A471 PRIA Fee Category
PRIA 3 Fee Determination Decision Tree:
Antimicrobial Active Ingredient New Use Registration for Additional Food Use
Below is the fee for your selected Fee Category for Fiscal Years 2016/2017
|Action Code||Description||FY16/17 Fee||Decision Time (months)|
|A471||Additional food uses; establish tolerances; 6 or more submitted in one application (3) (4) (5)||$ 191,452||15|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 95,726|
|75% waiver||You pay ---->>>>>||$ 47,863|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
How to submit your application directly to EPA.
|Action Code Interpretation|
An application that proposes a food use. Additional food use includes a proposed food use of any U. S. registered active ingredient for which there currently is an approved food use. The use may require the establishment of a tolerance, the increase in, or modification of a tolerance under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). The application may need to include a petition to establish a tolerance for all food commodities covered by the pending application(s). Refer to the definition of a “food use” for the uses subject to this 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 application must propose at least six (6) or more specific additional new food uses.
If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.
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 4 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.
Any new product or amendment to the proposed labeling, which contains the same new use(s), that is submitted subsequent to the submission of the new use application but prior to its decision review time expiration date, will be deemed a separate new use application subject to a separate fee and new decision review time.
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 uses application.
Finally, if the new use(s) application include non-food (indoor and/or outdoor) and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use, and the longest decision review time applies to all of the new uses requested in the application.
Go to the start of the Decision Tree