90 FR 144 pgs. 35906-35910 - Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026
Type: NOTICEVolume: 90Number: 144Pages: 35906 - 35910
Pages: 35906, 35907, 35908, 35909, 35910Docket number: [Docket No. FDA-2025-N-2337]
FR document: [FR Doc. 2025-14415 Filed 7-29-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2337]
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2026 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying for direct FDA accreditation.
DATES:
The fees apply from October 1, 2025, through September 30, 2026.
FOR FURTHER INFORMATION CONTACT:
For Questions Related to FSMA Program Fees: FSMAFeeStaff@fda.hhs.gov . For Questions Related to This Notice: Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, 240-402-4989; or the User Fees Support Staff at UFSS@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
I. Background
[top] Section 808(b)(1)(A) of the FD&C Act (21 U.S.C. 384d(b)(1)(A)) directed FDA to establish a recognition system for entities that accredit third-party certification bodies to conduct food
Section 808(c)(8) of the FD&C Act directed FDA to establish a reimbursement (user fee) program by which we assess fees and require reimbursement for our work to administer the third-party certification program. Our regulations pertaining to the user fee program for the third-party certification program can be found at 21 CFR 1.700 through 1.725.
The FY 2026 third-party certification program user fee rates announced in this notice is effective from October 1, 2025, through September 30, 2026.
II. Estimating the Average Cost of a Supported Direct FDA Work Hour for FY 2026
FDA estimates its costs for each activity to establish fee rates (see 21 CFR 1.705(b)).
A. Estimating the Full Cost per Direct Work Hour in FY 2026
Full-time Equivalent (FTE) reflects the total number of regular straight-time hours-not including overtime or holiday hours-worked by employees, divided by the number of compensable hours applicable to each fiscal year. Annual leave, sick leave, compensatory time off, and other approved leave categories are considered "hours worked" for purposes of defining FTE employment.
In general, the starting point for estimating the full cost per direct work hour is to estimate the cost of an FTE or paid staff year. Calculating an FDA-wide total cost per FTE requires three primary cost elements: payroll, non-payroll, and rent.
We used an average of past year cost elements to predict the FY 2026 cost. The FY 2026 FDA-wide average cost for payroll (salaries and benefits) is $225,917; non-payroll (including equipment, supplies, information technology, general and administrative overhead) is $116,581; and rent (including cost allocation analysis and adjustments for other rent and rent-related costs) is $24,627 per paid staff year, excluding travel costs.
Summing the average cost of an FTE for payroll, non-payroll, and rent brings the FY 2026 average fully supported cost to $367,125 (total includes rounding) per FTE, excluding travel costs. FDA will use this base unit fee in determining the hourly fee rate for third-party certification user fees for FY 2026 before including travel costs as applicable for the activity.
To calculate an hourly rate, we divide the FY 2026 average fully supported cost of $367,125 per FTE by the average number of supported direct FDA work hours in FY 2024 (the last FY for which data are available). See table 1.
| Total number of hours in a paid staff year | 2,080 |
| Less: | |
| 11 paid holidays | -88 |
| 20 days of annual leave | -160 |
| 10 days of sick leave | -80 |
| 12.5 days of training | -100 |
| 22 days of general administration | -176 |
| 26.5 days of travel | -212 |
| 2 hours of meetings per week | -104 |
| Net Supported Direct FDA Work Hours Available for Assignments | 1,160 |
Dividing the average fully supported FTE cost in FY 2026 ($367,125) by the total number of supported direct work hours available for assignment in FY 2024 (1,160) results in an average fully supported cost of $316 (rounded to the nearest dollar), excluding travel costs, per supported direct work hour in FY 2026.
B. Adjusting FY 2024 Travel Costs for Inflation To Estimate FY 2026 Travel Costs
To adjust the hourly rate for FY 2026, FDA estimates the cost of inflation in each year for FY 2025 and FY 2026. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) of the FD&C Act (21 U.S.C. 379h(c)(1))), the statutory method for inflation adjustment in the FD&C Act. FDA previously determined the FY 2025 inflation rate to be 4.1167 percent; this rate was published in the FY 2025 PDUFA user fee rates notice in the Federal Register (July 31, 2024, 89 FR 61474). Using the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation rate of 4.1167 percent for FY 2025 and 5.0313 percent for FY 2026, and FDA intends to use this inflation rate to make inflation adjustments for FY 2026.
[top] For the purpose of estimating the fee, we are using the travel cost rate for foreign travel because the majority of onsite assessments made by FDA under this program will require foreign travel. In FY 2024, the Office of Regulatory Affairs spent a total of $3,209,026 on 487 foreign inspection trips (averaging $6,589 per foreign inspection trip) related to FDA's Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine field activities programs. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $6,589 per trip by 120 hours per trip equals $55 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2024. To adjust $55 for inflation in FY 2025 and FY 2026, FDA multiplies it by the inflation factor (1.09355 or 9.355 percent), which results in an estimated cost of $60 per paid hour. That plus $316 in other costs per average supported direct work hour equals $376 per paid hour for each direct hour of work requiring foreign inspection travel. FDA will use this rate in charging fees in FY 2026 when travel is required for the third-party certification program.
| Fee category | Fee rates for FY 2026 |
|---|---|
| Hourly rate without travel | $316 |
| Hourly rate if travel is required | 376 |
III. Fees for Accreditation Bodies and Certification Bodies in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act
The third-party certification program assesses application fees and annual fees. Specifically, FDA can collect an initial application fee for accreditation bodies seeking recognition, an annual fee for recognized accreditation bodies, an annual fee for certification bodies accredited by a recognized accreditation body, an initial application fee for a certification body seeking direct accreditation from FDA, and a renewal application fee for recognized accreditation bodies. Table 3 provides an overview of the fees for FY 2026.
| Fee category | Fee rates for FY 2026 |
|---|---|
| Initial Application Fee for Accreditation Body Seeking Recognition | $53,440 |
| Annual Fee for Recognized Accreditation Body | 2,498 |
| Annual Fee for Accredited Certification Body | 3,122 |
| Initial Application Fee for a Certification Body Seeking Direct Accreditation from FDA | 53,440 |
| Renewal Application Fee for Recognized Accreditation Body | 32,724 |
A. Application Fee for Accreditation Bodies Applying for Recognition in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act
Our regulations, at §?1.705(a)(1), require an application fee for accreditation bodies applying for recognition; that fee covers the estimated average cost of the work FDA performs in reviewing and evaluating applications for recognition of accreditation bodies.
The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. Based on our data since starting the program, we estimate that it would take, on average, 80 person-hours to review an accreditation body's application, 48 person-hours for an onsite performance evaluation of the applicant (including travel and other steps necessary for a fully supported FTE to complete an onsite assessment), and 32 person-hours to prepare a written report documenting the onsite assessment.
FDA employees review applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel ($316 per hour) to calculate the user fee attributable to those activities: $316/hour × (80 hours (application review) + 32 hours (written report)) = $35,392. We use the fully supported FTE hourly rate for work requiring travel ($376 per hour) to calculate the user fee for onsite performance evaluations, since historically most accreditation bodies are in foreign countries: $376/hour × 48 hours ( i.e., two fully supported FTEs × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $18,048. The estimated average cost of our total work for reviewing an application for recognition for an accreditation body based on these figures would be $35,392 + $18,048 = $53,440. Therefore, the application fee for accreditation bodies applying for recognition in FY 2026 will be $53,440.
B. Annual Fee for Accreditation Bodies Participating in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act
To calculate the annual fee for each recognized accreditation body, FDA takes the estimated average cost of our work to monitor performance of a single recognized accreditation body and annualizes that over the average term of recognition. We assume an average term of recognition of 5 years. We also assume that FDA will monitor 10 percent of recognized accreditation bodies onsite. We estimate that one performance evaluation of a recognized accreditation body would take, on average, 22 hours to conduct records review, 8 hours to prepare a report detailing the records review and onsite performance evaluation, and 8 hours of onsite performance evaluation. Using the fully supported FTE hourly rates in table 2, the estimated average cost of our work to monitor performance of a single recognized accreditation body would be $9,480 ($316/hour × (22 hours (records review) + 8 hours (written report))) plus $3,008 ($376/hour × 8 hours (onsite evaluation)), which is $12,488. Annualizing this amount over 5 years leads to an annual fee for recognized accreditation bodies of $2,498 for FY 2026.
C. Annual Fee for Certification Bodies Accredited by a Recognized Accreditation Body in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act
To calculate the annual fee for a certification body accredited by a recognized accreditation body, FDA takes the estimated average cost of our work to monitor performance of a single certification body accredited by a recognized accreditation body and annualizes that over the average term of accreditation. We assume an average term of accreditation of 4 years. We estimate that FDA would conduct, on average, the same activities for the same amount of time to monitor certification bodies accredited by a recognized accreditation body as we would to monitor an accreditation body recognized by FDA. Using the fully supported FTE hourly rates in table 2, the estimated average cost of our work to monitor performance of a single accredited certification body would be $9,480 ($316/hour × (22 hours (records review) + 8 hours (written report))) plus $3,008 ($376/hour × 8 hours (onsite evaluation)), which is $12,488. Annualizing this amount over 4 years leads to an annual fee for accredited certification bodies of $3,122 for FY 2026.
D. Initial Application Fee for Certification Bodies Seeking Direct Accreditation From FDA in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act
[top] Our regulations, at §?1.705(a)(3), require an application fee for certification bodies applying for direct accreditation from FDA to cover the estimated average cost of our work to review and evaluating initial
The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. We estimate that it would take, on average, 80 person-hours to review a certification body's application, 48 person-hours for an onsite performance evaluation of the applicant, and 32 person-hours to prepare a written report documenting the onsite assessment.
FDA employees are likely to review applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel, $316 per hour, to calculate the portion of the user fee attributable to those activities: $316/hour × (80 hours (application review) + 32 hours (written report)) = $35,392. For the portion of the fee attributable to onsite performance evaluations, we use the fully supported FTE hourly rate for work requiring travel ($376 per hour) since historically most certification bodies are in foreign countries: $376/hour × 48 hours ( i.e., two fully supported FTEs × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $18,048. The estimated average cost of our work to review an application for direct accreditation of a certification body is $35,392 + $18,048 = $53,440. Therefore, the application fee for certification bodies applying for direct accreditation from FDA in FY 2026 will be $53,440.
E. Renewal Application Fee for Accreditation Bodies Participating in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act
Our regulations, at §?1.705(a)(2), require a renewal application fee for recognized accreditation bodies to cover the estimated average cost of our work to review and evaluate renewal applications for recognition of accreditation bodies.
The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. We estimate that it would take, on average, 43 person-hours to review an accreditation body's submitted renewal application, 24 person-hours for an onsite performance evaluation of the applicant, and 32 person-hours to prepare a written report documenting the onsite assessment.
FDA employees are likely to review renewal applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel ($316 per hour) to calculate the portion of the user fee attributable to those activities: $316/hour × (43 hours (application review) + 32 hours (written report)) = $23,700. For the portion of the fee attributable to onsite performance evaluations, we use the fully supported FTE hourly rate for work requiring travel ($376 per hour) since historically most accreditation bodies are in foreign countries: $3763/hour × 24 hours ( i.e., fully supported FTE × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $9,024. The estimated average cost of our work for reviewing a renewal application for recognition of an accreditation body is $23,700 + $9,024 = $32,724. Therefore, the renewal application fee for recognized accreditation bodies in FY 2026 will be $32,724.
IV. Estimated Fees for Accreditation Bodies and Certification Bodies in Other Fee Categories for FY 2026
Our regulations, at §?1.705(a)(4), require application fees for certification bodies applying for renewal of direct accreditation, while §?1.705(b)(2) requires annual fees for certification bodies directly accredited by FDA.
Although to date we have not directly accredited any certification bodies under the Third-Party Certification Program, FDA notifies the public of the program fee schedule annually (21 CFR 1.710). Therefore, we are providing estimates of annual fees and renewal applications for directly accredited certification bodies, based on the fully supported FTE hourly rates for FY 2026 and estimates of the number of hours it would take FDA to perform relevant activities as outlined in the Final Regulatory Impact Analysis for the Third-Party Certification regulation. Table 4 provides an overview of the estimated fees for these other categories.
| Fee category | Estimated fee rates for FY 2026 |
|---|---|
| Renewal application fee for directly accredited certification body | $32,724 |
| Annual fee for certification body directly accredited by FDA | 25,152 |
V. How must the fees be paid?
Accreditation bodies seeking recognition must submit the application fee with the application (21 CFR 1.715(a)). For recognized accreditation bodies and accredited certification bodies, an invoice will be sent annually. Payment must be made within 30 days of receipt of billing for the fee (§?1.715(b)). The payment is to be in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. The preferred payment method is online using an electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay . (Note: The system only accepts full payments.) Alternatively, electronic invoices will have a "Pay Now" option that redirects to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available only for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments should be made using U.S. bank accounts or credit cards.
When paying by wire transfer, the invoice number should be included; without the invoice number, the payment may not be applied. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, that amount should be added to the payment to ensure that the invoice is paid in full. For international wire transfers, please inquire with the financial institutions before submitting the payment. Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account Name: Food and Drug Administration, Account No.: 75060099, Routing No.: 021030004, Swift No.: FRNYUS33.
[top] The tax identification number of FDA is 53-0196965.
VI. What are the consequences of not paying this fee?
The consequences of not paying these fees are outlined in 21 CFR 1.725. If FDA does not receive an application fee with an application for recognition, the application will be considered incomplete, and FDA will not review the application. If a recognized accreditation body fails to submit its annual user fee within 30 days of the due date, we will suspend its recognition. If the recognized accreditation body fails to submit its annual user fee within 90 days of the due date, we will revoke its recognition. If an accredited certification body fails to pay its annual fee within 30 days of the due date, we will suspend its accreditation. If the accredited certification body fails to pay its annual fee within 90 days of the due date, we will withdraw its accreditation.
Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14415 Filed 7-29-25; 8:45 am]
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