A570 PRIA Fee Category
PRIA 3 Fee Determination Decision Tree:
Amend Antimicrobial Product Label Registration
Below is the fee for your selected Fee Category for Fiscal Years 2016/2017
|Action Code||Description||FY16/17 Fee||Decision Time (months)|
|A570||Label amendment requiring data review (3) (4)||$ 3,831||4|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 1,916|
|75% waiver||You pay ---->>>>>||$ 958|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application for amended registration which requires review of data. This includes chemistry, toxicology, efficacy or other science review. Examples include:
NOTE: Any significant increase in exposure requiring science review (increase in dosage rate, different method of application (fog vs. spray) will be treated as a new use.
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 label 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.
(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.