For other versions of this document, see http://wikileaks.org/wiki/CRS-RL31263 ------------------------------------------------------------------------------ Order Code RL31263 Report for Congress Received through the CRS Web Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law Updated August 21, 2002 C. Stephen Redhead Donna U. Vogt Domestic Social Policy Division Mary E. Tiemann Resources, Science, & Industry Division Congressional Research Service ~ The Library of Congress Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provisions and Changes to 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 is insufficiently prepared to respond to bioterrorist attacks. Improving public health preparedness and response capacity offers protection not only from bioterrorist attacks, but also from naturally occurring 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 intended to bolster the nation's ability to respond effectively to bioterrorist threats and other public health emergencies. The act builds on the programs and authorities established in Title III of the Public Health 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. The act authorizes the Secretary of Health and Human Services (HHS) to upgrade and renovate facilities at the Centers for Disease Control and Prevention (CDC), purchase smallpox vaccine, expand the national stockpile of drugs, vaccines, and other emergency medical supplies, and provide grants to state and local governments and hospitals to improve preparedness and planning. The Secretaries of HHS and Agriculture are required to register and regulate facilities that handle potentially dangerous 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 Drug Administration (FDA) to block the importation of unsafe foods. To protect the drinking water supply, the act requires community water systems to conduct vulnerability assessments and develop emergency response plans. P.L. 107-188 also reauthorizes the Prescription Drug Use Fee Act through FY2007. The following analysts may be contacted for additional information: Stephen Redhead (7-2261) HHS/CDC programs and policies & Pamela Smith (7-7048) Donna Vogt (7-7285) Food safety (FDA) Jean Rawson (7-7283) Agriculture safety and security (USDA) Mary Tiemann (7-5937) Drinking water safety and security (EPA) Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Public Health Security and Bioterrorism Preparedness and Response Act . . . . . . 2 Legislative History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Overview of P.L. 107-188 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Appendix A. Bioterrorism-Related Hearings 107th Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Appendix B. Bioterrorism-Related Web Sites . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Department of Health and Human Services . . . . . . . . . . . . . . . . . . . . . . . . . 34 Department of Defense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 State and Local Health Departments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Professional Associations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Academic Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 List of Tables Table 1. P.L. 107-188: Authorizations of Appropriations for FY2002 and FY2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Table 2. Comparison of P.L. 107-188 with Preexisting Law . . . . . . . . . . . . . . . . 6 Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law Introduction The September 11, 2001 terrorist attacks and the subsequent deliberate release of anthrax spores in the mail have focused policymakers' attention on the preparedness and response capability of the U.S. public health system. Though small in scale compared to the scenarios envisioned by bioterrorism experts and played out in recent government exercises, the recent anthrax attacks strained 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 a more sophisticated delivery mechanism or released a deadly communicable biological agent such as 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 health impact of a biological attack can unfold gradually over time. Until a sufficient number of people arrive at emergency rooms and doctors' offices complaining of similar illnesses, there may be no sign that an attack has taken place. The speed and accuracy with which doctors and laboratories reach the correct diagnoses and report their findings to public health authorities has a direct impact on the number of people who become ill and the number that die. The nation's ability to respond to a bioterrorist attack, therefore, depends crucially on the state of preparedness of its medical care systems 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 and insufficiently prepared to respond to a bioterrorist attack. For example, they point out that there are too few medical personnel trained to spot biological attacks, a shortage of sophisticated laboratories to identify the agents, and inadequate supplies of drugs and vaccines to counteract the threat. They also contend that inadequate plans exist for setting up quarantines and emergency facilities to handle the sick and infectious victims. Improving public health preparedness and response capacity offers protection not only from bioterrorist attacks, but also from naturally occurring public health emergencies. Public health officials are increasingly concerned about our exposure and susceptibility to infectious disease and food-borne illness because of global travel, ubiquitous food imports, and the evolution of antibiotic-resistant pathogens. CRS-2 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 intended to bolster the nation's ability to respond effectively to bioterrorist threats and other public health emergencies. This report provides a brief overview and legislative history of P.L. 107-188, followed by 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. Appendix B provides a list of bioterrorism-related Web sites. For a discussion of bioterrorism preparedness issues, see CRS Report RL31225, Bioterrorism: Summary of a CRS/National Health Policy Forum Seminar on Federal, State, and Local Public Health Preparedness. Public Health Security and Bioterrorism Preparedness and Response Act Legislative History 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 was immediately considered under suspension of the rules and passed by the House the following day on a vote of 418-2. H.R. 3448 built on the provisions of a bipartisan Senate bill, the Bioterrorism Preparedness Act (S. 1765), which had been introduced by Senators Frist and Kennedy on November 15, 2001. S. 1765 incorporated ideas and objectives from several other Senate bioterrorism bills introduced in the wake of the anthrax attacks.1 The Senate took up H.R. 3448 on December 20, 2001, following its passage in the House, substituted the 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 agreed to the conference report by a vote of 425-1. The Senate approved the conference report 98-0 on May 23, 2002. The President signed H.R. 3448 into law (P.L. 107- 188) on June 12, 2002. 1 Senate bioterrorism preparedness bills introduced in response to the September 11 attacks and the anthrax incidents include: the Biological and Chemical Weapons Preparedness Act of 2001 (S. 1486) introduced by Senator Edwards on October 3, 2001; the Biological and Chemical Attack Preparedness Act (S. 1508) introduced by Senator Corzine on October. 4, 2001; the State Bioterrorism Preparedness Act (S. 1520) introduced by Senator Bayh on October 9, 2001; the Protecting America's Children Against Terrorism Act (S. 1539) introduced by Senator Clinton on October 11, 2001; the Bioterrorism Awareness Act (S. 1548) introduced by Senator Carnahan on October 15, 2001; the Protecting the Food Supply from Bioterrorism Act (S. 1551) introduced by Senator Clinton on October 15, 2001; the Agricultural Bioterrorism Countermeasures Act of 2001 (S. 1563) introduced by Senator Hutchison on October 17, 2001; the Public Health Emergency Planning and Information Act of 2001 (S. 1574) introduced by Senator Rockefeller on October 25, 2001; the Pathogen Research, Emergency Preparedness and Response Efforts (PREPARE) Act of 2001 (S. 1635) introduced by Senator Hutchinson on November 6, 2001; and the Deadly Biological Agent Control Act of 2001 (S. 1661) introduced by Senator Feinstein on November 8, 2001. CRS-3 Overview of P.L. 107-188 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 Public Health 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 Other Public Health Emergencies. P.L. 107-188 is a 5-year authorization act, which calls for a total of $2.4 billion in funding for FY2002, $2.0 billion for FY2003, and such sums as may be necessary for the remaining years. The act authorizes grants to state and local health departments and hospitals to improve planning and preparedness activities, enhance laboratory capacity, and educate and train health care personnel. It also directs the Secretary to upgrade and renovate CDC's facilities. In addition, the act authorizes the HHS Secretary to purchase smallpox vaccine and expand the national stockpile 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 in possession of biological agents and toxins that pose a severe threat to public health and safety, and to promulgate new safety and security requirements for such facilities and individuals. The act grants authority to the Secretary of Agriculture to establish a parallel set of requirements for facilities that handle agents and toxins that threaten crops and livestock. The bioterrorism legislation also incorporates language taken from S. 1275 that authorizes grants to states and localities to increase public access to defibrillators (i.e., devices that restore normal heart rhythm to patients in 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 new border inspectors, develop new methods of detecting contaminated foods, work with state food safety regulators, and protect crops and livestock. It also provides FDA with new regulatory powers to require prior notice of all imported foods and detain suspicious foods for inspection. All foreign and domestic food facilities are required to register with the FDA. Finally, P.L. 107-188 includes a set of provisions aimed at protecting the nation's drinking water supply, including authorizing $160 million to provide financial assistance to community water systems to conduct vulnerability assessments and prepare response plans. The bioterrorism legislation also includes language reauthorizing the Prescription Drug User Fee Act (PDUFA), which was set to expire on September 30, 2002. Congress first enacted PDUFA in 1992.2 The original law authorized the FDA to collect fees from pharmaceutical companies and use the funds to hire additional reviewers to expedite the drug review and approval process, in accordance with performance goals developed by the agency in consultation with the industry prior to PDUFA enactment. The 1992 law directed the FDA to provide Congress with an annual report on the agency's progress in achieving those goals. Encouraged 2 P.L. 102-571, 21 U.S.C. Section 379(g). CRS-4 by the success of the user fee program, Congress in 1997 reauthorized PDUFA through FY2002.3 Under PDUFA II, the FDA tried to meet tighter performance goals, as well as achieve more transparency in the drug review process and better communication with drug makers and patient advocacy groups. For more information on PDUFA, see CRS Report RL31453, The Prescription Drug User Fee Act: Structure and Reauthorization Issues. Table 1 below summarizes the bioterrorism legislation's authorizations of appropriations for FY2002 and FY2003. Only those authorizations that specify a dollar amount are included. Table 1. P.L. 107-188: Authorizations of Appropriations for FY2002 and FY2003 ($ millions) FY2002 FY2003 Title I: National Preparedness for Bioterrorism and Other Public Health Emergencies Grants to state and local governments No provision $1,080 Grants for hospital preparedness No provision $520 Upgrading CDC $300 $300 Strategic National Stockpile $640 Such sums as may be necessary Smallpox vaccine $509 Such sums as may be necessary Antimicrobial resistance $25 $25 Emergency health professional verification $2 Such sums as may system be necessary Public access defibrillation programs $5 $30 Dept. of Veterans Affairs emergency $133 Such sums as may preparedness be necessary Title IIIA: Food Supply Safety and Security $130 Such sums as may be necessary Title IIIC: Agricultural Security $415 Such sums as may be necessary Title IV: Drinking water Safety and Security $210 Such sums as may be necessary Title V: FDA Drug-Related Authorizations No provision $10 TOTAL $2,369 $1,965 3 PDUFA reauthorization was included in Title I of the Food and Drug Administration Modernization Act of 1997, P.L. 105-115. CRS-5 Table 2, beginning on page 6, provides a detailed side-by-side comparison of the provisions of P.L. 107-188 with preexisting law, where applicable. All the PHS Act Title III provisions relating to public health emergencies that were established by P.L. 106-505 (i.e., Sections 319, 319A­319G) 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. CRS-6 Table 2. Comparison of P.L. 107-188 with Preexisting Law Topic Preexisting Law P.L. 107-188 National Preparedness for Bioterrorism and Other Public Health Emergencies National Preparedness Plan, reports No statutory provisions. Adds a new Title XXVIII (Section 2801) to the Public Health Service to Congress (PHS) Act that requires the Secretary, building on existing authority in PHS Act Section 319A, to develop and implement a national plan to prepare for and respond to bioterrorism and other public health emergencies. Establishes five national preparedness goals: (i) assist state and local governments in the event of bioterrorism or other public health emergencies; (ii) ensure that state and local governments have the capacity to detect and respond to such emergencies; (iii) develop and maintain countermeasures; (iv) ensure coordination and minimize duplication of federal, state, and local planning, preparedness, and response activities; and (v) enhance hospital and other health care facility readiness. Requires the Secretary to coordinate with the activities of state and local governments and develop outcome measures to evaluate progress in implementing the national plan and achieving its five goals. Requires the Secretary to report to Congress within 1 year, and biennially thereafter, on progress made towards meeting the national preparedness goals, including recommendations for new legislative authority to protect public health. Clarifies that the Act does not expand or limit any of the Secretary's preexisting authorities. Requires the Secretary to report to Congress within 1 year on: (i) the findings and recommendations of the National Advisory Committee on Children and Terrorism and the EPIC Advisory Committee; (ii) the vulnerability of rural and medically underserved communities to bioterrorism; (iii) recommendations for new legislative authority to strengthen rural and medically underserved communities; and (iv) the need for and benefits of a private-sector, community-based rapid response corps of medical volunteers. Requires the Secretary to conduct a study of best practices in local emergency response and report to Congress within 180 days. [Section 101] Establishing public health capacities Public Health Service (PHS) Act Section 319A requires the No provisions. Secretary, together with state and local health officials, to establish what capacities are needed for national, state, and local public health systems to be able to detect, diagnose, and contain outbreaks of infectious disease, drug-resistant pathogens, or acts of bioterrorism. Authorizes $4 million for FY2001, and such sums as may be necessary for FY2002­FY2006. CRS-7 Topic Preexisting Law P.L. 107-188 Assessing public health needs PHS Act Section 319B authorizes grants to states and local public No provisions. health departments to evaluate the extent to which they can achieve the capacities identified pursuant to Section 319A. Requires the Secretary to develop a national framework for the evaluations. Authorizes $45 million for FY2001, and such sums as may be necessary for FY2002­FY2003. Assistant Secretary for Public Health No statutory provisions. Adds a new Section 2811(a) to the PHS Act authorizing the Emergency Preparedness appointment of an Assistant Secretary for Public Health Emergency Preparedness to oversee the National Disaster Medical System (see below) and coordinate all HHS response activities related to bioterrorism and other public health emergencies and interface with other federal agencies and state and local entities. [Section 102(a)] Public health emergencies PHS Act Section 319 authorizes the Secretary to respond to public Requires the Secretary to notify Congress within 48 hours of declaring health emergencies, including diseases, disorders, or bioterrorist a public health emergency. Provides that public health emergencies attacks, by supporting grants, contracts, and investigations. expire by announcement of the Secretary or after 90 days, whichever Establishes the Public Health Emergency Fund and authorizes comes first, and permits the Secretary to renew emergency declarations, such sums as may be necessary. Requires an annual report to subject to the same 90-day limitation. [Section 144] Congress on expenditures from the Fund. Allows the Secretary during a public health emergency to waive deadlines for the submission of data and reports by individuals or public or private entities pursuant to any law administered by the Secretary. Requires the Secretary to notify Congress of such an action and publish a notice in the Federal Register. [Section 141] National Disaster Medical System No statutory provisions. The NDMS was established in 1984 as Adds a new Section 2811(b) to the PHS Act providing statutory (NDMS) a partnership of four federal agencies (HHS, FEMA, DOD, VA), authorization for the NDMS, to be coordinated by HHS, FEMA, DOD, state and local governments, and the private sector to provide and the VA, in collaboration with states and other appropriate public or medical assistance and hospitalization for mass casualties in the private entities. Requires the Secretary within 1 year, and periodically event of a natural or man-made disaster. It consists of more than thereafter, to conduct exercises to test the capability and timeliness of 7,000 volunteer health professionals and support personnel the NDMS to mobilize and respond effectively to a bioterrorist attack organized into medical response teams. For more information, go or other public health emergency. Appoints activated NDMS volunteers to [http://ndms.dhhs.gov/NDMS/ndms.html]. as temporary federal employees. Establishes liability protections, compensation for work injuries, and employment and reemployment rights for NDMS volunteers. Authorizes such sums as may be necessary for FY2002­FY2006 for NDMS operations and for the Assistant Secretary for Public Health Emergency Preparedness. [Section 102(b)] Requires the VA Secretary, in consultation with the Secretaries of HHS and DOD and the FEMA Director, to establish a training program to facilitate the participation of VA medical center staff in the NDMS. [Section 154(e)] CRS-8 Topic Preexisting Law P.L. 107-188 Upgrading CDC, national public PHS Act Section 319D authorizes funds for the construction and Amends PHS Act Section 319D by recognizing CDC's essential role in health co mmunications and renovation of CDC facilities, and to support the agency's activities defending against and combating bioterrorism and other public health surveillance networks to combat threats to public health. Authorizes $180 million for emergencies. Provides CDC's Director with multi-year contracting FY2001, and such sums as may be necessary for authority for facility construction, renovation, and security. Requires FY2002­FY2010. the Secretary to improve CDC's preparedness and response capacities. Provides for the establishment of public health communications and Since FY1999, CDC has awarded grants to all 50 states and some surveillance networks and requires the Secretary, within 1 year and in metropolitan health departments to enhance state and local cooperation with health care providers and state and local public health laboratory capacity and to help develop the Health Alert Network officials, to establish technical and reporting standards for such (NAH), a national electronic communications network connecting networks. Authorizes $300 million for FY2002 and for FY2003, and all the components of the public health community. For more such sums as may be necessary for FY2004­FY2006, to upgrade CDC's information, go to [http://www.bt.cdc.gov]. facilities. Authorizes such sums as may be necessary for FY2002­FY2006 for improving CDC's capacities and establishing national communications and surveillance networks. [Section 103] Federal working groups and advisory PHS Act Section 319F requires the Secretary to: (i) establish, Amends PHS Act Section 319F by replacing the two existing working committees with the Secretary of Defense, an interagency working group on groups with a single interagency working group on the prevention, bioterrorism preparedness, and (ii) establish, in collaboration with preparedness, and response to bioterrorism and other public health the Director of FEMA, the Attorney General, and the Secretary of emergencies, to be established by the Secretary in coordination with the Agriculture, an interagency working group to address the public Attorney General, the Directors of FEMA and Central Intelligence, the health and medical consequences of a bioterrorist attack. Secretaries of Agriculture, Defense, Energy, Labor, and Veterans Affairs, the EPA Administrator, and with other federal officials, as appropriate. Requires the working group, or its subcommittees, to meet periodically for the purpose of consultation on, assisting in, and making recommendations on a range of specified topics related to preparedness for and response to bioterrorism and other public health emergencies (including research and development of countermeasures to treat, prevent, and identify exposure to biological agents). [Section 108] Amends PHS Act Section 319F as follows: (i) establishes the National Advisory Committee on Children and Terrorism, and the Emergency Public Information and Communications (EPIC) Advisory Committee (both of which sunset after 1 year); (ii) requires the Secretary to develop a strategy for effectively communicating information on bioterrorism and other public health emergencies; and (iii) recommends establishing a federal web site on bioterrorism with links to state and local government sites. Requires the Secretary, in consultation with other federal agencies, to conduct a study of the ability of local public health entities to maintain communications during a bioterrorist attack or other public health emergency. [Sections 104] CRS-9 Topic Preexisting Law P.L. 107-188 Education and training of health care PHS Act Section 319F requires the Secretary to develop programs Amends PHS Act Section 319F by requiring the Secretary, in personnel to educate health professionals in recognizing and caring for collaboration with the interagency working group and professional victims of bioterrorist attacks, and programs to train laboratory organizations, to award grants: (i) to develop education materials to personnel in identifying bioweapons. teach health officials and other emergency personnel to identify potential bioweapons and other dangerous agents and to care for victims of public health emergencies, recognizing the special needs of children and other vulnerable populations; (ii) to develop education materials for community-wide planning to respond to bioterrorism or other public health emergencies; (iii) to develop materials for proficiency testing of lab and other public health personnel for the recognition and identification of potential bioweapons and other dangerous agents; and (iv) to provide for the dissemination and teaching of these materials. Authorizes the Secretary, in consultation with the Attorney General and the FEMA Director, to provide technical assistance for emergency response personnel training carried out by the Justice Department and FEMA. [Section 105] National Pharmaceutical Stockpile No statutory provisions. The NPS, which was established and is Provides statutory authorization for a Strategic National Stockpile of (NPS) managed by the CDC, includes pharmaceuticals, vaccines, and drugs, vaccines, medical devices, and other supplies to meet the nation's medical supplies that can be deployed anywhere in the country in health security needs in the event of a bioterrorist attack or other public response to a public health emergency. For more information, go health emergency. Requires the Secretary to manage the stockpile, in to [http://www.cdc.gov/nceh/nps/default.htm]. coordination with the VA Secretary, and ensure its physical security. Protects information on stockpile locations from disclosure under the Freedom of Information Act. Authorizes $640 million for FY2002, and such sums as may be necessary for FY2003­FY2006. [Section 121] Grants to address national shortages No applicable provisions, although PHS Act Titles VII (Health Adds a new Section 319H to the PHS Act establishing a grant program of specific types of health Professionals Education) and VIII (Nursing Workforce to provide financial assistance for the education and training of professionals Development) authorize federal support for training of health individuals in any category of the health professions where there is a professionals for specific purposes. shortage that the Secretary determines should be alleviated to improve public health emergency readiness. Authorizes sums as may be necessary for FY2002­FY2006. [Section 106] Health professional volunteers No applicable provisions. Adds a new Section 319I to the PHS Act requiring the Secretary to establish a electronic database for the advance registration of health professionals to verify their credentials, licenses, accreditations, and hospital privileges when they volunteer to respond during public health emergencies. Authorizes the Secretary to encourage states to permit out-of-state health professionals to provide health services during public health emergencies. Authorizes $2 million for FY2002, and such sums as may be necessary for FY2003­FY2006. [Section 107] CRS-10 Topic Preexisting Law P.L. 107-188 State public emergency The Stafford Act (42 U.S.C. 5121 et seq.) authorizes federal Amends Section 613(b) of the Stafford Act by requiring states to announcements assistance when the President determines that a natural or man- include a plan for providing a coordinated public communications made disaster has overwhelmed state and local resources. response in their submission for federal funds to help pay for state Stafford assistance is administered by the Federal Emergency emergency preparedness personnel and administrative expenses. Management Agency (FEMA). [Section 151] Quarantine and inspection PHS Act Section 361 authorizes the Surgeon General, in Amends PHS Act Sections 361 and 363 by expanding the authority of consultation with the Secretary, to develop quarantine, inspection, the Secretary, in consultation with the Surgeon General, to issue a fumigation, sanitation, and pest extermination regulations to quarantine rule or a rule providing for the apprehension of individuals prevent the introduction, transmission, or spread of communicable during wartime. Permits federal regulations under Sections 361 and diseases. Section 363 authorizes the development of regulations 363, as amended, to preempt state laws that conflict with the exercise of for the apprehension and examination of infected individuals in such federal authority. [Section 142] times of war. GAO Report PHS Act Section 319F requires a GAO report to Congress, within Requires a new GAO report to Congress on federal bioterrorism-related 6 months, on federal bioterrorism-related activities, including activities, including research, preparedness, and response. [Section 157] research, preparedness, and response. [This report, GAO-01-915, was issued by GAO on September 28, 2001.] Occupational safety and health Section 22 of the Occupational Safety and Health Act of 1970 (29 Requires the Secretary, acting through the Director of NIOSH, to U.S.C. 671) created the National Institute for Occupational Safety expand research on bioterrorism threats and attacks in the workplace. and Health (NIOSH) as the federal agency responsible for [Section 153] conducting research and making recommendations for the prevention of work-related disease and injury. NIOSH is part of the CDC. Department of Veterans Affairs No statutory provisions. Directs the VA Secretary to enhance the readiness of VA medical centers and research facilities to respond to a chemical or biological attack, based on the results of an evaluation of the security needs at these facilities. Requires the VA Secretary to develop a centralized tracking system for pharmaceuticals and medical supplies and equipment throughout the VA health care system, and train VA health care personnel in emergency medical response. Authorizes $100 million for FY2002, and such sums as may be necessary for FY2003­FY2006. Requires the VA Secretary, in consultation with the HHS Secretary, the American Red Cross, and the interagency working group, to provide mental health counseling to individuals seeking care at a VA medical center following a bioterrorist attack or other public health emergency. Authorizes $33 million for FY2002, and such sums as may be necessary for FY2003­FY2006. [Section 154] CRS-11 Topic Preexisting Law P.L. 107-188 Supplies and services in lieu of No applicable provisions. Adds a new Section 319J to the PHS Act allowing the Secretary to federal grant funds provide supplies, equipment, or services instead of, or in conjunction with, grants awarded under Sections 319 through 319I, or Section 319K. [Section 110] Psychological impact of trauma PHS Act Section 582 authorizes the Secretary to award grants to Extends grant authority and authorizes such sums as may be necessary study the psychological impact of trauma, in order to improve the for FY2003­FY2006. [Section 155] treatment children and youth that suffer from psychiatric disorders as a result of witnessing or experiencing traumatic events. Authorizes $50 million for FY2001, and such sums as may be necessary for FY2002­FY2003. Public access to automated external PHS Act Section 247 requires the Secretary, in consultation with Community Access to Emergency Defibrillation Act of 2002: Adds a defibrillators other federal agencies and appropriate public and private entities, new Section 312 to the PHS Act authorizing grants to develop and to establish guidelines for placing automated external implement public access defibrillation programs. Funds may be used defibrillators (AEDs) in federal buildings, and to publish in the to purchase AEDs, to provide training in AED usage, to provide Federal Register recommendations for AED placement. information to community members about the public access defibrillation program, to provide information to local emergency PHS Act Section 248 establishes the conditions under which a medical services on AED placement, and to encourage private person who uses or attempts to use an AED in a medical companies to purchase AEDs. Authorizes $25 million for FY2003, and emergency is immune from civil liability for any resulting harm such sums as may be necessary for FY2004­FY2006. to the victim. Adds a new Section 313 to the PHS Act authorizing grants to develop and implement innovative, community-based public access defibrillation demonstration projects. Authorizes $5 million for each of FY2002­FY2006. [Section 159] Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP) Emergency waivers Medicare covers medically necessary acute care and follow-up Authorizes the Secretary to temporarily waive conditions of services (hospital, short-term nursing home care, physician participation and other certification requirements for any entity that services, home health and a variety of outpatient services) for all furnishes health care items or services to Medicare, Medicaid, or SCHIP persons age 65 and over, as well as certain disabled persons. beneficiaries in an emergency area during a declared disaster or public Medicare beneficiaries may receive services through the health emergency. In addition, during such an emergency, authorizes traditional fee-for-service setting or may enroll in a Medicare the Secretary to waive: (i) participation, state licensing (as long as managed care plan through the Medicare + Choice (M+C) equivalent licensure from another state is held and there is no exclusion program. Medicaid covers acute and long-term care services for from practicing in that state or any state in the emergency area), and low-income persons who are aged, blind, disabled, members of pre-approval requirements for physicians and other practitioners; (ii) families with dependent children, and certain other pregnant sanctions for failing to meet requirements for emergency transfers women and children. The State Children's Health Insurance between hospitals; (iii) sanctions for physician self-referral; and (iv) Program (SCHIP) covers uninsured children living in families limitations on payments for health care and services furnished to with income above applicable Medicaid standards, typically up to individuals enrolled in M+C plans when services are provided outside or above 200% of the federal poverty level. In all three programs, the plan. To the extent possible, the Secretary shall ensure that M+C providers must meet certain standards in order to participate and enrollees do not pay more than would have been required had they CRS-12 Topic Preexisting Law P.L. 107-188 receive reimbursement for services rendered to program received care within their plan network. Requires the Secretary to beneficiaries. For example, hospitals and other facilities must provide Congress with certification and written notice at least 2 days meet established conditions of participation, and laboratories must prior to exercising this waiver authority. Provides for the waiver be certified under the Clinical Laboratories Improvement Act authority to continue for 60 days. Permits the Secretary to extend the (CLIA). Physicians must be licensed to provide medical services waiver period. Requires the Secretary, within 1 year after the end of the in the state where medical care is rendered, and must follow emergency, to provide Congress with an evaluation of this approach and established rules for obtaining prior approval to deliver certain recommendations for improvements under this waiver authority. types of services. Also, physicians must not refer patients to [Section 143] medical entities with which they have a financial relationship. Other statutory provisions require hospitals to fully stabilize patients receiving emergency care prior to transfer to another medical facility. Regulation of the Use, Possession, and Transfer of Potentially Dangerous Biological Agents and Toxins HHS regulation of biological agents The 1996 Antiterrorism and Effective Death Penalty Act (P.L. Codifies and expands provisions of P.L. 104-132 in the PHS Act under and toxins that pose a threat to public 104-132, Section 511(d)-(g)) required the Secretary to: (i) a new Section 351A. Requires the Secretary to: (i) establish and, at health and safety establish a list of biological agents that may pose a severe threat least biennially, review and, if necessary, revise a list of biological to public health and safety; and (ii) establish safety procedures for agents and toxins that may pose a severe threat to public health and transferring listed agents and toxins, including measures to protect safety; (ii) establish safety procedures for transferring listed agents and public safety, prevent access by terrorists, and ensure the toxins, including measures to protect public safety, prevent access by availability of bioagents for research, education, and other terrorists, and ensure the availability of agents and toxins for research, legitimate purposes. The regulations issued pursuant to the Act education, and other legitimate purposes; (iii) establish standards and (i.e., 42 C.F.R. 72.6) include: (i) a list of 36 agents and toxins; (ii) procedures for the possession and use of listed agents and toxins, registration requirements for facilities transferring these agents; including the same measures listed in (ii); (iv) require registration for (iii) transfer requirements; (iv) verification procedures including the possession, use, and transfer of listed agents and toxins; and (v) audit and quality control; (v) agent disposal requirements; and (vi) maintain a national database of registered facilities and the location of research and clinical exemptions. listed agents and toxins. Directs the Secretary, in consultation with the Attorney General, to establish appropriate safety and security requirements for registered entities and individuals, commensurate with the level of risk to public health and safety. These requirements must ensure that persons registering facilities: (i) limit access to listed agents and toxins to only those individuals (employees) with a legitimate need; (ii) identify such individuals to the Secretary and the Attorney General for background screening; (iii) deny access to individuals determined by the Attorney General to be "restricted individuals" (see Criminal Penalties below); and (iv) limit or deny access to individuals found to meet other specified criteria. Requires prompt screening and notification by the Attorney General and Secretary and provides for an expedited screening process where the registered person has demonstrated good cause. Establishes procedures for the review of denials based on the screening process. CRS-13 Topic Preexisting Law P.L. 107-188 Requires persons seeking to register a facility, as well as individuals seeking to register themselves, to be screened in the same manner as individuals working at a registered facility, but without the option of expedited review. Allows the Secretary to exempt federal, state, and local government facilities from screening. Requires that the Secretary be promptly notified of the theft or loss of listed agents or toxins. Authorizes the Secretary to conduct compliance inspections. Exempts from the above requirements clinical and diagnostic labs presented with a listed agent or toxin for diagnosis, verification, or proficiency testing, provided that they report the identification of the agent or toxin to the Secretary and transfer or destroy it. Exempts agents or toxins licensed or approved under specified federal laws, unless the Secretary determines that additional regulation is necessary to protect public health and safety. Permits the Secretary to exempt investigational products being used in research or clinical trials and requires the Secretary to make a prompt (within 14 days) determination on a request for such an exemption. Permits the Secretary to grant temporary exemptions during public health and agricultural emergencies. Protects information collected under the above requirements for the possession, use, and transfer of listed agents and toxins from disclosure under the Freedom of Information Act. Establishes civil penalties of up to $500,000 for violations of Section 351A. Requires prompt notification of the Secretary in the event of an unintentional release of a listed agent or toxin. Requires the Secretary to report to Congress within 1 year. Authorizes such sums as may be necessary for FY2002­FY2007. [Section 201] Implementation time frame for HHS No statutory provisions. Requires that all persons in possession of listed agents or toxins notify regulations the Secretary within 90 days, based on guidance issued by the Secretary within 30 days. Requires the Secretary within 180 days to issue an interim final rule for carrying out Section 351A (including time frames for the applicability of the rule to minimize disruption of research and education). [Section 202] Repeals current law (i.e., P.L. 104-132, Section 511(d)-(g)). [Section 204] CRS-14 Topic Preexisting Law P.L. 107-188 USDA regulation of biological No statutory provisions. Gives USDA comparable regulatory authority to that provided to HHS agents and toxins that pose a threat to under Section 201 of the Act for regulating the use, possession, and agriculture transfer of listed biological agents and toxins that may pose a severe threat to animal or plant health, or to animal or plant products. The USDA provisions differ from those of HHS in the criteria used to develop a list of agriculturally significant biological agents and toxins. Also, there is no mandated denial of access for "restricted individuals" because possession of USDA-listed agents by such persons is not a federal crime. Additional provisions address overlap agents and toxins that appear in both the HHS and the USDA list. [Section 212] Implementation time frame for No statutory provisions. Requires the USDA Secretary to issue an interim final rule establishing USDA regulations the initial list of agents and toxins within 60 days and, no later than 60 days after that date, requires all persons in possession of listed agents or toxins to notify the Secretary. Requires the USDA Secretary within 180 days to issue an interim final rule for carrying out Section 212 of the Act (including time frames for the applicability of the rule to minimize disruption of research and education). [Section 213] HHS-USDA coordination No statutory provisions. Requires the Secretaries of HHS and Agriculture to coordinate activities regarding overlap agents and toxins that appear in both lists, so as to minimize the administrative burden on those persons subject to both sets of regulations. Requires both Secretaries, within 180 days, to enter into a memorandum of understanding providing for the development of a single system of registration for persons who use, possess, or transfer overlap agents or toxins, and to coordinate inspections and enforcement. Requires the Secretaries to issue joint regulations for the use, possession, and transfer of overlap agents and toxins within 18 months. [Section 221] Criminal penalties Section 175 of the U.S. Criminal Code (i.e., 18 U.S.C. 175): (i) Amends 18 U.S.C. 175b by adding the following criminal penalties: (i) prohibits the production, stockpiling, transfer, acquisition, or fines and/or up to 5 years imprisonment for anyone who transfers a possession of biological agents for use as a weapon, subject to listed agent or toxin to a person whom the transferor knows or has fines and/or imprisonment for life or any term of years; and (ii) reasonable cause to believe has not obtained a registration; and (ii) fines establishes fines and/or up to 10 years imprisonment for and/or up to 5 years imprisonment for unregistered persons in individuals who knowingly possess any biological agent, toxin, or possession of listed agents or toxins. Note: These new penalties apply delivery system of a type and in a quantity not reasonably justified to both the HHS and USDA regulations described above. [Section 231] by research or other peaceful purposes. Section 175b prohibits "restricted individuals" (i.e., indicted criminals, illegal aliens, and other specified individuals) from possessing, shipping, or receiving listed agents or toxins, subject to fines and/or up to 10 years imprisonment. Section 176 provides for the seizure, forfeiture, and destruction of biological weapons. CRS-15 Topic Preexisting Law P.L. 107-188 State and Local Preparedness and Response Capacity Core capacity grants to state and PHS Act Section 319C authorizes grants to states and local Deletes PHS Act Section 319C(f) (i.e., Authorization of local public health agencies governments, after they have completed a Section 319B Appropriations). [Section 131(b)] evaluation, to address core public health capacity needs. Requires the Secretary to report to Congress on activities carried out under Sections 319A, 319B, and 319C by January 1, 2005. Authorizes $50 million for FY2001, and such sums as may be necessary for FY2002­FY2006. Bioterrorism preparedness grants to PHS Act Section 319F(c) authorizes grants to states, localities, Adds a new Section 319C-1 to the PHS Act authorizing grants to states states and local public health and health care facilities to increase their capacity to detect, and local governments to improve preparedness and response to agencies, and health care facilities diagnose, and respond to bioterrorist attacks, including training of bioterrorism and other public health emergencies. Eligible entities must personnel. [Note: For all activities under Section 319F, authorizes have completed a Section 319B evaluation of core public health $215 million for FY2001, and such sums as may be necessary for capacity needs and must, within 60 days of receiving an award, submit FY2002­FY2006.] an emergency preparedness and response plan (including performance measures) describing the activities to be carried out by the entity to address identified needs. Use of funds for preparedness and response to bioterrorism and outbreaks of infectious disease takes priority over other public health emergencies, subject to any modification in the assessment of risk by the Secretary. Authorizes $1.6 billion for FY2003: $1.08 billion for block grants to states and territories based on population, with each state/territory guaranteed a minimum level of funding; and $520 million for grants to states for hospital preparedness. Authorizes such sums as may be necessary for FY2004­FY2006. Note: The requirement that public health preparedness funding be awarded as block grants applies only to FY2003; greater flexibility in awarding funding is provided to the Secretary beyond FY2003. [Section 131(a)] Grants to hospitals No applicable provisions. Adds a new Section 319C-2 to the PHS Act authorizing grants to improve community and hospital preparedness for bioterrorism and other public health emergencies. Eligible entities must be a partnership between one or more hospitals (or other health care facilities) and one or more states and/or local governments. Grant proposals must be coordinated and consistent with the state's emergency preparedness and response plan. Use of funds for preparedness and response to bioterrorism and outbreaks of infectious disease takes priority over other public health emergencies, subject to any modification in the assessment of risk by the Secretary. Authorizes such sums as may be necessary for FY2004­FY2006. [Section 131(a)] CRS-16 Topic Preexisting Law P.L. 107-188 Demonstration grants PHS Act Section 319G authorizes up to three demonstration No provisions. grants for up to 5 years to states, localities, or non-profit organizations to carry out programs to improve biopathogen detection, develop plans for responding to bioterrorist attacks, and train response personnel. Requires a GAO report to Congress at the conclusion of the demonstration programs describing the capabilities of the grantees. Authorizes $6 million for FY2001, and such sums as may be necessary for FY2002­FY2006. Countermeasures (Research, Development, and Production of New Vaccines, Drugs, and Technologies) Smallpox vaccine No statutory provisions. Existing supplies of smallpox vaccine Requires the Secretary to ensure that the national stockpile contains consist of 15.4 million doses of freeze-dried vaccine (produced by enough smallpox vaccine to meet the nation's health security needs. Wyeth Laboratories) that HHS indicates could be expanded to 77 Authorizes $509 million for FY2002, and such sums as may be million doses by 1:5 dilution, plus another 75­90 million doses of necessary for FY2003­FY2006, to purchase smallpox vaccine. [Section a different vaccine (produced by Aventis Pasteur) that HHS is 121] testing for safety and effectiveness. In addition, HHS has contracted with Acambis Inc. to produce a total of 209 million doses of a new type of smallpox vaccine by the end of 2002 (the new vaccine needs FDA approval before it can be used). FDA approval of drugs and biologics Under the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 Authorizes the Secretary to designate a priority countermeasure as a U.S.C. 301 et seq.), manufacturers of drugs and biologics (e.g., fast-track product for accelerated approval by the FDA. Permits a drug vaccines) must provide clinical trial data to demonstrate that their for which FDA approval is being sought on the basis of animal data to product is safe and effective, in order to obtain FDA marketing be designated a fast-track product. Requires the FDA, within 90 days, approval. The FFDCA provides for the designation of products to issue as a final rule the October 5, 1999 proposed rule (64 Fed. Reg. as fast track to expedite the approval process. 53960) permitting the use of animal data for demonstrating the effectiveness of new drugs and vaccines when ethical issues preclude conducting human clinical trials. (Note: FDA published a final rule on May 31, 2002 (67 Fed. Reg. 37988).) [Section 122, 123] Security at research and production No applicable provisions. Adds a new Section 319K to the PHS Act authorizing the Secretary, in facilities consultation with the Secretary of Defense and the Attorney General, to provide technical or other assistance to enhance security at facilities that develop, produce, distribute, or store priority countermeasures. [Section 124] CRS-17 Topic Preexisting Law P.L. 107-188 Research and development PHS Act Section 319F requires the Secretary, in consultation with Directs the Secretary to accelerate research and development on priority the interagency working group, to conduct research on the pathogens (as determined by the NIH Director in consultation with the epidemiology and pathogenesis of biopathogens, diagnostic tests interagency working group) and priority countermeasures. Requires the for biopathogens, and vaccines and other therapeutics. Secretary to consider research collaboration with the VA. Defines priority countermeasures as any drug, vaccine, biological product, device, or diagnostic test that the Secretary determines to be a priority to treat, identify, or prevent infection by a listed biological agent or toxin, or harm from any other agent that may cause a public health emergency. [Section 125] Detection, identification, diagnosis, No applicable provisions. Requires the Secretary of Energy and the Administrator of the National and surveillance technologies Nuclear Safety Administration, in coordination with the interagency working group, to expand research on the rapid detection and identification of biopathogens and other agents that may cause a public health emergency, and report to Congress within 180 days. Authorizes such sums as may be necessary for FY2002­FY2006. [Section 152] Requires the Secretary, in consultation with the interagency working group, to evaluate new and emerging technologies for improving surveillance of public health emergencies and report to Congress within 180 days, and periodically thereafter. [Section 126] Potassium iodide Under general authority provided by the Atomic Energy Act of Directs the President to provide KI from the national stockpile to state 1954 (42 U.S.C. 2011 et seq.) and the Energy Reorganization Act and local governments that submit a plan for the local stockpiling and of 1974 (42 U.S.C. 5801 et seq.), the Nuclear Regulatory distribution to everyone within 20 miles of a nuclear power plant. Commission (NRC) requires that the use of potassium iodide (KI) Additional eligibility requirements apply to local government plans. by the public be considered during development of nuclear power Requires the President within 1 year, in consultation with appropriate plant emergency plans (see 10 C.F.R. 50.47). Under a policy federal, state, and local agencies, to establish guidelines on stockpiling, adopted December 22, 2000, NRC will pay for state KI stockpiles. distributing, and using KI in the event of a nuclear incident. Requires the President within 6 months to report to Congress on state and local Note: Taking KI in the event of a nuclear attack or accident slows KI stockpiles. Directs the President to request a study by the National a person's uptake of radioactive iodine by flooding the thyroid Academy of Sciences on the safest and most effective way to distribute gland with nonradioactive iodine. and administer KI on a large scale, to be submitted to Congress within 6 months. Permits the program to be terminated if the President determines that there are more effective measures to protect against thyroid disease. [Section 127] CRS-18 Topic Preexisting Law P.L. 107-188 Antimicrobial Resistance Combating antimicrobial resistance PHS Act 319E requires the Secretary to establish an Antimicrobial Amends PHS Act Section 319E to authorize additional research on Resistance Task Force to coordinate federal programs on priority pathogens. Authorizes $25 million for FY2002 and for antimicrobial resistance and to work on surveillance plans and FY2003, and such sums as may be necessary for FY2004­FY2006. information systems for detection and control of drug-resistant [Section 109] pathogens. Authorizes research and development initiatives for new antimicrobial drugs and diagnostics. Directs the Secretary to conduct a nationwide campaign to educate the public and health care professionals about the appropriate use of antibiotics. Authorizes grants for public health agencies to combat antimicrobial resistance. Authorizes demonstration grants for hospitals, clinics, and other entities to promote the judicious use of antibiotics and to control the spread of resistant infections. Authorizes $40 million for FY2001, and such sums as may be necessary for FY2002­FY2006. Drug and Device Supply Safety and Security Drug and device importation FFDCA Section 510(i) requires foreign drug and device Amends Section 510(i) of the FFDCA by requiring annual registration, manufacturers that import into the United States to register with through electronic means, of foreign manufacturers importing drugs and the Secretary their name, place of business, and the name of their devices into the United States. Requires the registration to include the U.S. agent. Section 801 governs the import and export of food, name of each importer and agent used by the manufacturer, and the drugs, devices, and other items, and specifies the circumstances name of each person who imports or offers for import such drugs or under which imported articles are inspected, detained, or refused devices. Amends Section 801 by refusing entry to drugs or devices that entry into the United States. are offered for importation, if the import declaration does not include registration information about the manufacturer. Requires refused articles to be held at the port of entry or removed to a secure facility, as appropriate, until registration information is provided. [Section 321] Import components intended for FFDCA Section 301 is the prohibited acts and penalties section of Amends Section 801 of the FFDCA mandating a chain-of-possession export the statute. Section 801 governs the import and export of food, identification and a customs bond for firms seeking to import drugs, devices, and other items, and specifies the circumstances components of drugs, devices, food additives, color additives, or dietary under which imported articles are inspected, detained, or refused supplements for further processing and export. Requires certificates of entry into the United States. analysis to identify such components, except for components of devices and blood and tissue components. Permits the Secretary to exclude from importation any article for which there is credible evidence or information indicating that the article is not intended to be imported for export. Amends Section 301 making it illegal to knowingly submit false statements, certificates, records, or reports required under Section 801, as amended. [Section 322] CRS-19 Topic Preexisting Law P.L. 107-188 Additional Authorizations of Appropriations for FDA Drug Regulation Drug safety The Office of Drug Safety in FDA's Center for Drug Evaluation Authorizes the following amounts for the Office of Drug Safety (ODS): and Research (CDER) conducts postmarket surveillance and FY2003=ODS FY2002 appropriation + $5 million; FY2004=ODS monitors adverse drug reactions and medication errors. FY2002 appropriation + $10 million; each subsequent fiscal year=ODS FY2004 appropriation adjusted for inflation since beginning of FY2004. [Section 521] Drug marketing, advertising, and FDA/CDER's Division of Drug Marketing, Advertising, and Authorizes the following amounts for the Division of Drug Marketing, communications Communications is responsible for ensuring that prescription drug Advertising, and Communications, expressed as an increase over its information provided by manufacturers is truthful, balanced, and FY2002 appropriation: FY2003=$2.5 million; FY2004=$4 million; accurate. FY2005=$5.5 million; FY2006=$7.5 million; FY2007= $7.5 million. [Section 522] Generic drugs FDA/CDER's Office of Generic Drugs is responsible for Authorizes the following amounts for the Office of Generic Drugs, reviewing and approving generic product applications. expressed as an increase over its FY2002 appropriation: FY2003=$3 million; FY2004=$6 million; FY2005=$9 million; FY2006=$12 million; FY2007=$15 million. [Section 523] Food Supply Safety and Security Food safety and security strategy. Executive Order 13100 created the President's Council on Food Requires the Council, in consultation with the Secretaries of Safety, headed by the Secretaries of Agriculture and HHS, the Transportation and Treasury, other interested federal agencies, states, EPA Administrator, and the Assistant to the President for Science the food industry, scientific organizations, and consumer and producer and Technology. On January 18, 2001, the Council published a groups to develop a crisis communications and education strategy strategic plan for food safety, which contained recommendations against bioterrorist threats to the food supply. Requires the strategic on making statutory changes to unify federal food safety plan to address threat assessments, technologies and procedures for regulations. securing food processing facilities, modes of transportation of foods, response and notification procedures, and public risk communication plans. Authorizes $750,000 for FY2002, and such sums as may be necessary in each subsequent fiscal year, to implement the strategy. [Section 301] Protection against adulteration of FFDCA Chapter IV prohibits the entry into interstate commerce Amends FFDCA Section 801 to create a new subsection (h): to food. of adulterated or misbranded foods. FDA monitors through authorize the Secretary to increase inspections for the detection of inspections whether food manufacturers adhere to their legal intentional adulteration of imported food; to give high priority to responsibility to produce food that is not defective, unsafe, filthy, improving FDA's food import information management systems; to or produced under unsanitary conditions. FFDCA Section 801 improve linkages with other federal regulatory agencies, states and gives general authority to the Secretary to sample and regulate Indian tribes (under the Indian Self-Determination and Education imported products. Assistance Act) that share responsibility for food safety; to fund research on improved testing and sampling methods to rapidly detect intentionally adulterated food at ports of entry; to coordinate with the heads of CDC, NIH, EPA and USDA on the research; and to provide an annual report to Congress on the research findings. Requires the CRS-20 Topic Preexisting Law P.L. 107-188 Secretary, acting through FDA and not later than 6 months after enactment, to complete an assessment of threats to food posed by intentional adulteration and report to Congress. Authorizes a total of $100 million for FY2002, and such sums as are necessary for FY2003­FY2006, to carry out these activities. [Section 302] Administrative detention FFDCA Section 304 allows for the seizure of food in interstate Amends FFDCA Section 304 to add a new subsection (h) to authorize commerce under restricted circumstances. FFDCA Section 301 the detention of food for 20 days, and if needed for 30 days and to lists prohibited acts; Section 801 is the general authority for institute an action if an officer or qualified employee of FDA has regulating imports and exports. credible evidence (and the Secretary or Secretary's designee approves) showing the food presents a threat of serious adverse health consequences or death to humans or animals, with expedited procedures for perishable foods. A detained food may be placed in a secure facility, may be marked or labeled as detained, and cannot be transferred out of detention unless it is released by the Secretary or the detention period expires, whichever occurs first. The person responsible for the detained food can appeal the decision to the Secretary. After an appeal is filed, within 5 days the Secretary must provide for an informal hearing to confirm or end the detention order. If the Secretary fails to act, the detention is terminated. An appeal is also terminated if the district court files an injunction or restraining order on the food. Amends FFDCA Section 301 prohibiting the removal of a detained product or any mark or label identifying the product as detained. Amends FFDCA Section 801to authorize an FDA officer or qualified employee to request the Treasury Secretary to temporarily hold imported food at a port for 24 hours, if FDA has credible evidence indicating that the food presents a threat of serious adverse health consequences or death to humans or animals, and the FDA official is unable to inspect, examine, or investigate the import to determine whether to detain the food. If necessary, the Treasury Secretary may remove the food to a secure facility from where it will not be delivered pursuant to the execution of a bond. Requires that the Secretary notify the state in which the involved port is located. [Section 303] Debarment for repeated or serious FFDCA Section 306 gives the Secretary authority to debar, Amends FFDCA Section 306 to debar from importing foods any person food import violations. temporarily deny approval, or suspend the rights of individuals who is convicted of a felony related to the importation of food or who who have been convicted of a felony to submit an application for repeatedly imports, or knows, or should have known, that the imported approval of a drug. food was adulterated. Requires food imported by a debarred person to be refused admission and held in a secure facility, as appropriate, unless a non-debarred person establishes that the food complies with the requirements of the FFDCA, as determined by the Secretary. Imported food that is refused admission may not be delivered pursuant to the CRS-21 Topic Preexisting Law P.L. 107-188 execution of a bond under Section 801(b). Amends FFDCA Section 301 prohibiting the importing of a food by a debarred person. Amends FFDCA Section 801 to include in the definition of "adulterated food" any food imported by debarred persons as a prohibited act under Section 301. The prohibited act is not intended to include an innocent purchaser who did not know of the importer's debarred status. Authorizes the Secretary to terminate the debarment of companies or persons. [Section 304] Registration of food facilities. Currently, only states have records of food processing, packing Creates a new Section 415 in the FFDCA requiring all facilities, and holding facilities. The federal government must ask the states domestic and foreign, that manufacture, process, and handle food to for this information. register with the Secretary on a one-time basis and give timely updates of all the identities (trade names) under which business is conducted, names and addresses of the facilities, and general food categories (as identified in 21 C.F.R. 170.3). Foreign registrants must name a U.S. agent. Requires the Secretary to give each facility a number and the failure of a facility to register is a prohibited act under FFDCA Section 301. Protect the list of registrants from disclosure under the Freedom of Information Act. Exempts restaurants, certain retail stores, nonprofit food establishments, fishing vessels, and farms from registration requirements. Registration does not imply a license. Amends 801 to prohibit foods from being imported from unregistered foreign facilities. Adds that the Secretary may provide for and encourage the use of electronic submissions to register as long as there are authorization protocols used to identify the registrant and validate the data. Requires the Secretary within 18 months to promulgate regulations for facilities to register. If the final regulations had not become effective after 18 months, the requirements for registration will be self-executing. [Section 305] Maintenance and inspection of FDCA Section 701(a) authorizes FDA to promulgate regulations Adds a new Section 414 to the FFDCA allowing the Secretary to inspect records for foods to enforce the Act. FFDCA Section 704 authorizes FDA to records, if a food is believed to be adulterated and presents a threat of conduct factory inspections. Currently, FDA inspectors have serious adverse health consequences or death to humans or animals. access to company records but can only request access to copy, Inspectors must present credentials and written notice in a reasonable and verify records for restricted medical devices, prescription manner to access and copy all records related to the food to help the drugs, not for foods. Inspectors may not require that records be Secretary decide if the food is a threat to health. Excludes restaurants kept nor do officials have authority to copy records found during and farms. The Secretary is to consider the size of a business in inspections. promulgating regulations. Requires records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to be kept no longer than 2 years. The Secretary will use the records to identify the immediate previous sources and immediate subsequent recipients of food. including its packaging. Excludes records on USDA-regulated foods (meat, poultry, and egg products). CRS-22 Topic Preexisting Law P.L. 107-188 Requires procedures to protect trade secrets or confidential information. Inspection of records does not extend to recipes for food, or financial, pricing, personnel, research, or sales data (other than shipment data regarding sales). Amends FFDCA Section 704(a) to add a clause to allow the inspection of all records and other information described in the new Section 414. Requires final record keeping rules to be issued within 18 months. [Section 306] Prior notice of imported food Under FFDCA Section 801, a food that (i) is found to be Adds a new section 801(m)(1) to the FFDCA to require the Secretary, shipments manufactured, processed, or packed under unsanitary conditions, after consultation with the Secretary of the Treasury, to promulgate (ii) is forbidden or restricted in the producing country or from regulations, not later than 18 months after enactment, requiring that the where it was exported, or (iii) is adulterated or misbranded at the importer give notice that a food will be presented for import. Requires border, can have its admission deferred while the food is that the notice include the following: a description of the food; the reconditioned, relabeled or destroyed. identity of the manufacturer and shipper and, if possible, the grower; the country of origin of the food; the country from which the article is shipped; and the anticipated U.S. port of entry. Requires the Secretary to establish by regulation the period of time for prior notice, that must be no less than the minimum amount of time necessary for the Secretary to receive, review, and respond to the notice, but that may not exceed 5 days. In developing these regulations, the Secretary should consider the effect on commerce, locations of U.S. ports, the transport modes, the types of food, and other such considerations. Requires that food without a notice be held at the port of entry until such notice is delivered to the Secretary and found to be in order. Food so held may not be delivered pursuant to the execution of a bond under Section 801(b) and may be taken to a secure facility, as appropriate. During this period, the Secretary will decide if there is evidence or information on whether the food presents a threat to health. All USDA-regulated foods (i.e., meat, poultry, and egg products) are exempt from this section. Amends Section 301 prohibiting imports of food without prior notice. If the final rules are not effective within 18 months, the requirement for an import notice is self executing and will take effect so that notice must be given not less than 8 hours nor more than 5 days when a food is be offered for import. [Section 307] CRS-23 Topic Preexisting Law P.L. 107-188 Authority to mark articles refused FFDCA Section 403 defines misbranded foods as food whose Amends Sections 403 and 801(a) definitions of misbranded food to admission into the United States. labeling or advertising is false or misleading. Section 801(a) include food that has been refused admission to the United States and gives the Secretary the general authority to refuse imports deemed not destroyed, and which presents a threat of serious adverse health adulterated or misbranded. consequences or death, unless the packaging is clearly and conspicuously labeled United States: Refused Entry at the expense of the food's owner until the food is brought into compliance. If there is an adverse health threat, the Secretary must notify the owner or consignee that the food presents a threat. Nothing in this section limits the Secretaries of HHS or Treasury to require marketing the refused articles under any other provision of law. [Section 308] Prohibition against port shopping FFDCA Section 402 defines "adulterated" food as any food that Amends FFDCA Section 402 to require that an importer offering food bears or contains any poisonous or deleterious substance which that has been refused admission prove at his own expense that the food may render it injurious to health. is in compliance with the applicable requirements of the Act. [Section 309] Notices to states regarding imported No statutory provisions. Amends Chapter IX of the FFDCA to add a new Section 908 to require food that the Secretary notify the states that hold or will hold imported food, and the states where the manufacturer, packer, or distributor of the imported food is located, when there is credible evidence that it presents a threat of serious adverse health consequences or death to humans or animals. Requires the Secretary to request that states take appropriate action to protect the public health. [Section 310] Grants to states for inspections FFDCA Section 702 states that the Secretary is authorized to Amends Chapter IX of the FFDCA to add a new Section 909 conduct food inspections (examinations and investigations) authorizing the Secretary to make grant to states for increased food through officers and employees of HHS, or any health, food, or safety inspection, examinations, and investigations under Section 702, drug officer of a state that has been duly commissioned by the and to cover the costs of taking appropriate actions to protect the public Secretary as an officer of the Department. health as required under Section 908. Authorizes $10 million for FY2002, and such sums as may be necessary for FY2003­FY2006. [Section 311] Surveillance and information grants FoodNet, established in 1995 by USDA and FDA, tracks the Amends PHS Act Title III, Part B to create a new Section 317R to and authorities incidence of illnesses caused by nine pathogens in nine authorize $19.5 million for FY2002, and such sums as may be necessary geographic areas across the United States. PulseNet compares for FY2003­FY2006, in grants to states, and Indian tribes to expand the genetic patterns of bacteria isolated from patients with foodborne number participating in FoodNet and PulseNet and other surveillance illness and/or contaminated food. networks and to maintain technical and laboratory capacity needed for such participation. [Section 312] Surveillance of zoonotic diseases. CDC has more than 20 surveillance programs that monitor Requires the Secretary to coordinate surveillance of zoonotic diseases outbreaks of food borne illness caused by specific pathogens. (i.e., animal diseases communicable to man) through FDA, CDC, and USDA. [Section 313] CRS-24 Topic Preexisting Law P.L. 107-188 Authority to commission other FFDCA Section 702 states that the Secretary is authorized to Amends FFDCA Section 702 to authorize the Secretary to commission federal officials to conduct conduct food inspections (examinations and investigations) other federal officials to conduct inspections, examinations, and inspections. through officers and employees of HHS, or any health, food, or investigations, pursuant to a memorandum of understanding (MOU) drug officer of a state that has been duly commissioned by the between the Secretary and the head of the agency to which the other Secretary as an officer of the Department. officials belong. Inspections can take place only at facilities or other locations that are jointly regulated by HHS and the other agency. Requires the Secretary and the other agency head to report to Congress on the number of persons that carried out activities under the MOU, and the number of additional investigations and foods inspected or examined as a result of the MOU. [Section 314] Rule of construction. USDA regulates meat under the Federal Meat Inspection Act (21 Prohibits FDA from regulating any food under USDA's jurisdiction. U.S.C. 601 et seq.), poultry under the Poultry Products Inspection [Section 315] Act (21 U.S.C. 451 et seq.), and processed egg products under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.). Agricultural Security USDA activities USDA's Food Safety and Inspection Service (FSIS) inspects meat, Authorizes $15 million for FY2002, and such sums as may be necessary poultry, and processed egg products sold for human consumption for each subsequent fiscal year, for enhanced FSIS inspections for safety, wholesomeness, and proper labeling. The Animal and domestically and internationally and collaboration with other federal Plant Inspection Service (APHIS) inspects cargo and passengers agencies. Authorizes $30 million for FY2002, and such sums as may at U.S. ports for animal and plant pests, quarantines some of these be necessary for each subsequent fiscal year, for APHIS for increased products, and responds to animal disease outbreaks. The inspections, cooperative agreements with state and private veterinarians, Agricultural Research Service (ARS) conducts research on animal and an automated, integrated, interagency emergency warning, diseases and food safety to support other USDA regulatory response, and record-keeping system. Authorizes $180 million for responsibilities. FY2002, and such sums as may be necessary for FY2003­FY2006, to upgrade biosecurity at ARS labs in New York and Iowa. Authorizes the appropriation of such sums as necessary for: (i) grants not exceeding $50,000 to land grant colleges of agriculture for reviewing security standards and practices; and (ii) grants not exceeding $100,000 to agricultural producer groups to develop and implement on-farm biosecurity education programs. Authorizes $190 million for FY2002, and such sums as may be necessary in subsequent years, to support ARS and federal-state cooperative research on bioterrorism prevention, preparedness, and response; to strengthen coordination with U.S. intelligence agencies; and to develop an early warning surveillance system for agricultural bioterrorism. Establishes civil fines and criminal penalties for acts of terrorism against animal enterprises. [Sections 331­336] CRS-25 Topic Preexisting Law P.L. 107-188 Drinking Water Security and Safety Vulnerability assessments and PHS Act Title XIV, the Safe Drinking Water Act (SDWA), Adds a new Section 1433 to the SDWA to require each community emergency response plans authorizes federal regulation of public water systems, particularly water system serving 3,300 or more individuals to conduct a through a program that regulates contaminants in public water vulnerability assessment. Requires EPA, not later than August 1, 2002, supplies. The Act defines a community water system as a public to provide information to these systems concerning probable threats. water system that serves at least 15 service connections used by Establishes deadlines for community water systems to certify to EPA year-round residents or that regularly serves at least 25 year-round that they have conducted vulnerability assessments and to submit to residents. The SDWA is administered and enforced by the EPA a copy of the assessment. Certifications and submissions must be Environmental Protection Agency (EPA). made before March 31, 2003, by systems serving 100,000+ persons; December 31, 2003, by systems serving 50,000­99,999 persons; and June 30, 2004, by systems serving 3,300­49,999 persons. Exempts assessments from disclosure under the Freedom of Information Act and requires EPA to develop protocols to protect the assessments from unauthorized disclosure. Provides that any individual designated by the Administrator who acquires assessments or information from them and who knowingly or recklessly reveals such information to unauthorized individuals shall be subject to up to 1 year imprisonment or a fine, unless the information is revealed for specified purposes. Requires each community water system serving 3,300+ individuals to prepare or revise an emergency response plan incorporating the results of the vulnerability assessment. Systems must certify to EPA, within 6 months of completing an assessment, that they have completed response plans, and each system must keep a copy of its plan for 5 years. Directs EPA to provide guidance to community water systems serving fewer than 3,300 individuals on how to conduct vulnerability assessments, prepare emergency response plans, and address threats. Authorizes $160 million for FY2002, and such sums as may be necessary for FY2003­FY2005, to provide financial assistance to community water systems to conduct assessments and prepare response plans, and to address basic security enhancements and significant threats. Security enhancements may include purchase and installation of intruder detection equipment and lighting, enhancing security of automated systems, personnel training and security screening. Authorizes EPA to use not more than $5 million of the funds to make grants to community water systems to assist in responding to and alleviating any vulnerability to an attack or intentional act, which the Administrator determines to present an immediate and urgent security need. Further authorizes EPA to use not more than $5 million of the funds made available to make grants to community water systems serving fewer than 3,300 persons for activities and projects undertaken in accordance with the guidance for small systems that EPA must provide. [Section 401] CRS-26 Topic Preexisting Law P.L. 107-188 Contaminant prevention, detection, No statutory provisions. Adds a new Section 1434 to the SDWA directing the EPA and response Administrator, in consultation with CDC, and after consultation with other federal departments and state and local governments, to review (directly or through contracts or cooperative agreements) current and future methods to prevent, detect and respond to the intentional introduction of chemical, biological or radiological contaminants into community water systems and their source waters. The review must cover methods, means and equipment, including real time monitoring systems, for monitoring and detecting levels of contaminants; methods for providing sufficient notice to water system operators and those served by the system of the introduction of contaminants; methods, means and equipment for preventing the flow of contaminated water to people served by a system and for mitigating adverse effects on public health; methods and means for developing educational and awareness programs for water systems; and biomedical research on the public health impact of various contaminants that may be used in attacks on water systems. Funding is authorized under Section 1435. [Section 402] Supply disruption: prevention, No statutory provisions. Adds a new Section 1435 to the SDWA directing the EPA detection and response Administrator, in coordination with appropriate federal departments and agencies, to review methods and means by which terrorists or others could disrupt the drinking water supply or render it unsafe. This review must include a review of methods and means by which water systems could be destroyed, impaired, or made subject to cross-contamination, or by which information systems, including process controls, supervisory control and data acquisition (SCADA) and computer systems could be disrupted. EPA must also review methods and means by which systems could be reasonably protected from attacks, and by which alternative drinking water supplies could be provided if a water system was destroyed, impaired or contaminated. Requires EPA to ensure that these reviews reflect the needs of water systems of various sizes and geographic locations; EPA may consider the vulnerability of a specific region or service area, including the National Capital area. Directs EPA to share, as appropriate, the information developed under this section and Section 1434 with community water systems through the Information Sharing and Analysis Center (ISAC). Authorizes $15 million for FY2002, and such sums as may be necessary for FY2003­FY2005 to carry out Sections 1434 and 1435. [Section 402] Enforceable requirements SDWA Section 1414(i)(1) identifies the sections of SDWA for Amends SDWA Section 1414(i)(1) to include a new Section 1433 which the Act's enforcement authorities apply. requiring community water systems to conduct vulnerability assessments and to prepare emergency response plans, as an applicable and enforceable requirement under the Act. [Section 403] CRS-27 Topic Preexisting Law P.L. 107-188 Emergency powers SDWA Section 1431 grants the EPA Administrator emergency Amends SDWA Section 1431 to specify that EPA's emergency powers powers to take such actions as deemed necessary to protect include the authority to act when there is a threatened or potential persons served by a public water system upon receipt of terrorist attack or other intentional act to disrupt the provision of safe information that a contaminant that is present in, or is likely to drinking water or to impact the safety of a community's drinking water enter, a public water system or an underground source of drinking supply. [Section 403] water may present an imminent and substantial endangerment to health of those persons. Penalties for tampering with public SDWA Section 1432 authorizes criminal and civil penalties for Amends SDWA Section 1432 to increase criminal and civil penalties water systems persons who tamper, attempt to tamper, or threaten to tamper with for tampering, attempting to tamper, or making threats to tamper with public water supplies. Provides that any person who tampers with public water supplies. The maximum prison sentence for tampering is a public water system shall be imprisoned for not more than 5 increased from 5 to 20 years. The maximum prison sentence for years, or fined, or both. Any person who attempts to tamper, or attempting to tamper, or making threats to tamper, is increased from 3 threatens to tamper, with a system shall be imprisoned for not to 10 years. The maximum fine that may be imposed for tampering is more than 3 years. Provides that EPA may bring a civil action and increased from $50,000 to $1 million. The maximum fine for that the appropriate federal court may impose a penalty of not attempting to tamper, or threatening to tamper, is increased from more than $50,000 for tampering or not more than $20,000 for $20,000 to $100,000. [Section 403] such attempt or threat. Technical assistance SDWA Section 1442(b) authorizes EPA to provide technical Amends SDWA Section 1442(d) to authorize appropriations to carry assistance and to make grants to states and public water systems out Section 1442(b) of not more than $35 million for FY2002, and such to assist in responding to and alleviating emergency situations. sums as may be necessary for each fiscal year thereafter. [Section 403] Reauthorization of the Prescription Drug User Fee Act (FFDCA Sections 735­736) Types of fees FFDCA Section 736(a) authorizes the Secretary to assess and Amends FFDCA Section 736(a) by requiring the annual establishment collect three types of fees. First, a human drug application and and product fees to be paid by October 1. Reduces by 50% the supplement fee is due upon submission of the application or application and supplement fee for applications that contain no clinical supplement. The Secretary may refund 75% of the fee if the data to review, and for filing a supplement. Eliminates the waiver for application is not accepted. In the event the application is supplements for pediatric indications. Clarifies that the sponsor of the withdrawn after being filed, the Secretary may refund the fee or drug application is responsible for paying the annual product fee. a portion of the fee if no substantial work was performed on it. Exempts from the product fee those products that are listed in the The fee is waived for orphan drug applications and for "Orange Book" with a potency described in terms of per 100mL, or supplements to drug applications that propose a new use for which are the same as another approved products. [Section 504(a)] children. Second, annual establishment fees are assessed on each manufacturer of an approved drug for each fiscal year that an establishment manufactures the drug. Third, annual product fees are assessed on certain drugs registered under the FFDCA. Both establishment and product fees are due on Jan. 31 of each year. CRS-28 Topic Preexisting Law P.L. 107-188 Fee amounts Under FFDCA Section 736(b), the application fee shall be Amends FFDCA Section 736(b) by substituting a table setting out $250,704 in FY1998, $256,338 in FY1999 and in FY2000, application/supplement, establishment, and product fee revenue, and $267,606 in FY2001, and $258,451 in FY2002. The fee for an total fee revenue, for FY2003 through FY2007. If subsequent application that contains no clinical data to review, or for filing a legislation requires the Secretary to fund the additional costs of supplement, is 50% of the application fee. Total establishment fee retirement of federal personnel, fee revenue amounts may be increased revenues shall be $35.6 million in FY1998, $36.4 million in to fully fund the portion of the added costs attributable to the process of FY1999 and in FY2000, $38 million in FY2001, and $36.7 review of drug applications. [Section 504(b)] million in FY2002. Total product fee revenues must equal the total establishment fee revenues. Fee adjustments FFDCA Section 736(c) requires the Secretary each fiscal year to Amends FFDCA Section 736(c) as follows: (i) requires the inflation adjust fees and total fee revenues for inflation using either the adjustment to use the CPI for the 12-month period ending June 30 of the average urban Consumer Price Index (CPI) or the increase in the year preceding the fiscal year for which the fees are being established civil service base pay for federal employees in Washington DC, or the civil service base pay as stated in the current law, whichever is whichever is greater. Each year's adjustment is added on a greater; (ii) beginning in FY2004, creates a new workload adjustment compounded basis to the sum of all the adjustments made for prior (in addition to the inflation adjustment) to reflect changes in review fiscal years. Requires the Secretary to adjust the annual workload; (iii) creates a new final year adjustment that permits the establishment and product fees to ensure that the total amount FDA, if necessary, to make a one-time fee increase in FY2007 to ensure collected equals that collected from application/supplement fees. that the agency has enough funds to operate for up to 3 months in Total fees collected for a fiscal year, as adjusted, may not exceed FY2008 if there is a delay in reauthorizing PDUFA at the end of the total costs of reviewing drug applications for that year. FY2007; and (iv) requires that the application/supplement, establishment, and product fees be established 60 days before the start of the fiscal year, based on the revenue amounts set out in Section 736(b) and the adjustments enumerated above. [Section 504(c)] Fee waiver or reduction FFDCA Section 736(d) permits the Secretary to reduce or waive Amends FFDCA Section 736(d) by eliminating the waiver for brand- one or more fees to protect public health or to remove barriers to name drug manufacturers that claim the fee would put them at an innovation. Brand-name drug makers may seek a waiver if the fee economic disadvantage relative to generic drug producers. [Section would put them at an economic disadvantage relative to a generic 504(d)] drug manufacturer. The Secretary may also waive the application fee for first-time drug applications from small businesses with fewer than 500 employees. Assessment of fees Under FFDCA Section 736(f), fees may only be assessed for a Changes the title of Section 736(f) but leaves the trigger as is. [Section fiscal year if the FDA's annual appropriation for salaries and 504(e)] expenses for that year is equal to or greater than its FY1997 appropriation, multiplied by whichever inflation adjustment factor is applicable for the fiscal year in question. This "trigger" ensures that PDUFA fees are not a substitute for the agency's annual appropriations. CRS-29 Topic Preexisting Law P.L. 107-188 Crediting and availability of fees FFDCA Section 736(g) permits FDA to transfer collected fees to Amends FFDCA Section 736(g) by providing FDA a 5% margin of its salaries and expenses account, without fiscal year limitation, to error for meeting the requirements of the second trigger. The intent of be used solely for reviewing drug applications. Fees must be this modification is to relieve FDA of the need to overspend each year, collected in an amount equal to that specified in the annual which the agency has done consistently to ensure that its expenditures appropriations act and may only be collected and available to do not fall below the trigger amount and cause it to lose the authority to defray the increase in application review costs over the costs for collect fees. such activities in FY1997, adjusted for inflation. This second "trigger" is intended to ensure that PDUFA fees are used to Authorizes the following appropriations for fees: $222.9 million for accelerate the drug application review process and not substitute FY2003; $231million for FY2004; $252 million for FY2005; $259.3 for "normal level" expenses. million for FY2006; and $259.3 million for FY2007, adjusting as specified above. [Section 504(f)] Authorizes the following appropriations for fees: $106.8 million for FY1997; $109.2 million for FY1999 and for FY2000; $114 million for FY2001; and $110.1 million for FY2002, adjusting as specified above. Collected fees that exceed the authorized amount must be subtracted from the amount of fees authorized to be collected in the subsequent fiscal year. Accountability and reports The Food and Drug Administration Modernization Act of 1997 Requires the Secretary to consult with Congress and interested public (FDAMA; P.L. 105-115, Section 104) required the Secretary to and private stakeholders in developing recommendations for the next provide Congress with an annual performance report and an PDUFA reauthorization. Requires the Secretary to publish the annual fiscal report. recommendations in the Federal Register for public comment. Requires the Secretary to provide Congress with an annual performance report and an annual fiscal report [Section 505] Reports of postmarketing studies FFDCA Section 506B establishes annual reporting requirements Amends FFDCA Section 506B to require the Secretary, in the event a for drug sponsors who enter into agreements with the Secretary to sponsor fails to complete an agreed upon study, to post a statement on conduct a postmarketing study. the FDA's Web site to that effect. Give the Secretary the authority to require sponsors who fail to complete studies of fast-track drugs and biological products for serious and life-threatening illnesses to notify health care practitioners of the sponsor's failure to complete the study and of unanswered questions relating to the clinical benefits and safety of the product. [Section 506] Effective date and sunset FDAMA Sections 106­107 reauthorized PDUFA from October 1, The amendments made by this subtitle take effect on October 1, 2002, 1997 through September 30, 2002, with required annual reports and sunset on September 30, 2007. The annual reporting requirements due no later than 120 days thereafter. of Section 505 remain effective for an additional 120 days. [Sections 508­509] CRS-30 Topic Preexisting Law P.L. 107-188 Miscellaneous Provisions Digital television Section 201 of the Telecommunications Act of 1996 (P.L. 104- Requires the FCC to allot a digital channel to any requesting full-power 104) provided that digital television licenses issued by the Federal television station that had an application pending for an analog Communications Commission (FCC) should be limited to existing television station construction permit as of October 24, 1991, and which broadcasters. On April 3, 1997, the FCC allotted digital television had its application granted after April 3, 1997. Any station receiving spectrum to all eligible broadcasters existing at that time. digital spectrum under this provision is required to complete construction of its digital facility within 18 months, without the possibility of an extension. Stations are also prohibited from operating an analog signal on their designated digital channel. [Section 531] Medicare + Choice Section 1853 of the Social Security Act (SSA) requires the Moves the CMS annual announcement of M+C payment rates from no Centers for Medicare and Medicaid Services (CMS) to announce later than March 1 to no later than the second Monday in May, effective the annual Medicare + Choice (M+C) payment rates on March 1 only in 2003 and 2004. Moves the deadline for plans to submit of each year that will be applicable on January 1 of the following information about ACRs, M+C premiums, cost sharing, and additional year. Section 1854 requires that each M+C organization must benefits (if any) from no later than July 1 to no later than the second submit to the Secretary for approval, for each of its M+C plans, Monday in September in 2002, 2003, and 2004. Changes the annual specific information about the adjusted community rate (ACR), coordinated election period from the month of November to November M+C premiums, cost sharing, and additional benefits (if any) no 15 ­ December 31 in 2002, 2003, and 2004. later than July 1 of each year, also for the following year. Section 1851 permits individuals to make and change election to Allows Medicare beneficiaries to make and change election to an M+C an M+C plan on an ongoing basis. Beginning in 2002, elections plan on an ongoing basis through 2004. Beginning in 2005, individuals and changes to elections are available on a more limited basis. would only be able to make changes on the more limited basis, Individuals can make or change elections each November, during originally scheduled to be phased in beginning in 2002. [Section 532] the annual coordinated election period. Current Medicare beneficiaries may also change their election at any time during the first 6 months of 2002 (or first 3 months of any subsequent year). Special enrollment rules apply to newly eligible aged beneficiaries. Special enrollment periods apply to enrollees under limited situations, such as a change in place of residence. CRS-31 Appendix A. Bioterrorism-Related Hearings 107th Congress Senate Appropriations Subcommittee on Labor, HHS, and Education October 3, 2001 Bioterrorism: Public health preparedness and response October 23, 2001 Public health response to anthrax attack November 2, 2001 Smallpox: Public health preparedness and response November 29, 2001 Funding for bioterrorism preparedness Senate Appropriations Subcommittee on VA-HUD and Independent Agencies November 28, 2001 Anthrax decontamination Senate Armed Services Subcommittee on Emerging Threats and Capabilities October 25, 2001 Bioterrorism and the Dark Winter exercise Senate Commerce, Science and Transportation Committee February 5, 2002 Bioterrorism: Countermeasures R&D (Subcommittee on Science, Technology, and Space) Senate Environment and Public Works Committee December 4, 2001 Anthrax decontamination Senate Foreign Relations Committee September 5, 2001 Bioterrorism threat and the spread of infectious diseases Senate Governmental Affairs Committee July 23, 2001 Bioterrorism: FEMA's role and public health preparedness (Subcommittee on National Security, Proliferation and Federal Services) October 17, 2001 Bioterrorism: Federal agency preparedness October 30-31, 2001 Anthrax in the mail: Protecting postal workers and the public April 18, 2002 Public health preparedness CRS-32 Senate Health, Education, Labor, and Pensions Committee September 26, 2001 Psychological trauma of terrorism October 9, 2001 Bioterrorism: Public health preparedness and response November 2, 2001 Kids and terrorism (Subcommittee on Children and Families) Senate Judiciary Committee November 6, 2001 Law enforcement and the domestic bioterrorism threat (Subcommittee on Technology, Terrorism and Government Information) House Appropriations Subcommittee on Labor, HHS, and Education May 1, 2002 HHS bioterrorism preparedness House Energy and Commerce Committee October 10, 2001 Bioterrorism preparedness and response (Subcommittee on Oversight and Investigations) November 1, 2001 Public health early-warning surveillance systems (Subcommittee on Oversight and Investigations) November 7, 2001 Physical security and NIH and CDC facilities (Subcommittee on Oversight and Investigations) November 15, 2001 Bioterrorism: Public health preparedness and response House Government Reform Committee May 1, 2001 Management of medical stockpiles (Subcommittee on National Security, Veterans Affairs and International Relations) July 23, 2001 Federal response to a bioterrorism attack: Dark Winter (Subcommittee on National Security, Veterans Affairs and International Relations) October 5, 2001 Bioterrorism: Federal, state, and local preparedness (Subcommittee on Government Efficiency, Financial Management and Intergovernmental Relations) October 12, 2001 Assessing the threat of bioterrorism (Subcommittee on National Security, Veterans Affairs and International Relations) October 23, 2001 Vaccine research and development (Subcommittee on National Security, Veterans Affairs and International Relations) October 30, 2001 Anthrax and postal worker safety CRS-33 November 7, 2001 DOD medical readiness for chemical and biological warfare (Subcommittee on National Security, Veterans Affairs and International Relations) November 14, 2001 Medical care for bioterrorism victims November 29, 2001 Risk communication: National security and public health (Subcommittee on National Security, Veterans Affairs and International Relations) December 14, 2001 Bioterrorism response: Information sharing between local, state, and federal governments (Subcommittee on Technology and Procurement Policy) February 28, 2002 Anthrax antitoxin research March 1, 2002 Federal, state, and local response to biological and chemical attack (Subcommittee on Government Efficiency, Financial Management and Intergovernmental Relations) March 21, 2002 Combating terrorism (Subcommittee on National Security, Veterans Affairs and International Relations) House International Relations Committee December 5, 2001 Bioterrorism and potential sources of anthrax House Science Committee November 8, 2001 Anthrax decontamination December 5, 2001 Bioterrorism: Federal preparedness and response House Veterans' Affairs Committee April 10, 2002 Bioterrorism legislation (H.R. 3253, H.R. 3254) CRS-34 Appendix B. Bioterrorism-Related Web Sites Department of Health and Human Services Information on public health preparedness [http://www.hhs.gov/hottopics/healing] DHHS Office of Emergency Preparedness [http://www.oep.dhhs.gov] DHHS Office of Public Health Preparedness [http://www.hhs.gov/ophp] Metropolitan Medical Response Systems [http://www.mmrs.hhs.gov] National Pharmaceutical Stockpile Program [http://www.cdc.gov/nceh/nps/default.htm] Centers for Disease Control and Prevention [http://www.bt.cdc.gov] Health Resources and Services Admin. [http://www.hrsa.gov/bioterrorism.htm] Food and Drug Administration [http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html] National Institutes of Health [http://www.niaid.nih.gov/publications/bioterrorism.htm] National Library of Medicine [http://www.nlm.nih.gov/medlineplus/biologicalandchemicalweapons.html] Department of Defense U.S. Army Medical Research Institute of Infectious Diseases [http://www.usamriid.army.mil] DOD Anthrax Vaccine Immunization Program [http://www.anthrax.osd.mil] Nuclear, Biological, Chemical Medical Reference Site [http://www.nbc-med.org/others] State and Local Health Departments Many health departments have included information on bioterrorism and public health preparedness on their Web sites. For links to state and local health departments, go to [http://www.apha.org/state_local/afflinks.htm]. Professional Associations American College of Emergency Physicians [http://www.acep.org/1,4634,0.html] American College of Physicians [http://www.acponline.org/bioterro] American Hospital Association [http://www.hospitalconnect.com/aha/key_issues/disaster_readiness/index.html] CRS-35 American Medical Association [http://www.ama-assn.org/ama/pub/category/6671.html] American Society for Microbiology [http://www.asmusa.org/pasrc/bioprep.htm] Association for Professionals in Infection Control and Epidemiology [http://www.apic.org/bioterror] Association of State and Territorial Health Officials [http://www.astho.org] Council of State and Territorial Epidemiologists [http://www.cste.org] Federation of American Scientists, Chemical & Biological Arms Control Program [http://fas.org/bwc/index.html] Nat. Assoc. of County & City Health Officials [http://www.naccho.org/files/documents/responds_to_bioterrorism.html] Academic Resources Johns Hopkins Center for Civilian Biodefense Studies [http://www.hopkins-biodefense.org] The Henry L. Stimson Center [http://www.stimson.org/cbw] Monterey Institute of International Studies [http://www.cns.miis.edu] Chemical and Biological Arms Control Institute [http://www.cbaci.org] UCLA Center for Public Health and Disaster Relief [http://www.ph.ucla.edu/cphdr] University of Minnesota Center for Infectious Disease Research and Policy [http://www1.umn.edu/cidrap] St. Louis University Center for the Study of Bioterrorism and Emerging Infections [http://bioterrorism.slu.edu] Columbia University Center for Public Health Preparedness [http://cpmcnet.columbia.edu/dept/sph/CPHP/index.html] University of North Carolina Center for Public Health Preparedness [http://www.sph.unc.edu/bioterrorism] ------------------------------------------------------------------------------ For other versions of this document, see http://wikileaks.org/wiki/CRS-RL31263