M001 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Study Protocol 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)
M001	Study protocol 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 study protocols submitted to EPA, in support of an active ingredient, which propose 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 protocol that describes research that would provide 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 from this type of research are intended to support many active ingredients, and the resulting study would not be submitted in support of a particular active ingredient. EPA will review both the scientific and ethical aspects of protocols covered by this category. If EPA determines that the protocol is of sufficiently high quality, EPA will submit its review of the protocol, 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 protocol. EPA will consider the HSRB’s advice in determining whether to approve the protocol.

Action Code Interpretation

This category includes study protocols submitted to EPA, in support of an active ingredient, which propose 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 protocol that describes research that would provide 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 from this type of research are intended to support many active ingredients, and the resulting study would not be submitted in support of a particular active ingredient.

EPA will review both the scientific and ethical aspects of protocols covered by this category.

If EPA determines that the protocol is of sufficiently high quality, EPA will submit its review of the protocol, 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 protocol. EPA will consider the HSRB’s advice in determining whether to approve the protocol.

Go to the start of the Decision Tree

M001 PRIA Fee Category

PRIA 4 Fee Determination Decision Tree:

Study Protocol Requiring Human Studies Review Board

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

PRIA Fees