B670 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)|
|B670||New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)(3)||$5,363||7|
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 microbial or biochemical pesticide product that is not substantially similar or identical in its uses and/or formulation to products that are currently registered and, which contains a registered source of active ingredient. If the proposed new product contains an unregistered source of active ingredient, then see category B672. These applications require product specific chemistry data, acute toxicity data and other Tier I mammalian and non-target toxicity data as determined by the general use patterns for the product. When public health pests are claimed, efficacy (product performance) data for the product must be submitted. Formulator’s exemption for the data requirements can be claimed when the source of the TGAI is registered by another pesticide registrant. If the registered source of the active ingredient is owned by the current applicant, Formulator’s exemption is not applicable. The data used to support the registered source is instead referenced on the applicant’s data matrix. This category is not for a new use.
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.