B641 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 2020-2021
|Action Code||Description||FY'20-FY'21 Fee||Decision Time (months)|
|B641||Amendment of an established tolerance or tolerance exemption.||$13,403||13|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$6,702|
|75% waiver||You pay ---->>>>>||$3,351|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
A petition to amend an established tolerance for a microbial or biochemical pesticide, with supporting data to demonstrate that dietary exposures to residues of the active ingredient at the tolerance level meet the FFDCA standard of reasonable certainty of no harm. This category includes amendments to temporary tolerances, such as those established in connection with an experimental use permit. In addition to the petition, there may be an application to register a product, or to amend an existing registered product or experimental use permit. All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.
The Agency will provide the applicant with a pre-decisional determination 4 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 first food use 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.