PRIA Fee Category Table - Registration Division - New Products

Table 4.

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'20 - FY'21 Fees ($)
R300	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; 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	1,662
R301	46	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 (identical data citation and claims to cited product(s)), where applicant does not own all required data and does not have a specific authorization letter from data owner. ⁽²⁾ ⁽³⁾	4	1,992
R310	47	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; excludes products requiring or citing an animal safety study; 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 Child resistant packaging and/or pest(s) requiring efficacy – for up to 3 target pests ^{(2) (3) (4)}	7	7,667
R314	48	New end use product containing up to three 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; excludes products requiring or citing an animal safety study; 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 child resistant packaging and/or pest(s) requiring efficacy ⁽⁴⁾ for up to 3 target pests ⁽²⁾ ⁽³⁾	8	9,058
R319	49 (new)	New end use product containing up to three 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; excludes products requiring or citing an animal safety study; 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 child resistant packaging and/or pest(s) requiring efficacy ⁽⁴⁾ - for 4 to 7 target pests. ^(2) (3)	10	13,258
R318	50 (new)	New end-use product containing four 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; excludes products requiring or citing an animal safety study; 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 child resistant packaging and/or pest(s) requiring efficacy – for up to 3 target pests ^{(2) (3) (4)}	9	13,915
R321	51 (new)	New end use product containing four 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; excludes products requiring or citing an animal safety study; 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 child resistant packaging and/or pest(s) requiring efficacy ⁽⁴⁾ - for 4 to 7 target pests. ^{(2) (3)}	11	18,115
R315	52	New end-use on-animal product, registered source of active ingredient(s) with submission of data and/or waivers for only: animal safety and pest(s) requiring efficacy and/or product chemistry and/or acute toxicity and/or child resistant packaging ⁽²⁾ ^(3) (4)	9	10,311
R316	53 (new)	New end-use or manufacturing product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: product chemistry and/or acute toxicity and/or child resistant packaging and/or pest(s) requiring efficacy - for greater than 3 and up to 7 target pests ⁽²⁾ ⁽³⁾⁽⁴⁾	9	11,867
R317	54 (new)	New end-use or manufacturing product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: product chemistry and/or acute toxicity and/or child resistant packaging and/or Pest(s) requiring efficacy - for greater than 7 target pests ⁽²⁾ ^(3) (4)	10	16,067
R320	55	New product; new physical form; requires data review in science divisions ⁽²⁾ ⁽³⁾	12	13,888
R331	56	New product; repack of identical registered end-use product as a manufacturing-use product, or identical registered manufacturing-use product as an end-use product; same registered uses only ⁽²⁾ ⁽³⁾	3	2,657
R332	57	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	297,376
R333	58	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	20,830
R334	59	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	24,255

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.

⁴For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against a pest group (general), use the group listing below and each group will count as 1. The general pests groups are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes, lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies, mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites, arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without a general claim then each specific pest will count as 1.