PRIA Conventional New Product Registration - Manufacturing Use
PRIA 4 Fee Determination Decision Tree:
Conventional
You selected Conventional Active Ingredient - New Product Registration - Manufacturing Use Product. Please select the appropriate fee category:
| Action Code | Description |
|---|---|
| R300 | 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) |
| R310 | 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) |
| R316 |
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: |
| R317 |
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: |
| R331 | 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) |
| R332 | 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) |
| R333 | 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) |
| R334 | 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) |