Notice2025-14407
Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2026
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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 importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2025, and will remain in effect through September 30, 2026.
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 35863-35866]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14407]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2359]
Food Safety Modernization Act Voluntary Qualified Importer
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 importers approved to
participate in the Voluntary Qualified Importer Program (VQIP) that is
authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the FDA Food Safety Modernization Act (FSMA). This fee is
effective on August 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#cc8a9f818d8aa9a99fb8adaaaa8caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="f7b1a4bab6b19292a483969191b7919396d99f9f84d9909881">[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#f2a7b4a1a1b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="0a5f4c59594a6c6e6b24626279246d657c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 806 of the FD&C Act (21 U.S.C. 384b) directs FDA to
establish a program to provide for the expedited review and importation
of food offered for importation by importers who have voluntarily
agreed to participate in such program, and a process, consistent with
section 808 of the FD&C Act (21 U.S.C. 384d), for the issuance of a
facility certification to accompany a food offered for importation by
importers participating in VQIP.
Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to
assess and collect fees from each importer participating in VQIP to
cover FDA's costs of administering the program. Each fiscal year, fees
are to be established based on an estimate of 100 percent of the costs
for the year (section 743(b)(2)(A)(iii) of the FD&C Act). The fee rates
must be published in a Federal Register notice not later than 60 days
before the start of each fiscal year (section 743(b)(1) of the FD&C
Act). After FDA approves a VQIP application, the user fee is to be paid
before October 1, the start of the VQIP fiscal year, to begin receiving
benefits for that VQIP fiscal year.
The FY 2026 VQIP user fee will support benefits 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 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, non-payroll, and rent.
We used an average of past year cost elements to predict the FY
2026 cost.
[[Page 35864]]
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, 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 VQIP 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 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................................
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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 2025
Travel Costs
To adjust the hourly rate for FY 2026, FDA estimates the cost of
inflation in each year for FYs 2025 and 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 (July 31, 2024, 89 FR 61474). 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.
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, FDA multiplies the FY 2025 PDUFA inflation rate adjustor
(1.041167) by 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 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) 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
------------------------------------------------------------------------
Fee rates
Fee category for FY
2026
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Hourly rate without travel................................... $316
Hourly rate if domestic travel is required................... 339
Hourly rate if foreign travel is required.................... 376
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III. Fees for Importers Approved To Participate in the Voluntary
Qualified Importer Program Under Section 743 of the FD&C Act
FDA assesses fees for VQIP annually. Table 3 provides an overview
of the fees for FY 2026.
Table 3--FSMA VQIP User Fee Schedule for FY 2026
------------------------------------------------------------------------
Fee rates
Fee category for FY
2026
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VQIP User Fee............................................... $9,620
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Section 743 of the FD&C Act requires that each importer
participating in VQIP pay a fee to cover FDA's costs of administering
the program. This fee represents the estimated average cost of the work
FDA performs in reviewing and evaluating a VQIP importer. At this
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time, FDA is not offering an adjusted fee for small businesses. As
required by section 743(b)(2)(B)(iii) of the FD&C Act, FDA published
guidelines in consideration of the burden of the VQIP fee on small
businesses and provided for a period of public comment on the
guidelines (80 FR 32136, June 5, 2015). While we received some
comments, the comments did not address the questions posed (that is,
how a small business fee reduction should be structured, what
percentage of fee reduction would be appropriate, or what alternative
structures FDA might consider to indirectly reduce fees for small
businesses by charging different fee amounts to different VQIP
participants). Consistent with section 743(b)(2)(B)(iii) of the FD&C
Act, if we determine to provide for a small business fee reduction, we
will adjust the fee schedule for small businesses only through notice
and comment rulemaking.
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. These estimates represent FDA's current thinking, and as
the program evolves, FDA will reconsider the estimated hours. We
estimate that it would take, on average, 39 person-hours to review a
new VQIP application (including communication provided through the VQIP
Importer's Help Desk), 28 person-hours to review a returning VQIP
application (including communication provided through the VQIP
Importer's Help Desk), 16 person-hours for an onsite performance
evaluation of a domestic VQIP importer (including travel and other
steps necessary for a fully supported FTE to complete and document an
onsite assessment), and 34 person-hours for an onsite performance
evaluation of a foreign VQIP importer (including travel and other steps
necessary for a fully supported FTE to complete and document an onsite
assessment).
Based on updated data, FDA anticipates that there may be up to
seven returning VQIP applicants and up to two new applicants this
fiscal year. FDA employees are likely to review new VQIP applications
from their worksites, so we use the fully supported FTE hourly rate
excluding travel, $316/hour, to calculate the portion of the user fee
attributable to those activities: $316/hour x (39 hours) = $12,324. FDA
employees are likely to review returning VQIP applications from their
worksites, so we use the fully supported FTE hourly rate excluding
travel, $316/hour, to calculate the portion of the user fee
attributable to those activities: $316/hour x (28 hours) = $8,848.
FDA employees may conduct a VQIP inspection to verify the
eligibility criteria and full implementation of the food safety and
food defense systems established in the Quality Assurance Program. For
FY 2026, FDA does not anticipate conducting dedicated VQIP inspections
and will instead use existing inspection programs (such as the Foreign
Supplier Verification Program and Hazard Analysis and Critical Control
Point regulations) for program participants.
FDA employees are likely to prepare for and report on the
performance evaluation of a domestic VQIP importer at an FTE's
worksite, so we use the fully supported FTE hourly rate excluding
travel, $316/hour, to calculate the portion of the user fee
attributable to those activities: $316/hour x (8 hours) = $2,528. For
the portion of the fee covering onsite evaluation of a domestic VQIP
importer, we use the fully supported FTE hourly rate for work requiring
domestic travel, $339/hour, to calculate the portion of the user fee
attributable to those activities: $339/hour x 8 hours (i.e., one fully
supported FTE x (1 day onsite x 8 hours)) = $2,712. Therefore, the
total cost of conducting the domestic performance evaluation of a VQIP
importer is determined to be $2,528 + $2,712 = $5,240.
Coordination of the onsite performance evaluation of a foreign VQIP
importer is estimated to take place at an FTE's worksite, so we use the
fully supported FTE hourly rate excluding travel, $316/hour, to
calculate the portion of the user fee attributable to those activities:
$316/hour x (10 hours) = $3,160. For the portion of the fee covering
onsite evaluation of a foreign VQIP importer, we use the fully
supported FTE hourly rate for work requiring foreign travel, $376/hour,
to calculate the portion of the user fee attributable to those
activities: $376/hour x 24 hours (i.e., one fully supported FTE x ((2
travel days x 8 hours) + (1 day onsite x 8 hours))) = $9,024.
Therefore, the total cost of conducting the foreign performance
evaluation of a VQIP importer is determined to be $3,160 + $9,024 =
$12,184.
Therefore, the estimated average cost of the work FDA performs in
total for approving an application for a VQIP importer in FY 2026 based
on these figures would be ($12,324 x \2/9\) + ($8,848 x \7/9\) =
$9,620.
IV. How must the fee be paid?
Section 743(a)(1)(C) of the FD&C Act requires FDA to assess and
collect user fees from each importer participating in VQIP. An invoice
will be sent to VQIP importers approved to participate in the program.
Payment are to be made before October 1, 2025, to be eligible for VQIP
participation for the benefit year beginning October 1, 2025. FDA will
not refund the VQIP user fee for any reason.
The payments are to be made 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 (via the U.S.
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: only full payments are accepted. No
partial payments can be made online.) Once you have found your invoice,
select ``Pay Now'' to be redirected 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 are to be made
using U.S. bank accounts as well as U.S. 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, the fee
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 prior to 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.
V. What are the consequences of not paying this fee?
The consequences of not paying these fees are outlined in Section J
of our Guidance for Industry, ``FDA's Voluntary Qualified Importer
Program'' (November 2024) (available at <a href="https://www.fda.gov/media/92196/download">https://www.fda.gov/media/92196/download</a>). If the user fee is not paid before October 1, a VQIP
importer will not be eligible to participate in VQIP. For the first
year a VQIP application is approved, if the user fee is not paid before
October 1, 2025, you are not eligible to participate
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in VQIP. If you subsequently pay the user fee, FDA will begin your
benefits after we receive the full payment. The user fee may not be
paid after December 31, 2025. For a subsequent year, if you do not pay
the user fee before October 1, FDA will send a Notice of Intent to
Revoke your participation in VQIP. If you do not pay the user fee
within 30 days of the date of the Notice of Intent to Revoke, we will
revoke your participation in VQIP.
Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14407 Filed 7-29-25; 8:45 am]
BILLING CODE 4164-01-P
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