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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)