Following the terrorist attacks of 2001, both the Administration and Congress determined that the federal government needed new medical countermeasures (such as diagnostic tests, drugs, vaccines, and other treatments) to respond to an attack using chemical, biological, radiological, or nuclear (CBRN) agents. Representatives of the pharmaceutical industry attributed the paucity of CBRN agent countermeasures to the lack of a significant commercial market. They argued that, because these diseases and conditions occur infrequently, the private sector perceived little economic incentive to invest the millions of dollars required to bring treatments to market. In 2004, Congress passed the Project BioShield Act ( P.L. 108-276 ) to encourage the development of CBRN medical countermeasures. The 108 th Congress also appropriated $5.6 billion to acquire countermeasures through Project BioShield for FY2004 to FY2013. Subsequent Congresses have evaluated implementation of Project BioShield. In response to perceived problems with Project BioShield countermeasure procurement, the 109 th Congress created the Biomedical Advanced Research and Development Authority (BARDA) and the position of Assistant Secretary for Preparedness and Response in the Department of Health and Human Services (HHS) through the Pandemic and All-Hazards Preparedness Act (PAHPA, P.L. 109-417 ). The 112 th 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. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 ( H.R. 2405 , passed the House on December 6, 2011), the Pandemic and All-Hazards Preparedness Act Reauthorization of 2011 ( S. 1855 , passed the Senate on March 7, 2012), the Pandemic and All-Hazards Preparedness Reauthorization Act of 2012 ( H.R. 6672 , passed the House on December 19, 2012), and the WMD Prevention and Preparedness Act of 2011 ( H.R. 2356 , reported by the House Committee on Homeland Security on September 12, 2012) address some of these issues. This report will provide a brief overview of the authorities established by the Project BioShield Act of 2004, discuss the availability of Project BioShield appropriations, identify the medical countermeasures obtained through Project BioShield, review the relationship between Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA), review policy issues and options faced by congressional policymakers, and review current Project BioShield-related legislation. President Bush proposed Project BioShield in his 2003 State of the Union address. The 108 th Congress considered this proposal and passed the Project BioShield Act of 2004 ( P.L. 108-276 , signed into law July 21, 2004). It has three main provisions. The first provision, the one generally referred to as Project BioShield, creates a government-market guarantee by permitting the HHS Secretary to obligate funds to purchase countermeasures while they still need several more years of development. The second main provision establishes a process through which the HHS Secretary may temporarily allow the emergency use of countermeasures that lack Food and Drug Administration (FDA) approval. The third main provision provides HHS with expedited procedures for CBRN terrorism-related spending, including procuring products, hiring experts, and awarding research grants. This law also requires HHS and the Government Accountability Office (GAO) to produce certain reports. When companies decide to develop a new product, its potential economic market value is often a key factor. With new CBRN countermeasures, the U.S. government may be the most economically significant customer. Thus, one difficulty facing potential CBRN developers is knowing whether the federal government would buy their product and, if so, at what price. Companies may find it difficult to justify investing millions of dollars developing new countermeasures without knowing the potential economic value of the government market. Congress designed the Project BioShield Act to guarantee companies that the government will buy new, successfully developed CBRN countermeasures for the Strategic National Stockpile (SNS). The act allows the Secretary of HHS, with the concurrence of the Secretary of Homeland Security and upon the approval of the President, to promise to buy a product up to eight years before it is reasonably expected to be delivered. Such contracts are only available for products designed for use against CBRN agents that the Department of Homeland Security (DHS) has determined pose "a material threat against the United States population sufficient to affect national security." These contracts define the minimum economic value of the market for the company developing the product. The Project BioShield Act, as passed, allowed the HHS to pay a company only on the delivery of a substantial portion of the countermeasure. Such contracts reduce the market risk faced by the developers, but do not mitigate the risk that the product might fail during development or testing and be undeliverable. The Pandemic and All-Hazards Preparedness Act ( P.L. 109-417 ) modified the Project BioShield Act to allow for milestone-based payments of up to half of the total award before delivery. The milestone payments can mitigate the cost to the company of the product failing during development. Thus, HHS can now use Project BioShield contracts to reduce the company's exposure to market risk and development risk. The Project BioShield Act allows HHS to purchase unapproved and unlicensed countermeasures. It requires the HHS Secretary to determine that "sufficient and satisfactory clinical experience or research data ... support a reasonable conclusion that the product will qualify for [FDA] approval or licensing ... within eight years." Because most drugs that begin the approval process fail to become approved treatments, critics of this provision suggest that the government will end up purchasing countermeasures that may never be approved. Some of the countermeasures procured through Project BioShield since 2004 lack FDA approval. To reduce the government's financial risk associated with this provision, the act, as amended, allows HHS to write contracts in which unapproved products may be purchased at lower cost than approved products. Additionally, HHS has included provisions for milestone payments and for payments contingent on FDA approval in Project BioShield contracts. For an overview of those countermeasures obtained through these authorities, see " Acquisitions " below. The FDA designed its standard approval and licensing processes to protect people from ineffective or dangerous treatments. During a military, domestic, or public health emergency, the Project BioShield Act allows the HHS Secretary to temporarily allow the use of medical products that FDA has not approved or licensed. These allowances are known as emergency use authorizations (EUAs). To exercise this authority, the HHS Secretary must conclude that the agent for which the countermeasure is designed can cause serious or life-threatening disease; the product may reasonably be believed to be effective in detecting, diagnosing, treating, or preventing the disease; the known and potential benefits of the product outweigh its known and potential risks; no adequate alternative to the product is approved and available; and any other criteria prescribed in regulation are met. Such EUAs remain in effect for one year unless the Secretary terminates them. The Secretary may renew expiring authorizations. The HHS Secretary has issued several EUAs. The HHS Secretary issued an EUA allowing the vaccination of Department of Defense (DOD) personnel with a specified type of anthrax vaccine. The HHS Secretary issued EUAs to permit use of certain countermeasures during the 2009 H1N1 "swine" influenza outbreak: the antiviral influenza treatments Tamiflu (oseltamivir), Relenza (zanamivir), and Peramivir; N95 respirators; and several diagnostic kits to help identify cases of this disease. Two EUAs remain active. One permits the distribution of antibiotic kits containing doxycycline hyclate to U.S. Postal Service employees volunteering in the National Postal Model emergency countermeasure distribution program. The other active EUA permits distributing doxycycline hyclate before an emergency and its mass dispensing without a prescription during an emergency to prevent inhalational anthrax. The Project BioShield Act relaxed and expedited the Federal Acquisition Regulation procedures HHS must follow when procuring property or services used in performing, administering, or supporting CBRN countermeasure research and development (R&D). These expedited procedures decrease both the amount of paperwork required for these expenditures and the potential for oversight. The act also increases the maximum amount (from $100,000 to $25 million) for contracts awarded under simplified acquisition procedures. According to the Government Accountability Office (GAO), HHS used the simplified acquisitions procedure authority for five contracts. These contracts, all executed in 2004 and 2005 using funds from the National Institutes of Health (NIH), totaled approximately $30 million. The Project BioShield Act authorizes the HHS Secretary to use an expedited peer review award process for grants, contracts, and cooperative agreements related to CBRN countermeasure R&D, if the Secretary deems that a pressing need for an expedited award exists. The act limits this authority to awards worth $1.5 million or less. This expedited award process replaces the normal peer review process. Some scientists have expressed concerns that an expedited review process would reduce research quality.