B810 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Biopesticides PIP Active Ingredient New Registration - New AI - Food Use
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)|
|B810||Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. (5) (12)||$247,920||19|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$123,960|
|75% waiver||You pay ---->>>>>||$61,980|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application for a new PIP active ingredient for a food/feed use. A temporary tolerance or a temporary exemption from a tolerance already exists to support a EUP for the active ingredient. A permanent tolerance or tolerance exemption is needed for registration. A petition to establish a tolerance or exemption from the requirement of a tolerance with supporting data must accompany the application. Issues that warrant an SAP.
This category is used for full commercial registration; a seed increase registration can be obtained under B882, B883, B884, B885, or B886.
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 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.