S.242 - Pandemic and All-Hazards Preparedness Reauthorization Act of 2013113th Congress (2013-2014)
|Sponsor:||Sen. Burr, Richard [R-NC] (Introduced 02/07/2013)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||02/07/2013 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.|
|Notes:||For further action, see H.R.307, which became Public Law 113-5 on 3/13/2013.|
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Summary: S.242 — 113th Congress (2013-2014)All Bill Information (Except Text)
Introduced in House (02/07/2013)
Pandemic and All-Hazards Preparedness Act Reauthorization of 2013 - 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 Congress in 2014.
Gives the Assistant Secretary for Preparedness lead responsibility within HHS for emergency preparedness and response policy and coordination.
Requires the Secretary to establish the National Advisory Committee on Children and Disasters.
Prescribes requirements for the voluntary emergency reassignment of state and local personnel during a public health emergency.
Reauthorizes appropriations for public health preparedness activities, including: (1) the National Disaster Medical System, (2) the public health emergency readiness of the Department of Veterans Affairs (VA) medical centers, (3) state and local public health security, (4) the influenza vaccine tracking and distribution program, (5) the Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP), (6) the Medical Reserve Corps, (7) surge capacity and community and hospital preparedness, (7) public health alert communications and surveillance and public health situational awareness capability, (8) the Special Reserve Fund, (8) the Biomedical Advanced Research and Development Authority (BARDA), and (9) the Strategic National Stockpile.
Amends the Federal Food, Drug, and Cosmetic Act to give the Secretary additional powers during a public health emergency related to: (1) the use of unapproved medical products or the unapproved use of an approved product, (2) the extension of the expiration date of eligible medical countermeasures, (3) deviations from good manufacturing practice requirements, (4) waiver of prescription requirements, and (5) waiver of requirements for a risk evaluation and mitigation strategy.
Requires the Secretary to establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures through written regulatory management plans.
Sets forth requirements regarding pediatric studies for medical countermeasures.
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.