SUPPLEMENTARY INFORMATION:

I. Background

Section 741(a) of the FD&C Act (21 U.S.C. 379j-21(a)), establishes four different types of generic new animal drug user fees: (1) fees for certain abbreviated applications for generic new animal drugs; (2) annual fees for certain generic new animal drug products; (3) annual fees for certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs; and (4) JINAD file fees. When certain conditions are met, section 741(d) of the FD&C Act authorizes FDA to waive or reduce fees for generic new animal drugs intended solely to provide for a minor use or minor species indication.

Section 741(b)(1) of the FD&C Act establishes a base revenue amount for each fiscal year. Per section 741(c)(2) and (3) of the FD&C Act, the base revenue amounts established for fiscal years after FY 2024 are subject to adjustment for inflation and workload. Beginning FY 2026, the annual fee revenue amounts are also subject to adjustment to reduce workload-based increases by the amount of certain excess collections. Section 741(b) of the FD&C Act establishes fees each year so that the percentage allocations for each of the fee categories is as follows: 20 percent shall be derived from fees for abbreviated applications for a generic new animal drug and JINAD file fees; 40 percent shall be derived from fees for generic new animal drug products; and 40 percent shall be derived from fees for generic new animal drug sponsors. The target revenue amounts for each fee category for FY 2027 are as follows: for application and/or JINAD file fees, the target revenue amount is $5,696,000; for product fees, the target revenue amount is $11,392,000; and for sponsor fees, the target revenue amount is $11,392,000.

For FY 2027, the AGDUFA rates are: $132,614 for each abbreviated application for a generic new animal drug other than those subject to the criteria in section 512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $66,307 for each abbreviated application for a generic new animal drug subject to the criteria in section 512(d)(4) of the FD&C Act; $50,000 for each JINAD file request or certain submissions to established JINAD files; $15,670 for each generic new animal drug product; $264,009 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $198,007 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $132,005 for each generic new animal drug sponsor paying 50 percent of the sponsor fee. FDA will issue invoices for FY 2027 product and sponsor fees by December 31, 2026, and payment will be due by January 31, 2027. The application fee rates are effective for all abbreviated applications for a generic new animal drug submitted on or after October 1, 2026, and will remain in effect through September 30, 2027. The fee rate for requests to establish a JINAD file, and for certain submissions to JINAD files established prior to October 1, 2023, is effective on October 1, 2026, and will remain in effect through September 30, 2027.

Applications will not be accepted for review until FDA has received full payment of application fees and any other fees owed under the AGDUFA program. Similarly, a request to establish a JINAD file or a submission to an existing JINAD file will not be accepted for action by FDA until FDA has received full payment of all fees owed under the AGDUFA program.

II. Fee Revenue Amount for FY 2027

A. Statutory Fee Revenue Amounts

Section 741(b)(1) of the FD&C Act specifies that the base fee revenue amount for FY 2027 for all generic animal drug user fee categories totals $25,000,000.

B. Inflation Adjustment to Fee Revenue Amount

Section 741(c)(2)(A) of the FD&C Act specifies that the annual fee revenue amount is to be adjusted for inflation increases for FY 2025 and subsequent fiscal years using two separate factors—one for personnel compensation and benefits (PC&B) costs and one for non-PC&B costs.

Section 741(c)(2)(A)(ii) of the FD&C Act specifies the component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all PC&B, per full-time equivalent (FTE) position of FDA, for the first 3 of the preceding 4 fiscal years of available data, multiplied by the average proportion of PC&B costs to total FDA costs for the first 3 of the 4 preceding fiscal years of available data. The data on total PC&B paid and numbers of FTE paid, from which the average cost per FTE can be derived, are published in FDA's Justification of Estimates for Appropriations Committees.

Table 1 summarizes the total PC&B costs per FTE for the specified fiscal years, provides the percentage change from the previous fiscal year, and provides the average percentage change over the first 3 of the 4 fiscal years preceding FY 2027. The 3-year average is 5.7330 percent. ( printed page 48150)

Section 741(c)(2)(A)(ii) of the FD&C Act specifies that the 5.7330 percent should be multiplied by the average proportion of PC&B costs to total FDA costs for the first 3 of the preceding 4 fiscal years for which data are available. Table 2 shows the amount of PC&B and the total costs obligated by FDA for the same 3 fiscal years.

The portion of the inflation adjustment relating to payroll costs is 5.7330 percent multiplied by 54.3054 percent, or 3.1133 percent.

Section 741(c)(2)(A)(iii) of the FD&C Act specifies that the non-payroll costs adjustment factor is calculated by multiplying the average annual percentage change that occurred in the Consumer Price Index for Urban Consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All Items Less Food and Energy; Annual Index) for the first 3 years of the preceding 4 years of available data by the average proportion of all non-PC&B costs to total FDA costs for the first 3 years of the preceding 4 fiscal years. Table 3 provides the summary data for the percentage change in the specified CPI for the Washington-Arlington-Alexandria area.^[1]

Section 741(c)(2)(A)(iii) of the FD&C Act specifies to calculate the inflation adjustment for non-payroll costs, we multiply 3.1441 percent by the average proportion of all costs other than PC&B to total FDA costs for the first 3 years of the preceding 4 fiscal years. Since 54.3054 percent was obligated for PC&B as shown in table 2, 45.6946 percent is the portion of costs other than PC&B (100 percent minus the PC&B percentage of 54.3054). The portion of the inflation adjustment relating to non-payroll costs is 3.1441 percent multiplied by 45.6946 percent, or 1.4367 percent.

Next, we add the payroll component (3.1133 percent) to the non-payroll component (1.4367 percent), for an inflation adjustment of 4.5500 percent for FY 2027.

Section 741(c)(2)(B) of the FD&C Act provides for the inflation adjustment to be compounded each fiscal year after FY 2025. The inflation adjustment for FY 2027 (4.5500 percent) is compounded by adding 1 and then multiplying by 1 plus the inflation adjustment factor for FY 2026 (1.0896), which equals 1.1392 (rounded) (1.0896 multiplied by 1.0455). We then multiply the base revenue amount for FY 2027 ($25,000,000) by 1.1392, yielding an inflation adjusted amount of $28,480,125.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

Section 741(c)(3)(A) of the FD&C Act specifies that fee revenue amounts for FY 2025 and subsequent fiscal years are subject to adjustment to account for changes in FDA's review workload. The workload adjustment would be applied to the inflation adjusted fee revenue amount.

To determine whether a workload adjustment applies, per AGDUFA IV commitments FDA calculates the weighted average of the change in the total number of each of the six types of applications and submissions specified in the workload adjustment provision (abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, investigational generic new animal drug protocol submissions, generic investigational new animal drug file requests, and generic investigational new animal drug meeting requests) received over the 5-year period that ended on September 30, 2025 (the base years; 2021 through 2025), and the average number of each of these types of applications and submissions over the most recent 5-year period that ended April 30, 2026.

The results of these calculations are presented in the first two columns of table 4. Column 3 reflects the percent change in workload over the two 5-year periods. Column 4 shows the weighting ( printed page 48151) factor for each type of application/submission, reflecting how much of the total FDA generic new animal drug review workload was accounted for by each type of application or submission in the table during the most recent 5 years. Column 5 is the weighted percent change in each category of workload and was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right of the table, the sum of the values in column 5 is calculated, reflecting a total change in workload of 1.5927 percent for FY 2027. This is the workload adjuster for FY 2027.

Per section 741(c)(3)(C) of the FD&C Act under no circumstances shall the workload adjustment result in fee revenues that are less than the base fee revenues for that fiscal year as adjusted for inflation. For FY 2027 the workload adjustment would not result in fee revenues less than the base fee revenues as adjusted for inflation, therefore a workload adjustment of $453,574 shall be applied.

Per section 741(c)(3)(B) of the FD&C Act, for each of fiscal years 2026 through 2028, if application of the workload adjustment increases the fee revenue amounts otherwise established for the fiscal year, as adjusted for inflation, such fee revenue increase shall be reduced by the amount of any excess collections for the second preceding fiscal year, up to the amount of such fee revenue increase. The second preceding fiscal year for FY 2027 resulted in excess collections of $3,359,210, which is higher than the corresponding workload adjustment for FY 2027, and therefore, the workload adjustment is reduced to $0.

D. FY 2027 Fee Revenue Amounts

AGDUFA IV specifies that the revenue amount of $28,480,000 (rounded) for FY 2027 is to be divided as follows: 20 percent, or a total of $5,696,000, is to come from application and/or JINAD file fees; 40 percent, or a total of $11,392,000, is to come from product fees; and 40 percent, or a total of $11,392,000 is to come from sponsor fees (See section 741(b) of the FD&C Act).

III. Abbreviated Application Fee and Generic Investigational New Animal Drug (JINAD) File Fee Calculations for FY 2027

A. Fee Revenues and Numbers of Fee-Paying Applications and Submissions

Section 741(a)(1)(A) of the FD&C Act states that each person who submits an abbreviated application for a generic new animal drug shall be subject to an application fee, with limited exceptions. The term “abbreviated application for a generic new animal drug” means an abbreviated application for the approval of any generic new animal drug submitted under section 512(b)(2) of the FD&C Act. FDA will assess fees related to JINAD files under section 741(a)(4)(A)(i) of the FD&C Act when a person submits a request to establish a new JINAD file. FDA will assess a fee under section 741(a)(4)(A)(ii) and (iii) of the FD&C Act for a person's first submission, as described below, to a JINAD file on or after October 1, 2023, where the JINAD file had been established prior to that date. The JINAD file fee is set in accordance with section 741(c)(1)(C) of the FD&C Act at $50,000. FDA will set the abbreviated application fee so that such fees combined with the JINAD file fees will generate a combined total of $5,696,000 in fee revenue for FY 2027.

To set fees for abbreviated applications for generic new animal drugs, FDA must first make some assumptions about the number of fee-paying abbreviated applications it will receive during FY 2027, the number of requests to establish new JINAD files it will receive during FY 2027, and the number of existing (prior to October 1, 2023) JINAD files to which it will receive submissions during FY 2027.

Regarding the fee for a person's first submission to an existing (prior to October 1, 2023) JINAD file on or after October 1, 2023, FDA intends to assess a fee only for the first data (or “P”) submission to the Bioequivalence (BE) or Chemistry, Manufacturing, and Controls (CMC) technical sections of the JINAD file. The Agency has selected P submissions to the BE or CMC technical sections as the basis for assessing this fee because P submissions to these sections consistently entail the substantial use of FDA review hours during the phased review process.

The Agency knows the numbers of applications and submissions that have been submitted in previous years. Those numbers fluctuate annually. In estimating the fee revenue to be generated by application and submission fees in FY 2027, FDA is assuming that the number of applications and submissions for which fees will be paid in FY 2027 will equal the average number of applications and submissions over the 5 most recently completed fiscal years of the AGDUFA program (FY 2021-FY 2025).

In addition, under section 741(a)(1)(C)(ii) of the FD&C Act an abbreviated application for a generic new animal drug subject to the criteria in section 512(d)(4) of the FD&C Act and submitted on or after October 1, 2013, shall be subject to 50 percent of the fee applicable to all other abbreviated applications for a generic new animal drug.

The average number of original submissions of abbreviated applications for generic new animal drugs over the 5 most recently completed fiscal years is ( printed page 48152) 22.6 applications not subject to the criteria in section 512(d)(4) of the FD&C Act and 3.0 submissions subject to the criteria in section 512(d)(4). Each of the submissions described under section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by the other applications and will be counted as one half of a fee. Adding all of the applications not subject to the criteria in section 512(d)(4) of the FD&C Act and 50 percent of the number that are subject to such criteria results in a total of 24.1 anticipated full fees.

Based on the previous assumptions, FDA is estimating that it will receive a total of 24.1 fee-paying generic new animal drug applications in FY 2027 (22.6 original applications paying a full fee and 3.0 applications paying a half fee).

For estimating the number of requests to establish a new JINAD file and the number of P submissions to the BE or CMC section of an existing (prior to October 1, 2023) JINAD file the Agency will receive in FY 2027, FDA took the number of new JINAD file requests and P submissions to the BE or CMC section of an existing JINAD file received in FY 2026. The number of requests to establish new JINAD files and P submissions to the BE or CMC section of existing JINAD files during FY 2026 as of June is 50.

Based on the previous assumptions, FDA is estimating that it will receive a total of 50 fee-paying JINAD file submissions in FY 2027 (including both requests to establish new JINAD files and first P submissions to the BE or CMC section of existing (prior to October 1, 2023) JINAD files).

B. Application Fee Rates for FY 2027

FDA must set the fee rates for FY 2027 so that the estimated 24.1 abbreviated application fees and 50 JINAD file fees will generate a total of $5,696,000. The fee for a new JINAD file request or the first submission to an existing (prior to October 1, 2023) JINAD file is $50,000 under section 741(c)(1)(C) of the FD&C Act. Therefore, the JINAD fees will generate a total of $2,500,000. Abbreviated application fees will have to generate a total of $3,196,000.

To generate this amount, the fee for a generic new animal drug application will be $132,614 and for those applications that are subject to the criteria set forth in section 512(d)(4) of the FD&C Act, 50 percent of that amount, or $66,307.

IV. Generic New Animal Drug Product Fee Calculations For FY 2027

A. Product Fee Revenues and Numbers of Fee-Paying Products

The generic new animal drug product fee must be paid annually by the person named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product submitted for listing under section 510 of the FD&C Act (21 U.S.C. 360), and who had an abbreviated application or supplemental abbreviated application for a generic new animal drug product pending at FDA after September 1, 2008 (21 U.S.C. 379j-21(a)(2)). Section 741(k)(6) of FD&C Act defines “generic new animal drug product” as a specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an abbreviated application for a generic new animal drug or supplemental abbreviated application for a generic new animal drug has been approved. The product fees are to be set so that they will generate $11,392,000 in fee revenue for FY 2027.

To set generic new animal drug product fees to realize $11,392,000, FDA must make some assumptions about the number of products for which these fees will be paid in FY 2027. FDA gathered data on all generic new animal drug products that have been submitted for listing under section 510 of the FD&C Act and matched this to the list of all persons who FDA estimated would have a generic new animal drug application or supplemental abbreviated application pending after September 1, 2008. As of May 2026, FDA estimates that there is a total of 731 products submitted for listing by persons who had an abbreviated application for a generic new animal drug or supplemental abbreviated application for a generic new animal drug pending after September 1, 2008. Based on this, FDA believes that a total of 731 products will be subject to this fee in FY 2027.

Per section 741(d) of the FD&C Act in estimating the fee revenue to be generated by generic new animal drug product fees in FY 2027, FDA is estimating that 0.5 percent of the products invoiced, or 4 products, will not pay fees in FY 2027, due to fee waivers and reductions. FDA has made this estimate at 0.5 percent this year, based on historical data over the past 5 completed fiscal years of the AGDUFA program.

Accordingly, the Agency estimates that a total of 727 (731 minus 4) products will be subject to product fees in FY 2027.

B. Product Fee Rates for FY 2027

FDA must set the fee rates for FY 2027 so that the estimated 727 products for which fees are paid will generate a total of $11,392,000. To generate this amount will require the fee for a generic new animal drug product, rounded to the nearest dollar, to be $15,670.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2027

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

The generic new animal drug sponsor fee must be paid annually by each person who: (1) is named as the applicant in an abbreviated application for a generic new animal drug, except for an approved application for which all subject products have been removed from listing under section 510 of the FD&C Act, or has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive; and (2) had an abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug pending at FDA after September 1, 2008. See section 741(k)(7) and (a)(3) of the FD&C Act.

Per section 741(a)(3)(C) of the FD&C Act, a generic new animal drug sponsor is subject to only one such fee each fiscal year. Applicants with more than 6 approved abbreviated applications will pay 100 percent of the sponsor fee; applicants with more than 1 and fewer than 7 approved abbreviated applications will pay 75 percent of the sponsor fee; and applicants with 1 or fewer approved abbreviated applications will pay 50 percent of the sponsor fee. The sponsor fees are to be set so that they will generate $11,392,000 in fee revenue for FY 2027.

To set generic new animal drug sponsor fees to realize $11,392,000, FDA must make some assumptions about the number of sponsors who will pay these fees in FY 2027. FDA developed data on all generic new animal drug sponsors and matched this to the list of all sponsors who had pending submissions and applications after September 1, 2008. As of May, 2026, FDA estimates that in FY 2027, 18 sponsors will pay 100 percent fees, 15 sponsors will pay 75 percent fees, and 30 sponsors will pay 50 percent fees. The total of these ( printed page 48153) figures is the equivalent of 44.25 full sponsor fees (18 times 100 percent or 18, plus 15 times 75 percent or 11.25 plus 30 times 50 percent or 15).

FDA estimates that about 2.5 percent of the 44.25 effective full sponsors, or 1.10, will not pay fees in FY 2027, due to fee waivers and reductions. FDA has made the estimate of the percentage of sponsors that will not pay fees at 2.5 percent this year, based on historical data over the past 5 completed fiscal years of the AGDUFA program. See section 741(d) of the FD&C Act.

Accordingly, the Agency estimates that the equivalent of 43.15 full sponsor fees (44.25 minus 1.10) are likely to be paid in FY 2027.

B. Sponsor Fee Rates for FY 2027

FDA must set the fee rates for FY 2027 so that the estimated equivalent of 43.15 full sponsor fees will generate a total of $11,392,000. To generate this amount will require the 100 percent fee for a generic new animal drug sponsor, rounded to the nearest dollar, to be $264,009. Accordingly, the fee for those paying 75 percent of the full sponsor fee will be $198,007, and the fee for those paying 50 percent of the full sponsor fee will be $132,005.

VI. Fee Schedule for FY 2027

The fee rates for FY 2027 are summarized in table 5.

VII. Fee Waiver or Reduction; Exemption From Fees

Per section 741(d)(1), of the FD&C Act the types of fees waivers and reductions that applied last fiscal year still exist for FY 2027. However, after September 30, 2023, there is no longer an exemption for any person who submits to CVM a supplemental abbreviated application relating to a generic new animal drug approved under section 512 of the FD&C Act, solely to add the application number to the labeling of the drug in the manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C. 352(w)(3)).

Waivers or reductions remain available for abbreviated applications for generic new animal drugs intended solely for a minor use/minor species indication; see section 741(d) of the FD&C Act.

VIII. Procedures for Paying the FY 2027 Fees

A. Abbreviated Application Fees, JINAD File Fees, and Payment Instructions

The FY 2027 fees established in the new fee schedule must be paid for the following applications/submissions that are subject to fees under AGDUFA IV and submitted on or after October 1, 2026: a generic new animal drug application, a submission requesting to establish a JINAD file, or the first BE or CMC submission to a JINAD file that was established prior to October 1, 2023. Payments made to FDA must be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. The preferred method for payments to FDA is online using electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website upon receipt of an invoice or after completing the User Fee Cover Sheet and generating the user fee ID number.

Secure electronic payments to FDA can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/​pay. ( Note: Only full payments are accepted; no partial payments can be made online.) Once an invoice or cover sheet is located, “Pay Now” should be selected to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

For payments made by wire transfer, include the unique user fee ID or invoice number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID or invoice number, the payment may not be applied. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account No: 75060099, Routing No: 021030004, SWIFT: FRNYUS33.

FDA's tax identification number is 53-0196965. If a fee is not paid in full, the fee will be treated as a claim of the U.S. Government (see section 741(h) of the FD&C Act and 45 CFR part 30), meaning the invoice balance due amount is referred to collections.

B. Application and JINAD File Submission Cover Sheet Procedures

Step One: Create a user account and password. Log onto the AGDUFA website at https://www.fda.gov/​ForIndustry/​UserFees/​AnimalGenericDrugUserFeeActAGDUFA/​ucm137049.htm and, under Application Submission Information, click on “Create AGDUFA User Fee Cover Sheet” and follow the directions. For security reasons, each firm submitting an application and/or a JINAD file submission will be assigned an organization identification number, and each user will also be required to set up a user account and password the first time you use this site. Online instructions will walk you through this process.

Step Two: Create an Animal Generic Drug User Fee Cover Sheet, transmit it to FDA, and print a copy. After logging into your account with your username and password, complete the steps required to create an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed for each abbreviated application for a generic new animal ( printed page 48154) drug or JINAD file submission. Once you are satisfied that the data on the cover sheet is accurate and you have finalized the cover sheet, you will be able to transmit it electronically to FDA and you will be able to print a copy of your cover sheet showing your unique PIN.

Step Three: Send the payment for your application or JINAD file submission as described in section VIII.A.

Step Four: Submit your application or JINAD file submission.

C. Product and Sponsor Fees

By December 31, 2026, FDA will issue invoices and payment instructions for product and sponsor fees for FY 2027 using this fee schedule. Payment will be due by January 31, 2027. FDA will issue invoices in November 2027 for any products and sponsors subject to fees for FY 2027 that qualify for fees after the December 2026 billing.

91 FR 48149