B750 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Biopesticide PIP Active Ingredient - New Product Experimental Use Permit
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)|
|B750||Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4)(12)||$134,012||9|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$67,006|
|75% waiver||You pay ---->>>>>||$33,503|
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 EUP to allow a registered PIP active ingredient to be used under controlled, field or actual use conditions so that the data required to support a federal registration can be developed to evaluate the PIP’s efficacy and potential for adverse effects on human health and the environment. A temporary tolerance or exemption is set for an appropriate period of time to allow the harvest of any treated food or feed commodities during the experimental period. No issues that warrant an SAP.
Example: transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
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 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.