Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2024, 48889-48893 [2023-15921]
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Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
and Radiological Health, Food and Drug
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FOR FURTHER INFORMATION CONTACT:
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Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2568, Silver Spring,
MD 20993–0002, 240–402–2980.
SUPPLEMENTARY INFORMATION:
I. Background
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design and development of clinical
studies to provide a reasonable
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Dated: July 24, 2023.
Lauren K. Roth,
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renewal fee rate for accreditation bodies
applying to be recognized in the thirdparty certification program that is
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 that are applying to be directly
accredited by FDA.
[FR Doc. 2023–15968 Filed 7–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food Safety Modernization Act ThirdParty Certification Program User Fee
Rate for Fiscal Year 2024
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the fiscal year (FY) 2024
annual fee rate for recognized
accreditation bodies and accredited
certification bodies, and the initial and
SUMMARY:
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This fee is effective on October
1, 2023, and will remain in effect
through September 30, 2024.
DATES:
[Docket No. FDA–2023–N–2897]
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assurance of safety and effectiveness for
a device intended to treat OUD. OUD
device studies designed using the
recommendations set out in this
guidance may advance the treatment of
OUD by providing scientific evidence
that aids FDA in determining whether
there is a reasonable assurance that a
device intended to treat OUD is safe and
effective. These recommendations may
change as more information becomes
available, and the research community
gains experience with different designs
in relation to OUD device studies.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo (Funmi) Ariyo, Food and
Drug Administration, 404 Powder Mill
Rd., Beltsville, MD 20705–4304, 240–
402–4989; or the FSMA Fee Staff, Office
of Food Policy and Response, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, FSMAFeeStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
Section 307 of FSMA (Pub. L. 111–
353), Accreditation of Third-Party
Auditors, amended the FD&C Act to
create a new provision, section 808,
under the same name. Section 808 of the
FD&C Act (21 U.S.C. 384d) directs FDA
to establish a program for accreditation
of third-party certification bodies 1
conducting food safety audits and
issuing food and facility certifications to
eligible foreign entities (including
registered foreign food facilities) that
meet our applicable requirements.
Under this provision, we established a
system for FDA to recognize
accreditation bodies to accredit
certification bodies, except for limited
circumstances in which we may directly
1 For the reasons explained in the third-party
certification final rule (80 FR 74570 at 74578–
74579, November 27, 2015), and for consistency
with the implementing regulations for the thirdparty 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(a)(3) of the FD&C Act.
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accredit certification bodies to
participate in the third-party
certification program.
Section 808(c)(8) of the FD&C Act
directs FDA to establish a
reimbursement (user fee) program by
which we assess fees and require
reimbursement for the work FDA
performs to establish and administer the
third-party certification program under
section 808 of the FD&C Act. The user
fee program for the third-party
certification program was established by
a final rule entitled ‘‘Amendments to
Accreditation of Third-Party
Certification Bodies To Conduct Food
Safety Audits and To Issue
Certifications To Provide for the User
Fee Program’’ (81 FR 90186, December
14, 2016).
The FSMA FY 2024 third-party
certification program user fee rate
announced in this notice is effective on
October 1, 2023 and will remain in
effect through September 30, 2024.
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2024
FDA must estimate its costs for each
activity in order to establish fee rates for
FY 2024. In each year, the costs of salary
(or personnel compensation) and
benefits for FDA employees account for
between 50 and 60 percent of the funds
available to, and used by, FDA. Almost
all the remaining funds (operating
funds) available to FDA are used to
support FDA employees for paying rent,
travel, utility, information technology,
and other operating costs.
A. Estimating the Full Cost per Direct
Work Hour in FY 2024
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
Agency-wide total cost per FTE requires
three primary cost elements: payroll,
non-payroll, and rent.
We have used an average of past year
cost elements to predict the FY 2024
cost. The FY 2024 FDA-wide average
cost for payroll (salaries and benefits) is
$192,848; non-payroll (including
equipment, supplies, information
technology, general and administrative
overhead) is $99,316; and rent
(including cost allocation analysis and
adjustments for other rent and rentrelated costs) is $23,239 per paid staff
year, excluding travel costs.
Summing the average cost of an FTE
for payroll, non-payroll, and rent, brings
the FY 2024 average fully supported
cost to $315,403 2 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
2024 prior to including travel costs as
applicable for the activity.
To calculate an hourly rate, FDA must
divide the FY 2024 average fully
supported cost of $315,403 per FTE by
the average number of supported direct
FDA work hours in FY 2022 (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 2022
Total number of hours in a paid staff year ..........................................................................................................................................
Less:
11 paid holidays ...........................................................................................................................................................................
20 days of annual leave ...............................................................................................................................................................
10 days of sick leave ....................................................................................................................................................................
12.5 days of training .....................................................................................................................................................................
22 days of general administration ................................................................................................................................................
26.5 days of travel ........................................................................................................................................................................
2 hours of meetings per week ......................................................................................................................................................
¥88
¥160
¥80
¥100
¥176
¥212
¥104
Net Supported Direct FDA Work Hours Available for Assignments .....................................................................................
1,160
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Dividing the average fully supported
FTE cost in FY 2024 ($315,403) by the
total number of supported direct work
hours available for assignment in FY
2022 (1,160) results in an average fully
supported cost of $272 (rounded to the
nearest dollar), excluding travel costs,
per supported direct work hour in FY
2024.
B. Adjusting FY 2022 Travel Costs for
Inflation To Estimate FY 2024 Travel
Costs
To adjust the hourly rate for FY 2024,
FDA must estimate the cost of inflation
in each year for FY 2023 and FY 2024.
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) (21 U.S.C.
2 Total
379h(c)(1))), the statutory method for
inflation adjustment in the FD&C Act
that FDA has used consistently. FDA
previously determined the FY 2023
inflation rate to be 1.6404 percent; this
rate was published in the FY 2023
PDUFA user fee rates notice in the
Federal Register (October 7, 2022, 87 FR
61063). Utilizing the method set forth in
section 736(c)(1) of the FD&C Act, FDA
has calculated an inflation rate of 1.6404
percent for FY 2023 and 3.8896 percent
for FY 2024. FDA intends to use this
inflation rate to make inflation
adjustments for FY 2024; the derivation
of this rate will be published in the
Federal Register in the FY 2024 notice
for the PDUFA user fee rates. The
compounded inflation rate for FYs 2023
and 2024, therefore, is 1.055938 (or
5.5938 percent) (calculated as 1 plus
1.6404 percent times 1 plus 3.8896
percent).
The average fully supported cost per
supported direct FDA work hour,
excluding travel costs, of $272 already
takes into account inflation as the
calculation above is based on FY 2024
predicted costs. FDA will use this base
unit fee in determining the hourly fee
rate for third-party certification program
fees for FY 2024 prior to including
travel costs as applicable for the
activity. For the purpose of estimating
the fee, we are using the travel cost rate
for foreign travel because we anticipate
that the vast majority of onsite
assessments made by FDA under this
program will require foreign travel. In
FY 2022, the Office of Regulatory Affairs
spent a total of $802,057 on 175 foreign
inspection trips related to FDA’s Center
includes rounding.
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for Food Safety and Applied Nutrition
and Center for Veterinary Medicine field
activities programs, which averaged a
total of $4,583 per foreign inspection
trip. These trips averaged 3 weeks (or
120 paid hours) per trip. Dividing
$4,583 per trip by 120 hours per trip
results in an additional cost of $38
(rounded to the nearest dollar) per paid
hour spent for foreign inspection travel
costs in FY 2022. To adjust $38 for
inflationary increases in FY 2023 and
FY 2024, FDA must multiply it by the
same inflation factor mentioned
previously in this document (1.055938
or 5.5938 percent), which results in an
estimated cost of $40 per paid hour in
addition to $272 for a total of $312 per
paid hour ($272 plus $40) for each
direct hour of work requiring foreign
inspection travel. FDA will use this rate
in charging fees in FY 2024 when travel
is required for the third-party
certification program.
TABLE 2—FSMA FEE SCHEDULE FOR FY 2024
Fee category
Fee rates for FY 2024
Hourly rate without travel .....................................................................................................................................................
Hourly rate if travel is required ............................................................................................................................................
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. In FY 2024, the only fees that
could be collected by FDA under
section 808(c)(8) of the FD&C Act are
the initial application fee for
accreditation bodies seeking
recognition, the annual fee for
recognized accreditation bodies, the
annual fee for certification bodies
$272
312
accredited by a recognized accreditation
body, the initial application fee for a
certification body seeking direct
accreditation from FDA, and the
renewal application fee for recognized
accreditation bodies. Table 3 provides
an overview of the fees for FY 2024.
TABLE 3—FSMA THIRD-PARTY CERTIFICATION PROGRAM USER FEE SCHEDULE FOR FY 2024
Fee category
Fee rates for FY 2024
Initial Application Fee for Accreditation Body Seeking Recognition ...................................................................................
Annual Fee for Recognized Accreditation Body .................................................................................................................
Annual Fee for Accredited Certification Body .....................................................................................................................
Initial Application Fee for a Certification Body Seeking Direct Accreditation from FDA .....................................................
Renewal Application Fee for Recognized Accreditation Body ............................................................................................
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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
Section 1.705(a)(1) (21 CFR
1.705(a)(1)) establishes an application
fee for accreditation bodies applying for
initial recognition that represents the
estimated average cost of the work FDA
performs in reviewing and evaluating
initial 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. These estimates represent
FDA’s current thinking, and as the
program evolves, FDA will continue to
reconsider the estimated hours. Based
on data we have acquired since starting
the program, we estimate that it would
take, on average, 80 person-hours to
review an accreditation body’s
submitted 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.
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FDA employees review applications
and prepare reports from their
worksites, so we use the fully supported
FTE hourly rate excluding travel, $272
per hour, to calculate the portion of the
user fee attributable to those activities:
$272/hour × (80 hours (application
review) + 32 hours (written report)) =
$30,464. FDA employees will likely
travel to foreign countries for the onsite
performance evaluations because most
accreditation bodies are anticipated to
be located in foreign countries. For this
portion of the fee, we use the fully
supported FTE hourly rate for work
requiring travel, $312 per hour, to
calculate the portion of the user fee
attributable to those activities: $312/
hour × 48 hours (i.e., two fully
supported FTEs × ((2 travel days × 8
hours) + (1 day onsite × 8 hours))) =
$14,976. The estimated average cost of
the work FDA performs in total for
reviewing an initial application for
recognition for an accreditation body
based on these figures would be $30,464
+ $14,976 = $45,440. Therefore, the
application fee for accreditation bodies
applying for recognition in FY 2024 will
be $45,440.
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$45,440
2,131
2,664
45,440
27,888
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 work
FDA performs to monitor performance
of a single recognized accreditation
body and annualizes that over the
average term of recognition. At this
time, we assume an average term of
recognition of 5 years. We also assume
that FDA will monitor 10 percent of
recognized accreditation bodies onsite.
As the program proceeds, we will adjust
the term of recognition as appropriate.
We estimate that for one performance
evaluation of a recognized accreditation
body, it would take, on average (taking
into account that not all recognized
accreditation bodies would be
monitored onsite), 22 hours for FDA 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 the work
FDA performs to monitor performance
of a single recognized accreditation
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body would be $8,160 ($272/hour × (22
hours (records review) + 8 hours
(written report))) plus $2,496 ($312/
hour × 8 hours (onsite evaluation)),
which is $10,656. Annualizing this
amount over 5 years would lead to an
annual fee for recognized accreditation
bodies of $2,131 for FY 2024.
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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 work
FDA performs to monitor performance
of a single certification body accredited
by a recognized accreditation body and
annualizes that over the average term of
accreditation. At this time, we assume
an average term of accreditation of 4
years. This 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 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 the work
FDA performs to monitor performance
of a single accredited certification body
would be $8,160 ($272/hour × (22 hours
(records review) + 8 hours (written
report))) plus $2,496 ($312/hour × 8
hours (onsite evaluation)), which is
$10,656. Annualizing this amount over
4 years would lead to an annual fee for
accredited certification bodies of $2,664
for FY 2024.
D. Initial Application Fee for
Certification Bodies Seeking Direct
Accreditation From FDA in the ThirdParty Certification Program Under
Section 808(c)(8) of the FD&C Act
Section 1.705(a)(3) establishes an
application fee for certification bodies
applying for direct accreditation from
FDA that represents the estimated
average cost of the work FDA performs
in reviewing and evaluating initial
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
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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, 80 person-hours
to review a certification body’s
submitted 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 are likely to review
applications and prepare reports from
their worksites, so we use the fully
supported FTE hourly rate excluding
travel, $272 per hour, to calculate the
portion of the user fee attributable to
those activities: $272/hour × (80 hours
(application review) + 32 hours (written
report)) = $30,464. FDA employees will
likely travel to foreign countries for the
onsite performance evaluations because
most certification bodies are anticipated
to be located in foreign countries. For
this portion of the fee, we use the fully
supported FTE hourly rate for work
requiring travel, $312 per hour, to
calculate the portion of the user fee
attributable to those activities: $312/
hour × 48 hours (i.e., two fully
supported FTEs × ((2 travel days × 8
hours) + (1 day onsite × 8 hours))) =
$14,976. The estimated average cost of
the work FDA performs in total for
reviewing an initial application for
direct accreditation of a certification
body based on these figures would be
$30,464 + $14,976 = $45,440. Therefore,
the application fee for certification
bodies applying for direct accreditation
from FDA in FY 2024 will be $45,440.
E. Renewal Application Fee for
Accreditation Bodies Participating in
the Third-Party Certification Program
Under Section 808(c)(8) of the FD&C Act
Section 1.705(a)(2) establishes a
renewal application fee for recognized
accreditation bodies that represents the
estimated average cost of the work FDA
performs in reviewing and evaluating
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. 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, 43 person-hours
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to review an accreditation body’s
submitted renewal application, 24
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 are likely to review
renewal applications and prepare
reports from their worksites, so we use
the fully supported FTE hourly rate
excluding travel, $272 per hour, to
calculate the portion of the user fee
attributable to those activities: $272/
hour × (43 hours (application review) +
32 hours (written report)) = $20,400.
FDA employees will likely travel to
foreign countries for the onsite
performance evaluations because most
certification bodies are anticipated to be
located in foreign countries. For this
portion of the fee, we use the fully
supported FTE hourly rate for work
requiring travel, $312 per hour, to
calculate the portion of the user fee
attributable to those activities: $312/
hour × 24 hours (i.e., fully supported
FTE × ((2 travel days × 8 hours) + (1 day
onsite × 8 hours))) = $7,488. The
estimated average cost of the work FDA
performs in total for reviewing a
renewal application for recognition of
an accreditation body based on these
figures would be $20,400 + $7,488 =
$27,888. Therefore, the renewal
application fee for recognized
accreditation bodies in FY 2024 will be
$27,888.
IV. Estimated Fees for Accreditation
Bodies and Certification Bodies in
Other Fee Categories for FY 2024
Section 1.705(a) also establishes
application fees for certification bodies
applying for renewal of direct
accreditation. Section 1.705(b) also
establishes annual fees for certification
bodies directly accredited by FDA.
Although we will not be collecting
these other fees in FY 2024, for
transparency and planning purposes, we
have provided an estimate of what these
fees would be for FY 2024 based on the
fully supported FTE hourly rates for FY
2024 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 other fee categories.
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TABLE 4—ESTIMATED FEE RATES FOR OTHER FEE CATEGORIES UNDER THE FSMA THIRD-PARTY CERTIFICATION
PROGRAM
Estimated fee rates
for FY 2024
Fee category
Renewal application fee for directly accredited certification body ......................................................................................
Annual fee for certification body directly accredited by FDA ..............................................................................................
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V. How must the fee be paid?
Accreditation bodies seeking initial
recognition must submit the application
fee with the application. For recognized
accreditation bodies and accredited
certification bodies, an invoice will be
sent annually. Payment must be made
within 30 days of the receipt invoice
date. The payment must be made in U.S.
currency from a U.S. bank by one of the
following methods: wire transfer,
electronically, check, bank draft, or U.S.
postal money order made payable to the
Food and Drug Administration. 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: 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 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 must be made using
U.S. bank accounts as well as U.S. credit
cards. When paying by check, bank
draft, or U.S. postal money order, please
include the invoice number. Also write
the FDA post office box number (P.O.
Box 979108) on the enclosed check,
bank draft, or money order. Mail the
payment, including the invoice number
on the check stub, to: Food and Drug
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000.
When paying by wire transfer, it is
required that the invoice number is
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, it is required to add that
amount 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
VerDate Sep<11>2014
17:16 Jul 27, 2023
Jkt 259001
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.
To send a check by a courier such as
Federal Express, the courier must
deliver the check to: U.S. Bank, Attn:
Government Lockbox 979108, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: this address is for courier
delivery only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 314–418–4013. This phone
number is only for questions about
courier delivery.) The tax identification
number of FDA is 53–0196965. (Note:
invoice copies do not need to be
submitted to FDA with the payments.)
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 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–15921 Filed 7–27–23; 8:45 am]
BILLING CODE 4164–01–P
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Frm 00108
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$27,888
21,184
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2898]
Food Safety Modernization Act
Voluntary Qualified Importer Program
User Fee Rate for Fiscal Year 2024
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2024 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, 2023 and
will remain in effect through September
30, 2024.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, FSMA Fee Staff,
Office of Food Policy and Response,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 240–402–4989, FSMAFeeStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 302 of FSMA, VQIP, amended
the FD&C Act to create a new provision,
section 806, under the same name.
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. The fee
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48889-48893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15921]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2897]
Food Safety Modernization Act Third-Party Certification Program
User Fee Rate for Fiscal Year 2024
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
fiscal year (FY) 2024 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 that is 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 that are applying to be directly accredited by
FDA.
DATES: This fee is effective on October 1, 2023, and will remain in
effect through September 30, 2024.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo (Funmi) Ariyo, Food and
Drug Administration, 404 Powder Mill Rd., Beltsville, MD 20705-4304,
240-402-4989; or the FSMA Fee Staff, Office of Food Policy and
Response, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 307 of FSMA (Pub. L. 111-353), Accreditation of Third-Party
Auditors, amended the FD&C Act to create a new provision, section 808,
under the same name. Section 808 of the FD&C Act (21 U.S.C. 384d)
directs FDA to establish a program for accreditation of third-party
certification bodies \1\ conducting food safety audits and issuing food
and facility certifications to eligible foreign entities (including
registered foreign food facilities) that meet our applicable
requirements. Under this provision, we established a system for FDA to
recognize accreditation bodies to accredit certification bodies, except
for limited circumstances in which we may directly
[[Page 48890]]
accredit certification bodies to participate in the third-party
certification program.
---------------------------------------------------------------------------
\1\ For the reasons explained in the third-party certification
final rule (80 FR 74570 at 74578-74579, November 27, 2015), and for
consistency with the implementing 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(a)(3) of the FD&C
Act.
---------------------------------------------------------------------------
Section 808(c)(8) of the FD&C Act directs FDA to establish a
reimbursement (user fee) program by which we assess fees and require
reimbursement for the work FDA performs to establish and administer the
third-party certification program under section 808 of the FD&C Act.
The user fee program for the third-party certification program was
established by a final rule entitled ``Amendments to Accreditation of
Third-Party Certification Bodies To Conduct Food Safety Audits and To
Issue Certifications To Provide for the User Fee Program'' (81 FR
90186, December 14, 2016).
The FSMA FY 2024 third-party certification program user fee rate
announced in this notice is effective on October 1, 2023 and will
remain in effect through September 30, 2024.
II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2024
FDA must estimate its costs for each activity in order to establish
fee rates for FY 2024. In each year, the costs of salary (or personnel
compensation) and benefits for FDA employees account for between 50 and
60 percent of the funds available to, and used by, FDA. Almost all the
remaining funds (operating funds) available to FDA are used to support
FDA employees for paying rent, travel, utility, information technology,
and other operating costs.
A. Estimating the Full Cost per Direct Work Hour in FY 2024
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 Agency-wide total cost per FTE requires three primary
cost elements: payroll, non-payroll, and rent.
We have used an average of past year cost elements to predict the
FY 2024 cost. The FY 2024 FDA-wide average cost for payroll (salaries
and benefits) is $192,848; non-payroll (including equipment, supplies,
information technology, general and administrative overhead) is
$99,316; and rent (including cost allocation analysis and adjustments
for other rent and rent-related costs) is $23,239 per paid staff year,
excluding travel costs.
Summing the average cost of an FTE for payroll, non-payroll, and
rent, brings the FY 2024 average fully supported cost to $315,403 \2\
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 2024 prior to including travel costs as applicable for the
activity.
---------------------------------------------------------------------------
\2\ Total includes rounding.
---------------------------------------------------------------------------
To calculate an hourly rate, FDA must divide the FY 2024 average
fully supported cost of $315,403 per FTE by the average number of
supported direct FDA work hours in FY 2022 (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 2022
------------------------------------------------------------------------
------------------------------------------------------------------------
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 2024 ($315,403)
by the total number of supported direct work hours available for
assignment in FY 2022 (1,160) results in an average fully supported
cost of $272 (rounded to the nearest dollar), excluding travel costs,
per supported direct work hour in FY 2024.
B. Adjusting FY 2022 Travel Costs for Inflation To Estimate FY 2024
Travel Costs
To adjust the hourly rate for FY 2024, FDA must estimate the cost
of inflation in each year for FY 2023 and FY 2024. 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)
(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 2023 inflation rate to be 1.6404 percent; this rate
was published in the FY 2023 PDUFA user fee rates notice in the Federal
Register (October 7, 2022, 87 FR 61063). Utilizing the method set forth
in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation
rate of 1.6404 percent for FY 2023 and 3.8896 percent for FY 2024. FDA
intends to use this inflation rate to make inflation adjustments for FY
2024; the derivation of this rate will be published in the Federal
Register in the FY 2024 notice for the PDUFA user fee rates. The
compounded inflation rate for FYs 2023 and 2024, therefore, is 1.055938
(or 5.5938 percent) (calculated as 1 plus 1.6404 percent times 1 plus
3.8896 percent).
The average fully supported cost per supported direct FDA work
hour, excluding travel costs, of $272 already takes into account
inflation as the calculation above is based on FY 2024 predicted costs.
FDA will use this base unit fee in determining the hourly fee rate for
third-party certification program fees for FY 2024 prior to including
travel costs as applicable for the activity. For the purpose of
estimating the fee, we are using the travel cost rate for foreign
travel because we anticipate that the vast majority of onsite
assessments made by FDA under this program will require foreign travel.
In FY 2022, the Office of Regulatory Affairs spent a total of $802,057
on 175 foreign inspection trips related to FDA's Center
[[Page 48891]]
for Food Safety and Applied Nutrition and Center for Veterinary
Medicine field activities programs, which averaged a total of $4,583
per foreign inspection trip. These trips averaged 3 weeks (or 120 paid
hours) per trip. Dividing $4,583 per trip by 120 hours per trip results
in an additional cost of $38 (rounded to the nearest dollar) per paid
hour spent for foreign inspection travel costs in FY 2022. To adjust
$38 for inflationary increases in FY 2023 and FY 2024, FDA must
multiply it by the same inflation factor mentioned previously in this
document (1.055938 or 5.5938 percent), which results in an estimated
cost of $40 per paid hour in addition to $272 for a total of $312 per
paid hour ($272 plus $40) for each direct hour of work requiring
foreign inspection travel. FDA will use this rate in charging fees in
FY 2024 when travel is required for the third-party certification
program.
Table 2--FSMA Fee Schedule for FY 2024
------------------------------------------------------------------------
Fee category Fee rates for FY 2024
------------------------------------------------------------------------
Hourly rate without travel..................... $272
Hourly rate if travel is required.............. 312
------------------------------------------------------------------------
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. In FY 2024, the only fees that could be collected by FDA
under section 808(c)(8) of the FD&C Act are the initial application fee
for accreditation bodies seeking recognition, the annual fee for
recognized accreditation bodies, the annual fee for certification
bodies accredited by a recognized accreditation body, the initial
application fee for a certification body seeking direct accreditation
from FDA, and the renewal application fee for recognized accreditation
bodies. Table 3 provides an overview of the fees for FY 2024.
Table 3--FSMA Third-Party Certification Program User Fee Schedule for FY
2024
------------------------------------------------------------------------
Fee category Fee rates for FY 2024
------------------------------------------------------------------------
Initial Application Fee for Accreditation Body $45,440
Seeking Recognition...........................
Annual Fee for Recognized Accreditation Body... 2,131
Annual Fee for Accredited Certification Body... 2,664
Initial Application Fee for a Certification 45,440
Body Seeking Direct Accreditation from FDA....
Renewal Application Fee for Recognized 27,888
Accreditation 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
Section 1.705(a)(1) (21 CFR 1.705(a)(1)) establishes an application
fee for accreditation bodies applying for initial recognition that
represents the estimated average cost of the work FDA performs in
reviewing and evaluating initial 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. These estimates represent FDA's current thinking, and as
the program evolves, FDA will continue to reconsider the estimated
hours. Based on data we have acquired since starting the program, we
estimate that it would take, on average, 80 person-hours to review an
accreditation body's submitted 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, $272 per hour, to calculate the portion of the user fee
attributable to those activities: $272/hour x (80 hours (application
review) + 32 hours (written report)) = $30,464. FDA employees will
likely travel to foreign countries for the onsite performance
evaluations because most accreditation bodies are anticipated to be
located in foreign countries. For this portion of the fee, we use the
fully supported FTE hourly rate for work requiring travel, $312 per
hour, to calculate the portion of the user fee attributable to those
activities: $312/hour x 48 hours (i.e., two fully supported FTEs x ((2
travel days x 8 hours) + (1 day onsite x 8 hours))) = $14,976. The
estimated average cost of the work FDA performs in total for reviewing
an initial application for recognition for an accreditation body based
on these figures would be $30,464 + $14,976 = $45,440. Therefore, the
application fee for accreditation bodies applying for recognition in FY
2024 will be $45,440.
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 work FDA performs to monitor
performance of a single recognized accreditation body and annualizes
that over the average term of recognition. At this time, we assume an
average term of recognition of 5 years. We also assume that FDA will
monitor 10 percent of recognized accreditation bodies onsite. As the
program proceeds, we will adjust the term of recognition as
appropriate. We estimate that for one performance evaluation of a
recognized accreditation body, it would take, on average (taking into
account that not all recognized accreditation bodies would be monitored
onsite), 22 hours for FDA 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 the work FDA performs to monitor performance of a single recognized
accreditation
[[Page 48892]]
body would be $8,160 ($272/hour x (22 hours (records review) + 8 hours
(written report))) plus $2,496 ($312/hour x 8 hours (onsite
evaluation)), which is $10,656. Annualizing this amount over 5 years
would lead to an annual fee for recognized accreditation bodies of
$2,131 for FY 2024.
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 work FDA performs to monitor performance of a single certification
body accredited by a recognized accreditation body and annualizes that
over the average term of accreditation. At this time, we assume an
average term of accreditation of 4 years. This 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 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 the work FDA performs to monitor
performance of a single accredited certification body would be $8,160
($272/hour x (22 hours (records review) + 8 hours (written report)))
plus $2,496 ($312/hour x 8 hours (onsite evaluation)), which is
$10,656. Annualizing this amount over 4 years would lead to an annual
fee for accredited certification bodies of $2,664 for FY 2024.
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
Section 1.705(a)(3) establishes an application fee for
certification bodies applying for direct accreditation from FDA that
represents the estimated average cost of the work FDA performs in
reviewing and evaluating initial 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. 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, 80 person-hours to review a
certification body's submitted 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 are likely to review applications and prepare reports
from their worksites, so we use the fully supported FTE hourly rate
excluding travel, $272 per hour, to calculate the portion of the user
fee attributable to those activities: $272/hour x (80 hours
(application review) + 32 hours (written report)) = $30,464. FDA
employees will likely travel to foreign countries for the onsite
performance evaluations because most certification bodies are
anticipated to be located in foreign countries. For this portion of the
fee, we use the fully supported FTE hourly rate for work requiring
travel, $312 per hour, to calculate the portion of the user fee
attributable to those activities: $312/hour x 48 hours (i.e., two fully
supported FTEs x ((2 travel days x 8 hours) + (1 day onsite x 8
hours))) = $14,976. The estimated average cost of the work FDA performs
in total for reviewing an initial application for direct accreditation
of a certification body based on these figures would be $30,464 +
$14,976 = $45,440. Therefore, the application fee for certification
bodies applying for direct accreditation from FDA in FY 2024 will be
$45,440.
E. Renewal Application Fee for Accreditation Bodies Participating in
the Third-Party Certification Program Under Section 808(c)(8) of the
FD&C Act
Section 1.705(a)(2) establishes a renewal application fee for
recognized accreditation bodies that represents the estimated average
cost of the work FDA performs in reviewing and evaluating 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. 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, 43 person-hours to review an
accreditation body's submitted renewal application, 24 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 are likely to review renewal applications and prepare
reports from their worksites, so we use the fully supported FTE hourly
rate excluding travel, $272 per hour, to calculate the portion of the
user fee attributable to those activities: $272/hour x (43 hours
(application review) + 32 hours (written report)) = $20,400. FDA
employees will likely travel to foreign countries for the onsite
performance evaluations because most certification bodies are
anticipated to be located in foreign countries. For this portion of the
fee, we use the fully supported FTE hourly rate for work requiring
travel, $312 per hour, to calculate the portion of the user fee
attributable to those activities: $312/hour x 24 hours (i.e., fully
supported FTE x ((2 travel days x 8 hours) + (1 day onsite x 8 hours)))
= $7,488. The estimated average cost of the work FDA performs in total
for reviewing a renewal application for recognition of an accreditation
body based on these figures would be $20,400 + $7,488 = $27,888.
Therefore, the renewal application fee for recognized accreditation
bodies in FY 2024 will be $27,888.
IV. Estimated Fees for Accreditation Bodies and Certification Bodies in
Other Fee Categories for FY 2024
Section 1.705(a) also establishes application fees for
certification bodies applying for renewal of direct accreditation.
Section 1.705(b) also establishes annual fees for certification bodies
directly accredited by FDA.
Although we will not be collecting these other fees in FY 2024, for
transparency and planning purposes, we have provided an estimate of
what these fees would be for FY 2024 based on the fully supported FTE
hourly rates for FY 2024 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
other fee categories.
[[Page 48893]]
Table 4--Estimated Fee Rates for Other Fee Categories Under the FSMA
Third-Party Certification Program
------------------------------------------------------------------------
Estimated fee rates
Fee category for FY 2024
------------------------------------------------------------------------
Renewal application fee for directly accredited $27,888
certification body............................
Annual fee for certification body directly 21,184
accredited by FDA.............................
------------------------------------------------------------------------
V. How must the fee be paid?
Accreditation bodies seeking initial recognition must submit the
application fee with the application. For recognized accreditation
bodies and accredited certification bodies, an invoice will be sent
annually. Payment must be made within 30 days of the receipt invoice
date. The payment must be made in U.S. currency from a U.S. bank by one
of the following methods: wire transfer, electronically, check, bank
draft, or U.S. postal money order made payable to the Food and Drug
Administration. 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: 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 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
must be made using U.S. bank accounts as well as U.S. credit cards.
When paying by check, bank draft, or U.S. postal money order, please
include the invoice number. Also write the FDA post office box number
(P.O. Box 979108) on the enclosed check, bank draft, or money order.
Mail the payment, including the invoice number on the check stub, to:
Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-
9000.
When paying by wire transfer, it is required that the invoice
number is 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,
it is required to add that amount 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.
To send a check by a courier such as Federal Express, the courier
must deliver the check to: U.S. Bank, Attn: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: this address is for
courier delivery only. If you have any questions concerning courier
delivery, contact U.S. Bank at 314-418-4013. This phone number is only
for questions about courier delivery.) The tax identification number of
FDA is 53-0196965. (Note: invoice copies do not need to be submitted to
FDA with the payments.)
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 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15921 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P
