B677 PRIA Fee Category

• product chemistry and/or
• acute toxicity and/or
• public health pest efficacy and/or
• animal safety studies and/or
• child resistant packaging ⁽²⁾⁽³⁾

An application for registration of a new microbial or biochemical pesticide end‐use animal product that is not substantially similar or identical in its uses and formulation to a product currently registered. For example, spot‐on and flea collars 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). All applications require the following:

• A data matrix is required with the application.
• Product chemistry data (Group A and B) and CSF. In some cases product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1. If the source of the active ingredient is not registered in this application; the decision review time line will be the longest of the associated application (see timeline for B672).
• 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.
• Acute toxicity, public health pest efficacy, child resistant packaging data, companion animal safety data and/or requirements must be addressed by using: 1) the cite-all method, or 2) selective data citation which includes submitting required data. A rationale for a waiver or bridging of these data falls within this category.
• 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 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 label for the end use product.

An application for a new end-use product using a source of active ingredient that is not yet registered but has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of an active ingredient. 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 new product 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 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.