R345 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Conventional Registration - Other Change or Amendment
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)|
|R345||Amending on- animal products previously registered, with the submission of data and/or waivers for only:||$9,261||7|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$4,631|
|75% waiver||You pay ---->>>>>||$2,315|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
This category applies to an application that proposes modifying an existing, registered label for an end use pesticide animal product by adding additional claims against pest(s) requiring efficacy for use on adults or juveniles or breeding animals of the same species. For example, spot-on products are generally labeled animal specific, in that a product is labeled for dogs or cats, but not generally both, while shampoos and sprays may be labeled for both animals (dogs and cats).
To fit this category this amendment would require the following but are not limited to:
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 amendment 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.