PRIA Fee Category Table - Biopesticides Division - New Products

Table 13.

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'16/17 Registration Service Fee ($)
B652	118	New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply ⁽²⁾	13	12,764
B660	119	New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. ⁽²⁾	4	1,278
B670	120	New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. ⁽²⁾	7	5,107
B671	121	New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. ⁽²⁾	17	12,764
B672	122	New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. ⁽²⁾	13	9,118
B673	123	New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. ⁽²⁾	10	5,107
B674	124	New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only ⁽²⁾	4	1,278
B675	125	New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. ⁽²⁾	10	9,118
B676	126	New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. ⁽²⁾	13	9,118
B677	127	New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: product chemistry and/or acute toxicity and/or public health pest efficacy and/or animal safety studies and/or child resistant packaging ⁽²⁾	10	8,820

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

²An 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.