Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for Congress

Publication Date: March 2007

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

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Abstract:

The Project BioShield Act of 2004 (P.L. 108-276) established a 10-year program to acquire civilian medical countermeasures to chemical, biological, radiological and nuclear (CBRN) agents for the Strategic National Stockpile. Provisions of this act were designed to encourage private companies to develop these countermeasures by guaranteeing a government market for successfully developed countermeasures. Both the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) have responsibilities in this program. Funds for this program are appropriated to DHS, while contracts are executed through HHS. The interagency process responsible for deciding which countermeasures to procure has changed multiple times since this program's inception.

The Homeland Security Appropriations Act, 2004 (P.L. 108-90) provided an advance appropriation of $5.6 billion to acquire CBRN countermeasures over a 10year period (FY2004 - FY2013). This act also limited the amount that could be obligated during specified time periods. The Project BioShield Act of 2004 (P.L. 108-276) assigned the $5.6 billion advance appropriation to Project BioShield countermeasure acquisitions. The Consolidated Appropriations Act, 2004 (P.L. 108199) and the Consolidated Appropriations Act, 2005 (P.L. 108-447) reduced the total amount available for Project BioShield by a total of $25 million. Congress retains the power to make additional appropriations and rescissions to this account.

HHS has awarded Project BioShield contracts for a countermeasure against botulinum toxin, two types of anthrax vaccine, two types of anthrax treatments, and three kinds of countermeasures against radiological or nuclear agents. HHS reports that it has obligated approximately $1.831 billion from the Project BioShield account. However, the largest contract, $878 million for an anthrax vaccine, was cancelled in December 2006, for failure to meet a contract milestone. Taking this into account, approximately $2.389 billion remains available for obligation in FY2007 - FY2008 and $4.564 billion available for obligation through the end of the program in FY2013.

Some outside observers and interested companies have criticized specific HHS awards decisions and the rate at which they are made. Additionally, contract awards reported by HHS do not directly correspond with budgetary figures provided in the President's annual budget documents, which may suggest problems with interagency coordination and communication.

This report discusses actions taken by Congress and the Administration that have affected this program, describes the decision-making process for choosing countermeasures, describes the countermeasures for which the Department of Health and Human Services (HHS) has contracted, and discusses accounting discrepancies present in budget documents describing Project BioShield. This report may be updated.