Notice2025-14415
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 30, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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<title>Federal Register, Volume 90 Issue 144 (Wednesday, July 30, 2025)</title>
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[Federal Register Volume 90, Number 144 (Wednesday, July 30, 2025)]
[Notices]
[Pages 35906-35910]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14415]
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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.
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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: <a href="/cdn-cgi/l/email-protection#f2b4a1bfb3b49797a186939494b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="5315001e121536360027323535133537327d3b3b207d343c25">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#4510031616052321246b2d2d366b222a33"><span class="__cf_email__" data-cfemail="84d1c2d7d7c4e2e0e5aaececf7aae3ebf2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
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
[[Page 35907]]
safety audits and issue food and facility certifications to eligible
foreign entities. (For the reasons explained in the third-party
certification final rule (80 FR 74570 at 74578 to 74579, November 27,
2015), and for consistency with our regulations for the third-party
certification program in 21 CFR parts 1, 11, and 16, this notice uses
the term ``third-party certification body'' rather than the term
``third-party auditor'' used in section 808 of the FD&C Act.) Section
808(b)(1)(A)(ii) of the FD&C Act also allowed us to directly accredit
certain third-party certification bodies.
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.
Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2024
------------------------------------------------------------------------
------------------------------------------------------------------------
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 1,160
for Assignments................................
------------------------------------------------------------------------
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.
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.
[[Page 35908]]
Table 2--FSMA Fee Schedule for FY 2026
------------------------------------------------------------------------
Fee rates
Fee category 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.
Table 3--FSMA Third-Party Certification Program User Fee Schedule for FY
2026
------------------------------------------------------------------------
Fee rates for
Fee category FY 2026
------------------------------------------------------------------------
Initial Application Fee for Accreditation Body Seeking $53,440
Recognition............................................
Annual Fee for Recognized Accreditation Body............ 2,498
Annual Fee for Accredited Certification Body............ 3,122
Initial Application Fee for a Certification Body Seeking 53,440
Direct Accreditation from FDA..........................
Renewal Application Fee for Recognized Accreditation 32,724
Body...................................................
------------------------------------------------------------------------
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 Sec. 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 x (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 x 48 hours (i.e., two fully
supported FTEs x ((2 travel days x 8 hours) + (1 day onsite x 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 x (22 hours (records review) + 8 hours (written
report))) plus $3,008 ($376/hour x 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 x (22 hours (records review) + 8 hours
(written report))) plus $3,008 ($376/hour x 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
Our regulations, at Sec. 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
[[Page 35909]]
applications for direct accreditation of certification 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, 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 x (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 x 48 hours (i.e., two fully supported FTEs x ((2
travel days x 8 hours) + (1 day onsite x 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 Sec. 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 x (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 x 24 hours (i.e., fully supported FTE x ((2
travel days x 8 hours) + (1 day onsite x 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 Sec. 1.705(a)(4), require application fees for
certification bodies applying for renewal of direct accreditation,
while Sec. 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.
Table 4--Estimated Fee Rates for Other Fee Categories Under the FSMA
Third-Party Certification Program
------------------------------------------------------------------------
Estimated fee rates
Fee category for FY 2026
------------------------------------------------------------------------
Renewal application fee for directly accredited $32,724
certification body...............................
Annual fee for certification body directly 25,152
accredited by FDA................................
------------------------------------------------------------------------
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 (Sec. 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 <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>. (Note: The system only accepts full payments.)
Alternatively, electronic invoices will have a ``Pay Now'' option that
redirects to <a href="http://Pay.gov">Pay.gov</a>. 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.
The tax identification number of FDA is 53-0196965.
[[Page 35910]]
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]
BILLING CODE 4164-01-P
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