B684 PRIA Fee Category

An application to amend a registered end-use pesticide animal product by adding additional claims for use on adult animals, juvenile animals, or breeding animals of the same species. For example, spot-on and flea collar 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). This amendment would require the following: proposed amended label for the end-use product, a data matrix, data compensation forms, and supporting data (animal safety and possibly efficacy and/or child-resistant packaging, see below).

If new efficacy claims are proposed for the same species of animal currently on the product label, efficacy data to support the proposed claims are required.

If the packaging type has changed (e.g., spot-on vs. stripe-on) so that the dose volume is altered (new or different), new child resistant packaging data are required.

Which companion animal safety studies are required is 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 on breeding cats, then two companion animal studies are required: the first one using 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.

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 as the end use product.

(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

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.