An application that proposes modification in the label, formula, or packaging of a registered product which is substantially similar or is not substantially similar to a currently registered product and which requires the submission of data or the citation of data by the registrant which requires an analysis by the Registration Division (RD) only. To fit this category the inert ingredients must already be approved or pending before the Agency for the applicable uses in the product. Examples of actions in this category include: alternate formulations with product chemistry data, label changes to Precautionary Statements based on product chemistry and/or acute product toxicity data; efficacy data; child resistant packaging data. An amendment requesting the addition of an unregistered source of active ingredient does not belong in this category, and instead falls under the R351 category. Registered source of active ingredient means that the active ingredient has been issued an EPA Registration Number (license). EPA-initiated amendment shall not be charged fees.

(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 amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (d) Submissions with data and requiring data review are subject to registration service fees.

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 amendment 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.