Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-2488]</DEPDOC> <SUBJECT>Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2026 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2026. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The application fee rates apply to applications submitted on or after October 1, 2025, and will remain in effect through September 30, 2026. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Visit FDA's website at: <E T="03">https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa.</E> For general questions, you may also email FDA's Center for Veterinary Medicine (CVM) at: <E T="03">cvmadufa@fda.hhs.gov. For questions relating to this notice:</E> UFFS, Office of Financial Management, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993; or email the User Fee Support Staff at <E T="03">UFSS@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Section 740(a) of the FD&C Act (21 U.S.C. 379j-12), as amended by ADUFA V, establishes four different types of user fees: (1) fees for certain animal drug applications and supplemental animal drug applications; (2) annual fees for certain animal drug products; (3) annual fees for certain establishments where such products are made; and (4) annual fees for certain sponsors of animal drug applications and/or investigational animal drug submissions. When certain conditions are met, FDA will waive or reduce fees per section 740(d) of the FD&C Act. For FYs 2024 through 2028, section 740(b)(1) of the FD&C Act establishes the base revenue amount for each fiscal year. Per section 740(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 in FY 2025, the annual fee revenue amount is also subject to an operating reserve adjustment to allow FDA to adjust the fee revenue amount to maintain a specified operating reserve of carryover user fees, per section 740(c)(4) of the FD&C Act. FDA may increase the fee revenue amount to maintain a 12-week minimum. If FDA has an excess operating reserve, FDA will decrease the fee revenue amount so that FDA has 22 weeks of operating reserve for FY 2025, 20 weeks for FY 2026, 18 weeks for FY 2027, and 16 weeks for FY 2028. Per section 740(b)(2) of the FD&C Act, fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the percentages of the total revenue that are derived from each type of user fee will be as follows: (1) revenue from application fees shall be 20 percent of total fee revenue; (2) revenue from product fees shall be 27 percent of total fee revenue; (3) revenue from establishment fees shall be 26 percent of total fee revenue; and (4) revenue from sponsor fees shall be 27 percent of total fee revenue. The target revenue amounts for each fee category for FY 2026 are as follows: for application fees, the target revenue amount is $7,230,400; for product fees, the target revenue amount is $9,761,040; for establishment fees, the target revenue amount is $9,399,520; and for sponsor fees, the target revenue amount is $9,761,010. For FY 2026, the animal drug user fee rates are: (1) $708,863 for an animal drug application; (2) $354,431 for a supplemental animal drug application for which safety or effectiveness data are required, for an animal drug application subject to the criteria set forth in section 512(d)(4) of the FD&C Act (21 U.S.C. 360b), and for an application for conditional approval under section 571 of the FD&C Act (21 U.S.C. 360ccc) for which an animal drug application submitted under section 512(b)(1) of the FD&C Act has been previously approved under section 512(d)(1) of the FD&C Act for another intended use; (3) $13,463 for the annual product fee; (4) $200,000 for the annual establishment fee; and (5) $165,441 for the annual sponsor fee. FDA will issue invoices for FY 2026 product, establishment, and sponsor fees by December 31, 2025, and payment will be due by January 31, 2026. The application fee rates are effective for applications submitted on or after October 1, 2025, and will remain in effect through September 30, 2026. Applications will not be accepted for review until FDA has received full payment of application fees and any other animal drug user fees owed under the ADUFA program. <HD SOURCE="HD1">II. Fee Revenue Amount for FY 2026</HD> <HD SOURCE="HD2">A. Statutory Fee Revenue Amounts</HD> Section 740(b)(1) of the FD&C Act specifies that the base fee revenue amount for FY 2026 for all animal drug user fee categories totals $33,500,000. <HD SOURCE="HD2">B. Inflation Adjustment to Fee Revenue Amount</HD> Section 740(c)(2)(A)(ii) and (iii) 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 adjustments: one for personnel compensation and benefits (PC&B) and one for non-PC&B costs. Section 740(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 paid per full-time equivalent position (FTE) at FDA for the first 3 of the 4 preceding 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 cost per FTE for the specified fiscal years, provides the percent change from the previous fiscal year, and provides the average percent change over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent. <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,15,15,15,15"> <TTITLE>Table 1—FDA Personnel Compensation and Benefits (PC&B) Each Year and Percentage Change</TTITLE> <CHED H="1">Fiscal year</CHED> <CHED H="1">2022</CHED> <CHED H="1">2023</CHED> <CHED H="1">2024</CHED> <CHED H="1">3-Year average</CHED> <ROW> <ENT I="01">Total PC&B</ENT> <ENT>$3,165,477,000</ENT> <ENT>$3,436,513,000</ENT> <ENT>$3,791,729,000</ENT> <ENT/> </ROW> <ROW> <ENT I="01">Total FTEs</ENT> <ENT>18,474</ENT> <ENT>18,729</ENT> <ENT>19,687</ENT> <ENT I="01">Percentage Change from Previous Year</ENT> <ENT>4.2967%</ENT> <ENT>7.0838%</ENT> <ENT>4.9677%</ENT> <ENT>5.4494%</ENT> </ROW> </GPOTABLE> Section 740(c)(2)(A)(ii) of the FD&C Act specifies that this 5.4494 percent should be multiplied by the 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 amount obligated by FDA for the same 3 fiscal years. <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,15,15,15,15"> <TTITLE>Table 2—PC&B as a Percent of Total Cost at FDA</TTITLE> <CHED H="1">Fiscal year</CHED> <CHED H="1">2022</CHED> <CHED H="1">2023</CHED> <CHED H="1">2024</CHED> <CHED H="1">3-Year average</CHED> <ROW> <ENT I="01">Total PC&B</ENT> <ENT>$3,165,477,000</ENT> <ENT>$3,436,513,000</ENT> <ENT>$3,791,729,000</ENT> <ENT/> </ROW> <ROW> <ENT I="01">Total Costs</ENT> <ENT>$6,251,981,000</ENT> <ENT>$6,654,058,000</ENT> <ENT>$6,976,495,000</ENT> <ENT>50.6316%</ENT> <ENT>51.6454%</ENT> <ENT>54.3501%</ENT> <ENT>52.2090%</ENT> </ROW> </GPOTABLE> The portion of the inflation adjustment relating to payroll costs is 5.4494 percent multiplied by 52.2090 percent, or 2.8451 percent. Section 740(c)(2)(A)(iii) of the FD&C Act specifies that the portion of the inflation adjustment for non-payroll costs is the average annual percent change that occurred in the Consumer Price Index (CPI) (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 multiplied by the average proportion of all costs other than 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 percent change in the specified CPI for the Washington-Arlington-Alexandria area. The data from the Bureau of Labor Statistics are shown in table 3. <SU>1</SU> <FTREF/> <FTNT> <SU>1</SU>  The data is published by the Bureau of Labor Statistics and can be found on its website at: <E T="03">https://data.bls.gov/timeseries/CUURS35ASA0L1E.</E> </FTNT> <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,15,15,15,15"> <TTITLE>Table 3—Annual and 3-Year Average Percentage Change in CPI (Less Food and Energy) for Washington-Arlington-Alexandria Area</TTITLE> <CHED H="1">Fiscal year</CHED> <CHED H="1">2022</CHED> <CHED H="1">2023</CHED> <CHED H="1">2024</CHED> <CHED H="1">3-Year average</CHED> <ROW> <ENT I="01">Annual CPI< ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 42k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━