PRIA Fee Category Table - Registration Division - New Products

Table 4.

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'16/17 Registration Service Fee ($)
R300	44	New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP – only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. ⁽²⁾ ⁽³⁾	4	1,582
R301	45	New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. ⁽²⁾ ⁽³⁾	4	1,897
R310	46	New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only: product chemistry and/or acute toxicity and/or public health pest efficacy and/or child resistant packaging. ⁽²⁾ ⁽³⁾	7	5,301
R314	47	New end use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: product chemistry and/or acute toxicity and/or ublic health pest efficacy and/or child resistant packaging. ⁽²⁾ ⁽³⁾	8	6,626
R315	48	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: product chemistry and/or acute toxicity and/or public health pest efficacy and/or animal safety studies and/or child resistant packaging ⁽²⁾ ⁽³⁾	9	8,820
R320	49	New product; new physical form; requires data review in science divisions ⁽²⁾ ⁽³⁾	12	13,226
R331	50	New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only ⁽²⁾ ⁽³⁾	3	2,530
R332	51	New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions ⁽²⁾ ⁽³⁾	24	283,215
R333	52	New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. ⁽²⁾ ⁽³⁾	10	19,838
R334	53	New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. ⁽²⁾ ⁽³⁾	11	19,838

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 registrants written or electronic confirmation of agreement to the Agency.