A536 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)|
|A536||Conditional Ruling on Pre-application Direct Food, Indirect Food, Nonfood use determination; applicant-initiated||$2,607||4|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$1,304|
|75% waiver||You pay ---->>>>>||$652|
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 direct, indirect or nonfood food determination associated with any of the above pre-applications. The fee for this category is for a single determination request. The request must include a written rationale for the proposed use determination, the identity of the new active ingredient (chemical structure), and a draft label or explanation of the use pattern. A 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 use determination(s). Once a determination is made, the application for the new active ingredient, new use or new product can only be submitted once the appropriate studies have been conducted and the applicant has a complete application for registration. Once a decision on the use pattern has been made, the decision is conditional upon the review of the formal registration application and the data accompanying the application. Formal decisions or formal feedback on the proposed use pattern will not be made in any pre-submission meetings.
New uses are defined within 40CFR part 152.3(p)