B674 PRIA Fee Category

An application for registration of an end-use or a manufacturing-use microbial or biochemical pesticide product that is a 100% repack of a registered end-use product, a 100% repack of a registered manufacturing-use product, or a repack of a registered end-use product as a manufacturing-use product.

All applications require the following:

• A formulator’s exemption statement (or if the registered source of the active ingredient is owned by the current applicant, the data used to support the registered source must be referenced on a data matrix).
• The applicant must identify the currently registered product being repacked for this application in a CSF listing the original product in Box 10, the EPA registration number in Box 12, and “100% repack” in Box 13.

Submission of data or requests to waive data is not allowed in this category. Products that require a “substantially similar” determination fall under PRIA Category B660.

If the use pattern for the proposed product differs from the currently registered product, then additional data are required and the application does not fall within this category (see Table 12 for applicable new use categories).

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.