R345 PRIA Fee Category

• animal safety and
• pest(s) requiring efficacy and/or
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging ^{(2) (3) (4)}

This category applies to an application that proposes modifying an existing, registered label for an end use pesticide animal product by adding additional claims against pest(s) requiring efficacy for use on adults or juveniles or breeding animals of the same species. 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 but are not limited to: 

• 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 animal safety 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.
• 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.

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.