B660 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)
B660	New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. ⁽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 an end-use or a manufacturing use microbial or biochemical pesticide product that is substantially similar, identical in its uses and formulation, or that differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment to products that are currently registered 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. The applicant must identify the similar registered products for all active ingredients in the proposed product. All applications require the following: A data matrix is required with the application if it is not a 100% re-packaged product. Product chemistry data (Group A and B) unless the product is identical (e.g., 100% repackaged product). In some cases, product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1. The active ingredient(s) must be currently registered and the CSF must include its EPA Registration Number(s). In all cases, the registrant must identify the registered similar product for this category. Acute toxicity requirements must be addressed by using: The cite-all method Selective data citation where the applicant owns all required data, or Applicant submits specific authorization letter from the data owner The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or child resistant packaging data are submitted and must be reviewed to support the application. The application does not fall into this category if it contains a request to waive any of these data. An application that requires review of cited or submitted data other than product chemistry does not belong in this fee category. If the use pattern on the TGAI differs from the proposed products, then additional data are required and the application does not fall within this category. Substantially similar: Product must have the same active ingredient, in substantially the same proportion, same chemical composition (solid, liquid, granular), and substantially similar inert ingredients as the already registered product. In addition, substantially similar means that the proposed product bears the same use pattern. Adding to or changing existing use patterns excludes the proposed product from treatment as a substantially similar product. Deleting use patterns is acceptable. Identical: Same composition and use patterns as a currently registered end-use product. Manufacturing Use Product: A 100% re-package of a manufacturing use product that requires no data submission or data matrix is covered by this category. 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 an end-use or a manufacturing use microbial or biochemical pesticide product that is substantially similar, identical in its uses and formulation, or that differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment to products that are currently registered 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. The applicant must identify the similar registered products for all active ingredients in the proposed product. All applications require the following:

A data matrix is required with the application if it is not a 100% re-packaged product.
Product chemistry data (Group A and B) unless the product is identical (e.g., 100% repackaged product). In some cases, product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1. The active ingredient(s) must be currently registered and the CSF must include its EPA Registration Number(s).
In all cases, the registrant must identify the registered similar product for this category.
Acute toxicity requirements must be addressed by using:
1. The cite-all method
2. Selective data citation where the applicant owns all required data, or
3. Applicant submits specific authorization letter from the data owner

The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or child resistant packaging data are submitted and must be reviewed to support the application. The application does not fall into this category if it contains a request to waive any of these data. An application that requires review of cited or submitted data other than product chemistry does not belong in this fee category. If the use pattern on the TGAI differs from the proposed products, then additional data are required and the application does not fall within this category.

Substantially similar: Product must have the same active ingredient, in substantially the same proportion, same chemical composition (solid, liquid, granular), and substantially similar inert ingredients as the already registered product. In addition, substantially similar means that the proposed product bears the same use pattern. Adding to or changing existing use patterns excludes the proposed product from treatment as a substantially similar product. Deleting use patterns is acceptable.

Identical: Same composition and use patterns as a currently registered end-use product.

Manufacturing Use Product: A 100% re-package of a manufacturing use product that requires no data submission or data matrix is covered by this category.

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

B660 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