PRIA Fee Category Table - Biopesticides Division - New Uses

Table 12.

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'20 - FY'21 Fees ($)
B630	115	First food use; petition to establish a tolerance exemption ⁽²⁾ ⁽⁴⁾	13	13,403
B631	116	New food use; petition to amend an established tolerance ⁽³⁾ ⁽⁴⁾	12	13,403
B640	117	First food use; petition to establish a tolerance ⁽²⁾ ⁽⁴⁾	19	20,104
B643	118	New Food use; petition to amend tolerance exemption ⁽³⁾ ⁽⁴⁾	10	13,403
B642	119	First food use; indoor; food/food handling⁽²⁾ ⁽⁴⁾	12	33,506
B644	120	New use, no change to an established tolerance or tolerance exemption ⁽³⁾ ⁽⁴⁾	8	13,403
B650	121	New use; non-food ⁽³⁾ ⁽⁴⁾	7	6,703
B645	122 (new)	New food use; Experimental Use Permit application; petition to amend or add a tolerance exemption ⁽⁴⁾	12	13,403
B646	123 (new)	New use; non-food use including crop destruct; Experimental Use Permit application ⁽⁴⁾	7	6,703

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.

²All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

³Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicants initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

⁴Where 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.