In a Federal Register Notice today (here), the Agency announced the FY 2022 user fees for New Animal Drug Applications. While the application and certain fee-paying supplemental applications increased modestly, the remainder of the annual fees decreased. “Fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the percentages of the total revenue that are derived from each type of user fee will be as follows: (1) revenue from application fees shall be 20 percent of total fee revenue; (2) revenue from product fees shall be 27 percent of total fee revenue; (3) revenue from establishment fees shall be 26 percent of total fee revenue; and (4) revenue from sponsor fees shall be 27 percent of total fee revenue.”
|Fee Category||FY 2021 Fees||FY 2022 Fees||% Change|
|Animal Drug Application||$574,810||$580,569||+1.0%|
|Supplemental Animal Drug Application for Which
Safety or Effectiveness Data are Required or
Animal Drug Application Subject to the Criteria
Set Forth in Section 512(d)(4) of the FD&C Act
|Animal Drug Product Fee||$12,230||$10,787||-11.8%|
|Animal Drug Establishment Fee1||$166,695||$155,220||-6.9%|
|Animal Drug Sponsor Fee2||$142,881||$137,791||-3.6%|
1 An animal drug establishment is subject to only one such fee each fiscal year.
2 An animal drug sponsor is subject to only one such fee each fiscal year.
Again, setting the yearly fees depends on a number of factors, including estimation of workload, inflation, and excess collected in previous years. While the FR notice cited above provides the details, it looks like applicants for new animal drug applications are not going to get hit hard on this year’s increased application fees, and those that have applications might save a bit on the annually assessed fees.