[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61063-61070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2355]


Prescription Drug User Fee Rates for Fiscal Year 2023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates 
for prescription drug user fees for fiscal year (FY) 2023. 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 2023. 
These fees apply to the period from October 1, 2022, through September 
30, 2023.

FOR FURTHER INFORMATION CONTACT: Robert Marcarelli, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61075, Beltsville, MD, 301-796-7223; and the User Fees Support Staff at 
[email protected].

SUPPLEMENTARY INFORMATION:

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 (G), 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 2023 is $1,151,522,958. The FY 2023 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)(F) 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

[[Page 61064]]

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 2023 for an application 
requiring covered clinical data \1\ ($3,242,026), for an application 
not requiring covered clinical data ($1,621,013), and for the 
prescription drug program fee ($393,933). These fees are effective on 
October 1, 2022, and will remain in effect through September 30, 2023. 
For applications that are submitted on or after October 1, 2022, the 
new fee schedule must be used.
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    \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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II. Fee Revenue Amount for FY 2023

    The base revenue amount for FY 2023 is $1,151,522,958 (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 2023 Statutory Fee Revenue Adjustments for Inflation

    PDUFA VII specifies that the $1,151,522,958 is to be adjusted for 
inflation increases for FY 2023 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 2023. The 3-year average is 1.3918 percent.
[GRAPHIC] [TIFF OMITTED] TN07OC22.033

    The payroll adjustment is 1.3918 percent from table 1 multiplied by 
61.8539 percent resulting in 0.8609 percent.
    The statute specifies that this 1.3918 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.
[GRAPHIC] [TIFF OMITTED] TN07OC22.034

    The payroll adjustment is 1.3918 percent from table 1 multiplied by 
61.8539 percent resulting in 0.8609 percent.
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs is the average annual percent change that 
occurred in the Consumer Price Index for urban consumers (Washington-
Arlington-Alexandria, DC-VA-MD-WV; 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 costs other than 
personnel compensation and benefits costs to total costs of the process 
for the review of human drug applications (as defined in section 
735(6)) for the first 3 years of the preceding 4 fiscal years (see 
section 736(c)(1)(A) and (B)(ii)). Table 3 provides the summary data 
for the percent changes in the specified CPI for the Washington-
Arlington-Alexandria area.\2\
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    \2\ The data are published by the Bureau of Labor Statistics and 
can be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

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[[Page 61065]]

[GRAPHIC] [TIFF OMITTED] TN07OC22.035

    The statute specifies that this 2.0434 percent be multiplied by the 
proportion of all costs other than PC&B to total costs of the process 
for the review of human drug applications obligated. Because 61.8539 
percent was obligated for PC&B (as shown in table 2), 38.1461 percent 
is the portion of costs other than PC&B (100 percent minus 61.8539 
percent equals 38.1461 percent). The non-payroll adjustment is 2.0434 
percent times 38.1461 percent, or 0.7795 percent.
    Next, we add the payroll adjustment (0.8609 percent) to the non-
payroll adjustment (0.7795 percent), for a total inflation adjustment 
of 1.6404 percent (rounded) for FY 2023.
    We then multiply the base revenue amount for FY 2023 
($1,151,522,958) by 1.6404 percent which produces an inflation 
adjustment amount of 18,889,582. Adding this amount to the base revenue 
amount yields an inflation-adjusted base revenue amount of 
$1,170,412,541.

B. FY 2023 Strategic Hiring and Retention Adjustment

    For each fiscal year, after the annual base revenue established in 
section II is adjusted for inflation in accordance with section II.A 
above, the statute directs FDA to further increase the fee revenue and 
fees to support strategic hiring and retention. For FY 2023, this 
amount is $9,000,000 (see section 736(c)(2)(A) of the FD&C Act).

C. FY 2023 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that after the base revenue amount for FY 
2023 of $1,151,522,958 has been adjusted as described in sections II.A 
and II.B above, this amount shall be further adjusted to reflect 
changes in the resource capacity needs for the process of human drug 
application reviews (see section 736(c)(3) of the FD&C Act). Following 
a process required in statute, FDA established a new CPA methodology 
and first applied it in the setting of FY 2021 fees. The establishment 
of this methodology is described in the Federal Register of August 3, 
2020 (85 FR 46651). This methodology includes a continuous, iterative 
improvement approach, under which the Agency intends to refine its data 
and estimates for the core review activities to improve their accuracy 
over time.
    For FY 2023, updates were made to refine the time reporting 
categories included within the CPA. As such, the time reporting data 
and baseline capacity have been revised to match the refinements. In 
the coming fiscal years, additional updates are anticipated to be made 
to account for additional activities that are also directly related to 
the direct review of applications and supplements, including additional 
formal meeting types and the direct review of postmarketing commitments 
and requirements, the direct review of risk evaluation and mitigation 
strategies, and the direct review of annual reports for approved 
prescription drug products.
    The CPA methodology includes four steps:
    1. Forecast workload volumes: predictive models estimate the volume 
of workload for the upcoming FY.
    2. Forecast the resource needs: forecast algorithms are generated 
utilizing time reporting data. These algorithms estimate the required 
demand in FTEs \3\ for direct review-related effort. This is then 
compared to current available resources for the direct review-related 
workload.
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    \3\ Full-time equivalents refer to a paid staff year, rather 
than a count of individual employees.
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    3. Assess the resource forecast in the context of additional 
internal factors: program leadership examines operational, financial, 
and resourcing data to assess whether FDA will be able to utilize 
additional funds during the FY, and the funds are required to support 
additional review capacity. FTE amounts are adjusted, if needed.
    4. Convert the FTE need to dollars: utilizing FDA's fully loaded 
FTE cost model, the final feasible FTEs are converted to an equivalent 
dollar amount.
    To determine the FY 2023 CPA, FDA calculated a CPA for the Center 
for Drug Evaluation and Research (CDER) and the Center for Biologics 
Evaluation and Research (CBER) individually. The final Center-level 
results were then combined to determine the total FY 2023 PDUFA CPA. 
The following section outlines the major components of each Center's FY 
2023 PDUFA CPA.
    Table 4 summarizes the forecasted workload volumes for CDER in FY 
2023 based on predictive models, as well as historical actuals from FY 
2021 for comparison.

[[Page 61066]]

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    Utilizing the resource forecast algorithms, the forecasted workload 
volumes for FY 2023 were then converted into estimated FTE needs for 
CDER's PDUFA direct review-related work. The resulting expected FY 2023 
FTE need for CDER was compared to current resource capacity for direct 
review related work to determine the FY 2023 resource delta, as 
summarized in table 5. Refinement of the time reporting categories 
included in the CPA resulted in a lowering of both the resource 
capacity and resource forecast compared to prior years.
[GRAPHIC] [TIFF OMITTED] TN07OC22.037

    The projected 151 FTE delta was then assessed by FDA in the context 
of additional operational and internal factors to ensure that a fee 
adjustment is only made for resources that can be utilized in the 
fiscal year and for which funds are required to support additional 
review capacity. CDER recognizes that FY 2023 presents significant 
hiring commitments for the Center, including the hiring goals set forth 
for FY 2023 per the PDUFA VII Commitment Letter, as well as hiring 
commitments for other user fee programs. In addition, current labor 
market conditions may present continuing hiring and retention 
challenges. In light of these commitments and challenges, CDER is 
opting to take a conservative adjustment for FY 2023.
    CDER emphasizes that the limiting factor on the FY 2023 adjustment 
is its ability to net gain additional hires above and beyond the 
existing committed hires across its user fee programs. If a significant 
resource gap persists in future years and the Agency's ability to net 
gain additional hires above existing commitments improves, larger CPA 
adjustments should be expected.
    After assessing current hiring capacity and existing funded 
vacancies, CDER adjusted the 151 FTE delta to 27 FTEs. The FY 2023 
PDUFA CPA for CDER is therefore $8,541,423, as summarized in table 6.
[GRAPHIC] [TIFF OMITTED] TN07OC22.038

    To calculate the FY 2023 PDUFA CPA for CBER, FDA followed the 
approach outlined above. Table 7 summarizes the forecasted workload 
volumes for CBER in FY 2023 as well as the corresponding historical 
actuals from FY 2021 for comparison.
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[[Page 61067]]


    The forecasted CBER PDUFA workload for FY 2023 was then converted 
into expected FTE resources and compared to current resource capacity 
for PDUFA direct review work, as summarized in table 8.
[GRAPHIC] [TIFF OMITTED] TN07OC22.040

    The projected 10 FTE delta for CBER was also assessed in the 
context of other operational and financial factors that may impact the 
need and/or feasibility of obtaining the additional resources. After 
considering subject matter expert input on industry trends and ongoing 
workload impacts stemming from the COVID-19 pandemic, accounting for 
historical net FTE gains within CBER and the hiring necessary to meet 
the hiring commitments set forth for FY 2023 in the PDUFA VII 
commitment letter, subtracting previously funded PDUFA vacancies 
aligned with CPA-covered activities, CBER determined that an adjustment 
of 10 additional FTEs for FY 2023 is needed. The FY 2023 CPA for CBER 
is therefore $3,116,730, as summarized in table 9.
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    The CDER and CBER CPA amounts were then added together to determine 
the PDUFA CPA for FY 2023 of $11,658,153, as outlined in table 10. FDA 
will track the utilization of the CPA funds to ensure they are 
supporting the organizational components engaged in PDUFA direct review 
work to enhance resources and expand staff capacity and capability. 
Should FDA be unable to utilize any amounts of the CPA funds during the 
fiscal year, it will not spend those funds and the unspent funds will 
be transferred to the carryover balance at the end of the fiscal year.
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D. FY 2023 Statutory Fee Revenue Adjustments for Additional Dollar 
Amounts

    PDUFA VII provides an additional dollar amount for each of the 5 
fiscal years covered by PDUFA VII for additional FTE to support 
enhancements outlined in the PDUFA VII commitment letter. The 
additional dollar amount for FY 2023 as outlined in statute is 
$65,773,693 (see section 736(b)(1)(F) of the FD&C Act). This amount 
will be added to the total FY 2023 PDUFA VII revenue amount.
[GRAPHIC] [TIFF OMITTED] TN07OC22.043

E. FY 2023 Statutory Fee Revenue Adjustments for Operating Reserve

    PDUFA VII provides for an operating reserve that may result in an 
increase or decrease in fee revenue and fees for a given FY (see 
section 736(c)(4) of the FD&C Act). For FY 2023, FDA is required to 
further increase fee revenue and fees if an adjustment is necessary to 
provide for at least 8 weeks of operating reserves of carryover user 
fees (see section 736(c)(4)(A)(i) of the FD&C Act). If FDA has 
carryover balances of user fees in excess of 14 weeks of operating 
reserves, FDA is required to decrease fee revenue and fees to provide 
for not more than 14 weeks of operating reserves of

[[Page 61068]]

carryover user fees (see section 736(c)(4)(B) of the FD&C Act).
    To determine the dollar amounts for the 8-week and 14-week 
operating reserve thresholds, the adjustments (inflation, strategic 
hiring and retention, capacity planning, and additional dollar amount) 
discussed in sections II.A, II.B, II.C, and II.D are applied to the FY 
2023 base revenue (see section 736(c)(4)(A) of the FD&C Act), resulting 
in $1,256,844,387. This amount is then divided by 52 to generate the 1-
week operating amount of $24,170,084. The one-week operating amount is 
then multiplied by 8 and 14. This results in an 8-week threshold amount 
of $193,360,675 and a 14-week threshold amount of $338,381,181.
    To determine the FY 2022 end-of-year operating reserves of 
carryover user fees, the Agency assessed the operating reserve of 
carryover fees at the end of July 2022 and forecast collections and 
obligations in the fourth quarter of FY 2022 combined. This provides an 
estimated end-of-year FY 2022 operating reserve of carryover user fees, 
or $184,271,732, which equates to 7.6 weeks of operations.\5\
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    \5\ For purposes of the operating reserve adjustment under PDUFA 
VII, the operating reserve of carryover user fees includes only user 
fee funds that are available for obligation. FDA does not consider 
part of the operating reserve of carryover user fees certain user 
fee funds that were collected prior to 2010 and that are held by 
FDA, but which are considered unavailable for obligation due to lack 
of an appropriation ($78,850,995).
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    Because the estimated FY 2022 end-of-year operating reserves of 
carryover user fees does not exceed the 14-week threshold amount, FDA 
will not reduce the FY 2023 fees or fee revenue. However, because the 
estimated FY 2022 end-of-year operating reserves of carryover user fees 
of $184,271,732 is below the 8-week threshold amount of $193,360,675 by 
$9,088,943, FDA will apply an operating reserve adjustment of 
$9,088,943 to increase the fee revenue and fees for FY 2023.
    With respect to target revenue for FY 2023, adding the operating 
reserve adjustment amount of $9,088,943 to the inflation, strategic 
hiring and retention, CPA, and additional dollar amount of 
$1,256,844,387 results in the cumulative revenue amount of 
$1,265,933,330.
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F. FY 2023 Statutory Fee Revenue Adjustments for Additional Direct Cost

    PDUFA VII specifies that an additional direct cost of $44,386,150 
is to be added to the total FY 2023 PDUFA revenue amount (see section 
736(c)(5) of the FD&C Act). With respect to target revenue for FY 2023, 
adding the additional direct cost amount of $44,386,150 to the 
inflation, strategic hiring and retention, CPA, additional dollar 
amount, and operating reserve adjustment of $1,265,933,330 results in 
the total revenue amount of $1,310,319,000 (rounded to the nearest 
thousand dollars).
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III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate 20 percent of the total 
revenue amount, amounting to $262,063,800 in FY 2023.

B. Estimate of the Number of Fee-Paying Applications and Setting the 
Application Fees

    Historically, FDA has estimated the total number of fee-paying full 
application equivalents (FAEs) it expects to receive during the next 
fiscal year by averaging the number of fee-paying FAEs received in the 
three most recently completed fiscal years. For FY 2023 fee setting, 
the three relevant fiscal years are FYs 2019, 2020,\6\ and 2021. Prior 
year FAE totals are updated annually to reflect refunds and waivers 
processed after the close of the fiscal year.
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    \6\ FY 2020 data was omitted in FY 2022 methodology as FDA took 
into account the global COVID-19 pandemic situation at the time. 
However, after reviewing the data trend, FY 2020 data is included in 
this year's methodology given the higher FAE count for FY 2021. See 
table 13.
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    In estimating the number of fee-paying FAEs, an application 
requiring covered clinical data \7\ counts as one FAE. An application 
not requiring covered clinical data counts as one-half of an FAE. An 
application that is withdrawn before filing, or refused for filing, 
counts as one-fourth of an FAE if the applicant initially paid a full 
application fee, or one-eighth of an FAE if the applicant initially 
paid one-half of the full application fee amount.
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    \7\ As defined in section 736(a)(1)(A)(i) of the FD&C Act.
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    As table 14 shows, the average number of fee-paying FAEs received 
annually in FY 2019 through FY 2021 is 80.8333. FDA will set fees for 
FY 2023 based on this estimate as the number of full application 
equivalents that will be subject to fees.
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    The FY 2023 application fee is estimated by dividing the average 
number of full applications that paid fees from FY 2019 through FY 
2021, 80.8333, into the fee revenue amount to be derived from 
application fees in FY 2023, $262,063,800. The result is a fee of 
$3,242,026 per full application requiring clinical data, and $1,621,013 
per application not requiring clinical data.

IV. Fee Calculation for Prescription Drug Fees

    PDUFA VII assesses prescription drug program fees for certain 
prescription drug products. Program fees will be set to generate 80 
percent of the total target revenue amount amounting to $1,048,255,200 
in FY 2023.
    An applicant will not be assessed more than five program fees for a 
FY for prescription drug products identified in a single approved NDA 
or BLA (see section 736(a)(2)(C) of the FD&C Act). Applicants are 
assessed a program fee for a fiscal year for user fee eligible 
prescription drug products identified in a human drug application 
approved as of October 1 of such fiscal year. Additionally, applicants 
are assessed a program fee for a product that is not a prescription 
drug product on October 1 because it is included in the discontinued 
section of the Orange Book or the CDER/CBER Biologics List on that 
date, if the product becomes a fee-eligible prescription drug product 
during the fiscal year.
    FDA estimates 2,876 program fees will be invoiced in FY 2023 before 
factoring in waivers, refunds, and exemptions. FDA approximates that 
there will be 70 waivers and refunds granted. In addition, FDA 
approximates that another 43 program fees will be exempted in FY 2023 
based on the orphan drug exemption in section 736(k) of the FD&C Act.
    PDUFA VII changes the definition of the same product exception for 
program fees. FDA determined that 93 products may be eligible for the 
pharmaceutical equivalence same product exception. An additional 
exception for program fees for skin-test diagnostic products is 
included in the PDUFA VII. FDA has determined that there are nine skin-
test diagnostic application products that may be eligible for the 
exception for skin diagnostic tests. FDA estimates 2,661 program fees 
in FY 2023, after allowing for an estimated 215 waivers and reductions, 
including the orphan drug exemptions, excepted and exempted fee-liable 
products. The FY 2023 prescription drug program fee rate is calculated 
by dividing the adjusted total revenue from program fees 
($1,048,255,200) by the estimated 2,661 program fees resulting in a FY 
2023 program fee of $393,933 (rounded to the nearest dollar).

V. Fee Schedule for FY 2023

    The fee rates for FY 2023 are displayed in table 15.
    [GRAPHIC] [TIFF OMITTED] TN07OC22.047
    

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VI. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule 
must be paid for any application subject to fees under PDUFA VII that 
is submitted on or after October 1, 2022. Payment must be made in U.S. 
currency by electronic check, check, bank draft, wire transfer, or U.S. 
postal money order payable to the order of the Food and Drug 
Administration. 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).
    FDA has partnered with the U.S. Department of the Treasury to use 
Pay.gov, a web-based payment application, for online electronic 
payment. The Pay.gov feature is available on the FDA website after 
completing the Prescription Drug User Fee Cover Sheet and generating 
the user fee ID number. 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 an invoice is located, ``Pay Now'' should be selected to 
be redirected to Pay.gov. Electronic payment options are based on the 
balance due. Payment by credit card is available for balances that are 
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.
    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 979107, 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 979107, 1005 Convention Plaza, St. Louis, 
MO 63101. (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 314-418-4013. This telephone number is only for questions about 
courier delivery). Please make sure that the FDA post office box number 
(P.O. Box 979107) is written on the check, bank draft, or postal money 
order.
    For payments made by wire transfer, include the unique user fee ID 
number to ensure that the payment is applied to the correct fee(s). 
Without the unique user fee ID number, the payment may not be applied, 
which could result in FDA not filing an application and other 
penalties.

    Note: The originating financial institution may charge a wire 
transfer fee, especially for international wire transfers. 
Applicable wire transfer fees must be included with payment to 
ensure fees are paid in full. Questions about wire transfer fees 
should be addressed to the financial institution. The account 
information for wire transfers is as follows: U.S. Department 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.

B. Prescription Drug Program Fees

    FDA will issue invoices and payment instructions for FY 2023 
program fees under the new fee schedule in October 2022. Under section 
736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are 
generally due on October 3, 2022. However, given the late date of the 
PDUFA reauthorization, invoices should be paid within 30 days of 
invoice.
    FDA will issue invoices in December 2023 for products that qualify 
for FY 2023 program fee assessments after the October 2022 billing.

C. Fee Waivers and Refunds

    To qualify for consideration for a waiver or reduction under 
section 736(d) of the FD&C Act, an exemption under section 736(k) of 
the FD&C Act, or the return of an application or program fee paid under 
section 736 of the FD&C Act, including if the fee is claimed to have 
been paid in error, a person must submit to FDA a written request 
justifying such waiver, reduction, exemption or return not later than 
180 days after such fee is due (section 736(i) of the FD&C Act). A 
request submitted under this paragraph must include any legal 
authorities under which the request is made.

    Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21968 Filed 10-5-22; 11:15 am]
BILLING CODE 4164-01-P