R352 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Conventional Registration - Change Product Label
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)|
|R352||Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data (2) (3)||$13,888||8|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$6,944|
|75% waiver||You pay ---->>>>>||$3,472|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application that proposes modification in the label of a registered end-use or manufacturing product, which is substantially similar or identical to a currently registered product and proposes to add uses to the label that already exist on the label of the substantially similar or identical product identified by the applicant. This category does not require review of new data or bridging of data. Data that are selectively cited to support the amendment must have already been reviewed by the Agency for the same uses, formulation type, active ingredient and claims. Review of efficacy and/or performance data are not included in this category. To fit into this category applications require the following:
(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant- initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
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.