B722 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Biopesticide SCLP Active Ingredient Registration
Below is the fee for your selected Fee Category for Fiscal Years 2020-2021
|Action Code||Description||FY'20-FY'21 Fee||Time (months)|
|B722||New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5) (6)||$2,601||7|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$1,301|
|75% waiver||You pay ---->>>>>||$650|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application for a new use for a registered SCLP active ingredient that is not covered by the SCLP tolerance exemption. A petition to amend the established tolerance exemption for SCLPs, with supporting data to demonstrate that dietary exposures to residues of the active ingredient meet the FFDCA safety standard, i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, must accompany the application.
All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.
(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 new use or amendment. 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.