PRIA Fee Category Table - Biopesticides and Pollution Prevention Division (BPPD) - New Products
Table 13.
EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | FY'25 - FY'26 Fees ($) |
---|---|---|---|---|
B660 | 133 | New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption; no data submission or data matrix (or submission of product chemistry data only). (2) (3) | 6 | 1,925 |
B670 | 134 | New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption (including non-food); must address Product Specific Data Requirements. (2) (3) | 9 | 7,689 |
B672 | 135 | New product; unregistered source of at least one active ingredient (or registered source with new generic data package); no change in an established tolerance or tolerance exemption (including; non-food); must address Product Specific Requirements. (2) (3) | 15 | 13,723 |
B673 | 136 | New product; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency; requires an Agency determination that the cited data supports the new product. (2) (3) | 12 | 7,689 |
B674 | 137 | New product; repack of identical registered end-use product or repack of an end-use product as a manufacturing-use product; same registered use only. (2) (3) | 4 | 1,925 |
B677 | 138 | New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: | 12 | 13,276 |
1A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
2An 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.
3Where 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.