PRIA Fee Category Table - Registration Division (RD) - New Products
Table 4.
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | FY'25 - FY'26 Fees ($) |
|---|---|---|---|---|
| R300 | 50 | 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 child resistant packaging -- 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 | 2,384 |
| R301 | 51 | 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 | 2,856 |
| R310 | 52 | 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: | 7 | 10,990 |
| R314 | 53 | 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: | 8 | 12,983 |
| R319 | 54 | 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: | 10 | 19,002 |
| R318 | 55 | 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: | 9 | 19,944 |
| R321 | 56 | 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: | 11 | 25,964 |
| R315 | 57 | New end-use on-animal product, registered source of active ingredient(s) with submission of data and/or waivers for only: | 9 | 14,779 |
| R316 | 58 | New end-use or manufacturing-use 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: | 9 | 17,009 |
| R317 | 59 | New end-use or manufacturing-use 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: | 10 | 23,029 |
| R320 | 60 | New product; new physical form; requires data review in science divisions. (2) (3) (5) | 12 | 19,906 |
| R331 | 61 | New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only. (2) (3) | 3 | 3,809 |
| R332 | 62 | 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 | 426,215 |
| R333 | 63 | New product; manufacturing use product 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) | 11 | 29,856 |
| R334 | 64 | New product; manufacturing use product or end use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2) (3) | 12 | 34,764 |
| R361 | 65 (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: | 12 | 24,570 |
| R362 | 66 (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 within RD only; includes data and/or waivers of data for only: | 13 | 26,618 |
| R363 | 67 (new) | New product; repack of identical registered manufacturing-use product as an end-use product; same registered uses only, with no additional data. (2) (3) | 6 | 8,190 |
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 both invertebrate and vertebrate pests. Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are listed in the product performance rule, subpart R of part 158 of title 40, Code of Federal Regulations. This list may be updated/refined as invasive pest needs arise. All other pests (e.g., vertebrates) are listed in the Pesticide Registration Notice 2002-1. To determine the number of pests for the PRIA categories, pest groups, subgroups, and pest specific claims as listed in part 158 of title 40, Code of Federal Regulations, should be counted as follows. If seeking a label claim against a general pest group (e.g., cockroaches, mosquitoes, termites, etc.), each group will count as 1. If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.) or specific pests (e.g., smokybrown cockroach, house fly, etc.) without a general claim, then each subgroup or specific pest will count as 1.
5If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.