116th Congress > House > Vote 12

Date: January 08, 2019

Result: 401-17 (Passed)

Clerk session vote number: 13

Sponsor: ESHOO, Anna Georges (D-CA)

Bill number: HR269

Question: On Motion to Suspend the Rules and Pass

Description: Pandemic and All-Hazards Preparedness and Advancing Innovation Act

Bill summary:

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.



Bill titles: To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.; Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019; Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019; Over-the-Counter Monograph User Fee Act of 2019

Links for more info on the vote: congress.gov

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