FDA Announces OTC Monograph Drug User Fee Program

March 28, 2024

FDA Announces OTC Monograph Drug User Fee Program - Facility Fee Rates for Fiscal Year 2024

Today, the U.S. Food and Drug Administration announced the over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) facility fee rates for fiscal year (FY) 2024 in a Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2024.”

This FRN publishes annual OMUFA fees for OTC monograph drug facilities for FY 2024 (October 1, 2023 – September 30, 2024) and includes information about facility fee calculations, fee due dates, and fee payment procedures. The FY 2024 facility fee rates are shown below, and the fees are due by June 3, 2024.

FDA-OTC-Monograph-Drug-User-Fee-Program---Facility-Fee-Rates-for-Fiscal-Year-2024

FDA recognizes that the FY 2024 facility fee rates increased when compared to the FY 2023 facility fee rates. FDA calculates fees in accordance with our statutory authority, considering factors that include the 1) number of fee-liable facilities, 2) ratio of Monograph Drug Facilities (MDF) to Contract Manufacturing Organizations (CMO), and 3) increases in the total target revenue due to inflation and other adjustments. The fee calculations are described in detail in the FRN.

This notice publishes the OMUFA facility fee rates for FY 2024. The over-the-counter monograph order request (OMOR) fee rates for FY 2024 were published on September 12, 2023.

For more information on the facility fee rates, please refer to the FRN or the FDA’s Over-the-Counter User Fee Program (OMUFA) webpage.

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