82 FR 41029 - Medical Device User Fee Rates for Fiscal Year 2018

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 166 (August 29, 2017)

Page Range		41029-41035
FR Document		2017-18378

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.

Federal Register, Volume 82 Issue 166 (Tuesday, August 29, 2017)

[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Pages 41029-41035]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-18378]

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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.

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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
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Total..................................... .............. .............. ................ 193,278,722
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[[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:
[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: 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

Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices 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 Classification Information ................ 69 75 69 71
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 $440,243 lower than the statutory fee rate being increased by $10 to
necessary to estimate the amount of revenue limit. Accordingly, the next determine the new establishment
revenue that will be collected based on step in the fee setting process is to registration fee rate of $4,624 (see 21
the fee amounts. Table 4 displays the FY increase the base fee amounts on a U.S.C. 379j(c)(3) and table 4, column
2018 base fees set in statute (column uniform proportionate basis to generate three), leaving a total revenue shortfall
one) and the inflation adjusted base fees the inflation adjusted total revenue of $12,278. The fees in the second
(per calculations in section III.A.) amounts (see 21 U.S.C. 379j(c)(2)(D)(ii) column from the right are those we are
(column two). Using the inflation and table 4, column three). Applying establishing in FY 2018, which are the
adjusted fees and the 3-year averages of these further adjusted fee rates to the 3- standard fees.
fee paying submissions, the collections year average of fee paying submissions
would total $192,850,757, which is results in the establishment registration

TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2018 REVENUE TARGET
Adjusted FY
FY 2018 2018 fees FY 2018
FY 2018 statu- inflation to meet revenue
Application type tory fees adjusted revenue from adjusted
(base fees) statutory target 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
sradovich on DSK3GMQ082PROD with NOTICES

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

VerDate Sep<11>2014 18:45 Aug 28, 2017 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\29AUN1.SGM 29AUN1

Document Created: 2017-08-29 01:57:47
Document Modified: 2017-08-29 01:57:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		For information on Medical Device User Fees: Visit FDA's Web site at https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ ucm20081521.htm.
FR Citation		82 FR 41029

82 FR 41029 - Medical Device User Fee Rates for Fiscal Year 2018

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 166 (August 29, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration