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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 Years 2014/2015

Action Code Description FY14/15
Fee
Decision Time
(months)
B684 Amending non-food animal product that includes submission of target animal safety data; previously registered (2) $ 8,400 8

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
Generally 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 and flea collar products are generally labeled species specific, in that a product is labeled for dogs or cats, but not generally both, while shampoos and sprays may be labeled for both species (dogs and cats). This amendment would require the following:
  • A data matrix and data compensation forms are required with the application.
  • All of the inerts used in the product 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 on 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.
  • Proposed amended label for the end use product.
  • EPA-initiated amendment shall not be charged fees. Label amendments submitted by notification under PR Notices, such as and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.

    (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.


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