New end-use on-animal product, registered source of active ingredient(s) with submission of data and/or waivers for only:

• Animal safety and
• Pest(s) requiring efficacy ⁽⁴⁾ and/or
• Product chemistry and/or
• Acute toxicity and/or
• Child resistant packaging ^(2) (3)

This category applies to an application for registration of a new end-use on-animal product where animal safety studies are required to be submitted or cited.  The types of product that require animal safety studies include, but are not limited to, spot-ons, flea collars, shampoos and sprays.

To fit this category all applications require the following but are not limited to:

• A data matrix is required with the application.
• 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
• All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses. In those cases where the product relies upon a pending inert clearance, the new animal safety studies must be conducted with the pending inert in the tested product in the same concentrations as is intended to be marketed and sold.
• Acute toxicity, 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.
• Appropriate animal safety studies 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 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.

An application proposed as a 100% re-packaged product does not fall within this category (see category R300). The application does not fall into this category if it contains a request to waive generic data or a request to review any generic data. Even if the Agency may have reviewed the animal safety data previously, a product citing those data will need to be re-assessed for applicability of those data to the new product. (If the new product is a 100% repack of a registered product, the R300 category applies. If selective citation is utilized and the formulation is identical to the cited product, the R301 category may apply.)    

Applications for new end use products that are submitted using an unregistered source of an existing active ingredient will be recoded to either category R333 or R334. All active ingredients derived from a manufacturing source which does not hold an active EPA registration number are considered unregistered. Even if the Agency may have reviewed the product chemistry data previously for that source of the active ingredient for another end use product, the active ingredient is considered unregistered.

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 end-use 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.