Pesticide Registration Improvement Extenstion Act (PRIA 3)
Fee Determination Decision Tree
Decision Tree Resources:
Below is the fee for your selected Fee Category for Fiscal Years 2014/2015
| Decision Time
|A390||New Active Ingredient Food use, establish tolerance (2) (3)||$ 182,327||24|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 91,164|
|75% waiver||You pay ---->>>>>||$ 45,582|
To pay the fee shown above, go to http://www.pay.gov and follow the instructions.
|Action Code Interpretation|
An application that proposes a food use for an active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. The use requires the establishment of or the increase in a tolerance under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). If residues are reasonably foreseeable or likely to occur in or around food, either directly or indirectly, the application may need to include a petition to establish a tolerance for all food commodities covered by the pending registration application(s). However, some uses may not require a petition but still be considered under this category. Refer to the definition of a “food use” for the uses subject to this category. All uses (food and non-food) included in any original application or petition for a new active ingredient or a first food use are covered by the base fee for that application in this category if submitted simultaneously. within the original application.
All of the inerts used in the product must be either approved, pending with the Agency, or a new inert is submitted within the package for the applicable 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.
A maximum of five new products are covered by the base fee. After the first five new products, each application for an additional new product or new inert ingredient approval that is submitted within this new active ingredient package is subject to the registration service fee for a new product or a new inert ingredient approval. All such associated applications that are submitted together will be subject to the new active ingredient decision review time.
Until the new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be charged a new active ingredient service fee and decision review timeframe.
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 active ingredient application.
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 new active ingredient 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.
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