Notice2025-14414
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026
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Published
July 30, 2025
Effective
September 30, 2026
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 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).
Full Text
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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 35910-35913]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14414]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2362]
Food Safety Modernization Act Domestic and Foreign Facility
Reinspection, Recall, and Importer Reinspection Fee Rates 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 fee rates for certain domestic and foreign
facility reinspections, failures to comply with a recall order, and
importer reinspections that are authorized by the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety
Modernization Act (FSMA).
DATES: These fees apply to the period from October 1, 2025, and will
remain in effect through September 30, 2026.
FOR FURTHER INFORMATION CONTACT: For questions related to FSMA program
fees: <a href="/cdn-cgi/l/email-protection#eea8bda3afa88b8bbd9a8f8888ae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="94d2c7d9d5d2f1f1c7e0f5f2f2d4f2f0f5bafcfce7baf3fbe2">[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#feabb8adadbe989a9fd096968dd0999188"><span class="__cf_email__" data-cfemail="9bceddc8c8dbfdfffab5f3f3e8b5fcf4ed">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to
assess and collect fees from, in part: (1) the responsible party for
each domestic facility and the U.S. agent for each foreign facility
subject to a reinspection to cover reinspection-related costs; (2) the
responsible party for a domestic facility and an importer who does not
comply with a recall order to cover food recall activities associated
with such order; and (3) each importer subject to a reinspection to
cover reinspection-related costs (sections 743(a)(1)(A), (B), and (D)
of the FD&C Act). Section 743 of the FD&C Act directs FDA to establish
fees for each of these activities based on an estimate of 100 percent
of the costs of each activity for each year (sections 743(b)(2)(A)(i),
(ii), and (iv) of the FD&C Act), and these fees must be made available
solely to pay for the costs of each activity for which the fee was
incurred (section 743(b)(3) of the FD&C Act). These fees are effective
on October 1, 2025, and will remain in effect through September 30,
2026.
In section 743(b)(2)(B)(iii) of the FD&C Act, Congress directed FDA
to develop a proposed set of guidelines in consideration of the burden
of fee amounts on small businesses. FDA issued guidance on this subject
in October 2011 (2011 Fee Provision Guidance) (FDA Guidance for
Industry, ``Implementation of the Fee Provisions of Section 107 of the
FDA Food Safety Modernization Act'' (October 2011)). As stated in our
2011 Fee Provision Guidance, FDA recognizes that the full
[[Page 35911]]
cost recovery of FDA reinspection or recall oversight could impose
severe economic hardship for small businesses (id.). Therefore, as the
2011 Fee Provision Guidance explains, FDA intends to consider reducing
certain fees for those firms (id.). Consistent with the 2011 Fee
Provision Guidance, FDA does not intend to issue invoices for
reinspection or recall order fees until FDA publishes a separate
guidance document outlining the process through which firms may request
a reduction in fees.
In addition, as stated in the 2011 Fee Provision Guidance, FDA is
considering various issues associated with the assessment and
collection of importer reinspection fees. The fee rates set forth in
this notice will be used to determine any importer reinspection fees
assessed in FY 2026.
II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2026
FDA estimates 100 percent of its costs for each activity to
establish fee rates for FY 2026 (see section 743(b)(2)(A) of the FD&C
Act).
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, nonpayroll, 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, IT,
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, nonpayroll, 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 reinspection
and recall order fees for FY 2026 before including domestic or foreign
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 fiscal year for which data
are available). See table 1.
Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2024
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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
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Net Supported Direct FDA Work Hours Available 1,160
for Assignments................................
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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 inspection
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, we estimate 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 that FDA has used consistently.
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 (89 FR 61474, July 31, 2024). Using the
method set forth in section 736(c)(1) of the FD&C Act, FDA calculated
an inflation rate of 4.1167 percent for FY 2025 and 5.0313 percent for
FY 2026, and FDA intends to use these inflation rates to make inflation
adjustments for FY 2026 for several of its user fee programs.
In FY 2024, FDA's Office of Regulatory Affairs (ORA) spent a total
of $7,498,059 for domestic regulatory inspection travel costs and
General Services Administration Vehicle costs related to FDA's Center
for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary
Medicine (CVM) field activities programs. The total ORA domestic travel
costs spent is then divided by the 7,851 CFSAN and CVM domestic
inspections, which averages a total of $955 per inspection. These
inspections average 45.09 hours per inspection. Dividing $955 per
inspection by 45.09 hours per inspection results in a total and an
additional cost of $21 (rounded to the nearest dollar) per hour spent
for domestic inspection travel costs in FY 2024. To adjust for the $21
per hour additional domestic cost inflation increases for FY 2025 and
FY 2026, we multiply the FY 2025 PDUFA inflation rate adjustor
(1.041167) times the FY 2026 PDUFA inflation rate adjustor (1.050313)
times the $21 additional domestic cost, which results in an estimated
cost of $23 (rounded to the nearest dollar) per paid hour in addition
to $316 for a total of $339 per paid hour ($316 plus $23) for each
direct hour of work requiring domestic inspection travel. FDA will use
these rates in charging fees in FY 2026 when domestic travel is
required.
In FY 2024, ORA spent a total of $3,209,026 on 487 foreign
inspection trips related to FDA's CFSAN and CVM field activities
programs, which averaged a total of $6,589 per foreign
[[Page 35912]]
inspection trip. These trips averaged 3 weeks (or 120 paid hours) per
trip. Dividing $6,589 per trip by 120 hours per trip results in a total
and an additional cost of $55 (rounded to the nearest dollar) per paid
hour spent for foreign inspection travel costs in FY 2024. To adjust
$55 for inflationary increases in FY 2025, and FY 2026, FDA multiplies
it by the same inflation factors mentioned previously in this document
(1.041167 and 1.050313), which results in an estimated cost of $60
(rounded to the nearest dollar) per paid hour in addition to $316 for a
total of $376 per paid hour ($316 plus $60) for each direct hour of
work requiring foreign inspection travel. FDA will use these rates in
charging fees in FY 2026 when foreign travel is required.
Table 2--FSMA Fee Schedule for FY 2026
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Fee rates
Fee category for FY
2026
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Hourly rate if domestic travel is required................... $339
Hourly rate if foreign travel is required.................... 376
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III. Fees for Reinspections of Domestic or Foreign Facilities Under
Section 743(a)(1)(A) of the FD&C Act
A. What will cause this fee to be assessed?
The fee will be assessed for a reinspection conducted under section
704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective
actions have been implemented and are effective and compliance has been
achieved to the Secretary of Health and Human Services' (the Secretary)
(and, by delegation, FDA's) satisfaction at a facility that
manufactures, processes, packs, or holds food for consumption
necessitated as a result of a previous inspection (also conducted under
section 704 of the FD&C Act) of this facility, which had a final
classification of Official Action Indicated (OAI) conducted by or on
behalf of FDA, when FDA determined the noncompliance was materially
related to food safety requirements of the FD&C Act. FDA considers such
noncompliance to include noncompliance with a statutory or regulatory
requirement under section 402 of the FD&C Act (21 U.S.C. 342) and
section 403(w) of the FD&C Act (21 U.S.C. 343(w)). However, FDA does
not consider noncompliance that is materially related to a food safety
requirement to include circumstances where the noncompliance is of a
technical nature and not food safety related (e.g., failure to comply
with a food standard or incorrect font size on a food label).
Determining when noncompliance, other than under sections 402 and
403(w) of the FD&C Act, is materially related to a food safety
requirement of the FD&C Act may depend on the facts of a particular
situation. FDA intends to issue guidance to provide additional
information about the circumstances under which FDA would consider
noncompliance to be materially related to a food safety requirement of
the FD&C Act.
Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to
assess and collect fees from the responsible party for each domestic
facility (as defined in section 415(b) of the FD&C Act (21 U.S.C.
350d(b))) and the U.S. agent for each foreign facility subject to a
reinspection to cover reinspection-related costs.
Section 743(a)(2)(A)(i) of the FD&C Act defines the term
``reinspection'' with respect to domestic facilities as 1 or more
inspections conducted under section 704 of the FD&C Act subsequent to
an inspection conducted under such provision which identified
noncompliance materially related to a food safety requirement of this
Act, specifically to determine whether compliance has been achieved to
the Secretary's satisfaction.
The FD&C Act does not contain a definition of ``reinspection''
specific to foreign facilities. In order to give meaning to the
language in section 743(a)(1)(A) of the FD&C Act to collect fees from
the U.S. agent of a foreign facility subject to a reinspection, we are
using the following definition of ``reinspection'' for purposes of
assessing and collecting fees under section 743(a)(1)(A) of the FD&C
Act, with respect to a foreign facility: ``1 or more inspections
conducted by officers or employees duly designated by the Secretary
subsequent to such an inspection which identified noncompliance
materially related to a food safety requirement of the FD&C Act,
specifically to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction.''
This definition allows FDA to fulfill the mandate to assess and
collect fees from the U.S. agent of a foreign facility in the event
that an inspection reveals noncompliance materially related to a food
safety requirement of the FD&C Act, causing one or more subsequent
inspections to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction. By requiring the
initial inspection to be conducted by officers or employees duly
designated by the Secretary, the definition ensures that a foreign
facility would be subject to fees only in the event that FDA, or an
entity designated to act on its behalf, has made the requisite
identification at an initial inspection of noncompliance materially
related to a food safety requirement of the FD&C Act. The definition of
``reinspection-related costs'' in section 743(a)(2)(B) of the FD&C Act
relates to both a domestic facility reinspection and a foreign facility
reinspection, as described in section 743(a)(1)(A) of the FD&C Act.
B. Who will be responsible for paying this fee?
The FD&C Act states that this fee is to be paid by the responsible
party for each domestic facility (as defined in section 415(b) of the
FD&C Act) and by the U.S. agent for each foreign facility (section
743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send
the invoice for any fees that are assessed under this section.
C. How much will this fee be?
The fee is based on the number of direct hours spent on such
reinspections, including time spent conducting the physical
surveillance and/or compliance reinspection at the facility, or
whatever components of such an inspection are deemed necessary, making
preparations and arrangements for the reinspection, traveling to and
from the facility, preparing any reports, analyzing any samples or
examining any labels if required, and performing other activities as
part of the OAI reinspection until the facility is again determined to
be in compliance. The direct hours spent on each such reinspection will
be billed at the appropriate hourly rate shown in table 2 of this
document.
IV. Fees for Noncompliance With a Recall Order Under Section
743(a)(1)(B) of the FD&C Act
A. What will cause this fee to be assessed?
The fee will be assessed for not complying with a recall order
under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C
Act (21 U.S.C. 350a(f)) to cover food recall activities associated with
such order performed by the Secretary (and by delegation, FDA) (section
743(a)(1)(B) of the FD&C Act). Noncompliance may include the following:
(1) not initiating a recall as ordered by FDA; (2) not conducting the
recall in the manner specified by FDA in the recall order; or
[[Page 35913]]
(3) not providing FDA with requested information regarding the recall,
as ordered by FDA.
B. Who will be responsible for paying this fee?
Section 743(a)(1)(B) of the FD&C Act states that the fee is to be
paid by the responsible party for a domestic facility (as defined in
section 415(b) of the FD&C Act) and an importer who does not comply
with a recall order under section 423 or under section 412(f) of the
FD&C Act. In other words, the party paying the fee would be the party
that received the recall order.
C. How much will this fee be?
The fee is based on the number of direct hours spent taking action
in response to the firm's failure to comply with a recall order. Types
of activities could include conducting recall audit checks, reviewing
periodic status reports, analyzing the status reports and the results
of the audit checks, conducting inspections, traveling to and from
locations, and monitoring product disposition. The direct hours spent
on each such recall will be billed at the appropriate hourly rate shown
in table 2 of this document.
D. How must the fees be paid?
Section 743(a)(1)(A) and (B) of the FD&C Act require FDA to assess
and collect reinspection and recall fees, as appropriate, from
responsible parties for domestic and foreign food facilities. Further,
section 743(a)(1)(D) requires FDA to assess and collect reinspection
fees from importers. An invoice will be sent to the responsible party
for paying the fee after FDA completes the work on which the invoice is
based. Payment is to be made within 30 days of the invoice date in U.S.
currency by electronic check, credit card, or wire transfer. Detailed
payment information will be included with the invoice when it is
issued.
V. What are the consequences of not paying these fees?
Under section 743(e)(2) of the FD&C Act, any fee that is not paid
within 30 days after it is due shall be treated as a claim of the U.S.
Government subject to provisions of subchapter II of chapter 37 of
title 31, United States Code.
Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14414 Filed 7-29-25; 8:45 am]
BILLING CODE 4164-01-P
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