The FDA published the OTC User Fee rates for FY 2022 today These rates were announced this morning in a Federal Register notice (here) and cover fees for OTC manufacturing facilities, contract manufacturing organizations (CMO), and OTC monograph order requests (OMOR) for which there are tier 1 and tier 2 requests. A comparison of the FY 2021 and new FY 2022 fees are presented in the chart below.
| OTC User Fee Schedule | ||
| FY 2021 | FY 2022 | |
| OMOR | ||
| Tier 1 | $500,000 | $507,021 |
| Tier 2 | $100,000 | $101,404 |
| Facility | ||
| MFD | $20,322 | $24,178 |
| CMO | $13,548 | $16,119 |
The User Fees are adjusted each year based on a complex calculation of inflation, staffing cost changes, and the target revenue projection figures, but the 19% increase in the manufacturing facility fee increases were primarily driven by the lower number of manufacturing facilities in FY 2022 (1,118) compared to those in FY 2021 (1,184). Also note that facilities that solely manufactured alcohol-based hand sanitizers to support the need generated by the COVID-19 pandemic were exempted from facility fees.
For a further discussion of what the OTC User Fee program is all about, please see our previous blog post here.
