The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to Preexisting Law
Released: 2007-03-12T00:00:00

Introduction

On December 19, 2006, President George W. Bush signed S. 3678 , the Pandemic and All-Hazards Preparedness Act ( P.L. 109-417 ), which authorizes appropriations through FY2011 to improve bioterrorism and other public health emergency preparedness and response activities, and establishes the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS) for the advanced research and development of medical countermeasures.

The Pandemic and All-Hazards Preparedness Act effected the second comprehensive reauthorization of federal programs designed to improve the nation's readiness for public health threats such as bioterrorism or pandemic influenza. Many of these authorities, found principally in the Public Health Service Act and implemented by the Secretary of Health and Human Services (HHS), were first explicitly authorized in 2000 ( P.L. 106-505 ), amid growing concerns about global terrorist activity and emerging infectious diseases. Congress reviewed, extended and expanded many of these authorities following the terrorist attacks of 2001 ( P.L. 107-188 ). The anthrax attacks, in particular, had put a harsh spotlight on a public health system that was poorly coordinated and otherwise unfit for 21 st century challenges.

As the 109 th Congress began its consideration of the Pandemic and All-Hazards Preparedness Act in 2005, Hurricane Katrina slammed into the Gulf Coast, while a new strain of avian flu, on a steady march across Europe and Asia, threatened a global pandemic. In this context, Members of Congress considered the challenges of bolstering a public health system that is based largely in state authority, and a healthcare system that is largely in private hands. Congress grappled, on the federal level, with integrating the new Department of Homeland Security (DHS) into the nation's preparedness and response activities. The challenges of building effective, coordinated systems across federal agencies, with state and local governments, with private industry, with citizens, and with foreign nations, were formidable as well.

The 110 th Congress will likely be interested in the implementation of provisions in P.L. 109-417 , and in the continued evolution of relationships between HHS, DHS, the states, and others among whom coordination is essential in a time of heightened concern about national security. Members of the 110 th Congress may wish to consider legislation to address additional expiring public health authorities, such as the Select Agent program to control access to pathogens that could be used for bioterrorism, which expires at the end of FY2007. Congress may also wish to examine certain permanent emergency response and funding authorities of the Secretary of HHS.

This report discusses some key provisions in the Pandemic and All-Hazards Preparedness Act ( P.L. 109-417 ), and provides a history of prior public health and medical preparedness and response legislation. A comparison of provisions in P.L. 109-417 with preexisting law is provided in Table 1 later in this report.

Legislative History

The 109th Congress

In July 2006, Senator Burr introduced S. 3678 , the Pandemic and All-Hazards Preparedness Act. This bill proposed a comprehensive reauthorization of health preparedness and response programs in Title I of P.L. 107-188 , the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In addition, several bills were introduced in the 109 th Congress to enhance Project BioShield, the HHS program to develop and procure specific countermeasures (such as drugs and vaccines for victims of bioterrorism) for the Strategic National Stockpile. These included S. 3 (Gregg), S. 975 (Lieberman), S. 1873 (Burr), S. 1880 (Kennedy), S. 2564 (Burr), and H.R. 5533 (Rogers). The two legislative initiatives proceeded along parallel tracks until December 2006, when BioShield provisions were attached to S. 3678 as a new Title IV, and the amended bill passed in both chambers. The bill was signed by the President on December 19, 2006, and became P.L. 109-417 . Some key provisions of this law are discussed below. A comparison of provisions in P.L. 109-417 with preexisting law is provided in Table 1 later in this report.

One of the most difficult challenges faced by Congress and other policymakers following the 2001 terror attacks was to envision those catastrophic threats for which the nation must be prepared, define the capabilities needed to assure national preparedness, and determine the appropriate federal activities and incentives needed to achieve these goals among federal, state, and local governments, and the private sector. Both of the earlier bioterrorism laws, P.L. 106-505 and P.L. 107-188 , had called on the Secretary of HHS, in collaboration with other stakeholders, to define core national capacities for preparedness and response for public health and medical emergencies. The process has been a challenge. However, recent efforts at DHS, to develop national preparedness goals and target capabilities, have helped to define certain large-scale public health and medical capabilities—such as rapid disease detection, mass prophylaxis, and medical surge—that would be required for an effective response to mass casualty incidents, and that would require a substantial federal coordinating effort. The Pandemic and All-Hazards Preparedness Act would require the Secretary of HHS to prepare a quadrennial National Health Security Strategy and implementation plan, to include preparedness goals for federal, state, and local governments in harmony with national preparedness and response efforts at DHS.

In October 2006, the President signed P.L. 109-295 , the Post-Katrina Emergency Management Reform Act of 2006 (called the "Post-Katrina Act," included in DHS appropriations for FY2007). The act reauthorized and reorganized programs in the Federal Emergency Management Agency (FEMA, in DHS). Among other things, the law also codified the position of Chief Medical Officer (CMO) at DHS, the individual who coordinates all departmental activities regarding medical and public health aspects of disasters. Since the Secretary of DHS serves as the federal lead for a coordinated national response to disasters, including terrorism, Members of Congress were interested in clarifying the relationship between the CMO and the Secretary of HHS in disaster preparedness and response. The Post-Katrina Act provides that the CMO "shall have the primary responsibility within the Department for medical issues related to natural disasters, acts of terrorism, and other man-made disasters." (Emphasis added.) The Pandemic and All-Hazards Preparedness Act provides that "The Secretary of Health and Human Services shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Plan...." (Emphasis added.) Members of Congress will likely be interested in how this statutory division of authority is implemented by the two departments.

The 109 th Congress considered several measures to improve Project BioShield, a program to encourage the development of promising chemical, biological, radiological, or nuclear countermeasures that the private sector might not otherwise develop. The 108 th Congress launched the program in the Project BioShield Act of 2004 ( P.L. 108-276 ), providing $5.6 billion for the program over 10 years. Project BioShield allows the government to guarantee a market for specified amounts of particular countermeasures. Under this program, HHS can solicit bids for specific countermeasures and execute contracts for the delivery of countermeasures at guaranteed prices even if the countermeasure has up to eight more years of development. The government only pays for the countermeasure on delivery. As time has passed with little perceived progress on some major identified countermeasure targets, criticism of this program has mounted. The cancellation of the next-generation anthrax vaccine contract, the largest BioShield contract to date, has highlighted these criticisms.

The 109 th Congress considered several measures to improve Project BioShield results, including S. 3 (Gregg), S. 975 (Lieberman), S. 1873 (Burr), S. 1880 (Kennedy), S. 2564 (Burr), and H.R. 5533 (Rogers). Congress incorporated some of the proposals in these bills into the Pandemic and All-Hazards Preparedness Act, Title IV. This law requires the HHS Secretary to develop and make public a strategic plan to guide HHS research and development and procurement of countermeasures. It also creates the Biodefense Advanced Research and Development Authority (BARDA) in HHS. This office is to help implement the strategic plan, directly support countermeasure advanced development, and facilitate communication between the government and countermeasure developers. This law allows HHS to make milestone-based payments for Project BioShield contracts which do not have to be repaid even if the product is never delivered. It also permits the HHS Secretary to hold meetings and execute specific agreements with multiple potential countermeasure developers that would otherwise violate antitrust laws, contingent on prior approval of the Attorney General and the Chairman of the Federal Trade Commission.

Since FY2002, Congress has provided approximately $7 billion in grants to states to build public health and hospital preparedness for public health threats. Presumably due to national security concerns and other sensitivities, HHS has not published comprehensive or state-specific information regarding states' performance toward meeting the objectives for these grant programs. Congress has been keenly interested in the management of these grants, on topics ranging from the relevance of broad program goals in achieving national preparedness, to the rigor of fiscal accounting mechanisms, to the balance of federal vs. state funding shares, to issues of program transparency. The Pandemic and All-Hazards Preparedness Act extended the programs, adding certain new program elements including federal authority to withhold funds for failure to meet program requirements, a state matching requirement, and a requirement that the Secretary of HHS publish certain information about program activities and performance on a federal Internet website available to the public.

There was considerable discussion in the 109 th Congress regarding whether a medical disaster response could function effectively when the National Disaster Medical System (NDMS), a key federal medical response asset, was based at DHS rather than at HHS. NDMS had been transferred from HHS to DHS in P.L. 107-296 , the Homeland Security Act, effective when the new department was created in 2003. In studying the response to Hurricane Katrina, Congressional and White House investigators found that, among other problems, NDMS deployments were made by FEMA without the knowledge or involvement of personnel at HHS. The Pandemic and All-Hazards Preparedness Act transferred NDMS back to HHS, effective January 1, 2007. (Congress also made this transfer in the Post-Katrina Act. The transfer was supported by the Administration. )

A key to the management of incidents of bioterrorism or emerging infectious disease threats is the ability to detect the incidents early, and to distribute countermeasures to affected populations in time to prevent or cure illness. An element of early detection are the information systems used to report and compare a variety of types of relevant information in a timely manner across jurisdictions. The Pandemic and All-Hazards Preparedness Act requires the Secretary of HHS to establish a national electronic network for sharing of public health surveillance information in near-real time, and authorizes grants to states to establish or operate systems in this network. The act also requires the Secretary to establish a nationwide system to track influenza vaccine that may be used during a pandemic, and to identify ways to expand the use of telehealth capabilities in emergency response. Achieving near-real-time national information systems for disease detection or resource tracking is complicated by the need to develop a common set of data standards to serve multiple purposes. At the same time, the systems must address concerns about the privacy and security of personal health information, as well as commercially sensitive information such as the health status of food-producing animals, or the quantities and distribution pathways of patented medicines.

Authority for health professions programs in Title VII of the Public Health Service Act expired in 2002. These programs, administered by the Health Resources and Services Administration (HRSA), an agency in HHS, are primarily intended to alleviate shortages and maldistributions of healthcare workers. The public health workforce has, in contrast, received little federal attention over the years. The Pandemic and All-Hazards Preparedness Act would authorize a loan repayment demonstration project for individuals who serve in health professional shortage areas or areas at high risk of a public health emergency. S. 506 , the Public Health Preparedness Workforce Development Act of 2005, introduced in the Senate, proposed broader provisions to provide scholarship and loan repayment programs for health professionals who work in government public health agencies. The bill did not advance in the 109 th Congress.

Major Legislation in the 107th and 108th Congresses

Following the terror attacks of 2001, the 107 th Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act ( P.L. 107-188 , signed in June 2002, often called "the Bioterrorism Act") to improve the nation's readiness for bioterrorism, emerging infectious diseases, and other public health threats. A program of grants for state and local public health capacity, administered by the Centers for Disease Control and Prevention (CDC), was reauthorized at $1.08 billion for FY2003, and such sums as may be necessary through FY2006. (The program had previously been authorized at $50 million for FY2001, prior to the terror attacks.) The law stipulated a funding formula, including a base amount plus an amount determined by population, with the intent that every state and territory receive funding for a variety of core public health preparedness activities. Under prior statutory authority (see below), the grants had been competitive.

The Bioterrorism Act also established, for the first time, a program of grants to states to prepare hospitals, clinics and other healthcare facilities for bioterrorism and other mass-casualty events, to be administered by HRSA. Congress authorized $520 million for this program in FY2003, and such sums as may be necessary through FY2006.

The Bioterrorism Act contained a number of other provisions for public health preparedness. Title I of the act included numerous additional provisions for building federal public health capacity, including creation of the position of Assistant Secretary for Public Health Emergency Preparedness (ASPHEP) at HHS, and expansion of security and preparedness activities at CDC. Title I also expanded the program for the Strategic National Stockpile (SNS) of countermeasures to diagnose and treat potential victims of terrorism or other public health emergencies. Title II of the act called on the Secretary of HHS to register laboratories and individuals in possession of Select Agents, those 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. Title III contained several provisions to protect the nation's food and drug supply and enhance agricultural security. Finally, Title IV of the act included 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 Project BioShield Act of 2004 ( P.L. 108-276 , signed in July 2004) created market incentives for the development of drugs, vaccines, biologics, other treatments and tests for biological and chemical agents—collectively called countermeasures —that would not otherwise be attractive to entrepreneurs. In addition, budget authority for the SNS was transferred from DHS back to HHS in the act, though both the Secretaries of HHS and of DHS retain authority to deploy SNS assets in an emergency. CDC continues to provide administrative management of the SNS, as it always has.

In creating the new Department of Homeland Security, the 107 th Congress considered a variety of public health preparedness programs and where they would best be located. In the end, the Homeland Security Act ( P.L. 107-296 , signed in November 2002) transferred to the new department only the Metropolitan Medical Response System (a municipal grant program), NDMS, and budget authority for the SNS, leaving most public health preparedness and response activities in HHS. The act directed the Secretary of HHS to collaborate with the Secretary of DHS in setting priorities for human health-related countermeasures research and development, and for all public health-related activities to improve state, local, and hospital preparedness and response, though these programmatic activities remained at HHS.

Major Legislation Prior to the 2001 Terrorist Attacks

Prior to the terrorist attacks of 2001, Congress passed the Public Health Threats and Emergencies Act of 2000 (Title I of the Public Health Improvement Act, P.L. 106-505 , signed in November 2000) to address growing concerns about bioterrorism and emerging infectious diseases, and about the ability of the public health system to respond. Among other provisions, the law authorized $50 million for FY2001 (and such sums as may be necessary through FY2006) for competitive grants to build capacity in state and local health departments. This and other provisions would augment several public health infrastructure programs begun by CDC in the 1990s, including grants to states for epidemiology and laboratory capacity, and the creation of the Laboratory Response Network to assure nationwide capability for testing of biological agents during an actual or suspected bioterrorism incident.

In the Antiterrorism and Effective Death Penalty Act of 1996 ( P.L. 104-132 , signed in April 1996), Congress called on the Secretary of HHS to establish a program to identify and list specific infectious agents that could be used for bioterrorism, and to require the registration of facilities (typically laboratories) shipping those agents. The resultant Select Agent program is overseen by CDC and the U.S. Department of Agriculture (USDA). Program authority was expended and extended through FY2007 in P.L. 107-188 , in the aftermath of the anthrax attack.

Additional Congressional Research Service (CRS) Reports

For more information regarding provisions in P.L. 107-188 , see

CRS Report RL31263, Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law , by [author name scrubbed], [author name scrubbed], and [author name scrubbed]. For more information regarding Project BioShield, see CRS Report RS21507, Project BioShield: Purposes and Authorities , by [author name scrubbed]. CRS Report RL33907, Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for Congress , by [author name scrubbed].

For more information regarding public health preparedness and response authorities and programs in general, and in the context of specific threats, see:

CRS Report RS22602, Public Health and Medical Preparedness and Response: Issues in the 110th Congress , by [author name scrubbed]; CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding , by [author name scrubbed]; CRS Report RL31719, An Overview of the U.S. Public Health System in the Context of Emergency Preparedness , by [author name scrubbed]; CRS Report RL33096, 2005 Gulf Coast Hurricanes: The Public Health and Medical Response , by [author name scrubbed]; CRS Report RL33145, Pandemic Influenza: Domestic Preparedness Efforts , by [author name scrubbed]; CRS Report RL33738, Gulf Coast Hurricanes: Addressing Survivors' Mental Health and Substance Abuse Treatment Needs , by [author name scrubbed], [author name scrubbed], and [author name scrubbed].

For more information regarding the Stafford Act and related preparedness and response planning activities in DHS, see:

CRS Report RL33729, Federal Emergency Management Policy Changes After Hurricane Katrina: A Summary of Statutory Provisions , by [author name scrubbed] et al. CRS Report RL33053, Federal Stafford Act Disaster Assistance: Presidential Declarations, Eligible Activities, and Funding , by [author name scrubbed].