A527 PRIA Fee Category

PRIA 3 Fee Determination Decision Tree:

Antimicrobial New Product for Experimental Use Permit

Below is the fee for your selected Fee Category for Fiscal Years 2016/2017

Action Code	Description	FY16/17 Fee	Decision Time (months)
A527	New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2)	$ 63,945	15

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$ 31,973
75% waiver	You pay ---->>>>>	$ 15,987

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
An Experimental Use Permit (EUP) application for non-food use(s) of an active ingredient that is not contained as an active ingredient in any currently U.S. registered pesticide product. A non-food use includes a proposed use that is not a food use as described in the food use categories. Indoor means that the proposed use is for use inside of manmade structures. All indoor non-food uses included in the application are covered by the base fee for the application in this category if submitted simultaneously. A credit of 45% of the New Active Ingredient fee will be applied to the application that follows. Examples include: Residential use (i.e., carpet sanitizer, hard surface disinfectant) Commercial, institutional, industrial premise and equipment (e.g. offices, hotels, industrial buildings, nursing homes) Agricultural premise treatment (e.g., farm structures, buildings and equipment, animal drinking water equipment) Materials Preservatives (e.g., adhesives, coatings, plastic, fabric) Medical premises and equipment (e.g., dental equipment, dental unit water lines, hospitals) HVAC 45% of this category’s fee will be credited against the new active ingredient’s application fee whose submission follows that of this EUP. All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses. The Agency will provide the applicant with a pre-decisional determination 4 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested experimental use permit. If the label issues cannot be resolved prior to the PRIA decision review time due date and if a PRIA due date time extension has not been agreed upon, then the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.

Action Code Interpretation

An Experimental Use Permit (EUP) application for non-food use(s) of an active ingredient that is not contained as an active ingredient in any currently U.S. registered pesticide product. A non-food use includes a proposed use that is not a food use as described in the food use categories. Indoor means that the proposed use is for use inside of manmade structures. All indoor non-food uses included in the application are covered by the base fee for the application in this category if submitted simultaneously. A credit of 45% of the New Active Ingredient fee will be applied to the application that follows.

Examples include:

Residential use (i.e., carpet sanitizer, hard surface disinfectant)
Commercial, institutional, industrial premise and equipment (e.g. offices, hotels, industrial buildings, nursing homes)
Agricultural premise treatment (e.g., farm structures, buildings and equipment, animal drinking water equipment)
Materials Preservatives (e.g., adhesives, coatings, plastic, fabric)
Medical premises and equipment (e.g., dental equipment, dental unit water lines, hospitals)
HVAC

45% of this category’s fee will be credited against the new active ingredient’s application fee whose submission follows that of this EUP.

All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.

The Agency will provide the applicant with a pre-decisional determination 4 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested experimental use permit. If the label issues cannot be resolved prior to the PRIA decision review time due date and if a PRIA due date time extension has not been agreed upon, then the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.

Go to the start of the Decision Tree

A527 PRIA Fee Category

PRIA 3 Fee Determination Decision Tree:

Antimicrobial New Product for Experimental Use Permit

Below is the fee for your selected Fee Category for Fiscal Years 2016/2017

PRIA Decision Tree