B681 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Biopesticide Biochemical/Microbial 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)|
|B681||Amendment; unregistered source of active ingredient(s). Requires data submission. (2)(3)||$6,383||7|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$3,192|
|75% waiver||You pay ---->>>>>||$1,596|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application to amend a registration is in this category when it contains data to support a change in the label (such as use patterns, use site changes) or to add an alternate formulation or change the basic formulation of a currently registered product. These data include but are not limited to: toxicity data, non‐target toxicity data, efficacy/product performance, child‐ resistant packaging data, additional (unregistered) sources of the active ingredient with supporting chemistry data, manufacturing process, efficacy (if public health pests are claimed), and data to support a pattern of use (e.g., increased application rate, different application methods) that changes the potential for human and/or environmental risks or exposure.
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 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.