PRIA Conventional New Product Registration - May Not Require Efficacy Review

PRIA 4 Fee Determination Decision Tree:

Conventional

You selected Conventional Active Ingredient - New Product Registration - Not Substantially Similar - May Not Require Efficacy Review. Please select the appropriate fee category:

Action Code	Description
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: 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)
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: 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)
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: 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)
M005	New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7)