HR 4273
Advanced toward a vote
Reauthorizes and revises the user fee program that funds FDA oversight of over-the-counter monograph drugs, setting fee amounts and collection timing for fiscal years 2026 through 2030.
Official title: Over-the-Counter Monograph Drug User Fee Amendments
Timeline each lane is a chamber; dates pull from congress.gov actions
House
Introduced
02-JUL-2025
Referred
02-JUL-2025
Approved by committee
23-JUL-2025
Reported
17-SEP-2025
On the calendar
17-SEP-2025
- Sets facility and order request fees for fiscal years 2026 through 2030, with fee revenue tied to inflation and a fixed dollar add-on for each year
- Changes due dates for facility fees, including two installments for fiscal year 2027
- Allows a one-time fee increase for fiscal years 2028 through 2030 if facility counts exceed 1,625 and arrears rates stay below 30 percent
- Adds certain voluntary consensus testing procedures to the list of activities the fees can cover, and lets advocacy organizations act for sponsors in certain FDA proceedings
- Extends the program's sunset date to October 1, 2030 and reporting requirements to January 31, 2031
Covers an older version. The newest CRS summary describes the bill as of "Introduced in House" (02-JUL-2025); the text has changed since (Reported in House, 17-SEP-2025).
CRS is the Library of Congress's nonpartisan research office. Read it on congress.gov- Energy and Commerce Committee (House)
Health
■ 2 D■ 1 R
2 Democrats
1 Republican