B677 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Biopesticide Biochemical/Microbial New Use Registration
Below is the fee for your selected Fee Category for Fiscal Years 2020-2021
|Decision Time (months)
|New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only:
Do you plan to request either of the following types of waivers?
|You pay ---->>>>>
|You pay ---->>>>>
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 end‐use animal product that is not substantially similar or identical in its uses and formulation to a product currently registered. For example, spot‐on and flea collars products are generally labeled species specific, in that a product is labeled for dogs or cats, but not generally both, while shampoos and sprays may be labeled for both species (dogs and cats). All applications require the following:
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.