Table 1—FDA PC&Bs Each Year and Percent Change
FY 2021 FY 2022 FY 2023 3-Year average Total PC&B $3,039,513,000 $3,165,477,000 $3,436,513,000 Total FTE 18,501 18,474 18,729 PC&B per FTE $164,289 $171,348 $183,486 Percent change from previous year 0.1811% 4.2967% 7.0838% 3.8539% The payroll adjustment is 3.8539 percent multiplied by 60 percent, or 2.3123 percent. The statute specifies that the component of the inflation adjustment for non-payroll costs for FY 2025 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All Items; Annual Index) for the first 3 of the preceding 4 years of available data multiplied by 0.40, or 40 percent (see section 738(c)(2)(C)(i)(II) of the FD&C Act).
Table 2 provides the summary data and the 3-year average percent change in the specified CPI for the Washington-Arlington-Alexandria area. These data are published by the Bureau of Labor Statistics and can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.
Table 2—Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
2021 2022 2023 3-Year average Annual CPI 277.728 296.117 305.317 Annual Percent Change 3.9568% 6.6212% 3.1069% 3-Year Average Percent Change in CPI 4.5616% The non-payroll adjustment is 4.5616 percent multiplied by 40 percent, or 1.8246 percent. Next, the payroll adjustment (2.3123 percent or 0.023123) is added to the non-payroll adjustment (1.8246 percent or 0.018246), for a total of 4.1369 percent (or 0.041369). To complete the inflation adjustment, 1 (100 percent or 1.0) is added for a total base inflation adjustment of 1.041369 for FY 2025. If the base inflation adjustment for a fiscal year is greater than 1.04, such adjustment shall be considered to be equal to 1.04 (see section 738(c)(2)(C)(ii)(II) of the FD&C Act). The total base inflation adjustment for FY 2025 is 1.04.
MDUFA V provides for this inflation adjustment to be compounded for FY 2023 and each subsequent fiscal year (see section 738(c)(2)(B) of the FD&C Act). To complete the compounded inflation adjustment for FY 2025, the FY 2024 compounded adjustment (1.079318) is multiplied by the FY 2025 base inflation adjustment (1.040000) to reach the applicable inflation adjustment of 1.122491 (rounded) for FY 2025. We then multiply the total revenue amount for FY 2025 ($350,746,400) by 1.122491, yielding an inflation adjusted total revenue amount of $393,710,000 (rounded to the nearest thousand dollars).
III. Adjustments to Base Fee Amounts for FY 2025
Under the FD&C Act, all submission fees and the periodic reporting fee are set as a percent of the standard (full) fee for a premarket application (see section 738(a)(2)(A) and (b)(1) of the FD&C Act).
A. Inflation Adjustment
MDUFA specifies that the base fees of $445,000 (premarket application) and $7,100 (establishment registration) are to be adjusted for FY 2025 using the same methodology as that for the total revenue inflation adjustment in section II (see section 738I(2)(D)(i) of the FD&C Act). Multiplying the base fees by the compounded inflation adjustment of 1.122491 yields inflation adjusted base fees of $499,508 (premarket application) and $7,970 (establishment registration).
B. Further Adjustments To Generate the Inflation-Adjusted Total Revenue Amount
After the applicable inflation adjustment to fees is done, FDA may increase, if necessary to achieve the inflation adjusted total revenue amount, the base fee amounts on a uniform proportionate basis (see section 738(c)(2)(D)(ii) of the FD&C Act). After this adjustment, if necessary, FDA may further increase the base establishment registration fees to generate the inflation-adjusted total revenue amount (see section 738(c)(3) of the FD&C Act).
For FY 2025, further adjustments were required to meet the inflation adjusted total revenue amount of $393,710,000. After increasing base fees, on a uniform proportionate basis, and further increasing establishment registration fees, this yields inflation adjusted base fees of $540,783 (premarket application) and $8,716 (establishment registration).
C. MDUFA V Adjustments Solely to Registration Fees
MDUFA V has three new potential adjustments that will not change the total revenue amount but may impact collections by increasing or decreasing establishment registration base fees only. These adjustments are the performance improvement adjustment, the hiring adjustment, and the operating reserve adjustment.
1. Performance Improvement Adjustment
Beginning with FY 2025, this adjustment allows FDA to collect fees in addition to the total revenue amount in FYs 2025, 2026, and 2027, if the Agency meets certain performance goals in FYs 2023, 2024, and 2025. If applicable, this provision further increases base establishment registration fee amounts to achieve an increase in total fee collections equal to the applicable performance improvement adjustment, which is set forth in the statute (see section 738(c)(4) of the FD& C Act). FDA met the FY 2023 Pre-Submission Written Feedback goal, which triggers the performance improvement adjustment for FY 2025.
For FY 2025, the performance improvement adjustment is equal to the product of the pre-submission amount in section 738(c)(4)(B)(i)(I) of the FD&C Act, $15,396,600, and the inflation adjustment under section 738(c)(2)(B) of the FD&C Act, 1.122491. See section 738(c)(4)(A)(i) of the FD&C Act. For FY 2025, the performance improvement adjustment is $17,282,545.
2. Hiring Adjustment
Beginning with FY 2025, this adjustment provides for the reduction of base establishment registration fees in FYs 2025, 2026, and 2027, if specified hiring goals for FYs 2023, 2024, and 2025 are not met by a certain threshold. The hiring adjustment would serve to decrease the base establishment registration fee amounts, as necessary, to achieve a reduction in total fee collections equal to the hiring adjustment amount, which is set forth in the statute (see section 738(c)(5) of the FD&C Act).
FDA met the FY 2023 statutory hiring threshold of 123 hires, so establishment registration fees will not need to be lowered by the hiring adjustment amount in FY 2025. Since FDA met the FY 2023 Pre-Submission Written Feedback goal, the FY 2027 statutory hiring goal will be 83 hires for fiscal year 2025 (see section 738(c)(5)(D)(iii)(II) of the FD&C Act) and the threshold will be 75 hires for fiscal year 2025 (see section 738(c)(5)(B)(iii)(II) of the FD&C Act).
3. Operating Reserve Adjustment
For FYs 2023 to 2027, the operating reserve adjustment requires FDA to decrease base establishment registration fees if the amount of operating reserves of carryover user fees exceeds the “designated amount”, and such reduction is necessary to provide for not more than such designated amount of operating reserves of carryover user fees (see section 738(c)(6)(A) of the FD&C Act). In making this calculation for FYs 2023 to 2026, a certain amount is excluded from the designated amount and is not subject to the decrease (see section 738(c)(6)(C) of the FD&C Act). For FY 2025, this excluded amount is $77,496,161.
The designated amount is equal to the sum of 13 weeks of operating reserves of carryover user fees plus 1 month of operating reserves, as described in 738(c)(8) (see 738(c)(6)(B) of the FD&C Act).
To determine the 13-week operating reserves of carryover user fees amount, the FY 2025 inflation-adjusted total revenue amount (from section II), $393,710,000, is added to the inflation-adjusted performance improvement adjustment amount (from section III.C.1), $17,282,545, resulting in $410,992,545. This amount is then divided by 52, and then multiplied by 13. The 13-week operating reserve amount for FY 2025 is $102,748,136.
To determine the 1 month of operating reserves described in section 738(c)(8) of the FD&C Act, the FY 2025 inflation-adjusted total revenue amount of $393,710,000 is added to the inflation-adjusted performance improvement adjustment amount of $17,282,545, resulting in $410,992,545. This amount is then divided by 12. The 1 month of operating reserves for FY 2025 is $34,249,379.
For FY 2025, the designated amount is equal to the 13-week operating reserve of $102,748,136 plus the 1 month of operating reserves of $34,249,379, totaling $136,997,515.
To determine the FY 2024 end-of-year operating reserves of carryover user fees amount, FDA combined the actual collections and obligations at the end of the third quarter (June 2024) and added the forecasted collections and obligations for the fourth quarter of FY 2024 to generate a full year estimate for FY 2024. The estimated end-of-year FY 2024 operating reserves of carryover user fees is $50,394,972 (Note, this amount includes the 1-month reserve).
Note that under MDUFA V, for the purposes of calculating the operating reserve adjustment, this amount does not include user fee funds considered unappropriated ($26,680,243) or unearned revenue ($62,498,454). In addition, as noted above, for purposes of the operating reserve adjustment, operating reserves of carryover user fees do not include the estimated $77,496,161 remaining to spend at the end of FY 2024 from the total of $118,000,000 intended to support the Total Product Life Cycle Advisory Program Pilot and Third-Party Review programs.
Because the estimated end-of-year FY 2024 MDUFA operating reserves of carryover user fees amount totaling $50,394,972 does not exceed the FY 2025 designated amount of $136,997,515, FDA will not decrease the base establishment registration fee amounts for FY 2025 to provide for not more than such designated amount.
As there is a performance improvement adjustment for FY 2025, but no hiring adjustment or operating reserve adjustment, establishment registration fees are increased to achieve an increase in total fee collections for FY 2025 equal to the performance improvement adjustment amount of $17,282,545. After so increasing establishment registration fees only, this yields fees of $540,783 (premarket application) and $9,280 (establishment registration).
IV. Calculation of Fee Rates
As noted in section II, the total revenue amount after the applicable inflation adjustment is $393,710,000 (rounded to the nearest thousand dollar). As noted in section III, the performance improvement adjustment solely to registration fees for FY 2025 is $17,282,545. There is no hiring adjustment or operating reserve adjustment for FY 2025.
Table 3A provides fee-paying submission counts, excluding establishment registration, for the last 3 years and the 3-year average. Table 3B provides establishment registration fee-paying submission counts for the most recently completed fiscal year (FY 2023). Historically, FDA has estimated the total number of fee-paying submission counts it expects to receive during the next fiscal year by averaging the number of fee-paying submission counts received in the 3 most recently completed fiscal years; for FY 2025 fee-setting, this would be an average of FY 2021 through FY 2023. FDA received an abnormally high volume of fee-paying establishment registrations due to the COVID-19 pandemic in FY 2020 and FY 2021. The surge in fee-paying establishment registrations has been declining starting in FY 2022, trending back toward pre-pandemic levels. In an effort to normalize the projected volume of establishment registration submissions for the FY 2025 fee-setting calculation, and more accurately project the associated establishment registration revenue, FDA decided to utilize the number of establishment registration fee-paying submission counts from FY 2023.
Table 3A—Three-Year Average of Fee-Paying Submissions
[Excluding establishment registration]
Application type FY 2021 actual FY 2022 actual FY 2023 actual 3 Yr average Full Fee applications 25 18 31 25 Small Business 5 3 3 4 Panel-Track Supplements 31 21 22 25 Small Business 6 1 5 4 De Novo Classifications 16 23 26 22 Small Business 42 53 68 54 180-Day Supplements 98 93 113 101 Small Business 34 31 12 26 Real-Time Supplements 150 140 138 143 Small Business 20 12 28 20 510(k)s 2,133 2,012 1,943 2,029 Small Business 1,846 1,757 2,031 1,878 30-Day Notice (Note also includes counts for 135 Day Supplements) 843 782 825 817 Small Business 77 67 53 66 513(g)(21 U.S.C. 360c(g)) Request for Classification Information 83 93 82 86 Small Business 53 58 59 57 Annual Fee for Periodic Reporting 613 620 657 630 Small Business 84 87 22 64 Table 3B—Fiscal Year 2023 Actual Fee-Paying Establishment Registration Submissions
Application type FY 2023 FY 2025 estimate for registrations Establishment Registrations 30,645 30,645 The information in tables 3A and 3B is necessary to estimate the amount of revenue that will be collected based on the fee amounts. Tables 4A and 4B display the FY 2025 base fees set in statute (column one) and the inflation adjusted base fees (per calculations in section III.A.) (column two). Using the inflation adjusted fees, the 3-year average of fee-paying submissions (excluding establishment registration), and the fee-paying establishment registration submissions from FY 2023, collections are projected to total $361,177,583 which is $32,532,417 lower than the inflation adjusted total revenue amount (in section II). Accordingly, the next step in the fee setting process is to increase the base fee amounts on a uniform proportionate basis to generate the inflation adjusted total revenue amounts (see 738(c)(2)(D)(ii) of the FD&C Act and table 4A, column three).
Applying these further adjusted fee rates to the 3-year average of fee-paying submissions, and the fee-paying establishment registration submissions from FY 2023 results in estimated total fee collections of $391,014,947 which is still $2,695,053 lower than the inflation adjusted total revenue amount (in Section II). The next step in the fee setting process, after the adjustment in (2)(D) is done, is to increase the base establishment registration fee amount as necessary for total fee collections to generate the inflation adjusted total revenue amount, as adjusted under paragraph (2) (see 738(c)(3) of the FD&C Act). Accordingly, the base establishment registration fee was increased by $88 for an establishment registration fee rate of $8,716 (see 738(c)(3) of the FD& C Act and table 4B, column three). The performance improvement adjustment amount is $17,282,544. Per statute, the establishment registration fee is further adjusted to account for the performance improvement adjustment amount. The inflation adjusted establishment registration fee is increased by $564 for an establishment registration fee of $9,280. The fees in column three in table 4A and column four in table 4B are those we are establishing for FY 2025, which are the standard fees.
Table 4A—Fees Needed To Achieve New FY 2025 Revenue Target
Application type FY 2025 statutory fees (base fees) FY 2025 inflation adjusted statutory base fees Adjusted FY 2025 fees to meet revenue target (uniform proportionate increase) 3-Year average of fee-paying submissions FY 2025 revenue from adjusted fees Full Fee Applications $445,000 $499,508 $540,783 25 $13,519,575 Small Business 111,250 124,877 135,196 4 540,784 Panel-Track Supplement 356,000 399,607 432,626 25 10,815,650 Small Business 89,000 99,902 108,157 4 432,628 De Novo Classification Request 133,500 149,583 162,235 22 3,569,170 Small Business 33,375 37,463 40,559 54 2,190,186 180-Day Supplements 66,750 74,926 81,117 101 8,192,817 Small Business 16,688 18,732 20,279 26 527,254 Real-Time Supplements 31,150 34,966 37,855 143 5,413,265 Small Business 7,788 8,741 9,464 20 189,280 510(k)s 20,025 22,478 24,335 2,029 49,375,715 Small Business 5,006 5,619 6,084 1,878 11,425,752 30-Day Notice 7,120 7,992 8,653 817 7,069,501 Small Business 3,560 3,996 4,326 66 285,516 513(g) Request for Classification Information 6,008 6,743 7,301 86 627,886 Small Business 3,004 3,372 3,650 57 208,050 Annual Fee for Periodic Reporting 15,575 17,483 18,927 630 11,924,010 Small Business 3,894 4,371 4,732 64 302,848 Total 126,609,887 Table 4B—Fees Needed To Achieve New FY 2025 Revenue Target Plus/Minus Adjustments
Application type FY 2025 statutory fees (base fees) FY 2025 inflation adjusted statutory base fees Adjusted FY 2025 fees to meet inflation adjusted total revenue amount (uniform proportionate increase + further adjustment to establishment registrations) Adjusted FY 2025 fees to meet inflation adjusted total revenue +/− adjustments FY 2023 fee-paying submissions FY 2025 revenue from adjusted fees Establishment Registrations $7,100 $7,970 $8,716 $9,280 30,645 $267,101,820 The standard fee (adjusted base amount) for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $540,783 for FY 2025. The fees set by reference to the standard fee for a premarket application are:
- For a panel-track supplement, 80 percent of the standard fee
- For a de novo classification request, 30 percent of the standard fee
- For a 180-day supplement, 15 percent of the standard fee
- For a real-time supplement, 7 percent of the standard fee
- For an annual fee for periodic reporting concerning a class III device, 3.5 percent of the standard fee
- For a 510(k) premarket notification, 4.5 percent of the standard fee
- For a 30-day notice, 1.6 percent of the standard fee
- For a 513(g) request for classification information, 1.35 percent of the standard fee
For all submissions other than a 30-day notice and a 513(g) request for classification information, the small business fee is 25 percent of the standard (full) fee for the submission (see section 738(d)(2)(C) and (e)(2)(C) of the FD&C Act). For a 30-day notice and a 513(g) request for classification information, the small business fee is 50 percent of the standard (full) fee for the submission (see section 738(d)(2)(C) of the FD&C Act).
The annual fee for establishment registration, after adjustments, is set at $9,280 for FY 2025. For FY 2025, there is no small business waiver for the annual establishment registration fee; all establishments pay the same fee.
For more information on reduced fees and waivers for small businesses, please see Section IX. Small Business Fee Reductions and Fee Waivers.
Table 5 summarizes the FY 2025 rates for all medical device fees.
Table 5—Medical Device Fees for FY 2025
Application fee type Standard fee (as a percent of the standard fee for a premarket application) FY 2025 standard fee FY 2025 small business fee Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) Base fee specified in statute $540,783 $135,196 Premarket report (submitted under section 515(c)(2) of the FD&C Act) 100% 540,783 135,196 Efficacy supplement (to an approved BLA under section 351 of the PHS Act) 100% 540,783 135,196 Panel-track supplement 80% 432,626 108,157 De novo classification request 30% 162,235 40,559 180-day supplement 15% 81,117 20,279 Real-time supplement 7% 37,855 9,464 510(k) premarket notification submission 4.5% 24,335 6,084 30-day notice 1.60% 8,653 4,326 513(g) request for classification information 1.35% 7,301 3,650 Annual Fee Type Annual fee for periodic reporting on a class III device 3.50% 18,927 4,732 Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14)) Base fee specified in statute 9,280 9,280
Document Information
- Published:
- 07/31/2024
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 2024-16883
- Pages:
- 61433-61441 (9 pages)
- Docket Numbers:
- Docket No. FDA-2024-N-3453
- PDF File:
- 2024-16883.pdf