R295 PRIA Fee Category

A petition that proposes to establish tolerances for each crop that is rotated and results in rotational crop residues. The active ingredient is currently contained in a pesticide product registered in the U.S. The fee to establish tolerances for each crop will be multiplied by the number of crops in the petition e.g., for 5 crops, the fee will be multiplied 5 times the fee for this category). If a crop group or subgroup is requested, the fee is based on the number of representative crops in that group or subgroup that are not currently registered. If all of the representative crops have been registered, then requesting the crop group will count as one additional use. This category covers the establishment of the rotational crop tolerance as well as any corresponding label amendments which specify necessary plant-back restrictions. Additional amendment requests not related to the proposed tolerance amendment would not be covered under this category.

All of the inerts used in the product must be either approved, pending with the Agency, or a new inert petition submitted within the package for the applicable uses (food or nonfood).

Amendment applications to add the revised use pattern(s) to registered product labels are covered by the base fee for this category. All items in the covered application must be submitted together in one package. Each application for a new product registration and/or new inert approval(s) that is submitted in this application package is subject to its own registration service fee. The only exception would be if the revised use pattern were to be added only to a new product (no amendments to registered product labels in the application package) in which case the review of the one new product application would be covered by the base fee for this category.  All such associated applications that are submitted together will be subject to the category decision review time.

The Agency will provide the applicant with a pre-decisional determination 4 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 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.