B710 PRIA Fee Category

An application for registration of a SCLP product that is substantially similar or identical in its uses and formulation to products that are currently registered, or differ from a currently registered product only in ways that would not significantly increase the risk of unreasonable adverse effects to humans or the environment. In all cases, the product must contain a registered source of active ingredient, and the applicant must identify the similar registered product. If the proposed new product contains an unregistered source of active ingredient, or if new data, scientific literature, and/or waivers are submitted, another category is applicable (B720 or B721). Identical products are identical to another registered product and bear identical use patterns.

For a 100% repackaging or repack of a registered SCLP product, the data requirements are satisfied by the registered product that is being repackaged. The Confidential Statement of Formula (CSF) of the proposed product must indicate that the product is a 100% repack of the previously registered product.

Substantially similar products must contain the same active ingredient, in substantially the same proportion. They must have the same physical state (solid, liquid, granular), and contain substantially similar other (inert) ingredients. All of the inerts used in the product must be EPA approved for the proposed uses. The proposed product must have the same use patterns.

Identical/substantially similar products may have fewer uses, but all of its uses must have been approved for the claimed similar product. Adding or changing the use patterns (other than removal of uses) excludes the product from treatment as a substantially similar product.

If the new product is a simple dilution of or differs only by a minor change in inert ingredients from the registered product, some minor product chemistry may be required. Any cited data must have been previously reviewed and accepted by the Agency.

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.