B730 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Amend Biopesticide SCLP Amended Registration for Changing Product Label

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)
B730	Label amendment requiring data submission. ^{(4) (6)}	$1,342	5

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$671
75% waiver	You pay ---->>>>>	$336

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 to amend an existing registration containing an SCLP active ingredient. The application contains for Agency review data that is submitted to support a change to the formulation and/or data that is necessary to support a product labeling change (e.g., use pattern, use sites, etc.) EPA-initiated amendments shall not be charged fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 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 use or amendment. 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 to amend an existing registration containing an SCLP active ingredient. The application contains for Agency review data that is submitted to support a change to the formulation and/or data that is necessary to support a product labeling change (e.g., use pattern, use sites, etc.)

EPA-initiated amendments shall not be charged fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 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 use or amendment. 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

B730 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Amend Biopesticide SCLP Amended Registration for Changing Product Label

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

PRIA Decision Tree