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?
|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.
|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.