B927 PRIA Fee Category

An application for an EUP to allow a new exogenous RNA active ingredient to be used under controlled, field or actual use conditions so that data required for a federal registration can be developed to evaluate its efficacy and/or potential for adverse effects on humans and the environment. Exogenous RNA is defined as formulations of gene silencing/interfering RNAs applied by spraying, injection, spreading, bait formulations, mechanical inoculation, root/seek soaking, or other non-transgenic methods. A petition to establish a temporary tolerance or tolerance exemption is needed to support food/feed uses.

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 EUP. 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.