HR4273-119

What This Bill Does

This bill reauthorizes and amends FDA's over-the-counter monograph drug user fee program. It updates the definition of an OTC monograph order request to include adding or modifying a testing procedure that reflects a voluntary consensus standard for pharmaceutical quality, when that standard is established by a national or international standards development organization and recognized by FDA guidance. This gives OTC manufacturers a defined route for consensus quality-testing procedures to be handled within the monograph process.

The bill revises OTC monograph facility fee timing for fiscal years 2026, 2027, and later years; adjusts when facility activity counts for fee liability; changes when fees are due; and updates reporting requirements so annual reports are due within 120 calendar days after each fiscal year. It extends statutory references from 2025 to 2030, sets sections 744L and 744M to sunset on October 1, 2030, and sets section 744N to sunset on January 31, 2031. A savings clause keeps prior law in effect for assessment and collection of fees required for fiscal years before 2026.

Who Benefits and How

FDA OTC monograph program staff benefit from reauthorized user fee funding and updated fee-collection rules through 2030. OTC monograph drug manufacturers benefit from clearer facility fee timing and a pathway to use recognized voluntary consensus pharmaceutical quality standards for testing procedures. National and international standards development organizations benefit because their standards can be recognized in FDA monograph work. Consumers benefit if reauthorized fees support faster FDA review of OTC monograph requests and safety updates. Congressional health committee staff benefit from annual user-fee reporting.

Who Bears the Burden and How

OTC monograph drug facility owners must determine fee liability under new fiscal-year activity periods and installment due dates. FDA finance and reporting staff must update fee notices, collection systems, and annual performance reports. Manufacturers that ceased OTC monograph drug activities must track cutoff dates to avoid facility fees. FDA guidance staff must maintain the recognition process for voluntary consensus standards. Companies with pre-2026 fee liabilities remain subject to prior-law assessment and collection under the savings clause.

Key Provisions

• Adds recognized voluntary consensus pharmaceutical quality testing procedures to OTC monograph order request coverage.
• Modifies OTC monograph facility fee activity periods and due dates for fiscal years 2026, 2027, and later years.
• Extends annual FDA OTC monograph reporting references through 2030.
• Establishes October 1, 2030 and January 31, 2031 sunset dates for OTC monograph user fee authorities.
• Provides a savings clause for assessing and collecting pre-fiscal-year-2026 fees.