[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46673-46679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16793]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3505]
Medical Device User Fee Rates for Fiscal Year 2021
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) 2021. 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 2021, which apply from October 1, 2020, through September
30, 2021. 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 fee you must pay is the fee that is in effect
on the later of the date that your application is received by FDA or
the date your fee payment is recognized by the U.S. Treasury. If you
want to pay a reduced small business fee, you must qualify as a small
business before making your submission to FDA; if you do not qualify as
a small business before making your submission to FDA, you will have to
pay the higher standard fee. Please note that the establishment
registration fee is not eligible for a
[[Page 46674]]
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 2021, you should not submit a Small Business Certification
Request. This document provides information on how the fees for FY 2021
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: David Haas, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 62041A, Beltsville, MD 20705, 240-402-9845.
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 2021 is
$328,000. From this starting point, this document establishes FY 2021
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 2021 is $4,975. 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 2021
The total revenue amount for FY 2021 is $211,748,789, 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 2021 are described in this document.
Inflation Adjustment
MDUFA specifies that the $211,748,789 is to be adjusted for
inflation increases for FY 2021 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 2021 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 2021.
The 3-year average is 1.2644 percent (rounded).
Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2017 2018 2019 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $2,581,551,000 $2,690,678,000 $2,620,052,000 .................
Total FTE........................... 17,022 17,023 17,144 .................
PC&B per FTE........................ $151,660 $158,061 $152,826 .................
Percent change from previous year... 2.8845 4.2206 -3.3120 1.2644
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 1.2644 percent multiplied by 60 percent,
or 0.7586 percent. The statute specifies that the component of the
inflation adjustment for non-payroll costs for FY 2021 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 will be used
in calculating the relevant adjustment factors for FY 2021 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.
[[Page 46675]]
Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
----------------------------------------------------------------------------------------------------------------
Fiscal year 2017 2018 2019 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................... 256.221 261.445 264.777 ..............
Annual Percent Change........................... 1.1045 2.0389 1.2745 ..............
3-Year Average Percent Change in CPI............ .............. .............. .............. 1.4726
----------------------------------------------------------------------------------------------------------------
The non-payroll adjustment is 1.4726 percent multiplied by 40
percent, or 0.5890 percent. Next, the payroll adjustment (0.7586
percent or 0.007586) is added to the non-payroll adjustment (0.5890
percent or .005890), for a total of 1.3476 percent (or 0.013476). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.013476 for FY 2021.
MDUFA IV provides for this inflation adjustment to be compounded
for FY 2021 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2021, the FY 2020 compounded adjustment (1.099985) is multiplied by
the FY 2021 base inflation adjustment (1.013476) to reach the
applicable inflation adjustment of 1.114808 (rounded) for FY 2021. We
then multiply the total revenue amount for FY 2021 ($211,748,789) by
1.114808, yielding an inflation adjusted total revenue amount of
$236,059,000 (rounded to the nearest thousand dollars).
III. Fees for FY 2021
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 $328,000 (premarket
application) and $4,975 (establishment registration) are to be adjusted
for FY 2021 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
1.114808 yields inflation adjusted base fees of $365,657 (premarket
application) and $5,546 (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 2021.
Table 3--Three-Year Average of Fee-Paying Submissions
----------------------------------------------------------------------------------------------------------------
FY 2017 FY 2018 FY 2019 3-Year
Application type actual actual actual average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... 37 38 32 36
Small Business.............................. 6 7 8 7
Panel-Track Supplement.......................... 22 23 14 20
Small Business.............................. 2 5 4 4
De Novo Classification Request \1\.............. .............. 27 12 20
Small Business \1\.......................... .............. 29 37 33
180-Day Supplements............................. 167 133 124 141
Small Business.............................. 33 27 23 28
Real-Time Supplements........................... 187 169 213 190
Small Business.............................. 19 34 43 32
510(k)s......................................... 2,969 2,122 2,069 2,387
Small Business.............................. 1,072 1,385 1,558 1,338
30-Day Notice................................... 998 1,058 925 994
Small Business.............................. 78 98 111 96
513(g) (21 U.S.C. 360c(g)) Request for 93 84 75 84
Classification Information.....................
Small Business.............................. 41 33 54 43
Annual Fee for Periodic Reporting \2\........... 618 624 629 624
Small Business \2\.......................... 57 74 96 76
Establishment Registration...................... 27,115 27,544 27,734 27,464
----------------------------------------------------------------------------------------------------------------
\1\ Two-year average for De Novo is based on actuals from available data.
\2\ Includes collection of quarter 4 billing for FY 2019 during FY 2020.
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 2021 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
$236,842,961, which is $783,961 higher than the inflation adjusted
total revenue amount (in section II). The fees in column two are those
we are establishing in FY 2021, which are the standard fees.
[[Page 46676]]
Table 4--Fees Needed To Achieve New FY 2021 Revenue Target
----------------------------------------------------------------------------------------------------------------
FY 2021 inflation
adjusted 3-Year average of FY 2021 revenue
Application type FY 2021 statutory statutory base fee-paying from adjusted
fees (base fees) fees (standard submissions fees
fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications............... $328,000 $365,657 36 $13,163,652
Small Business.................. 82,000 91,414 7 639,898
Panel-Track Supplement.............. 246,000 274,243 20 5,484,860
Small Business.................. 61,500 68,561 4 274,244
De Novo Classification Request...... 98,400 109,697 20 2,193,940
Small Business.................. 24,600 27,424 33 904,992
180-Day Supplements................. 49,200 54,849 141 7,733,709
Small Business.................. 12,300 13,712 28 383,936
Real-Time Supplements............... 22,960 25,596 190 4,863,240
Small Business.................. 5,740 6,399 32 204,768
510(k)s............................. 11,152 12,432 2,387 29,675,184
Small Business.................. 2,788 3,108 1,338 4,158,504
30-Day Notice....................... 5,248 5,851 994 5,815,894
Small Business.................. 2,624 2,926 96 280,896
513(g) Request for Classification 4,428 4,936 84 414,624
Information........................
Small Business.................. 2,214 2,468 43 106,124
Annual Fee for Periodic Reporting... 11,480 12,798 624 7,985,952
Small Business.................. 2,870 3,200 76 243,200
Establishment Registration.......... 4,975 5,546 27,464 152,315,344
---------------------------------------------------------------------------
Total....................... ................. ................. ................. 236,842,961
----------------------------------------------------------------------------------------------------------------
The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $365,657 for FY 2021. 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 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 $5,546 for FY 2021. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 5 summarizes the FY 2021 rates for all medical device fees.
Table 5--Medical Device Fees for FY 2021
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent
Application fee type of the standard fee for a FY 2021 FY 2021 small
premarket application) standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under section Base fee specified in $365,657 $91,414
515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a statute.
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) 100....................... 365,657 91,414
of the FD&C Act).
Efficacy supplement (to an approved BLA under 100....................... 365,657 91,414
section 351 of the PHS Act).
Panel-track supplement.............................. 75........................ 274,243 68,561
De novo classification request...................... 30........................ 109,697 27,424
180-day supplement.................................. 15........................ 54,849 13,712
Real-time supplement................................ 7......................... 25,596 6,399
510(k) premarket notification submission............ 3.40...................... 12,432 3,108
30-day notice....................................... 1.60...................... 5,851 2,926
513(g) request for classification information....... 1.35...................... 4,936 2,468
Annual Fee Type..................................... .......................... .............. ..............
Annual fee for periodic reporting on a class III 3.50...................... 12,798 3,200
device.
Annual establishment registration fee (to be paid by Base fee specified in 5,546 5,546
the establishment engaged in the manufacture, statute.
preparation, propagation, compounding, or
processing of a device, as defined by 21 U.S.C.
379i(14)).
----------------------------------------------------------------------------------------------------------------
[[Page 46677]]
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. 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 2020, your
status as a small business will expire at the close of business on
September 30, 2020. You must re-qualify for FY 2021 in order to pay
small business fees during FY 2021.
If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2021, submit the following to FDA:
1. A completed MDUFA Small Business Certification Request For a
Business Headquartered in the U.S. (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 2020, except:
If you submit your MDUFA Small Business Certification Request for
FY 2021 before April 15, 2021, and you have not yet filed your return
for 2020, you may use tax year 2019.
If you submit your MDUFA Small Business Certification Request for
FY 2021 on or after April 15, 2021, and have not yet filed your 2020
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.
If you are a foreign business, and wish to qualify as a small
business for FY 2021, 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.
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 (2020 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, 2020, and September 30,
2021, you must pay the fee in effect for FY 2021. 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 2020 or FY 2021 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, 2020. One choice is for
applications and fees that will be received on or before September 30,
2020, which are subject to FY 2020 fee rates. A second choice is for
applications and fees received on or after October 1, 2020, which are
subject to FY 2021 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.
[[Page 46678]]
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.
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 that 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 2021 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
[[Page 46679]]
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 2021 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.
C. Complete the Information Online to Update Your Establishment's
Annual Registration for FY 2021, or To Register a New Establishment for
FY 2021
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 2020. Manufacturers of
licensed biologics should register in the Biologics Establishment
Registration (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 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16793 Filed 7-29-20; 4:15 pm]
BILLING CODE 4164-01-P