B710 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Biopesticide SCLP Active Ingredient New Registration for New Product - Identical End 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)|
|B710||New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3)(6)||$1,342||4|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$671|
|75% waiver||You pay ---->>>>>||$336|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
An application for registration of a SCLP product that is substantially similar or identical in its uses and formulation to products that are currently registered, or differ from a currently registered product only in ways that would not significantly increase the risk of unreasonable adverse effects to humans or the environment. In all cases, the product must contain a registered source of active ingredient, and the applicant must identify the similar registered product. If the proposed new product contains an unregistered source of active ingredient, then see category B721. Identical products are identical to another registered product and bear identical use patterns.
For an identical (100% repackaging or repack) of a registered SCLP product, the data requirements are satisfied by the registered identical product. The Confidential Statement of Formula (CSF) of the proposed product must indicate the product is a 100% repack of the previously registered product.
Substantially similar products must contain the same active ingredient, in substantially the same proportion. They must have the same physical state (solid, liquid, granular), and contain substantially similar other (inert) ingredients. The proposed product must have the same use patterns.
Identical/substantially similar products may have fewer uses, but all of its uses must have been approved for the claimed similar product. Adding or changing the use patterns (other than removal of uses) excludes the product from treatment as a substantially similar product.
If the new product is a simple dilution of, or differs only by a minor change in inert ingredients from the registered product, some minor product chemistry may be required. Any cited data must have been previously reviewed and accepted by the Agency.
A new product is not substantially similar to a registered product if an unregistered source of TGAI material is used to formulate the new product, or if new data, scientific literature, and/or waivers are submitted to satisfy the data requirements for the new product.
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. 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 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.