SUPPLEMENTARY INFORMATION:

I. Background

Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h) establish two different kinds of user fees. Fees are assessed as follows: (1) application fees are assessed on certain types of applications for the review of human drug and biological products and (2) prescription drug program fees are assessed on certain approved products (section 736(a) of the FD&C Act). The statute also includes conditions under which such fees may be waived or reduced (section 736(d) of the FD&C Act), or under which fee exceptions, refunds, or exemptions apply (sections 736(a)(1)(C) through (H), 736(a)(2)(B) through (C), and 736(k) of the FD&C Act).

For FY 2023 through FY 2027, the base revenue amounts for the total revenues from all PDUFA fees are established by PDUFA VII. The base revenue amount for FY 2027 is $1,515,410,160. The FY 2027 base revenue amount is adjusted for (1) inflation, (2) strategic hiring and retention, and for (3) the resource capacity needs for the process for the review of human drug applications (the capacity planning adjustment (CPA)). This amount is further adjusted to include the additional dollar amount as specified in the statute (see section 736(b)(1)(G) of the FD&C Act) to provide for additional full-time equivalent (FTE) ^[1] positions to support PDUFA VII initiatives. If applicable, an operating reserve adjustment is added to provide sufficient operating reserves of carryover user fees. The amount from the preceding adjustments is then adjusted to provide for additional direct costs to fund PDUFA VII initiatives. Fee amounts are to be established each year so that revenues from application fees provide 20 percent of the total revenue, and prescription drug program fees provide 80 percent of the total revenue (see section 736(b)(2) of the FD&C Act).

This document provides fee rates for FY 2027 for an application requiring covered clinical data ^[2] ($4,600,753), for an application not requiring covered clinical data ($2,300,376), and for the prescription drug program fee ($416,857). These fees are effective on October 1, 2026, and will remain in effect through September 30, 2027. For applications that are submitted on or after October 1, 2026, the new fee schedule must be used.

II. Fee Revenue Amount for FY 2027

The base revenue amount for FY 2027 is $1,515,410,160 (see section 736(b)(1)(A) and (b)(3) of the FD&C Act). This amount is prior to any adjustments made for inflation, the strategic hiring and retention adjustment, CPA, additional dollar amount, operating reserve adjustment (if applicable), and additional direct costs (see section 736(b)(1) of the FD&C Act).

A. FY 2027 Statutory Fee Revenue Adjustments for Inflation

PDUFA VII specifies that the $1,515,410,160 is to be adjusted for inflation increases for FY 2027 using two separate adjustments: one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 736(c)(1) of the FD&C Act).

The component of the inflation adjustment for payroll costs is the average annual percent change in the ( printed page 48161) cost of all PC&B paid per FTE position at FDA for the first 3 of the preceding 4 fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of the process for the review of human drug applications for the first 3 of the preceding 4 fiscal years (see section 736(c)(1)(A) and (B)(i) of the FD&C Act).

Table 1 summarizes the actual cost and FTE data for the specified fiscal years, provides the percent changes from the previous fiscal years, and provides the average percent changes over the first 3 of the 4 fiscal years preceding FY 2027. The 3-year average is 5.7330 percent.

The statute specifies that this 5.7330 percent be multiplied by the proportion of PC&B costs to the total FDA costs of the process for the review of human drug applications. Table 2 shows the PC&B and the total obligations for the process for the review of human drug applications for the first 3 of the preceding 4 fiscal years.

The payroll adjustment is 5.7330 percent from table 1 multiplied by 65.1015 percent from table 2 resulting in 3.7323 percent.

The statute 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) for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years (see section 736(c)(1)(A) and (B)(ii)). Table 3 provides the summary data for the percent changes in the specified CPI for the Washington-Arlington-Alexandria area.^[3]

The statute specifies that this 2.8330 percent be multiplied by the proportion of all costs other than PC&B to total costs of the process for the review of human drug applications. Because 65.1015 percent was obligated for PC&B (as shown in table 2), 34.8985 percent is the portion of costs other than PC&B (100 percent minus 65.1015 percent equals 34.8985 percent). The non-payroll adjustment is 2.8330 percent times 34.8985 percent, or 0.9887 percent.

Next, we add the payroll adjustment (3.7323 percent) to the non-payroll adjustment (0.9887 percent), for a total inflation adjustment of 4.7210 percent (rounded) for FY 2027.

We then multiply the base revenue amount for FY 2027 ($1,515,410,160) by 4.7210 percent, which produces an inflation adjustment amount of $71,542,514. Adding this amount to the base revenue amount yields an inflation-adjusted base revenue amount of $1,586,952,674.

B. FY 2027 Strategic Hiring and Retention Adjustment

For each fiscal year, after the annual base revenue established in section II is adjusted for inflation in accordance with section II.A, the statute directs FDA to further increase the fee revenue and fees to support strategic hiring and retention. For FY 2027, this amount is $4,000,000 (see section 736(c)(2)(A) of the FD&C Act).

C. FY 2027 Statutory Fee Revenue Adjustments for Capacity Planning

The statute specifies that after the base revenue amount for FY 2027 of $1,515,410,160 has been adjusted as described in sections II.A and II.B, this amount shall be further adjusted to reflect changes in the resource capacity needs for the process of human drug application reviews (see section 736(c)(3) of the FD&C Act). Following a process agreed upon by FDA and industry during PDUFA VI reauthorization discussions and subsequently required in statute, FDA established a new CPA methodology and first applied it in the setting of FY 2021 fees. The establishment of this methodology is described in the Federal Register of August 3, 2020 (85 FR 46651). This methodology includes a continuous, iterative improvement approach, under which the Agency intends to refine its data and estimates for the core review activities to improve their accuracy over time. An adjustment for workload has been a critical aspect of the PDUFA program since PDUFA III in FY 2003 as it enables the program to adjust to shifts in review workload resulting from industry submissions to the Agency. The annual adjustment process allows greater accuracy than would be expected if workload adjustments were fixed at the start of the reauthorization period. The CPA is an evolution of the PDUFA workload adjuster and was implemented through a process agreed to by FDA and industry during PDUFA VI. The CPA builds on the concepts of the workload adjuster but realizes enhancements including the use of leading indicators of workload, use of full-time reporting data, the introduction of a managerial adjustment process as an internal check on the reasonableness of any adjustment, outputs measured in full-time equivalent employees, and the incorporation of adjustments into the base revenue amounts to ensure sustainability of payroll to support any new hires.

The CPA methodology includes four steps:

1. Forecast workload volumes: predictive models estimate the volume of workload for the upcoming FY.

2. Forecast the resource needs: forecast algorithms are generated utilizing time reporting data. These algorithms estimate the required demand in FTEs for direct review-related effort. This is then compared to current available resources for the direct review-related workload.

3. A managerial adjustment to assess the resource forecast in the context of additional internal factors: program leadership examines operational, financial, and resourcing data to assess whether FDA will be able to utilize additional funds during the FY, and whether such funds are required to support additional review capacity. FTE amounts are adjusted, if needed.

4. Convert the FTE need to dollars: utilizing FDA's fully loaded FTE cost model, the final feasible FTEs are converted to an equivalent dollar amount.

FDA calculated workload models for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) individually. The final Center-level results were then combined to determine the total FY 2027 PDUFA CPA.

Table 6 summarizes the forecasted workload volumes for CDER in FY 2027 based on predictive models, as well as historical actuals from FY 2025 for comparison.

Table 7 summarizes the forecasted workload volumes for CBER in FY 2027 based on predictive models, as well as the corresponding historical actuals from 2025 for comparison.

FDA anticipates that any FTE gains could be funded through the expected FY 2027 collections amount without further adjustment from the CPA. As such, FDA determined that in FY 2027 the PDUFA fee amounts do not need adjustment from the CPA to provide funds for the program.

D. FY 2027 Statutory Fee Revenue Adjustments for Additional Dollar Amounts

PDUFA VII provides an additional dollar amount for each of the 5 fiscal years covered by PDUFA VII for additional FTEs to support enhancements outlined in the PDUFA VII commitment letter. The additional dollar amount for FY 2027 as outlined in statute is $1,314,620 (see section 736(b)(1)(G)(v) of the FD&C Act). This amount will be added to the total FY 2027 PDUFA VII revenue amount.

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E. FY 2027 Statutory Fee Revenue Adjustments for Operating Reserve

PDUFA VII provides for an operating reserve adjustment that may result in an increase or decrease in fee revenue and fees for a given FY (see section 736(c)(4) of the FD&C Act). For FY 2027, FDA is required to further increase fee revenue and fees if an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees (see section 736(c)(4)(A)(iii) of the FD&C Act). If FDA has carryover balances of user fees in excess of 14 weeks of operating reserves, FDA is required to decrease fee revenue and fees to provide for not more than 14 weeks of operating reserves of carryover user fees (see section 736(c)(4)(B) of the FD&C Act).

To determine the dollar amounts for the 10-week and 14-week operating reserve thresholds, the adjustments (inflation, strategic hiring and retention, capacity planning, and additional dollar amount) discussed in sections II.A, II.B, II.C, and II.D are applied to the FY 2027 base revenue (see section 736(c)(4)(A) of the FD&C Act), resulting in $1,592,267,294. This amount is then divided by 52 to generate the 1-week operating amount of $30,620,525. The 1-week operating amount is then multiplied by 10 and 14. This results in a 10-week threshold amount of $306,205,250 and a 14-week threshold amount of $428,687,350.

To determine the FY 2026 end-of-year operating reserves of carryover user fees, the Agency assessed the operating reserve of carryover fees at the end of June 2026 and forecasted collections and obligations in the fourth quarter of FY 2026 combined. This provides an estimated end-of-year FY 2026 operating reserve of carryover user fees of $564,378,337, which equates to 18.43 weeks of operations.^[4]

Because the estimated FY 2026 end-of-year operating reserves of carryover user fees exceeds the 14-week threshold of $428,687,350, FDA will apply an operating reserve adjustment of −$135,690,987 to reduce the FY 2027 fee revenue and fees under the statutory provision for operating reserve adjustments.

F. FY 2027 Statutory Fee Revenue Adjustments for Additional Direct Cost

PDUFA VII specifies that an additional direct cost of $41,505,100 is to be added to the total FY 2027 PDUFA revenue amount (see sections 736(c)(5)(A)(ii) and 736(c)(5)(B)(iv) of the FD&C Act). With respect to target revenue for FY 2027, adding the additional direct cost amount of $41,505,100 to the inflation, strategic hiring and retention, CPA, additional dollar amount, and operating reserve adjustment results in the total revenue amount of $1,498,081,000 (rounded to the nearest thousand dollars).

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

Application fees will be set to generate 20 percent of the total revenue amount, amounting to $299,616,200 in FY 2027.

B. Estimate of the Number of Fee-Paying Applications and Setting the Application Fees

FDA has estimated the total number of fee-paying full application equivalents (FAEs) it expects to receive during the next fiscal year by averaging the number of fee-paying FAEs received in the ten most recently completed fiscal years. For FY 2027 fee setting, the 10 relevant fiscal years are FY 2016-2025. Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the fiscal year.^[5]

In estimating the number of fee-paying FAEs, an application requiring ( printed page 48165) covered clinical data ^[6] counts as one FAE. An application not requiring covered clinical data counts as one-half of an FAE. An application that is withdrawn before filing, or refused for filing, counts as one-fourth of an FAE if the applicant initially paid a full application fee, or one-eighth of an FAE if the applicant initially paid one-half of the full application fee amount.

As table 13 shows, the average number of fee-paying FAEs received annually in FY 2016 through FY 2025 is 65.123. FDA will set fees for FY 2027 based on this estimate as the number of full application equivalents that will be subject to fees.

The FY 2027 application fee is estimated by dividing the average number of full applications that paid fees from FY 2016 through FY 2025, 65.123, into the fee revenue amount to be derived from application fees in FY 2027, $299,616,200. The result is a fee of $4,600,753 per full application requiring clinical data, and $2,300,376 per application not requiring clinical data.

IV. Fee Calculation for Prescription Drug Program Fees

PDUFA VII assesses prescription drug program fees for certain prescription drug products. Program fees will be set to generate 80 percent of the total target revenue, amounting to $1,198,464,800 in FY 2027.

An applicant will not be assessed more than five program fees for a FY for prescription drug products identified in a single approved NDA or BLA (see section 736(a)(2)(C) of the FD&C Act). Applicants are assessed a program fee for a FY for user fee eligible prescription drug products identified in a human drug application approved as of October 1 of such FY. Additionally, applicants are assessed a program fee for a product that is not a prescription drug product on October 1 because it is included in the discontinued section of the Orange Book or the CDER/CBER Billable Biologics List on that date, if the product becomes a fee-eligible prescription drug product during the FY.

FDA estimates 3,031 program fees will be invoiced in FY 2027 before factoring in waivers, refunds, exceptions, and exemptions. FDA approximates that there will be 113 waivers and refunds granted. Additionally, FDA approximates that another 43 program fees will be exempted in FY 2027 based on the orphan drug exemption in section 736(k) of the FD&C Act.

FDA estimates 2,875 program fees in FY 2027, after allowing for an estimated 156 waivers and reductions, including the orphan drug exemptions, excepted and exempted fee-liable products. The FY 2027 prescription drug program fee rate is calculated by dividing the adjusted total revenue from program fees ($1,198,464,800) by the estimated 2,875 program fees, resulting in a FY 2027 program fee of $416,857 (rounded to the nearest dollar).

V. Fee Schedule for FY 2027

The fee rates for FY 2027 are displayed in table 14.

VI. Fee Payment Options and Procedures

A. Application Fees

The appropriate application fee established in the new fee schedule must be paid for any application subject to fees under PDUFA VII that is submitted on or after October 1, 2026. To pay, complete the Prescription Drug User Fee Cover Sheet, available at https://userfees.fda.gov/​OA_​HTML/​pdufaCAcdLogin.jsp, and generate a user fee identification (ID) number.

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 736(h) of the FD&C Act and 45 CFR part 30), ( printed page 48166) meaning the invoice balance due amount is referred to collections.

B. Prescription Drug Program Fees

FDA will issue invoices and payment instructions for FY 2027 program fees under the new fee schedule in August 2026. Under section 736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are due on October 1, 2026.

FDA will issue invoices in December 2026 for products that qualify for FY 2027 program fee assessments after the October 2026 billing.

C. Fee Waivers and Refunds

To qualify for consideration for a waiver or reduction under section 736(d) of the FD&C Act, an exemption under section 736(k) of the FD&C Act, or the return of an application or program fee paid under section 736 of the FD&C Act, including if the fee is claimed to have been paid in error, a person must submit to FDA a written request justifying such waiver, reduction, exemption or return not later than 180 days after such fee is due (section 736(i) of the FD&C Act). A request submitted under this paragraph must include any legal authorities under which the request is made.

91 FR 48160