A540 PRIA Fee Category

An application for registration of a pesticide product that is not substantially similar or identical in its uses or formulation to products that are currently registered.

All applications require the following:

• A data matrix is required with the application.
• Product chemistry data (Group A and B) unless the product is identical. In some cases product chemistry data can be satisfied as outlined in PR Notice 98-1.
• All inerts must be already approved or pending with the Agency for the applicable uses in the product.
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or child resistant packaging data requirements must be addressed by using: 1) the cite-all method, or 2) selective data citation which includes submitting the required data. A rationale for a waiver of these data falls within this category.
• For a wood preservative, antifoulant or ballast water treatment product, a claim that differs from those described in FIFRA 2mm will place the product in the A550 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.

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.

Up to 25 public health organisms may be requested within a single application under this PRIA category.   The number of supporting data volumes per organism does not impact the total organism count.  One organism is counted irrespective of the total number of organisms that must be tested to support a marketing claim/ testing protocol/data guideline.  

For example:

• If data is submitted in two volumes for one organism; the requested count for that application will be one public health organism.
• If one guideline/protocol/marketing claim requires three organisms to be tested; the requested count for that application will be three public health organisms.

Once a submission for a new product with public health organisms has been submitted and classified in either A540 or A541, additional organisms submitted for the same product before expiration of the first submission’s original decision review time period will result in reclassification of both the original and subsequent submission into the appropriate new category based on the sum of the number or organisms in both submissions.  A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the new category.