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A522 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Antimicrobial Active Ingredient - Other Actions - Protocol Review

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)
A522 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2 $12,764 12

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

Waiver Pay Amount
50% waiver You pay ---->>>>> $6,382
75% waiver You pay ---->>>>> $3,191

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 that requires the review of a new public health efficacy protocol, or a major change to an existing efficacy method (e.g. AOAC International, ASTM, AATCC, EPA guideline 810, or an AD approved method described in A431). Applies to a study design that requires review by external members of an assembled AD Efficacy Protocol Review Expert Panel. A draft label with proposed directions for use and use claims must accompany the protocol and the application, along with proposed performance measures. The draft label submitted with this application is not  subject to the Agency’s approval under this category. Examples of major protocol changes would include surrogate consideration, field test component, simulated or in‐use testing, changes in growth conditions [e.g., novel protocols for products with label claims that don’t meet the current recommended conventional sterilant/disinfectant/sanitizer standards (e.g., treated materials). A pre‐registration meeting is recommended prior to submission of the protocol. The Agency will make every effort during this meeting to determine if the protocol is Tier 2.

Go to the start of the Decision Tree