The September 11, 2001 terrorist attacks and the subsequent deliberate release of anthrax sporesin the mail have focused policymakers' attention on the preparedness and response capability of theU.S. public health system. Though small in scale compared to the scenarios envisioned bybioterrorism experts and played out in recent government exercises, the recent anthrax attacksstrained the public health system and exposed weaknesses at the federal, state, and local levels. Many bioterrorism experts believe that had those responsible for the anthrax attacks employed amore sophisticated delivery mechanism or released a deadly communicable biological agent suchas smallpox, the health care system may have been overwhelmed. Bioterrorism poses a unique challenge to the medical care and public health systems. Unlike an explosion or chemical attack, which results in immediate and visible casualties, the public healthimpact of a biological attack can unfold gradually over time. Until a sufficient number of peoplearrive at emergency rooms and doctors' offices complaining of similar illnesses, there may be nosign that an attack has taken place. The speed and accuracy with which doctors and laboratoriesreach the correct diagnoses and report their findings to public health authorities has a direct impacton the number of people who become ill and the number that die. The nation's ability to respondto a bioterrorist attack, therefore, depends crucially on the state of preparedness of its medical caresystems and public health infrastructure. Public health experts have for years complained about the deterioration of the public health system through neglect and lack of funding. They warn that the nation is ill-equipped andinsufficiently prepared to respond to a bioterrorist attack. For example, they point out that there aretoo few medical personnel trained to spot biological attacks, a shortage of sophisticated laboratoriesto identify the agents, and inadequate supplies of drugs and vaccines to counteract the threat. Theyalso contend that inadequate plans exist for setting up quarantines and emergency facilities to handlethe sick and infectious victims. Improving public health preparedness and response capacity offersprotection not only from bioterrorist attacks, but also from naturally occurring public healthemergencies. Public health officials are increasingly concerned about our exposure andsusceptibility to infectious disease and food-borne illness because of global travel, ubiquitous foodimports, and the evolution of antibiotic-resistant pathogens. On June 12, 2002, the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ( P.L. 107-188 , H.R. 3448 ), which is intendedto bolster the nation's ability to respond effectively to bioterrorist threats and other public healthemergencies. This report provides a brief overview and legislative history of P.L. 107-188 , followedby a detailed side-by-side comparison of the act's provisions with preexisting law. Appendix A lists,by committee, all the bioterrorism-related hearings held in the 107th Congress prior to enactment of P.L. 107-188 . In most cases, hearing testimony is available on the committee Web sites. AppendixB provides a list of bioterrorism-related Web sites. For a discussion of bioterrorism preparednessissues, see CRS Report RL31225, Bioterrorism: Summary of a CRS/National Health Policy ForumSeminar on Federal, State, and Local Public Health Preparedness. Representatives Tauzin (R-LA) and Dingell (D-MI) introduced the Public Health Security and Bioterrorism Response Act ( H.R. 3448 ) on December 11, 2001. The bill wasimmediately considered under suspension of the rules and passed by the House the following dayon a vote of 418-2. H.R. 3448 built on the provisions of a bipartisan Senate bill, theBioterrorism Preparedness Act ( S. 1765 ), which had been introduced by Senators Fristand Kennedy on November 15, 2001. S. 1765 incorporated ideas and objectives fromseveral other Senate bioterrorism bills introduced in the wake of the anthrax attacks. (1) The Senatetook up H.R. 3448 on December 20, 2001, following its passage in the House, substitutedthe text of S. 1765 and passed H.R. 3448, as amended, by unanimous consent. A conference report ( H.Rept. 107-481 ) was filed on May 21, 2002. The next day the House agreedto the conference report by a vote of 425-1. The Senate approved the conference report 98-0 on May23, 2002. The President signed H.R. 3448 into law ( P.L. 107-188 ) on June 12, 2002. As enacted, P.L. 107-188 incorporates many of the provisions in the original House and Senate-passed bills. It adds to the programs and authorities established in Title III of the PublicHealth Service (PHS) Act by the Public Health Threats and Emergencies Act of 2000 ( P.L. 106-505 ,Title I) and creates a new PHS Act Title XXVIII: National Preparedness for Bioterrorism and OtherPublic Health Emergencies. P.L. 107-188 is a 5-year authorization act, which calls for a total of $2.4billion in funding for FY2002, $2.0 billion for FY2003, and such sums as may be necessary for theremaining years. The act authorizes grants to state and local health departments and hospitals toimprove planning and preparedness activities, enhance laboratory capacity, and educate and trainhealth care personnel. It also directs the Secretary to upgrade and renovate CDC's facilities. Inaddition, the act authorizes the HHS Secretary to purchase smallpox vaccine and expand the nationalstockpile of medicine and medical supplies to meet the nation's health security needs. To help prevent bioterrorism and to establish a national database of potentially dangerous pathogens, P.L. 107-188 requires the HHS Secretary to register facilities and individuals inpossession of biological agents and toxins that pose a severe threat to public health and safety, andto promulgate new safety and security requirements for such facilities and individuals. The actgrants authority to the Secretary of Agriculture to establish a parallel set of requirements for facilitiesthat handle agents and toxins that threaten crops and livestock. The bioterrorism legislation alsoincorporates language taken from S. 1275 that authorizes grants to states and localitiesto increase public access to defibrillators (i.e., devices that restore normal heart rhythm to patientsin cardiac arrest by administering a controlled electric shock). P.L. 107-188 contains several provisions to protect the nation's food and drug supply and enhance agricultural security. The act authorizes $545 million for FDA and USDA to hire newborder inspectors, develop new methods of detecting contaminated foods, work with state foodsafety regulators, and protect crops and livestock. It also provides FDA with new regulatory powersto require prior notice of all imported foods and detain suspicious foods for inspection. All foreignand domestic food facilities are required to register with the FDA. Finally, P.L. 107-188 includesa set of provisions aimed at protecting the nation's drinking water supply, including authorizing $160million to provide financial assistance to community water systems to conduct vulnerabilityassessments and prepare response plans. The bioterrorism legislation also includes language reauthorizing the Prescription Drug User Fee Act (PDUFA), which was set to expire on September 30, 2002. Congress first enacted PDUFAin 1992. (2) The original law authorized the FDA tocollect fees from pharmaceutical companies anduse the funds to hire additional reviewers to expedite the drug review and approval process, inaccordance with performance goals developed by the agency in consultation with the industry priorto PDUFA enactment. The 1992 law directed the FDA to provide Congress with an annual reporton the agency's progress in achieving those goals. Encouraged by the success of the user feeprogram, Congress in 1997 reauthorized PDUFA through FY2002. (3) Under PDUFA II, the FDA triedto meet tighter performance goals, as well as achieve more transparency in the drug review processand better communication with drug makers and patient advocacy groups. For more information onPDUFA, see CRS Report RL31453(pdf) , The Prescription Drug User Fee Act: Structure andReauthorization Issues. Table 1 below summarizes the bioterrorism legislation's authorizations of appropriations forFY2002 and FY2003. Only those authorizations that specify a dollar amount are included. Table 1. P.L.107-188: Authorizations of Appropriations for FY2002 and FY2003 ($ millions) Table 2 , beginning on page 6, provides a detailed side-by-side comparison of the provisionsof P.L. 107-188 with preexisting law, where applicable. All the PHS Act Title III provisions relatingto public health emergencies that were established by P.L. 106-505 (i.e., Sections 319, 319A --319G) are included in the table, regardless of whether they are amended by the bioterrorism bill. Unless specifically noted otherwise, the term Secretary refers to the Secretary of HHS. Table 2. Comparison of P.L.107-188 with Preexisting Law

Summary:
Last fall's anthrax attacks, though small in scale compared to the scenarios envisioned by bioterrorism experts, strained the public health system and raised concern that the nation isinsufficiently prepared to respond to bioterrorist attacks. Improving public health preparedness andresponse capacity offers protection not only from bioterrorist attacks, but also from naturallyoccurring public health emergencies. On June 12, 2002, the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ( P.L. 107-188 , H.R. 3448 ), which is intendedto bolster the nation's ability to respond effectively to bioterrorist threats and other public healthemergencies. The act builds on the programs and authorities established in Title III of the PublicHealth Service (PHS) Act by the Public Health Threats and Emergencies Act of 2000 ( P.L. 106-505 ,Title I). P.L. 107-188 is a 5-year authorization bill, which calls for a total of $2.4 billion in funding in FY2002, $2.0 billion in FY2003, and such sums as may be necessary for the remaining years. Theact authorizes the Secretary of Health and Human Services (HHS) to upgrade and renovate facilitiesat the Centers for Disease Control and Prevention (CDC), purchase smallpox vaccine, expand thenational stockpile of drugs, vaccines, and other emergency medical supplies, and provide grants tostate and local governments and hospitals to improve preparedness and planning. The Secretariesof HHS and Agriculture are required to register and regulate facilities that handle potentiallydangerous biological agents. The anti-bioterrorism legislation also includes provisions to protect the nation's food and drug supply and enhance agricultural security, including new regulatory powers for the Food and DrugAdministration (FDA) to block the importation of unsafe foods. To protect the drinking watersupply, the act requires community water systems to conduct vulnerability assessments and developemergency response plans. P.L. 107-188 also reauthorizes the Prescription Drug Use Fee Actthrough FY2007. The following analysts may be contacted for additional information: