A574 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Antimicrobial Product Label 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)|
|A574||Label amendment requiring data review; ≥ 51 public health organisms. (2) (3) (5) (7)||$11,550||9|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$5,775|
|75% waiver||You pay ---->>>>>||$2,888|
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 an existing registration which requires review of product-specific data. This includes product chemistry, acute toxicology, and efficacy data. Examples include:
Excludes: Product-specific data required as a term of registration, such as storage stability data.
NOTE: Any significant increase in exposure requiring science review/a risk assessment (increase in rate, different method of application (fogging vs. spraying) will be treated under category A572, or as a new use.
A minimum of 51 public health organisms must be requested within a single application under this PRIA category. The number of supporting data volumes per organism does not impact the total organism count. One organism is counted irrespective of the total number of organisms that must be tested to support a marketing claim/ testing protocol/data guideline.
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.