PRIA Fee Category Table - Antimicrobial Division - Experimental Use Permits and Other Actions
Table 10.
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | FY'16/17 Registration Service Fee ($) |
|---|---|---|---|---|
| A520 | 92 | Experimental Use Permit application, non-food use (2) | 9 | 6,383 |
| A521 | 93 | Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1 | 3 | 2,482 |
| A522 | 94 | Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2 | 12 | 12,156 |
| A523 | 101 | Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols) | 9 | 12,156 |
| A524 | 95 | New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2) | 18 | 153,156 |
| A525 | 96 | New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows. (2) | 18 | 92,163 |
| A526 | 97 | New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) | 15 | 95,724 |
| A527 | 98 | New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) | 15 | 63,945 |
| A528 | 99 | Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2) | 15 | 22,337 |
| A529 | 100 | Amendment to Experimental Use Permit; requires data review or risk assessment (2) | 9 | 11,429 |
| A571 | 102 | Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated. | 18 | 95,724 |
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.
2Where 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 registrants written or electronic confirmation of agreement to the Agency.