Medical Device User Fee Rates for Fiscal Year 2014, 46970-46976 [2013-18623]
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Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
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III. How To Submit Comments
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Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18630 Filed 8–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0007]
Medical Device User Fee Rates for
Fiscal Year 2014
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2014. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Medical Device User
Fee Amendments of 2012, which was
signed by the President on July 9, 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.
The FY 2014 fee rates are provided in
this document. These fees apply from
October 1, 2013, through September 30,
2014. To avoid delay in the review of
your application, you should pay the 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 you make your
submission to FDA; if you do not
qualify as a small business before you
make your submission to FDA, you will
have to pay the higher standard fee.
This document provides information on
how the fees for FY 2014 were
determined, the payment procedures
you should follow, and how you may
qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT: For
information on Medical Device User
Fees: Visit FDA’s Web site at https://
www.fda.gov/mdufa.
For questions relating to this notice:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301–796–7103.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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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 2014 is $252,960.
From this starting point, this document
establishes FY 2014 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 2014 is $3,200. 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 2014
The base revenue amount for FY 2014
is $112,580,497, as set forth in the
statute prior to the inflation adjustment.
MDUFA directs FDA to use the yearly
revenue amount as a starting point to set
the fee rates for each fee type. The fee
calculations for FY 2014 are described
in this document.
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Inflation Adjustment
MDUFA specifies that the
$112,580,497 is to be further adjusted
for inflation increases for FY 2014 using
two separate adjustments—one for
payroll costs and one for non-pay cost
(see 21 U.S.C. 379j(c)(2)).
The component of the inflation
adjustment for payroll costs shall be one
plus 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 .60, or 60 percent
(see 21 U.S.C. 379j(c)(2)(C)). The data on
total PC&B paid and numbers of FTE
paid, from which the average cost per
FTE can be derived, are published in
FDA’s Justification of Estimates for
Appropriations Committees.
Table 1 summarizes that 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 2014. The 3-year average
is 2.05 percent.
TABLE 1—FDA PC&B’S EACH YEAR AND PERCENT CHANGE
Fiscal year
2010
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent change from previous year ........................................
The payroll adjustment is 2.05
percent multiplied by 60 percent, or
1.23 percent.
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs for FY 2014 is the average
annual percent change that occurred in
the Consumer Price Index (CPI) for
urban consumers (Washington-
2011
$1,634,108,000
12,526
$130,457
1.67%
2012
$1,761,655,000
13,331
$132,147
1.30%
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 .40,
or 40 percent (see 21 U.S.C.
379j(c)(2)(C)).
Table 2 provides the summary data
for the percent change in the specified
CPI for the Baltimore-Washington area.
3-Year average
$1,824,703,000
13,382
$136,355
3.18%
..............................
..............................
..............................
2.05%
This data is published by the Bureau of
Labor Statistics and can be found on
their Web site at https://data.bls.gov/cgibin/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
Year
2010
Annual CPI ...............................................................................
Annual percent change ............................................................
The non-pay adjustment is 2.42
percent times 40 percent, or .968
percent.
To complete the inflation adjustment,
the payroll component (1.230 percent) is
added to the non-pay component (0.968
percent), for a total inflation adjustment
of 2.198 percent (rounded), and then
one is added, making 1.02198. The base
revenue amount for FY 2014
2011
142.218
1.72%
2012
146.975
3.34%
($112,580,497) is then multiplied by
1.02198, yielding an inflation adjusted
amount of $115,055,000 (rounded to the
nearest thousand dollars).
III. Fees for FY 2014
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).) For FY 2014, the
3-Year average
150.212
2.20%
..............................
2.42%
base fee will be adjusted as specified in
the FD&C Act for inflation (see 21 U.S.C.
379j(b) and (c)). Table 3 provides the
last 3 years of fee paying submission
counts. These numbers are used to
project the fee paying submission that
FDA will receive in FY 2014. The fee
paying submission counts are published
in the Agency’s MDUFA Financial
Report to Congress each year.
TABLE 3—3-YEAR AVERAGE OF FEE PAYING SUBMISSIONS
FY 2010
actual
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Application type
Full Fee Applications .......................................................................................
Small Business .........................................................................................
Panel Track Supplement .................................................................................
Small Business .........................................................................................
180-Day Supplements .....................................................................................
Small Business .........................................................................................
Real-Time Supplements ..................................................................................
Small Business .........................................................................................
510(k)s .............................................................................................................
Small Business .........................................................................................
30-Day Notice ..................................................................................................
Small Business .........................................................................................
513(g) Request for Classification Information .................................................
Small Business .........................................................................................
Annual Fee for Periodic Reporting ..................................................................
Small Business .........................................................................................
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FY 2011
actual
32
8
11
2
103
20
146
20
2,367
1,032
669
78
56
25
427
78
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24
7
7
1
92
15
145
17
2,398
938
755
67
40
35
466
78
02AUN1
FY 2012
actual
25
6
12
0
145
21
196
22
2,865
1,086
801
60
46
30
478
39
3-Year
average
27
7
10
1
113
19
162
20
2,543
1,019
742
68
47
30
457
65
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TABLE 3—3-YEAR AVERAGE OF FEE PAYING SUBMISSIONS—Continued
Application type
FY 2010
actual
FY 2011
actual
FY 2012
actual
Establishment Registration 1 * ..........................................................................
........................
........................
........................
1 Estimate
3-Year
average
22,500
for establishment registration based on preliminary FY 2013 numbers because the criteria for this fee changed beginning in FY
2013.
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
2014 base fees set in statute and the
estimated revenue adding the inflation
adjustment to the FY 2014 base fees.
The increases to the base fees are
needed in order to collect the new
revenue target of $115,055,000.
TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2014 REVENUE TARGET
FY 2014 base
fees
Application type
Estimated
revenue
Adjusted FY
2014 fees
(standard fee)
Adjusted
revenue
$252,960
63,240
189,720
47,430
37,944
9,486
17,707
4,427
5,059
2,530
4,047
2,024
3,415
1,707
8,854
2,213
3,200
$6,829,920
442,680
1,897,200
47,430
4,287,672
180,234
2,868,566
88,536
12,865,546
2,577,662
3,003,141
137,610
160,503
51,224
4,046,095
143,871
72,000,000
$258,520
64,630
193,890
48,473
38,778
9,695
18,096
4,524
5,170
2,585
4,136
2,068
3,490
1,745
9,048
2,262
3,313
$6,980,040
452,410
1,938,900
48,473
4,381,914
184,205
2,931,552
90,480
13,147,310
2,634,115
3,068,912
140,624
164,030
52,350
4,134,936
147,030
74,542,500
Total ..........................................................................................................
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Full Fee Applications .......................................................................................
Small Business .........................................................................................
Panel-Track Supplement .................................................................................
Small Business .........................................................................................
180-Day Supplements .....................................................................................
Small Business .........................................................................................
Real-Time Supplements ..................................................................................
Small Business .........................................................................................
510(k)s .............................................................................................................
Small Business .........................................................................................
30-Day Notice ..................................................................................................
Small Business .........................................................................................
513(g) Request for Classification Information .................................................
Small Business .........................................................................................
Annual Fee for Periodic Reporting ..................................................................
Small Business .........................................................................................
Establishment Registration ..............................................................................
........................
111,627,891
........................
115,039,781
The PMA and establishment
registration fees were increased over the
base by the inflation adjustment
(2.198%) as determined earlier in this
document. An additional $43 (rounded
to the nearest whole dollar) was added
to the establishment registration fee in
order to collect the shortfall in revenue
that resulted. This was done because the
statute directs that, after the inflation
adjustment is made, the base
establishment registration fee amounts
shall be further adjusted, as necessary,
for total fee collections to achieve the
total revenue amount specified after
inflation adjustment (see 21 U.S.C.
379j(c)(3)). Without this additional
adjustment to the establishment
registration fee, the total collections
would fall almost $1 million below the
total specified revenue after adjustment
for inflation.
The standard fee (adjusted base
amount) for a premarket application,
including a BLA, and for a premarket
report and a BLA efficacy supplement,
is $258,520 for FY 2014. 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 30-day notice, 1.6 percent of
the standard fee;
• For a 510(k) premarket notification,
2 percent of the standard fee;
• 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
$3,313 for FY 2014. There is no small
business rate for the annual
establishment registration fee; all
establishments pay the same fee.
Table 5 sets out the FY 2014 rates for
all medical device fees.
TABLE 5—MEDICAL DEVICE FEES FOR FY 2014
Standard fee (as a percent of the standard fee for a
premarket application)
Application Fee Type:
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FY 2014
Standard fee
FY 2014 Small
Business fee
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TABLE 5—MEDICAL DEVICE FEES FOR FY 2014—Continued
Standard fee (as a percent of the standard fee for a
premarket application)
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Premarket application (a PMA submitted under
section 515(c)(1) of the FD&C Act (21 U.S.C.
360e(c)(1)), a PDP submitted under section
515(f) of the FD&C Act (21 U.S.C. 360e(f)), or
a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C.
262)).
Premarket report (submitted under section
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under
section 351 of the PHS Act).
Panel-track supplement .........................................
180-day supplement ..............................................
Real-time supplement ...........................................
510(k) premarket notification submission .............
30-day notice .........................................................
513(g) (21 U.S.C. 360c(g)) request for classification information.
Annual Fee Type:
Annual fee for periodic reporting on a class III
device.
Annual establishment registration fee (to be paid
by the establishment engaged in the manufacture, preparation, propagation, compounding,
or processing of a device, as defined by 21
U.S.C. 379i(13)).
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 2013, your status as a
small business will expire at the close
of business on September 30, 2013. You
must re-qualify for FY 2014 in order to
pay small business fees during FY 2014.
If you are a domestic (U.S.) business,
and wish to qualify as a small business
for FY 2014, you must submit the
following to FDA:
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FY 2014 Small
Business fee
Base Fee Adjusted as Specified in the Statute ...........
$258,520
$64,630
100% .............................................................................
258,520
64,630
100% .............................................................................
258,520
64,630
75% ...............................................................................
15% ...............................................................................
7% .................................................................................
2% .................................................................................
1.6% ..............................................................................
1.35% ............................................................................
193,890
38,778
18,096
5,170
4,136
3,490
48,473
9,695
4,524
2,585
2,068
1,745
..................................................................................
3.5% ..............................................................................
9,048
2,262
Base Fee Adjusted as Specified in the Statute ...........
3,313
3,313
1. A completed FY 2014 MDUFA
Small Business Qualification
Certification (Form FDA 3602). This
form is provided in FDA’s guidance
document, ‘‘FY 2014 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Web site at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/Overview/Medical
DeviceUserFeeand
ModernizationActMDUFMA/
default.htm. This form is not available
separate from the guidance document.
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 2013, except:
If you submit your FY 2014 MDUFA
Small Business Qualification before
April 15, 2014, and you have not yet
filed your return for 2013, you may use
tax year 2012.
If you submit your FY 2014 MDUFA
Small Business Qualification on or after
April 15, 2014, and have not yet filed
your 2013 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
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Standard fee
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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.
If you are a foreign business, and wish
to qualify as a small business for FY
2014, you must submit the following:
1. A completed FY 2014 MDUFA
Foreign Small Business Qualification
Certification (Form FDA 3602A). This
form is provided in FDA’s guidance
document, ‘‘FY 2014 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Internet site at https://www.fda.gov/
mdufa. This form is not available
separate from the guidance document.
2. A National Taxing Authority
Certification, completed by, and bearing
the official seal of, the National Taxing
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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
(2013 or later), or
• If the affiliate is a foreign business
and cannot submit a Federal (U.S.)
Income Tax Return, a National Taxing
Authority Certification completed by,
and bearing the official seal of, the
National Taxing Authority of the
country in which the firm is
headquartered. The National Taxing
Authority is the foreign equivalent of
the U.S. Internal Revenue Service. This
certification must show the amount of
gross receipts or sales for the most
recent tax year, in both U.S. dollars and
the local currency of the country, the
exchange rate used in converting the
local currency to U.S. dollars, and the
dates for the gross receipts or sales
collected. The applicant must also
submit a statement signed by the head
of the applicant’s firm or by its chief
financial officer that the applicant has
submitted certifications for all of its
affiliates, identifying the name of each
affiliate, or that the applicant has no
affiliates.
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V. Procedures for Paying Application
Fees
If your application or submission is
subject to a fee and your payment is
received by FDA from October 1, 2013,
through September 30, 2014, you must
pay the fee in effect for FY 2014. 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
2013 or FY 2014 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.)
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A. Step One—Secure a Payment
Identification Number (PIN) and
Medical Device User Fee Cover Sheet
From FDA Before Submitting Either the
Application or the Payment
Log on to the MDUFA Web site at:
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDeviceUserFeeand
ModernizationActMDUFMA/
default.htm and click on ‘‘MDUFA
FORMS’’ at the left side of the page, and
then under the MDUFA Forms heading,
click on the link ‘‘Create MDUFA User
Fee Cover Sheet.’’ 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, 2013.
One choice is for applications and fees
that will be received on or before
September 30, 2013, which are subject
to FY 2013 fee rates. A second choice
is for applications and fees received on
or after October 1, 2013, which are
subject to FY 2014 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. Step Two—Electronically Transmit a
Copy of the Printed Cover Sheet With
the PIN to FDA’s Office of Financial
Management
Once you are satisfied that the data on
the cover sheet is accurate,
electronically transmit that data to FDA
according to instructions on the screen.
Because electronic transmission is
possible, applicants are required to set
up a user account and use passwords to
assure data security in the creation and
electronic submission of cover sheets.
C. Step Three—Submit Payment for the
Completed Medical Device User Fee
Cover Sheet as Described in This
Section, Depending on the Method You
Will Use To Make Payment
1. 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. (FDA’s tax
identification number is 53–0196965,
should your accounting department
need this information.)
• 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 956733,
St. Louis, MO 63195–6733. (Please note
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Sfmt 4703
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 (such as FedEx, DHL, United
Parcel Service (UPS), etc.), the courier
may deliver the check to: U.S. Bank,
Attn: Government Lockbox 956733,
1005 Convention Plaza, St. Louis, MO
63101. (Note: This address is for courier
delivery only. Contact the U.S. Bank at
314–418–4013 if you have any questions
concerning courier delivery.)
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.
2. If paying with credit card or
electronic check (Automated Clearing
House (ACH)):
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 are limited to
$49,999.99.
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. Please
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, 1350 Piccard Dr.,
Rockville, MD 20850.
D. Step Four—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
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Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
Radiological Health, Document Mail
Center, Bldg. 66, Rm. 0609, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002.
2. Biologic applications should be
sent to: Food and Drug Administration,
Center for Biologics Evaluation and
Research, Document Control Center
(HFM–99), Suite 200N, 1401 Rockville
Pike, Rockville, MD 20852–1448.
sroberts on DSK5SPTVN1PROD with NOTICES
VI. Procedures for Paying the Annual
Fee for Periodic Reporting
As of FY 2011, you are no longer able
to create a cover sheet and obtain a PIN
to pay the MDUFA Annual Fee for
Periodic Reporting. Instead, 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 to ensure your billing
information is kept up-to-date (you can
update your contact for the PMA by
submitting an amendment).
1. 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. (FDA’s tax
identification number is 53–0196965,
should your accounting department
need this information.)
• 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 956733, St.
Louis, MO 63195–6733.
(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 (such as FedEx, DHL, UPS, etc.),
the courier may deliver the check to:
U.S. Bank, Attn: Government Lockbox
956733, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is
for courier delivery only. Contact the
U.S. Bank at 314–418–4013 if you have
any questions concerning courier
delivery.)
2. 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. Please
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
VerDate Mar<15>2010
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Jkt 229001
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, 1350 Piccard Dr.,
Rockville, MD 20850.
VII. Procedures for Paying Annual
Establishment Fees
In order to pay the annual
establishment fee, firms must access the
Device Facility User Fee (DFUF) Web
site at https://fdasfinapp8.fda.gov/
OA_HTML/fdaCAcdLogin.jsp. (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.) You will create a DFUF order
and you will be issued a PIN once 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 2014 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. Step One—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 2014 store.
Complete the DFUF order by entering
the number of establishments you are
registering that require payment. Once
you are satisfied that the data on the
order are accurate, electronically
transmit that data to FDA according to
instructions on the screen. Print a copy
of the final DFUF order and note the
unique PIN located in the upper righthand corner of the printed order.
B. Step Two—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):
The DFUF order will include payment
information, including details on how
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46975
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:
If you prefer not to pay online, 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. A copy of your
printed order should also be mailed
along with your check. FDA’s tax
identification number is 53–0196965.
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, from
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 will be delayed.
The originating financial institution
may charge a wire transfer fee. Please
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,
1350 Piccard Dr., Rockville, MD 20850.
C. Step Three—Complete the
Information Online To Update Your
Establishment’s Annual Registration for
FY 2014, or To Register a New
Establishment for FY 2014
Go to the Center for Devices and
Radiological Health’s Web site at https://
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Howto
MarketYourDevice/Registrationand
Listing/default.htm and click the
‘‘Access Electronic Registration’’ link on
the left of the page. This opens up a new
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Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
page with important information about
the FDA Unified Registration and
Listing System (FURLS). After reading
this information, click on the link
(Access Electronic Registration) at the
bottom 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 2013. Manufacturers of licensed
biologics should register in the BER
system at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
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. Once you
choose to register or update your annual
registration, the system will prompt you
through the entry of information about
your establishment and your devices. If
you have any problems with this
process, email: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
this email address and this telephone
number are for assistance with
establishment registration only, and not
for any other aspects of medical device
user fees.) Problems with BERS should
be directed to bloodregis@fda.hhs.gov or
call 301–827–3546.
D. Step Four—Enter Your DFUF Order
PIN and PCN
sroberts on DSK5SPTVN1PROD with NOTICES
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 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18623 Filed 8–1–13; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 10, 2013, from 8 a.m.
to 4:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Stephanie Begansky,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email:
PADAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On September 10, 2013, the
committee will discuss the new
molecular entity new drug application
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(NDA) 203975, for umeclidinium and
vilanterol powder for inhalation
(proposed trade name Anoro Ellipta),
sponsored by Glaxo Group (d/b/a/GSK)
for the long-term, once-daily,
maintenance treatment of airflow
obstruction in patients with chronic
obstructive pulmonary disease,
including chronic bronchitis and
emphysema.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 26, 2013.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before August
16, 2013. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 19, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Stephanie
Begansky at least 7 days in advance of
the meeting.
E:\FR\FM\02AUN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46970-46976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18623]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0007]
Medical Device User Fee Rates for Fiscal Year 2014
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 2012,
which was signed by the President on July 9, 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. The FY 2014 fee rates are
provided in this document. These fees apply from October 1, 2013,
through September 30, 2014. To avoid delay in the review of your
application, you should pay the 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 you make your submission to FDA; if you do not
qualify as a small business before you make your submission to FDA, you
will have to pay the higher standard fee. This document provides
information on how the fees for FY 2014 were determined, the payment
procedures you should follow, and how you may qualify for reduced small
business fees.
FOR FURTHER INFORMATION CONTACT: For information on Medical Device User
Fees: Visit FDA's Web site at https://www.fda.gov/mdufa.
For questions relating to this notice: David Miller, Office of
Financial Management (HFA-100), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 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 2014 is
$252,960. From this starting point, this document establishes FY 2014
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 2014 is $3,200. 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 2014
The base revenue amount for FY 2014 is $112,580,497, as set forth
in the statute prior to the inflation adjustment. MDUFA directs FDA to
use the yearly revenue amount as a starting point to set the fee rates
for each fee type. The fee calculations for FY 2014 are described in
this document.
[[Page 46971]]
Inflation Adjustment
MDUFA specifies that the $112,580,497 is to be further adjusted for
inflation increases for FY 2014 using two separate adjustments--one for
payroll costs and one for non-pay cost (see 21 U.S.C. 379j(c)(2)).
The component of the inflation adjustment for payroll costs shall
be one plus 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 .60, or 60 percent (see 21 U.S.C. 379j(c)(2)(C)).
The data on total PC&B paid and numbers of FTE paid, from which the
average cost per FTE can be derived, are published in FDA's
Justification of Estimates for Appropriations Committees.
Table 1 summarizes that 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 2014.
The 3-year average is 2.05 percent.
Table 1--FDA PC&B's Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2010 2011 2012 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $1,634,108,000 $1,761,655,000 $1,824,703,000 .................
Total FTE........................... 12,526 13,331 13,382 .................
PC&B per FTE........................ $130,457 $132,147 $136,355 .................
Percent change from previous year... 1.67% 1.30% 3.18% 2.05%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.05 percent multiplied by 60 percent, or
1.23 percent.
The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2014 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 .40, or 40 percent (see 21 U.S.C. 379j(c)(2)(C)).
Table 2 provides the summary data for the 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
https://data.bls.gov/cgi-bin/surveymost?cu by checking the box marked
``Washington-Baltimore All Items, November 1996 = 100--CUURA311SA0''
and then clicking on the ``Retrieve Data'' button.
Table 2--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
Year 2010 2011 2012 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 142.218 146.975 150.212 .................
Annual percent change............... 1.72% 3.34% 2.20% 2.42%
----------------------------------------------------------------------------------------------------------------
The non-pay adjustment is 2.42 percent times 40 percent, or .968
percent.
To complete the inflation adjustment, the payroll component (1.230
percent) is added to the non-pay component (0.968 percent), for a total
inflation adjustment of 2.198 percent (rounded), and then one is added,
making 1.02198. The base revenue amount for FY 2014 ($112,580,497) is
then multiplied by 1.02198, yielding an inflation adjusted amount of
$115,055,000 (rounded to the nearest thousand dollars).
III. Fees for FY 2014
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).) For FY 2014, the base fee
will be adjusted as specified in the FD&C Act for inflation (see 21
U.S.C. 379j(b) and (c)). Table 3 provides the last 3 years of fee
paying submission counts. These numbers are used to project the fee
paying submission that FDA will receive in FY 2014. The fee paying
submission counts are published in the Agency's MDUFA Financial Report
to Congress each year.
Table 3--3-Year Average of Fee Paying Submissions
----------------------------------------------------------------------------------------------------------------
Application type FY 2010 actual FY 2011 actual FY 2012 actual 3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... 32 24 25 27
Small Business.............................. 8 7 6 7
Panel Track Supplement.......................... 11 7 12 10
Small Business.............................. 2 1 0 1
180-Day Supplements............................. 103 92 145 113
Small Business.............................. 20 15 21 19
Real-Time Supplements........................... 146 145 196 162
Small Business.............................. 20 17 22 20
510(k)s......................................... 2,367 2,398 2,865 2,543
Small Business.............................. 1,032 938 1,086 1,019
30-Day Notice................................... 669 755 801 742
Small Business.............................. 78 67 60 68
513(g) Request for Classification Information... 56 40 46 47
Small Business.............................. 25 35 30 30
Annual Fee for Periodic Reporting............... 427 466 478 457
Small Business.............................. 78 78 39 65
[[Page 46972]]
Establishment Registration \1\ *................ .............. .............. .............. 22,500
----------------------------------------------------------------------------------------------------------------
\1\ Estimate for establishment registration based on preliminary FY 2013 numbers because the criteria for this
fee changed beginning in FY 2013.
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 2014 base fees set in
statute and the estimated revenue adding the inflation adjustment to
the FY 2014 base fees. The increases to the base fees are needed in
order to collect the new revenue target of $115,055,000.
Table 4--Fees Needed To Achieve New FY 2014 Revenue Target
----------------------------------------------------------------------------------------------------------------
Adjusted FY
Application type FY 2014 base Estimated 2014 fees Adjusted
fees revenue (standard fee) revenue
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... $252,960 $6,829,920 $258,520 $6,980,040
Small Business.............................. 63,240 442,680 64,630 452,410
Panel-Track Supplement.......................... 189,720 1,897,200 193,890 1,938,900
Small Business.............................. 47,430 47,430 48,473 48,473
180-Day Supplements............................. 37,944 4,287,672 38,778 4,381,914
Small Business.............................. 9,486 180,234 9,695 184,205
Real-Time Supplements........................... 17,707 2,868,566 18,096 2,931,552
Small Business.............................. 4,427 88,536 4,524 90,480
510(k)s......................................... 5,059 12,865,546 5,170 13,147,310
Small Business.............................. 2,530 2,577,662 2,585 2,634,115
30-Day Notice................................... 4,047 3,003,141 4,136 3,068,912
Small Business.............................. 2,024 137,610 2,068 140,624
513(g) Request for Classification Information... 3,415 160,503 3,490 164,030
Small Business.............................. 1,707 51,224 1,745 52,350
Annual Fee for Periodic Reporting............... 8,854 4,046,095 9,048 4,134,936
Small Business.............................. 2,213 143,871 2,262 147,030
Establishment Registration...................... 3,200 72,000,000 3,313 74,542,500
---------------------------------------------------------------
Total....................................... .............. 111,627,891 .............. 115,039,781
----------------------------------------------------------------------------------------------------------------
The PMA and establishment registration fees were increased over the
base by the inflation adjustment (2.198%) as determined earlier in this
document. An additional $43 (rounded to the nearest whole dollar) was
added to the establishment registration fee in order to collect the
shortfall in revenue that resulted. This was done because the statute
directs that, after the inflation adjustment is made, the base
establishment registration fee amounts shall be further adjusted, as
necessary, for total fee collections to achieve the total revenue
amount specified after inflation adjustment (see 21 U.S.C. 379j(c)(3)).
Without this additional adjustment to the establishment registration
fee, the total collections would fall almost $1 million below the total
specified revenue after adjustment for inflation.
The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $258,520 for FY 2014. 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 30-day notice, 1.6 percent of the standard fee;
For a 510(k) premarket notification, 2 percent of the
standard fee;
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 $3,313 for FY 2014. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 5 sets out the FY 2014 rates for all medical device fees.
Table 5--Medical Device Fees for FY 2014
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of
the standard fee for a premarket FY 2014 FY 2014 Small
application) Standard fee Business fee
----------------------------------------------------------------------------------------------------------------
Application Fee Type:
[[Page 46973]]
Premarket application (a PMA submitted Base Fee Adjusted as Specified $258,520 $64,630
under section 515(c)(1) of the FD&C Act 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%............................ 258,520 64,630
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA 100%............................ 258,520 64,630
under section 351 of the PHS Act).
Panel-track supplement.................... 75%............................. 193,890 48,473
180-day supplement........................ 15%............................. 38,778 9,695
Real-time supplement...................... 7%.............................. 18,096 4,524
510(k) premarket notification submission.. 2%.............................. 5,170 2,585
30-day notice............................. 1.6%............................ 4,136 2,068
513(g) (21 U.S.C. 360c(g)) request for 1.35%........................... 3,490 1,745
classification information.
Annual Fee Type: ................................ .............. ..............
Annual fee for periodic reporting on a 3.5%............................ 9,048 2,262
class III device.
Annual establishment registration fee (to Base Fee Adjusted as Specified 3,313 3,313
be paid by the establishment engaged in in the Statute.
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 2013, your
status as a small business will expire at the close of business on
September 30, 2013. You must re-qualify for FY 2014 in order to pay
small business fees during FY 2014.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2014, you must submit the following to FDA:
1. A completed FY 2014 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2014 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm. This form is
not available separate from the guidance document.
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 2013,
except:
If you submit your FY 2014 MDUFA Small Business Qualification
before April 15, 2014, and you have not yet filed your return for 2013,
you may use tax year 2012.
If you submit your FY 2014 MDUFA Small Business Qualification on or
after April 15, 2014, and have not yet filed your 2013 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.
If you are a foreign business, and wish to qualify as a small
business for FY 2014, you must submit the following:
1. A completed FY 2014 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2014 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
https://www.fda.gov/mdufa. This form is not available separate from the
guidance document.
2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing
[[Page 46974]]
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 (2013 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 from October 1, 2013, through September 30,
2014, you must pay the fee in effect for FY 2014. 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 2013 or FY 2014 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. Step One--Secure a Payment Identification Number (PIN) and Medical
Device User Fee Cover Sheet From FDA Before Submitting Either the
Application or the Payment
Log on to the MDUFA Web site at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm and click on
``MDUFA FORMS'' at the left side of the page, and then under the MDUFA
Forms heading, click on the link ``Create MDUFA User Fee Cover Sheet.''
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, 2013. One choice is for applications and fees
that will be received on or before September 30, 2013, which are
subject to FY 2013 fee rates. A second choice is for applications and
fees received on or after October 1, 2013, which are subject to FY 2014
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. Step Two--Electronically Transmit a Copy of the Printed Cover Sheet
With the PIN to FDA's Office of Financial Management
Once you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Because electronic transmission is
possible, applicants are required to set up a user account and use
passwords to assure data security in the creation and electronic
submission of cover sheets.
C. Step Three--Submit Payment for the Completed Medical Device User Fee
Cover Sheet as Described in This Section, Depending on the Method You
Will Use To Make Payment
1. 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. (FDA's tax
identification number is 53-0196965, should your accounting department
need this information.)
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 956733, St. Louis, MO
63195-6733. (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 (such as FedEx, DHL,
United Parcel Service (UPS), etc.), the courier may deliver the check
to: U.S. Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza,
St. Louis, MO 63101. (Note: This address is for courier delivery only.
Contact the U.S. Bank at 314-418-4013 if you have any questions
concerning courier delivery.)
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.
2. If paying with credit card or electronic check (Automated
Clearing House (ACH)):
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 are limited to
$49,999.99.
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. Please 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, 1350 Piccard Dr.,
Rockville, MD 20850.
D. Step Four--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
[[Page 46975]]
Radiological Health, Document Mail Center, Bldg. 66, Rm. 0609, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002.
2. Biologic applications should be sent to: Food and Drug
Administration, Center for Biologics Evaluation and Research, Document
Control Center (HFM-99), Suite 200N, 1401 Rockville Pike, Rockville, MD
20852-1448.
VI. Procedures for Paying the Annual Fee for Periodic Reporting
As of FY 2011, you are no longer able to create a cover sheet and
obtain a PIN to pay the MDUFA Annual Fee for Periodic Reporting.
Instead, 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 to ensure your billing
information is kept up-to-date (you can update your contact for the PMA
by submitting an amendment).
1. 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. (FDA's tax identification
number is 53-0196965, should your accounting department need this
information.)
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 956733, St. Louis, MO 63195-6733.
(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 (such as FedEx, DHL,
UPS, etc.), the courier may deliver the check to: U.S. Bank, Attn:
Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier delivery only. Contact the U.S. Bank
at 314-418-4013 if you have any questions concerning courier delivery.)
2. 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. Please 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, 1350 Piccard Dr.,
Rockville, MD 20850.
VII. Procedures for Paying Annual Establishment Fees
In order to pay the annual establishment fee, firms must access the
Device Facility User Fee (DFUF) Web site at https://fdasfinapp8.fda.gov/OA_HTML/fdaCAcdLogin.jsp. (FDA has verified the
Web site address, but FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register.)
You will create a DFUF order and you will be issued a PIN once 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 2014 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. Step One--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 2014 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. Once you are satisfied that the data on the order are
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. Step Two--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):
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:
If you prefer not to pay online, 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. A copy of your printed order should
also be mailed along with your check. FDA's tax identification number
is 53-0196965.
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, from 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
will be delayed.
The originating financial institution may charge a wire transfer
fee. Please 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, 1350 Piccard Dr., Rockville, MD 20850.
C. Step Three--Complete the Information Online To Update Your
Establishment's Annual Registration for FY 2014, or To Register a New
Establishment for FY 2014
Go to the Center for Devices and Radiological Health's Web site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the
``Access Electronic Registration'' link on the left of the page. This
opens up a new
[[Page 46976]]
page with important information about the FDA Unified Registration and
Listing System (FURLS). After reading this information, click on the
link (Access Electronic Registration) at the bottom 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 2013. Manufacturers of
licensed biologics should register in the BER system at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register and existing establishments will update their annual
registration using choices on the DRLM menu. Once you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
reglist@cdrh.fda.gov or call 301-796-7400 for assistance. (Note: this
email address and this telephone number are for assistance with
establishment registration only, and not for any other aspects of
medical device user fees.) Problems with BERS should be directed to
bloodregis@fda.hhs.gov or call 301-827-3546.
D. Step Four--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 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18623 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P
