R315 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Conventional Registration - New Use - Non-Food Use
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)|
New end-use on-animal product, registered source of active ingredient(s) with submission of data and/or waivers for only:
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$5,156|
|75% waiver||You pay ---->>>>>||$2,578|
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 for registration of a new end-use on-animal product where animal safety studies are required to be submitted or cited. The types of product that require animal safety studies include, but are not limited to, spot-ons, flea collars, shampoos and sprays.
To fit this category all applications require the following but are not limited to:
An application proposed as a 100% re-packaged product does not fall within this category (see category R300). The application does not fall into this category if it contains a request to waive generic data or a request to review any generic data. Even if the Agency may have reviewed the animal safety data previously, a product citing those data will need to be re-assessed for applicability of those data to the new product. (If the new product is a 100% repack of a registered product, the R300 category applies. If selective citation is utilized and the formulation is identical to the cited product, the R301 category may apply.)
Applications for new end use products that are submitted using an unregistered source of an existing active ingredient will be recoded to either category R333 or R334. All active ingredients derived from a manufacturing source which does not hold an active EPA registration number are considered unregistered. Even if the Agency may have reviewed the product chemistry data previously for that source of the active ingredient for another end use product, the active ingredient is considered unregistered.
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 end-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.