Generic Drug User Fee Rates for Fiscal Year 2022, 40582-40587 [2021-16039]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40582-40587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16039]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0661]


Generic Drug User Fee Rates for Fiscal Year 2022

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act or 
statute), as amended by the Generic Drug User Fee Amendments of 2017 
(GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, 
or we) to assess and collect fees for abbreviated new drug applications 
(ANDAs); drug master files (DMFs); generic drug active pharmaceutical 
ingredient (API) facilities, finished dosage form (FDF) facilities, and 
contract manufacturing organization (CMO) facilities; and generic drug 
applicant program user fees. In this document, FDA is announcing fiscal 
year (FY) 2022 rates for GDUFA II fees.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61077B, Beltsville, MD 20705-4304, 240-402-4244.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42) establish fees associated with human generic drug products. Fees 
are assessed on: (1) Certain types of applications for

[[Page 40583]]

human generic drug products; (2) certain facilities where APIs and FDFs 
are produced; (3) certain DMFs associated with human generic drug 
products; and (4) generic drug applicants who have approved ANDAs (the 
program fee) (see section 744B(a)(2) through (5) of the FD&C Act).
    GDUFA II provides that user fees should total $493,600,000 annually 
adjusted each year for inflation. For FY 2022, the generic drug fee 
rates are: ANDA ($225,712), DMF ($74,952), domestic API facility 
($42,557) foreign API facility ($57,557), domestic FDF facility 
($195,012), foreign FDF facility ($210,012), domestic CMO facility 
($65,004), foreign CMO facility ($80,004), large size operation generic 
drug applicant program ($1,536,856), medium size operation generic drug 
applicant program ($614,742), and small business generic drug applicant 
program ($153,686). These fees are effective on October 1, 2021, and 
will remain in effect through September 30, 2022.

II. Fee Revenue Amount for FY 2022

    GDUFA II directs FDA to use the yearly revenue amount determined 
under the statute as a starting point to set the fee rates for each fee 
type. The base revenue amount for FY 2022 is $520,208,640. This is the 
amount calculated for the prior fiscal year, FY 2021, pursuant to the 
statute (see section 744B(b)(1) of the FD&C Act). For more information 
about GDUFA II, please refer to the FDA website (https://www.fda.gov/gdufa). The ANDA, DMF, API facility, FDF facility, CMO facility, and 
generic drug applicant program fee (GDUFA program fee) calculations for 
FY 2022 are described in this document.

A. Inflation Adjustment

    The base revenue amount for FY 2022 is $520,208,640. This is the 
amount calculated for the prior fiscal year, FY 2021, pursuant to the 
statute (see section 744B(b)(1) of the FD&C Act). GDUFA II specifies 
that the $520,208,640 is to be adjusted for inflation increases for FY 
2022 using two separate adjustments--one for personnel compensation and 
benefits (PC&B) and one for non-PC&B costs (see sections 744B(c)(1)(B) 
and (C) of the FD&C Act).
    The component of the inflation adjustment for PC&B costs shall be 
one plus the average annual percent change in the cost of all PC&B paid 
per full-time equivalent position (FTE) at FDA for the first 3 of the 4 
preceding fiscal years, multiplied by the proportion of PC&B costs to 
total FDA costs of human generic drug activities for the first 3 of the 
preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act).
    Table 1 summarizes the actual cost and total FTEs 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 2022. The 3-year average is 2.7383 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                Fiscal year                       2018              2019              2020        3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,690,678,000    $2,620,052,000    $2,875,592,000  ..............
Total FTEs................................            17,023            17,144            17,535  ..............
PC&B per FTE..............................          $158,061          $152,826          $163,992  ..............
Percent Change from Previous Year.........            4.2206           -3.3120            7.3063          2.7383
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 2.7383 percent should be multiplied 
by the proportion of PC&B expended for human generic drug activities 
for the first 3 of the preceding 4 fiscal years. Table 2 shows the 
amount of PC&B and the total amount obligated for human generic drug 
activities from FY 2018 through FY 2020.

Table 2--PC&B as a Percent of Fee Revenues Spent on the Process of Human Generic Drug Applications Over the Last
                                                     3 Years
----------------------------------------------------------------------------------------------------------------
                   Fiscal year                         2018            2019            2020       3-Year average
----------------------------------------------------------------------------------------------------------------
PC&B............................................    $332,617,643    $356,874,114    $397,392,785  ..............
Non-PC&B........................................    $276,911,265    $290,439,277    $300,692,399  ..............
Total Costs.....................................    $609,528,908    $647,313,391    $698,085,185  ..............
PC&B Percent....................................         54.5696         55.1316         56.9261         55.5424
Non-PC&B Percent................................         45.4304         44.8684         43.0739         44.4576
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.7383 percent multiplied by 55.5424 
percent (or 1.5209 percent).
    The statute specifies that the portion of the inflation adjustment 
for non-PC&B costs for FY 2022 is the average annual percent change 
that occurred in the Consumer Price Index (CPI) for urban consumers 
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items; 
annual index) for the first 3 of the preceding 4 years of available 
data multiplied by the proportion of all costs other than PC&B costs to 
total costs of human generic drug activities (see section 744B(c)(1)(C) 
of the FD&C Act). As a result of a geographical revision made by the 
Bureau of Labor and Statistics in January 2018,\1\ the Washington-
Baltimore, DC-MD-VA-WV index was discontinued and replaced with two 
separate indices (i.e., Washington-Arlington-Alexandria, DC-VA-MD-WV 
and Baltimore-Columbia-Towson, MD). In order to continue applying a CPI 
that best reflects the geographic region in which FDA is headquartered 
and that provides the most current data available, the Washington-
Arlington-Alexandria index will be used in calculating the relevant 
adjustment factors for FY 2022 and subsequent years. Table 3 provides 
the summary data for the percent change in the specified CPI. The data 
are published by

[[Page 40584]]

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.

---------------------------------------------------------------------------

    \1\ The Bureau of Labor Statistics' announcement of the 
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

        Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
                      Year                             2018            2019            2020       3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         261.445         264.777         267.157  ..............
Annual Percent Change...........................          2.0389          1.2745          0.8989          1.4041
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we 
multiply the 3-year average percent change in the CPI (1.4041 percent) 
by the proportion of all costs other than PC&B to total costs of human 
generic drug activities obligated. Because 55.5424 percent was 
obligated for PC&B as shown in table 2, 44.4576 percent is the portion 
of costs other than PC&B. The non-pay adjustment is 1.4041 percent 
times 44.4576 percent, or 0.6242 percent.
    To complete the inflation adjustment for FY 2022, we add the PC&B 
component (1.5209 percent) to the non-PC&B component (0.6242 percent) 
for a total inflation adjustment of 2.1451 percent (rounded), and then 
add 1, making an inflation adjustment multiple of 1.021451. We then 
multiply the base revenue amount for FY 2022 ($520,208,640) by 
1.021451, yielding an inflation-adjusted amount of $531,367,636.

B. Final Year Adjustment

    For FY 2022, FDA may, in addition to the inflation adjustment, 
further increase the fee revenue and fees established if such an 
adjustment is necessary to provide for not more than 3 months of 
operating reserves of carryover user fees for human generic drug 
activities for the first 3 months of FY 2023. To determine whether a 
final year adjustment applies, FDA calculates operating reserves of 
carryover and its estimated balance as of the beginning of FY 2023.
    After running analyses on the projected collections and obligations 
for FY 2021 and FY 2022, FDA estimates available carryover balance will 
be $63,131,283 as of the beginning of FY 2023. FDA estimates the cost 
of operations per week is $10,202,769; thus, the projected available 
carryover balance of $63,131,283 at the beginning of FY 2023 represents 
approximately 6 weeks of operating reserves. Per the statute, FDA could 
raise the fee revenue by $59,301,948 (12 weeks x $10,202,769 minus 
projected carryover of $63,131,283) for the final year adjustment. FDA 
recognizes that adding $59,301,948 to the fee revenue in FY 2022 may 
pose as a burden to the regulated industry. In light of this, and in 
light of the fact that the legislative language authorizing the final 
year adjustment allows FDA discretion in whether to make this 
adjustment for a full 3 months of operating reserves or for a shorter 
period, FDA has decided to make the final year adjustment to allow for 
only 7 weeks of operating reserves. Accordingly, the final year 
adjustment will be $8,288,102 (7 x $10,202,769 less projected carryover 
of $63,131,283). Adding this amount to the inflation adjusted amount of 
$531,367,636 results in a total revenue target of $539,656,000 (rounded 
to the nearest thousand dollars).

III. ANDA Filing Fee

    Under GDUFA II, the FY 2022 ANDA filing fee is owed by each 
applicant that submits an ANDA on or after October 1, 2021. This fee is 
due on the submission date of the ANDA. Section 744B(b)(2)(B) of the 
FD&C Act specifies that the ANDA fee will make up 33 percent of the 
$539,656,000, which is $178,086,480.
    To calculate the ANDA fee, FDA estimated the number of full 
application equivalents (FAEs) that will be submitted in FY 2022. The 
submissions are broken down into three categories: New originals 
(submissions that have not been received by FDA previously); 
submissions that FDA refused to receive (RTR) for reasons other than 
failure to pay fees; and applications that are resubmitted after an RTR 
decision for reasons other than failure to pay fees. An ANDA counts as 
one FAE; however, 75 percent of the fee paid for an ANDA that has been 
RTR shall be refunded according to GDUFA II if: (1) The ANDA is refused 
for a cause other than failure to pay fees or (2) the ANDA has been 
withdrawn prior to receipt (section 744B(a)(3)(D)(i) of the FD&C Act). 
Therefore, an ANDA that is considered not to have been received by FDA 
due to reasons other than failure to pay fees or withdrawn prior to 
receipt counts as one-fourth of an FAE. After an ANDA has been RTR, the 
applicant has the option of resubmitting. For user fee purposes, these 
resubmissions are equivalent to new original submissions--ANDA 
resubmissions are charged the full amount for an application (one FAE).
    FDA utilized data from ANDAs submitted from October 1, 2019, to 
April 30, 2021, to estimate the number of new original ANDAs that will 
incur filing fees in FY 2022. For FY 2022, the Agency estimates that 
approximately 788 new original ANDAs will be submitted and incur filing 
fees. Not all of the new original ANDAs will be received by the Agency 
and some of those not received will be resubmitted in the same fiscal 
year. Therefore, the Agency expects that the FAE count for ANDAs will 
be 789 for FY 2022.
    The FY 2022 application fee is estimated by dividing the number of 
FAEs that will pay the fee in FY 2022 (789) into the fee revenue amount 
to be derived from ANDA application fees in FY 2022 ($178,086,480). The 
result, rounded to the nearest dollar, is a fee of $225,712 per ANDA.
    The statute provides that those ANDAs that include information 
about the production of active pharmaceutical ingredients other than by 
reference to a DMF will pay an additional fee that is based on the 
number of such active pharmaceutical ingredients and the number of 
facilities proposed to produce those ingredients (see section 
744B(a)(3)(F) of the FD&C Act). FDA anticipates that this additional 
fee is unlikely to be assessed often; therefore, FDA has not included 
projections concerning the amount of this fee in calculating the fees 
for ANDAs.

IV. DMF Fee

    Under GDUFA II, the DMF fee is owed by each person that owns a type 
II API DMF that is referenced, on or after October 1, 2012, in a 
generic drug submission by an initial letter of authorization. This is 
a one-time fee for each DMF. This fee is due on the earlier of the date 
on which the first generic drug submission is submitted that references 
the associated DMF or the date on which the DMF holder requests the 
initial completeness assessment. Under section 744B(a)(2)(D)(iii) of 
the FD&C Act, if a DMF has successfully undergone an initial 
completeness

[[Page 40585]]

assessment and the fee is paid, the DMF will be placed on a publicly 
available list documenting DMFs available for reference.
    To calculate the DMF fee, FDA assessed the volume of DMF 
submissions over time. The Agency assessed DMFs from October 1, 2019, 
to April 30, 2021, and concluded that averaging the number of fee-
paying DMFs provided the most accurate model for predicting fee-paying 
DMFs for FY 2022. The monthly average of paid DMF submissions the 
Agency received in FY 2020 and FY 2021 is 30. To determine the FY 2022 
projected number of fee-paying DMFs, the average of 30 DMF submissions 
is multiplied by 12 months, which results in 360 estimated FY 2022 fee-
paying DMFs. FDA is estimating 360 fee-paying DMFs for FY 2022.
    The FY 2022 DMF fee is determined by dividing the DMF target 
revenue by the estimated number of fee-paying DMFs in FY 2022. Section 
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up 
5 percent of the $539,656,000, which is $26,982,800. Dividing the DMF 
revenue amount ($26,982,800) by the estimated fee-paying DMFs (360), 
and rounding to the nearest dollar, yields a DMF fee of $74,952 for FY 
2022.

V. Foreign Facility Fee Differential

    Under GDUFA II, the fee for a facility located outside the United 
States and its territories and possessions shall be $15,000 higher than 
the amount of the fee for a facility located in the United States and 
its territories and possessions. The basis for this differential is the 
extra cost incurred by conducting an inspection outside the United 
States and its territories and possessions.

VI. FDF and CMO Facility Fees

    Under GDUFA II, the annual FDF facility fee is owed by each person 
who owns an FDF facility that is identified in at least one approved 
generic drug submission owned by that person or its affiliates. The CMO 
facility fee is owed by each person who owns an FDF facility that is 
identified in at least one approved ANDA but is not identified in an 
approved ANDA held by the owner of that facility or its affiliates. 
These fees are due no later than the first business day on or after 
October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act 
specifies that the FDF and CMO facility fee revenue will make up 20 
percent of the $539,656,000, which is $107,931,200.
    To calculate the fees, data from FDA's Integrity Services (IS) were 
utilized as the primary source of facility information for determining 
the denominators of each facility fee type. IS is the master data 
steward for all facility information provided in generic drug 
submissions received by FDA. A facility's reference status in an 
approved generic drug submission is extracted directly from submission 
data rather than relying on data from self-identification. This 
information provided the number of facilities referenced as FDF 
manufacturers in at least one approved generic drug submission. Based 
on FDA's IS data, the FDF and CMO facility denominators are 181 FDF 
domestic, 279 FDF foreign, 88 CMO domestic, and 104 CMO foreign 
facilities for FY 2022.
    GDUFA II specifies that the CMO facility fee is to be equal to one-
third the amount of the FDF facility fee. Therefore, to generate the 
target collection revenue amount from FDF and CMO facility fees 
($107,931,200), FDA must weight a CMO facility as one-third of an FDF 
facility. FDA set fees based on the estimate of 181 FDF domestic, 279 
FDF foreign, 29.33 CMO domestic (88 multiplied by one-third), and 34.67 
CMO foreign facilities (104 multiplied by one-third), which equals 524 
total weighted FDF and CMO facilities for FY 2022.
    To calculate the fee for domestic facilities, FDA first determines 
the total fee revenue that will result from the foreign facility 
differential by subtracting the fee revenue resulting from the foreign 
facility fee differential from the target collection revenue amount 
($107,931,200) as follows. The foreign facility fee differential 
revenue equals the foreign facility fee differential ($15,000) 
multiplied by the number of FDF foreign facilities (279) plus the 
foreign facility fee differential ($15,000) multiplied by the number of 
CMO foreign facilities (104), totaling $5,745,000. This results in 
foreign fee differential revenue of $5,745,000 from the total FDF and 
CMO facility fee target collection revenue. Subtracting the foreign 
facility differential fee revenue ($5,745,000) from the total FDF and 
CMO facility target collection revenue ($107,931,200) results in a 
remaining facility fee revenue balance of $102,186,200. To determine 
the domestic FDF facility fee, FDA divides the $102,186,200 by the 
total weighted number of FDF and CMO facilities (524), which results in 
a domestic FDF facility fee of $195,012. The foreign FDF facility fee 
is $15,000 more than the domestic FDF facility fee, or $210,012.
    According to GDUFA II, the domestic CMO fee is calculated as one-
third the amount of the domestic FDF facility fee. Therefore, the 
domestic CMO fee is $65,004, rounded to the nearest dollar. The foreign 
CMO fee is calculated as the domestic CMO fee plus the foreign fee 
differential of $15,000. Therefore, the foreign CMO fee is $80,004.

VII. API Facility Fee

    Under GDUFA II, the annual API facility fee is owed by each person 
who owns a facility that is identified in: (1) At least one approved 
generic drug submission or (2) in a Type II API DMF referenced in at 
least one approved generic drug submission. These fees are due no later 
than the first business day on or after October 1 of each such year. 
Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee 
will make up 7 percent of $539,656,000 in fee revenue, which is 
$37,775,920.
    To calculate the API facility fee, data from FDA's IS were utilized 
as the primary source of facility information for determining the 
denominator. As stated above, IS is the master data steward for all 
facility information provided in generic drug submissions received by 
FDA. A facility's reference status in an approved generic drug 
submission is extracted directly from submission data rather than 
relying on data from self-identification. This information provided the 
number of facilities referenced as API manufacturers in at least one 
approved generic drug submission.
    The total number of API facilities identified was 679; of that 
number, 87 were domestic and 592 were foreign facilities. The foreign 
facility differential is $15,000. To calculate the fee for domestic 
facilities, FDA must first subtract the fee revenue that will result 
from the foreign facility fee differential. FDA takes the foreign 
facility differential ($15,000) and multiplies it by the number of 
foreign facilities (592) to determine the total fee revenue that will 
result from the foreign facility differential. As a result of that 
calculation, the foreign fee differential revenue will make up 
$8,880,000 of the total API fee revenue. Subtracting the foreign 
facility differential fee revenue ($8,880,000) from the total API 
facility target revenue ($37,775,920) results in a remaining balance of 
$28,895,920. To determine the domestic API facility fee, we divide the 
$28,895,920 by the total number of facilities (679), which gives us a 
domestic API facility fee of $42,557. The foreign API facility fee is 
$15,000 more than the domestic API facility fee, or $57,557.

VIII. Generic Drug Applicant Program Fee

    Under GDUFA II, if a person and its affiliates own at least one but 
not more

[[Page 40586]]

than five approved ANDAs on October 1, 2021, the person and its 
affiliates shall owe a small business GDUFA program fee. If a person 
and its affiliates own at least 6 but not more than 19 approved ANDAs, 
the person and its affiliates shall owe a medium size operation GDUFA 
program fee. If a person and its affiliates own at least 20 approved 
ANDAs, the person and its affiliates shall owe a large size operation 
GDUFA program fee. These fees are due no later than the first business 
day on or after October 1 of each such year. Section 744B(b)(2)(E) of 
the FD&C Act specifies the GDUFA program fee will make up 35 percent of 
$539,656,000 in fee revenue, which is $188,879,600.
    To determine the appropriate number of parent companies for each 
tier, the Agency asked companies to claim their ANDAs and affiliates in 
the Center for Drug Evaluation and Research (CDER) NextGen Portal. The 
companies were able to confirm relationships currently present in the 
Agency's records, while also reporting newly approved ANDAs, newly 
acquired ANDAs, and new affiliations.
    In determining the appropriate number of approved ANDAs, the Agency 
has factored in a number of variables that could affect the collection 
of the target revenue: (1) Inactive ANDAs--applicants who have not 
submitted an annual report for one or more of their approved 
applications within the past 2 years; (2) Program Fee Arrears List--
parent companies that are on the arrears list for any fiscal year; (3) 
Center for Biologics Evaluation and Research (CBER) approved ANDAs--
applicants and their affiliates with CBER-approved ANDAs in addition to 
CDER's approved ANDAs; and (4) withdrawals of approved ANDAs by April 
1st--applicants who have submitted a written request for withdrawal of 
approval by April 1st of the previous fiscal year. The list of original 
approved ANDAs from the Generic Drug Review Platform as of April 30, 
2021, shows 291 applicants in the small business tier, 76 applicants in 
the medium size tier, and 76 applicants in the large size tier. 
Factoring in all the variables for the fourth year of GDUFA II, the 
Agency estimates there will be 203 applicants in the small business 
tier, 69 applicants in the medium size tier, and 75 applicants in the 
large size tier for FY 2022.
    To calculate the GDUFA program fee, GDUFA II provides that large 
size operation generic drug applicants pay the full fee, medium size 
operation applicants pay two-fifths of the full fee, and small business 
applicants pay one-tenth of the full fee. To generate the target 
collection revenue amount from GDUFA program fees ($188,879,600), we 
must weigh medium and small tiered applicants as a subset of a large 
size operation generic drug applicant. FDA will set fees based on the 
weighted estimate of 20.30 applicants in the small business tier (203 
multiplied by 10 percent), 27.6 applicants in the medium size tier (69 
multiplied by 40 percent), and 75 applicants in the large size tier, 
arriving at 122.90 total weighted applicants for FY 2022.
    To generate the large size operation GDUFA program fee, FDA divides 
the target revenue amount of $188,879,600 by 122.90, which equals 
$1,536,856. The medium size operation GDUFA program fee is 40 percent 
of the full fee ($614,742), and the small business operation GDUFA 
program fee is 10 percent of the full fee ($153,686).

IX. Fee Schedule for FY 2022

    The fee rates for FY 2022 are set out in table 4.

                    Table 4--Fee Schedule for FY 2022
------------------------------------------------------------------------
                                                          Fees rates for
                      Fee category                            FY 2022
------------------------------------------------------------------------
Applications:
  Abbreviated New Drug Application (ANDA)...............        $225,712
  Drug Master File (DMF)................................          74,952
Facilities:
  Active Pharmaceutical Ingredient (API)--Domestic......          42,557
  API--Foreign..........................................          57,557
  Finished Dosage Form (FDF)--Domestic..................         195,012
  FDF--Foreign..........................................         210,012
  Contract Manufacturing Organization (CMO)--Domestic...          65,004
  CMO--Foreign..........................................          80,004
GDUFA Program:
    Large size operation generic drug applicant.........       1,536,856
    Medium size operation generic drug applicant........         614,742
    Small business operation generic drug applicant.....         153,686
------------------------------------------------------------------------

X. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2021. To pay the ANDA, 
DMF, API facility, FDF facility, CMO facility, and GDUFA program fees, 
a Generic Drug User Fee Cover Sheet must be completed, available at 
https://www.fda.gov/gdufa and https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and a user fee identification (ID) number must be 
generated. Payment must be made in U.S. currency drawn on a U.S. bank 
by electronic check, check, bank draft, U.S. postal money order, credit 
card, or wire transfer. 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 utilize Pay.gov, 
a web-based payment application, for online electronic payment. The 
Pay.gov feature is available on the FDA website after completing the 
Generic 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 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.
    The user fee ID number must be included on the check, bank draft, 
or postal money order and must be made payable to the order of the Food 
and Drug Administration. Payments can be mailed to: Food and Drug 
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks 
are to be sent by a courier that requests a street address, the courier 
can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108, 
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank 
address is for courier delivery only. For questions concerning courier 
delivery, U.S. Bank can be contacted at 314-418-4013. This telephone 
number is only for questions about courier delivery.) The FDA post 
office box number (P.O. Box 979108) must be written on the check, bank 
draft, or postal money order.
    For payments made by wire transfer, the unique user fee ID number 
must be referenced. Without the unique user fee ID number, the payment 
may not be applied. 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. Applicable wire transfer 
fees must be included with payment to ensure fees are fully paid. 
Questions about wire transfer fees should be addressed to the financial 
institution. The following account information should be used to send 
payments by

[[Page 40587]]

wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty 
St., New York, NY 10045, account number: 75060099, routing number: 
021030004, SWIFT: FRNYUS33. FDA's tax identification number is 53-
0196965.

    Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16039 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P