Bill > HR4273

This bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter (OTC) monograph drugs through fiscal year 2030, introducing several key changes to how fees are assessed and collected. The legislation establishes a new framework for facility fees, with specific fee revenue amounts and adjustment mechanisms for fiscal years 2026-2030, including provisions for inflation adjustments and potential workload-based fee modifications. It modifies the due dates and calculation of fees, with different schedules for fiscal years 2026-2028, and allows the FDA to adjust fees based on factors like the number of OTC monograph drug facilities and their payment history. The bill also expands the definition of what can trigger a fee assessment, such as adding or modifying testing procedures that align with voluntary consensus standards for pharmaceutical quality. Additionally, the legislation includes technical corrections to regulations concerning nonprescription drugs, extends reporting requirements, and sets a sunset date of October 1, 2030, for the authorization of these fee provisions. The bill aims to provide the FDA with a sustainable funding mechanism for reviewing and regulating OTC monograph drugs while ensuring flexibility in fee assessment and collection.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/4273/all-info