Pesticide Registration Improvement Extension Act (PRIA 3)
Fee Determination Decision Tree
Decision Tree Resources:
Below is the fee for your selected Fee Category for Fiscal Year 2013
| Decision Time
|R334||New product; MUP or end use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2) (3)||$ 17,993||11|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 8,997|
|75% waiver||You pay ---->>>>>||$ 4,499|
To pay the fee shown above, go to http://www.pay.gov and follow the instructions.
|Action Code Interpretation|
An application for registration of a new product (MUP or end use product). New manufacturing use product is any product intended (labeled) for formulation or repackaging into an end use formulated pesticide product. The active ingredient is not a new active ingredient, but either (1) one that claims to be substantially similar or identical to another active ingredient which is currently registered (as referenced by EPA registration number) and will use selective data citation, or (2) an end use product which claims to be substantially similar or identical in its formulation to another end use product that is currently registered for which the selective data citation was used, but the active ingredient used in the formulation is derived from an unregistered source (i.e., does not have a EPA registration number).
To fit this category all applications require the following:
Applications for new end use products that are submitted using an unregistered source of an existing active ingredient will be recoded to either category R333 or R334. All active ingredients derived from a manufacturing source which does not hold an active EPA registration number are considered unregistered. Even if the Agency may have reviewed the product chemistry data previously for that unregistered source of the active ingredient for another end use product, the active ingredient is considered unregistered.
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 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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