R332 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Conventional New Product Registration - Manufacturing Use

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)
R332	New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science division (2) (3)	$297,376	24

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$148,688
75% waiver	You pay ---->>>>>	$74,344

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 manufacturing use pesticide product that is not substantially similar or identical in its formulation to products that are currently registered. New manufacturing use product is any product intended (labeled) for formulation or repackaging into an end use formulated pesticide product. This product does not contain directions for use of the product as distributed or sold, or after combination by the user with other substances. To fit this category all applications require the following but are not limited to: A data matrix is required with the application. Product chemistry data (Group A and B) and CSF. Acute toxicity data must be addressed by submitting data or using: selective data citation. A rationale for a waiver or bridging of these data falls within this category. The source of the active ingredient is unregistered The proposed uses must already be on currently registered products. The applicant must cite the similar product with the proposed uses. The application contains generic data such as toxicity, environmental fate and/or eco-toxicity. 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 new manufacturing-use 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 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 for registration of a manufacturing use pesticide product that is not substantially similar or identical in its formulation to products that are currently registered. New manufacturing use product is any product intended (labeled) for formulation or repackaging into an end use formulated pesticide product. This product does not contain directions for use of the product as distributed or sold, or after combination by the user with other substances. To fit this category all applications require the following but are not limited to:

A data matrix is required with the application.
Product chemistry data (Group A and B) and CSF.
Acute toxicity data must be addressed by submitting data or using: selective data citation. A rationale for a waiver or bridging of these data falls within this category.
The source of the active ingredient is unregistered
The proposed uses must already be on currently registered products.
The applicant must cite the similar product with the proposed uses.
The application contains generic data such as toxicity, environmental fate and/or eco-toxicity.

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 new manufacturing-use 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 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

R332 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Conventional New Product Registration - Manufacturing Use

Below is the fee for your selected Fee Category for Fiscal Years 2020-2021

PRIA Decision Tree