The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 () is a law enacted by the 113th United States Congress. The Act amends the Public Health Service Act in order to extend, fund, and improve several programs designed to prepare the United States and health professionals in the event of a pandemic, epidemic, or biological, chemical, radiological, or nuclear accident or attack. The Act clarifies the authority of different American officials, makes it easier to temporarily reassign personnel to respond to emergency situations, and alters the process for testing and producing medical countermeasures. The Act is focused on improving preparedness for any public health emergency.
Background The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013 is a follow-up bill to both the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006. These acts were focused on preparing the country to deal with possible Chemical, Biological, Radiological, and Nuclear (CBRN) attacks, a high-profile concern in the wake of the September 11 attacks. During the 112th United States Congress, the House voted to pass the Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 () in a lame duck session, but the bill did not pass in the Senate and never became law. One doctor also argued that the bill was important because it would help doctors deal with critical patients in the event of natural disasters as well as CBRN attacks.
Provisions/Elements of the Act This summary is based largely on the summary provided by the Congressional Research Service, a public domain source.
Title I: Strengthening National Preparedness and Response for Public Health Emergencies Section 101 of the Act amends the Public Health Service Act (PHSA) to require the Secretary of Health and Human Services (HHS) to submit the National Health Security Strategy to the relevant congressional committees in 2014. The Act revises the Strategy's preparedness goals, particularly to require that regular preparedness drills also include drills and exercises to ensure medical surge capacity for events without notice.
Section 101 also requires that the National Health Security Strategy include: (1) provisions for increasing the preparedness, response capabilities, and surge capacity of ambulatory care facilities, dental health facilities, and critical care service systems; (2) plans for optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, critical care, and trauma care and emergency medical systems; (3) provisions taking into account the unique needs of individuals with disabilities in a public health emergency; and (4) strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin or any chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.
Section 101 further requires the Secretary to: (1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency; (2) disseminate and update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and (3) ensure that public health and medical information distributed by HHS during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals.
Section 102 of the Act requires the Assistant Secretary for Preparedness and Response to provide integrated policy coordination and strategic direction with respect to all matters related to federal public health and medical preparedness and execution and deployment of the federal response for public health emergencies and incidents covered by the National Response Plan before, during, and following public health emergencies.
Section 102 then requires the Assistant Secretary for Preparedness and Response, with respect to overseeing advanced research, development, and procurement of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, to: (1) identify and minimize gaps, duplication and other inefficiencies in medical and public health preparedness and response activities and the actions necessary to overcome these obstacles; (2) align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under the Public Health Service Act; (3) carry out drills and operational exercises to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness; and (4) conduct periodic meetings with the Assistant to the President for National Security Affairs to provide an update on, and to discuss, medical and public health preparedness and response activities.
Section 102 also changes some of the responsibilities and tasks assigned to the Assistant Secretary for Preparedness and Response. For example, the Assistant Secretary's office is required to develop and update annually a five-year budget plan based on medical countermeasures priorities. The office is also assigned lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy and coordination. It is also granted authority over and responsibility for the Biomedical Advanced Research and Development Authority (BARDA) as well as grants and related authorities related to trauma care. The Assistant Secretary will also now be in charge the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health Professionals.
The Assistant Secretary is required to develop the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. The Government Accountability Office (GAO) is required to conduct an independent evaluation of the strategy and implementation plan.
Section 103 creates a new National Advisory Committee on Children and Disasters and sets the termination of the Committee for September 30, 2018.
Section 104 revises and reauthorizes through Fiscal Year 2018 the National Disaster Medical System. The section requires the Secretary of Health and Human Services to take steps to ensure that a range of public health and medical capabilities are represented in the National Disaster Medical System, and that this will take into account the needs of at-risk individuals in the event of a public health emergency. The Act authorizes the Secretary to determine and pay claims for reimbursement for services provided through the National Disaster Medical System directly or through contracts that provide for payment in advance or by way of reimbursement.
Section 105 of the Act reauthorizes through Fiscal Year 2018 a program for public health emergency readiness of the Department of Veterans Affairs (VA) medical centers.
Title II: Optimizing State and Local All-Hazards Preparedness and Response Section 201 of the new law allows the Secretary of Health and Human Services to authorize a state or tribe to temporarily reassign state and local public health department or agency personnel funded through Public Health Service Act programs to immediately address a public health emergency in the state or tribe. The Act, however, requires that such reassignments to be voluntary and that the Government Accountability Office evaluate such temporary reassignments.
Section 202 of the Act revises and reauthorizes for Fiscal Years 2014-2018 a program of cooperative agreements to improve state and local public health security. It also requires the Secretary of Health and Human Services to update periodically the criteria for an effective state plan for responding to pandemic influenza and integrate that criteria into the benchmarks and standards that measure levels of preparedness. The section also sets rules regarding the roll-over of funds from one year to the next. Specific funds are reauthorized to be appropriated for FY2014-FY2018 for the influenza vaccine tracking and distribution program in an influenza pandemic.
Section 203 of the Act adds dental entities among those that may carry out education and training activities to improve responses to public health emergencies.
Section 203 also reauthorizes the Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP) for FY2014-FY2018, which provides a single national interoperable network of systems to verify the credentials and licenses of health care professionals who volunteer to provide health services during a public health emergency. Likewise, the section reauthorizes for FY2014-FY2018 the Medical Reserve Corps to provide for an adequate supply of volunteers in the case of a public health emergency. The Act requires that training exercises incorporate the needs of at-risk individuals in the event of such an emergency.
Section 203 also revises and reauthorizes appropriations for FY2014-FY2018 for a program of grants and cooperative agreements to improve surge capacity and enhance community and hospital preparedness. The revisions would ensure that some of the programs address the needs of children and at-risk individuals, and would also make community health centers eligible for the program. The Secretary of Health and Human Services is required to implement objective, evidence-based metrics to ensure that entities receiving such grant awards are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy.
Section 204 of the Act reauthorizes appropriations for FY2014-FY2018 for a program to improve public health alert communications and surveillance and public health situational awareness capability. This section adds poison control centers to the integrated system of public health alert communications and surveillance networks.
Section 204 requires the Secretary to submit to the appropriate congressional committees a coordinated strategy and an accompanying implementation plan that demonstrates the measurable steps the Secretary will carry out to: (1) develop, implement, and evaluate the public health situation awareness network; (2) modernize and enhance biosurveillance activities; and (3) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by HHS.
Section 204 defines "biosurveillance" as the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity. The National Biodefense Science Board is required to provide expert advice and guidance regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of HHS to ensure comprehensive, real-time all-hazards biosurveillance capabilities.
Title III: Enhancing Medical Countermeasure Review Section 301 amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements about animal testing. The revision would increase regulatory predictability for medical countermeasures sponsors by expanding the use of Special Protocol Assessments to animal trials and any associated clinical trials necessary to support licensure of medical countermeasures.