This morning, the FDA published the OTC User Fee rates for FY 2023 in a Federal Register notice (here); these rates cover fees for OTC manufacturing facilities (MFD), contract manufacturing organizations (CMO), and OTC monograph order requests (OMORs) for which there are tier 1 and tier 2 requests. A comparison of the first three fiscal years is presented in the chart below to give you an idea of how the fees have increased since the OTC Monograph User Fee Act (OMUFA) was passed three years ago.
| OTC User Fee Schedule | |||
| Fee Type | FY 2021 | FY 2022 | FY 2023 |
| OMOR | |||
| Tier 1 | $500,000 | $507,021 | $517,381 |
| Tier 2 | $100,000 | $101,404 | $103,476 |
| Facility | |||
| MFD | $20,322 | $24,178 | $26,153 |
| CMO | $13,548 | $16,119 | $17,435 |
To read more about the OTC user fee program and better understand what tier 1 and tier 2 OMORs are, please see our previous post here.
