PRIA Fee Category Table - Antimicrobial Division (AD) - Experimental Use Permits and Other Actions
Table 10.
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | FY'25 - FY'26 Fees ($) |
|---|---|---|---|---|
| A520 | 109 | Experimental Use Permit application, non-food use. (2) (3) | 9 | 9,609 |
| A521 | 110 | 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; applicant-initiated; Tier 1. | 6 | 7,115 |
| A522 | 111 | 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 study protocol; applicant-initiated; Tier 2. | 12 | 18,296 |
| A537 | 112 | New Active Ingredient/New Use, Experimental Use Permit application; Direct food use; Establish tolerance or tolerance exemption if required. Credit 45% of fee toward new active ingredient/new active ingredient/new use application that follows. (3) | 18 | 230,488 |
| A538 | 113 | New Active Ingredient/New-Use, Experimental Use Permit application; Indirect food use, Establish tolerance or tolerance exemption if required. Credit 45% of fee toward new active ingredient/new use application that follows. (3) | 18 | 144,058 |
| A539 | 114 | New Active Ingredient/New Use, Experimental Use Permit application; Nonfood use Credit 45% of fee toward new active ingredient/new use application that follows. (3) | 15 | 138,699 |
| A529 | 115 | Amendment to Experimental Use Permit; requires data review or risk assessment. (2) (3) | 9 | 17,203 |
| A523 | 116 | Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols). | 9 | 18,296 |
| A571 | 117 | Science reassessment: refined ecological risk, and/or endangered species; applicant-initiated. (3) | 18 | 144,058 |
| A533 | 118 | Exemption from the requirement of an Experimental Use Permit. (2) | 4 | 3,737 |
| A534 | 119 | Rebuttal of Agency reviewed protocol, applicant initiated. | 4 | 7,115 |
| A535 | 120 | Conditional ruling on pre-application study waiver or data bridging argument; applicant-initiated. | 6 | 3,627 |
| A536 | 121 | Conditional ruling on pre-application direct food, indirect food, nonfood use determination; applicant-initiated. | 4 | 3,737 |
| A575 | 122 (new) | Efficacy similarity determination; if two products can be bridged or if confirmatory efficacy data are needed. | 4 | 3,559 |
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 registrant’s written or electronic confirmation of agreement to the Agency.
3If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.