The FDA announced the Generic Animal Drug User Fee Rates for FY 2022 in today’s Federal Register here. This will be a first in an avalanche of announcements of new User Fee rates for the coming FY.
The rates for Generic Animal Drugs for FY 2022 are provided in the table below:
| Fee Category | FY 2021 Fees | FY 2022 Fees | % increase |
| Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) | $513,423 | $548,628 | 6.8% |
| Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) | $256,712 | $274,314 | 6.8% |
| Generic New Animal Drug Product Fee | $17,235 | $17,513 | 1.6% |
| 100% Generic New Animal Drug Sponsor Fee | $201,687 | $234,297 | 16% |
| 75% Generic New Animal Drug Sponsor Fee | $151,265 | $175,723 | 16% |
| 50% Generic New Animal Drug Sponsor Fee | $100,843 | $117,149 | 16% |
Just like a helium balloon – nothing seems to go down! Fee increases for FY 2022 are provided in the table above. Please note that the graduation for the Sponsor Fee, which is a one-time annual fee is as follows: 100% (holds > 6 approved abbreviated applications), 75% (holds 2-6 approved abbreviated applications), and 50% (holds 0-1 approved abbreviated applications).
In addition to the fee rates and their respective calculations, the FR notice provides additional detail as to when and where to pay the fees.
