Outsourcing Facility Fee Rates for Fiscal Year 2025, 61470-61474 [2024-16876]
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
with the letters ‘‘AG’’, on the upper
right-hand corner of your completed
Animal Generic Drug User Fee Cover
Sheet. Also write FDA’s post office box
number (P.O. Box 979033) and PIN on
the enclosed check, bank draft, or
money order. Mail the payment and a
copy of the completed Animal Generic
Drug User Fee Cover Sheet to: Food and
Drug Administration, P.O. Box 979033,
St. Louis, MO 63197–9000. Note: In no
case should the payment for the fee be
submitted to FDA with the application
or JINAD file submission.
When paying by wire transfer, the
invoice number or PIN needs to be
included. Without the invoice number
or PIN, the payment may not be applied,
and the invoice amount would be
referred to collections. 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.
Use the following account information
when sending a payment by wire
transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Account Name:
Food and Drug Administration, Account
Number: 75060099, U.S. Department of
the Treasury routing/transit number:
021030004, SWIFT Number:
FRNYUS33.
To send a check by a courier such as
FedEx, the courier must deliver the
check and printed copy of the cover
sheet to U.S. Bank: U.S. Bank, Attn:
Government Lockbox 979033, 3180
Rider Trail S, Earth City, MO 63045.
(Note: This address is for courier
delivery only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 855–259–3064. This
telephone number is only for questions
about courier delivery.)
It is important that the fee arrives at
the bank at least a day or two before the
abbreviated application or JINAD
submission arrives at FDA’s CVM. FDA
records the official abbreviated
application or JINAD submission receipt
date as the later of the following: the
date the application or submission was
received by CVM, or the date U.S. Bank
notifies FDA that your payment in the
full amount has been received, or when
the U.S. Department of the Treasury
notifies FDA of payment. U.S. Bank and
the U.S. Department of the Treasury are
required to notify FDA within 1 working
day, using the PIN described previously.
The tax identification number of FDA
is 53–0196965.
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B. Application and JINAD File
Submission Cover Sheet Procedures
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Step One: Create a user account and
password. Log onto the AGDUFA
website at https://www.fda.gov/
ForIndustry/UserFees/
AnimalGenericDrug
UserFeeActAGDUFA/ucm137049.htm
and, under Application Submission
Information, click on ‘‘Create AGDUFA
User Fee Cover Sheet’’ and follow the
directions. For security reasons, each
firm submitting an application and/or a
JINAD file submission will be assigned
an organization identification number,
and each user will also be required to
set up a user account and password the
first time you use this site. Online
instructions will walk you through this
process.
Step Two: Create an Animal Generic
Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging
into your account with your username
and password, complete the steps
required to create an Animal Generic
Drug User Fee Cover Sheet. One cover
sheet is needed for each abbreviated
application for a generic new animal
drug or JINAD file submission. Once
you are satisfied that the data on the
cover sheet is accurate and you have
finalized the cover sheet, you will be
able to transmit it electronically to FDA
and you will be able to print a copy of
your cover sheet showing your unique
PIN.
Step Three: Send the payment for
your application or JINAD file
submission as described in section IX.A.
Step Four: Submit your application or
JINAD file submission.
Food and Drug Administration
C. Product and Sponsor Fees
By December 31, 2024, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2025
using this fee schedule. Payment will be
due by January 31, 2025. FDA will issue
invoices in November 2025 for any
products and sponsors subject to fees for
FY 2025 that qualify for fees after the
December 2024 billing.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16885 Filed 7–30–24; 8:45 am]
BILLING CODE 4164–01–P
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[Docket No. FDA–2024–N–3005]
Outsourcing Facility Fee Rates for
Fiscal Year 2025
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2025 rates for the
establishment and reinspection fees
related to entities that compound
human drugs and elect to register as
outsourcing facilities under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). The FD&C Act authorizes FDA to
assess and collect an annual
establishment fee from outsourcing
facilities, as well as a reinspection fee
for each reinspection of an outsourcing
facility. This document establishes the
FY 2025 rates for the small business
establishment fee ($6,488), the nonsmall business establishment fee
($21,534), and the reinspection fee
($19,465) for outsourcing facilities;
provides information on how the fees
for FY 2025 were determined; and
describes the payment procedures
outsourcing facilities should follow.
DATES: These fee rates are effective
October 1, 2024, and will remain in
effect through September 30, 2025.
FOR FURTHER INFORMATION CONTACT: For
more information on human drug
compounding and outsourcing facility
fees, visit FDA’s website at: https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
human-drug-compounding.
For questions relating to this notice:
Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20903, 240–
402–4989; or the User Fee Support Staff
at OO-OFBAP-OFM-UFSS-Government@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Under section 503B of the FD&C Act
(21 U.S.C. 353b), a human drug
compounder can register with FDA as
an ‘‘outsourcing facility.’’ Outsourcing
facilities, as defined in section
503B(d)(4), are facilities that meet all
the conditions described in section
503B(a), including registering with FDA
as an outsourcing facility and paying an
annual establishment fee. If the
conditions of section 503B are met, a
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
drug compounded by or under the
direct supervision of a licensed
pharmacist in an outsourcing facility is
exempt from three sections of the FD&C
Act: (1) section 502(f)(1) (21 U.S.C.
352(f)(1)), concerning the labeling of
drugs with adequate directions for use;
(2) section 505 (21 U.S.C. 355),
concerning the approval of human drug
products under new drug applications
or abbreviated new drug applications;
and (3) section 582 (21 U.S.C. 360eee–
1), concerning drug supply chain
security requirements. Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)), concerning current
good manufacturing practice
requirements for drugs.
Section 744K of the FD&C Act (21
U.S.C. 379j–62) authorizes FDA to
assess and collect the following fees
associated with outsourcing facilities:
(1) an annual establishment fee from
each outsourcing facility and (2) a
reinspection fee from each outsourcing
facility subject to a reinspection (see
section 744K(a)(1) of the FD&C Act).
Under statutorily defined conditions, a
qualified applicant may pay a reduced
small business establishment fee (see
section 744K(c)(4) of the FD&C Act).
FDA announced in the Federal
Register of November 24, 2014 (79 FR
69856), the availability of a final
guidance for industry entitled ‘‘Fees for
Human Drug Compounding Outsourcing
Facilities Under Sections 503B and
744K of the FD&C Act.’’ The guidance
provides additional information on the
annual fees for outsourcing facilities
and adjustments required by law,
reinspection fees, how to submit
payment, the effect of failure to pay fees,
and how to qualify as a small business
to obtain a reduction of the annual
establishment fee. This guidance can be
accessed on FDA’s website at: https://
www.fda.gov/media/136683/download.
II. Fees for FY 2025
A. Methodology for Calculating FY 2025
Adjustment Factors
61471
adjustment for outsourcing facility fees.
The inflation adjustment has two
components: one based on FDA’s
payroll costs and one based on FDA’s
non-payroll costs for the first 3 of the 4
previous fiscal years. The payroll
component of the annual inflation
adjustment is calculated by taking the
average change in FDA’s per full-time
equivalent (FTE) personnel
compensation and benefits (PC&B) in
the first 3 of the 4 previous fiscal years
(see section 744K(c)(2)(A)(ii) of the
FD&C Act). FDA’s total annual spending
on PC&B is divided by the total number
of FTEs per fiscal year to determine the
average PC&B per FTE.
Table 1 summarizes the actual cost
and FTE data for the specified fiscal
years and provides the percent change
from the previous fiscal year and the
average percent change over the first 3
of the 4 fiscal years preceding FY 2025.
The 3-year average is 3.8539 percent.
1. Inflation Adjustment Factor
Section 744K(c)(2) of the FD&C Act
specifies the annual inflation
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
FY 2021
Total PC&B ..........................................................................................
Total FTE .............................................................................................
PC&B per FTE .....................................................................................
Percent Change From Previous Year .................................................
Section 744K(c)(2)(A)(ii) of the FD&C
Act specifies that this 3.8539 percent
should be multiplied by the proportion
$3,039,513,000
$18,501
$164,289
0.1811%
FY 2022
FY 2023
$3,165,477,000
$18,474
$171,348
4.2967%
$3,436,513,000
$18,729
$183,486
7.0838%
3-Year
average
3.8539%
of PC&B to total costs of an average FDA
FTE for the same 3 fiscal years.
TABLE 2—FDA PC&BS AS A PERCENT OF FDA TOTAL COSTS OF AN AVERAGE FTE
FY 2021
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Total PC&B (proportion of costs) ........................................................
Total Costs ...........................................................................................
PC&B percent ......................................................................................
The payroll adjustment is 3.8539
percent multiplied by 50.6868 percent,
or 1.9534 percent.
Section 744K(c)(2)(A)(iii) of the FD&C
Act specifies that the portion of the
inflation adjustment for non-payroll
costs for FY 2025 is equal to the average
annual percent change in the Consumer
Price Index (CPI) for urban consumers
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$3,039,513,000
$6,105,480,000
49.7834%
FY 2022
$3,165,477,000
$6,251,981,000
50.6316%
(U.S. City Average; Not Seasonally
Adjusted; All items; Annual Index) for
the first 3 years of the preceding 4 years
of available data, multiplied by the
proportion of all non-PC&B costs to total
costs of an average FDA FTE for the
same period.
Table 3 provides the summary data
for the percent change in the specified
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FY 2023
$3,436,513,000
$6,654,058,000
51.6454%
3-Year
average
50.6868%
CPI for U.S. cities. These data are
published by the Bureau of Labor
Statistics and can be found on its
website: https://data.bls.gov/cgi-bin/
surveymost?cu. The data can be viewed
by checking the box marked ‘‘U.S. city
average, All items—CUUR0000SA0’’
and then selecting ‘‘Retrieve Data.’’
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TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN U.S. CITY AVERAGE CPI
2021
Annual CPI ...........................................................................................
Annual Percent Change ......................................................................
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Section 744K(c)(2)(A)(iii) of the FD&C
Act specifies that this 5.6057 percent
should be multiplied by the proportion
of all non-PC&B costs to total costs of an
average FTE for the same 3 fiscal years.
The proportion of all non-PC&B costs to
total costs of an average FDA FTE for
FYs 2021 to 2023 is 49.3132 percent
(100 percent minus 50.6868 percent
equals 49.3132 percent). Therefore, the
non-pay adjustment is 5.6057 percent
times 49.3132 percent, or 2.7644
percent.
The PC&B component (1.9534
percent) is added to the non-PC&B
component (2.7644 percent), for a total
inflation adjustment of 4.7178 percent
(rounded). Section 744K(c)(2)(A)(i) of
the FD&C Act specifies that one is
added to that figure, making the
inflation adjustment 1.047178.
Section 744K(c)(2)(B) of the FD&C Act
provides for this inflation adjustment to
be compounded after FY 2015. This
factor for FY 2025 (4.7178 percent) is
compounded by adding one to it, and
then multiplying it by one plus the
inflation adjustment factor for FY 2024
(23.9215 percent), as published in the
Federal Register on July 28, 2023 (88 FR
48878). The result of this multiplication
of the inflation factors for the 10 years
since FY 2015 (1.047178 × 1.239215)
becomes the inflation adjustment for FY
2025. For FY 2025, the inflation
adjustment is 29.7679 percent
(rounded). We then add one, making the
FY 2025 inflation adjustment factor
1.297679.
2. Small Business Adjustment Factor
Section 744K(c)(3) of the FD&C Act
specifies that in addition to the inflation
adjustment factor, the establishment fee
for non-small businesses is to be further
adjusted for a small business adjustment
factor. Section 744K(c)(3)(B) of the
FD&C Act provides that the small
business adjustment factor is the
adjustment to the establishment fee for
non-small businesses that is necessary
to achieve total fees equaling the
amount that FDA would have collected
if no entity qualified for the small
business exception in section 744K(c)(4)
of the FD&C Act. Additionally, section
744K(c)(5)(A) states that in establishing
the small business adjustment factor for
a fiscal year, FDA shall provide for the
crediting of fees from the previous year
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2022
270.970
4.6980%
to the next year if FDA overestimated
the amount of the small business
adjustment factor for such previous
fiscal year.
Therefore, to calculate the small
business adjustment to the
establishment fee for non-small
businesses for FY 2025, FDA must
estimate: (1) the number of outsourcing
facilities that will pay the reduced fee
for small businesses for FY 2025 and (2)
the total fee revenue it would have
collected if no entity had qualified for
the small business exception (i.e., if
each entity that registers as an
outsourcing facility for FY 2025 were to
pay the inflation-adjusted fee amount of
$19,465).
With respect to (1), FDA estimates
that 11 entities will qualify for small
business exceptions and will pay the
reduced fee for FY 2025. With respect
to (2), to estimate the total number of
entities that will register as outsourcing
facilities for FY 2025, FDA used data
submitted by outsourcing facilities
through the voluntary registration
process, which began in December 2013.
Accordingly, FDA estimates that 80
outsourcing facilities, including 11
small businesses, will be registered with
FDA in FY 2025.
If the projected 80 outsourcing
facilities paid the full inflation-adjusted
fee of $19,465, this would result in total
revenue of $1,557,200 in FY 2025
($19,465 × 80). However, 11 of the
entities that are expected to register as
outsourcing facilities for FY 2025 are
projected to qualify for the small
business exception and to pay one-third
of the full fee ($6,488 × 11), totaling
$71,368 instead of paying the full fee
($19,465 × 11), which would total
$214,115. This would leave a potential
shortfall of $142,747 ($214,115 minus
$71,368).
Additionally, section 744K(c)(5)(A) of
the FD&C Act states that in establishing
the small business adjustment factor for
a fiscal year, FDA shall provide for the
crediting of fees from the previous year
to the next year if FDA overestimated
the amount of the small business
adjustment factor for such previous
fiscal year. FDA has determined that it
is appropriate to credit excess fees
collected from the last completed fiscal
year, due to the inability to conclusively
determine the amount of excess fees
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2023
292.655
8.0027%
304.702
4.1165%
3-Year
average
5.6057%
from the fiscal year that is in progress
at the time this calculation is made.
This crediting is done by comparing the
small business adjustment factor for the
last completed fiscal year, FY 2023
($1,747), to what would have been the
small business adjustment factor for FY
2023 ($2,011) if FDA had estimated
perfectly.
The calculation for what the small
business adjustment would have been if
FDA had estimated perfectly begins by
determining the total target collections
(15,000 × [inflation adjustment factor] ×
[number of registrants]). For the most
recent complete fiscal year, FY 2023,
this was $1,354,548 ($17,823 × 76). The
actual FY 2023 revenue from the 76
total registrants (i.e., 65 registrants
paying FY 2023 non-small business
establishment fee and 11 small business
registrants) paying establishment fees is
$1,223,846. $1,223,846 is calculated as
follows: (FY 2023 Non-Small Business
Establishment Fee adjusted for inflation
only) × (total number of registrants in
FY 2023 paying Non-Small Business
Establishment Fee) + (FY 2023 Small
Business Establishment Fee) × (total
number of small business registrants in
FY 2023 paying Small Business
Establishment Fee). $17,823 × 65 +
$5,824 × 11 = $1,223,846. This left a
shortfall of $130,702 from the estimated
total target collection amount
($1,354,548 minus $1,223,846). This
amount ($130,702) divided by the total
number of registrants in FY 2023 paying
Standard Establishment Fee (65) equals
$2,011.
The difference between the small
business adjustment factor used in FY
2023 and the small business adjustment
factor that would have been used had
FDA estimated perfectly is ¥$263
($1,747 minus $2,011). The ¥$263
(rounded to the nearest dollar) is then
multiplied by the number of actual
registrants who paid the standard fee for
FY 2023 (65), which provides us a total
collection deficit of ¥$17,124 in FY
2023. No credit will be applied in FY
2025.
Therefore, to calculate the small
business adjustment factor for FY 2025,
FDA divides the projected shortfall of
$142,747 for FY 2025 by 69 (the number
of expected non-small businesses for FY
2025), which is $2,069 (rounded to the
nearest dollar).
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B. FY 2025 Rates for Small Business
Establishment Fee, Non-Small Business
Establishment Fee, and Reinspection
Fee
1. Establishment Fee for Qualified Small
Businesses 1
The amount of the establishment fee
for a qualified small business is equal to
$15,000 multiplied by the inflation
adjustment factor for that fiscal year,
divided by 3 (see section 744K(c)(4)(A)
and (c)(1)(A) of the FD&C Act). The
inflation adjustment factor for FY 2025
is 1.297679. See section II.A.1 of this
document for the methodology used to
calculate the FY 2025 inflation
adjustment factor. Therefore, the
establishment fee for a qualified small
business for FY 2025 is one third of
$19,465, which equals $6,488 (rounded
to the nearest dollar).
2. Establishment Fee for Non-Small
Businesses
Under section 744K(c) of the FD&C
Act, the amount of the establishment fee
for a non-small business is equal to
$15,000 multiplied by the inflation
adjustment factor for that fiscal year,
plus the small business adjustment
factor for that fiscal year, and plus or
minus an adjustment factor to account
for over or under collections due to the
small business adjustment factor in the
prior year. The inflation adjustment
factor for FY 2025 is 1.297609. The
small business adjustment amount for
FY 2025 is $2,069. See section II.A.2 of
this document for the methodology used
to calculate the small business
adjustment factor for FY 2025.
Therefore, the establishment fee for a
non-small business for FY 2025 is
$15,000 multiplied by 1.297679 plus
$2,069, which equals $21,534 (rounded
to the nearest dollar).
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3. Reinspection Fee
Section 744K(c)(1)(B) of the FD&C Act
provides that the amount of the FY 2025
reinspection fee is equal to $15,000,
multiplied by the inflation adjustment
factor for that fiscal year. The inflation
adjustment factor for FY 2025 is
1.297679. Therefore, the reinspection
fee for FY 2025 is $15,000 multiplied by
1 To qualify for a small business reduction of the
FY 2025 establishment fee, entities had to submit
their exception requests by April 30, 2024. See
section 744K(c)(4)(B) of the FD&C Act. The time for
requesting a small business exception for FY 2025
has now passed. An entity that wishes to request
a small business exception for FY 2026 should
consult section 744K(c)(4) of the FD&C Act and
section III.D of FDA’s guidance for industry entitled
‘‘Fees for Human Drug Compounding Outsourcing
Facilities Under Sections 503B and 744K of the
FD&C Act,’’ which can be accessed on FDA’s
website at https://www.fda.gov/media/136683/
download.
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61473
C. Fee Payment Procedures
1. The preferred payment method is
online using electronic check
(Automated Clearing House (ACH) also
known as eCheck) or credit card
C. Summary of FY 2025 Fee Rates
(Discover, VISA, MasterCard, American
Express). Secure electronic payments
TABLE 4—OUTSOURCING FACILITY
can be submitted using the User Fees
FEES
Payment Portal at https://
userfees.fda.gov/pay. (Note: only full
Qualified Small Business Establishment Fee .....................................
$6,488 payments are accepted. No partial
Non-Small Business Establishment
payments can be made online.) Once
Fee ..............................................
21,534 you search for your invoice, click ‘‘Pay
Reinspection Fee ............................
19,465 Now’’ to be redirected to Pay.gov.
Electronic payment options are based on
III. Fee Payment Options and
the balance due. Payment by credit card
Procedures
is available for balances less than
$25,000. If the balance exceeds this
A. Establishment Fee
amount, only the ACH option is
Once an entity submits registration
available. Payments must be made using
information and FDA has determined
U.S. bank accounts as well as U.S. credit
that the information is complete, the
cards.
entity will incur the annual
2. If a check, bank draft, or postal
establishment fee. FDA will send an
money order is submitted, make it
invoice to the entity, via email to the
payable to the order of the Food and
email address indicated in the
Drug Administration and include the
registration file. The invoice will
user fee ID number to ensure that the
contain information regarding the
payment is applied to the correct fee(s).
obligation incurred, the amount owed,
Payments can be mailed to: Food and
and payment procedures. A facility will
Drug Administration, P.O. Box 979033,
not be registered as an outsourcing
St. Louis, MO 63197–9000. If a check,
facility until it has paid the annual
bank draft, or money order is to be sent
establishment fee under section 744K of
by a courier that requests a street
the FD&C Act. Accordingly, it is
address, the courier should deliver your
important that facilities seeking to
payment to: U.S. Bank, Attention:
operate as outsourcing facilities pay all
Government Lockbox 979033, 3180
fees immediately upon receiving an
invoice. If an entity does not pay the full Rider Trail S, Earth City, MO 63045.
(Note: This U.S. Bank address is for
invoiced amount within 15 calendar
courier delivery only. If you have any
days after FDA issues the invoice, FDA
questions concerning courier delivery,
will consider the submission of
contact the U.S. Bank at 800–495–4981.
registration information to have been
This telephone number is only for
withdrawn and adjust the invoice to
questions about courier delivery). Please
reflect that no fee is due.
make sure that the FDA post office box
Outsourcing facilities that registered
number (P.O. Box 979033) is written on
in FY 2024 and wish to maintain their
the check, bank draft, or postal money
status as an outsourcing facility in FY
order.
2025 must register during the annual
3. For payments made by wire
registration period that lasts from
transfer,
the invoice number must be
October 1, 2024, to December 31, 2024.
included. Without the invoice number,
Failure to register and complete
the payment may not be applied.
payment by December 31, 2024, will
Regarding reinspection fees, if the
result in a loss of status as an
payment amount is not applied, the
outsourcing facility on January 1, 2025.
Entities should submit their registration invoice amount will be referred to
collections. The originating financial
information no later than December 10,
institution may charge a wire transfer
2024, to allow enough time for review
fee. If the financial institution charges a
of the registration information,
wire transfer fee, it is required that the
invoicing, and payment of fees before
outsourcing facility add that amount to
the end of the registration period.
the payment to ensure that the invoice
B. Reinspection Fee
is paid in full. Use the following
account information when sending a
FDA will issue invoices for each
wire transfer: U.S. Dept of the Treasury,
reinspection after the conclusion of the
reinspection, via email to the email
TREAS NYC, 33 Liberty St., New York,
address indicated in the registration file NY 10045, Acct. No. 75060099, Routing
or via regular mail if email is not an
No. 021030004, SWIFT: FRNYUS33. If
option. Payments must be made within
needed, FDA’s tax identification
30 days of the invoice date.
number is 53–0196965.
1.297679, which equals $19,465
(rounded to the nearest dollar). There is
no reduction in this fee for small
businesses.
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16876 Filed 7–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0007]
Prescription Drug User Fee Rates for
Fiscal Year 2025
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the rates for prescription
drug user fees for fiscal year (FY) 2025.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Prescription Drug User Fee
Amendments of 2022 (PDUFA VII),
authorizes FDA to collect application
fees for certain applications for the
review of human drug and biological
products and prescription drug program
fees for certain approved products. This
notice establishes the fee rates for FY
2025.
DATES: These fees apply to the period
from October 1, 2024, through
September 30, 2025.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug
Administration, 10903 New Hampshire
Ave, Silver Spring, MD 20903, 240–
402–4989; and the User Fee Support
Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 735 and 736 of the FD&C Act
(21 U.S.C. 379g and 379h) establish two
different kinds of user fees. Fees are
assessed as follows: (1) application fees
are assessed on certain types of
applications for the review of human
drug and biological products and (2)
prescription drug program fees are
assessed on certain approved products
(section 736(a) of the FD&C Act). The
statute also includes conditions under
which such fees may be waived or
reduced (section 736(d) of the FD&C
Act), or under which fee exceptions,
refunds, or exemptions apply (sections
736(a)(1)(C) through (H), 736(a)(2)(B)
through (C), and 736(k) of the FD&C
Act).
For FY 2023 through FY 2027, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA VII. The base
revenue amount for FY 2025 is
$1,358,764,346. The FY 2025 base
revenue amount is adjusted for
inflation, strategic hiring and retention,
and for the resource capacity needs for
the process for the review of human
drug applications (the capacity planning
adjustment (CPA)). This amount is
further adjusted to include the
additional dollar amount as specified in
the statute (see section 736(b)(1)(G) of
the FD&C Act) to provide for additional
full-time equivalent (FTE) positions to
support PDUFA VII initiatives. If
applicable, an operating reserve
adjustment is added to provide
sufficient operating reserves of
carryover user fees. The amount from
the preceding adjustments is then
adjusted to provide for additional direct
costs to fund PDUFA VII initiatives. Fee
amounts are to be established each year
so that revenues from application fees
provide 20 percent of the total revenue,
and prescription drug program fees
provide 80 percent of the total revenue
(see section 736(b)(2) of the FD&C Act).
This document provides fee rates for
FY 2025 for an application requiring
covered clinical data 1 ($4,310,002), for
an application not requiring covered
clinical data ($2,155,001), and for the
prescription drug program fee
($403,889). These fees are effective on
October 1, 2024, and will remain in
effect through September 30, 2025. For
applications that are submitted on or
after October 1, 2024, the new fee
schedule must be used.
II. Fee Revenue Amount for FY 2025
The base revenue amount for FY 2025
is $1,358,764,346 (see section
736(b)(1)(A) and (b)(3) of the FD&C Act).
This amount is prior to any adjustments
made for inflation, the strategic hiring
and retention adjustment, CPA,
additional dollar amount, operating
reserve adjustment (if applicable), and
additional direct costs (see section
736(b)(1) of the FD&C Act).
A. FY 2025 Statutory Fee Revenue
Adjustments for Inflation
PDUFA VII specifies that the
$1,358,764,346 is to be adjusted for
inflation increases for FY 2025 using
two separate adjustments: one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see
section 736(c)(1) of the FD&C Act).
The component of the inflation
adjustment for payroll costs is the
average annual percent change in the
cost of all PC&B paid per FTE positions
at FDA for the first 3 of the preceding
4 fiscal years, multiplied by the
proportion of PC&B costs to total FDA
costs of the process for the review of
human drug applications for the first 3
of the preceding 4 fiscal years (see
section 736(c)(1)(A) and (B)(i) of the
FD&C Act).
Table 1 summarizes the actual cost
and FTE data for the specified fiscal
years, provides the percent changes
from the previous fiscal years, and
provides the average percent changes
over the first 3 of the 4 fiscal years
preceding FY 2025. The 3-year average
is 3.8539 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES
2021
lotter on DSK11XQN23PROD with NOTICES1
Total PC&B ..........................................................................................
Total FTEs ...........................................................................................
PC&B per FTE .....................................................................................
Percent Change from Previous Year ...................................................
2022
$3,039,513,000
18,501
$164,289
0.1811%
2023
$3,165,477,000
18,474
$171,348
4.2967%
$3,436,513,000
18,729
$183,486
7.0838%
3-Year
average
........................
........................
........................
3.8539%
The statute specifies that this 3.8539
percent be multiplied by the proportion
of PC&B costs to the total FDA costs of
the process for the review of human
drug applications. Table 2 shows the
PC&B and the total obligations for the
process for the review of human drug
applications for the first 3 of the
preceding 4 fiscal years.
1 As used herein, ‘‘covered clinical data’’ is
‘‘clinical data (other than bioavailability or
bioequivalence studies) with respect to safety or
effectiveness [that] are required for approval’’ (see
section 736(a)(1)(A) of the FD&C Act).
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]]>Agencies
[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61470-61474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16876]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3005]
Outsourcing Facility Fee Rates for Fiscal Year 2025
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2025 rates for the establishment and reinspection fees
related to entities that compound human drugs and elect to register as
outsourcing facilities under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual
establishment fee from outsourcing facilities, as well as a
reinspection fee for each reinspection of an outsourcing facility. This
document establishes the FY 2025 rates for the small business
establishment fee ($6,488), the non-small business establishment fee
($21,534), and the reinspection fee ($19,465) for outsourcing
facilities; provides information on how the fees for FY 2025 were
determined; and describes the payment procedures outsourcing facilities
should follow.
DATES: These fee rates are effective October 1, 2024, and will remain
in effect through September 30, 2025.
FOR FURTHER INFORMATION CONTACT: For more information on human drug
compounding and outsourcing facility fees, visit FDA's website at:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding.
For questions relating to this notice: Olufunmilayo Ariyo, Office
of Financial Management, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903, 240-402-4989; or the User Fee
Support Staff at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under section 503B of the FD&C Act (21 U.S.C. 353b), a human drug
compounder can register with FDA as an ``outsourcing facility.''
Outsourcing facilities, as defined in section 503B(d)(4), are
facilities that meet all the conditions described in section 503B(a),
including registering with FDA as an outsourcing facility and paying an
annual establishment fee. If the conditions of section 503B are met, a
[[Page 61471]]
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from three sections of
the FD&C Act: (1) section 502(f)(1) (21 U.S.C. 352(f)(1)), concerning
the labeling of drugs with adequate directions for use; (2) section 505
(21 U.S.C. 355), concerning the approval of human drug products under
new drug applications or abbreviated new drug applications; and (3)
section 582 (21 U.S.C. 360eee-1), concerning drug supply chain security
requirements. Drugs compounded in outsourcing facilities are not exempt
from the requirements of section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)), concerning current good manufacturing practice
requirements for drugs.
Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to
assess and collect the following fees associated with outsourcing
facilities: (1) an annual establishment fee from each outsourcing
facility and (2) a reinspection fee from each outsourcing facility
subject to a reinspection (see section 744K(a)(1) of the FD&C Act).
Under statutorily defined conditions, a qualified applicant may pay a
reduced small business establishment fee (see section 744K(c)(4) of the
FD&C Act).
FDA announced in the Federal Register of November 24, 2014 (79 FR
69856), the availability of a final guidance for industry entitled
``Fees for Human Drug Compounding Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act.'' The guidance provides additional
information on the annual fees for outsourcing facilities and
adjustments required by law, reinspection fees, how to submit payment,
the effect of failure to pay fees, and how to qualify as a small
business to obtain a reduction of the annual establishment fee. This
guidance can be accessed on FDA's website at: https://www.fda.gov/media/136683/download.
II. Fees for FY 2025
A. Methodology for Calculating FY 2025 Adjustment Factors
1. Inflation Adjustment Factor
Section 744K(c)(2) of the FD&C Act specifies the annual inflation
adjustment for outsourcing facility fees. The inflation adjustment has
two components: one based on FDA's payroll costs and one based on FDA's
non-payroll costs for the first 3 of the 4 previous fiscal years. The
payroll component of the annual inflation adjustment is calculated by
taking the average change in FDA's per full-time equivalent (FTE)
personnel compensation and benefits (PC&B) in the first 3 of the 4
previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act).
FDA's total annual spending on PC&B is divided by the total number of
FTEs per fiscal year to determine the average PC&B per FTE.
Table 1 summarizes the actual cost and FTE data for the specified
fiscal years and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2025. The 3-year average is 3.8539 percent.
Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
FY 2021 FY 2022 FY 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $3,039,513,000 $3,165,477,000 $3,436,513,000
Total FTE................................. $18,501 $18,474 $18,729
PC&B per FTE.............................. $164,289 $171,348 $183,486
Percent Change From Previous Year......... 0.1811% 4.2967% 7.0838% 3.8539%
----------------------------------------------------------------------------------------------------------------
Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this
3.8539 percent should be multiplied by the proportion of PC&B to total
costs of an average FDA FTE for the same 3 fiscal years.
Table 2--FDA PC&Bs as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
FY 2021 FY 2022 FY 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B (proportion of costs).......... $3,039,513,000 $3,165,477,000 $3,436,513,000
Total Costs............................... $6,105,480,000 $6,251,981,000 $6,654,058,000
PC&B percent.............................. 49.7834% 50.6316% 51.6454% 50.6868%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 3.8539 percent multiplied by 50.6868
percent, or 1.9534 percent.
Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the
portion of the inflation adjustment for non-payroll costs for FY 2025
is equal to the average annual percent change in the Consumer Price
Index (CPI) for urban consumers (U.S. City Average; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years of the
preceding 4 years of available data, multiplied by the proportion of
all non-PC&B costs to total costs of an average FDA FTE for the same
period.
Table 3 provides the summary data for the percent change in the
specified CPI for U.S. cities. These data are published by the Bureau
of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking
the box marked ``U.S. city average, All items--CUUR0000SA0'' and then
selecting ``Retrieve Data.''
[[Page 61472]]
Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
----------------------------------------------------------------------------------------------------------------
2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................ 270.970 292.655 304.702
Annual Percent Change..................... 4.6980% 8.0027% 4.1165% 5.6057%
----------------------------------------------------------------------------------------------------------------
Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this
5.6057 percent should be multiplied by the proportion of all non-PC&B
costs to total costs of an average FTE for the same 3 fiscal years. The
proportion of all non-PC&B costs to total costs of an average FDA FTE
for FYs 2021 to 2023 is 49.3132 percent (100 percent minus 50.6868
percent equals 49.3132 percent). Therefore, the non-pay adjustment is
5.6057 percent times 49.3132 percent, or 2.7644 percent.
The PC&B component (1.9534 percent) is added to the non-PC&B
component (2.7644 percent), for a total inflation adjustment of 4.7178
percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies
that one is added to that figure, making the inflation adjustment
1.047178.
Section 744K(c)(2)(B) of the FD&C Act provides for this inflation
adjustment to be compounded after FY 2015. This factor for FY 2025
(4.7178 percent) is compounded by adding one to it, and then
multiplying it by one plus the inflation adjustment factor for FY 2024
(23.9215 percent), as published in the Federal Register on July 28,
2023 (88 FR 48878). The result of this multiplication of the inflation
factors for the 10 years since FY 2015 (1.047178 x 1.239215) becomes
the inflation adjustment for FY 2025. For FY 2025, the inflation
adjustment is 29.7679 percent (rounded). We then add one, making the FY
2025 inflation adjustment factor 1.297679.
2. Small Business Adjustment Factor
Section 744K(c)(3) of the FD&C Act specifies that in addition to
the inflation adjustment factor, the establishment fee for non-small
businesses is to be further adjusted for a small business adjustment
factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small
business adjustment factor is the adjustment to the establishment fee
for non-small businesses that is necessary to achieve total fees
equaling the amount that FDA would have collected if no entity
qualified for the small business exception in section 744K(c)(4) of the
FD&C Act. Additionally, section 744K(c)(5)(A) states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year.
Therefore, to calculate the small business adjustment to the
establishment fee for non-small businesses for FY 2025, FDA must
estimate: (1) the number of outsourcing facilities that will pay the
reduced fee for small businesses for FY 2025 and (2) the total fee
revenue it would have collected if no entity had qualified for the
small business exception (i.e., if each entity that registers as an
outsourcing facility for FY 2025 were to pay the inflation-adjusted fee
amount of $19,465).
With respect to (1), FDA estimates that 11 entities will qualify
for small business exceptions and will pay the reduced fee for FY 2025.
With respect to (2), to estimate the total number of entities that will
register as outsourcing facilities for FY 2025, FDA used data submitted
by outsourcing facilities through the voluntary registration process,
which began in December 2013. Accordingly, FDA estimates that 80
outsourcing facilities, including 11 small businesses, will be
registered with FDA in FY 2025.
If the projected 80 outsourcing facilities paid the full inflation-
adjusted fee of $19,465, this would result in total revenue of
$1,557,200 in FY 2025 ($19,465 x 80). However, 11 of the entities that
are expected to register as outsourcing facilities for FY 2025 are
projected to qualify for the small business exception and to pay one-
third of the full fee ($6,488 x 11), totaling $71,368 instead of paying
the full fee ($19,465 x 11), which would total $214,115. This would
leave a potential shortfall of $142,747 ($214,115 minus $71,368).
Additionally, section 744K(c)(5)(A) of the FD&C Act states that in
establishing the small business adjustment factor for a fiscal year,
FDA shall provide for the crediting of fees from the previous year to
the next year if FDA overestimated the amount of the small business
adjustment factor for such previous fiscal year. FDA has determined
that it is appropriate to credit excess fees collected from the last
completed fiscal year, due to the inability to conclusively determine
the amount of excess fees from the fiscal year that is in progress at
the time this calculation is made. This crediting is done by comparing
the small business adjustment factor for the last completed fiscal
year, FY 2023 ($1,747), to what would have been the small business
adjustment factor for FY 2023 ($2,011) if FDA had estimated perfectly.
The calculation for what the small business adjustment would have
been if FDA had estimated perfectly begins by determining the total
target collections (15,000 x [inflation adjustment factor] x [number of
registrants]). For the most recent complete fiscal year, FY 2023, this
was $1,354,548 ($17,823 x 76). The actual FY 2023 revenue from the 76
total registrants (i.e., 65 registrants paying FY 2023 non-small
business establishment fee and 11 small business registrants) paying
establishment fees is $1,223,846. $1,223,846 is calculated as follows:
(FY 2023 Non-Small Business Establishment Fee adjusted for inflation
only) x (total number of registrants in FY 2023 paying Non-Small
Business Establishment Fee) + (FY 2023 Small Business Establishment
Fee) x (total number of small business registrants in FY 2023 paying
Small Business Establishment Fee). $17,823 x 65 + $5,824 x 11 =
$1,223,846. This left a shortfall of $130,702 from the estimated total
target collection amount ($1,354,548 minus $1,223,846). This amount
($130,702) divided by the total number of registrants in FY 2023 paying
Standard Establishment Fee (65) equals $2,011.
The difference between the small business adjustment factor used in
FY 2023 and the small business adjustment factor that would have been
used had FDA estimated perfectly is -$263 ($1,747 minus $2,011). The -
$263 (rounded to the nearest dollar) is then multiplied by the number
of actual registrants who paid the standard fee for FY 2023 (65), which
provides us a total collection deficit of -$17,124 in FY 2023. No
credit will be applied in FY 2025.
Therefore, to calculate the small business adjustment factor for FY
2025, FDA divides the projected shortfall of $142,747 for FY 2025 by 69
(the number of expected non-small businesses for FY 2025), which is
$2,069 (rounded to the nearest dollar).
[[Page 61473]]
B. FY 2025 Rates for Small Business Establishment Fee, Non-Small
Business Establishment Fee, and Reinspection Fee
1. Establishment Fee for Qualified Small Businesses \1\
---------------------------------------------------------------------------
\1\ To qualify for a small business reduction of the FY 2025
establishment fee, entities had to submit their exception requests
by April 30, 2024. See section 744K(c)(4)(B) of the FD&C Act. The
time for requesting a small business exception for FY 2025 has now
passed. An entity that wishes to request a small business exception
for FY 2026 should consult section 744K(c)(4) of the FD&C Act and
section III.D of FDA's guidance for industry entitled ``Fees for
Human Drug Compounding Outsourcing Facilities Under Sections 503B
and 744K of the FD&C Act,'' which can be accessed on FDA's website
at https://www.fda.gov/media/136683/download.
---------------------------------------------------------------------------
The amount of the establishment fee for a qualified small business
is equal to $15,000 multiplied by the inflation adjustment factor for
that fiscal year, divided by 3 (see section 744K(c)(4)(A) and (c)(1)(A)
of the FD&C Act). The inflation adjustment factor for FY 2025 is
1.297679. See section II.A.1 of this document for the methodology used
to calculate the FY 2025 inflation adjustment factor. Therefore, the
establishment fee for a qualified small business for FY 2025 is one
third of $19,465, which equals $6,488 (rounded to the nearest dollar).
2. Establishment Fee for Non-Small Businesses
Under section 744K(c) of the FD&C Act, the amount of the
establishment fee for a non-small business is equal to $15,000
multiplied by the inflation adjustment factor for that fiscal year,
plus the small business adjustment factor for that fiscal year, and
plus or minus an adjustment factor to account for over or under
collections due to the small business adjustment factor in the prior
year. The inflation adjustment factor for FY 2025 is 1.297609. The
small business adjustment amount for FY 2025 is $2,069. See section
II.A.2 of this document for the methodology used to calculate the small
business adjustment factor for FY 2025. Therefore, the establishment
fee for a non-small business for FY 2025 is $15,000 multiplied by
1.297679 plus $2,069, which equals $21,534 (rounded to the nearest
dollar).
3. Reinspection Fee
Section 744K(c)(1)(B) of the FD&C Act provides that the amount of
the FY 2025 reinspection fee is equal to $15,000, multiplied by the
inflation adjustment factor for that fiscal year. The inflation
adjustment factor for FY 2025 is 1.297679. Therefore, the reinspection
fee for FY 2025 is $15,000 multiplied by 1.297679, which equals $19,465
(rounded to the nearest dollar). There is no reduction in this fee for
small businesses.
C. Summary of FY 2025 Fee Rates
Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------
------------------------------------------------------------------------
Qualified Small Business Establishment Fee.................... $6,488
Non-Small Business Establishment Fee.......................... 21,534
Reinspection Fee.............................................. 19,465
------------------------------------------------------------------------
III. Fee Payment Options and Procedures
A. Establishment Fee
Once an entity submits registration information and FDA has
determined that the information is complete, the entity will incur the
annual establishment fee. FDA will send an invoice to the entity, via
email to the email address indicated in the registration file. The
invoice will contain information regarding the obligation incurred, the
amount owed, and payment procedures. A facility will not be registered
as an outsourcing facility until it has paid the annual establishment
fee under section 744K of the FD&C Act. Accordingly, it is important
that facilities seeking to operate as outsourcing facilities pay all
fees immediately upon receiving an invoice. If an entity does not pay
the full invoiced amount within 15 calendar days after FDA issues the
invoice, FDA will consider the submission of registration information
to have been withdrawn and adjust the invoice to reflect that no fee is
due.
Outsourcing facilities that registered in FY 2024 and wish to
maintain their status as an outsourcing facility in FY 2025 must
register during the annual registration period that lasts from October
1, 2024, to December 31, 2024. Failure to register and complete payment
by December 31, 2024, will result in a loss of status as an outsourcing
facility on January 1, 2025. Entities should submit their registration
information no later than December 10, 2024, to allow enough time for
review of the registration information, invoicing, and payment of fees
before the end of the registration period.
B. Reinspection Fee
FDA will issue invoices for each reinspection after the conclusion
of the reinspection, via email to the email address indicated in the
registration file or via regular mail if email is not an option.
Payments must be made within 30 days of the invoice date.
C. Fee Payment Procedures
1. The preferred payment method is online using 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 search for your invoice,
click ``Pay Now'' to be redirected to Pay.gov. Electronic payment
options are based on the balance due. Payment by credit card is
available 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.
2. If a check, bank draft, or postal money order is submitted, make
it payable to the order of the Food and Drug Administration and include
the user fee ID number to ensure that the payment is applied to the
correct fee(s). Payments can be mailed to: Food and Drug
Administration, P.O. Box 979033, St. Louis, MO 63197-9000. If a check,
bank draft, or money order is to be sent by a courier that requests a
street address, the courier should deliver your payment to: U.S. Bank,
Attention: Government Lockbox 979033, 3180 Rider Trail S, Earth City,
MO 63045. (Note: This U.S. Bank address is for courier delivery only.
If you have any questions concerning courier delivery, contact the U.S.
Bank at 800-495-4981. This telephone number is only for questions about
courier delivery). Please make sure that the FDA post office box number
(P.O. Box 979033) is written on the check, bank draft, or postal money
order.
3. For payments made by wire transfer, the invoice number must be
included. Without the invoice number, the payment may not be applied.
Regarding reinspection fees, if the payment amount is not applied, the
invoice amount will be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required that the
outsourcing facility add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number
is 53-0196965.
[[Page 61474]]
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16876 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P
