Jump to main content.


Pesticide Registration Improvement Extension Act (PRIA 3)
Fee Determination Decision Tree

Decision Tree Resources:

Below is the fee for your selected Fee Category for Fiscal Year 2014 & 2015

Action Code Description FY14/FY15
Fee
Decision Time
(months)
R345 Amending non-food animal product that includes submission of target animal safety data; previously registered (2) (3) $ 8,400 7

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


50% waiver You pay ---->>>>> $ 4,200  
75% waiver You pay ---->>>>> $ 2,100  

To pay the fee shown above, go to http://www.pay.gov and follow the instructions.

How to submit your application directly to EPA.


Action Code Interpretation

An application that proposes modifying an existing, previously registered label by adding additional claims for use on adults or juveniles or breeding animals of the same species. An application to amend a registered end-use pesticide animal product. For example, spot-on products are generally labeled animal specific, in that a product is labeled for dogs or cats, but not generally both, while shampoos and sprays may be labeled for both animals (dogs and cats). To fit this category this amendment would require the following:

  • A data matrix and data compensation forms are required with the application.
  • All of the inerts listed on the must be either approved or pending with the Agency for the applicable uses. In those cases where the product relies upon a pending inert clearance, the new companion animal studies must be conducted with the pending inert in the tested product as it is intended to be marketed and sold as the end use product.
  • Same species of animal previously listed on registered label.
  • If new efficacy claims are sought, then new pest efficacy data matching the claim(s) are required.
  • If the packing type has changed ( e.g., spot-on vs. stripe-on) so that the dose volume is altered (new or different), new child resistant packaging data is required.
  • Which companion animal safety studies are required is based upon the specific label claims in the proposed label. For example, if the proposed end use product label claim is to use the product on 12-week old kittens weighing =3 lbs and on breeding cats, then two companion animal studies are required: the first using kittens = 12 weeks of age and weighing at least 3 lbs. and a second study on pregnant and nursing adult cats. Each of these studies must demonstrate an adequate margin of safety.

(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 9810, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

The Agency will provide the applicant with a pre-decisional determination 2 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 amendment registration. 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

Publications | Glossary | A-Z Index | Jobs


Local Navigation


Jump to main content.