Medical Device User Fee Rates for Fiscal Year 2022, 41477-41483 [2021-16408]
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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
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[FR Doc. 2021–16356 Filed 7–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0659]
Medical Device User Fee Rates for
Fiscal Year 2022
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2022. The Federal Food, Drug, and
SUMMARY:
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Cosmetic Act (FD&C Act), as amended
by the Medical Device User Fee
Amendments of 2017 (MDUFA IV),
authorizes FDA to collect user fees for
certain medical device submissions and
annual fees both for certain periodic
reports and for establishments subject to
registration. This notice establishes the
fee rates for FY 2022, which apply from
October 1, 2021, through September 30,
2022, and provides information on how
the fees for FY 2022 were determined,
the payment procedures you should
follow, and how you may qualify for
reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device
User Fees: https://www.fda.gov/
industry/fda-user-fee-programs/
medical-device-user-fee-amendmentsmdufa.
For questions relating to the MDUFA
Small Business Program, please visit the
Center for Devices and Radiological
Health’s website: https://www.fda.gov/
medical-devices/premarketsubmissions/reduced-medical-deviceuser-fees-small-business-determinationsbd-program.
For questions relating to this notice:
Andrew Bank, Office of Financial
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 62019A, Beltsville, MD 20705, 301–
796–0292.
SUPPLEMENTARY INFORMATION:
by FDA during FY 2022 is $329,000.
From this starting point, this document
establishes FY 2022 fee rates for certain
types of submissions, and for periodic
reporting, by applying criteria specified
in the FD&C Act.
I. Background
MDUFA specifies that the
$213,687,660 is to be adjusted for
inflation increases for FY 2022 using
two separate adjustments—one for
payroll costs and one for non-payroll
costs (see 21 U.S.C. 379j(c)(2)). The base
inflation adjustment for FY 2022 is the
sum of one plus the two separate
adjustments and is compounded as
specified in the statute (see 21 U.S.C.
379j(c)(2)(C) and 379j(c)(2)(B)).
Section 738 of the FD&C Act (21
U.S.C. 379j) establishes fees for certain
medical device applications,
submissions, supplements, notices, and
requests (for simplicity, this document
refers to these collectively as
‘‘submissions’’ or ‘‘applications’’); for
periodic reporting on class III devices;
and for the registration of certain
establishments. Under statutorily
defined conditions, a qualified
applicant may receive a fee waiver or
may pay a lower small business fee (see
21 U.S.C. 379j(d) and (e)).
Under the FD&C Act, the fee rate for
each type of submission is set at a
specified percentage of the standard fee
for a premarket application (a premarket
application is a premarket approval
application (PMA), a product
development protocol (PDP), or a
biologics license application (BLA)).
The FD&C Act specifies the base fee for
a premarket application for each year
from FY 2018 through FY 2022; the base
fee for a premarket application received
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The FD&C Act specifies the base fee
for establishment registration for each
year from FY 2018 through FY 2022; the
base fee for an establishment
registration in FY 2022 is $4,978. There
is no reduction in the registration fee for
small businesses. Each establishment
that is registered (or is required to
register) with the Secretary of Health
and Human Services under section 510
of the FD&C Act (21 U.S.C. 360) because
such establishment is engaged in the
manufacture, preparation, propagation,
compounding, or processing of a device
is required to pay the annual fee for
establishment registration.
II. Revenue Amount for FY 2022
The total revenue amount for FY 2022
is $213,687,660, as set forth in the
statute prior to the inflation adjustment
(see 21 U.S.C. 379j(b)(3)). MDUFA
directs FDA to use the yearly total
revenue amount as a starting point to set
the standard fee rates for each fee type.
The fee calculations for FY 2022 are
described in this document.
Inflation Adjustment
The component of the inflation
adjustment for payroll costs is the
average annual percent change in the
cost of all personnel compensation and
benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the
first 3 of the 4 preceding FYs,
multiplied by 0.60, or 60 percent (see 21
U.S.C. 379j(c)(2)(C)).
Table 1 summarizes the actual cost
and FTE data for the specified FYs, and
provides the percent change from the
previous FY and the average percent
change over the first 3 of the 4 FYs
preceding FY 2022. The 3-year average
is 2.7383 percent (rounded).
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TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year
2018
Total PC&B ......................................................................
Total FTE .........................................................................
PC&B per FTE .................................................................
Percent change from previous year ................................
The payroll adjustment is 2.7383
percent multiplied by 60 percent, or
1.6430 percent. The statute specifies
that the component of the inflation
adjustment for non-payroll 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-VAWV; Not Seasonally Adjusted; All Items;
Annual Index) for the first 3 of the
preceding 4 years of available data
multiplied by 0.40, or 40 percent (see 21
U.S.C. 379j(c)(2)(C)). As a result of a
2019
$2,690,678,000
17,023
$158,061
4.2206%
2020
$2,620,052,000
17,144
$152,826
¥3.3120%
geographical revision made by the
Bureau of Labor and Statistics in
January 2018,1 the ‘‘WashingtonBaltimore, DC-MD-VA-WV’’ index was
discontinued and replaced with two
separate indices (i.e., ‘‘WashingtonArlington-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-ArlingtonAlexandria index has been used since
3-Year average
$2,875,592,000
17,535
$163,992
7.3063%
................................
................................
................................
2.7383%
FY 2020 and will be used in calculating
the relevant adjustment factors for FY
2022 and subsequent years.
Table 2 provides the summary data
and the 3-year average percent change
in the specified CPI for the WashingtonArlington-Alexandria area. These data
are published by the Bureau of Labor
Statistics and can be found on their
website under series Id CUURS35ASA0
at: https://data.bls.gov/pdq/Survey
OutputServlet?data_
tool=dropmap&series_
id=CUURS35ASA0,CUUSS35ASA0.
TABLE 2—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN WASHINGTON-ARLINGTON-ALEXANDRIA AREA CPI
Fiscal year
2018
2019
2020
3-Year average
Annual CPI .......................................................................
Annual Percent Change ..................................................
3-Year Average Percent Change in CPI .........................
261.445
2.0389%
................................
264.777
1.2745%
................................
267.157
0.8989%
................................
................................
................................
1.4041%
The non-payroll adjustment is 1.4041
percent multiplied by 40 percent, or
0.5616 percent. Next, the payroll
adjustment (1.6430 percent or 0.016430)
is added to the non-payroll adjustment
(0.5616 percent or .005616), for a total
of 2.2046 percent (or 0.022046). To
complete the inflation adjustment, 1
(100 percent or 1.0) is added for a total
base inflation adjustment of 1.022046
for FY 2022.
MDUFA IV provides for this inflation
adjustment to be compounded for FY
2022 and each subsequent fiscal year
(see 21 U.S.C. 379j(c)(2)(B)(ii)). To
complete the compounded inflation
adjustment for FY 2022, the FY 2021
compounded adjustment (1.114808) is
multiplied by the FY 2022 base inflation
adjustment (1.022046) to reach the
applicable inflation adjustment of
1.139385 (rounded) for FY 2022. We
then multiply the total revenue amount
for FY 2022 ($213,687,660) by 1.139385,
fees of $374,858 (premarket application)
and $5,672 (establishment registration).
yielding an inflation adjusted total
revenue amount of $243,473,000
(rounded to the nearest thousand
dollars).
B. Further Adjustments
III. Fees for FY 2022
Under the FD&C Act, all submission
fees and the periodic reporting fee are
set as a percent of the standard (full) fee
for a premarket application (see 21
U.S.C. 379j(a)(2)(A)).
A. Inflation Adjustment
MDUFA specifies that the base fees of
$329,000 (premarket application) and
$4,978 (establishment registration) are
to be adjusted for FY 2022 using the
same methodology as that for the total
revenue inflation adjustment in section
II (see 21 U.S.C. 379j(c)(2)(D)(i)).
Multiplying the base fees by the
compounded inflation adjustment of
1.139385 yields inflation adjusted base
After the applicable inflation
adjustment to fees is done, FDA may
increase, if necessary to achieve the
inflation adjusted total revenue amount,
the base fee amounts on a uniform
proportionate basis (see 21 U.S.C.
379j(c)(2)(D)(ii)). If necessary, after this
adjustment, FDA may further increase
the base establishment registration fees
to generate the inflation adjusted total
revenue amount (see 21 U.S.C.
379j(c)(3)).
C. Calculation of Fee Rates
Table 3 provides the last 3 years of
fee-paying submission counts and the 3year average. These numbers are used to
project the fee-paying submission
counts that FDA will receive in FY
2022.
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TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS
FY 2018
actual
Application type
Full Fee Applications .......................................................................................
Small Business .........................................................................................
Panel-Track Supplement .................................................................................
1 The Bureau of Labor Statistics’ Announcement
of the geographical revision can be viewed at
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FY 2019
actual
38
7
23
FY 2020
actual
32
8
14
https://www.bls.gov/cpi/additional-resources/
geographic-revision-2018.htm.
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3-Year
average
30
6
22
33
7
20
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TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS—Continued
FY 2018
actual
Application type
Small Business .........................................................................................
De Novo Classification Request ......................................................................
Small Business .........................................................................................
180-Day Supplements .....................................................................................
Small Business .........................................................................................
Real-Time Supplements ..................................................................................
Small Business .........................................................................................
510(k)s .............................................................................................................
Small Business .........................................................................................
30-Day Notice ..................................................................................................
Small Business .........................................................................................
513(g) (21 U.S.C. 360c(g)) Request for Classification Information ................
Small Business .........................................................................................
Annual Fee for Periodic Reporting ..................................................................
Small Business 2 .......................................................................................
Establishment Registration ..............................................................................
The information in table 3 is
necessary to estimate the amount of
revenue that will be collected based on
the fee amounts. Table 4 displays the FY
2022 base fees set in statute (column
one) and the inflation adjusted base fees
FY 2019
actual
5
27
29
133
27
169
34
2,122
1,385
1,058
98
84
33
624
74
27,544
(per calculations in section III.A.)
(column two). Using the inflation
adjusted fees and the 3-year averages of
fee-paying submissions, collections are
projected to total $262,694,460, which is
$19,221,460 higher than the inflation
FY 2020
actual
4
12
37
124
23
213
43
2,069
1,558
925
111
75
54
629
96
27,734
6
11
18
126
21
175
29
2,049
1,667
867
105
96
57
420
68
41,409
3-Year
average
5
17
28
128
24
186
35
2,080
1,537
950
105
85
48
558
79
32,229
adjusted total revenue amount (in
section II). The fees in column two are
those we are establishing in FY 2022,
which are the standard fees.
TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2022 REVENUE TARGET
Application type
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FY 2022
Inflation adjusted
statutory
base fees
(standard fees)
FY 2022
statutory fees
(base fees)
3-Year
average of
fee-paying
submissions
FY 2022
revenue from
adjusted fees
Full Fee Applications .....................................................................
Small Business .......................................................................
Panel-Track Supplement ...............................................................
Small Business .......................................................................
De Novo Classification Request ....................................................
Small Business .......................................................................
180-Day Supplements ...................................................................
Small Business .......................................................................
Real-Time Supplements ................................................................
Small Business .......................................................................
510(k)s ...........................................................................................
Small Business .......................................................................
30-Day Notice ................................................................................
Small Business .......................................................................
513(g) Request for Classification Information ...............................
Small Business .......................................................................
Annual Fee for Periodic Reporting ................................................
Small Business .......................................................................
Establishment Registration ............................................................
$329,000
82,250
246,750
61,688
98,700
24,675
49,350
12,338
23,030
5,758
11,186
2,797
5,264
2,632
4,442
2,221
11,515
2,879
4,978
$374,858
93,714
281,143
70,286
112,457
28,114
56,229
14,057
26,240
6,560
12,745
3,186
5,998
2,999
5,061
2,530
13,120
3,280
5,672
33
7
20
5
17
28
128
24
186
35
2,080
1,537
950
105
85
48
558
79
32,229
$12,370,303
656,001
5,622,865
351,429
1,911,774
787,201
7,197,267
337,372
4,880,647
229,600
26,509,934
4,897,328
5,697,837
314,880
430,149
121,454
7,320,970
259,120
182,798,329
Total .................................................................................
..............................
..............................
........................
262,694,460
The standard fee (adjusted base
amount) for a premarket application,
including a BLA, and for a premarket
report and a BLA efficacy supplement,
is $374,858 for FY 2022. The fees set by
reference to the standard fee for a
premarket application are:
• For a panel-track supplement, 75
percent of the standard fee;
• For a de novo classification request,
30 percent of the standard fee;
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• For a 180-day supplement, 15
percent of the standard fee;
• For a real-time supplement, 7
percent of the standard fee;
• For an annual fee for periodic
reporting concerning a class III device,
3.5 percent of the standard fee;
• For a 510(k) premarket notification,
3.4 percent of the standard fee;
• For a 30-day notice, 1.6 percent of
the standard fee; and
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• For a 513(g) request for
classification information, 1.35 percent
of the standard fee.
For all submissions other than a 30day notice and a 513(g) request for
classification information, the small
business fee is 25 percent of the
standard (full) fee for the submission
(see 21 U.S.C. 379j(d)(2)(C) and
(e)(2)(C)). For a 30-day notice and a
513(g) request for classification
information, the small business fee is 50
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percent of the standard (full) fee for the
submission (see 21 U.S.C. 379j(d)(2)(C)).
The annual fee for establishment
registration, after adjustment, is set at
$5,672 for FY 2022. There is no small
business rate for the annual
establishment registration fee; all
establishments pay the same fee.
Table 5 summarizes the FY 2022 rates
for all medical device fees.
TABLE 5—MEDICAL DEVICE FEES FOR FY 2022
Standard fee
(as a percent of the standard
fee for a premarket
application)
Application fee type
Premarket application (a PMA submitted under section 515(c)(1) of the
FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of
the FD&C Act, or a BLA submitted under section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262)).
Premarket report (submitted under section 515(c)(2) of the FD&C Act) ..........
Efficacy supplement (to an approved BLA under section 351 of the PHS Act)
Panel-track supplement .....................................................................................
De novo classification request ...........................................................................
180-day supplement ...........................................................................................
Real-time supplement ........................................................................................
510(k) premarket notification submission ..........................................................
30-day notice ......................................................................................................
513(g) request for classification information ......................................................
Annual Fee Type
Annual fee for periodic reporting on a class III device ...............................
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or
processing of a device, as defined by 21 U.S.C. 379i(14)).
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IV. How To Qualify as a Small Business
for Purposes of Medical Device Fees
If your business, including your
affiliates, has gross receipts or sales of
no more than $100 million for the most
recent tax year, you may qualify for
reduced small business fees. If your
business, including your affiliates, has
gross sales or receipts of no more than
$30 million, you may also qualify for a
waiver of the fee for your first premarket
application (i.e. PMA, PDP, or BLA) or
premarket report. If you want to pay the
small business fee rate for a submission
or you want to receive a waiver of the
fee for your first premarket application
or premarket report, you should submit
the materials showing you qualify as a
small business at least 60 days before
you send your submission to FDA.
Please note that the establishment
registration fee is not eligible for a
reduced small business fee. As a result,
if the establishment registration fee is
the only medical device user fee that
you will pay in FY 2022, you should not
submit a Small Business Certification
Request. FDA will review your
information and determine whether you
qualify as a small business eligible for
the reduced fee and/or fee waiver. If you
make a submission before FDA finds
that you qualify as a small business, you
must pay the standard (full) fee for that
submission.
If your business qualified as a small
business for FY 2021, your status as a
small business will expire at the close
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$374,858
$93,714
100 ..........................................
100 ..........................................
75 ............................................
30 ............................................
15 ............................................
7 ..............................................
3.40 .........................................
1.60 .........................................
1.35 .........................................
374,858
374,858
281,143
112,457
56,229
26,240
12,745
5,998
5,061
93,714
93,714
70,286
28,114
14,057
6,560
3,186
2,999
2,530
3.50 .........................................
Base fee specified in statute ..
13,120
5,672
3,280
5,672
A. Domestic (U.S.) Businesses
If you are a domestic (U.S.) business
and wish to qualify as a small business
for FY 2022, submit the following to
FDA:
1. A completed MDUFA Small
Business Certification Request For a
Business Headquartered in the United
States (Form FDA 3602). Form FDA
3602 is provided in the FDA Forms
database: https://www.fda.gov/
downloads/AboutFDA/Reports
ManualsForms/Forms/UCM573420.pdf.
2. A signed copy of your Federal
(U.S.) Income Tax Return for the most
recent tax year. The most recent tax year
will be 2021, except:
If you submit your MDUFA Small
Business Certification Request for FY
2022 before April 15, 2022, and you
have not yet filed your return for 2021,
you may use tax year 2020.
If you submit your MDUFA Small
Business Certification Request for FY
2022 on or after April 15, 2022, and
have not yet filed your 2021 return
because you obtained an extension, you
may submit your most recent return
filed prior to the extension.
3. For each of your affiliates, either:
• If the affiliate is a domestic (U.S.)
business, a signed copy of the affiliate’s
Federal (U.S.) Income Tax Return for the
most recent tax year, or
Frm 00048
Fmt 4703
FY 2022
small business
fee
Base fee specified in statute ..
of business on September 30, 2021. You
must re-qualify for FY 2022 in order to
pay small business fees during FY 2022.
PO 00000
FY 2022
standard fee
Sfmt 4703
• If the affiliate is a foreign business
and cannot submit a Federal (U.S.)
Income Tax Return, a National Taxing
Authority Certification completed by,
and bearing the official seal of, the
National Taxing Authority of the
country in which the firm is
headquartered. The National Taxing
Authority is the foreign equivalent of
the U.S. Internal Revenue Service. This
certification must show the amount of
gross receipts or sales for the most
recent tax year, in both U.S. dollars and
the local currency of the country, the
exchange rate used in converting the
local currency to U.S. dollars, and the
dates of the gross receipts or sales
collected. The business must also
submit a statement signed by the head
of the business’s firm or by its chief
financial officer that the business has
submitted certifications for all of its
affiliates, identifying the name of each
affiliate, or that the business has no
affiliates.
B. Foreign Businesses
If you are a foreign business, and wish
to qualify as a small business for FY
2022, submit the following:
1. A completed MDUFA Foreign
Small Business Certification Request
For a Business Headquartered Outside
the United States (Form FDA 3602A).
Form FDA 3602A is provided in the
FDA Forms database: https://
www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM573423.pdf.
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2. A National Taxing Authority
Certification, completed by, and bearing
the official seal of, the National Taxing
Authority of the country in which the
firm is headquartered. This certification
must show the amount of gross receipts
or sales for the most recent tax year, in
both U.S. dollars and the local currency
of the country, the exchange rate used
in converting the local currency to U.S.
dollars, and the dates of the gross
receipts or sales collected.
3. For each of your affiliates, either:
• If the affiliate is a domestic (U.S.)
business, a signed copy of the affiliate’s
Federal (U.S.) Income Tax Return for the
most recent tax year (2021 or later), or
• If the affiliate is a foreign business
and cannot submit a Federal (U.S.)
Income Tax Return, a National Taxing
Authority Certification completed by,
and bearing the official seal of, the
National Taxing Authority of the
country in which the firm is
headquartered. The National Taxing
Authority is the foreign equivalent of
the U.S. Internal Revenue Service. This
certification must show the amount of
gross receipts or sales for the most
recent tax year, in both U.S. dollars and
the local currency of the country, the
exchange rate used in converting the
local currency to U.S. dollars, and the
dates for the gross receipts or sales
collected. The business must also
submit a statement signed by the head
of the business’s firm or by its chief
financial officer that the applicant has
submitted certifications for all of its
affiliates, identifying the name of each
affiliate, or that the business has no
affiliates.
V. Procedures for Paying Application
Fees
If your application or submission is
subject to a fee and your payment is
received by FDA between October 1,
2021, and September 30, 2022, you must
pay the fee in effect for FY 2022. To
avoid delay in the review of your
application, you should pay the
application fee before or at the time you
submit your application to FDA. The
later of the date that the application is
received in the reviewing center’s
document room or the date the U.S.
Treasury recognizes the payment
determines whether the fee rates for FY
2021 or FY 2022 apply. FDA must
receive the correct fee at the time that
an application is submitted, or the
application will not be accepted for
filing or review.
FDA requests that you follow the
steps below before submitting a medical
device application subject to a fee to
ensure that FDA links the fee with the
correct application. (Note: Do not send
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Jkt 253001
your user fee check to FDA with the
application.)
A. Secure a Payment Identification
Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before
Submitting Either the Application or the
Payment
Log into the User Fee System at:
https://userfees.fda.gov/OA_HTML/
mdufmaCAcdLogin.jsp. Complete the
Medical Device User Fee cover sheet. Be
sure you choose the correct application
submission date range. (Two choices
will be offered until October 1, 2021.
One choice is for applications and fees
that will be received on or before
September 30, 2021, which are subject
to FY 2021 fee rates. A second choice
is for applications and fees received on
or after October 1, 2021, which are
subject to FY 2022 fee rates.) After
completing data entry, print a copy of
the Medical Device User Fee cover sheet
and note the unique PIN located in the
upper right-hand corner of the printed
cover sheet.
B. Electronically Transmit a Copy of the
Printed Cover Sheet With the PIN
When you are satisfied that the data
on the cover sheet is accurate,
electronically transmit that data to FDA
according to instructions on the screen.
Applicants are required to set up a user
account and password to assure data
security in the creation and electronic
submission of cover sheets.
C. Submit Payment for the Completed
Medical Device User Fee Cover Sheet
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). FDA has partnered with the
U.S. Department of the Treasury to
utilize Pay.gov, a web-based payment
system, for online electronic payment.
You may make a payment via electronic
check or credit card after submitting
your cover sheet. 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, select ‘‘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 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.
2. If paying with a paper check:
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41481
• All paper checks must be in U.S.
currency from a U.S. bank and made
payable to the Food and Drug
Administration. If needed, FDA’s tax
identification number is 53–0196965.
• Please write your application’s
unique PIN (from the upper right-hand
corner of your completed Medical
Device User Fee cover sheet) on your
check.
• Mail the paper check and a copy of
the completed cover sheet to: Food and
Drug Administration, P.O. Box 979033,
St. Louis, MO 63197–9000. (Please note
that this address is for payments of
application and annual report fees only
and is not to be used for payment of
annual establishment registration fees.)
If you prefer to send a check by a
courier, the courier may deliver the
check to: U.S. Bank, Attn: Government
Lockbox 979033, 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 U.S.
Bank at 314–418–4013. This telephone
number is only for questions about
courier delivery.)
3. If paying with a wire transfer:
• Please include your application’s
unique PIN (from the upper right-hand
corner of your completed Medical
Device User Fee cover sheet) in your
wire transfer. Without the PIN, your
payment may not be applied to your
cover sheet and review of your
application may be delayed.
• The originating financial institution
may charge a wire transfer fee. If the
financial institution charges a wire
transfer fee it is required that you 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. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.
75060099, Routing No. 021030004,
SWIFT: FRNYUS33.
FDA records the official application
receipt date as the later of the following:
(1) The date the application was
received by the FDA Document Control
Center for the reviewing Center or (2)
the date the U.S. Treasury recognizes
the payment. It is helpful if the fee
arrives at the bank at least 1 day before
the application arrives at FDA.
D. Submit Your Application to FDA
With a Copy of the Completed Medical
Device User Fee Cover Sheet
Please submit your application and a
copy of the completed Medical Device
User Fee cover sheet to the address
located at https://www.fda.gov/
cdrhsubmissionaddress.
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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
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VI. Procedures for Paying the Annual
Fee for Periodic Reporting
You will be invoiced at the end of the
quarter in which your PMA Periodic
Report is due. Invoices will be sent
based on the details included on your
PMA file. You are responsible for
ensuring FDA has your current billing
information, and you may update your
contact information for the PMA by
submitting an amendment to the
pending PMA or a supplement to the
approved PMA.
1. The preferred payment method is
online using electronic check (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, select ‘‘Pay
Now’’ to be redirected to Pay.gov. Note
that 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.
2. If paying with a paper check:
The check must be in U.S. currency
from a U.S. bank and made payable to
the Food and Drug Administration. If
needed, FDA’s tax identification
number is 53–0196965.
• Please write your invoice number
on the check.
• Mail the paper check and a copy of
the invoice to: Food and Drug
Administration, P.O. Box 979033, St.
Louis, MO 63197–9000. (Please note
that this address is for payments of
application and annual report fees only
and is not to be used for payment of
annual establishment registration fees.)
To send a check by a courier, the
courier must deliver the check and
printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox
979033, 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 U.S. Bank at
314–418–4013. This telephone number
is only for questions about courier
delivery).
3. When paying by a wire transfer, it
is required that the invoice number is
included; without the invoice number
the payment may not be applied. If the
payment amount is not applied, the
invoice amount would be referred to
collections. The originating financial
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Jkt 253001
institution may charge a wire transfer
fee. If the financial institution charges a
wire transfer fee, it is required that you
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. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.
75060099, Routing No. 021030004,
SWIFT: FRNYUS33.
VII. Procedures for Paying Annual
Establishment Registration Fees
To pay the annual establishment
registration fee, firms must access the
Device Facility User Fee (DFUF) website
at https://userfees.fda.gov/OA_HTML/
furls.jsp. (FDA has verified the website
address, but FDA is not responsible for
any subsequent changes to the website
address after this document publishes in
the Federal Register.) Create a DFUF
order and you will be issued a PIN
when you place your order. After
payment has been processed, you will
be issued a payment confirmation
number (PCN). You will not be able to
register your establishment if you do not
have a PIN and a PCN. An establishment
required to pay an annual establishment
registration fee is not legally registered
in FY 2022 until it has completed the
steps below to register and pay any
applicable fee (see 21 U.S.C. 379j(f)(2)).
Companies that do not manufacture
any product other than a licensed
biologic are required to register in the
Blood Establishment Registration (BER)
system. FDA’s Center for Biologics
Evaluation and Research (CBER) will
send establishment registration fee
invoices annually to these companies.
A. Submit a DFUF Order With a PIN
From FDA Before Registering or
Submitting Payment
To submit a DFUF Order, you must
create or have previously created a user
account and password for the user fee
website listed previously in this section.
After creating a user name and
password, log into the Establishment
Registration User Fee FY 2022 store.
Complete the DFUF order by entering
the number of establishments you are
registering that require payment. When
you are satisfied that the information in
the order is accurate, electronically
transmit that data to FDA according to
instructions on the screen. Print a copy
of the final DFUF order and note the
unique PIN located in the upper righthand corner of the printed order.
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B. Pay for Your DFUF Order
Unless paying by U.S. credit card, all
payments must be in U. S. currency and
drawn on a U.S. bank.
1. If paying by credit card or
electronic check (ACH or eCheck):
The DFUF order will include payment
information, including details on how
you can pay online using a credit card
or electronic check. Follow the
instructions provided to make an
electronic payment.
2. If paying with a paper check:
The check must be in U.S. currency
and drawn on a U.S. bank, and mailed
to: Food and Drug Administration, P.O.
Box 979108, St. Louis, MO 63197–9000.
(Note: This address is different from the
address for payments of application and
annual report fees and is to be used only
for payment of annual establishment
registration fees.)
If a check is sent by a courier that
requests a street address, the courier can
deliver the check to: U.S. Bank, Attn:
Government Lockbox 979108, 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 U.S. Bank at 314–418–4013.
This telephone number is only for
questions about courier delivery.)
Please make sure that both of the
following are written on your check: (1)
The FDA post office box number (P.O.
Box 979108) and (2) the PIN that is
printed on your order. Include a copy of
your printed order when you mail your
check.
3. If paying with a wire transfer:
Wire transfers may also be used to pay
annual establishment registration fees.
To send a wire transfer, please read and
comply with the following information:
Include your order’s unique PIN (in
the upper right-hand corner of your
completed DFUF order) in your wire
transfer. Without the PIN, your payment
may not be applied to your facility and
your registration may be delayed.
The originating financial institution
may charge a wire transfer fee. If the
financial institution charges a wire
transfer fee, it is required that you 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.
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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
C. Complete the Information Online To
Update Your Establishment’s Annual
Registration for FY 2022, or To Register
a New Establishment for FY 2022
Go to the Center for Devices and
Radiological Health’s website at https://
www.fda.gov/medical-devices/howstudy-and-market-your-device/deviceregistration-and-listing and click the
‘‘Access Electronic Registration’’ link on
the left side of the page. This opens up
a new page with important information
about the FDA Unified Registration and
Listing System (FURLS). After reading
this information, click on the ‘‘Access
Electronic Registration’’ link in the
middle of the page. This link takes you
to an FDA Industry Systems page with
tutorials that demonstrate how to create
a new FURLS user account, if your
establishment did not create an account
in FY 2021. Manufacturers of licensed
biologics should register in the BER
system at https://www.fda.gov/vaccinesblood-biologics/guidance-complianceregulatory-information-biologics/
biologics-establishment-registration.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
click on the Device Registration and
Listing Module (DRLM) of FURLS
button. New establishments will need to
register and existing establishments will
update their annual registration using
choices on the DRLM menu. When you
choose to register or update your annual
registration, the system will prompt you
through the entry of information about
your establishment and your devices. If
you have any problems with this
process, email: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
This email address and this telephone
number are for assistance with
establishment registration only; they are
not to be used for questions related to
other aspects of medical device user
fees.) Problems with the BER system
should be directed to https://
www.accessdata.fda.gov/scripts/email/
cber/bldregcontact.cfm or call 240–402–
8360.
khammond on DSKJM1Z7X2PROD with NOTICES
D. Enter Your DFUF Order PIN and PCN
After completing your annual or
initial registration and device listing,
you will be prompted to enter your
DFUF order PIN and PCN, when
applicable. This process does not apply
to establishments engaged only in the
manufacture, preparation, propagation,
compounding, or processing of licensed
biologic devices. CBER will send
invoices for payment of the
establishment registration fee to such
establishments.
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Jkt 253001
Dated: July 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16408 Filed 7–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0658]
Vithal K. Patel; Denial of Hearing; Final
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying a
request for a hearing submitted by
Vithal K. Patel (Mr. Patel) and issuing
an order under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) debarring
Mr. Patel for 1 year from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Mr. Patel was
convicted of conspiracy to commit a
felony under Federal law for conduct
relating to the regulation of drug
products under the FD&C Act and that
the type of conduct underlying the
conviction undermined the process for
the regulation of drugs. In determining
the appropriateness and period of Mr.
Patel’s debarment, FDA considered the
relevant factors listed in the FD&C Act.
Mr. Patel has failed to file with the
Agency information and analyses
sufficient to create a basis for a hearing
concerning this action.
DATES: This order is applicable August
2, 2021.
ADDRESSES: Any application for
termination of debarment by Mr. Patel
under section 306(d) of the FD&C Act
(application) may be submitted as
follows:
SUMMARY:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
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41483
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
application, that information will be
posted on https://www.regulations.gov.
• If you want to submit an
application with confidential
information that you do not wish to be
made available to the public, submit the
application as a written/paper
submission and in the manner detailed
(see ‘‘Written/Paper Submissions’’ and
‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For a written/paper application
submitted to the Dockets Management
Staff, FDA will post your application, as
well as any attachments, except for
information submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All applications must
include the Docket No. FDA–2011–N–
0658. Received applications will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit an application with confidential
information that you do not wish to be
made publicly available, submit your
application only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of your application.
The second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your application and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41477-41483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16408]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0659]
Medical Device User Fee Rates for Fiscal Year 2022
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV),
authorizes FDA to collect user fees for certain medical device
submissions and annual fees both for certain periodic reports and for
establishments subject to registration. This notice establishes the fee
rates for FY 2022, which apply from October 1, 2021, through September
30, 2022, and provides information on how the fees for FY 2022 were
determined, the payment procedures you should follow, and how you may
qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device User Fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
For questions relating to the MDUFA Small Business Program, please
visit the Center for Devices and Radiological Health's website: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program.
For questions relating to this notice: Andrew Bank, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 62019A, Beltsville, MD 20705, 301-796-0292.
SUPPLEMENTARY INFORMATION:
I. Background
Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for
certain medical device applications, submissions, supplements, notices,
and requests (for simplicity, this document refers to these
collectively as ``submissions'' or ``applications''); for periodic
reporting on class III devices; and for the registration of certain
establishments. Under statutorily defined conditions, a qualified
applicant may receive a fee waiver or may pay a lower small business
fee (see 21 U.S.C. 379j(d) and (e)).
Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2018 through FY 2022; the
base fee for a premarket application received by FDA during FY 2022 is
$329,000. From this starting point, this document establishes FY 2022
fee rates for certain types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
The FD&C Act specifies the base fee for establishment registration
for each year from FY 2018 through FY 2022; the base fee for an
establishment registration in FY 2022 is $4,978. There is no reduction
in the registration fee for small businesses. Each establishment that
is registered (or is required to register) with the Secretary of Health
and Human Services under section 510 of the FD&C Act (21 U.S.C. 360)
because such establishment is engaged in the manufacture, preparation,
propagation, compounding, or processing of a device is required to pay
the annual fee for establishment registration.
II. Revenue Amount for FY 2022
The total revenue amount for FY 2022 is $213,687,660, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). MDUFA directs FDA to use the yearly total revenue amount
as a starting point to set the standard fee rates for each fee type.
The fee calculations for FY 2022 are described in this document.
Inflation Adjustment
MDUFA specifies that the $213,687,660 is to be adjusted for
inflation increases for FY 2022 using two separate adjustments--one for
payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)).
The base inflation adjustment for FY 2022 is the sum of one plus the
two separate adjustments and is compounded as specified in the statute
(see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).
The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all personnel compensation
and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
Table 1 summarizes the actual cost and FTE data for the specified
FYs, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2022.
The 3-year average is 2.7383 percent (rounded).
[[Page 41478]]
Table 1--FDA PC&Bs 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 FTE....................... 17,023 17,144 17,535 ..................
PC&B per FTE.................... $158,061 $152,826 $163,992 ..................
Percent change from previous 4.2206% -3.3120% 7.3063% 2.7383%
year...........................
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.7383 percent multiplied by 60 percent,
or 1.6430 percent. The statute specifies that the component of the
inflation adjustment for non-payroll 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 0.40, or 40 percent (see 21
U.S.C. 379j(c)(2)(C)). 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 has been used
since FY 2020 and will be used in calculating the relevant adjustment
factors for FY 2022 and subsequent years.
---------------------------------------------------------------------------
\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 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Washington-Arlington-Alexandria
area. These data are published by the Bureau of Labor Statistics and
can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.
Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
----------------------------------------------------------------------------------------------------------------
Fiscal year 2018 2019 2020 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................... 261.445 264.777 267.157 ..................
Annual Percent Change........... 2.0389% 1.2745% 0.8989% ..................
3-Year Average Percent Change in .................. .................. .................. 1.4041%
CPI............................
----------------------------------------------------------------------------------------------------------------
The non-payroll adjustment is 1.4041 percent multiplied by 40
percent, or 0.5616 percent. Next, the payroll adjustment (1.6430
percent or 0.016430) is added to the non-payroll adjustment (0.5616
percent or .005616), for a total of 2.2046 percent (or 0.022046). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.022046 for FY 2022.
MDUFA IV provides for this inflation adjustment to be compounded
for FY 2022 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2022, the FY 2021 compounded adjustment (1.114808) is multiplied by
the FY 2022 base inflation adjustment (1.022046) to reach the
applicable inflation adjustment of 1.139385 (rounded) for FY 2022. We
then multiply the total revenue amount for FY 2022 ($213,687,660) by
1.139385, yielding an inflation adjusted total revenue amount of
$243,473,000 (rounded to the nearest thousand dollars).
III. Fees for FY 2022
Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A)).
A. Inflation Adjustment
MDUFA specifies that the base fees of $329,000 (premarket
application) and $4,978 (establishment registration) are to be adjusted
for FY 2022 using the same methodology as that for the total revenue
inflation adjustment in section II (see 21 U.S.C. 379j(c)(2)(D)(i)).
Multiplying the base fees by the compounded inflation adjustment of
1.139385 yields inflation adjusted base fees of $374,858 (premarket
application) and $5,672 (establishment registration).
B. Further Adjustments
After the applicable inflation adjustment to fees is done, FDA may
increase, if necessary to achieve the inflation adjusted total revenue
amount, the base fee amounts on a uniform proportionate basis (see 21
U.S.C. 379j(c)(2)(D)(ii)). If necessary, after this adjustment, FDA may
further increase the base establishment registration fees to generate
the inflation adjusted total revenue amount (see 21 U.S.C. 379j(c)(3)).
C. Calculation of Fee Rates
Table 3 provides the last 3 years of fee-paying submission counts
and the 3-year average. These numbers are used to project the fee-
paying submission counts that FDA will receive in FY 2022.
Table 3--Three-Year Average of Fee-Paying Submissions
----------------------------------------------------------------------------------------------------------------
FY 2018 FY 2019 FY 2020
Application type actual actual actual 3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... 38 32 30 33
Small Business.............................. 7 8 6 7
Panel-Track Supplement.......................... 23 14 22 20
[[Page 41479]]
Small Business.............................. 5 4 6 5
De Novo Classification Request.................. 27 12 11 17
Small Business.............................. 29 37 18 28
180-Day Supplements............................. 133 124 126 128
Small Business.............................. 27 23 21 24
Real-Time Supplements........................... 169 213 175 186
Small Business.............................. 34 43 29 35
510(k)s......................................... 2,122 2,069 2,049 2,080
Small Business.............................. 1,385 1,558 1,667 1,537
30-Day Notice................................... 1,058 925 867 950
Small Business.............................. 98 111 105 105
513(g) (21 U.S.C. 360c(g)) Request for 84 75 96 85
Classification Information.....................
Small Business.............................. 33 54 57 48
Annual Fee for Periodic Reporting............... 624 629 420 558
Small Business \2\.......................... 74 96 68 79
Establishment Registration...................... 27,544 27,734 41,409 32,229
----------------------------------------------------------------------------------------------------------------
The information in table 3 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 4
displays the FY 2022 base fees set in statute (column one) and the
inflation adjusted base fees (per calculations in section III.A.)
(column two). Using the inflation adjusted fees and the 3-year averages
of fee-paying submissions, collections are projected to total
$262,694,460, which is $19,221,460 higher than the inflation adjusted
total revenue amount (in section II). The fees in column two are those
we are establishing in FY 2022, which are the standard fees.
Table 4--Fees Needed To Achieve New FY 2022 Revenue Target
----------------------------------------------------------------------------------------------------------------
FY 2022 Inflation
adjusted 3-Year average FY 2022 revenue
Application type FY 2022 statutory statutory base of fee-paying from adjusted
fees (base fees) fees (standard submissions fees
fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications.................. $329,000 $374,858 33 $12,370,303
Small Business..................... 82,250 93,714 7 656,001
Panel-Track Supplement................. 246,750 281,143 20 5,622,865
Small Business..................... 61,688 70,286 5 351,429
De Novo Classification Request......... 98,700 112,457 17 1,911,774
Small Business..................... 24,675 28,114 28 787,201
180-Day Supplements.................... 49,350 56,229 128 7,197,267
Small Business..................... 12,338 14,057 24 337,372
Real-Time Supplements.................. 23,030 26,240 186 4,880,647
Small Business..................... 5,758 6,560 35 229,600
510(k)s................................ 11,186 12,745 2,080 26,509,934
Small Business..................... 2,797 3,186 1,537 4,897,328
30-Day Notice.......................... 5,264 5,998 950 5,697,837
Small Business..................... 2,632 2,999 105 314,880
513(g) Request for Classification 4,442 5,061 85 430,149
Information...........................
Small Business..................... 2,221 2,530 48 121,454
Annual Fee for Periodic Reporting...... 11,515 13,120 558 7,320,970
Small Business..................... 2,879 3,280 79 259,120
Establishment Registration............. 4,978 5,672 32,229 182,798,329
------------------------------------------------------------------------
Total.......................... ................. ................. .............. 262,694,460
----------------------------------------------------------------------------------------------------------------
The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $374,858 for FY 2022. The fees set by reference
to the standard fee for a premarket application are:
For a panel-track supplement, 75 percent of the standard
fee;
For a de novo classification request, 30 percent of the
standard fee;
For a 180-day supplement, 15 percent of the standard fee;
For a real-time supplement, 7 percent of the standard fee;
For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee;
For a 510(k) premarket notification, 3.4 percent of the
standard fee;
For a 30-day notice, 1.6 percent of the standard fee; and
For a 513(g) request for classification information, 1.35
percent of the standard fee.
For all submissions other than a 30-day notice and a 513(g) request
for classification information, the small business fee is 25 percent of
the standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C)). For a 30-day notice and a 513(g) request for
classification information, the small business fee is 50
[[Page 41480]]
percent of the standard (full) fee for the submission (see 21 U.S.C.
379j(d)(2)(C)).
The annual fee for establishment registration, after adjustment, is
set at $5,672 for FY 2022. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 5 summarizes the FY 2022 rates for all medical device fees.
Table 5--Medical Device Fees for FY 2022
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of
Application fee type the standard fee for a FY 2022 FY 2022 small
premarket application) standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Base fee specified in statute... $374,858 $93,714
section 515(c)(1) of the FD&C Act (21 U.S.C.
360e(c)(1)), a PDP submitted under section
515(f) of the FD&C Act, or a BLA submitted
under section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262)).
Premarket report (submitted under section 100............................. 374,858 93,714
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under 100............................. 374,858 93,714
section 351 of the PHS Act).
Panel-track supplement........................ 75.............................. 281,143 70,286
De novo classification request................ 30.............................. 112,457 28,114
180-day supplement............................ 15.............................. 56,229 14,057
Real-time supplement.......................... 7............................... 26,240 6,560
510(k) premarket notification submission...... 3.40............................ 12,745 3,186
30-day notice................................. 1.60............................ 5,998 2,999
513(g) request for classification information. 1.35............................ 5,061 2,530
Annual Fee Type
Annual fee for periodic reporting on a 3.50............................ 13,120 3,280
class III device.
Annual establishment registration fee (to be Base fee specified in statute... 5,672 5,672
paid by the establishment engaged in the
manufacture, preparation, propagation,
compounding, or processing of a device, as
defined by 21 U.S.C. 379i(14)).
----------------------------------------------------------------------------------------------------------------
IV. How To Qualify as a Small Business for Purposes of Medical Device
Fees
If your business, including your affiliates, has gross receipts or
sales of no more than $100 million for the most recent tax year, you
may qualify for reduced small business fees. If your business,
including your affiliates, has gross sales or receipts of no more than
$30 million, you may also qualify for a waiver of the fee for your
first premarket application (i.e. PMA, PDP, or BLA) or premarket
report. If you want to pay the small business fee rate for a submission
or you want to receive a waiver of the fee for your first premarket
application or premarket report, you should submit the materials
showing you qualify as a small business at least 60 days before you
send your submission to FDA. Please note that the establishment
registration fee is not eligible for a reduced small business fee. As a
result, if the establishment registration fee is the only medical
device user fee that you will pay in FY 2022, you should not submit a
Small Business Certification Request. FDA will review your information
and determine whether you qualify as a small business eligible for the
reduced fee and/or fee waiver. If you make a submission before FDA
finds that you qualify as a small business, you must pay the standard
(full) fee for that submission.
If your business qualified as a small business for FY 2021, your
status as a small business will expire at the close of business on
September 30, 2021. You must re-qualify for FY 2022 in order to pay
small business fees during FY 2022.
A. Domestic (U.S.) Businesses
If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2022, submit the following to FDA:
1. A completed MDUFA Small Business Certification Request For a
Business Headquartered in the United States (Form FDA 3602). Form FDA
3602 is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573420.pdf.
2. A signed copy of your Federal (U.S.) Income Tax Return for the
most recent tax year. The most recent tax year will be 2021, except:
If you submit your MDUFA Small Business Certification Request for
FY 2022 before April 15, 2022, and you have not yet filed your return
for 2021, you may use tax year 2020.
If you submit your MDUFA Small Business Certification Request for
FY 2022 on or after April 15, 2022, and have not yet filed your 2021
return because you obtained an extension, you may submit your most
recent return filed prior to the extension.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year, or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The business must also submit a
statement signed by the head of the business's firm or by its chief
financial officer that the business has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the business has no affiliates.
B. Foreign Businesses
If you are a foreign business, and wish to qualify as a small
business for FY 2022, submit the following:
1. A completed MDUFA Foreign Small Business Certification Request
For a Business Headquartered Outside the United States (Form FDA
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573423.pdf.
[[Page 41481]]
2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority of the
country in which the firm is headquartered. This certification must
show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year (2021 or later), or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The business must also
submit a statement signed by the head of the business's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the business has no affiliates.
V. Procedures for Paying Application Fees
If your application or submission is subject to a fee and your
payment is received by FDA between October 1, 2021, and September 30,
2022, you must pay the fee in effect for FY 2022. To avoid delay in the
review of your application, you should pay the application fee before
or at the time you submit your application to FDA. The later of the
date that the application is received in the reviewing center's
document room or the date the U.S. Treasury recognizes the payment
determines whether the fee rates for FY 2021 or FY 2022 apply. FDA must
receive the correct fee at the time that an application is submitted,
or the application will not be accepted for filing or review.
FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: Do not send your user fee
check to FDA with the application.)
A. Secure a Payment Identification Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before Submitting Either the Application or
the Payment
Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet.
Be sure you choose the correct application submission date range. (Two
choices will be offered until October 1, 2021. One choice is for
applications and fees that will be received on or before September 30,
2021, which are subject to FY 2021 fee rates. A second choice is for
applications and fees received on or after October 1, 2021, which are
subject to FY 2022 fee rates.) After completing data entry, print a
copy of the Medical Device User Fee cover sheet and note the unique PIN
located in the upper right-hand corner of the printed cover sheet.
B. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN
When you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Applicants are required to set up a user
account and password to assure data security in the creation and
electronic submission of cover sheets.
C. Submit Payment for the Completed Medical Device User Fee Cover Sheet
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). FDA has partnered with
the U.S. Department of the Treasury to utilize Pay.gov, a web-based
payment system, for online electronic payment. You may make a payment
via electronic check or credit card after submitting your cover sheet.
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, select ``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 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.
2. If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. If needed, FDA's
tax identification number is 53-0196965.
Please write your application's unique PIN (from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet) on your check.
Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 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 U.S. Bank at 314-418-4013. This telephone number is
only for questions about courier delivery.)
3. If paying with a wire transfer:
Please include your application's unique PIN (from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet) in your wire transfer. Without the PIN, your payment may not be
applied to your cover sheet and review of your application may be
delayed.
The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee
it is required that you 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. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
FDA records the official application receipt date as the later of
the following: (1) The date the application was received by the FDA
Document Control Center for the reviewing Center or (2) the date the
U.S. Treasury recognizes the payment. It is helpful if the fee arrives
at the bank at least 1 day before the application arrives at FDA.
D. Submit Your Application to FDA With a Copy of the Completed Medical
Device User Fee Cover Sheet
Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to the address located at https://www.fda.gov/cdrhsubmissionaddress.
[[Page 41482]]
VI. Procedures for Paying the Annual Fee for Periodic Reporting
You will be invoiced at the end of the quarter in which your PMA
Periodic Report is due. Invoices will be sent based on the details
included on your PMA file. You are responsible for ensuring FDA has
your current billing information, and you may update your contact
information for the PMA by submitting an amendment to the pending PMA
or a supplement to the approved PMA.
1. The preferred payment method is online using electronic check
(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, select ``Pay Now'' to be
redirected to Pay.gov. Note that 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.
2. If paying with a paper check:
The check must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. If needed, FDA's tax
identification number is 53-0196965.
Please write your invoice number on the check.
Mail the paper check and a copy of the invoice to: Food
and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
(Please note that this address is for payments of application and
annual report fees only and is not to be used for payment of annual
establishment registration fees.)
To send a check by a courier, the courier must deliver the check
and printed copy of the cover sheet to: U.S. Bank, Attn: Government
Lockbox 979033, 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 U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery).
3. When paying by a wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. If the payment amount is not applied, 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 that you 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. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
VII. Procedures for Paying Annual Establishment Registration Fees
To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website address after this document publishes in the Federal Register.)
Create a DFUF order and you will be issued a PIN when you place your
order. After payment has been processed, you will be issued a payment
confirmation number (PCN). You will not be able to register your
establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2022 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(f)(2)).
Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.
A. Submit a DFUF Order With a PIN From FDA Before Registering or
Submitting Payment
To submit a DFUF Order, you must create or have previously created
a user account and password for the user fee website listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2022 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. When you are satisfied that the information in the
order is accurate, electronically transmit that data to FDA according
to instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.
B. Pay for Your DFUF Order
Unless paying by U.S. credit card, all payments must be in U. S.
currency and drawn on a U.S. bank.
1. If paying by credit card or electronic check (ACH or eCheck):
The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic check.
Follow the instructions provided to make an electronic payment.
2. If paying with a paper check:
The check must be in U.S. currency and drawn on a U.S. bank, and
mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO
63197-9000. (Note: This address is different from the address for
payments of application and annual report fees and is to be used only
for payment of annual establishment registration fees.)
If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979108, 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 U.S. Bank at 314-418-4013. This
telephone number is only for questions about courier delivery.)
Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 979108) and (2) the
PIN that is printed on your order. Include a copy of your printed order
when you mail your check.
3. If paying with a wire transfer:
Wire transfers may also be used to pay annual establishment
registration fees. To send a wire transfer, please read and comply with
the following information:
Include your order's unique PIN (in the upper right-hand corner of
your completed DFUF order) in your wire transfer. Without the PIN, your
payment may not be applied to your facility and your registration may
be delayed.
The originating financial institution may charge a wire transfer
fee. If the financial institution charges a wire transfer fee, it is
required that you 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 41483]]
C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2022, or To Register a New Establishment for
FY 2022
Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing and click the ``Access Electronic
Registration'' link on the left side of the page. This opens up a new
page with important information about the FDA Unified Registration and
Listing System (FURLS). After reading this information, click on the
``Access Electronic Registration'' link in the middle of the page. This
link takes you to an FDA Industry Systems page with tutorials that
demonstrate how to create a new FURLS user account, if your
establishment did not create an account in FY 2021. Manufacturers of
licensed biologics should register in the BER system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register and existing establishments will update their annual
registration using choices on the DRLM menu. When you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
[email protected] or call 301-796-7400 for assistance. (Note: This
email address and this telephone number are for assistance with
establishment registration only; they are not to be used for questions
related to other aspects of medical device user fees.) Problems with
the BER system should be directed to https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call 240-402-8360.
D. Enter Your DFUF Order PIN and PCN
After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.
Dated: July 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16408 Filed 7-30-21; 8:45 am]
BILLING CODE 4164-01-P
