Medical Device User Fee Rates for Fiscal Year 2019, 36598-36604 [2018-16178]
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FoodborneIllnessRiskFactorReduction/
ucm224321.htm.
4. FDA National Retail Food Team. ‘‘FDA
Trend Analysis Report on the
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
Foodservice, Restaurant, and Retail Food
Store Facility Types (1998–2008).’’
Available at: https://wayback.archiveit.org/7993/20170406022950/https://
www.fda.gov/Food/GuidanceRegulation/
RetailFoodProtection/FoodborneIllness
RiskFactorReduction/ucm223293.htm.
5. ‘‘FDA Food Code.’’ Available at: https://
www.fda.gov/FoodCode.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16189 Filed 7–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0007]
Medical Device User Fee Rates for
Fiscal Year 2019
AGENCY:
Food and Drug Administration,
HHS.
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) 2019. 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 2019, which apply from
October 1, 2018, through September 30,
2019. 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
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SUMMARY:
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
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 2019, you should not
submit a Small Business Certification
Request. This document provides
information on how the fees for FY 2019
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: Visit FDA’s website at:
https://www.fda.gov/ForIndustry/
UserFees/MedicalDeviceUserFee/
ucm20081521.htm.
For questions relating to the MDUFA
Small Business Program, please visit
CDRH’s website: https://www.fda.gov/
medicaldevices/deviceregulation
andguidance/howtomarketyourdevice/
premarketsubmissions/ucm577696.htm.
For questions relating to this notice:
David Haas, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.
(COLE–14202I), Silver Spring, MD
20993–0002, 240–402–9845.
SUPPLEMENTARY INFORMATION:
by FDA during FY 2019 is $300,000.
From this starting point, this document
establishes FY 2019 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 2019 is $4,548. 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.
I. Background
MDUFA specifies that the
$190,654,875 is to be adjusted for
inflation increases for FY 2019 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 2019 is the
sum of one plus these 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 2019. The 3-year average
is 2.4152 percent (rounded).
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
II. Revenue Amount for FY 2019
The total revenue amount for FY 2019
is $190,654,875, 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 2019 are
described in this document.
Inflation Adjustment
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year
2015
2016
2017
3-Year average
Total PC&B ..............................................................................................
$2,232,304,000
$2,414,728,159
$2,581,551,000
..........................
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TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE—Continued
Fiscal year
2015
Total FTE .................................................................................................
PC&B per FTE .........................................................................................
Percent change from previous year ........................................................
The payroll adjustment is 2.4152
percent multiplied by 60 percent, or
1.4491 percent.
The statute specifies that the
component of the inflation adjustment
for non-payroll costs for FY 2019 is the
average annual percent change that
occurred in the Consumer Price Index
(CPI) for urban consumers (Washington-
2016
15,484
$144,168
2.1136
2017
16,381
$147,408
2.2474
17,022
$151,660
2.8845
3-Year average
..........................
..........................
2.4152
Washington area. These data are
published by the Bureau of Labor
Statistics and can be found on their
website at: https://data.bls.gov/pdq/
SurveyOutputServlet?data_
tool=dropmap&series_
id=CUURA311SA0,CUUSA311SA0.
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)).
Table 2 provides the summary data
and the 3-year average percent change
in the specified CPI for the Baltimore-
TABLE 2—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI
Fiscal year
2015
2016
2017
3-Year average
Annual CPI ...............................................................................................
Annual Percent Change ..........................................................................
3-Year Average Percent Change in CPI .................................................
155.353
0.3268
..........................
157.180
1.1760
..........................
159.202
1.2864
..........................
..........................
..........................
0.9297
The non-pay adjustment is 0.9297
percent multiplied by 40 percent, or
0.3719 percent.
Next, the payroll adjustment (1.4491
percent or 0.014491) is added to the
non-payroll adjustment (0.3719 percent
or 0.003719), for a total of 1.8210
percent (or 0.018210). To complete the
inflation adjustment, 1 (100 percent or
1.0) is added for a total base inflation
adjustment of 1.018210 for FY 2019.
MDUFA IV provides for this inflation
adjustment to be compounded for FY
2019 and each subsequent fiscal year
(see 21 U.S.C. 379j(c)(2)(B)(ii)). The base
inflation adjustment for FY 2019
(1.018210) is compounded by
multiplying it by the compounded
applicable inflation factor from FY 2018
(1.054618). To complete the
compounded inflation adjustment for
FY 2019, the FY 2018 compounded
adjustment (1.054618) is multiplied by
the FY 2019 base inflation adjustment
(1.018210) to reach the applicable
inflation adjustment of 1.073823
(rounded) for FY 2019. We then
multiply the total revenue amount for
FY 2019 ($190,654,875) by 1.073823,
yielding an inflation adjusted total
revenue amount of $204,730,000
(rounded to the nearest thousand
dollars).
III. Fees for FY 2019
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
$300,000 (premarket application) and
$4,548 (establishment registration) are
to be adjusted for FY 2019 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
1.073823 yields inflation adjusted base
fees of $322,147 (premarket application)
and $4,884 (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 3year average. These numbers are used to
project the fee-paying submission
counts that FDA will receive in FY
2019. Most of the fee-paying submission
counts are published in the MDUFA
Financial Report to Congress each year.
TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS
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Application type
FY 2015 actual
FY 2016 actual
Full Fee Applications .......................................................
Small Business .........................................................
Panel-Track Supplement .................................................
Small Business .........................................................
De Novo Classification Request 1 ....................................
Small Business 1 .......................................................
180-Day Supplements .....................................................
Small Business .........................................................
Real-Time Supplements ..................................................
Small Business .........................................................
510(k)s .............................................................................
Small Business .........................................................
42
7
22
3
................................
................................
143
15
204
28
2,768
1,037
37
10
17
1
................................
................................
116
16
179
27
2,599
1,005
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FY 2017 actual
40
7
27
2
24
31
184
36
195
20
3,141
1,125
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3-Year average
40
8
22
2
24
31
148
22
193
25
2,836
1,056
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TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS—Continued
Application type
FY 2015 actual
30-Day Notice ..................................................................
Small Business .........................................................
513(g) (21 U.S.C. 360c(g)) Request for Classification
Information ...................................................................
Small Business .........................................................
Annual Fee for Periodic Reporting 2 ................................
Small Business 2 .......................................................
Establishment Registration ..............................................
FY 2016 actual
FY 2017 actual
3-Year average
920
71
929
76
1,080
82
976
76
75
33
554
73
25,363
68
46
582
75
26,046
98
41
429
37
27,268
80
40
522
62
26,226
1 Three-year
2 Includes
average for De Novo is based on estimate for FY 2019.
collection of quarter 4 billing for FY 2017 during FY 2018.
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
2019 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 $207,708,611, which is
$2,978,611 higher than the inflation
adjusted total revenue amount. The fees
in column two are those we are
establishing in FY 2019, which are the
standard fees.
TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2019 REVENUE TARGET
FY 2019
inflation
adjusted
statutory base fees
(standard fees)
FY 2019
statutory fees
(base fees)
Application type
FY 2019
revenue from
adjusted fees
$300,000
75,000
225,000
56,250
90,000
22,500
45,000
11,250
21,000
5,250
10,200
2,550
4,800
2,400
4,050
2,025
10,500
2,625
4,548
$322,147
80,537
241,610
60,403
96,644
24,161
48,322
12,081
22,550
5,638
10,953
2,738
5,154
2,577
4,349
2,175
11,275
2,819
4,884
$12,885,880
644,296
5,315,420
120,806
2,319,456
748,991
7,151,656
265,782
4,352,150
140,950
31,062,708
2,891,328
5,030,304
195,852
347,920
87,000
5,885,550
174,778
128,087,784
Total ..............................................................................................................
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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 ..................................................................................
................................
................................
207,708,611
The standard fee (adjusted base
amount) for a premarket application,
including a BLA, and for a premarket
report and a BLA efficacy supplement,
is $322,147 for FY 2019. 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;
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• 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 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
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(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
$4,884 for FY 2019. There is no small
business rate for the annual
establishment registration fee; all
establishments pay the same fee.
Table 5 summarizes the FY 2019 rates
for all medical device fees.
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36601
TABLE 5—MEDICAL DEVICE FEES FOR FY 2019
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 (21 U.S.C. 360e(f), 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(13)).
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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. 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 2018, your status as a
small business will expire at the close
of business on September 30, 2018. You
must re-qualify for FY 2019 in order to
pay small business fees during FY 2019.
If you are a domestic (U.S.) business,
and wish to qualify as a small business
for FY 2019, you must 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
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Base fee specified
in statute.
100 .........................
100 .........................
75 ...........................
30 ...........................
15 ...........................
7 .............................
3.40 ........................
1.60 ........................
1.35 ........................
................................
3.50 ........................
Base fee specified
in statute.
provided in the FDA Forms database:
https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM573420.pdf.
2. A signed certified copy of your
Federal (U.S.) Income Tax Return for the
most recent tax year. The most recent
tax year will be 2018, except:
If you submit your MDUFA Small
Business Certification Request for FY
2019 before April 15, 2019, and you
have not yet filed your return for 2018,
you may use tax year 2017.
If you submit your MDUFA Small
Business Certification Request for FY
2019 on or after April 15, 2019, and
have not yet filed your 2018 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 certified 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
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FY 2019
standard fee
Sfmt 4703
FY 2019 small
business fee
$322,147
$80,537
322,147
322,147
241,610
96,644
48,322
22,550
10,953
5,154
4,349
................................
11,275
4,884
80,537
80,537
60,403
24,161
12,081
5,638
2,738
2,577
2,175
................................
2,819
4,884
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
2019, you must 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 certified copy of the
affiliate’s Federal (U.S.) Income Tax
Return for the most recent tax year
(2018 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
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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.
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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,
2018, and September 30, 2019, you must
pay the fee in effect for FY 2019. 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
2018 or FY 2019 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, 2018.
One choice is for applications and fees
that will be received on or before
September 30, 2018, which are subject
to FY 2018 fee rates. A second choice
is for applications and fees received on
or after October 1, 2018, which are
subject to FY 2019 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.
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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
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
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 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 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
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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
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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 2019 until it has completed the
steps below to register and pay any
applicable fee (see 21 U.S.C. 379j(g)(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 2019 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.
B. Pay For Your DFUF Order
Unless paying by 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–
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
36603
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
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 2019, or To Register
a New Establishment for FY 2019
Go to the Center for Devices and
Radiological Health’s website at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
HowtoMarketYourDevice/
RegistrationandListing/default.htm 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 2018. Manufacturers of licensed
biologics should register in the BER
system at https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Establishmen
tRegistration/BloodEstablishment
Registration/default.htm.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
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.
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 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16178 Filed 7–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0549]
Prescription Polyethylene Glycol 3350;
Denial of a Hearing and Order
Withdrawing Approval of Abbreviated
New Drug Applications; Temporary
Stay of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
daltland on DSKBBV9HB2PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is providing
notice that the effective date of an April
2, 2018, order denying requests for a
hearing and withdrawing approval of
abbreviated new drug applications
(ANDAs) for certain prescription
laxatives with the active ingredient
SUMMARY:
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polyethylene glycol 3350 (PEG 3350) is
stayed until November 2, 2018.
DATES: FDA is staying the effective date
of the April 2, 2018, order withdrawing
approval of ANDAs for certain
prescription laxatives with the active
ingredient PEG 3350 until November 2,
2018.
ADDRESSES: For access to the docket, go
to https://www.regulations.gov and
insert the docket number, found in
brackets in the heading of this
document, into the ‘‘Search’’ box and
follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Julie
Finegan, Office of Scientific Integrity,
Office of the Chief Scientist, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 4218,
Silver Spring, MD 20993–0002, 301–
796–8618.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 2, 2018 (83 FR
13994), FDA denied requests for hearing
and issued an order withdrawing
approval of ANDAs for certain
prescription laxatives with the active
ingredient PEG 3350. The effective date
of the order was May 2, 2018. Between
April 6, 2018, and April 13, 2018, FDA
received petitions for stay under § 10.35
(21 CFR 10.35) on behalf of four ANDA
holders: Breckenridge Pharmaceutical,
Inc. and Nexgen Pharma, Inc. (hereafter
Breckenridge/Nexgen) who submitted a
joint petition; Lannett Company, Inc.;
and Paddock Laboratories, Inc.
(collectively the ANDA holders).
Breckenridge/Nexgen, Lannett, and
Paddock petitioned FDA to stay its
order withdrawing the approval of their
ANDAs for prescription PEG 3350 and
argued that all four criteria for a
mandatory stay under § 10.35(e) were
met. Bayer Healthcare, LLC, (Bayer)
which holds an approved New Drug
Application for MiraLAX, an over-thecounter laxative containing PEG 3350,
responded. Bayer argued that the
petitioners failed to meet any of the
factors in § 10.35(e).1
1 On April 30, 2018, Bayer filed a submission
titled ‘‘Request for Clarification of FDA Granting of
a Petition for Stay of Action.’’ Bayer requested that
FDA clarify that the stay allowed new
manufacturing only until May 2, 2018, with
shipment of product permitted until November 2,
2018. Breckenridge/Nexgen responded to Bayer’s
request for clarification and argued that Bayer’s
submission should have been a petition for
reconsideration and that it failed to meet the
standards required for reconsideration. Regardless
of whether Bayer’s submission should have been a
petition for reconsideration, FDA’s letter granting
PO 00000
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By a letter dated April 16, 2018, the
Acting Chief Scientist, pursuant to
authority delegated by the
Commissioner, concluded that the
ANDA holders had not met the criteria
for a mandatory stay under § 10.35(e).
The Acting Chief Scientist granted a
temporary, discretionary stay of the
effective date of the order until
November 2, 2018. As described in the
April 16, 2018, letter, based upon
information submitted by the ANDA
holders and not disputed by Bayer, it
would likely be difficult for
manufacturers of OTC PEG 3350
products to compensate for the removal
of prescription PEG 3350 products
within 30 days. The letter explained
that public health interests would not be
served should the 30-day effective date
negatively impact the availability of
PEG 3350, particularly given that the
basis of the withdrawal of the ANDA
products is not an issue of safety or
efficacy. The April 16, 2018, letter
additionally noted that FDA has
provided lengthier time frames to phase
out manufacturing and distribution of
affected products in other cases. While
the Acting Chief Scientist rejected the
petitioners’ arguments that financial
hardship and harm to reputation
resulting from the withdrawal order rise
to the level of irreparable injury
necessary for a mandatory stay under
§ 10.35(e), she agreed that there may
some validity to the petitioner’s
concerns of harm to their business
interests as a result of the 30-day
effective date. The Acting Chief
Scientist concluded that it is in the
public interest and in the interest of
justice to stay the effective date of the
April 2, 2018, order until November 2,
2018.
The parties’ submissions and the
Agency’s orders are available at https://
www.regulations.gov and with the
Dockets Management Staff (see
ADDRESSES).
FDA is providing notice of the
decision to grant a temporary stay in
accordance with § 10.35(f).
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16148 Filed 7–27–18; 8:45 am]
BILLING CODE 4164–01–P
the stay provides that the order is stayed until
November 2, 2018, without the limitations Bayer
now requests.
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]]>Agencies
[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36598-36604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0007]
Medical Device User Fee Rates for Fiscal Year 2019
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) 2019. 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 2019, which apply from October 1, 2018, through September
30, 2019. 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 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 2019, you should not submit a
Small Business Certification Request. This document provides
information on how the fees for FY 2019 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: Visit FDA's website
at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
For questions relating to the MDUFA Small Business Program, please
visit CDRH's website: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/ucm577696.htm.
For questions relating to this notice: David Haas, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202I), Silver Spring, MD 20993-0002, 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 2019 is
$300,000. From this starting point, this document establishes FY 2019
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 2019 is $4,548. 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 2019
The total revenue amount for FY 2019 is $190,654,875, 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 2019 are described in this document.
Inflation Adjustment
MDUFA specifies that the $190,654,875 is to be adjusted for
inflation increases for FY 2019 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 2019 is the sum of one plus these
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 2019.
The 3-year average is 2.4152 percent (rounded).
Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2015 2016 2017 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.................................. $2,232,304,000 $2,414,728,159 $2,581,551,000 ...............
[[Page 36599]]
Total FTE................................... 15,484 16,381 17,022 ...............
PC&B per FTE................................ $144,168 $147,408 $151,660 ...............
Percent change from previous year........... 2.1136 2.2474 2.8845 2.4152
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.4152 percent multiplied by 60 percent,
or 1.4491 percent.
The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2019 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)).
Table 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Baltimore-Washington area. These
data are published by the Bureau of Labor Statistics and can be found
on their website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0.
Table 2--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
Fiscal year 2015 2016 2017 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.................................. 155.353 157.180 159.202 ...............
Annual Percent Change....................... 0.3268 1.1760 1.2864 ...............
3-Year Average Percent Change in CPI........ ............... ............... ............... 0.9297
----------------------------------------------------------------------------------------------------------------
The non-pay adjustment is 0.9297 percent multiplied by 40 percent,
or 0.3719 percent.
Next, the payroll adjustment (1.4491 percent or 0.014491) is added
to the non-payroll adjustment (0.3719 percent or 0.003719), for a total
of 1.8210 percent (or 0.018210). To complete the inflation adjustment,
1 (100 percent or 1.0) is added for a total base inflation adjustment
of 1.018210 for FY 2019.
MDUFA IV provides for this inflation adjustment to be compounded
for FY 2019 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2019
(1.018210) is compounded by multiplying it by the compounded applicable
inflation factor from FY 2018 (1.054618). To complete the compounded
inflation adjustment for FY 2019, the FY 2018 compounded adjustment
(1.054618) is multiplied by the FY 2019 base inflation adjustment
(1.018210) to reach the applicable inflation adjustment of 1.073823
(rounded) for FY 2019. We then multiply the total revenue amount for FY
2019 ($190,654,875) by 1.073823, yielding an inflation adjusted total
revenue amount of $204,730,000 (rounded to the nearest thousand
dollars).
III. Fees for FY 2019
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 $300,000 (premarket
application) and $4,548 (establishment registration) are to be adjusted
for FY 2019 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
1.073823 yields inflation adjusted base fees of $322,147 (premarket
application) and $4,884 (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 2019. Most of the
fee-paying submission counts are published in the MDUFA Financial
Report to Congress each year.
Table 3--Three-Year Average of Fee-Paying Submissions
----------------------------------------------------------------------------------------------------------------
Application type FY 2015 actual FY 2016 actual FY 2017 actual 3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........... 42 37 40 40
Small Business.............. 7 10 7 8
Panel-Track Supplement.......... 22 17 27 22
Small Business.............. 3 1 2 2
De Novo Classification Request .................. .................. 24 24
\1\............................
Small Business \1\.......... .................. .................. 31 31
180-Day Supplements............. 143 116 184 148
Small Business.............. 15 16 36 22
Real-Time Supplements........... 204 179 195 193
Small Business.............. 28 27 20 25
510(k)s......................... 2,768 2,599 3,141 2,836
Small Business.............. 1,037 1,005 1,125 1,056
[[Page 36600]]
30-Day Notice................... 920 929 1,080 976
Small Business.............. 71 76 82 76
513(g) (21 U.S.C. 360c(g)) 75 68 98 80
Request for Classification
Information....................
Small Business.............. 33 46 41 40
Annual Fee for Periodic 554 582 429 522
Reporting \2\..................
Small Business \2\.......... 73 75 37 62
Establishment Registration...... 25,363 26,046 27,268 26,226
----------------------------------------------------------------------------------------------------------------
\1\ Three-year average for De Novo is based on estimate for FY 2019.
\2\ Includes collection of quarter 4 billing for FY 2017 during FY 2018.
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 2019 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
$207,708,611, which is $2,978,611 higher than the inflation adjusted
total revenue amount. The fees in column two are those we are
establishing in FY 2019, which are the standard fees.
Table 4--Fees Needed to Achieve New FY 2019 Revenue Target
----------------------------------------------------------------------------------------------------------------
FY 2019 inflation
FY 2019 statutory adjusted statutory FY 2019 revenue
Application type fees (base fees) base fees from adjusted fees
(standard fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications............................... $300,000 $322,147 $12,885,880
Small Business.................................. 75,000 80,537 644,296
Panel-Track Supplement.............................. 225,000 241,610 5,315,420
Small Business.................................. 56,250 60,403 120,806
De Novo Classification Request...................... 90,000 96,644 2,319,456
Small Business.................................. 22,500 24,161 748,991
180-Day Supplements................................. 45,000 48,322 7,151,656
Small Business.................................. 11,250 12,081 265,782
Real-Time Supplements............................... 21,000 22,550 4,352,150
Small Business.................................. 5,250 5,638 140,950
510(k)s............................................. 10,200 10,953 31,062,708
Small Business.................................. 2,550 2,738 2,891,328
30-Day Notice....................................... 4,800 5,154 5,030,304
Small Business.................................. 2,400 2,577 195,852
513(g) Request for Classification Information....... 4,050 4,349 347,920
Small Business.................................. 2,025 2,175 87,000
Annual Fee for Periodic Reporting................... 10,500 11,275 5,885,550
Small Business.................................. 2,625 2,819 174,778
Establishment Registration.......................... 4,548 4,884 128,087,784
-----------------------------------------------------------
Total........................................... .................. .................. 207,708,611
----------------------------------------------------------------------------------------------------------------
The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $322,147 for FY 2019. 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 $4,884 for FY 2019. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 5 summarizes the FY 2019 rates for all medical device fees.
[[Page 36601]]
Table 5--Medical Device Fees for FY 2019
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of the
Application fee type standard fee for a premarket FY 2019 standard FY 2019 small
application) fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA Base fee specified in statute.... $322,147 $80,537
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 (21 U.S.C. 360e(f),
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 100.............................. 322,147 80,537
section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved 100.............................. 322,147 80,537
BLA under section 351 of the PHS
Act).
Panel-track supplement............... 75............................... 241,610 60,403
De novo classification request....... 30............................... 96,644 24,161
180-day supplement................... 15............................... 48,322 12,081
Real-time supplement................. 7................................ 22,550 5,638
510(k) premarket notification 3.40............................. 10,953 2,738
submission.
30-day notice........................ 1.60............................. 5,154 2,577
513(g) request for classification 1.35............................. 4,349 2,175
information.
Annual Fee Type...................... ................................. .................. ..................
Annual fee for periodic reporting on 3.50............................. 11,275 2,819
a class III device.
Annual establishment registration fee Base fee specified in statute.... 4,884 4,884
(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(13)).
----------------------------------------------------------------------------------------------------------------
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 2018, your
status as a small business will expire at the close of business on
September 30, 2018. You must re-qualify for FY 2019 in order to pay
small business fees during FY 2019.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2019, you must 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 certified copy of your Federal (U.S.) Income Tax Return
for the most recent tax year. The most recent tax year will be 2018,
except:
If you submit your MDUFA Small Business Certification Request for
FY 2019 before April 15, 2019, and you have not yet filed your return
for 2018, you may use tax year 2017.
If you submit your MDUFA Small Business Certification Request for
FY 2019 on or after April 15, 2019, and have not yet filed your 2018
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
certified 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 2019, you must 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
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year (2018 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
[[Page 36602]]
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, 2018, and September 30,
2019, you must pay the fee in effect for FY 2019. 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 2018 or FY 2019 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, 2018. One choice is for
applications and fees that will be received on or before September 30,
2018, which are subject to FY 2018 fee rates. A second choice is for
applications and fees received on or after October 1, 2018, which are
subject to FY 2019 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 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 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
[[Page 36603]]
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 2019 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(g)(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 2019 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 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 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 2019, or To Register a New Establishment for
FY 2019
Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm 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 2018.
Manufacturers of licensed biologics should register in the BER system
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu,
[[Page 36604]]
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 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16178 Filed 7-27-18; 8:45 am]
BILLING CODE 4164-01-P
