B685 PRIA Fee Category

PRIA 4 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 2022-2023

Action Code	Description	FY'22-FY'23 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.⁽³⁾	$5,632	5

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$2,816
75% waiver	You pay ---->>>>>	$1,408

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
Amendment to add an unregistered source of active ingredient for a biochemical or to add a new production site for a microbial active ingredient. Applies to technical grade active ingredients and manufacturing use products only. Does not apply to an end-use product using a registered source of active ingredient. Does apply to an end-use product produced by an Integrated System as defined in 40 CFR Part 158.300. Requires the submission of confirmatory analysis of samples data for the new source or production site, and an updated manufacturing process description specific to the source or production site, to ensure a comparable source or production. EPA-initiated amendments shall not be charged fees. Label amendments submitted by notification under PR Notices, such as and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees. EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees. 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 active ingredient 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

Amendment to add an unregistered source of active ingredient for a biochemical or to add a new production site for a microbial active ingredient. Applies to technical grade active ingredients and manufacturing use products only. Does not apply to an end-use product using a registered source of active ingredient. Does apply to an end-use product produced by an Integrated System as defined in 40 CFR Part 158.300. Requires the submission of confirmatory analysis of samples data for the new source or production site, and an updated manufacturing process description specific to the source or production site, to ensure a comparable source or production.

EPA-initiated amendments shall not be charged fees. Label amendments submitted by notification under PR Notices, such as and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.

EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

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 active ingredient 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.

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