A572 PRIA Fee Category

An application for registration of a pesticide product that is not substantially similar or identical in its uses or formulation to products that are currently registered OR a modification to an existing registration that is not substantially similar or identical in its uses to a currently registered product; that requires risk analysis by the Science Branches (i.e., the Risk Assessment Branch (RAB)) to support the change.

Examples of actions in this category include:

• Label changes to Directions for Use (including REI, PPE, PHI, application rate, application frequency, application timing, increase in rate, different method of application (fogging vs. spraying);
• Exposure change, etc. that require risk analysis by EPA. In some cases, the applicant might not submit new data to support the label amendment, but the Agency would need a determination of whether the existing database would support a change or modification to the amended label;
• An application for a new end-use product using a source of active ingredient that is not yet registered but has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient; and
• Review of a unique selective cite generic data matrix.
• All inert ingredients used in the product must be EPA approved for the proposed use(s), pending approval with the Agency for the applicable uses, or included in an inert petition submitted within the package for the applicable uses. Each application for a new inert approval submitted in this package is subject to its own registration service fee.

If the Agency determines that endangered species analysis is required according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended to conduct the endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. This extension is contingent on Agency issuing the ESA guidance applicable to this PRIA category.

A different pattern of use that significantly changes or increases exposure such as a dosage rate increase or different method of application will result in the application being treated as a new use. The company is required to provide a cited label to support the proposed uses by showing that the use pattern and rates do not exceed currently registered products.

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 new product/amendment registration. If the label issues cannot be resolved prior to the PRIA decision review time due date, 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.

Registration amendment fees:
(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.