81 FR 49987 - Medical Device User Fee Rates for Fiscal Year 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 146 (July 29, 2016)

Page Range		49987-49993
FR Document		2016-17903

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), 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 2017, which apply from October 1, 2016, through September 30, 2017. 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 2017, you should not submit a FY 2017 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2017 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

Federal Register, Volume 81 Issue 146 (Friday, July 29, 2016)

[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)]
[Notices]
[Pages 49987-49993]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-17903]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]

Medical Device User Fee Rates for Fiscal Year 2017

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) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 2012
(MDUFA III), 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 2017, which apply from October 1, 2016, through
September 30, 2017. 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 2017, you should
not submit a FY 2017 Small Business Qualification and Certification
request. This document provides information on how the fees for FY 2017
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 http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
For questions relating to this notice: Maurille Beheton, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202C), Silver Spring, MD 20993-0002, 301-796-4689.

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, and
notices (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)). Additionally, the Secretary of Health and Human Services (the
Secretary) may, at the Secretary's sole discretion, grant a fee waiver
or reduction if the Secretary finds that such waiver or reduction is in
the interest of public health (see 21 U.S.C. 379j(f)).
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 2013 through FY 2017; the
base fee for a premarket application received by FDA during FY 2017 is
$268,443. From this starting point, this document establishes FY 2017
fee rates for other 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 2013 through FY 2017; the base fee for an
establishment registration in FY 2017 is $3,872. There is no reduction
in the registration fee for small businesses. Each establishment that
is registered (or is required to register) with the Secretary 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 2017

The total revenue amount for FY 2017 is $130,184,348, as set forth
in the statute prior to the inflation adjustment and offset of excess
collections (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 2017 are described
in this document.

A. Inflation Adjustment

MDUFA specifies that the $130,184,348 is to be adjusted for
inflation increases for FY 2017 using two separate adjustments--one for
payroll costs and one for non-pay cost (see 21 U.S.C. 379j(c)(2)). The
base inflation adjustment for FY 2017 is the sum of one plus these two
separate adjustments, and is compounded as specified (see 21 U.S.C.
379j(c)(2)(C)(1) and 379j(c)(2)(B)(ii)).
The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all personnel compensation
and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
Table 1 summarizes the actual cost and FTE data for the specified
FYs, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2017.
The 3-year average is 1.8759 percent (rounded).

Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
3-Year
Fiscal Year 2013 2014 2015 average
----------------------------------------------------------------------------------------------------------------
Total PC&B............................. $1,927,703,000 $2,054,937,000 $2,232,304,000 ..............
Total FTE.............................. 13,974 14,555 15,484 ..............
PC&B per FTE........................... $137,949 $141,184 $144,168 ..............
Percent change from previous year...... 1.1690% 2.3451% 2.1136% 1.8759%
----------------------------------------------------------------------------------------------------------------

[[Page 49988]]

The payroll adjustment is 1.8759 percent multiplied by 60 percent,
or 1.1255 percent.
The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2017 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. This
data is published by the Bureau of Labor Statistics and can be found on
their Web site at http://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 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
3-Year
Fiscal year 2013 2014 2015 average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................... 152.500 154.847 155.353 ..............
Annual Percent Change........................... 1.5232% 1.5390% 0.3268% ..............
3-Year Avg. Percent Change in CPI............... .............. .............. .............. 1.1297%
----------------------------------------------------------------------------------------------------------------

The non-pay adjustment is 1.1297 percent multiplied by 40 percent,
or 0.4519 percent.
Next, the payroll adjustment (1.1255 percent or 0.011255) is added
to the non-pay adjustment (0.4519 percent or 0.004519), for a total of
1.5774 percent (or 0.015774). To complete the inflation adjustment, 1
(100 percent or 1.0) is added for a total base inflation adjustment of
1.015774 for FY 2017.
MDUFA III provides for this inflation adjustment to be compounded
for FY 2015 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2017
(1.015774) is compounded by multiplying it by the compounded applicable
inflation adjustment for FY 2016 (1.064457), as published in the
Federal Register of August 3, 2015 (80 FR 46033 to 46039), to reach the
applicable inflation adjustment of 1.081248 (rounded) (1.015774 times
1.064457) for FY 2017. We then multiply the total revenue amount for FY
2017 ($130,184,348) by 1.081248, yielding an inflation adjusted total
revenue amount of $140,762,000 (rounded to the nearest thousand
dollars).

B. Offset for Excess Collections Through FY 2016

Under the offset provision of the FD&C Act (see section 738(i)(4)
(21 U.S.C. 379j(i)(4))), if the cumulative amount of fees collected
during FY 2013 through FY 2015, added to the amount estimated to be
collected for FY 2016, exceeds the cumulative amount appropriated for
these four FYs, the excess shall be credited to the appropriation
account of the Food and Drug Administration and shall be subtracted
from the amount of fees that would otherwise be authorized to be
collected for FY 2017. Table 3 presents the amount of MDUFA fees
collected during FY 2013 through FY 2015 (actuals), and the amount
estimated to be collected for FY 2016, and compares those amounts with
the fees specified to be appropriated in these four FYs.

Table 3--Statement of Fees Appropriated, Fees Collected, and Differences as of June 30, 2016
----------------------------------------------------------------------------------------------------------------
Fee
Fiscal year appropriated Fees collected Difference
--------------------------------------------------------------------------------------------------
2013 Actual....................................... $97,722,000 $103,991,182 $6,269,182
2014 Actual....................................... 114,833,000 124,297,628 9,464,628
2015 Actual....................................... 128,282,000 139,712,238 11,430,238
2016 Estimate..................................... 134,667,000 134,667,000 0
-------------------------------------------------------------
Total......................................... 478,504,000 505,668,048 27,164,048
Unearned Revenue Included in Above Amount......... .............. .............. 12,485,897
Excess Collections Less Unearned Revenue (Offset .............. .............. 14,678,151
Amount)..........................................
----------------------------------------------------------------------------------------------------------------

The total amount FDA expects to have collected in excess of
appropriations by the end of FY 2016 is $27,164,048. However, of that
amount, a total of $12,485,897 represents unearned revenue--primarily
fees paid for applications that have not yet been received. The
unearned revenue is held in reserve either to refund, if no application
is submitted, or to apply toward the future FY when the application is
received. The net of these two figures, $14,678,151, is the amount that
FDA has received in excess of appropriations that is available for
obligation, and the amount by which fee revenue will be offset in FY
2017.
For FY 2017, the statute authorizes $140,762,000 in user fees. In
order to determine the revised collection amount, we deduct the net
excess collection amount of $14,678,151 from $140,762,000, and the
revised revenue target for FY 2017 becomes $126,083,000 (rounded down
to the nearest thousand dollars).

III. Fees for FY 2017

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)). Table 4 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 2017. Most of the fee paying submission counts are
published in the MDUFA Financial Report to Congress each year.

[[Page 49989]]

Table 4--3-Year Average of Fee Paying Submissions
----------------------------------------------------------------------------------------------------------------
FY 2013 FY 2014 FY 2015 3-Year
Application type actual actual actual average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... 23 25 42 30
Small Business.............................. 9 5 7 7
Panel-Track Supplement.......................... 19 12 22 18
Small Business.............................. 0 3 3 2
180-Day Supplements............................. 128 122 143 131
Small Business.............................. 21 24 15 20
Real-Time Supplements........................... 182 192 204 193
Small Business.............................. 23 19 28 23
510(k)s......................................... 3,149 3,034 2,768 2,984
Small Business.............................. 1,202 1,037 1,037 1,092
30-Day Notice................................... 956 934 920 937
Small Business.............................. 69 91 71 77
513(g) (21 U.S.C. 360c(g)) Request for 65 69 75 70
Classification Information.....................
Small Business.............................. 38 31 33 34
Annual Fee for Periodic Reporting \1\........... 614 514 544 557
Small Business \1\.......................... 54 56 68 59
Establishment Registration \2\.................. 23,477 24,026 25,363 24,289
----------------------------------------------------------------------------------------------------------------
\1\ Includes collection of quarter 4 billing for FY 2015 during FY 2016.
\2\ Establishment Registration total comes from the registration system and will vary from the financial report.

The information in table 4 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 5
displays both the estimated revenue using the FY 2017 base fees set in
statute and the estimated revenue after the inflation adjustment and
offset of excess collections to the FY 2017 base fees. Using the fees
set in statute and the 3 year averages of fee paying submissions, the
collections would total $144,335,998, which is $18,252,998 higher than
the statutory revenue limit. Accordingly the PMA and establishment fee
need to be decreased so that collections come as close to the statutory
revenue limit of $126,083,000 as possible without exceeding the limit.
This is done by calculating the percentage difference between the
statutory revenue limit and the estimated resulting 2017 revenue
collections, and then lowering the fees proportionally by that
percentage (rounded to the nearest dollar). The fees in the second
column from the right are those we are establishing in FY 2017, which
are the standard fees.

Table 5--Fees Needed To Achieve New FY 2017 Revenue Target
----------------------------------------------------------------------------------------------------------------
Adjusted FY
FY 2017 2017 fees to
Statutory Estimated meet revenue FY 2017
Application type fees (base resulting target Revenue from
fees) 2017 revenue (standard adjusted fees
fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... $268,443 $8,053,290 $234,495 $7,034,850
Small Business.............................. 67,111 469,777 58,624 410,368
Panel-Track Supplement.......................... 201,332 3,623,976 175,871 3,165,678
Small Business.............................. 50,333 100,666 43,968 87,936
180-Day Supplements............................. 40,266 5,274,846 35,174 4,607,794
Small Business.............................. 10,067 201,340 8,794 175,880
Real-Time Supplements........................... 18,791 3,626,663 16,415 3,168,095
Small Business.............................. 4,698 108,054 4,104 94,392
510(k)s......................................... 5,369 16,021,096 4,690 13,994,960
Small Business.............................. 2,685 2,932,020 2,345 2,560,740
30-Day Notice................................... 4,295 4,024,415 3,752 3,515,624
Small Business.............................. 2,148 165,396 1,876 144,452
513(g) Request for Classification Information... 3,624 253,680 3,166 221,620
Small Business.............................. 1,812 61,608 1,583 53,822
Annual Fee for Periodic Reporting............... 9,396 5,233,572 8,207 4,571,299
Small Business.............................. 2,349 138,591 2,052 121,068
Establishment Registration...................... 3,872 94,047,008 3,382 82,145,398
---------------------------------------------------------------
Total....................................... .............. 144,335,998 .............. 126,073,976
----------------------------------------------------------------------------------------------------------------

The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $234,495 for FY 2017. 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 180-day supplement, 15 percent of the standard fee;
For a real-time supplement, 7 percent of the standard fee;
For a 510(k) premarket notification, 2 percent of the
standard fee;
For a 30-day notice, 1.6 percent of the standard fee;

[[Page 49990]]

For a 513(g) request for classification information, 1.35
percent of the standard fee; and
For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee.
For all submissions other than a 510(k) premarket notification, 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)). For a 510(k) premarket
notification submission, 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) and
(e)(2)(C)).
The annual fee for establishment registration, after adjustment, is
set at $3,382 for FY 2017. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 6 summarizes the FY 2017 rates for all medical device fees.

Table 6--Medical Device Fees for FY 2017
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of
Application fee type the standard fee for a FY 2017 FY 2017 Small
premarket application) Standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Base fee specified in statute at $234,495 $58,624
section 515(c)(1) of the FD&C Act (21 U.S.C. $268,443, but multiplied by
360e(c)(1)), a PDP submitted under section 87.3538 percent.
515(f) of the FD&C Act, or a BLA submitted
under section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262)).
Premarket report (submitted under section 100............................. 234,495 58,624
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under 100............................. 234,495 58,624
section 351 of the PHS Act).
Panel-track supplement........................ 75.............................. 175,871 43,968
180-day supplement............................ 15.............................. 35,174 8,794
Real-time supplement.......................... 7............................... 16,415 4,104
510(k) premarket notification submission...... 2............................... 4,690 2,345
30-day notice................................. 1.60............................ 3,752 1,876
513(g) request for classification information. 1.35............................ 3,166 1,583
Annual Fee Type:
Annual fee for periodic reporting on a 3.50............................ 8,207 2,052
class III device.
Annual establishment registration fee (to Base fee specified in statute at 3,382 3,382
be paid by the establishment engaged in $3,872, but multiplied by
the manufacture, preparation, 87.3538 percent.
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 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 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 (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates
along with your own gross receipts or sales when determining whether
you meet the $100 million or $30 million threshold. 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 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 2016, your
status as a small business will expire at the close of business on
September 30, 2016. You must re-qualify for FY 2017 in order to pay
small business fees during FY 2017.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2017, you must submit the following to FDA:
1. A completed FY 2017 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2017 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
http://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 2016,
except:
If you submit your FY 2017 MDUFA Small Business Qualification
before April 15, 2017, and you have not yet filed your return for 2016,
you may use tax year 2015.
If you submit your FY 2017 MDUFA Small Business Qualification on or
after April 15, 2017, and have not yet filed your 2016 return because
you obtained an extension, you may submit your most recent return filed
prior to the extension.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year, or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The 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

[[Page 49991]]

affiliate, or that the applicant has no affiliates.
If you are a foreign business, and wish to qualify as a small
business for FY 2017, you must submit the following:
1. A completed FY 2017 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2017 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://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 (2016 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, 2016, and September 30,
2017, you must pay the fee in effect for FY 2017. 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 2016 or FY 2017 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, 2016. One choice is for
applications and fees that will be received on or before September 30,
2016, which are subject to FY 2016 fee rates. A second choice is for
applications and fees received on or after October 1, 2016, which are
subject to FY 2017 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. Once you search for your
invoice, click ``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
drawn on 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 the 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. Ask your financial institution about the fee and add it
to your payment to ensure that your cover sheet is fully paid.
Use the following account information when sending a wire transfer:
U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
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 FDA or (2)
the date the U.S. Treasury recognizes the payment. It is helpful if the
fee arrives at the bank at

[[Page 49992]]

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 one of the following addresses:
1. Medical device applications should be submitted to: Food and
Drug Administration, Center for Devices and Radiological Health,
Document Control Center, 10903 New Hampshire Ave., Building 66, Rm.
0609, Silver Spring, MD 20993-0002.
2. Biologics license applications and other medical device
submissions reviewed by the Center for Biologics Evaluation and
Research should be sent to: Food and Drug Administration, Center for
Biologics Evaluation and Research, Document Control Center, 10903 New
Hampshire Ave, Building 71, Rm. G112, Silver Spring, MD 20993-0002.

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 PMA.
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). Secure electronic
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. Once you search for your invoice, click ``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 drawn on 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 invoice number on the check.
Mail the paper check and a copy of 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.)

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 the 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 invoice number in your wire transfer.
Without the invoice number, your payment may not be applied and you may
be referred to collections.
The originating financial institution may charge a wire
transfer fee. Ask your financial institution about the fee and add it
to your payment to ensure that your invoice is fully paid.
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 Fees

To pay the annual establishment 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 2017
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 2016 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:
You may pay by a check, in U.S. dollars and drawn on a U.S. bank,
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 the 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 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 49993]]

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. Ask your financial institution about the fee and add it to your
payment to ensure that your order is fully paid. 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 2017, or To Register a New Establishment for
FY 2017

Go to the Center for Devices and Radiological Health's Web site at
http://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 2016.
Manufacturers of licensed biologics should register in the BER system
at http://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
BERS should be directed to http://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call 240-402-8360.

D. Enter Your DFUF Order PIN and PCN

After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.

Dated: July 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17903 Filed 7-28-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices 49987

Dated: July 21, 2016. how the fees for FY 2017 were The FD&C Act specifies the base fee
Leslie Kux, determined, the payment procedures for establishment registration for each
Associate Commissioner for Policy. you should follow, and how you may year from FY 2013 through FY 2017; the
[FR Doc. 2016–17659 Filed 7–28–16; 8:45 am] qualify for reduced small business fees. base fee for an establishment
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: registration in FY 2017 is $3,872. There
For information on Medical Device is no reduction in the registration fee for
User Fees: Visit FDA’s Web site at small businesses. Each establishment
DEPARTMENT OF HEALTH AND http://www.fda.gov/ForIndustry/ that is registered (or is required to
HUMAN SERVICES UserFees/MedicalDeviceUserFee/ register) with the Secretary under
ucm20081521.htm. section 510 of the FD&C Act (21 U.S.C.
Food and Drug Administration For questions relating to this notice: 360) because such establishment is
[Docket No. FDA–2016–N–0007] Maurille Beheton, Office of Financial engaged in the manufacture,
Management, Food and Drug preparation, propagation, compounding,
Medical Device User Fee Rates for Administration, 8455 Colesville Rd. or processing of a device is required to
Fiscal Year 2017 (COLE–14202C), Silver Spring, MD pay the annual fee for establishment
20993–0002, 301–796–4689. registration.
AGENCY: Food and Drug Administration,
HHS. SUPPLEMENTARY INFORMATION: II. Revenue Amount for FY 2017
ACTION: Notice. I. Background
The total revenue amount for FY 2017
SUMMARY: The Food and Drug Section 738 of the FD&C Act (21 is $130,184,348, as set forth in the
Administration (FDA) is announcing the U.S.C. 379j) establishes fees for certain statute prior to the inflation adjustment
fee rates and payment procedures for medical device applications, and offset of excess collections (see 21
medical device user fees for fiscal year submissions, supplements, and notices U.S.C. 379j(b)(3)). MDUFA directs FDA
(FY) 2017. The Federal Food, Drug, and (for simplicity, this document refers to to use the yearly total revenue amount
Cosmetic Act (the FD&C Act), as these collectively as ‘‘submissions’’ or as a starting point to set the standard fee
amended by the Medical Device User ‘‘applications’’); for periodic reporting rates for each fee type. The fee
Fee Amendments of 2012 (MDUFA III), on class III devices; and for the calculations for FY 2017 are described
authorizes FDA to collect user fees for registration of certain establishments. in this document.
certain medical device submissions and Under statutorily defined conditions, a
qualified applicant may receive a fee A. Inflation Adjustment
annual fees both for certain periodic
reports and for establishments subject to waiver or may pay a lower small MDUFA specifies that the
registration. This notice establishes the business fee (see 21 U.S.C. 379j(d) and $130,184,348 is to be adjusted for
fee rates for FY 2017, which apply from (e)). Additionally, the Secretary of inflation increases for FY 2017 using
October 1, 2016, through September 30, Health and Human Services (the two separate adjustments—one for
2017. To avoid delay in the review of Secretary) may, at the Secretary’s sole payroll costs and one for non-pay cost
your application, you should pay the discretion, grant a fee waiver or (see 21 U.S.C. 379j(c)(2)). The base
application fee before or at the time you reduction if the Secretary finds that inflation adjustment for FY 2017 is the
submit your application to FDA. The fee such waiver or reduction is in the sum of one plus these two separate
you must pay is the fee that is in effect interest of public health (see 21 U.S.C. adjustments, and is compounded as
on the later of the date that your 379j(f)). specified (see 21 U.S.C. 379j(c)(2)(C)(1)
application is received by FDA or the Under the FD&C Act, the fee rate for and 379j(c)(2)(B)(ii)).
date your fee payment is recognized by each type of submission is set at a
the U.S. Treasury. If you want to pay a specified percentage of the standard fee The component of the inflation
reduced small business fee, you must for a premarket application (a premarket adjustment for payroll costs is the
qualify as a small business before application is a premarket approval average annual percent change in the
making your submission to FDA; if you application (PMA), a product cost of all personnel compensation and
do not qualify as a small business before development protocol (PDP), or a benefits (PC&B) paid per full-time
making your submission to FDA, you biologics license application (BLA)). equivalent position (FTE) at FDA for the
will have to pay the higher standard fee. The FD&C Act specifies the base fee for first 3 of the 4 preceding FYs,
Please note that the establishment a premarket application for each year multiplied by 0.60, or 60 percent (see 21
registration fee is not eligible for a from FY 2013 through FY 2017; the base U.S.C. 379j(c)(2)(C)).
reduced small business fee. As a result, fee for a premarket application received Table 1 summarizes the actual cost
if the establishment registration fee is by FDA during FY 2017 is $268,443. and FTE data for the specified FYs, and
the only medical device user fee that From this starting point, this document provides the percent change from the
you will pay in FY 2017, you should not establishes FY 2017 fee rates for other previous FY and the average percent
submit a FY 2017 Small Business types of submissions, and for periodic change over the first 3 of the 4 FYs
Qualification and Certification request. reporting, by applying criteria specified preceding FY 2017. The 3-year average
This document provides information on in the FD&C Act. is 1.8759 percent (rounded).

TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
ebenthall on DSK5MVXVN1PROD with NOTICES

3-Year
Fiscal Year 2013 2014 2015 average

Total PC&B .................................................................................... $1,927,703,000 $2,054,937,000 $2,232,304,000 ........................
Total FTE ....................................................................................... 13,974 14,555 15,484 ........................
PC&B per FTE ............................................................................... $137,949 $141,184 $144,168 ........................
Percent change from previous year .............................................. 1.1690% 2.3451% 2.1136% 1.8759%

VerDate Sep<11>2014 21:05 Jul 29, 2016 Jkt 238001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\29JYN1.SGM 29JYN1

Document Created: 2018-02-08 07:52:02
Document Modified: 2018-02-08 07:52:02

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 http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ ucm20081521.htm.
FR Citation		81 FR 49987

81 FR 49987 - Medical Device User Fee Rates for Fiscal Year 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 146 (July 29, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration