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PRIA External Reviews and Miscellaneous Actions

PRIA 5 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 26 in support of a currently registered ingredient.
M002	Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient. ⁽²⁾
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. ⁽³⁾
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. ⁽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. ⁽⁴⁾ ⁽⁵⁾ ⁽⁶⁾
M006	Request for up to 5 letters of certification (Gold Seal) for one actively registered product (excludes distributor products). ⁽⁷⁾
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. ⁽⁸⁾
M012	Request for up to 5 letters of certification (Certificate of Establishment) for one actively registered product or one product produced for export (excludes distributor products). ⁽⁷⁾
M013	Cancer reassessment; applicant-initiated.
M014	Pre-application nano-particle determination.