PRIA Fee Category Table - Registration Division - Import and Other Tolerances

TABLE 3.

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'20 - FY'21 Fees ($)
R280	34	Establish import tolerance; new active ingredient or first food use ⁽²⁾	21	335,026
R290	35	Establish Import tolerance; Additional new food use	15	67,007
R291	36	Establish import tolerances; additional food uses; 6 or more crops submitted in one petition	15	402,031
R292	37	Amend an established tolerance (e.g., decrease or increase) and/or harmonize established tolerances with Codex MRLs; domestic or import; applicant-initiated	11	47,609
R293	38	Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated	12	56,158
R294	39	Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated	12	336,939
R295	40	Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated ⁽³⁾ ⁽⁴⁾	15	69,431
R296	41	Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated ⁽³⁾ ⁽⁴⁾	15	416,580
R297	42	Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated	11	285,639
R298	43	Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review) ⁽³⁾⁽⁴⁾	13	61,494
R299	44	Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review) ⁽³⁾⁽⁴⁾	13	299,525

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 applicants 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.

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 registrants written or electronic confirmation of agreement to the Agency.

⁴Amendment applications to add the revised use pattern(s) to registered product labels are covered by the base fee for the category. 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 amendment application package is subject to the registration service fee for a new product or a new inert approval. However, if an amendment application only proposes to register the amendment for a new product and there are no amendments in the application, then review of one new product application is covered by the base fee. All such associated applications that are submitted together will be subject to the category decision review time.