R276 PRIA Fee Category

An application that proposes an additional seed treatment use only for any U.S. registered active ingredient that has limited uptake into raw agricultural commodities. In order for a food crop seed treatment to be considered in this category, residues in all raw agricultural commodities including animal feeds must be less than the level of quantitation (LOQ) requiring a tolerance at the LOQ of the enforcement method as described in the guidance. Guidance is available at Series 860 - Residue Chemistry Test Guidelines.

Examples of food uses are corn, soybean, and wheat. If a seed treatment use is proposed on ornamental seed or other non-food use seed treatments, then the application would not be in this category because it is known, without consideration of any data, that a tolerance is not required.

The fee applies to each seed treatment use requested up to 5 uses. The fee applies to each seed treatment use requested up to 5 uses (i.e. the fee for this category is multiplied by 4 if 4 seed uses are proposed). 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. If a tolerance does not need to be established, the application does not belong in this category (see R273 or R274). If six or more seed treatment uses are being proposed that require a tolerance, this is not the correct category (see R277).

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 new use(s) to registered product labels are covered by the base fee for this category as long as they are all submitted in the same package. Each application for a new product submitted in this package and/or new inert approval, however, is subject to its own registration service fee. The only exception would be if the new use(s) 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 the new use(s).

Any new product or amendment to the proposed labeling, which contains the same new use(s), that is submitted subsequent to the submission of the new use application but prior to its decision review time expiration date, will be deemed a separate new use application subject to a separate fee and new decision review time.

If the applicant on his own initiative submits any additional information that was neither requested nor required by the Agency, after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, the applicant will be charged an additional 25% of the full registration service fee for the new use application.

If the new seed treatment use(s) application include non-food (indoor and/or outdoor) and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use, and the longest decision review time applies to all of the new uses requested in the application.

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 additional use 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.

If the Agency determines that endangered species analysis is required according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended to conduct the endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. This extension is contingent on Agency issuing the ESA guidance applicable to this PRIA category.