B928 PRIA Fee Category
PRIA 5 Fee Determination Decision Tree:
New Registration - New Active Ingredient - Food Use
Below is the fee for your selected Fee Category for Fiscal Years 2025-2026
| Action Code | Description | FY'25-FY'26 Fee | Decision Time (months) |
|---|---|---|---|
| B928 | Registration application; new active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; with petition to establish a permanent tolerance/tolerance exemption of an active ingredient. (5) (12) (14) | $144,071 | 22 |
Do you plan to request either of the following types of waivers?
| Waiver | Pay | Amount |
|---|---|---|
| 50% waiver | You pay ---->>>>> | $72,036 |
| 75% waiver | You pay ---->>>>> | $36,018 |
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 for registration of a new exogenous RNA active ingredient. Exogenous RNA is defined as formulations of gene silencing/interfering RNAs applied by spraying, injection, spreading, bait formulations, mechanical inoculation, root/seek soaking, or other non-transgenic methods. A petition to establish a permanent tolerance or tolerance exemption is needed to support food/feed uses. The tolerance or exemption petition can (but is not required to) be based on a temporary exemption previously established for an EUP. 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. |