B673 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Biochemical or Microbial Biopesticide Active Ingredient - New Product 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)|
|B673||New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2)(3)||$5,363||10|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$2,682|
|75% waiver||You pay ---->>>>>||$1,341|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application for registration of a new microbial or biochemical pesticide product (MUP or end use product) containing an unregistered source of a registered active ingredient for which the data cited to fulfill all TGAI data requirements has been previously reviewed and accepted by the Agency. If an update to the TGAI risk assessment is required, then this category does not apply. See category B672.
For microbial pesticides this category does not apply when data to demonstrate similarity is needed to bridge to previously reviewed and accepted data. See Table 11; New Active Ingredients.
All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.
An application for a new end‐use product using a source of active ingredient that is not yet registered but has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of an active ingredient.
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 product 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 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.