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?
|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.
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.