Primary and Secondary New Product Applications, Submitted at the Same Time (PC = Product Chemistry Data) F Y'23-FY'24 Fees Primary Application1 Secondary Application2 Description PRIA Code Application Fee ($) Where the only data submitted with a secondary application is product chemistry data or where the secondary application is a 100% repack of the primary Where the secondary application contains more data than just PC such as efficacy and/or acute toxicity data Agency Code3 Expected Fee ($) Agency Code3 Expected Fee4 ($) Registration Division 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/orwaivers 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 R310 10,466 R310.1 2,617 R310.2 10,466 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/orwaivers of data for only: • product chemistry and/or • acute toxicity and/or • child resistant packaging and/or • pest(s) requiring efficacy for up to three target pests R314 12,364 R314.1 3,091 R314.2 10,466 Each new product application is subject to a PRIA fee. Where one set of data or data waivers apply to two or more new product applications that are submitted at the same time, the Agency refers to the first product application containing the data or data waivers as the primary application. Additional new product applications that rely on data or data waivers that were submitted with the primary product application are referred to as secondary applications. 3 EPA will assign a tracking code to alert reviewers to the relationship between primary and secondary applications. These codes are internal EPA tracking codes only. 4 Based on previous years of experience, EPA expects that it can grant a discretionary refund that will likely result in a reduced fee equal to the amount indicated in this column. This expected fee is based on either the fee for an identical/substantially similar product with no data review for the type of product (i.e. conventional, antimicrobial, or biopesticide or 25% of the fee for the primary, whichever is greater and rounded up to the nearest whole dollar. In accordance with FIFRA 33(b)(2)(C), payment of at least 25% of the fee for the applicable PRIA category accompanied by a request for a refund of all or part of the remaining fee would allow this application to go forward into review. Where this chart indicates the expected fee is more than 25%, EPA recommends submitting the amount of the expected fee as listed in this column along with a request for a refund to avoid delays in processing applications for which a complete fee has not been received. 1 ------- Primary Application1 Secondary Application2 Description PRIA Code Application Fee ($) Where the only data submitted with a secondary application is product chemistry data or where the secondary application is a 100% repack of the primary Where the secondary application contains more data than just PC such as efficacy and/or acute toxicity data Agency Code3 Expected Fee ($) Agency Code3 Expected Fee4 ($) 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 for 4 to 7 target pests R319 18,097 R319.1 4,525 R319.2 10,466 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: Only: • product chemistry and/or • acute toxicity and/or • child resistant packaging and/or • pest(s) requiring efficacy - for up to 3 target pests R318 18,994 R318.1 4,749 R318.2 10,466 2 ------- Primary Application1 Secondary Application2 Description PRIA Code Application Fee ($) Where the only data submitted with a secondary application is product chemistry data or where the secondary application is a 100% repack of the primary Where the secondary application contains more data than just PC such as efficacy and/or acute toxicity data Agency Code3 Expected Fee ($) Agency Code3 Expected Fee4 ($) New end-use product containing four or more registered active ingredient(s) never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: • product chemistry and/or • acute toxicity and/or • child resistant packaging and/or • pest(s) requiring efficacy - for 4 to 7 target pests R321 24,727 R321.1 6,182 R321.2 10,466 New end-use on-animal product, registered source of active ingredient(s) with submission of data and/or waivers for only: • animal safety and • pest(s) requiring efficacy and/or • product chemistry and/or • acute toxicity and/or • child resistant packaging R315 14,075 R315.1 3,519 R315.2 10,466 New end-use or manufacturing-use product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredient previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: • product chemistry and/or • acute toxicity and/or • child resistant packaging and/or • pest(s) requiring efficacy for 4 to 7 target pests R316 16,199 R316.1 4,050 R316.2 10,466 3 ------- Primary Application1 Secondary Application2 Description PRIA Code Application Fee ($) Where the only data submitted with a secondary application is product chemistry data or where the secondary application is a 100% repack of the primary Where the secondary application contains more data than just PC such as efficacy and/or acute toxicity data Agency Code3 4 Expected Fee ($) Agency Code3 Expected Fee4 ($) New end-use or manufacturing-use product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredient 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 R317 21,932 R317.1 5,483 R317.2 10,466 New product; new physical form; requires data review in science divisions R320 18,958 R320.1 4,740 R320.2 10,466 New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only R331 3,627 R331 N/A R331 N/A 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 R332 405,919 R332.1 101,480 R332.2 101,480 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 R333 28,434 R333.1 7,109 R333.2 10,466 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. R334 33,108 R334.1 8,277 R334.2 10,466 4 ------- Primary Application1 Secondary Application2 Description PRIA Code Application Fee ($) Where the only data submitted with a secondary application is product chemistry data or where the secondary application is a 100% repack of the primary Where the secondary application contains more data than just PC such as efficacy and/or acute toxicity data Agency Code3 4 Expected Fee ($) Agency Code3 Expected Fee4 ($) New end-use product containing up to three registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of the currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • child resistant packaging and/or • pest(s) requiring efficacy - for more than 7 target pests R361 23,400 R361.1 5,850 R361.2 10,466 New end-use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of the currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • child resistant packaging and/or • pest(s) requiring efficacy - for more than 7 target pests R362 25,350 R362.1 6,338 R362.2 10,466 New product; repack of identical registered manufacturing-use product as an end-use product; same registered uses only, with no additional data. R363 7,800 R363.1 N/A R363.2 N/A 5 ------- Primary Application' Secondary Application^ Description PRIA Code Application Fee ($) Where the only data submitted with a secondary application is product chemistry data or where the secondary application does not require confirmatory efficacy data Where the secondary application contains more data than just PC such as efficacy and/or acute toxicity data Agency Code'3 Expected Fee4 ($) Agency Code'3 Expected Fee4 ($) Antimicrobials Division New end use product; FIFRA§2(mm) uses only; 0 to 10 public health organisms A460 7,322 A460.1 1,831 A460.2 7,322 New end use product; FIFRA§2(mm) uses only; 11 to 20 public health organisms A461 10,158 A461.1 2,540 A461.2 7,322 New end use product; FIFRA§2(mm) uses only; 21 to 30 public health organisms A462 12,995 A462.1 3,249 A462.2 7,322 New end use product; FIFRA§2(mm) uses only; 31 to 40 public health organisms A463 15,831 A463.1 3,958 A463.2 7,322 New end use product; FIFRA§2(mm) uses only; 41 to 50 public health organisms A464 18,668 A464.1 4,667 A464.2 7,322 New end use product; FIFRA§2(mm) uses only; 51 or more public health organisms A465 21,505 A465.1 5,377 A465.2 7,322 New end-use product; uses other than FIFRA §2(mm); non-FQPA product A550 18,958 A550.1 4,740 A550.2 7,322 New manufacturing-use product; registered active ingredient; selective data citation A560 18,054 A560.1 4,514 A560.2 7,322 New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of new generic data package; registered uses only; requires science review A565 26,135 A565.1 6,534 A565.2 7,322 New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to Restricted Entry Interval, or Personal Protective Equipment, or use rate) A572 18,958 A572.1 4,740 A572.2 7,322 6 ------- Primary Application1 Secondary Application2 Description PRIA Code Application Fee ($) Where the only data submitted with a secondary application is product chemistry data or where the secondary application is a 100% repack of the primary Where the secondary application contains more data than just PC such as efficacy and/or acute toxicity data Agency Codea Expected Fee4 ($) Agency Codea Expected Fee4 ($) Biopesticides and Pollution Prevention Division New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; (including non-food); must address product specific data requirements. B670 7,322 B670.1 1,831 B670.2 7,322 New product; unregistered source of at least one active ingredient (or registered source with new generic data package); no change to an established tolerance or tolerance exemption (including non-food); must address product specific and generic data requirements. B672 13,069 B672.1 3,268 B672.2 7,322 New product; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency; requires an Agency determination that the cited data support the new product. B673 7,322 B673.1 1,831 B673.2 7,322 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 B677 12,643 B677.1 3,161 B677.2 7,322 SCLP; new product; unregistered source of active ingredient; no change in an established tolerance or tolerance exemption (including non-food); must address product specific data requirements. B721 3,836 B721.1 959 B721.2 3,836 Registration application; registered PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active inqredient(s). B880 45,737 B880.1 11,435 B880.2 11,435 Registration application; registered PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). B885 45,737 B885.1 11,435 B885.2 11,435 Registration application; new product, registered active ingredient; exogenous applications of RNAto elicit the RNA interference pathway in pests; no petition since a permanent tolerance/tolerance exemption is already Established for the active ingredient(s). B929 7,322 B929.1 1,831 B929.2 7,322 7 ------- Example A company submits 3 new antimicrobial registration applications. The 3 applications are: one 20% concentrate, a 15% concentrate and a 10% concentrate. The package consists of chemistry data for each application, one set of acute toxicity studies using the 20% concentrate and one set of efficacy data generated at the use dilution (the use dilution is the same for all three products). All three products will rely on the same efficacy data because all three products will be diluted to the same concentration and the difference in the inert ingredients is water. Description of action Expected Fee ($) Tracking Code New product cone 20% 7,322 A460 New product cone 15 % 1,831 A460.1 New product cone 10% 1,831 A460.1 T otal F ee 10,984 8 ------- |