A575 PRIA Fee Category

An application for conditional ruling by EPA on the substantial similarity between a cited, registered product and a not-yet submitted new product or product amendment, as it relates to product efficacy data requirements and/or guidelines.  The EPA response for this category is a letter indicating agreement/disagreement that the product cited by the applicant is substantially similar to an existing product, such that cited efficacy studies could adequately address product specific guideline requirements for the new product or amendment application when submitted. This is a conditional ruling, subject to change, should the actual registration or amendment application, once submitted, differ from the pre-application submission in formulation, labeling, or cited studies.

Substantially similar: Product must have the same active ingredient(s), in the same proportion, same chemical composition (solid, liquid, granular and gas), and substantially similar inert ingredients as the already registered product that is being cited. In addition, an efficacy similarity decision means that the proposed product bears the same use patterns – based on use sites and product application. Efficacy claims made on the proposed label should be identical to those of the cited product. Adding use patterns or changing existing use patterns (other than deleting them) may exclude the proposed product from being found as substantially similar. A substantial similarity finding for other product-specific characteristics (e.g., acute toxicity and/or chemistry) is not a substitute for a similarity determination for efficacy. Conversely, substantial similarity in the efficacy context does not indicate definite substantial similarity in other scientific disciplines (e.g., acute toxicity and/or chemistry).

To make the similarity determinations, documentation must be submitted to show the composition of the product and the uses. The following must be submitted, although additional items may be submitted as appropriate:

• Confidential Statement of Formula(s) (CSF(s));
• Label(s) 
• Data matrix listing the specific studies being cited;
• Cover letter identifying the EPA Reg. No. of the product being cited; and providing justification for the proposed similarity.

The product that is being cited must be a registered product.

This category does not contemplate multiple iterations of substantial similarity requests or rebuttal of the pre-conditional ruling on substantial similarity under the same application; each submission for efficacy similarity determination is managed independently. Any new proposal for citation to a different registered product must be submitted as a separate A575 application. This category does not contemplate multiple products being submitted for consideration of substantial similarity as part of one application. This determination is not required by the Agency as a pre-condition of a registration application, and such a request is at the discretion of the applicant.