PRIA External Reviews and Miscellaneous Actions
PRIA 4 Fee Determination Decision Tree
You selected External Reviews and Miscellaneous Actions. Please select the appropriate fee category:
| Action Code | Description |
|---|---|
| M001 | Study protocol requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient (4) |
| M002 | Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient (4) |
| M003 | External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5) |
| M004 | External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5) |
| 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) |
| M006 | Request for up to 5 letters of certification (Gold Seal) for one actively registered product (excludes distributor products).(8) |
| M007 | Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii) |
| M008 | Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required |
| M009 | Non-FIFRA Regulated Determination: Applicant initiated, per product. |
| M010 | Conditional ruling on pre-application, product substantial similarity. |
| M011 | Label amendment to add the DfE logo; requires data review; no other label changes.(3) |