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FDA's: OTC Monograph Drug User Fees for Fiscal Year 2022

Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice (FRN) titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022"

This document provides detailed information about facility fee calculations, OMOR fee calculations, fee due dates, and fee payment options and procedures for FY 2022. Fees for OTC monograph drug facilities for FY 2022 are due June 1, 2022.

To calculate the facility fee rates FDA bases its calculation on factors for each fiscal year that includes the

  1. Number of fee-liable facilities

  2. Ratio of Monograph Drug Facilities (MDF) to Contract Manufacturing Organizations (CMO)

  3. Increases in the total target revenue due to inflation and other adjustments.

Also, the FY 2022 target revenue is set under the statute.

  • Number of Facilities:

In FY 2022, FDA estimates fewer fee-liable facilities (1,118) in comparison to those estimates from FY 2021 (1,184).

  • MDF to CMO Ratio:

Based on FY 2021 data and other data provided by firms regarding their operations, FDA determined the MDF to CMO ratio in FY 2022 to be 65:35, an adjustment from the FY 2021 ratio of 90:10.

  • Inflation and Operating Reserve adjustments:

FY 2022 was the first year for which the inflation adjustment applied. FDA also made an operating reserve adjustment and otherwise reserved sufficient carryover fees to sustain program operations until facility fees for the subsequent fiscal year are due on June 1, 2023.

For more detailed information on the OTC Monograph Drug User Fees click this LINK

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