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R275 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Conventional Active Ingredient - Other Actions

Below is the fee for your selected Fee Category for Fiscal Years 2020-2021

Action Code Description FY'20-FY'21 Fee Decision Time (months)
R275 Rebuttal of agency reviewed protocol, applicant initiated $2,657 3

Do you plan to request either of the following types of waivers?

Waiver Pay Amount
50% waiver You pay ---->>>>> $1,329
75% waiver You pay ---->>>>> $664

To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.

How to submit your application directly to EPA.

Action Code Interpretation

An application or submission to the EPA rebutting the conclusion(s) reached by the EPA for a previously submitted study protocol request. The science review of the study protocol is considered the completed PRIA decision on the protocol review request, so any written response contesting the conclusions in the review is considered to be a separate action and subject to a separate fee under PRIA.

This PRIA category applies to rebuttals of all protocol reviews (except HSRB protocol reviews), whether the original protocol was subject to PRIA or not. The fee for this category is multiplied by each rebuttal application that is submitted for review. PRIA fees are not applicable to pre-submission or pre-registration conferences or discussions with the EPA such as Dose Adequacy Response Team (DART), EFED Rapid Response Team, ChemSAC review, and DNT protocol reviews.