A573 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)|
|A573||Label amendment requiring data review; 26-50 public health organisms (2) (3) (5) (7)||$6,668||6|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$3,334|
|75% waiver||You pay ---->>>>>||$1,667|
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.
Between 26 and 50 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.
Once a submission for a label amendment with public health organisms has been submitted and classified in either A570 or A573, additional organisms submitted for the same product before expiration of the first submission’s original decision review time period will result in reclassification of both the original and subsequent submission into the appropriate new category based on the sum of the number or organisms in both submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the new category.