A532 PRIA Fee Category
PRIA 3 Fee Determination Decision Tree:
Antimicrobial Active Ingredient Registration for End Use Product
Below is the fee for your selected Fee Category for Fiscal Years 2016/2017
|Action Code||Description||FY16/17 Fee||Decision Time (months)|
|A532||New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted. (2) (3)||$ 5,107||5|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$ 2,554|
|75% waiver||You pay ---->>>>>||$ 1,277|
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 an end-use pesticide or manufacturing use product that uses an unregistered source of the active ingredient and that is substantially similar or identical in its uses and/or formulation to products that are currently registered or differ only in ways that would not significantly increase the risk of unreasonable adverse effects.
All applications require the following:
The application is not this category if efficacy, acute toxicity, companion animal safety, and/or child resistant packaging data are submitted and must be reviewed to support the application. The application does not fall into this category if it contains a request to waive any of these data. An application that requires review of cited or submitted data other than product chemistry does not belong in this fee category. If the use pattern on the TGAI differs from the proposed product, then additional data are required and the application does not fall within this category.
Substantially similar: Product must have the same active ingredient, in substantially the same proportion, same chemical composition (solid, liquid, granular) and substantially similar inert ingredients as the already registered product. In addition, substantially similar means that the proposed product bears the same use patterns. Adding to or changing existing use patterns excludes the proposed product from treatment as a substantially similar product. Deleting use patterns is acceptable.
Identical: Same composition and use patterns as a currently registered end use product.
An application for a new end-use product using a source of active ingredient that is not yet registered but has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
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.