R351 PRIA Fee Category

An application that proposes the addition of a new unregistered source of active ingredient to a registered product. A multiplier applies for each individual manufacturing site/new unregistered source being added under one package. If the submission includes addition of multiple unregistered sources/production sites, Group A data for each unregistered source should be submitted in separate MRIDs. Alternatively, separate R351 applications can be submitted for each new manufacturing site/new unregistered source. An example of this category would be adding a new production facility for a registered technical product or adding a source of a.i. to an end use product that is not an EPA-registered source product. 

To fit this category, all applications require the following:

• Certification with respect to Citation of Data and Data Matrix.
• 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).
• If amending an MUP, then one set of product specific product chemistry data and CSF is required (under #1 below).
• If amending an end-use product, then two sets of product chemistry data are required (under #1 and #2 below).

1. Product chemistry (Group A and B) on the unregistered source of the active ingredient and CSF. The applicant must identify to the Agency the toxicity of the impurities associated with the active ingredient; particularly impurities of toxicological significance (at any level). The impurity profile of the unregistered source of the active ingredient will be compared to registered source. The impurity profile of the unregistered source of the active ingredient either results in new impurities; or impurities of toxicological significance, or if the toxicity of new impurities are unknown to the applicant, then the application is submitted to HED for review. 
2.  Product chemistry data (Group A and B) for the end use product and CSF. In some cases, product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1.

• Acute toxicity, public health pest efficacy and/or child resistant packaging data requirements must be addressed by using selective data citation. A rationale for a waiver or bridging of these data falls within this category. However, this code does not include new acute toxicity/efficacy data review. A data matrix must have been previously approved to fit in this category.
• Proposed label for the MUP and/or end use product

EPA-initiated amendments shall not be charged registration service fees.

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 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.