B674 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Biochemical or Microbial Biopesticide Active Ingredient - New Product Registration

Below is the fee for your selected Fee Category for Fiscal Years 2022-2023

Action Code	Description	FY'22-FY'23 Fee	Decision Time (months)
B674	New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only ⁽²⁾⁽³⁾	$1,410	4

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$705
75% waiver	You pay ---->>>>>	$353

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 microbial or biochemical pesticide manufacturing use product that is identical in its formulation and uses to end use products that are currently registered. All applications require the following: A formulator’s exemption statement The applicant must identify the registered identical product for this category The active ingredient listed on the CSF must be an EPA registered product in order to satisfy the data requirements for the active ingredient. If the use pattern for the proposed product differs from the currently registered product, then additional data are required and the application does not fall within this category (see applicable new use categories). An application for a new end-use product using a source of active ingredient that is not yet registered but has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of an active ingredient. 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 product 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 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 for registration of a new microbial or biochemical pesticide manufacturing use product that is identical in its formulation and uses to end use products that are currently registered. All applications require the following:

A formulator’s exemption statement
The applicant must identify the registered identical product for this category
The active ingredient listed on the CSF must be an EPA registered product in order to satisfy the data requirements for the active ingredient.

If the use pattern for the proposed product differs from the currently registered product, then additional data are required and the application does not fall within this category (see applicable new use categories).

An application for a new end-use product using a source of active ingredient that is not yet registered but has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of an active ingredient.

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 product 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 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

B674 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Biochemical or Microbial Biopesticide Active Ingredient - New Product Registration

Below is the fee for your selected Fee Category for Fiscal Years 2022-2023

PRIA Fees