B675 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)
B675	New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. ⁽²⁾⁽³⁾	$10,053	10

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$5,027
75% waiver	You pay ---->>>>>	$2,514

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 (MUP) and, which contains a registered source of active ingredient. If the proposed new product contains an unregistered source of active ingredient, then see category B672. New manufacturing use product is any product intended (labeled) for formulation or repackaging into an end use formulated pesticide product. The active ingredient is not a new active ingredient, but one that claims to be substantially similar or identical to another active ingredient which is currently registered (as referenced by EPA registration number) and has the selective data citation used. All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses. 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 (MUP) and, which contains a registered source of active ingredient. If the proposed new product contains an unregistered source of active ingredient, then see category B672. New manufacturing use product is any product intended (labeled) for formulation or repackaging into an end use formulated pesticide product. The active ingredient is not a new active ingredient, but one that claims to be substantially similar or identical to another active ingredient which is currently registered (as referenced by EPA registration number) and has the selective data citation used.

All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.

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

B675 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