R175 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Conventional Registration - New Use - Additional Food Use
Below is the fee for your selected Fee Category for Fiscal Years 2020-2021
|Action Code||Description||FY'20-FY'21 Fee||Decision Time (months)|
|R175||Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups (3) (4)||$69,431||10|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$34,716|
|75% waiver||You pay ---->>>>>||$17,358|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application that proposes conversion of one or more crop groups (or subgroups) for a currently registered active ingredient resulting from a published federal register definition for a revised crop group (or subgroup). The application may reflect the conversion of multiple crop group revisions under the base fee for this category. A request to add uses through the establishment of a crop group or subgroup tolerance where a crop group or subgroup tolerance does not already exist does not fall into this category. The appropriate category will be one of the food use categories (see R170 interpretation). A request to add uses associated with a crop group or subgroup update but before that new crop group definition has been formally established in the Federal Register does not fall into this category. The application will not contain new data for review in this category. If conversion of a crop group or subgroup requires submission of new data, the action does not belong in this category.
The application requires a petition for the establishment of, or the exemption from the requirement of a tolerance under Section 408 of the FFDCA as well as a new or amended product label which incorporates the new crop group or subgroup term. The application submission must contain a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s).
All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.
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 additional food use 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.
Amendment applications to add new use(s) to registered product labels are covered by the base fee for this category as long as they are all submitted in the same package. Each application for a new product submitted in this package and/or new inert approval, however, is subject to its own registration service fee. The only exception would be if the new use(s) were to be added only to a new product (no amendments to registered product labels in the application package) in which case the review of the one new product application would be covered by the base fee for the new uses.
If the applicant on his own initiative submits any additional information that was neither requested nor required by the Agency, after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, the applicant will be charged an additional 25% of the full registration service fee for the new use application.