PRIA Conventional Active Ingredient - New Registration - New Product - Registered Source - Not Substantially Similar End Use Product - May Not Require Efficacy Review
PRIA 5 Fee Determination Decision Tree:
Conventional
You selected Conventional Active Ingredient - New Registration - New Product - Registered Source - Not Substantially Similar End Use Product - May Not Require Efficacy Review. Please select the appropriate fee category:
Action Code | Description |
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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; 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: |
R314 | 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: |
R318 | 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: |