R110 PRIA Fee Category

An application that proposes a non-food use for an active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. A non-food use includes a proposed use that is not a food use as described in the food use categories. Indoor means that the proposed use is for use inside of manmade structures. All indoor non-food uses included in the application are covered by the base fee for the application in this category if submitted simultaneously. Some examples of indoor uses are termiticide structural protection, and indoor residential treatments (i.e. cockroach treatments).

Treatment of ornamentals in a shade house is classified as outdoor uses and is not covered in this category.

A maximum of five new products (e.g., any combination of technical product, manufacturing-use product and end use product) are covered by the base fee. After the first five new products, each application for an additional new product approval that is submitted within this new active ingredient package is subject to the registration service fee for a new product approval. Any inert ingredient petition submitted concurrently with a new active ingredient package will receive its own PRIA category and will not be counted among the five products covered under the base fee for the new active ingredient category. 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.

All of the inerts used in the product must be either approved, pending with the Agency, or a new inert petition submitted within the package for the applicable uses (food or nonfood).

If the Agency determines that endangered species analysis is required according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended to conduct the endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. This extension is contingent on Agency issuing the ESA guidance applicable to this PRIA category.

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 must 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.