An application for a product containing a new active ingredient SCLP which either has no food uses or if there is a food use, is anticipated to meet the existing tolerance exemption for SCLPs.

All uses (food and/or non-food) included in any original application or petition for a first food use that otherwise satisfy the conditions for the category are covered by the base fee.

All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.

A maximum of five new products are covered by the base fee. After the first five new products, each application for an additional new product or new inert ingredient approval that is submitted within this new active ingredient package is subject to the registration service  fee for a new product or a new inert ingredient approval. All such associated applications that are submitted together will be subject to the new active ingredient decision review time.

Until the new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be charged a new active ingredient service fee and decision review timeframe.

Any additional information that was neither requested nor required by the Agency, submitted at the applicant’s initiative after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, shall be assessed an additional 25% of the full service fee.

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. 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.