M005 PRIA Fee Category

PRIA 5 Fee Determination Decision Tree:

New Product Combination from a Registered and/or Unregistered Source

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)
M005	New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. ⁽⁴⁾ ⁽⁵⁾ ⁽⁶⁾	$33,185	9

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$16,593
75% waiver	You pay ---->>>>>	$8,297

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 for registration of a new end-use product that contains more than one registered conventional, antimicrobial or biopesticide active ingredient. The active ingredients have never been registered as this combination before. The proposed label has the same uses as those found on the registered product labels for the single active ingredients. Each active ingredient may use a registered or unregistered source of active ingredient. If using an unregistered source of any of the active ingredients, the application for the source product would reside in the respective division for processing. All of the inerts used in the product must be either approved, pending with the Agency, or a new inert petition submitted within the package for the applicable uses (food or nonfood). The decision review time for the pending products will carry the longest of the pending products associated with all of the actions (i.e. the source product or the inert petition timeframes). All applications require the following: Certification with Respect to Citation of Data and a data matrix Product chemistry data If applicable, acute toxicity, efficacy, and or child resistant packaging data requirements must be addressed by using; (1) the cite-all method; (2) selective data citation. A rationale for a waiver or bridging of these data can be submitted. A determination on whether data can be bridged or translated to other formulation types (for the individual active ingredients) will not be done in this category. 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 new combination product registration.

Action Code Interpretation

An application for registration of a new end-use product that contains more than one registered conventional, antimicrobial or biopesticide active ingredient. The active ingredients have never been registered as this combination before. The proposed label has the same uses as those found on the registered product labels for the single active ingredients. Each active ingredient may use a registered or unregistered source of active ingredient. If using an unregistered source of any of the active ingredients, the application for the source product would reside in the respective division for processing. All of the inerts used in the product must be either approved, pending with the Agency, or a new inert petition submitted within the package for the applicable uses (food or nonfood). The decision review time for the pending products will carry the longest of the pending products associated with all of the actions (i.e. the source product or the inert petition timeframes). All applications require the following:

Certification with Respect to Citation of Data and a data matrix
Product chemistry data
If applicable, acute toxicity, efficacy, and or child resistant packaging data requirements must be addressed by using; (1) the cite-all method; (2) selective data citation. A rationale for a waiver or bridging of these data can be submitted.

A determination on whether data can be bridged or translated to other formulation types (for the individual active ingredients) will not be done in this category.

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 new combination product registration.

Go to the start of the Decision Tree

M005 PRIA Fee Category

PRIA 5 Fee Determination Decision Tree:

New Product Combination from a Registered and/or Unregistered Source

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

PRIA Fees