An application for registration of a new end-use product that contains more than one registered conventional active ingredient. The active ingredients have never been registered as this combination before. The proposed label has the same uses as those found on the registered product labels for the single active ingredients. Each active ingredient must use a registered source of active ingredient. Any science review must be within RD only. All of the inerts used in the product must be approved or pending with the Agency for the applicable uses. To fit this category all applications require the following:

• Certification with Respect to Citation of Data and a data matrix
• Product chemistry data (Group A and B) and CSF. In some cases product chemistry data can be satisfied as outlined In PR Notice 98-1.
• If applicable, acute toxicity, efficacy, and or child resistant packaging data requirements must be addressed by using; (1) the cite-all method; (2) selective data citation. A rationale for a waiver or bridging of these data can be submitted.

This category does not include applications that require a determination on whether data can be bridged or translated to other formulation types (for the individual active ingredients).

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 an active EPA registration number are considered unregistered. Even if the Agency may have reviewed the product chemistry data previously for that unregistered 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 end-use 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 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.