Pandemic and All-Hazards Preparedness Act Reauthorization of 2011 - 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. Requires the Strategy to include:
Requires the Secretary to:
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. Give the Assistant Secretary direct authority over and responsibility for:
Authorizes the Assistant Secretary to exercise the responsibilities and authorities of the Secretary with respect to the coordination of the Public Health Emergency Preparedness Cooperative Agreement Program. Requires the Assistant Secretary to:
Requires the Secretary, acting through the Assistant Secretary, to:
Requires the Government Accountability Office (GAO) to conduct an independent evaluation on the strategy and implementation plan. Requires the Secretary to:
Requires the Secretary to establish the National Advisory Committee on Children and Disasters. Terminates the Committee after five years.
Revises and reauthorizes through FY2016 the National Disaster Medical System. Requires the Secretary to take steps to ensure that a range of public health and medical capabilities are represented in the System, which take into account the needs of at-risk individuals, in the event of a public health emergency. Authorizes the Secretary to determine and pay claims for reimbursement for services provided through the System directly or through contracts that provide for payment in advance or by way of reimbursement.
Reauthorizes through FY2016 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 -
Requires the Secretary to:
Provides that amounts provided to an eligible entity under a cooperative agreement to achieve preparedness goals for a fiscal year that are unobligated at the end of such year shall remain available to such entity for the next fiscal year. Makes continued availability of such funds contingent upon achieving benchmarks and submitting a pandemic influenza plan. Eliminates provisions limiting the amount of an award that an entity may carry over to the succeeding fiscal year. Reauthorizes appropriations for FY2012-FY2016 for the influenza vaccine tracking and distribution program in an influenza pandemic. Requires GAO to conduct an evaluation of federal programs at HHS that support medical and public health preparedness and response programs at the state and local levels.
Includes dental entities among entities that may carry out education and training activities to improve responses to public health emergencies. Reauthorizes through FY2016 the Medical Reserve Corps to provide for an adequate supply of volunteers in the case of a public health emergency. Revises such provisions to require the training exercises to incorporate the needs of at-risk individuals in the event of a public health emergency. Revises and reauthorizes appropriations for FY2012-FY2016 for a program of grants and cooperative agreements to improve surge capacity and enhance community and hospital preparedness. Makes community health centers eligible for such a program. Provides that amounts provided to an eligible entity under such program for a fiscal year that are unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided. Makes continued availability of such funds contingent upon achieving benchmarks and submitting a pandemic influenza plan.
Reauthorizes appropriations for FY2012-FY2016 for a program to improve public health alert communications and surveillance and public health situational awareness capability. Includes poison control centers in the integrated system of public health alert communications and surveillance networks. Requires the Secretary to submit to the appropriate congressional committees a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measurable steps the Secretary will carry out to:
Requires the network to include data from community health centers and health centers. Requires the National Biodefense Science Board 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 -
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing 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 provisions permitting the Secretary to authorize the use of unapproved medical products or the unapproved use of an approved product, including to:
Authorizes the Secretary to extend the expiration date of eligible medical countermeasures if the Secretary determines:
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 requirements for a risk evaluation and mitigation strategy for domestic, military, and public health emergencies (currently, such waiver authority applies only to public health emergencies) and for the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens abroad. Permits a government entity to introduce into interstate commerce a product intended for emergency use if that product is intended to be held and not used, and is held and not used, unless and until it is:
Requires the Secretary to:
Requires the Secretary to establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigation device exemption, may request and receive:
Requires such meetings to include discussion of animal models for pediatric populations, as appropriate. Requires the Secretary to take into account the material threat posed by the chemical, biological, radiological, or nuclear agent for which the countermeasure under review is intended when evaluating a countermeasure for approval, licensure, or clearance. Directs that, when practicable and appropriate, teams of FDA personnel reviewing applications or submissions shall include a reviewer with sufficient training or experience with countermeasures pursuant to established protocols. Requires the Secretary to establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans. Allows prioritization of countermeasures to receive regulatory management plans if the Commissioner of Food and Drugs determines that resources are not available to establish regulatory management plans for all eligible countermeasures. Directs the Secretary to submit to the specified congressional committees a report detailing the countermeasure development and review activities of the FDA. Requires the Secretary to solicit input from the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority (BARDA) regarding pediatric studies for medical countermeasures. Requires the Secretary to notify the Assistant Secretary and the Director of BARDA of all pediatric studies in the written request for a pediatric study issued by the Commissioner of Food and Drugs. Title IV: Accelerating Medical Countermeasure Advanced Research and Development -
Reauthorizes appropriations for FY2014-FY2018 for the Special Reserve Fund. Requires the Secretary to report to the appropriate congressional committees if the amount in such Fund falls below a specified threshold. Extends from eight years to ten years:
Requires a contract to procure security countermeasures to include a clear statement of defined government purpose limited to uses related to a security countermeasure. Authorizes the Secretary to enter into contracts and other agreements that are in the best interest of the government 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. Revises provisions governing BARDA. Expands the program authorizing the Secretary to support innovation to include promotion of dose sparing technologies, efficacy increasing technologies, and platform technologies. Authorizes the Secretary, acting through the Director of BARDA, to enter into an agreement with an independent non-profit entity to support innovation related to medical countermeasures. Terminates such authority on October 1, 2016. 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. Revises and reauthorizes for FY2012-FY2016 the Biodefense Medical Countermeasure Development Fund used to support BARDA to accelerate countermeasure and product advanced research and development. Extends the Freedom of Information Act (FOIA) exemption for specific technical data or scientific information that is created or obtained during countermeasure and product advanced research and development carried out under PHSA that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. Extends the antitrust exemption to permit meetings and consultations to discuss the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products. Requires GAO to report on activities carried out to facilitate flexible manufacturing capacity. Includes within the definition of a qualified countermeasure and a qualified pandemic or epidemic product a product or technology intended to enhance the use or effect of a drug, biological product, or device that is a medical countermeasure.
Reauthorizes the Strategic National Stockpile through FY2016. Requires the Secretary to submit to Congress the annual review of the contents of the Stockpile and to identify and address the potential depletion of, and ensure appropriate replenishment of, medical countermeasures. Directs the Secretary to submit to the appropriate congressional committees a report on the stockpiling of potassium iodide.
Revises membership requirements for the National Biodefense Science Board. Requires the Board to provide any recommendation, finding, or report provided to the Secretary to the appropriate congressional committees.