Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

Bill: 113-s-242
Sponsor: Sen. Burr, Richard [R-NC]
Introduced: 2013-02-07 in the Senate
Policy area: Health
Subjects: Administrative law and regulatory procedures
Advanced technology and technological innovations
Advisory bodies
Chemical and biological weapons
Child health
Congressional oversight
Department of Health and Human Services
Department of Veterans Affairs
Drug safety, medical device, and laboratory regulation
Emergency medical services and trauma care
Emergency planning and evacuation
Executive agency funding and structure
Food and Drug Administration (FDA)
Government employee pay, benefits, personnel management
Government information and archives
Government studies and investigations
Health facilities and institutions
Health information and medical records
Health personnel
Health programs administration and funding
Home and outpatient care
Hospital care
Immunology and vaccination
Infectious and parasitic diseases
Manufacturing
Medical education
Medical research
Medical tests and diagnostic methods
Nuclear weapons
Prescription drugs
Radioactive wastes and releases
Research administration and funding
Research and development
Social work, volunteer service, charitable organizations
Strategic materials and reserves
Terrorism
Veterans' medical care

Summary:
action_date: 2013-02-07
text: 
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.


Legislative actions:
action_date: 2013-02-07
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2013-02-07
text: Introduced in Senate