"Pandemic and All-Hazards Preparedness Reauthorization Act of 2013"

To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes. Congressional Research Service Summary Title I: Strengthening National Preparedness and Response for Public Health Emergencies 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. Revises the Strategy's preparedness goals, in part to specify that the drills and exercises included in periodic evaluations of federal, state, local, and tribal preparedness and response capabilities also include drills and exercises to ensure medical surge capacity for events without notice. Requires the Strategy to 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. 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.

Title II: Optimizing State and Local All-Hazards Preparedness and Response Allows the Secretary to authorize a state or tribe to temporarily reassign state and local public health department or agency personnel funded through PHSA programs to immediately address a public health emergency in the state or tribe. Requires such reassignments to be voluntary. Requires GAO to evaluate such temporary reassignments. Terminates this temporary reassignment authority on September 30, 2018. 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. Reauthorizes for FY2014-FY2018 the Medical Reserve Corps to provide for an adequate supply of volunteers in the case of a public health emergency. Requires training exercises to incorporate the needs of at-risk individuals in the event of such an emergency. 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.

Title III: Enhancing Medical Countermeasure Review Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for special protocol assessments to include agreements on the design and size of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim for a countermeasure or epidemic or pandemic product when human efficacy studies are not ethical or feasible. Revises the Secretary's authority to allow the use of unapproved medical products or the unapproved use of an approved product. Authorizes the Secretary to make a declaration that the circumstances exist justifying such an authorization and base the determination on: (1) a (general) threat (rather than a specific threat as under current law), (2) a significant potential for a public health emergency, (3) the health and security of U.S. citizens abroad, and (4) the identification of a material threat sufficient to affect national security. Eliminates the one-year expiration date for such an authorization (thus allowing it to continue). Authorizes the Secretary to permit deviations from good manufacturing practice requirements when the circumstances of a domestic, military, or public health emergency or material threat so warrant. Authorizes the Secretary to waive prescription requirements during an emergency and create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning the product's approved, licensed, or cleared conditions. Authorizes the Secretary to waive requirements for a risk evaluation and mitigation strategy in the event of a domestic, military, or public health emergency (currently, such waiver authority applies only to a public health emergency) or the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens abroad.

Title IV: Accelerating Medical Countermeasure Advanced Research and Development Authorizes the Secretary to enter into contracts and other agreements that are in the government's best interest in meeting identified security countermeasure needs, including reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved. Reauthorizes appropriations for FY2014-FY2018 for the Special Reserve Fund for procurement of security countermeasures and for countermeasure advanced research and development under Biomedical Advanced Research and Development Authority (BARDA). Prohibits the Secretary from utilizing more than 50% of such amount for research and development. Requires the Secretary to report to the appropriate congressional committees if the amount in the Fund falls below a specified threshold. Revises and reauthorizes for FY2014-FY2018 the Biodefense Medical Countermeasure Development Fund used to support BARDA to accelerate countermeasure and product advanced research and development. Authorizes the Secretary to support innovation under BARDA by promoting dose sparing technologies, efficacy increasing technologies, and platform technologies. Requires the Secretary to provide a clear statement of defined government purpose related to BARDA activities for the awarding of contracts, grants, and cooperative agreements for a qualified countermeasure or qualified pandemic or epidemic product. Extends the antitrust exemption to permit meetings and consultations to discuss the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products. Reauthorizes the Strategic National Stockpile for FY2014-FY2018.

Note: Much more detail provided at Congressional Research Service Summary link above. CBO Estimate, dated 2/21/13.

H.R. 307 would amend the Public Health Service Act and the United States Code to authorize funding for certain activities carried out by the Departments of Health and Human Services (HHS) and Veterans Affairs (VA) that would support the readiness of the public health system to address public health and medical emergencies. Based on information provided by HHS and VA, CBO estimates that implementing the act would cost about $11 billion over the 2014-2018 period, assuming the appropriation of the authorized amounts. The Consolidated Appropriations Act, 2012, included funding totaling about $2 billion in fiscal year 2012 for activities similar to those that would be authorized by H.R. 307. CBO assumes that amounts appropriated through the Continuing Appropriations Resolution, 2013, for those activities are similar to 2012 levels. H.R. 307 also would change the terms for Project Bioshield contracts, which would result in a change in direct spending. Assuming H.R. 307 is enacted this spring, it would decrease direct spending by $58 million over the 2013-2018 period, but would result in no net change in direct spending over the 2013-2023 period. Library of Congress Summary and Status