Bill
Bill > HR269
US HR269
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
summary
Introduced
01/08/2019
01/08/2019
In Committee
01/08/2019
01/08/2019
Crossed Over
01/09/2019
01/09/2019
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 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.
AI Summary
This bill reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response, and addresses the approval process for over-the-counter (OTC) drugs. Key provisions include:
- Reauthorizing and revising the Public Health Emergency Preparedness cooperative-agreement program, the Hospital Preparedness Program, the CDC situational-awareness and biosurveillance program, and several other programs related to emergency preparedness and response.
- Establishing a new grant program to enable military trauma teams to provide trauma care at high-acuity trauma centers.
- Providing statutory authority for existing programs like the CDC's Children's Preparedness Unit and the Public Health Emergency Medical Countermeasures Enterprise.
- Establishing new programs and entities, including a trauma-center grant program to support military trauma teams.
- Modifying the approval process for OTC drugs by providing statutory authority for the FDA to regulate certain OTC drugs marketed without an approved new-drug application and to issue administrative orders for OTC drugs.
- Requiring the FDA to assess and collect user fees for OTC drugs, including OTC-drug facility and OTC-drug order-request fees.
Committee Categories
Business and Industry
Sponsors (8)
Anna Eshoo (D)*,
Susan Brooks (R),
Diana DeGette (D),
Debbie Dingell (D),
Brett Guthrie (R),
Bob Latta (R),
Frank Pallone (D),
Greg Walden (R),
Last Action
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10. (on 01/10/2019)
Official Document
bill text
bill summary
Loading...
bill summary
Loading...
bill summary
Loading...