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PRIA Conventional New Product Registration - Requires Efficacy Review

PRIA 4 Fee Determination Decision Tree:

Conventional


You selected Conventional Active Ingredient - New Product Registration - Not Substantially Similar - Requires 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 - for up to 3 target pests. (2) (3) (4)
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)
R315 New end-use, on-animal product, registered source of active ingredient(s), with the submission of data and/or waivers for only:
  • Animal safety and
  • Pest(s) requiring efficacy (4) and/or
  • Product chemistry and/or
  • Acute toxicity 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:
  • Product chemistry and/or
  • Acute toxicity and/or
  • Child resistant packaging and/or
  • Pest(s) requiring efficacy (4) - for greater than 3 and up to 7 target pests (2) (3)
R317 New end-use or manufacturing product with registered source(s) of active ingredient(s) including products containing 2 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:
  • Product chemistry and/or
  • Acute toxicity and/or
  • Child resistant packaging and/or
  • Pest(s) requiring efficacy (4) - for greater than 7 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 greater than 3 target pests (2) (3)
R319 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 4 to 7 target pests. (2) (3)
R321 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 4 to 7 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)