B720 PRIA Fee Category

An application for a new product for an existing SCLP active ingredient that includes data to support the registration. The source of the active ingredient must be an EPA-registered product. If the proposed new product contains an unregistered source of active ingredient, then see category B721.

All of the inerts used in the product must be either: (1) EPA approved for the proposed uses; (2) pending approval with the Agency; or (3) have been submitted as a new inert petition application (concurrent with the application. The application package must address product-specific data requirements on the formulated end-use product.

Product-specific data requirements can be addressed with 1) submission of product-specific data; 2) citation of previously reviewed and accepted data; 3) submission or citation of data generated at government expense; 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply.

An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.