R352 PRIA Fee Category

PRIA 5 Fee Determination Decision Tree:

PRIA Conventional Active Ingredient - Amend Registration - Adding approved uses by selective citation

Below is the fee for your selected Fee Category for Fiscal Years 2025-2026

Action Code	Description	FY'25 - FY'26 Fee	Decision Time (months)
R352	Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data. ⁽²⁾ ⁽³⁾	$19,906	8

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$9,953
75% waiver	You pay ---->>>>>	$4,977

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 proposes modification in the label of a registered end-use or manufacturing use product, which is substantially similar or identical to a currently registered product and proposes to add uses to the label that already exist on the label of that single substantially similar or identical product identified by the applicant. This category does not require review of new data or bridging of data. Data that are selectively cited to support the amendment must have already been reviewed by the Agency for the same uses, formulation type, active ingredient and claims. This code is not applicable to products that are currently registered as 100% repack of a registered product. Review of product chemistry/acute toxicity/efficacy and/or performance data are not included in this category. To fit into this category, applications require the following: A completed data matrix is required identifying the selective method of support. The application/amendment form must cite the substantial similar or identical product where the uses already exist. If using the cite-all method of support, the amendment application does not fall into this category, and may be considered as a non-PRIA fast-track submission. EPA-initiated amendments shall not be charged registration service fees. The Agency will provide the applicant with a pre-decisional determination 2 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 amendment registration. 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.

Action Code Interpretation

An application that proposes modification in the label of a registered end-use or manufacturing use product, which is substantially similar or identical to a currently registered product and proposes to add uses to the label that already exist on the label of that single substantially similar or identical product identified by the applicant. This category does not require review of new data or bridging of data. Data that are selectively cited to support the amendment must have already been reviewed by the Agency for the same uses, formulation type, active ingredient and claims. This code is not applicable to products that are currently registered as 100% repack of a registered product. Review of product chemistry/acute toxicity/efficacy and/or performance data are not included in this category.

To fit into this category, applications require the following:

A completed data matrix is required identifying the selective method of support.
The application/amendment form must cite the substantial similar or identical product where the uses already exist.
If using the cite-all method of support, the amendment application does not fall into this category, and may be considered as a non-PRIA fast-track submission.

EPA-initiated amendments shall not be charged registration service fees.

The Agency will provide the applicant with a pre-decisional determination 2 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 amendment registration. 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.

Go to the start of the Decision Tree

R352 PRIA Fee Category

PRIA 5 Fee Determination Decision Tree:

PRIA Conventional Active Ingredient - Amend Registration - Adding approved uses by selective citation

Below is the fee for your selected Fee Category for Fiscal Years 2025-2026

PRIA Fees