A565 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Antimicrobial Product Label 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)|
|A565||New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of new generic data package; registered uses only; requires science review (2) (3)||$19,146||12|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$9,573|
|75% waiver||You pay ---->>>>>||$4,787|
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 manufacturing use pesticide product that is not substantially similar or identical in its formulation to products that are currently registered. The proposed product contains an active ingredient that is currently registered. The source of the active ingredient is not registered. New manufacturing use product is any product intended (labeled) for formulation or repackaging into an end use formulated pesticide product. This category may also include an end-use product relying on a new generic data package.
To fit this category all applications require the following:
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 manufacturing-use 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 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.