M005 PRIA Fee Category

An application for registration of a new end‐use product that contains more than one registered conventional, antimicrobial or biopesticide active ingredient. The active ingredients have never been registered as this combination before. The proposed label has the same uses as those found on the registered product labels for the single active ingredients. Each active ingredient may use a registered or unregistered source of active ingredient. If using an unregistered source of any of the active ingredients, the application for the source product would reside in the respective division for processing. All of the inerts used in the product must be approved or pending with the Agency for the applicable uses. The decision review time for the pending products will carry the longest of the pending products associated with all of the actions (i.e. the source product or the inert petition timeframes). All applications require the following:

• Certification with Respect to Citation of Data and a data matrix
• Product chemistry data
• If applicable, acute toxicity, efficacy, and or child resistant packaging data requirements must be addressed by using; (1) the cite-all method; (2) selective data citation. A rationale for a waiver or bridging of these data can be submitted.

A determination on whether data can be bridged or translated to other formulation types (for the individual active ingredients) will not be done in this category.

• 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 combination 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 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.