discretion, for the purchase of countermeasures. The enacted version of Project BioShield authorizes the appropriation of $5.593 billion for FY2004-FY2013. The Department of Homeland Security (DHS) Appropriations Act (P.L. 108-90) appropriated this amount. The Project BioShield Act of 2004 (P.L. 108-276) also: transfers the SNS from DHS to HHS, permits procurement of countermeasures with commercial markets, permits countermeasure procurement contracts to be written up to eight years before countermeasures are expected to be deliverable, and authorizes appropriations to allow DHS to improve its ability to perform threat analysis. A provision that would have allowed HHS to develop countermeasures directly was excluded from the enacted version Project BioShield. This report will not be updated. For more analysis and the current status of Project BioShield, see CRS Report RS21507, Project BioShield, by Frank Gottron.