M002 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Complete Study Requiring Human Studies Review Board

Below is the fee for your selected Fee Category for Fiscal Years 2022-2023

Action Code	Description	FY'22-FY'23 Fee	Decision Time (months)
M002	Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient ⁽⁴⁾	$8,752	9

Do you plan to request either of the following types of waivers?

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$4,376
75% waiver	You pay ---->>>>>	$2,188

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
This category includes completed studies submitted to EPA, in support of an active ingredient, which report research involving intentional exposure of a human subject, as those terms are defined in 40 CFR parts 26.1102(d), (e), and (i). Worker exposure studies and insect repellant efficacy studies are the most common types of studies submitted to OPP that may meet the regulatory definition of “research involving intentional exposure.” A study conducted to generate data to populate a generic database such as the Agricultural Handler Exposure Database (AHED) or the Biocide Handler Exposure Database (BHED) will not be considered a PRIA action because the data are not intended to be used to support a particular active ingredient. EPA will review both the scientific and ethical aspects of completed studies covered by this category. EPA will submit its review of the completed study, together with the available supporting materials, to the Human Studies Review Board (HSRB). The HSRB will provide comment on both the scientific and ethical aspects of the study. EPA will consider the HSRB’s advice in determining whether to rely on the study. Any other covered application that is associated with and dependent upon the HSRB review will be subject to its separate fee. The decision review time for the associated action will run concurrently with that of the HSRB review but will end at the date of the latest review time.

Action Code Interpretation

This category includes completed studies submitted to EPA, in support of an active ingredient, which report research involving intentional exposure of a human subject, as those terms are defined in 40 CFR parts 26.1102(d), (e), and (i). Worker exposure studies and insect repellant efficacy studies are the most common types of studies submitted to OPP that may meet the regulatory definition of “research involving intentional exposure.”

A study conducted to generate data to populate a generic database such as the Agricultural Handler Exposure Database (AHED) or the Biocide Handler Exposure Database (BHED) will not be considered a PRIA action because the data are not intended to be used to support a particular active ingredient.

EPA will review both the scientific and ethical aspects of completed studies covered by this category. EPA will submit its review of the completed study, together with the available supporting materials, to the Human Studies Review Board (HSRB). The HSRB will provide comment on both the scientific and ethical aspects of the study. EPA will consider the HSRB’s advice in determining whether to rely on the study.

Any other covered application that is associated with and dependent upon the HSRB review will be subject to its separate fee. The decision review time for the associated action will run concurrently with that of the HSRB review but will end at the date of the latest review time.

Go to the start of the Decision Tree

M002 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Complete Study Requiring Human Studies Review Board

Below is the fee for your selected Fee Category for Fiscal Years 2022-2023

PRIA Fees