Notice2021-16039
Generic Drug User Fee Rates for Fiscal Year 2022
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40582-40587]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16039]
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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.
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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 (<a href="https://www.fda.gov/gdufa">https://www.fda.gov/gdufa</a>). 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
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Fiscal year 2018 2019 2020 3-Year average
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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
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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
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Fiscal year 2018 2019 2020 3-Year average
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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
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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:
<a href="https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0">https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0</a>.
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\1\ The Bureau of Labor Statistics' announcement of the
geographical revision can be viewed at <a href="https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm">https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm</a>.
Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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Year 2018 2019 2020 3-Year average
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Annual CPI...................................... 261.445 264.777 267.157 ..............
Annual Percent Change........................... 2.0389 1.2745 0.8989 1.4041
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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
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Fees rates for
Fee category FY 2022
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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
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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
<a href="https://www.fda.gov/gdufa">https://www.fda.gov/gdufa</a> and <a href="http://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp">http://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp</a>, 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 <a href="http://Pay.gov">Pay.gov</a>,
a web-based payment application, for online electronic payment. The
<a href="http://Pay.gov">Pay.gov</a> 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 <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>. (Note: only full
payments are accepted; no partial payments can be made online.) Once an
invoice is located, ``Pay Now'' should be selected to be redirected to
<a href="http://Pay.gov">Pay.gov</a>. Electronic payment options are based on the balance due.
Payment by credit card is available 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
</pre></body>
</html>Indexed from Federal Register on July 28, 2021.
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