80 FR 46033 - Medical Device User Fee Rates for Fiscal Year 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

Page Range		46033-46039
FR Document		2015-18907

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016. 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 2016, which apply from October 1, 2015, through September 30, 2016. 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 2016, you should not submit a FY 2016 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2016 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

Federal Register, Volume 80 Issue 148 (Monday, August 3, 2015)

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46033-46039]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-18907]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]

Medical Device User Fee Rates for Fiscal Year 2016

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) 2016. 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 2016, which apply from October 1, 2015, through
September 30, 2016. 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 2016, you should
not submit a FY 2016 Small Business Qualification and Certification
request. This document provides information on how the fees for FY 2016
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/mdufa.
For questions relating to this notice: David Miller, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202E), Silver Spring, MD 20993-0002, 301-796-7103.

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 2016 is
$263,180. From this starting point, this document establishes FY 2016
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 2016 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 2016

The total revenue amount for FY 2016 is $129,339,949, as set forth
in the statute prior to the inflation adjustment. (See 21 U.S.C.
379j(b)(3)(D)). MDUFA III (Pub. L. 112-144) 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 2016 are described
in this document.

Inflation Adjustment

MDUFA III specifies that the $129,339,949 is to be adjusted for
inflation increases for FY 2016 using two separate adjustments--one for
payroll costs and one for non-pay costs (see 21 U.S.C. 379j(c)(2)). The
base inflation adjustment for FY 2016 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 2016.
The 3-year average is 2.2328 percent (rounded).

Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2012 2013 2014 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $1,824,703,000 $1,927,703,000 $2,054,937,000
Total FTE........................... 13,382 13,974 14,555

[[Page 46034]]

PC&B per FTE........................ $136,355 $137,949 $141,184
Percent change from previous year... 3.1843% 1.1690% 2.3451% 2.2328%
----------------------------------------------------------------------------------------------------------------

The payroll adjustment is 2.2328 percent multiplied by 60 percent,
or 1.3397 percent.
The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2016 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 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
----------------------------------------------------------------------------------------------------------------
Fiscal year 2012 2013 2014 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 150.212 152.500 154.847
Annual Percent Change............... 2.2024% 1.5232% 1.5390%
3-Yr Avg. Percent Change in CPI..... ................. ................. ................. 1.7549%
----------------------------------------------------------------------------------------------------------------

The non-pay adjustment is 1.7549 percent multiplied by 40 percent,
or 0.7019 percent.
Next, the payroll adjustment (1.3397 percent or 0.013397) is added
to the non-pay adjustment (0.7019 percent or 0.007019), for a total of
2.0416 percent (or 0.020416). To complete the inflation adjustment, 1
(100 percent or 1.0) is added for a total base inflation adjustment of
1.020416 for FY 2016.
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 2016
(1.020416) is compounded by multiplying it by the compounded applicable
inflation adjustment for FY 2015 (1.04316), as published in the Federal
Register of July 30, 2014 (79 FR 44178 to 44184), to reach the
applicable inflation adjustment of 1.064457 (rounded) (1.020416 times
1.04316) for FY 2016. We then multiply the total revenue amount for FY
2016 ($129,339,949) by 1.064457, yielding an inflation adjusted total
revenue amount of $137,677,000 (rounded to the nearest thousand
dollars).

III. Fees for FY 2016

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 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 2016. The fee paying submission counts are published
in the MDUFA Financial Report to Congress each year.

Table 3--3-Year Average of Fee Paying Submissions
----------------------------------------------------------------------------------------------------------------
Application type FY 2012 actual FY 2013 actual FY 2014 actual 3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications............... 25 23 25 24
Small Business.................. 6 9 5 7
Panel-Track Supplement.............. 12 19 12 14
Small Business.................. 0 0 3 1
180-Day Supplements................. 145 128 122 132
Small Business.................. 21 21 24 22
Real-Time Supplements............... 196 182 192 190
Small Business.................. 22 23 19 21
510(k)s............................. 2,865 3,149 3,034 3,016
Small Business.................. 1,086 1,202 1,037 1,108
30-Day Notice....................... 801 956 934 897
Small Business.................. 60 69 91 73
513(g) Request for Classification 46 65 69 60
Information........................
Small Business.................. 30 38 31 33
Annual Fee for Periodic Reporting 478 614 514 535
\1\................................
Small Business \1\.............. 39 54 56 50
Establishment Registration \2\...... ................. 23,477 24,026 23,752
----------------------------------------------------------------------------------------------------------------
\1\ Includes collection of quarter 4 billing for FY 2014 during FY 2015.
\2\ Establishment Registration total comes from the registration system and will vary from the financial report.

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 both the estimated revenue using the FY 2016 base fees set in
statute and the

[[Page 46035]]

estimated revenue after the inflation adjustment to the FY 2016 base
fees. Using the fees set in statute and the 3-year averages of fee
paying submissions, the collections would total $138,620,884, which is
$943,884 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 $137,677,000 as possible
without exceeding the limit. This is done by calculating the percentage
difference between the statutory revenue limit and the estimated
resulting 2016 revenue collections, and then lowering the fees
proportionally by that percentage (rounded to the nearest dollar).
After recalculating the fees, a further $1 negative adjustment is made
to the establishment fee in order for the estimated revenue to not
exceed the statutory limit. The fees in the second column from the
right are those we are establishing in FY 2016, which are the standard
fees.

Table 4--Fees Needed To Achieve New FY 2016 Revenue Target
----------------------------------------------------------------------------------------------------------------
Adjusted FY 2016
FY 2016 Statutory Estimated fees to meet FY 2016 revenue
Application type fees (base fees) resulting 2016 revenue target from adjusted
revenue (standard fees) fees
----------------------------------------------------------------------------------------------------------------
Full Fee Applications............... $263,180 $6,316,320 $261,388 $6,273,312
Small Business.................. 65,795 460,565 65,347 457,429
Panel-Track Supplement.............. 197,385 2,763,390 196,041 2,744,574
Small Business.................. 49,346 49,346 49,010 49,010
180-Day Supplements................. 39,477 5,210,964 39,208 5,175,456
Small Business.................. 9,869 217,118 9,802 215,644
Real-Time Supplements............... 18,423 3,500,370 18,297 3,476,340
Small Business.................. 4,606 96,726 4,574 96,054
510(k)s............................. 5,264 15,876,224 5,228 15,764,648
Small Business.................. 2,632 2,916,256 2,614 2,896,312
30-Day Notice....................... $4,211 $3,777,267 $4,182 $3,751,254
Small Business.................. 2,106 153,738 2,091 152,643
513(g) Request for Classification 3,553 213,180 3,529 211,740
Information........................
Small Business.................. 1,777 58,641 1,765 58,245
Annual Fee for Periodic Reporting... 9,211 4,927,885 9,149 4,894,715
Small Business.................. 2,303 115,150 2,287 114,350
Establishment Registration.......... 3,872 91,967,744 3,845 91,326,440
---------------------------------------------------------------------------
Total........................... ................. 138,620,884 ................. 137,661,256
----------------------------------------------------------------------------------------------------------------

The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $261,388 for FY 2016. 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;
for a 513(g) (21 U.S.C. 360c(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 $3,845 for FY 2016. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 5 summarizes the FY 2016 rates for all medical device fees.

Table 5--Medical Device Fees for FY 2016
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of
Application fee type the standard fee for a FY 2016 Standard FY 2016 Small
premarket application) fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted Base Fee Adjusted as $261,388 $65,347
under section 515(c)(1) of the FD&C Act Specified in the Statute.
(21 U.S.C. 360e(c)(1)), a PDP submitted
under section 515(f) of the FD&C Act (21
U.S.C. 360e(f)), or a BLA submitted under
section 351 of the Public Health Service
Act (the PHS Act) (42 U.S.C. 262)).
Premarket report (submitted under section 100.......................... 261,388 65,347
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA 100.......................... 261,388 65,347
under section 351 of the PHS Act).
Panel-track supplement..................... 75........................... 196,041 49,010
180-day supplement......................... 15........................... 39,208 9,802
Real-time supplement....................... 7............................ 18,297 4,574
510(k) premarket notification submission... 2............................ 5,228 2,614

[[Page 46036]]

30-day notice.............................. 1.60......................... 4,182 2,091
513(g) request for classification 1.35......................... 3,529 1,765
information.
Annual Fee Type:
Annual fee for periodic reporting on a 3.50......................... 9,149 2,287
class III device.
Annual establishment registration fee Base Fee Adjusted as 3,845 3,845
(to be paid by the establishment Specified in the Statute.
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 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. 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 2015, your
status as a small business will expire at the close of business on
September 30, 2015. You must requalify for FY 2016 in order to pay
small business fees during FY 2016.

A. Domestic (U.S.) Small Business

If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2016, you must submit the following to FDA:
1. A completed FY 2016 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2016 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 2015,
except:
If you submit your FY 2016 MDUFA Small Business Qualification
before April 15, 2016, and you have not yet filed your return for 2015,
you may use tax year 2014.
If you submit your FY 2016 MDUFA Small Business Qualification on or
after April 15, 2016, and have not yet filed your 2015 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 affiliate, or that
the applicant has no affiliates.

B. Foreign Small Business

If you are a foreign business, and wish to qualify as a small
business for FY 2016, you must submit the following:
1. A completed FY 2016 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2016 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 (2015 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

[[Page 46037]]

received by FDA between October 1, 2015, and September 30, 2016, you
must pay the fee in effect for FY 2016. 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 2015 or FY 2016 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: In no case should the
check for the fee be submitted 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, 2015. One choice is for
applications and fees that will be received on or before September 30,
2015, which are subject to FY 2015 fee rates. A second choice is for
applications and fees received on or after October 1, 2015, which are
subject to FY 2016 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 are
accurate, electronically transmit the 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. If paying with credit card or electronic check (Automated
Clearing House (ACH) also known as eCheck):
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. To pay online, select the ``Pay
Now'' button. Credit card transactions for cover sheets cannot exceed
$49,999.99.
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 address is for
courier delivery only. Contact U.S. Bank at 314-418-4013 if you have
any 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:
New York Federal Reserve Bank, 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 Rd.,
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 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 Mail Center, 10903 New Hampshire Ave., Building 66, Rm. 0609,
Silver Spring, MD 20993-0002.
2. Biologics license applications 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.
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. After searching for and locating 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 that do not exceed $49,999.99. If the balance
exceeds this amount, only the ACH option is available. Payments must be
drawn on U.S bank accounts or made with 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.

[[Page 46038]]

(Note: This address is for courier delivery only. Contact the
U.S. Bank at 314-418-4013 if you have any 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:
New York Federal Reserve Bank, 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.,
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 2016
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 the 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; do not send mail to this
address.)
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 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: New York Federal
Reserve Bank, 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., 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 2016, or To Register a New Establishment for
FY 2016

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 2015.
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 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

[[Page 46039]]

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 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18907 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46033

heading of this document. Received making your submission to FDA, you From this starting point, this document
comments may be seen in the Division will have to pay the higher standard fee. establishes FY 2016 fee rates for other
of Dockets Management between 9 a.m. Please note that the establishment types of submissions, and for periodic
and 4 p.m., Monday through Friday, and registration fee is not eligible for a reporting, by applying criteria specified
will be posted to the docket at http:// reduced small business fee. As a result, in the FD&C Act.
www.regulations.gov. if the establishment registration fee is The FD&C Act specifies the base fee
the only medical device user fee that for establishment registration for each
IV. Electronic Access you will pay in FY 2016, you should not year from FY 2013 through FY 2017; the
Persons with access to the Internet submit a FY 2016 Small Business base fee for an establishment
may obtain the guidance at either http:// Qualification and Certification request. registration in FY 2016 is $3,872. There
www.fda.gov/BiologicsBloodVaccines/ This document provides information on is no reduction in the registration fee for
GuidanceComplianceRegulatory how the fees for FY 2016 were small businesses. Each establishment
Information/Guidances/default.htm or determined, the payment procedures that is registered (or is required to
http://www.regulations.gov. you should follow, and how you may register) with the Secretary under
Dated: July 29, 2015. qualify for reduced small business fees. section 510 of the FD&C Act (21 U.S.C.
Leslie Kux, FOR FURTHER INFORMATION CONTACT: For 360) because such establishment is
Associate Commissioner for Policy. information on Medical Device User engaged in the manufacture,
[FR Doc. 2015–18956 Filed 7–31–15; 8:45 am]
Fees: Visit FDA’s Web site at http:// preparation, propagation, compounding,
www.fda.gov/mdufa. or processing of a device is required to
BILLING CODE 4164–01–P
For questions relating to this notice: pay the annual fee for establishment
David Miller, Office of Financial registration.
Management, Food and Drug
DEPARTMENT OF HEALTH AND II. Revenue Amount for FY 2016
Administration, 8455 Colesville Rd.
HUMAN SERVICES
(COLE–14202E), Silver Spring, MD The total revenue amount for FY 2016
Food and Drug Administration 20993–0002, 301–796–7103. is $129,339,949, as set forth in the
SUPPLEMENTARY INFORMATION: statute prior to the inflation adjustment.
[Docket No. FDA–2015–N–0007]
I. Background (See 21 U.S.C. 379j(b)(3)(D)). MDUFA III
Medical Device User Fee Rates for (Pub. L. 112–144) directs FDA to use the
Section 738 of the FD&C Act (21 yearly total revenue amount as a starting
Fiscal Year 2016 U.S.C. 379j) establishes fees for certain point to set the standard fee rates for
AGENCY: Food and Drug Administration, medical device applications, each fee type. The fee calculations for
HHS. submissions, supplements, and notices FY 2016 are described in this document.
ACTION: Notice. (for simplicity, this document refers to
these collectively as ‘‘submissions’’ or Inflation Adjustment
SUMMARY: The Food and Drug ‘‘applications’’); for periodic reporting
Administration (FDA) is announcing the MDUFA III specifies that the
on class III devices; and for the
fee rates and payment procedures for $129,339,949 is to be adjusted for
registration of certain establishments.
medical device user fees for fiscal year inflation increases for FY 2016 using
Under statutorily defined conditions, a
(FY) 2016. The Federal Food, Drug, and two separate adjustments—one for
qualified applicant may receive a fee
Cosmetic Act (the FD&C Act), as payroll costs and one for non-pay costs
waiver or may pay a lower small
amended by the Medical Device User (see 21 U.S.C. 379j(c)(2)). The base
business fee. (See 21 U.S.C. 379j(d) and
Fee Amendments of 2012 (MDUFA III), inflation adjustment for FY 2016 is the
(e).) Additionally, the Secretary of
authorizes FDA to collect user fees for sum of one plus these two separate
Health and Human Services (the
certain medical device submissions and adjustments, and is compounded as
Secretary) may, at the Secretary’s sole
annual fees both for certain periodic specified (see 21 U.S.C. 379j(c)(2)(C)(1)
discretion, grant a fee waiver or
reports and for establishments subject to and 379j(c)(2)(B)(ii)).
reduction if the Secretary finds that
registration. This notice establishes the such waiver or reduction is in the The component of the inflation
fee rates for FY 2016, which apply from interest of public health. (See 21 U.S.C. adjustment for payroll costs is the
October 1, 2015, through September 30, 379j(f).) average annual percent change in the
2016. To avoid delay in the review of Under the FD&C Act, the fee rate for cost of all personnel compensation and
your application, you should pay the each type of submission is set at a benefits (PC&B) paid per full-time
application fee before or at the time you specified percentage of the standard fee equivalent position (FTE) at FDA for the
submit your application to FDA. The fee for a premarket application (a premarket first 3 of the 4 preceding FYs,
you must pay is the fee that is in effect application is a premarket approval multiplied by 0.60, or 60 percent (see 21
on the later of the date that your application (PMA), a product U.S.C. 379j(c)(2)(C)).
application is received by FDA or the development protocol (PDP), or a Table 1 summarizes the actual cost
date your fee payment is recognized by biologics license application (BLA)). and FTE data for the specified FYs, and
the U.S. Treasury. If you want to pay a The FD&C Act specifies the base fee for provides the percent change from the
reduced small business fee, you must a premarket application for each year previous FY and the average percent
qualify as a small business before from FY 2013 through FY 2017; the base change over the first 3 of the 4 FYs
making your submission to FDA; if you fee for a premarket application received preceding FY 2016. The 3-year average
mstockstill on DSK4VPTVN1PROD with NOTICES

do not qualify as a small business before by FDA during FY 2016 is $263,180. is 2.2328 percent (rounded).

TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year 2012 2013 2014 3-Year average

Total PC&B .............................................................................. $1,824,703,000 $1,927,703,000 $2,054,937,000
Total FTE ................................................................................. 13,382 13,974 14,555

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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46039

manufacture, preparation, propagation, included in the Recommended Uniform comments should identify the
compounding, or processing of licensed Screening Panel (RUSP) and constitute individual’s name, address, email,
biologic devices. CBER will send part of the comprehensive guidelines telephone number, professional or
invoices for payment of the supported by the Health Resources and business affiliation, type of expertise
establishment registration fee to such Services Administration. Pursuant to (i.e., parent, researcher, clinician, public
establishments. section 2713 of the Public Health health, etc.), and the topic/subject
Dated: July 28, 2015. Service Act, codified at 42 U.S.C. matter of comments. To ensure that all
300gg–13, non-grandfathered health individuals who have registered to make
Leslie Kux,
plans and group and individual health oral comments can be accommodated,
Associate Commissioner for Policy.
insurance issuers are required to cover the allocated time may be limited.
[FR Doc. 2015–18907 Filed 7–31–15; 8:45 am] evidence-informed care and screenings Individuals who are associated with
BILLING CODE 4164–01–P included in the HRSA-supported groups or have similar interests may be
comprehensive guidelines without requested to combine their comments
charging a co-payment, co-insurance, or and present them through a single
DEPARTMENT OF HEALTH AND deductible for plan years (in the representative. No audiovisual
HUMAN SERVICES individual market, policy years) presentations are permitted. For
beginning on or after the date that is one additional information or questions on
Health Resources and Services
year from the Secretary’s adoption of the public comments, please contact Lisa
Administration
condition for screening. Vasquez, Maternal and Child Health
Advisory Committee on Heritable Agenda: The meeting will include: (1) Bureau, Health Resources and Services
Disorders in Newborns and Children; A final evidence review report on the Administration; email: lvasquez@
Notice of Meeting Adrenoleukodystrophy (ALD) condition hrsa.gov.
nomination for inclusion in the RUSP; Contact Person: Anyone interested in
In accordance with section 10(a)(2) of (2) a presentation by the Newborn obtaining other relevant information
the Federal Advisory Committee Act Screening Technical Assistance and should contact Debi Sarkar, Maternal
(Pub. L. 92–463, codified at 5 U.S.C. Evaluation Program (NewSTEPs) on and Child Health Bureau, Health
App.), notice is hereby given of the their activities and the NewSTEPs data Resources and Services Administration,
following meeting: repository, a centralized and secure Room 18W68, Parklawn Building, 5600
Name: Advisory Committee on database designed for state newborn Fishers Lane, Rockville, Maryland
Heritable Disorders in Newborns and screening programs to explore data to 20857; email: dsarkar@hrsa.gov.More
Children meet program needs; (3) updates on the information on the Advisory Committee
Dates and Times: August 27, 2015, 9 implementation of screening for Severe is available at http://www.hrsa.gov/
a.m. to 5 p.m. Combined Immunodeficiency, Critical advisorycommittees/mchbadvisory/
August 28, 2015, 10 a.m. to 1 p.m. Congenital Heart Disease, and Pompe heritabledisorders.
Place: Webinar and In-Person, Disease; and (4) updates from
National Institutes of Health, 5635 workgroups focused on cost analysis in Jackie Painter,
Fishers Lane, Rockville, Maryland newborn screening, newborn screening Director, Division of the Executive Secretariat.
20857 timeliness, and pilot studies for [FR Doc. 2015–18953 Filed 7–31–15; 8:45 am]
Status: The meeting will be open to evidence-based reviews of conditions. BILLING CODE 4165–15–P
the public with attendance limited to Following the final evidence review
space availability. Participants also have report on ALD, the Committee also is
the option of viewing the meeting via expected to vote on whether or not to DEPARTMENT OF HEALTH AND
webinar. Whether attending in-person recommend to the Secretary the HUMAN SERVICES
or via webinar, all participants must addition of ALD to the RUSP. Agenda
register for the meeting. Please register items are subject to change as necessary National Institutes of Health
at https://www.blsmeetings.net/ or appropriate. The agenda, webinar
ACHDNCAugust2015. The registration Center for Scientific Review; Notice of
information, Committee Roster, Charter, Closed Meeting
deadline is Friday, August 14, 2015, presentations, and other meeting
11:59 p.m. Eastern Time. materials will be located on the Pursuant to section 10(d) of the
Purpose: The Advisory Committee on Advisory Committee’s Web site at Federal Advisory Committee Act, as
Heritable Disorders in Newborns and http://www.hrsa.gov/ amended (5 U.S.C. App.), notice is
Children (Committee), as authorized by advisorycommittees/mchbadvisory/ hereby given of the following meeting.
Public Health Service Act, Title XI, heritabledisorders. The meeting will be closed to the
§ 1111 (42 U.S.C. 300b-10), as amended Public Comments: Members of the public in accordance with the
by the Newborn Screening Saves Lives public may present oral comments and/ provisions set forth in sections
Reauthorization Act of 2014 (Pub. L. or submit written comments. Comments 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
113–240), was established to advise the are part of the official Committee record. as amended. The grant applications and
Secretary of the Department of Health The public comment period is the discussions could disclose
and Human Services about the tentatively scheduled for both days of confidential trade secrets or commercial
development of newborn screening the meeting. Advance registration is property such as patentable material,
activities, technologies, policies, required to present oral comments and/ and personal information concerning
mstockstill on DSK4VPTVN1PROD with NOTICES

guidelines, and programs for effectively or submit written comments. Please individuals associated with the grant
reducing morbidity and mortality in register at https://www.blsmeetings.net/ applications, the disclosure of which
newborns and children having, or at risk ACHDNCAugust2015. The registration would constitute a clearly unwarranted
for, heritable disorders. In addition, the deadline is Friday, August 14, 2015, invasion of personal privacy.
Committee’s recommendations 11:59 p.m. Eastern Time. Written Name of Committee: Center for Scientific
regarding additional conditions/ comments must be received by the Review Special Emphasis Panel; Member
heritable disorders for screening that deadline in order to be included in the Conflict: HIV Molecular Biology.
have been adopted by the Secretary are August meeting briefing book. Written Date: August 7, 2015.

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Document Created: 2018-02-23 10:51:59
Document Modified: 2018-02-23 10:51:59

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/mdufa.
FR Citation		80 FR 46033

80 FR 46033 - Medical Device User Fee Rates for Fiscal Year 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration