M005 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
New Product Combination from a Registered and/or Unregistered Source
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)|
|M005||New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7)||$23,153||9|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$11,577|
|75% waiver||You pay ---->>>>>||$5,788|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application for registration of a new end‐use product that contains more than one registered conventional, antimicrobial or biopesticide active ingredient. The active ingredients have never been registered as this combination before. The proposed label has the same uses as those found on the registered product labels for the single active ingredients. Each active ingredient may use a registered or unregistered source of active ingredient. If using an unregistered source of any of the active ingredients, the application for the source product would reside in the respective division for processing. All of the inerts used in the product must be approved or pending with the Agency for the applicable uses. The decision review time for the pending products will carry the longest of the pending products associated with all of the actions (i.e. the source product or the inert petition timeframes). All applications require the following:
A determination on whether data can be bridged or translated to other formulation types (for the individual active ingredients) will not be done in this category.