Medical Device User Fee Rates for Fiscal Year 2017, 49987-49993 [2016-17903]
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49987
Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices
Dated: July 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17659 Filed 7–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0007]
Medical Device User Fee Rates for
Fiscal Year 2017
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2017. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Medical Device User
Fee Amendments of 2012 (MDUFA III),
authorizes FDA to collect user fees for
certain medical device submissions and
annual fees both for certain periodic
reports and for establishments subject to
registration. This notice establishes the
fee rates for FY 2017, which apply from
October 1, 2016, through September 30,
2017. To avoid delay in the review of
your application, you should pay the
application fee before or at the time you
submit your application to FDA. The fee
you must pay is the fee that is in effect
on the later of the date that your
application is received by FDA or the
date your fee payment is recognized by
the U.S. Treasury. If you want to pay a
reduced small business fee, you must
qualify as a small business before
making your submission to FDA; if you
do not qualify as a small business before
making your submission to FDA, you
will have to pay the higher standard fee.
Please note that the establishment
registration fee is not eligible for a
reduced small business fee. As a result,
if the establishment registration fee is
the only medical device user fee that
you will pay in FY 2017, you should not
submit a FY 2017 Small Business
Qualification and Certification request.
This document provides information on
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SUMMARY:
The FD&C Act specifies the base fee
for establishment registration for each
year from FY 2013 through FY 2017; the
base fee for an establishment
registration in FY 2017 is $3,872. There
is no reduction in the registration fee for
small businesses. Each establishment
that is registered (or is required to
register) with the Secretary under
section 510 of the FD&C Act (21 U.S.C.
360) because such establishment is
engaged in the manufacture,
preparation, propagation, compounding,
or processing of a device is required to
pay the annual fee for establishment
registration.
how the fees for FY 2017 were
determined, the payment procedures
you should follow, and how you may
qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device
User Fees: Visit FDA’s Web site at
https://www.fda.gov/ForIndustry/
UserFees/MedicalDeviceUserFee/
ucm20081521.htm.
For questions relating to this notice:
Maurille Beheton, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.
(COLE–14202C), Silver Spring, MD
20993–0002, 301–796–4689.
SUPPLEMENTARY INFORMATION:
II. Revenue Amount for FY 2017
I. Background
Section 738 of the FD&C Act (21
U.S.C. 379j) establishes fees for certain
medical device applications,
submissions, supplements, and notices
(for simplicity, this document refers to
these collectively as ‘‘submissions’’ or
‘‘applications’’); for periodic reporting
on class III devices; and for the
registration of certain establishments.
Under statutorily defined conditions, a
qualified applicant may receive a fee
waiver or may pay a lower small
business fee (see 21 U.S.C. 379j(d) and
(e)). Additionally, the Secretary of
Health and Human Services (the
Secretary) may, at the Secretary’s sole
discretion, grant a fee waiver or
reduction if the Secretary finds that
such waiver or reduction is in the
interest of public health (see 21 U.S.C.
379j(f)).
Under the FD&C Act, the fee rate for
each type of submission is set at a
specified percentage of the standard fee
for a premarket application (a premarket
application is a premarket approval
application (PMA), a product
development protocol (PDP), or a
biologics license application (BLA)).
The FD&C Act specifies the base fee for
a premarket application for each year
from FY 2013 through FY 2017; the base
fee for a premarket application received
by FDA during FY 2017 is $268,443.
From this starting point, this document
establishes FY 2017 fee rates for other
types of submissions, and for periodic
reporting, by applying criteria specified
in the FD&C Act.
The total revenue amount for FY 2017
is $130,184,348, as set forth in the
statute prior to the inflation adjustment
and offset of excess collections (see 21
U.S.C. 379j(b)(3)). MDUFA directs FDA
to use the yearly total revenue amount
as a starting point to set the standard fee
rates for each fee type. The fee
calculations for FY 2017 are described
in this document.
A. Inflation Adjustment
MDUFA specifies that the
$130,184,348 is to be adjusted for
inflation increases for FY 2017 using
two separate adjustments—one for
payroll costs and one for non-pay cost
(see 21 U.S.C. 379j(c)(2)). The base
inflation adjustment for FY 2017 is the
sum of one plus these two separate
adjustments, and is compounded as
specified (see 21 U.S.C. 379j(c)(2)(C)(1)
and 379j(c)(2)(B)(ii)).
The component of the inflation
adjustment for payroll costs is the
average annual percent change in the
cost of all personnel compensation and
benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the
first 3 of the 4 preceding FYs,
multiplied by 0.60, or 60 percent (see 21
U.S.C. 379j(c)(2)(C)).
Table 1 summarizes the actual cost
and FTE data for the specified FYs, and
provides the percent change from the
previous FY and the average percent
change over the first 3 of the 4 FYs
preceding FY 2017. The 3-year average
is 1.8759 percent (rounded).
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal Year
2013
Total PC&B ....................................................................................
Total FTE .......................................................................................
PC&B per FTE ...............................................................................
Percent change from previous year ..............................................
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2014
$1,927,703,000
13,974
$137,949
1.1690%
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2015
$2,054,937,000
14,555
$141,184
2.3451%
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$2,232,304,000
15,484
$144,168
2.1136%
3-Year
average
........................
........................
........................
1.8759%
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Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices
The payroll adjustment is 1.8759
percent multiplied by 60 percent, or
1.1255 percent.
The statute specifies that the
component of the inflation adjustment
for non-payroll costs for FY 2017 is the
average annual percent change that
occurred in the Consumer Price Index
(CPI) for urban consumers (Washington-
Baltimore, DC–MD–VA–WV; not
seasonally adjusted; all items; annual
index) for the first 3 of the preceding 4
years of available data multiplied by
0.40, or 40 percent (see 21 U.S.C.
379j(c)(2)(C)).
Table 2 provides the summary data
and the 3-year average percent change
in the specified CPI for the Baltimore-
Washington area. This data is published
by the Bureau of Labor Statistics and
can be found on their Web site at https://
data.bls.gov/cgi-bin/surveymost?cu by
checking the box marked ‘‘WashingtonBaltimore 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
2013
2014
2015
3-Year
average
Annual CPI .......................................................................................................
Annual Percent Change ..................................................................................
3-Year Avg. Percent Change in CPI ...............................................................
152.500
1.5232%
........................
154.847
1.5390%
........................
155.353
0.3268%
........................
........................
........................
1.1297%
The non-pay adjustment is 1.1297
percent multiplied by 40 percent, or
0.4519 percent.
Next, the payroll adjustment (1.1255
percent or 0.011255) is added to the
non-pay adjustment (0.4519 percent or
0.004519), for a total of 1.5774 percent
(or 0.015774). To complete the inflation
adjustment, 1 (100 percent or 1.0) is
added for a total base inflation
adjustment of 1.015774 for FY 2017.
MDUFA III provides for this inflation
adjustment to be compounded for FY
2015 and each subsequent fiscal year
(see 21 U.S.C. 379j(c)(2)(B)(ii)). The base
inflation adjustment for FY 2017
(1.015774) is compounded by
multiplying it by the compounded
applicable inflation adjustment for FY
2016 (1.064457), as published in the
Federal Register of August 3, 2015 (80
FR 46033 to 46039), to reach the
applicable inflation adjustment of
1.081248 (rounded) (1.015774 times
1.064457) for FY 2017. We then
multiply the total revenue amount for
FY 2017 ($130,184,348) by 1.081248,
yielding an inflation adjusted total
revenue amount of $140,762,000
(rounded to the nearest thousand
dollars).
B. Offset for Excess Collections Through
FY 2016
Under the offset provision of the
FD&C Act (see section 738(i)(4) (21
U.S.C. 379j(i)(4))), if the cumulative
amount of fees collected during FY 2013
through FY 2015, added to the amount
estimated to be collected for FY 2016,
exceeds the cumulative amount
appropriated for these four FYs, the
excess shall be credited to the
appropriation account of the Food and
Drug Administration and shall be
subtracted from the amount of fees that
would otherwise be authorized to be
collected for FY 2017. Table 3 presents
the amount of MDUFA fees collected
during FY 2013 through FY 2015
(actuals), and the amount estimated to
be collected for FY 2016, and compares
those amounts with the fees specified to
be appropriated in these four FYs.
TABLE 3—STATEMENT OF FEES APPROPRIATED, FEES COLLECTED, AND DIFFERENCES AS OF JUNE 30, 2016
Fee
appropriated
Fiscal year
Difference
Actual ..................................................................................................................................
Actual ..................................................................................................................................
Actual ..................................................................................................................................
Estimate ..............................................................................................................................
$97,722,000
114,833,000
128,282,000
134,667,000
$103,991,182
124,297,628
139,712,238
134,667,000
$6,269,182
9,464,628
11,430,238
0
Total ......................................................................................................................................
Unearned Revenue Included in Above Amount ..........................................................................
Excess Collections Less Unearned Revenue (Offset Amount) ..................................................
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2013
2014
2015
2016
Fees collected
478,504,000
........................
........................
505,668,048
........................
........................
27,164,048
12,485,897
14,678,151
The total amount FDA expects to have
collected in excess of appropriations by
the end of FY 2016 is $27,164,048.
However, of that amount, a total of
$12,485,897 represents unearned
revenue—primarily fees paid for
applications that have not yet been
received. The unearned revenue is held
in reserve either to refund, if no
application is submitted, or to apply
toward the future FY when the
application is received. The net of these
two figures, $14,678,151, is the amount
that FDA has received in excess of
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appropriations that is available for
obligation, and the amount by which fee
revenue will be offset in FY 2017.
For FY 2017, the statute authorizes
$140,762,000 in user fees. In order to
determine the revised collection
amount, we deduct the net excess
collection amount of $14,678,151 from
$140,762,000, and the revised revenue
target for FY 2017 becomes
$126,083,000 (rounded down to the
nearest thousand dollars).
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III. Fees for FY 2017
Under the FD&C Act, all submission
fees and the periodic reporting fee are
set as a percent of the standard (full) fee
for a premarket application (see 21
U.S.C. 379j(a)(2)(A)). Table 4 provides
the last 3 years of fee paying submission
counts and the 3-year average. These
numbers are used to project the fee
paying submission counts that FDA will
receive in FY 2017. Most of the fee
paying submission counts are published
in the MDUFA Financial Report to
Congress each year.
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TABLE 4—3-YEAR AVERAGE OF FEE PAYING SUBMISSIONS
FY 2013
actual
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) (21 U.S.C. 360c(g)) Request for Classification Information ................
Small Business .........................................................................................
Annual Fee for Periodic Reporting 1 ................................................................
Small Business 1 .......................................................................................
Establishment Registration 2 ............................................................................
1 Includes
FY 2014
actual
23
9
19
0
128
21
182
23
3,149
1,202
956
69
65
38
614
54
23,477
FY 2015
actual
25
5
12
3
122
24
192
19
3,034
1,037
934
91
69
31
514
56
24,026
42
7
22
3
143
15
204
28
2,768
1,037
920
71
75
33
544
68
25,363
3-Year
average
30
7
18
2
131
20
193
23
2,984
1,092
937
77
70
34
557
59
24,289
collection of quarter 4 billing for FY 2015 during FY 2016.
Registration total comes from the registration system and will vary from the financial report.
2 Establishment
The information in table 4 is
necessary to estimate the amount of
revenue that will be collected based on
the fee amounts. Table 5 displays both
the estimated revenue using the FY
2017 base fees set in statute and the
estimated revenue after the inflation
adjustment and offset of excess
collections to the FY 2017 base fees.
Using the fees set in statute and the 3
year averages of fee paying submissions,
the collections would total
$144,335,998, which is $18,252,998
higher than the statutory revenue limit.
Accordingly the PMA and establishment
fee need to be decreased so that
collections come as close to the
statutory revenue limit of $126,083,000
as possible without exceeding the limit.
This is done by calculating the
percentage difference between the
statutory revenue limit and the
estimated resulting 2017 revenue
collections, and then lowering the fees
proportionally by that percentage
(rounded to the nearest dollar). The fees
in the second column from the right are
those we are establishing in FY 2017,
which are the standard fees.
TABLE 5—FEES NEEDED TO ACHIEVE NEW FY 2017 REVENUE TARGET
FY 2017
Statutory
fees
(base fees)
Application type
Estimated
resulting
2017
revenue
Adjusted FY
2017 fees to
meet revenue
target
(standard
fees)
FY 2017
Revenue from
adjusted fees
$268,443
67,111
201,332
50,333
40,266
10,067
18,791
4,698
5,369
2,685
4,295
2,148
3,624
1,812
9,396
2,349
3,872
$8,053,290
469,777
3,623,976
100,666
5,274,846
201,340
3,626,663
108,054
16,021,096
2,932,020
4,024,415
165,396
253,680
61,608
5,233,572
138,591
94,047,008
$234,495
58,624
175,871
43,968
35,174
8,794
16,415
4,104
4,690
2,345
3,752
1,876
3,166
1,583
8,207
2,052
3,382
$7,034,850
410,368
3,165,678
87,936
4,607,794
175,880
3,168,095
94,392
13,994,960
2,560,740
3,515,624
144,452
221,620
53,822
4,571,299
121,068
82,145,398
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 ..............................................................................
........................
144,335,998
........................
126,073,976
The standard fee (adjusted base
amount) for a premarket application,
including a BLA, and for a premarket
report and a BLA efficacy supplement,
is $234,495 for FY 2017. The fees set by
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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;
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• 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;
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• For a 513(g) request for
classification information, 1.35 percent
of the standard fee; and
• For an annual fee for periodic
reporting concerning a class III device,
3.5 percent of the standard fee.
For all submissions other than a
510(k) premarket notification, a 30-day
notice, and a 513(g) request for
classification information, the small
business fee is 25 percent of the
standard (full) fee for the submission
(see 21 U.S.C. 379j(d)(2)(C)). For a
510(k) premarket notification
submission, a 30-day notice, and a
513(g) request for classification
information, the small business fee is 50
percent of the standard (full) fee for the
submission (see 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C)).
The annual fee for establishment
registration, after adjustment, is set at
$3,382 for FY 2017. There is no small
business rate for the annual
establishment registration fee; all
establishments pay the same fee.
Table 6 summarizes the FY 2017 rates
for all medical device fees.
TABLE 6—MEDICAL DEVICE FEES FOR FY 2017
Standard fee
(as a percent of the standard fee
for a premarket application)
Application fee type
Premarket application (a PMA submitted under section 515(c)(1) of the
FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section
515(f) of the FD&C Act, 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) request for classification information .............................................
Annual Fee Type:
Annual fee for periodic reporting on a class III device ......................
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation,
compounding, or processing of a device, as defined by 21 U.S.C.
379i(13)).
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IV. How To Qualify as a Small Business
for Purposes of Medical Device Fees
If your business has gross receipts or
sales of no more than $100 million for
the most recent tax year, you may
qualify for reduced small business fees.
If your business has gross sales or
receipts of no more than $30 million,
you may also qualify for a waiver of the
fee for your first premarket application
(PMA, PDP, or BLA) or premarket
report. You must include the gross
receipts or sales of all of your affiliates
along with your own gross receipts or
sales when determining whether you
meet the $100 million or $30 million
threshold. If you want to pay the small
business fee rate for a submission, or
you want to receive a waiver of the fee
for your first premarket application or
premarket report, you should submit the
materials showing you qualify as a small
business 60 days before you send your
submission to FDA. FDA will review
your information and determine
whether you qualify as a small business
eligible for the reduced fee and/or fee
waiver. If you make a submission before
FDA finds that you qualify as a small
business, you must pay the standard
(full) fee for that submission.
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FY 2017 Small
business fee
Base fee specified in statute at
$268,443, but multiplied by
87.3538 percent.
$234,495
$58,624
100 ...................................................
100 ...................................................
234,495
234,495
58,624
58,624
75 .....................................................
15 .....................................................
7 .......................................................
2 .......................................................
1.60 ..................................................
1.35 ..................................................
175,871
35,174
16,415
4,690
3,752
3,166
43,968
8,794
4,104
2,345
1,876
1,583
3.50 ..................................................
Base fee specified in statute at
$3,872, but multiplied by 87.3538
percent.
8,207
3,382
2,052
3,382
If your business qualified as a small
business for FY 2016, your status as a
small business will expire at the close
of business on September 30, 2016. You
must re-qualify for FY 2017 in order to
pay small business fees during FY 2017.
If you are a domestic (U.S.) business,
and wish to qualify as a small business
for FY 2017, you must submit the
following to FDA:
1. A completed FY 2017 MDUFA
Small Business Qualification
Certification (Form FDA 3602). This
form is provided in FDA’s guidance
document, ‘‘FY 2017 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Web site at https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
2. A certified copy of your Federal
(U.S.) Income Tax Return for the most
recent tax year. The most recent tax year
will be 2016, except:
If you submit your FY 2017 MDUFA
Small Business Qualification before
April 15, 2017, and you have not yet
filed your return for 2016, you may use
tax year 2015.
If you submit your FY 2017 MDUFA
Small Business Qualification on or after
April 15, 2017, and have not yet filed
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FY 2017
Standard fee
Sfmt 4703
your 2016 return because you obtained
an extension, you may submit your most
recent return filed prior to the
extension.
3. For each of your affiliates, either:
• If the affiliate is a domestic (U.S.)
business, a certified copy of the
affiliate’s Federal (U.S.) Income Tax
Return for the most recent tax year, or
• If the affiliate is a foreign business
and cannot submit a Federal (U.S.)
Income Tax Return, a National Taxing
Authority Certification completed by,
and bearing the official seal of, the
National Taxing Authority of the
country in which the firm is
headquartered. The National Taxing
Authority is the foreign equivalent of
the U.S. Internal Revenue Service. This
certification must show the amount of
gross receipts or sales for the most
recent tax year, in both U.S. dollars and
the local currency of the country, the
exchange rate used in converting the
local currency to U.S. dollars, and the
dates of the gross receipts or sales
collected. The applicant must also
submit a statement signed by the head
of the applicant’s firm or by its chief
financial officer that the applicant has
submitted certifications for all of its
affiliates, identifying the name of each
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affiliate, or that the applicant has no
affiliates.
If you are a foreign business, and wish
to qualify as a small business for FY
2017, you must submit the following:
1. A completed FY 2017 MDUFA
Foreign Small Business Qualification
Certification (Form FDA 3602A). This
form is provided in FDA’s guidance
document, ‘‘FY 2017 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Internet site at https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
2. A National Taxing Authority
Certification, completed by, and bearing
the official seal of, the National Taxing
Authority of the country in which the
firm is headquartered. This certification
must show the amount of gross receipts
or sales for the most recent tax year, in
both U.S. dollars and the local currency
of the country, the exchange rate used
in converting the local currency to U.S.
dollars, and the dates of the gross
receipts or sales collected.
3. For each of your affiliates, either:
• If the affiliate is a domestic (U.S.)
business, a certified copy of the
affiliate’s Federal (U.S.) Income Tax
Return for the most recent tax year
(2016 or later), or
• If the affiliate is a foreign business
and cannot submit a Federal (U.S.)
Income Tax Return, a National Taxing
Authority Certification completed by,
and bearing the official seal of, the
National Taxing Authority of the
country in which the firm is
headquartered. The National Taxing
Authority is the foreign equivalent of
the U.S. Internal Revenue Service. This
certification must show the amount of
gross receipts or sales for the most
recent tax year, in both U.S. dollars and
the local currency of the country, the
exchange rate used in converting the
local currency to U.S. dollars, and the
dates for the gross receipts or sales
collected. The applicant must also
submit a statement signed by the head
of the applicant’s firm or by its chief
financial officer that the applicant has
submitted certifications for all of its
affiliates, identifying the name of each
affiliate, or that the applicant has no
affiliates.
V. Procedures for Paying Application
Fees
If your application or submission is
subject to a fee and your payment is
received by FDA between October 1,
2016, and September 30, 2017, you must
pay the fee in effect for FY 2017. The
later of the date that the application is
received in the reviewing center’s
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document room or the date the U.S.
Treasury recognizes the payment
determines whether the fee rates for FY
2016 or FY 2017 apply. FDA must
receive the correct fee at the time that
an application is submitted, or the
application will not be accepted for
filing or review.
FDA requests that you follow the
steps below before submitting a medical
device application subject to a fee to
ensure that FDA links the fee with the
correct application. (Note: Do not send
your user fee check to FDA with the
application.)
A. Secure a Payment Identification
Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before
Submitting Either the Application or the
Payment
Log into the User Fee System at:
https://userfees.fda.gov/OA_HTML/
mdufmaCAcdLogin.jsp. Complete the
Medical Device User Fee cover sheet. Be
sure you choose the correct application
submission date range. (Two choices
will be offered until October 1, 2016.
One choice is for applications and fees
that will be received on or before
September 30, 2016, which are subject
to FY 2016 fee rates. A second choice
is for applications and fees received on
or after October 1, 2016, which are
subject to FY 2017 fee rates.) After
completing data entry, print a copy of
the Medical Device User Fee cover sheet
and note the unique PIN located in the
upper right-hand corner of the printed
cover sheet.
B. Electronically Transmit a Copy of the
Printed Cover Sheet With the PIN
When you are satisfied that the data
on the cover sheet is accurate,
electronically transmit that data to FDA
according to instructions on the screen.
Applicants are required to set up a user
account and password to assure data
security in the creation and electronic
submission of cover sheets.
C. Submit Payment for the Completed
Medical Device User Fee Cover Sheet
1. The preferred payment method is
online using electronic check
(Automated Clearing House (ACH) also
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
Express). FDA has partnered with the
U.S. Department of the Treasury to
utilize Pay.gov, a Web-based payment
system, for online electronic payment.
You may make a payment via electronic
check or credit card after submitting
your cover sheet. Secure electronic
payments can be submitted using the
User Fees Payment Portal at https://
userfees.fda.gov/pay. Once you search
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49991
for your invoice, click ‘‘Pay Now’’ to be
redirected to Pay.gov. Note that
electronic payment options are based on
the balance due. Payment by credit card
is available for balances less than
$25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be drawn on
U.S bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
• All paper checks must be in U.S.
currency from a U.S. bank and made
payable to the Food and Drug
Administration. (If needed, FDA’s tax
identification number is 53–0196965.)
• Please write your application’s
unique PIN (from the upper right-hand
corner of your completed Medical
Device User Fee cover sheet) on your
check.
• Mail the paper check and a copy of
the completed cover sheet to: Food and
Drug Administration, P.O. Box 979033,
St. Louis, MO 63197–9000. (Please note
that this address is for payments of
application and annual report fees only
and is not to be used for payment of
annual establishment registration fees.)
If you prefer to send a check by a
courier, the courier may deliver the
check to: U.S. Bank, Attn: Government
Lockbox 979033, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
only. If you have any questions
concerning courier delivery contact the
U.S. Bank at 314–418–4013. This
telephone number is only for questions
about courier delivery).
3. If paying with a wire transfer:
• Please include your application’s
unique PIN (from the upper right-hand
corner of your completed Medical
Device User Fee cover sheet) in your
wire transfer. Without the PIN, your
payment may not be applied to your
cover sheet and review of your
application may be delayed.
• The originating financial institution
may charge a wire transfer fee. Ask your
financial institution about the fee and
add it to your payment to ensure that
your cover sheet is fully paid.
Use the following account
information when sending a wire
transfer: U.S. Department of Treasury,
TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Road,
14th Floor, Silver Spring, MD 20993–
0002.
FDA records the official application
receipt date as the later of the following:
(1) The date the application was
received by FDA or (2) the date the U.S.
Treasury recognizes the payment. It is
helpful if the fee arrives at the bank at
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least 1 day before the application arrives
at FDA.
Administration, P.O. Box 979033, St.
Louis, MO, 63197–9000.
D. Submit Your Application to FDA
With a Copy of the Completed Medical
Device User Fee Cover Sheet
(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.)
Please submit your application and a
copy of the completed Medical Device
User Fee cover sheet to one of the
following addresses:
1. Medical device applications should
be submitted to: Food and Drug
Administration, Center for Devices and
Radiological Health, Document Control
Center, 10903 New Hampshire Ave.,
Building 66, Rm. 0609, Silver Spring,
MD 20993–0002.
2. Biologics license applications and
other medical device submissions
reviewed by the Center for Biologics
Evaluation and Research should be sent
to: Food and Drug Administration,
Center for Biologics Evaluation and
Research, Document Control Center,
10903 New Hampshire Ave, Building
71, Rm. G112, Silver Spring, MD 20993–
0002.
If you prefer to send a check by a
courier, the courier may deliver the
check to: U.S. Bank, Attn: Government
Lockbox 979033, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
only. If you have any questions
concerning courier delivery contact the
U.S. Bank at 314–418–4013. This
telephone number is only for questions
about courier delivery).
3. If paying with a wire transfer:
• Please include your invoice number
in your wire transfer. Without the
invoice number, your payment may not
be applied and you may be referred to
collections.
• The originating financial institution
may charge a wire transfer fee. Ask your
financial institution about the fee and
add it to your payment to ensure that
your invoice is fully paid.
Use the following account
information when sending a wire
transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.
75060099, Routing No. 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA,
8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993–0002.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
VI. Procedures for Paying the Annual
Fee for Periodic Reporting
You will be invoiced at the end of the
quarter in which your PMA Periodic
Report is due. Invoices will be sent
based on the details included on your
PMA file. You are responsible for
ensuring FDA has your current billing
information, and you may update your
contact information for the PMA by
submitting an amendment to the PMA.
1. The preferred payment method is
online using electronic check
(Automated Clearing House (ACH) also
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
Express). Secure electronic payments
can be submitted using the User Fees
Payment Portal at https://
userfees.fda.gov/pay. Once you search
for your invoice, click ‘‘Pay Now’’ to be
redirected to Pay.gov. Note that
electronic payment options are based on
the balance due. Payment by credit card
is available for balances less than
$25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be drawn on
U.S bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
All paper checks must be in U.S.
currency from a U.S. bank and made
payable to the Food and Drug
Administration. (If needed, FDA’s tax
identification number is 53–0196965,)
• Please write your invoice number
on the check.
• Mail the paper check and a copy of
invoice to: Food and Drug
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18:42 Jul 28, 2016
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VII. Procedures for Paying Annual
Establishment Fees
To pay the annual establishment fee,
firms must access the Device Facility
User Fee (DFUF) Web site at https://
userfees.fda.gov/OA_HTML/furls.jsp.
(FDA has verified the Web site address,
but FDA is not responsible for any
subsequent changes to the Web site
address after this document publishes in
the Federal Register.) Create a DFUF
order and you will be issued a PIN
when you place your order. After
payment has been processed, you will
be issued a payment confirmation
number (PCN). You will not be able to
register your establishment if you do not
have a PIN and a PCN. An establishment
required to pay an annual establishment
registration fee is not legally registered
in FY 2017 until it has completed the
steps below to register and pay any
applicable fee. (See 21 U.S.C. 379j(g)(2).)
Companies that do not manufacture
any product other than a licensed
biologic are required to register in the
Blood Establishment Registration (BER)
system. FDA’s Center for Biologics
Evaluation and Research (CBER) will
send establishment registration fee
invoices annually to these companies.
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A. Submit a DFUF Order With a PIN
From FDA Before Registering or
Submitting Payment
To submit a DFUF Order, you must
create or have previously created a user
account and password for the user fee
Web site listed previously in this
section. After creating a user name and
password, log into the Establishment
Registration User Fee FY 2016 store.
Complete the DFUF order by entering
the number of establishments you are
registering that require payment. When
you are satisfied that the information in
the order is accurate, electronically
transmit that data to FDA according to
instructions on the screen. Print a copy
of the final DFUF order and note the
unique PIN located in the upper righthand corner of the printed order.
B. Pay for Your DFUF Order
Unless paying by credit card, all
payments must be in U. S. currency and
drawn on a U.S. bank.
1. If paying by credit card or
electronic check (ACH or eCheck):
The DFUF order will include payment
information, including details on how
you can pay online using a credit card
or electronic check. Follow the
instructions provided to make an
electronic payment.
2. If paying with a paper check:
You may pay by a check, in U.S.
dollars and drawn on a U.S. bank,
mailed to: Food and Drug
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000. (Note: This
address is different from the address for
payments of application and annual
report fees and is to be used only for
payment of annual establishment
registration fees.)
If a check is sent by a courier that
requests a street address, the courier can
deliver the check to: U.S. Bank, Attn:
Government Lockbox 979108, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for
courier delivery only. If you have any
questions concerning courier delivery
contact the U.S. Bank at 314–418–4013.
This telephone number is only for
questions about courier delivery).
Please make sure that both of the
following are written on your check: (1)
The FDA post office box number (P.O.
Box 979108) and (2) the PIN that is
printed on your order. Include a copy of
your printed order when you mail your
check.
3. If paying with a wire transfer:
Wire transfers may also be used to pay
annual establishment fees. To send a
wire transfer, please read and comply
with the following information:
Include your order’s unique PIN (in
the upper right-hand corner of your
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
completed DFUF order) in your wire
transfer. Without the PIN, your payment
may not be applied to your facility and
your registration may be delayed.
The originating financial institution
may charge a wire transfer fee. Ask your
financial institution about the fee and
add it to your payment to ensure that
your order is fully paid. Use the
following account information when
sending a wire transfer: U.S. Dept. of
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.
75060099, Routing No. 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA,
8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993–0002. (If needed,
FDA’s tax identification number is 53–
0196965.)
C. Complete the Information Online To
Update Your Establishment’s Annual
Registration for FY 2017, or To Register
a New Establishment for FY 2017
Go to the Center for Devices and
Radiological Health’s Web site at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
HowtoMarketYourDevice/Registration
andListing/default.htm and click the
‘‘Access Electronic Registration’’ link on
the left side of the page. This opens up
a new page with important information
about the FDA Unified Registration and
Listing System (FURLS). After reading
this information, click on the ‘‘Access
Electronic Registration’’ link in the
middle of the page. This link takes you
to an FDA Industry Systems page with
tutorials that demonstrate how to create
a new FURLS user account if your
establishment did not create an account
in FY 2016. Manufacturers of licensed
biologics should register in the BER
system at https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Establishment
Registration/BloodEstablish
mentRegistration/default.htm.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
click on the Device Registration and
Listing Module (DRLM) of FURLS
button. New establishments will need to
register and existing establishments will
update their annual registration using
choices on the DRLM menu. When you
choose to register or update your annual
registration, the system will prompt you
through the entry of information about
your establishment and your devices. If
you have any problems with this
process, email: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
This email address and this telephone
number are for assistance with
establishment registration only; they are
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18:42 Jul 28, 2016
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not to be used for questions related to
other aspects of medical device user
fees.) Problems with BERS should be
directed to https://
www.accessdata.fda.gov/scripts/email/
cber/bldregcontact.cfm or call 240–402–
8360.
D. Enter Your DFUF Order PIN and PCN
After completing your annual or
initial registration and device listing,
you will be prompted to enter your
DFUF order PIN and PCN, when
applicable. This process does not apply
to establishments engaged only in the
manufacture, preparation, propagation,
compounding, or processing of licensed
biologic devices. CBER will send
invoices for payment of the
establishment registration fee to such
establishments.
Dated: July 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17903 Filed 7–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1039]
General Wellness: Policy for Low Risk
Devices; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘General Wellness: Policy for Low Risk
Devices.’’ The guidance is intended to
provide clarity to industry and FDA
staff on Center for Devices and
Radiological Health’s (CDRH)
compliance policy for low-risk products
that promote a healthy lifestyle (general
wellness products). By clarifying the
policy on general wellness products, we
hope to improve the predictability,
consistency, and transparency on
CDRH’s regulation of these products.
For purposes of the guidance, CDRH
defines ‘‘general wellness products’’ as
products which meet the following
factors: They are intended for only
general wellness use as defined in the
guidance and present a low risk to the
safety of users and other persons.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
SUMMARY:
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guidance documents are welcome at any
time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1039 for ‘‘General Wellness:
Policy for Low Risk Devices.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
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[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)]
[Notices]
[Pages 49987-49993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0007]
Medical Device User Fee Rates for Fiscal Year 2017
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 2012
(MDUFA III), authorizes FDA to collect user fees for certain medical
device submissions and annual fees both for certain periodic reports
and for establishments subject to registration. This notice establishes
the fee rates for FY 2017, which apply from October 1, 2016, through
September 30, 2017. To avoid delay in the review of your application,
you should pay the application fee before or at the time you submit
your application to FDA. The fee you must pay is the fee that is in
effect on the later of the date that your application is received by
FDA or the date your fee payment is recognized by the U.S. Treasury. If
you want to pay a reduced small business fee, you must qualify as a
small business before making your submission to FDA; if you do not
qualify as a small business before making your submission to FDA, you
will have to pay the higher standard fee. Please note that the
establishment registration fee is not eligible for a reduced small
business fee. As a result, if the establishment registration fee is the
only medical device user fee that you will pay in FY 2017, you should
not submit a FY 2017 Small Business Qualification and Certification
request. This document provides information on how the fees for FY 2017
were determined, the payment procedures you should follow, and how you
may qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device User Fees: Visit FDA's Web site
at https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
For questions relating to this notice: Maurille Beheton, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202C), Silver Spring, MD 20993-0002, 301-796-4689.
SUPPLEMENTARY INFORMATION:
I. Background
Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for
certain medical device applications, submissions, supplements, and
notices (for simplicity, this document refers to these collectively as
``submissions'' or ``applications''); for periodic reporting on class
III devices; and for the registration of certain establishments. Under
statutorily defined conditions, a qualified applicant may receive a fee
waiver or may pay a lower small business fee (see 21 U.S.C. 379j(d) and
(e)). Additionally, the Secretary of Health and Human Services (the
Secretary) may, at the Secretary's sole discretion, grant a fee waiver
or reduction if the Secretary finds that such waiver or reduction is in
the interest of public health (see 21 U.S.C. 379j(f)).
Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2013 through FY 2017; the
base fee for a premarket application received by FDA during FY 2017 is
$268,443. From this starting point, this document establishes FY 2017
fee rates for other types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
The FD&C Act specifies the base fee for establishment registration
for each year from FY 2013 through FY 2017; the base fee for an
establishment registration in FY 2017 is $3,872. There is no reduction
in the registration fee for small businesses. Each establishment that
is registered (or is required to register) with the Secretary under
section 510 of the FD&C Act (21 U.S.C. 360) because such establishment
is engaged in the manufacture, preparation, propagation, compounding,
or processing of a device is required to pay the annual fee for
establishment registration.
II. Revenue Amount for FY 2017
The total revenue amount for FY 2017 is $130,184,348, as set forth
in the statute prior to the inflation adjustment and offset of excess
collections (see 21 U.S.C. 379j(b)(3)). MDUFA directs FDA to use the
yearly total revenue amount as a starting point to set the standard fee
rates for each fee type. The fee calculations for FY 2017 are described
in this document.
A. Inflation Adjustment
MDUFA specifies that the $130,184,348 is to be adjusted for
inflation increases for FY 2017 using two separate adjustments--one for
payroll costs and one for non-pay cost (see 21 U.S.C. 379j(c)(2)). The
base inflation adjustment for FY 2017 is the sum of one plus these two
separate adjustments, and is compounded as specified (see 21 U.S.C.
379j(c)(2)(C)(1) and 379j(c)(2)(B)(ii)).
The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all personnel compensation
and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
Table 1 summarizes the actual cost and FTE data for the specified
FYs, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2017.
The 3-year average is 1.8759 percent (rounded).
Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
3-Year
Fiscal Year 2013 2014 2015 average
----------------------------------------------------------------------------------------------------------------
Total PC&B............................. $1,927,703,000 $2,054,937,000 $2,232,304,000 ..............
Total FTE.............................. 13,974 14,555 15,484 ..............
PC&B per FTE........................... $137,949 $141,184 $144,168 ..............
Percent change from previous year...... 1.1690% 2.3451% 2.1136% 1.8759%
----------------------------------------------------------------------------------------------------------------
[[Page 49988]]
The payroll adjustment is 1.8759 percent multiplied by 60 percent,
or 1.1255 percent.
The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2017 is the average annual
percent change that occurred in the Consumer Price Index (CPI) for
urban consumers (Washington-Baltimore, DC-MD-VA-WV; not seasonally
adjusted; all items; annual index) for the first 3 of the preceding 4
years of available data multiplied by 0.40, or 40 percent (see 21
U.S.C. 379j(c)(2)(C)).
Table 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Baltimore-Washington area. This
data is published by the Bureau of Labor Statistics and can be found on
their Web site at 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
----------------------------------------------------------------------------------------------------------------
3-Year
Fiscal year 2013 2014 2015 average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................... 152.500 154.847 155.353 ..............
Annual Percent Change........................... 1.5232% 1.5390% 0.3268% ..............
3-Year Avg. Percent Change in CPI............... .............. .............. .............. 1.1297%
----------------------------------------------------------------------------------------------------------------
The non-pay adjustment is 1.1297 percent multiplied by 40 percent,
or 0.4519 percent.
Next, the payroll adjustment (1.1255 percent or 0.011255) is added
to the non-pay adjustment (0.4519 percent or 0.004519), for a total of
1.5774 percent (or 0.015774). To complete the inflation adjustment, 1
(100 percent or 1.0) is added for a total base inflation adjustment of
1.015774 for FY 2017.
MDUFA III provides for this inflation adjustment to be compounded
for FY 2015 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2017
(1.015774) is compounded by multiplying it by the compounded applicable
inflation adjustment for FY 2016 (1.064457), as published in the
Federal Register of August 3, 2015 (80 FR 46033 to 46039), to reach the
applicable inflation adjustment of 1.081248 (rounded) (1.015774 times
1.064457) for FY 2017. We then multiply the total revenue amount for FY
2017 ($130,184,348) by 1.081248, yielding an inflation adjusted total
revenue amount of $140,762,000 (rounded to the nearest thousand
dollars).
B. Offset for Excess Collections Through FY 2016
Under the offset provision of the FD&C Act (see section 738(i)(4)
(21 U.S.C. 379j(i)(4))), if the cumulative amount of fees collected
during FY 2013 through FY 2015, added to the amount estimated to be
collected for FY 2016, exceeds the cumulative amount appropriated for
these four FYs, the excess shall be credited to the appropriation
account of the Food and Drug Administration and shall be subtracted
from the amount of fees that would otherwise be authorized to be
collected for FY 2017. Table 3 presents the amount of MDUFA fees
collected during FY 2013 through FY 2015 (actuals), and the amount
estimated to be collected for FY 2016, and compares those amounts with
the fees specified to be appropriated in these four FYs.
Table 3--Statement of Fees Appropriated, Fees Collected, and Differences as of June 30, 2016
----------------------------------------------------------------------------------------------------------------
Fee
Fiscal year appropriated Fees collected Difference
--------------------------------------------------------------------------------------------------
2013 Actual....................................... $97,722,000 $103,991,182 $6,269,182
2014 Actual....................................... 114,833,000 124,297,628 9,464,628
2015 Actual....................................... 128,282,000 139,712,238 11,430,238
2016 Estimate..................................... 134,667,000 134,667,000 0
-------------------------------------------------------------
Total......................................... 478,504,000 505,668,048 27,164,048
Unearned Revenue Included in Above Amount......... .............. .............. 12,485,897
Excess Collections Less Unearned Revenue (Offset .............. .............. 14,678,151
Amount)..........................................
----------------------------------------------------------------------------------------------------------------
The total amount FDA expects to have collected in excess of
appropriations by the end of FY 2016 is $27,164,048. However, of that
amount, a total of $12,485,897 represents unearned revenue--primarily
fees paid for applications that have not yet been received. The
unearned revenue is held in reserve either to refund, if no application
is submitted, or to apply toward the future FY when the application is
received. The net of these two figures, $14,678,151, is the amount that
FDA has received in excess of appropriations that is available for
obligation, and the amount by which fee revenue will be offset in FY
2017.
For FY 2017, the statute authorizes $140,762,000 in user fees. In
order to determine the revised collection amount, we deduct the net
excess collection amount of $14,678,151 from $140,762,000, and the
revised revenue target for FY 2017 becomes $126,083,000 (rounded down
to the nearest thousand dollars).
III. Fees for FY 2017
Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A)). Table 4 provides the last 3
years of fee paying submission counts and the 3-year average. These
numbers are used to project the fee paying submission counts that FDA
will receive in FY 2017. Most of the fee paying submission counts are
published in the MDUFA Financial Report to Congress each year.
[[Page 49989]]
Table 4--3-Year Average of Fee Paying Submissions
----------------------------------------------------------------------------------------------------------------
FY 2013 FY 2014 FY 2015 3-Year
Application type actual actual actual average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... 23 25 42 30
Small Business.............................. 9 5 7 7
Panel-Track Supplement.......................... 19 12 22 18
Small Business.............................. 0 3 3 2
180-Day Supplements............................. 128 122 143 131
Small Business.............................. 21 24 15 20
Real-Time Supplements........................... 182 192 204 193
Small Business.............................. 23 19 28 23
510(k)s......................................... 3,149 3,034 2,768 2,984
Small Business.............................. 1,202 1,037 1,037 1,092
30-Day Notice................................... 956 934 920 937
Small Business.............................. 69 91 71 77
513(g) (21 U.S.C. 360c(g)) Request for 65 69 75 70
Classification Information.....................
Small Business.............................. 38 31 33 34
Annual Fee for Periodic Reporting \1\........... 614 514 544 557
Small Business \1\.......................... 54 56 68 59
Establishment Registration \2\.................. 23,477 24,026 25,363 24,289
----------------------------------------------------------------------------------------------------------------
\1\ Includes collection of quarter 4 billing for FY 2015 during FY 2016.
\2\ Establishment Registration total comes from the registration system and will vary from the financial report.
The information in table 4 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 5
displays both the estimated revenue using the FY 2017 base fees set in
statute and the estimated revenue after the inflation adjustment and
offset of excess collections to the FY 2017 base fees. Using the fees
set in statute and the 3 year averages of fee paying submissions, the
collections would total $144,335,998, which is $18,252,998 higher than
the statutory revenue limit. Accordingly the PMA and establishment fee
need to be decreased so that collections come as close to the statutory
revenue limit of $126,083,000 as possible without exceeding the limit.
This is done by calculating the percentage difference between the
statutory revenue limit and the estimated resulting 2017 revenue
collections, and then lowering the fees proportionally by that
percentage (rounded to the nearest dollar). The fees in the second
column from the right are those we are establishing in FY 2017, which
are the standard fees.
Table 5--Fees Needed To Achieve New FY 2017 Revenue Target
----------------------------------------------------------------------------------------------------------------
Adjusted FY
FY 2017 2017 fees to
Statutory Estimated meet revenue FY 2017
Application type fees (base resulting target Revenue from
fees) 2017 revenue (standard adjusted fees
fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........................... $268,443 $8,053,290 $234,495 $7,034,850
Small Business.............................. 67,111 469,777 58,624 410,368
Panel-Track Supplement.......................... 201,332 3,623,976 175,871 3,165,678
Small Business.............................. 50,333 100,666 43,968 87,936
180-Day Supplements............................. 40,266 5,274,846 35,174 4,607,794
Small Business.............................. 10,067 201,340 8,794 175,880
Real-Time Supplements........................... 18,791 3,626,663 16,415 3,168,095
Small Business.............................. 4,698 108,054 4,104 94,392
510(k)s......................................... 5,369 16,021,096 4,690 13,994,960
Small Business.............................. 2,685 2,932,020 2,345 2,560,740
30-Day Notice................................... 4,295 4,024,415 3,752 3,515,624
Small Business.............................. 2,148 165,396 1,876 144,452
513(g) Request for Classification Information... 3,624 253,680 3,166 221,620
Small Business.............................. 1,812 61,608 1,583 53,822
Annual Fee for Periodic Reporting............... 9,396 5,233,572 8,207 4,571,299
Small Business.............................. 2,349 138,591 2,052 121,068
Establishment Registration...................... 3,872 94,047,008 3,382 82,145,398
---------------------------------------------------------------
Total....................................... .............. 144,335,998 .............. 126,073,976
----------------------------------------------------------------------------------------------------------------
The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $234,495 for FY 2017. The fees set by reference
to the standard fee for a premarket application are:
For a panel-track supplement, 75 percent of the standard
fee;
For a 180-day supplement, 15 percent of the standard fee;
For a real-time supplement, 7 percent of the standard fee;
For a 510(k) premarket notification, 2 percent of the
standard fee;
For a 30-day notice, 1.6 percent of the standard fee;
[[Page 49990]]
For a 513(g) request for classification information, 1.35
percent of the standard fee; and
For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee.
For all submissions other than a 510(k) premarket notification, a
30-day notice, and a 513(g) request for classification information, the
small business fee is 25 percent of the standard (full) fee for the
submission (see 21 U.S.C. 379j(d)(2)(C)). For a 510(k) premarket
notification submission, a 30-day notice, and a 513(g) request for
classification information, the small business fee is 50 percent of the
standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C) and
(e)(2)(C)).
The annual fee for establishment registration, after adjustment, is
set at $3,382 for FY 2017. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 6 summarizes the FY 2017 rates for all medical device fees.
Table 6--Medical Device Fees for FY 2017
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of
Application fee type the standard fee for a FY 2017 FY 2017 Small
premarket application) Standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Base fee specified in statute at $234,495 $58,624
section 515(c)(1) of the FD&C Act (21 U.S.C. $268,443, but multiplied by
360e(c)(1)), a PDP submitted under section 87.3538 percent.
515(f) of the FD&C Act, or a BLA submitted
under section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262)).
Premarket report (submitted under section 100............................. 234,495 58,624
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under 100............................. 234,495 58,624
section 351 of the PHS Act).
Panel-track supplement........................ 75.............................. 175,871 43,968
180-day supplement............................ 15.............................. 35,174 8,794
Real-time supplement.......................... 7............................... 16,415 4,104
510(k) premarket notification submission...... 2............................... 4,690 2,345
30-day notice................................. 1.60............................ 3,752 1,876
513(g) request for classification information. 1.35............................ 3,166 1,583
Annual Fee Type:
Annual fee for periodic reporting on a 3.50............................ 8,207 2,052
class III device.
Annual establishment registration fee (to Base fee specified in statute at 3,382 3,382
be paid by the establishment engaged in $3,872, but multiplied by
the manufacture, preparation, 87.3538 percent.
propagation, compounding, or processing
of a device, as defined by 21 U.S.C.
379i(13)).
----------------------------------------------------------------------------------------------------------------
IV. How To Qualify as a Small Business for Purposes of Medical Device
Fees
If your business has gross receipts or sales of no more than $100
million for the most recent tax year, you may qualify for reduced small
business fees. If your business has gross sales or receipts of no more
than $30 million, you may also qualify for a waiver of the fee for your
first premarket application (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates
along with your own gross receipts or sales when determining whether
you meet the $100 million or $30 million threshold. If you want to pay
the small business fee rate for a submission, or you want to receive a
waiver of the fee for your first premarket application or premarket
report, you should submit the materials showing you qualify as a small
business 60 days before you send your submission to FDA. FDA will
review your information and determine whether you qualify as a small
business eligible for the reduced fee and/or fee waiver. If you make a
submission before FDA finds that you qualify as a small business, you
must pay the standard (full) fee for that submission.
If your business qualified as a small business for FY 2016, your
status as a small business will expire at the close of business on
September 30, 2016. You must re-qualify for FY 2017 in order to pay
small business fees during FY 2017.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2017, you must submit the following to FDA:
1. A completed FY 2017 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2017 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
2. A certified copy of your Federal (U.S.) Income Tax Return for
the most recent tax year. The most recent tax year will be 2016,
except:
If you submit your FY 2017 MDUFA Small Business Qualification
before April 15, 2017, and you have not yet filed your return for 2016,
you may use tax year 2015.
If you submit your FY 2017 MDUFA Small Business Qualification on or
after April 15, 2017, and have not yet filed your 2016 return because
you obtained an extension, you may submit your most recent return filed
prior to the extension.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year, or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The applicant must also submit a
statement signed by the head of the applicant's firm or by its chief
financial officer that the applicant has submitted certifications for
all of its affiliates, identifying the name of each
[[Page 49991]]
affiliate, or that the applicant has no affiliates.
If you are a foreign business, and wish to qualify as a small
business for FY 2017, you must submit the following:
1. A completed FY 2017 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2017 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority of the
country in which the firm is headquartered. This certification must
show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year (2016 or later), or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The applicant must also
submit a statement signed by the head of the applicant's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the applicant has no affiliates.
V. Procedures for Paying Application Fees
If your application or submission is subject to a fee and your
payment is received by FDA between October 1, 2016, and September 30,
2017, you must pay the fee in effect for FY 2017. The later of the date
that the application is received in the reviewing center's document
room or the date the U.S. Treasury recognizes the payment determines
whether the fee rates for FY 2016 or FY 2017 apply. FDA must receive
the correct fee at the time that an application is submitted, or the
application will not be accepted for filing or review.
FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: Do not send your user fee
check to FDA with the application.)
A. Secure a Payment Identification Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before Submitting Either the Application or
the Payment
Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet.
Be sure you choose the correct application submission date range. (Two
choices will be offered until October 1, 2016. One choice is for
applications and fees that will be received on or before September 30,
2016, which are subject to FY 2016 fee rates. A second choice is for
applications and fees received on or after October 1, 2016, which are
subject to FY 2017 fee rates.) After completing data entry, print a
copy of the Medical Device User Fee cover sheet and note the unique PIN
located in the upper right-hand corner of the printed cover sheet.
B. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN
When you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Applicants are required to set up a user
account and password to assure data security in the creation and
electronic submission of cover sheets.
C. Submit Payment for the Completed Medical Device User Fee Cover Sheet
1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). FDA has partnered with
the U.S. Department of the Treasury to utilize Pay.gov, a Web-based
payment system, for online electronic payment. You may make a payment
via electronic check or credit card after submitting your cover sheet.
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay. Once you search for your
invoice, click ``Pay Now'' to be redirected to Pay.gov. Note that
electronic payment options are based on the balance due. Payment by
credit card is available for balances less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
drawn on U.S bank accounts as well as U.S. credit cards.
2. If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. (If needed, FDA's
tax identification number is 53-0196965.)
Please write your application's unique PIN (from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet) on your check.
Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is
for courier delivery only. If you have any questions concerning courier
delivery contact the U.S. Bank at 314-418-4013. This telephone number
is only for questions about courier delivery).
3. If paying with a wire transfer:
Please include your application's unique PIN (from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet) in your wire transfer. Without the PIN, your payment may not be
applied to your cover sheet and review of your application may be
delayed.
The originating financial institution may charge a wire
transfer fee. Ask your financial institution about the fee and add it
to your payment to ensure that your cover sheet is fully paid.
Use the following account information when sending a wire transfer:
U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Road, 14th Floor, Silver Spring, MD
20993-0002.
FDA records the official application receipt date as the later of
the following: (1) The date the application was received by FDA or (2)
the date the U.S. Treasury recognizes the payment. It is helpful if the
fee arrives at the bank at
[[Page 49992]]
least 1 day before the application arrives at FDA.
D. Submit Your Application to FDA With a Copy of the Completed Medical
Device User Fee Cover Sheet
Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to one of the following addresses:
1. Medical device applications should be submitted to: Food and
Drug Administration, Center for Devices and Radiological Health,
Document Control Center, 10903 New Hampshire Ave., Building 66, Rm.
0609, Silver Spring, MD 20993-0002.
2. Biologics license applications and other medical device
submissions reviewed by the Center for Biologics Evaluation and
Research should be sent to: Food and Drug Administration, Center for
Biologics Evaluation and Research, Document Control Center, 10903 New
Hampshire Ave, Building 71, Rm. G112, Silver Spring, MD 20993-0002.
VI. Procedures for Paying the Annual Fee for Periodic Reporting
You will be invoiced at the end of the quarter in which your PMA
Periodic Report is due. Invoices will be sent based on the details
included on your PMA file. You are responsible for ensuring FDA has
your current billing information, and you may update your contact
information for the PMA by submitting an amendment to the PMA.
1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). Secure electronic
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. Once you search for your invoice, click ``Pay
Now'' to be redirected to Pay.gov. Note that electronic payment options
are based on the balance due. Payment by credit card is available for
balances less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be drawn on U.S bank
accounts as well as U.S. credit cards.
2. If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. (If needed, FDA's tax
identification number is 53-0196965,)
Please write your invoice number on the check.
Mail the paper check and a copy of invoice to: Food and
Drug Administration, P.O. Box 979033, St. Louis, MO, 63197-9000.
(Please note that this address is for payments of application
and annual report fees only and is not to be used for payment of
annual establishment registration fees.)
If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is
for courier delivery only. If you have any questions concerning courier
delivery contact the U.S. Bank at 314-418-4013. This telephone number
is only for questions about courier delivery).
3. If paying with a wire transfer:
Please include your invoice number in your wire transfer.
Without the invoice number, your payment may not be applied and you may
be referred to collections.
The originating financial institution may charge a wire
transfer fee. Ask your financial institution about the fee and add it
to your payment to ensure that your invoice is fully paid.
Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver Spring, MD
20993-0002.
VII. Procedures for Paying Annual Establishment Fees
To pay the annual establishment fee, firms must access the Device
Facility User Fee (DFUF) Web site at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site address after
this document publishes in the Federal Register.) Create a DFUF order
and you will be issued a PIN when you place your order. After payment
has been processed, you will be issued a payment confirmation number
(PCN). You will not be able to register your establishment if you do
not have a PIN and a PCN. An establishment required to pay an annual
establishment registration fee is not legally registered in FY 2017
until it has completed the steps below to register and pay any
applicable fee. (See 21 U.S.C. 379j(g)(2).)
Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.
A. Submit a DFUF Order With a PIN From FDA Before Registering or
Submitting Payment
To submit a DFUF Order, you must create or have previously created
a user account and password for the user fee Web site listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2016 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. When you are satisfied that the information in the
order is accurate, electronically transmit that data to FDA according
to instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.
B. Pay for Your DFUF Order
Unless paying by credit card, all payments must be in U. S.
currency and drawn on a U.S. bank.
1. If paying by credit card or electronic check (ACH or eCheck):
The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic check.
Follow the instructions provided to make an electronic payment.
2. If paying with a paper check:
You may pay by a check, in U.S. dollars and drawn on a U.S. bank,
mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO
63197-9000. (Note: This address is different from the address for
payments of application and annual report fees and is to be used only
for payment of annual establishment registration fees.)
If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S.
Bank address is for courier delivery only. If you have any questions
concerning courier delivery contact the U.S. Bank at 314-418-4013. This
telephone number is only for questions about courier delivery).
Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 979108) and (2) the
PIN that is printed on your order. Include a copy of your printed order
when you mail your check.
3. If paying with a wire transfer:
Wire transfers may also be used to pay annual establishment fees.
To send a wire transfer, please read and comply with the following
information:
Include your order's unique PIN (in the upper right-hand corner of
your
[[Page 49993]]
completed DFUF order) in your wire transfer. Without the PIN, your
payment may not be applied to your facility and your registration may
be delayed.
The originating financial institution may charge a wire transfer
fee. Ask your financial institution about the fee and add it to your
payment to ensure that your order is fully paid. Use the following
account information when sending a wire transfer: U.S. Dept. of
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.
75060099, Routing No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA,
8455 Colesville Rd., 14th Floor, Silver Spring, MD 20993-0002. (If
needed, FDA's tax identification number is 53-0196965.)
C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2017, or To Register a New Establishment for
FY 2017
Go to the Center for Devices and Radiological Health's Web site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the
``Access Electronic Registration'' link on the left side of the page.
This opens up a new page with important information about the FDA
Unified Registration and Listing System (FURLS). After reading this
information, click on the ``Access Electronic Registration'' link in
the middle of the page. This link takes you to an FDA Industry Systems
page with tutorials that demonstrate how to create a new FURLS user
account if your establishment did not create an account in FY 2016.
Manufacturers of licensed biologics should register in the BER system
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register and existing establishments will update their annual
registration using choices on the DRLM menu. When you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
reglist@cdrh.fda.gov or call 301-796-7400 for assistance. (Note: This
email address and this telephone number are for assistance with
establishment registration only; they are not to be used for questions
related to other aspects of medical device user fees.) Problems with
BERS should be directed to https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call 240-402-8360.
D. Enter Your DFUF Order PIN and PCN
After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.
Dated: July 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17903 Filed 7-28-16; 8:45 am]
BILLING CODE 4164-01-P
