Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
This bill (1) reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response; and (2) addresses the approval process for over-the counter (OTC) drugs.
Among other programs, the bill reauthorizes through FY2023 and revises
the Public Health Emergency Preparedness cooperative-agreement program administered by the Centers for Disease Control and Prevention (CDC), the Hospital Preparedness Program, the CDC situational-awareness and biosurveillance program, the Emergency System for Advance Registration of Volunteer Health Professionals, the National Disaster Medical System, the Volunteer Medical Reserve Corps, the National Advisory Committee on Children and Disasters, the Strategic National Stockpile, and the Biomedical Advanced Research and Development Authority. In addition, the bill provides statutory authority for existing programs, including the CDC's Children's Preparedness Unit and the Public Health Emergency Medical Countermeasures Enterprise. The bill also establishes new programs and entities, including a trauma-center grant program to support military trauma teams.
The bill further modifies the approval process for OTC drugs by providing statutory authority for the Food and Drug Administration (FDA) to (1) regulate certain OTC drugs that are marketed without an approved new-drug application, and (2) issue administrative orders specifying the conditions under which an OTC drug may be deemed safe and effective and not subject to approval as a new drug. The FDA must assess and collect user fees for OTC drugs, including OTC-drug facility and OTC-drug order-request fees.
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