A537 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Antimicrobial New Active Ingredient/New Active Use, Experiment Use Permit
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)|
|A537||New Active Ingredient/New Use, Experimental Use Permit application; Direct food use; Establish tolerance or tolerance exemption if required. Credit 45% of fee toward new active ingredient/new use application that follows.||$160,814||18|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$80,407|
|75% waiver||You pay ---->>>>>||$40,204|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An Experimental Use Permit (EUP) application for direct food use(s) of an active ingredient that is not currently registered. The Antimicrobial Pesticide Use Site Index (USI) describes direct food uses and provides guidance to determine if labeled uses require the establishment of a tolerance or exemption from the requirement of a tolerance. The USI gives examples of the general types of use sites that are commonly listed on antimicrobial labels. All direct food uses included in any original application or petition for a new active ingredient are covered by the base fee for the application in this category if submitted simultaneously. A credit of 45% of the New Active Ingredient fee will be applied to the application that follows.
45% of this category’s fee will be credited against the new active ingredient’s application fee whose submission follows that of this EUP.
All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.
The Agency will provide the applicant with a pre‐decisional determination 4 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested experimental use permit. If the label issues cannot be resolved prior to the PRIA decision review time due date and if a PRIA due date time extension has not been agreed upon, then the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.