A574 PRIA Fee Category

An application to amend an existing registration which requires review of product-specific data. This includes product chemistry, acute toxicology, and efficacy data. Examples include:

• Any submission that includes efficacy data or that requires an efficacy review.
• Signal word changes/review of acute toxicity data
• Changes to active ingredient sources - change from one unregistered source to another or change from a registered source to an unregistered source
• Any submission requesting a CRP exemption
• Any formula change that requires product specific data including toxicity, product chemistry, efficacy data (including confirmatory data). Routine formula changes are not PRIA actions. Routine formula changes are those which do not require data to support the change such as a surfactant, dye or other addition or modification to the inert ingredients in the formula.
• A data matrix is required with the application.

Excludes: Product-specific data required as a term of registration, such as storage stability data.

NOTE: Any significant increase in exposure requiring science review/a risk assessment (increase in rate, different method of application (fogging vs. spraying) will be treated under category A572, or as a new use.

A minimum of 51 public health organisms must be requested within a single application under this PRIA category. The number of supporting data volumes per organism does not impact the total organism count.  One organism is counted irrespective of the total number of organisms that must be tested to support a marketing claim/ testing protocol/data guideline.  

For example:

• If data is submitted in two volumes for one organism; the requested count for that application will be one public health organism.
• If one guideline/protocol/marketing claim requires three organisms to be tested; the requested count for that application will be three public health organisms.

The Agency will provide the applicant with a pre-decisional determination 2 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested label amendment registration. If the label issues cannot be resolved prior to the PRIA decision review time due date and if a PRIA due date time extension has not been agreed upon, then the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.

(a) EPA‐initiated amendments shall not be charged registration service fees. (b) Registrant‐ initiated fast‐track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant‐initiated fast‐ track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.