B683 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Biopesticide Biochemical/Microbial Registration
Below is the fee for your selected Fee Category for Fiscal Years 2022-2023
|Decision Time (months)
|Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2) (3)
Do you plan to request either of the following types of waivers?
|You pay ---->>>>>
|You pay ---->>>>>
o pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation
Modification in the label of a registered product that is not substantially similar to a currently registered product and that requires review and Agency determination of whether the existing database would support a change or modification to the amended label. Agency update of existing risk analysis/assessment may be required. No data is submitted to support this label amendment. Examples of actions in this category include: label changes to Directions for Use (including restricted entry intervals (REI), personal protective equipment (PPE), pre‐harvest interval (PHI), application rate, application frequency, application timing, addition of aerial or chemigation application methods consistent with PR Notices 87‐1 and 93‐2, ground water or surface water advisory statements, etc. that require risk analysis by EPA.
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.
(a) 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 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.