Medical Device User Fee Rates for Fiscal Year 2018, 41029-41035 [2017-18378]
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preferred payment method is online
using electronic check (Automated
Clearing House (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 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.
FDA has partnered with the U.S.
Department of the Treasury to utilize
Pay.gov, a web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA Web site after
completing the Generic Drug User Fee
Cover Sheet and generating the user fee
ID number.
Please include the user fee ID number
on your check, bank draft, or postal
money order and make payable to the
order of the Food and Drug
Administration. Your payment can be
mailed to: Food and Drug
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000. If checks are to
be sent by a courier that requests a street
address, the courier can deliver checks
to: U.S. Bank, Attention: Government
Lockbox 979108, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
only. If you have any questions
concerning courier delivery, contact the
U.S. Bank at 314–418–4013. This
telephone number is only for questions
about courier delivery). Please make
sure that the FDA post office box
number (P.O. Box 979108) is written on
the check, bank draft, or postal money
order.
If paying by wire transfer, please
reference your unique user fee ID
number when completing your transfer.
Without your unique user fee ID
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. Please ask your financial
institution about the wire transfer fee
and include it with your payment to
ensure that your fee is fully paid. Use
the following account information when
sending a payment by wire transfer: U.S.
Department of Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045,
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account number: 75060099, routing
number: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 8455
Colesville Rd., 14th Floor, Silver Spring,
MD 20993–0002. If needed, FDA’s tax
identification number is 53–0196965.
Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18377 Filed 8–28–17; 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 2018
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) 2018. The Federal Food, Drug, and
Cosmetic Act (the 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 2018, which apply from
October 1, 2017, through September 30,
2018. 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 2018, you should not
submit a FY 2018 Small Business
Qualification and Certification request.
This document provides information on
how the fees for FY 2018 were
determined, the payment procedures
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41029
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 Web site at
https://www.fda.gov/ForIndustry/
UserFees/MedicalDeviceUserFee/
ucm20081521.htm.
For questions relating to this notice:
Robert Marcarelli, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.
(COLE–14202F), Silver Spring, MD
20993–0002, 301–796–7223.
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 statutorilydefined 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 2018 is $294,000.
From this starting point, this document
establishes FY 2018 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 2018 is $4,375. 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 2018
The total revenue amount for FY 2018
is $183,280,756, as set forth in the
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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 2018 are
described in this document.
Inflation Adjustment
MDUFA specifies that the
$183,280,756 is to be adjusted for
inflation increases for FY 2018 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 2018 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 three of the four 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 2018. The 3-year average
is 2.2354 percent (rounded).
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year
2014
Total PC&B ..........................................................................................
Total FTE .............................................................................................
PC&B per FTE .....................................................................................
Percent change from previous year ....................................................
The payroll adjustment is 2.2354
percent multiplied by 60 percent, or
1.3412 percent.
The statute specifies that the
component of the inflation adjustment
for non-payroll costs for FY 2018 is the
average annual percent change that
occurred in the Consumer Price Index
(CPI) for urban consumers (Washington-
2015
$2,054,937,000
14,555
$141,184
2.3451%
2016
$2,232,304,000
15,484
$144,168
2.1136%
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-
$2,414,728,159
16,381
$147,408
2.2474%
3-year
average
........................
........................
........................
2.2354%
Washington area. These data are
published by the Bureau of Labor
Statistics and can be found on their Web
site at https://data.bls.gov/cgi-bin/
surveymost?cu by checking the box
marked ‘‘Washington-Baltimore All
Items, November 1996 =
100¥CUURA311SA0’’ and then
clicking on the ‘‘Retrieve Data’’ button.
TABLE 2—ANNUAL AND THREE-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI
2014
2015
2016
3-year
average
Annual CPI ...........................................................................................
Annual Percent Change ......................................................................
3-Year Avg. Percent Change in CPI ...................................................
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Fiscal year
154.847
1.5390%
............................
155.353
0.3268%
............................
157.180
1.1760%
............................
........................
........................
1.0139%
The non-pay adjustment is 1.0139
percent multiplied by 40 percent, or
0.4056 percent.
Next, the payroll adjustment (1.3412
percent or 0.013412) is added to the
non-payroll adjustment (0.4056 percent
or 0.004056), for a total of 1.7468
percent (or 0.017468). To complete the
inflation adjustment, 1 (100 percent or
1.0) is added for a total base inflation
adjustment of 1.017468 for FY 2018.
MDUFA IV provides for this inflation
adjustment to be compounded for FY
2018 and each subsequent fiscal year
(see 21 U.S.C. 379j(c)(2)(B)(ii)). The base
inflation adjustment for FY 2018
(1.017468) is compounded by
multiplying it by the compounded
applicable inflation factors from FY
2016 and FY 2017 (1.020416 times
1.015774 or 1.036512). To complete the
compounded inflation adjustment for
FY 2018, the FY 2016 and FY 2017
compounded adjustment (1.036512) is
multiplied by the FY 2018 base inflation
adjustment (1.017468) to reach the
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applicable inflation adjustment of
1.054618 (rounded) for FY 2018. We
then multiply the total revenue amount
for FY 2018 ($183,280,756) by 1.054618,
yielding an inflation adjusted total
revenue amount of $193,291,000
(rounded to the nearest thousand
dollars).
III. Fees for FY 2018
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
$294,000 (premarket application) and
$4,375 (establishment registration) are
to be adjusted for inflation for FY 2018
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 these base fees by the
compounded inflation adjustment of
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1.054618 yields inflation adjusted base
fees of $310,058 (premarket application)
and $4,614 (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
2018. Most of the fee-paying submission
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41031
counts are published in the MDUFA
Financial Report to Congress each year.
TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS
Application type
FY 2014
actual
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 .........................................................................................
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 ..............................................................................
25
5
12
3
........................
........................
122
24
192
19
3,034
1,037
934
91
69
31
668
74
24,626
42
7
22
3
........................
........................
143
15
204
28
2,768
1,037
920
71
75
33
554
73
25,363
41
10
18
1
........................
........................
139
18
202
29
2,784
1,046
1,029
80
69
47
576
74
26,222
3-year
average
36
7
17
2
40
10
135
19
199
25
2,862
1,040
961
81
71
37
599
74
25,404
1 Three-year
2 Includes
average for De Novo is based on estimate used during MDUFA IV negotiations.
collection of quarter four billing for FY 2016 during FY 2017.
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
2018 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, the collections
would total $192,850,757, which is
$440,243 lower than the statutory
revenue limit. Accordingly, the next
step in the fee setting process is to
increase the base fee amounts on a
uniform proportionate basis to generate
the inflation adjusted total revenue
amounts (see 21 U.S.C. 379j(c)(2)(D)(ii)
and table 4, column three). Applying
these further adjusted fee rates to the 3year average of fee paying submissions
results in the establishment registration
fee rate being increased by $10 to
determine the new establishment
registration fee rate of $4,624 (see 21
U.S.C. 379j(c)(3) and table 4, column
three), leaving a total revenue shortfall
of $12,278. The fees in the second
column from the right are those we are
establishing in FY 2018, which are the
standard fees.
TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2018 REVENUE TARGET
FY 2018 statutory fees
(base fees)
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Application type
Adjusted FY
2018 fees
to meet
revenue
target
(standard fees)
FY 2018
inflation
adjusted
statutory
base fees
FY 2018
revenue
from adjusted
fees
Full Fee Applications ...................................................................................
Small Business .....................................................................................
Panel-Track Supplement .............................................................................
Small Business .....................................................................................
De Novo Classification Request ..................................................................
Small Business .....................................................................................
180-Day Supplements .................................................................................
Small Business .....................................................................................
Real-Time Supplements ..............................................................................
Small Business .....................................................................................
510(k)s .........................................................................................................
Small Business .....................................................................................
30-Day Notice ..............................................................................................
Small Business .....................................................................................
513(g) Request for Classification Information .............................................
Small Business .....................................................................................
Annual Fee for Periodic Reporting ..............................................................
Small Business .....................................................................................
Establishment Registration ..........................................................................
$294,000
73,500
220,500
55,125
88,200
22,050
44,100
11,025
20,580
5,145
9,996
2,499
4,704
2,352
3,969
1,985
10,290
2,573
4,375
$310,058
77,514
232,543
58,136
93,017
23,254
46,509
11,627
21,704
5,426
10,542
2,635
4,961
2,480
4,186
2,093
10,852
2,713
4,614
$310,764
77,691
233,073
58,268
93,229
23,307
46,615
11,654
21,753
5,438
10,566
2,642
4,972
2,486
4,195
2,098
10,877
2,719
4,624
$11,187,504
543,837
3,962,241
116,272
3,729,160
233,070
6,293,025
221,426
4,328,847
135,950
30,239,892
2,747,680
4,778,092
201,366
297,845
77,626
6,515,323
201,206
117,468,096
Total ......................................................................................................
........................
........................
............................
193,278,722
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The standard fee (adjusted base
amount) for a premarket application,
including a BLA, and for a premarket
report and a BLA efficacy supplement,
is $310,764 for FY 2018. 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 30day notice, and a 513(g) request for
classification information, the small
business fee is 25 percent of the
standard (full) fee for the submission
(see 21 U.S.C. 379j(d)(2)(C) and
(e)(2)(C)). For a 30-day notice, and a
513(g) request for classification
information, the small business fee is 50
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
$4,624 for FY 2018. There is no small
business rate for the annual
establishment registration fee; all
establishments pay the same fee.
Table 5 summarizes the FY 2018 rates
for all medical device fees.
TABLE 5—MEDICAL DEVICE FEES FOR FY 2018
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
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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.
pay the standard (full) fee for that
submission.
If your business qualified as a small
business for FY 2017, your status as a
small business will expire at the close
of business on September 30, 2017. You
must re-qualify for FY 2018 in order to
pay small business fees during FY 2018.
If you are a domestic (U.S.) business,
and wish to qualify as a small business
for FY 2018, you must submit the
following to FDA:
1. A completed FY 2018 MDUFA
Small Business Qualification
Certification (Form FDA 3602). This
form is provided in FDA’s guidance
document, ‘‘FY 2018 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Web site at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
default.htm.
2. A certified copy of your Federal
(U.S.) Income Tax Return for the most
recent tax year. The most recent tax year
will be 2017, except:
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FY 2018
standard fee
FY 2018
small
business
fee
$310,764
$77,691
310,764
310,764
233,073
93,229
46,615
21,753
10,566
4,972
4,195
........................
10,877
4,624
77,691
77,691
58,268
23,307
11,654
5,438
2,642
2,486
2,098
........................
2,719
4,624
If you submit your FY 2018 MDUFA
Small Business Qualification before
April 15, 2018, and you have not yet
filed your return for 2017, you may use
tax year 2016.
If you submit your FY 2018 MDUFA
Small Business Qualification on or after
April 15, 2018, and have not yet filed
your 2017 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
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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 applicant must also
submit a statement signed by the head
of the applicant’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 applicant has no
affiliates.
If you are a foreign business, and wish
to qualify as a small business for FY
2018, you must submit the following:
1. A completed FY 2018 MDUFA
Foreign Small Business Qualification
Certification (Form FDA 3602A). This
form is provided in FDA’s guidance
document, ‘‘FY 2018 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Web site at https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
default.htm.
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 (2017 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 applicant must also submit a statement
signed by the head of the applicant’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 applicant 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,
2017, and September 30, 2018, you must
pay the fee in effect for FY 2018. 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
2017 or FY 2018 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, 2017.
One choice is for applications and fees
that will be received on or before
September 30, 2017, which are subject
to FY 2017 fee rates. A second choice
is for applications and fees received on
or after October 1, 2017, which are
subject to FY 2018 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
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41033
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
E:\FR\FM\29AUN1.SGM
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41034
Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices
No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Road,
14th Floor, Silver Spring, MD 20993–
0002.
FDA records the official application
receipt date as the later of the following:
(1) The date the application was
received by an FDA Document Control
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.
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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/cdrh
submissionaddress.
VI. Procedures for Paying the Annual
Fee for Periodic Reporting
You will be invoiced at the end of the
quarter in which your PMA Periodic
Report is due. Invoices will be sent
based on the details included on your
PMA file. You are responsible for
ensuring FDA has your current billing
information, and you may update your
contact information for the PMA by
submitting an amendment to the
pending PMA or a supplement to the
approved PMA.
1. The preferred payment method is
online using electronic check (ACH also
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
Express). Secure electronic payments
can be submitted using the User Fees
Payment Portal at https://
userfees.fda.gov/pay (Note: Only full
payments are accepted. No partial
payments can be made online). Once
you search for your invoice, select ‘‘Pay
Now’’ to be redirected to Pay.gov. Note
that electronic payment options are
based on the balance due. Payment by
credit card is available for balances that
are less than $25,000. If the balance
exceeds this amount, only the ACH
option is available. Payments must be
made using U.S. bank accounts as well
as U.S. credit cards.
2. If paying with a paper check:
The check must be in U.S. currency
from a U.S. bank and made payable to
the Food and Drug Administration. If
needed, FDA’s tax identification
number is 53–0196965.
• Please write your invoice number
on the check.
• Mail the paper check and a copy of
the invoice to: Food and Drug
Administration, P.O. Box 979033, St.
Louis, MO 63197–9000.
(Please note that this address is for
payments of application and annual
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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, Beneficiary: FDA,
8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993–0002.
VII. Procedures for Paying Annual
Establishment Registration Fees
To pay the annual establishment
registration fee, firms must access the
Device Facility User Fee (DFUF) Web
site at https://userfees.fda.gov/OA_
HTML/furls.jsp. (FDA has verified the
Web site address, but FDA is not
responsible for any subsequent changes
to the Web site 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 2018 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.
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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
Web site listed previously in this
section. After creating a user name and
password, log into the Establishment
Registration User Fee FY 2018 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 314–418–4013.
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
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sradovich on DSK3GMQ082PROD with NOTICES
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, Beneficiary: FDA,
8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993–0002. If needed,
FDA’s tax identification number is 53–
0196965.
C. Complete the Information Online To
Update Your Establishment’s Annual
Registration for FY 2018, or To Register
a New Establishment for FY 2018
Go to the Center for Devices and
Radiological Health’s Web site at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Howto
MarketYourDevice/Registrationand
Listing/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 2017. Manufacturers of licensed
biologics should register in the BER
system at https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Establishment
Registration/BloodEstablishment
Registration/default.htm.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
click on the Device Registration and
Listing Module (DRLM) of FURLS
button. New establishments will need to
register and existing establishments will
update their annual registration using
choices on the DRLM menu. When you
choose to register or update your annual
registration, the system will prompt you
through the entry of information about
your establishment and your devices. If
you have any problems with this
process, email: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
This email address and this telephone
number are for assistance with
establishment registration only; they are
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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: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18378 Filed 8–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4119]
Food Safety Modernization Act ThirdParty Certification Program User Fee
Rate for Fiscal Year 2018
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2018 annual fee rate for
recognized accreditation bodies and
accredited certification bodies, and the
fee rate for accreditation bodies
applying to be recognized in the thirdparty certification program that is
authorized by the Federal Food, Drug,
and Cosmetic Act (the FD&C Act), as
amended by the FDA Food Safety
Modernization Act (FSMA).
FOR FURTHER INFORMATION CONTACT:
Donald Prater, Office of Foods and
Veterinary Medicine, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3234, Silver Spring,
MD 20993, 301–348–3007.
DATES: This fee is effective October 1,
2017.
SUPPLEMENTARY INFORMATION:
I. Background
Section 307 of FSMA, Accreditation
of Third-Party Auditors, amended the
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41035
FD&C Act to create a new provision,
section 808, under the same name.
Section 808 of the FD&C Act (21 U.S.C.
384d) directs FDA to establish a
program for accreditation of third-party
certification bodies 1 conducting food
safety audits and issuing food and
facility certifications to eligible foreign
entities (including registered foreign
food facilities) that meet our applicable
requirements. Under this provision, we
established a system for FDA to
recognize accreditation bodies to
accredit certification bodies, except for
limited circumstances in which we may
directly accredit certification bodies to
participate in the third-party
certification program.
Section 808(c)(8) of the FD&C Act
directs FDA to establish a
reimbursement (user fee) program by
which we assess fees and require
reimbursement for the work FDA
performs to establish and administer the
third-party certification program under
section 808 of the FD&C Act. The user
fee program for the third-party
certification program was established by
a final rule entitled ‘‘Amendments to
Accreditation of Third-Party
Certification Bodies to Conduct Food
Safety Audits and To Issue
Certifications to Provide for the User
Fee Program’’ (81 FR 90186, December
14, 2016).
The FSMA FY 2018 third-party
certification program user fee rate
announced in this notice is effective on
October 1, 2017, and will remain in
effect through September 30, 2018.
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2018
In each year, the costs of salary (or
personnel compensation) and benefits
for FDA employees account for between
50 and 60 percent of the funds available
to, and used by, FDA. Almost all of the
remaining funds (operating funds)
available to FDA are used to support
FDA employees for paying rent, travel,
utility, information technology, and
other operating costs.
A. Estimating the Full Cost per Direct
Work Hour in FY 2018
Full-time Equivalent (FTE) reflects the
total number of regular straight-time
hours—not including overtime or
holiday hours—worked by employees,
1 For the reasons explained in the third-party
certification final rule (80 FR 74570 at 74578–
74579, November 27, 2015), and for consistency
with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11,
and 16, this notice uses the term ‘‘third-party
certification body’’ rather than the term ‘‘third-party
auditor’’ used in section 808(a)(3) of the FD&C Act.
E:\FR\FM\29AUN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Pages 41029-41035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18378]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0007]
Medical Device User Fee Rates for Fiscal Year 2018
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) 2018. The Federal Food, Drug, and Cosmetic Act (the 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 2018, which apply from October 1, 2017, through
September 30, 2018. 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 2018, you should
not submit a FY 2018 Small Business Qualification and Certification
request. This document provides information on how the fees for FY 2018
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 Web site
at https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
For questions relating to this notice: Robert Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202F), Silver Spring, MD 20993-0002, 301-796-7223.
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 2018 is
$294,000. From this starting point, this document establishes FY 2018
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 2018 is $4,375. 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 2018
The total revenue amount for FY 2018 is $183,280,756, as set forth
in the
[[Page 41030]]
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 2018 are described in this document.
Inflation Adjustment
MDUFA specifies that the $183,280,756 is to be adjusted for
inflation increases for FY 2018 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 2018 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 three of the four 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 2018.
The 3-year average is 2.2354 percent (rounded).
Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
3-year
Fiscal year 2014 2015 2016 average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $2,054,937,000 $2,232,304,000 $2,414,728,159 ..............
Total FTE................................. 14,555 15,484 16,381 ..............
PC&B per FTE.............................. $141,184 $144,168 $147,408 ..............
Percent change from previous year......... 2.3451% 2.1136% 2.2474% 2.2354%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.2354 percent multiplied by 60 percent,
or 1.3412 percent.
The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2018 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 Web site at https://data.bls.gov/cgi-bin/surveymost?cu by
checking the box marked ``Washington-Baltimore All Items, November 1996
= 100-CUURA311SA0'' and then clicking on the ``Retrieve Data'' button.
Table 2--Annual and Three-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
3-year
Fiscal year 2014 2015 2016 average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................ 154.847 155.353 157.180 ..............
Annual Percent Change..................... 1.5390% 0.3268% 1.1760% ..............
3-Year Avg. Percent Change in CPI......... ................ ................ ................ 1.0139%
----------------------------------------------------------------------------------------------------------------
The non-pay adjustment is 1.0139 percent multiplied by 40 percent,
or 0.4056 percent.
Next, the payroll adjustment (1.3412 percent or 0.013412) is added
to the non-payroll adjustment (0.4056 percent or 0.004056), for a total
of 1.7468 percent (or 0.017468). To complete the inflation adjustment,
1 (100 percent or 1.0) is added for a total base inflation adjustment
of 1.017468 for FY 2018.
MDUFA IV provides for this inflation adjustment to be compounded
for FY 2018 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2018
(1.017468) is compounded by multiplying it by the compounded applicable
inflation factors from FY 2016 and FY 2017 (1.020416 times 1.015774 or
1.036512). To complete the compounded inflation adjustment for FY 2018,
the FY 2016 and FY 2017 compounded adjustment (1.036512) is multiplied
by the FY 2018 base inflation adjustment (1.017468) to reach the
applicable inflation adjustment of 1.054618 (rounded) for FY 2018. We
then multiply the total revenue amount for FY 2018 ($183,280,756) by
1.054618, yielding an inflation adjusted total revenue amount of
$193,291,000 (rounded to the nearest thousand dollars).
III. Fees for FY 2018
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 $294,000 (premarket
application) and $4,375 (establishment registration) are to be adjusted
for inflation for FY 2018 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 these base fees by the compounded
inflation adjustment of 1.054618 yields inflation adjusted base fees of
$310,058 (premarket application) and $4,614 (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 2018. Most of the
fee-paying submission
[[Page 41031]]
counts are published in the MDUFA Financial Report to Congress each
year.
Table 3--Three-Year Average of Fee-Paying Submissions
----------------------------------------------------------------------------------------------------------------
FY 2014 FY 2015 FY 2016 3-year
Application type actual actual actual average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... 25 42 41 36
Small Business.............................. 5 7 10 7
Panel-Track Supplement.......................... 12 22 18 17
Small Business.............................. 3 3 1 2
De Novo Classification Request \1\.............. .............. .............. .............. 40
Small Business \1\.......................... .............. .............. .............. 10
180-Day Supplements............................. 122 143 139 135
Small Business.............................. 24 15 18 19
Real-Time Supplements........................... 192 204 202 199
Small Business.............................. 19 28 29 25
510(k)s......................................... 3,034 2,768 2,784 2,862
Small Business.............................. 1,037 1,037 1,046 1,040
30-Day Notice................................... 934 920 1,029 961
Small Business.............................. 91 71 80 81
513(g) (21 U.S.C. 360c(g)) Request for 69 75 69 71
Classification Information.....................
Small Business.............................. 31 33 47 37
Annual Fee for Periodic Reporting \2\........... 668 554 576 599
Small Business \2\.......................... 74 73 74 74
Establishment Registration...................... 24,626 25,363 26,222 25,404
----------------------------------------------------------------------------------------------------------------
\1\ Three-year average for De Novo is based on estimate used during MDUFA IV negotiations.
\2\ Includes collection of quarter four billing for FY 2016 during FY 2017.
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 2018 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, the collections would total $192,850,757,
which is $440,243 lower than the statutory revenue limit. Accordingly,
the next step in the fee setting process is to increase the base fee
amounts on a uniform proportionate basis to generate the inflation
adjusted total revenue amounts (see 21 U.S.C. 379j(c)(2)(D)(ii) and
table 4, column three). Applying these further adjusted fee rates to
the 3-year average of fee paying submissions results in the
establishment registration fee rate being increased by $10 to determine
the new establishment registration fee rate of $4,624 (see 21 U.S.C.
379j(c)(3) and table 4, column three), leaving a total revenue
shortfall of $12,278. The fees in the second column from the right are
those we are establishing in FY 2018, which are the standard fees.
Table 4--Fees Needed To Achieve New FY 2018 Revenue Target
----------------------------------------------------------------------------------------------------------------
FY 2018 Adjusted FY
FY 2018 inflation 2018 fees to FY 2018
Application type statutory fees adjusted meet revenue revenue from
(base fees) statutory target adjusted fees
base fees (standard fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications......................... $294,000 $310,058 $310,764 $11,187,504
Small Business............................ 73,500 77,514 77,691 543,837
Panel-Track Supplement........................ 220,500 232,543 233,073 3,962,241
Small Business............................ 55,125 58,136 58,268 116,272
De Novo Classification Request................ 88,200 93,017 93,229 3,729,160
Small Business............................ 22,050 23,254 23,307 233,070
180-Day Supplements........................... 44,100 46,509 46,615 6,293,025
Small Business............................ 11,025 11,627 11,654 221,426
Real-Time Supplements......................... 20,580 21,704 21,753 4,328,847
Small Business............................ 5,145 5,426 5,438 135,950
510(k)s....................................... 9,996 10,542 10,566 30,239,892
Small Business............................ 2,499 2,635 2,642 2,747,680
30-Day Notice................................. 4,704 4,961 4,972 4,778,092
Small Business............................ 2,352 2,480 2,486 201,366
513(g) Request for Classification Information. 3,969 4,186 4,195 297,845
Small Business............................ 1,985 2,093 2,098 77,626
Annual Fee for Periodic Reporting............. 10,290 10,852 10,877 6,515,323
Small Business............................ 2,573 2,713 2,719 201,206
Establishment Registration.................... 4,375 4,614 4,624 117,468,096
-----------------------------------------------------------------
Total..................................... .............. .............. ................ 193,278,722
----------------------------------------------------------------------------------------------------------------
[[Page 41032]]
The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $310,764 for FY 2018. 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 $4,624 for FY 2018. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 5 summarizes the FY 2018 rates for all medical device fees.
Table 5--Medical Device Fees for FY 2018
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of the
Application fee type standard fee for a premarket FY 2018 FY 2018 small
application) standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted Base fee specified in statute........... $310,764 $77,691
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..................................... 310,764 77,691
section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved 100..................................... 310,764 77,691
BLA under section 351 of the PHS Act).
Panel-track supplement................ 75...................................... 233,073 58,268
De novo classification request........ 30...................................... 93,229 23,307
180-day supplement.................... 15...................................... 46,615 11,654
Real-time supplement.................. 7....................................... 21,753 5,438
510(k) premarket notification 3.40.................................... 10,566 2,642
submission.
30-day notice......................... 1.60.................................... 4,972 2,486
513(g) request for classification 1.35.................................... 4,195 2,098
information.
Annual Fee Type....................... ........................................ .............. ..............
Annual fee for periodic reporting on a 3.50.................................... 10,877 2,719
class III device.
Annual establishment registration fee Base fee specified in statute........... 4,624 4,624
(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 2017, your
status as a small business will expire at the close of business on
September 30, 2017. You must re-qualify for FY 2018 in order to pay
small business fees during FY 2018.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2018, you must submit the following to FDA:
1. A completed FY 2018 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2018 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
2. A certified copy of your Federal (U.S.) Income Tax Return for
the most recent tax year. The most recent tax year will be 2017,
except:
If you submit your FY 2018 MDUFA Small Business Qualification
before April 15, 2018, and you have not yet filed your return for 2017,
you may use tax year 2016.
If you submit your FY 2018 MDUFA Small Business Qualification on or
after April 15, 2018, and have not yet filed your 2017 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
[[Page 41033]]
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 applicant must also submit a
statement signed by the head of the applicant'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 applicant has no affiliates.
If you are a foreign business, and wish to qualify as a small
business for FY 2018, you must submit the following:
1. A completed FY 2018 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2018 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
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 (2017 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 applicant must also submit a statement signed by the
head of the applicant'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
applicant 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, 2017, and September 30,
2018, you must pay the fee in effect for FY 2018. 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 2017 or FY 2018 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, 2017. One choice is for
applications and fees that will be received on or before September 30,
2017, which are subject to FY 2017 fee rates. A second choice is for
applications and fees received on or after October 1, 2017, which are
subject to FY 2018 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
[[Page 41034]]
No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville Road,
14th Floor, Silver Spring, MD 20993-0002.
FDA records the official application receipt date as the later of
the following: (1) The date the application was received by an FDA
Document Control 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 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,
Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver Spring, MD
20993-0002.
VII. Procedures for Paying Annual Establishment Registration Fees
To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) Web site at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the Web site
address, but FDA is not responsible for any subsequent changes to the
Web site 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 2018 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 Web site listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2018 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
[[Page 41035]]
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, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor,
Silver Spring, MD 20993-0002. If needed, FDA's tax identification
number is 53-0196965.
C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2018, or To Register a New Establishment for
FY 2018
Go to the Center for Devices and Radiological Health's Web site 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 2017.
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, 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: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18378 Filed 8-28-17; 8:45 am]
BILLING CODE 4164-01-P
