B685 PRIA Fee Category

PRIA 5 Fee Determination Decision Tree:

Add a New Biochemical Unregistered Source of Active Ingredient or a New Microbial Production Site.

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)
B685	Amendment; add a new biochemical unregistered source of active ingredient or a new microbial production site; requires submission of analysis of samples data and source/production site-specific manufacturing process description.	$7,689	5

Do you plan to request eithe3r of the following types of waivers?

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$3,845
75% waiver	You pay ---->>>>>	$1,923

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 amendment to add an unregistered source of active ingredient (Integrated System as defined in 40 CFR Part 158.300) for a biochemical or to add a new production site for any microbial product containing an unregistered source of active ingredient (Integrated System as defined in 40 CFR Part 158.300). Data needed to support a new microbial active ingredient production site for products with an unregistered source are 1) an analysis of samples study generated at the new production site and, 2) a thorough description of the manufacturing process with specific attention given to any minor modifications made to the process used at the new production site. Such minor modifications may be made only if they are required for production at the new site and have no significant effect on the toxicological (mammalian or ecological) or pesticidal status of the resulting product. Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

Action Code Interpretation

An amendment to add an unregistered source of active ingredient (Integrated System as defined in 40 CFR Part 158.300) for a biochemical or to add a new production site for any microbial product containing an unregistered source of active ingredient (Integrated System as defined in 40 CFR Part 158.300). Data needed to support a new microbial active ingredient production site for products with an unregistered source are 1) an analysis of samples study generated at the new production site and, 2) a thorough description of the manufacturing process with specific attention given to any minor modifications made to the process used at the new production site. Such minor modifications may be made only if they are required for production at the new site and have no significant effect on the toxicological (mammalian or ecological) or pesticidal status of the resulting product.

Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

Go to the start of the Decision Tree

B685 PRIA Fee Category

PRIA 5 Fee Determination Decision Tree:

Add a New Biochemical Unregistered Source of Active Ingredient or a New Microbial Production Site.

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

PRIA Fees