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Over-the-Counter Monograph User Fee Act of 2019

Introduced: January 8, 2019 See on congress.gov
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 11 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 10, 2019
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10.
Jan 9, 2019
Received in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Jan 8, 2019
Motion to reconsider laid on the table Agreed to without objection.
Jan 8, 2019
On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 401 - 17 (Roll no. 13). (text: CR H237-262)
Jan 8, 2019
Considered as unfinished business. (consideration: CR H275-276)
Jan 8, 2019
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
Jan 8, 2019
DEBATE - The House proceeded with forty minutes of debate on H.R. 269.
Jan 8, 2019
Considered under suspension of the rules. (consideration: CR H237-266)
Jan 8, 2019
Mr. Pallone moved to suspend the rules and pass the bill.
Jan 8, 2019
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Jan 8, 2019
Introduced in House
 Votes taken on this bill 1
DateChamberWhat was voted onResultYes–No
Jan 8, 2019 House · vote #13 On Motion to Suspend the Rules and Pass Passed 401–17 See who voted →
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 Plain-English summary Congressional Research Service

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.

What's happening now January 10, 2019

Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10.

 Related & companion bills 5
  • HR 345 Related bill SMASH Act
  • HR 3443 Related bill To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved…
  • S 11 Related bill Strengthening the National Disaster Medical System Act of 2019
  • S 1379 Related bill Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
  • S 2740 Related bill Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 4
 Cosponsors 7
All 7 Democratic 3 Republican 2
Brooks, Susan
· Jan 8, 2019
 D
DeGette, Diana
Colorado · Jan 8, 2019
 D
Dingell, Debbie
Michigan · Jan 8, 2019
 R
Guthrie, Brett
Kentucky · Jan 8, 2019
 R
Latta, Robert E.
Ohio · Jan 8, 2019
 D
Pallone, Frank
New Jersey · Jan 8, 2019
WALDEN, GREG
· Jan 8, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-269/
MLA
"H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-269/.
Bluebook (legal)
H.R. 269, 116th Cong. (2026), https://openamerica.io/bill/116-HR-269/.
Markdown link
[H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019](https://openamerica.io/bill/116-HR-269/)
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