A521 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)|
|A521||Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1||$4,963||4|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$2,482|
|75% waiver||You pay ---->>>>>||$1,241|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application that requires the review of a modified protocol where only minor changes are made to an existing efficacy method (e.g. AOAC International, ASTM, AATCC, EPA guideline 810 or an AD approved method described in A431). A draft label with proposed directions for use and use claims must accompany the protocol and the application. The draft label submitted with this application is not subject to the Agency’s approval under this category. Examples of minor changes include: varied test conditions modification of standard method to support additional microorganisms [e.g., Germicidal Spray Products test for spore‐formers], and changes to support alternate application types [e.g., foams]. A pre‐registration meeting is recommended prior to submission of the protocol. The Agency will make every effort during this meeting to determine if the protocol is Tier 1. If during further review, the Agency determines that a Tier l protocol should be elevated to Tier 2 status (A522), the applicant will receive notification prior to this change.