R300 PRIA Fee Category

An application for registration of an end-use or a manufacturing use pesticide product that is substantially similar or identical in its uses and formulation to a single product that is currently registered and differs only in ways that would not significantly increase the risk of unreasonable adverse effects. The applicant must identify the substantially similar (me-too) product for the proposed product on the EPA application form (8570-1, box 6).

To fit this category, all applications require the following but are not limited to:

• Certification with Respect to Citation of Data and a Data Matrix (except for 100% repacks).
• Companies/registrants cannot claim formulator’s exemption for a product they own, 40 CFR 152.85(b) and FIFRA 3 (c)(2)(D), and therefore, the formulation must be listed on the CSF. A data matrix using selective data citation for the generic data to a registered technical is only applicable in this category where the applicant owns all the required data which has been previously reviewed/accepted or the applicant submits a specific authorization letter from the data owner.
• Product chemistry data (Group A and B) unless the product is identical (e.g., 100% repackaged product) and supporting CSF. In some cases, product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1. If submitting self-certification for Group B data, an MRID must be assigned.
• All inert ingredients must already be approved for the applicable uses in the product.
• The active ingredient listed on the CSF must be an EPA registered product.
• In all cases, the applicant must identify the currently registered similar product for this category.
• Acute toxicity requirements must be addressed by using: 1) cite-all method or 2) selective data citation where the applicant owns all required data, or the applicant submits specific authorization letter from data owner. If using selective data citation for acute toxicity data, list only one set of data (6-pack that belongs to a single substantially similar product) to support the proposed product on the data matrix. If review of new data is needed, the application does not fall within this category.

The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or child resistant packaging data are submitted or cited and must be reviewed to support the application. Data that are selectively cited to support the application must have already been reviewed by the Agency for the same uses, formulation type, active ingredient and claims. The application does not fall into this category if it contains a request to waive or bridge any of these data. An application that requires review of cited or submitted data other than product chemistry does not belong in this fee category. Companion animal end use products must be 100% identical in composition and uses to a currently registered product to be considered in this category.

Substantially similar: Product must have the same active ingredient, in substantially the same proportion, same chemical composition (solid, liquid, granular), and substantially similar inert ingredients as the already registered cited me-too product. In addition, substantially similar means that the proposed product bears the same use patterns. Adding use patterns or changing existing use patterns (other than deleting them) would exclude the proposed product from treatment as a substantially similar product. Deleting use patterns is acceptable.

Identical: Same composition and use patterns as a currently registered end use product.

For 100% repack applications, only one Confidential Statement of Formula (listing a single 100% repack) will be accepted under an R300 fee. Additional alternate 100% repack CSFs under the same submission needs to be identical and a multiplier applies for each individual repack being added under one package. Alternatively, separate R300 applications can be submitted for each new repack product.

Manufacturing Use Product: A 100% re-package of a manufacturing use product that requires no data submission or data matrix is covered by this category.

Applications for new end use products that are submitted using an unregistered source of an existing active ingredient will be recoded to either category R333 or R334. All active ingredients derived from a manufacturing source which does not hold active EPA registration numbers are considered unregistered. Even if the Agency may have reviewed the product chemistry data previously for that source of the active ingredient for another end use product, the active ingredient is considered unregistered.

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 new product 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 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.