B932 PRIA Fee Category

An application to amend a registered Emerging Technologies product. This category includes amendments involving data review, including changes in the label (such as use patterns, use site changes) or to add an alternate formulation, or change the basic formulation of a currently registered product. These data include (but are not limited to): toxicity data, product chemistry data, manufacturing process, non‐target toxicity data, efficacy/product performance, and data to support a new pattern of use (e.g., increased application rate, different application methods) that changes the potential for human and/or environmental risks or exposure. Emerging Technologies products are defined as registered non-PIP products issued under categories B922, B924, B926, B928, and B929 in Table 17.

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 active ingredient 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.