B677 PRIA Fee Category

• product chemistry and/or
• acute toxicity and/or
• public health pest efficacy and/or
• animal safety studies and/or
• child resistant packaging.

An application for registration of a new microbial or biochemical pesticide end‐use animal product that is not substantially similar or identical in its uses and formulation to a product currently registered. For example, spot‐on and flea collars products are generally labeled species specific, in that a product is labeled for dogs or cats, but not generally both, while shampoos and sprays may be labeled for both species (dogs and cats).

All applications require the following:

• A data matrix.
• Product chemistry data (Group A and B) and CSF. In some cases, product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1. If the source of the active ingredient is unregistered in this application, the decision review timeline will be the longest of the associated applications (see timeline for B672) and will be considered an application for a new product with an unregistered source of an active ingredient.
• Acute toxicity, public health pest efficacy, child resistant packaging data, companion animal safety data and/or requirements must be addressed by using: 1) the cite-all method, or 2) selective data citation which includes submitting required data. A rationale for a waiver or bridging of these data falls within this category.
• The required companion animal safety studies are based upon the specific label claims in the proposed label. For example, if the proposed end-use product label claim is to - use the product on 12 week old kittens weighing ≥ 3 lbs and breeding cats, then two companion animal studies are required: the first on kittens ≥ 12 weeks of age and weighing at least 3 lbs., and a second study on pregnant and nursing adult cats. Each of these studies must demonstrate an adequate margin of safety.
• Proposed label for the end-use product.

All inert ingredients used in the product must be EPA approved for the proposed use(s), pending approval with the Agency for the applicable uses, or included in an inert petition submitted within the package for the applicable uses. Each application for a new inert approval submitted in this package is subject to its own registration service fee. If the product relies upon a pending inert clearance, the new companion animal studies must be conducted with the pending inert in the tested product as it is intended to be marketed and sold in the end-use product.

An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) 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.

Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.