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Over-the-Counter Monograph Drug User Fee Amendments

USA119th CongressHR-4273| House 
| Updated: 9/17/2025
Robert E. Latta

Robert E. Latta

Republican Representative

Ohio

Cosponsors (3)
Debbie Dingell (Democratic)Diana DeGette (Democratic)Dan Crenshaw (Republican)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This legislation, known as the Over-the-Counter Monograph Drug User Fee Amendments, aims to reauthorize and significantly revise the user fee program for over-the-counter (OTC) monograph drugs. The program is extended for an additional five fiscal years, covering fiscal years 2026 through 2030 , ensuring continued funding for the Food and Drug Administration's (FDA) oversight of these products. Congress explicitly finds that the authorized fees will be dedicated to OTC monograph drug activities. Key changes include modifications to the assessment and collection of facility fees . The bill alters the applicable periods for fee assessment and revises due dates, introducing a two-installment payment system for fiscal year 2027. It also updates the methodology for calculating fee revenue amounts, incorporating adjustments for inflation, operating reserves, and additional direct costs, alongside specific dollar amounts for certain fiscal years. A notable addition is a one-time facility fee workload adjustment that the Secretary may apply for fiscal years 2028, 2029, or 2030 under specific conditions related to facility numbers and arrears rates. Furthermore, the bill amends the definition of an OTC monograph drug to include the addition or modification of testing procedures that reflect voluntary consensus standards recognized by the Secretary. It also clarifies that the FDA can provide development advice to sponsors, requestors, or organizations nominated by them regarding nonprescription drugs. The authorization for these fee provisions will cease on October 1, 2030 , with reporting requirements ending on January 31, 2031.

Bill Text Versions

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2 versions available

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Timeline
Jul 2, 2025
Introduced in House
Jul 2, 2025
Referred to the House Committee on Energy and Commerce.
Jul 23, 2025
Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
Jul 23, 2025
Committee Consideration and Mark-up Session Held
Sep 8, 2025

Latest Companion Bill Action

S 119-2292
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Sep 17, 2025
Placed on the Union Calendar, Calendar No. 254.
Sep 17, 2025
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
  • July 2, 2025
    Introduced in House


  • July 2, 2025
    Referred to the House Committee on Energy and Commerce.


  • July 23, 2025
    Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.


  • July 23, 2025
    Committee Consideration and Mark-up Session Held


  • September 8, 2025

    Latest Companion Bill Action

    S 119-2292
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.


  • September 17, 2025
    Placed on the Union Calendar, Calendar No. 254.


  • September 17, 2025
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.

Health

Related Bills

  • HR 119-5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026
  • S 119-2292: Over-the-Counter Monograph Drug User Fee Amendments
Congressional oversightDrug safety, medical device, and laboratory regulationUser charges and fees

Over-the-Counter Monograph Drug User Fee Amendments

USA119th CongressHR-4273| House 
| Updated: 9/17/2025
This legislation, known as the Over-the-Counter Monograph Drug User Fee Amendments, aims to reauthorize and significantly revise the user fee program for over-the-counter (OTC) monograph drugs. The program is extended for an additional five fiscal years, covering fiscal years 2026 through 2030 , ensuring continued funding for the Food and Drug Administration's (FDA) oversight of these products. Congress explicitly finds that the authorized fees will be dedicated to OTC monograph drug activities. Key changes include modifications to the assessment and collection of facility fees . The bill alters the applicable periods for fee assessment and revises due dates, introducing a two-installment payment system for fiscal year 2027. It also updates the methodology for calculating fee revenue amounts, incorporating adjustments for inflation, operating reserves, and additional direct costs, alongside specific dollar amounts for certain fiscal years. A notable addition is a one-time facility fee workload adjustment that the Secretary may apply for fiscal years 2028, 2029, or 2030 under specific conditions related to facility numbers and arrears rates. Furthermore, the bill amends the definition of an OTC monograph drug to include the addition or modification of testing procedures that reflect voluntary consensus standards recognized by the Secretary. It also clarifies that the FDA can provide development advice to sponsors, requestors, or organizations nominated by them regarding nonprescription drugs. The authorization for these fee provisions will cease on October 1, 2030 , with reporting requirements ending on January 31, 2031.

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jul 2, 2025
Introduced in House
Jul 2, 2025
Referred to the House Committee on Energy and Commerce.
Jul 23, 2025
Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
Jul 23, 2025
Committee Consideration and Mark-up Session Held
Sep 8, 2025

Latest Companion Bill Action

S 119-2292
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Sep 17, 2025
Placed on the Union Calendar, Calendar No. 254.
Sep 17, 2025
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
  • July 2, 2025
    Introduced in House


  • July 2, 2025
    Referred to the House Committee on Energy and Commerce.


  • July 23, 2025
    Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.


  • July 23, 2025
    Committee Consideration and Mark-up Session Held


  • September 8, 2025

    Latest Companion Bill Action

    S 119-2292
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.


  • September 17, 2025
    Placed on the Union Calendar, Calendar No. 254.


  • September 17, 2025
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
Robert E. Latta

Robert E. Latta

Republican Representative

Ohio

Cosponsors (3)
Debbie Dingell (Democratic)Diana DeGette (Democratic)Dan Crenshaw (Republican)

Energy and Commerce Committee

Health

Related Bills

  • HR 119-5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026
  • S 119-2292: Over-the-Counter Monograph Drug User Fee Amendments
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulationUser charges and fees