FDA, FY 2022 OTC Monograph Drug User Fee(OMUFA)

Mar 14 2022

On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022.

OTC monograph drug facility fees for FY 2022 are due June 1, 2022.

the fiscal year (FY) 2022 facility fee rates are an increase of 19 percent in comparison to the FY 2021 facility fee rates.

The FY 2022 increase in facility fee rates is largely attributed to these factors:

The FY 2022 target revenue 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.

If you have any questions about FDA regulation of NDA

(New Drug Application), Clinical studies... , please CONTACT US.

Office 1-909-493-3276

SOURCE :