A535 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Antimicrobial Active Ingredient - Other Actions - Protocol Review
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)|
|A535||Conditional Ruling on Pre-application Study Waiver or Data Bridging Argument; applicant-initiated||$2,530||6|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$1,265|
|75% waiver||You pay ---->>>>>||$633|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
A pre-application request for an active ingredient, new use, or new product. The request is for review of each study waiver associated with any of the above pre-applications. The fee for this category is for a single waiver request. The study waiver request must include a written rationale for the study waiver, the identity of the new 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. 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 active ingredient, 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 given approval, the final decision on the waiver is conditional 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 40CFR part 152.3(p)