R341 PRIA Fee Category
PRIA 4 Fee Determination Decision Tree:
Amend Conventional Registration - Change Product Label
Below is the fee for your selected Fee Category for Fiscal Years 2020-2021
Amendment requiring data review within RD (e.g., changes to precautionary label statements)
|Action Code||Description||FY'20-FY'21 Fee||Decision Time (months)|
|R341||Amendment requiring data review within RD (e.g., changes to precautionary label statements), includes adding/modifying pest(s) claims for greater than 2 target pests; excludes products requiring or citing an animal safety study. (2) (3)||$6,288||6|
Do you plan to request either of the following types of waivers?
|50% waiver||You pay ---->>>>>||$3,144|
|75% waiver||You pay ---->>>>>||$1,572|
To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.
|Action Code Interpretation|
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. For the purposes of public health claims, this category includes adding/modifying pest(s) claims for greater than 2 target pests. This category excludes on-animal products submitting or citing animal safety data for support of the amendment application.
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 (greater than 2 target pests), and 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 source product has been issued an EPA Registration Number (license). EPA-initiated amendments shall not be charged fees.
For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” (hereafter referred to as PRE) are: public health pests (e.g., disease transmitting, pathogen transferring, biting, stinging, allergen producing or pests otherwise injurious to humans or companion animals), livestock pests (e.g., horn flies, stable flies, cattle ticks, etc…), wood-destroying pests (i.e., termites, carpenter ants, and wood-boring beetles) and certain invasive species (e.g., Asian longhorned beetle and emerald ash borer).
The number of PREs, which determines the appropriate PRIA category, is the sum of: 1) the number of pest Groups (general; e.g., cockroaches, filth flies, mosquitoes, etc…) for which submitted or cited data require efficacy review, and 2) the number of individual pest Species not already covered as part of a Group for which submitted or cited data require efficacy review. If a registrant submits or cites data seeking a claim against an individual PRE species not already covered by a Group, then each pest species will count as 1 PRE. If a registrant submits or cites data seeking a label claim against a pest Group, then each Group will count as 1 PRE, even if data are required for more than one Species to support claims against that Group.
To determine whether a claim will count toward a Group or a Species, the Agency maintains a publicly available document, “Technical Support Document – Scientific Issues Associated with Product Performance Data Needs for Pesticide Products Claiming efficacy against Invertebrate Pests of Significant Public Health or Economic Importance”, which outlines Groups and Species. In this document, Appendix 1 (entitled “Pest Tables”) lists Groups of pests and the Species contained within each Group, and will serve as the guiding reference to determine Groups or Species as PREs. Use of this document in determining a PRIA category is limited to determining the number of PREs in a registrant’s application.
NOTE: Appendix 5 of this document, entitled “Label Claims and Representative Test Species for Pesticide Products Claiming Efficacy against Invertebrate Pests of Significant Public Health or Economic Importance”, provides guidance on the tests a registrant must provide to obtain a Group claim.
In addition, one individual PRE may encompass multiple claims. For example, if a registrant seeks both a general efficacy claim and a speed-of-kill claim against the singular PRE Group “Cockroaches”, then this will count as a singular PRE as long as the submitted or cited data adequately addresses each claim against the PRE.
Total Number of PRE Example: A registrant wishes to amend their label by adding pest claims for 3 target pests requiring efficacy for a currently registered product. The application will not require any animal safety data. The application will include submitted or cited product performance data to support claims against pests of public health significance.
The proposed label will include a general cockroach claim, a claim to control Oriental cockroaches, a general tick claim, and a claim against chiggers. In this example, the data necessary to support the desired claims are not on file at the Agency, so the registrant must submit or cite data with their application. To support the general cockroach claim, the Agency requires testing on both American and German cockroaches, so the prospective registrant must develop and submit or cite data supporting the desired claim on both species. Cockroaches are pest Group 8 and American and German cockroaches are the representative test species for the group; therefore, the studies supporting “cockroaches” count as one PRE for purposes of determining the PRIA category. Oriental cockroaches are part of pest Group 8. No additional data are required to support a claim against oriental cockroaches. The prospective registrant wishes to support a claim against “ticks”, pest Group 2. The prospective registrant must submit studies for each- lone star ticks, deer (blacklegged) ticks, and American or brown dog ticks- to support the general tick claim. The data to support the three required species of ticks count as one PRE for purposes of determining the PRIA category. Finally, the prospective registrant submits or cites data to support claims against chiggers. Chiggers count as a single PRE. Thus, the PRIA category for this action is R341 since data were submitted or cited to support claims against 3 pests requiring efficacy (i.e., cockroach (pest group 8), including Oriental cockroach specific claim; tick (pest group 2); and chiggers).
If the prospective registrant wishes to add a claim against the “gulf coast tick, which may transmit Rickettsia parkeri” an additional study will be required. The application would then contain product performance data supporting 4 pests requiring efficacy (i.e., cockroach (pest group 8), including Oriental cockroach specific claim; tick (pest group 2); chiggers; and gulf coast tick, which may transmit Rickettsia parkeri). The PRIA category would now be R316.
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.