A536 PRIA Fee Category

A pre-application request for new use, or new product. The request is for review of each direct, indirect or nonfood food determination associated with any of the above pre-applications. The fee for this category is for a single determination request. The request must include a written rationale for the proposed use determination, the identity of the active ingredient (chemical structure), and a draft label or explanation of the use pattern. A draft label submitted with this application is not subject to the Agency’s approval under this category. The application follows after the Agency has made a ruling on the use determination(s). Once a determination is made, the application for the new use or new product can only be submitted once the appropriate studies have been conducted and the applicant has a complete application for registration. Once a decision on the use pattern has been made, the decision is conditional upon the review of the formal registration application and the data accompanying the application. Formal decisions or formal feedback on the proposed use pattern will not be made in any pre-submission meetings. If a waiver request or bridging argument is submitted for a new a.i., EPA does not anticipate being able to grant the request because, if any exposures are expected to humans and/or the environment, studies providing information on the toxicity and fate and transport properties of the chemical are needed to support waiver and bridging argument requests. The Agency will not review the generic data normally associated with a new chemical application under this code.

New uses are defined within 40 CFR § 152.3. The ruling is subject to change if more/different information becomes available with the submission of a new product or new use.