A535 PRIA Fee Category
PRIA 5 Fee Determination Decision Tree:
Antimicrobial Active Ingredient - Other Actions - Protocol Review
Below is the fee for your selected Fee Category for Fiscal Years 2025-2026
| Action Code | Description | FY'25 - FY'26 Fee | Decision Time (months) |
|---|---|---|---|
| A535 | Conditional Ruling on Pre-application study waiver or data bridging Argument; applicant-initiated. | $3,627 | 6 |
Do you plan to request either of the following types of waivers?
| Waiver | Pay | Amount |
|---|---|---|
| 50% waiver | You pay ---->>>>> | $1,814 |
| 75% waiver | You pay ---->>>>> | $907 |
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
How to submit your application directly to EPA.
| Action Code Interpretation |
|---|
|
A voluntary pre-application request for a new active ingredient (a.i.) new use, or new product. The review requested is for a single study waiver associated with any of the above pre-applications. If multiple waivers are submitted the product will fail the technical screen. The study waiver request must include a written rationale for the study waiver, the identity of the active ingredient (chemical structure), and a draft label or explanation of the use pattern. The draft label submitted with this application is not subject to the Agency’s approval under this category. If a waiver request or bridging argument is submitted for a new a.i., EPA does not anticipate being able to grant the request because, if any exposures are expected to humans and/or the environment, studies providing information on the toxicity and fate and transport properties of the chemical are needed to support waiver and bridging argument requests. Agency will not review the generic data normally associated with a new chemical application under this code. The application follows after the Agency has made a ruling on the study waiver(s). If a study waiver is denied, the application for the new use or new product can only be submitted once the study has been conducted and the applicant has a complete application for registration. If a study waiver is conditionally approved, the final decision on the waiver may be changed upon the review of the formal registration application and the data accompanying the application. Formal decisions or formal feedback on study waivers will not be made in any pre-submission meetings. New uses are defined within 40 CFR § 152.3. The ruling is subject to change if more/different information becomes available with the submission of a new product, or new use. |