Prescription Drug User Fee Rates for Fiscal Year 2017, 49674-49678 [2016-17870]
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deferral period for other men and
women at increased risk for HIV
infection, such as those who had a
recent blood transfusion or who have
been accidentally exposed to the blood
of another individual through a needle
stick. In reviewing the Agency’s
recommendations to reduce the risk of
HIV transmission through blood and
blood products, FDA rigorously
examined several alternative options,
including individual risk assessment.
Ultimately, FDA concluded that the 12month deferral period is supported by
the best available scientific evidence, at
this point in time, relevant to the U.S.
population.
As described in the December 2015
guidance, throughout the process of
comprehensively updating blood donor
deferral policies, FDA has worked with
other government Agencies, considered
input from external advisory
committees, reviewed comments from
stakeholders to the draft guidance of the
same title (80 FR 27973, May 15, 2015),
and carefully examined the most recent
available scientific evidence. FDA also
has implemented a nationally
representative transfusion-transmissible
infections monitoring system for the
U.S. blood supply with assistance from
the National Heart, Lung, and Blood
Institute at the National Institutes of
Health. This system provides critical
information to help inform future
actions that FDA may take on blood
donor policies.
When FDA issued the December 2015
guidance, it noted that while the
December 2015 guidance represents
FDA’s current thinking on the subject,
FDA was committed to continuing to
reevaluate and update blood donor
deferral policies as new scientific
information becomes available. FDA
also noted that, because the process
must be data-driven, FDA could not
specify a time for when future policy
changes might occur.
As part of the effort to continue to
assess its donor deferral policies, FDA is
opening this docket to provide a
mechanism for the public to submit
additional information regarding
potential blood donor deferral policy
options. Specifically, we invite
interested persons to submit to the
docket comments supported by
scientific evidence regarding possible
revisions to FDA’s blood donor deferral
policies to reduce the risk of HIV
transmission by blood and blood
products. FDA requests that
commenters provide scientific evidence,
such as data from research, to support
any suggestions. Additionally,
comments are invited regarding the
design of potential studies to evaluate
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the feasibility or effectiveness of such
alternative deferral policy options.
FDA recognizes that many
stakeholders have expressed the desire
to move from a time-based deferral
period to a deferral policy based on
individual risk assessment. An
individual risk assessment would
involve asking potential donors a series
of questions designed to defer donors
with high risk behaviors. In particular,
we invite commenters to address the
following and provide supporting
scientific evidence such as data from
research:
1. What questions would most effectively
identify individuals at risk of
transmitting HIV through blood
donation?
2. Are there specific questions that could be
asked that might best capture the recent
risk of a donor acquiring HIV infection,
such as within the 2 to 4 weeks
immediately preceding blood donation?
3. How specific can the questions be
regarding sexual practices while
remaining understandable and
acceptable to all blood donors? For
example, could questions about specific
sexual behaviors be asked if they helped
to identify which donors should be at
least temporarily deferred because of risk
factors? To the extent the questions are
explicit about sexual practices, how
willing will donors be to answer such
questions accurately?
4. Under what circumstances would a short
deferral period for high risk behavior be
appropriate? For each short deferral
period identified, please specify the
duration of the deferral and provide the
scientific rationale.
5. What changes might be necessary within
blood collection establishments to assure
that accurate, individual HIV risk
assessments are performed?
6. How best to design a potential study to
evaluate the feasibility and effectiveness
of alternative deferral options such as
individual risk assessment?
FDA will consider comments and
supporting scientific data received as it
continues to reevaluate and update
blood donor deferral policies as new
scientific information becomes
available.
Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17804 Filed 7–26–16; 11:15 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0007]
Prescription Drug User Fee Rates for
Fiscal Year 2017
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates for prescription drug user fees for
fiscal year (FY) 2017. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Prescription Drug
User Fee Amendments of 2012 (PDUFA
V), authorizes FDA to collect user fees
for certain applications for the review of
human drug and biological products, on
establishments where the products are
made, and on such products. This
notice establishes the fee rates for FY
2017.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Robert J. Marcarelli, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14202F, Silver Spring, MD
20993–0002, 301–796–7223.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the FD&C Act
(21 U.S.C. 379g and 379h, respectively)
establish three different kinds of user
fees. Fees are assessed on the following:
(1) Certain types of applications and
supplements for the review of human
drug and biological products; (2) certain
establishments where such products are
made; and (3) certain products (section
736(a) of the FD&C Act). When certain
conditions are met, FDA may waive or
reduce fees (section 736(d) of the FD&C
Act).
For FY 2013 through FY 2017, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA V. The base
revenue amount for FY 2013, which
became the base amount for the
remaining four FYs of PDUFA V, is
$718,669,000, as published in the
Federal Register of August 1, 2012 (77
FR 45639). The FY 2013 base revenue
amount is further adjusted each year
after FY 2013 for inflation and
workload. For FY 2017, fee revenue and
fees may be further adjusted by the final
year adjustment. In addition, for FY
2017, excess collections are offset as
required by the FD&C Act. Fees for
applications, establishments, and
products are to be established each year
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by FDA so that revenues from each
category will provide one-third of the
total revenue to be collected each year.
This document provides fee rates for
FY 2017 for an application requiring
clinical data ($2,038,100), for an
application not requiring clinical data or
a supplement requiring clinical data
($1,019,050), for an establishment
($512,200), and for a product ($97,750).
These fees are effective on October 1,
2016, and will remain in effect through
September 30, 2017. For applications
and supplements that are submitted on
or after October 1, 2016, the new fee
schedule must be used. Invoices for
establishment and product fees for FY
2017 will be issued in August 2016
using the new fee schedule.
II. Fee Revenue Amount for FY 2017
The base revenue amount for FY 2017
is $718,669,000 prior to adjustments for
inflation, workload, the offset of excess
collections, and the final year
adjustment (see sections 736(c)(1),
736(c)(2), 736(g)(4), and 736(c)(3) of the
FD&C Act, respectively).
A. FY 2017 Statutory Fee Revenue
Adjustments for Inflation
PDUFA V specifies that the
$718,669,000 is to be further adjusted
for inflation increases for FY 2017 using
two separate adjustments—one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see
section 736(c)(1) of the FD&C Act).
The component of the inflation
adjustment for payroll costs shall be one
plus the average annual percent change
in the cost of all PC&B paid per full-time
equivalent (FTE) position at FDA for the
first three of the preceding four FYs,
multiplied by the proportion of PC&B
costs to total FDA costs of process for
the review of human drug applications
for the first three of the preceding four
FYs (see section 736(c)(1)(A) and
(c)(1)(B) of the FD&C Act).
Table 1 summarizes that actual cost
and FTE data for the specified FYs, and
provides the percent changes from the
previous FYs and the average percent
changes over the first three of the four
FYs preceding FY 2017. The 3-year
average is 1.8759 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES
Fiscal year
2013
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent Change From Previous Year .....................................
The statute specifies that this 1.8759
percent should be multiplied by the
proportion of PC&B costs to total FDA
$1,927,703,000
13,974
$137,949
1.1690
2014
2015
$2,054,937,000
14,555
$141,184
2.3451
costs of the process for the review of
human drug applications. Table 2 shows
the PC&B and the total obligations for
$2,232,304,000
15,484
$144,168
2.1136
3-year average
..............................
..............................
..............................
1.8759
the process for the review of human
drug applications for three FYs.
TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS FOR THE REVIEW OF HUMAN DRUG
APPLICATIONS
Fiscal year
2013
Total PC&B ..............................................................................
Total Costs ...............................................................................
PC&B Percent ..........................................................................
The payroll adjustment is 1.8759
percent from table 1 multiplied by
55.9064 percent (or 1.0487 percent).
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs 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;
$568,206,210
$966,169,007
58.8102
2014
2015
$585,260,720
$1,077,263,695
54.3285
all items; annual index) for the first
three years of the preceding four years
of available data multiplied by the
proportion of all costs other than PC&B
costs to total costs of the process for the
review of human drug applications for
the first three years of the preceding
four FYs (see section 736(c)(1)(C) of the
FD&C Act). Table 3 provides the
summary data for the percent changes in
$615,483,892
$1,127,664,528
54.5804
3-year average
..............................
..............................
55.9064
the specified CPI for the WashingtonBaltimore area. The data are published
by the Bureau of Labor Statistics and
can be found on its Web site at: https://
data.bls.gov/cgi-bin/surveymost?cu. The
data can be viewed by checking the box
marked ‘‘Washington-Baltimore All
Items, November 1996=100—
CUURA311SA0’’ and then selecting
‘‘Retrieve Data’’.
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-BALTIMORE AREA
Year
2013
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Annual CPI ...............................................................................
Annual Percent Change ..........................................................
To calculate the inflation adjustment
for non-payroll costs, we multiply the
1.1297 percent by the proportion of all
costs other than PC&B to total costs of
the process for the review of human
drug applications obligated. Since
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2014
152.500
1.5232
154.847
1.5390
55.9064 percent was obligated for PC&B
as shown in Table 2, 44.0936 percent is
the portion of costs other than PC&B
(100 percent minus 55.9064 percent
equals 44.0936 percent). The nonpayroll adjustment is 1.1297 percent
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2015
155.353
0.3268
3-year average
..............................
1.1297
times 44.0936 percent, or 0.4981
percent.
Next, we add the payroll adjustment
(1.0487 percent) to the non-payroll
adjustment (0.4981 percent), for a total
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inflation adjustment of 1.5468 percent
(rounded) for FY 2017.
PDUFA V provides for this inflation
adjustment to be compounded after FY
2013 (see section 736(c)(1) of the FD&C
Act). This factor for FY 2017 (1.5468
percent) is compounded by adding one
and then multiplying by one plus the
compound inflation adjustment factor
for FY 2016 (6.4414 percent), as
published in the Federal Register of
August 3, 2015 (80 FR 46028 at 46032),
which equals to 1.080878 (rounded)
(1.015468 × 1.064414) for FY 2017. We
then multiply the base revenue amount
for FY 2017 ($718,669,000) by 1.080878,
yielding an inflation-adjusted amount of
$776,793,511.
B. FY 2017 Statutory Fee Revenue
Adjustments for Workload
The statute specifies that after the
$718,669,000 has been adjusted for
inflation, the inflation-adjusted amount
shall be further adjusted for workload
(see section 736(c)(2) of the FD&C Act).
To calculate the FY 2017 workload
adjustment, FDA calculated the average
number of each of the four types of
applications specified in the workload
adjustment provision: (1) Human drug
applications; (2) active commercial
investigational new drug applications
(INDs) (applications that have at least
one submission during the previous 12
months); (3) efficacy supplements; and
(4) manufacturing supplements received
over the 3-year period that ended on
June 30, 2012 (base years), and the
average number of each of these types
of applications over the most recent 3year period that ended June 30, 2016.
The calculations are summarized in
table 4. The 3-year averages for each
application category are provided in
column 1 (‘‘3-Year Average Base Years
2010–2012’’) and column 2 (‘‘3-Year
Average 2014–2016’’). Column 3 reflects
the percent change in workload from
column 1 to column 2. Column 4 shows
the weighting factor for each type of
application, estimating how much of the
total FDA drug review workload was
accounted for by each type of
application in the table during the most
recent 3 years. Column 5 is the weighted
percent change in each category of
workload. This was derived by
multiplying the weighting factor in each
line in column 4 by the percent change
from the base years in column 3. The
values in column 5 are summed,
reflecting an increase in workload of
13.1047 percent (rounded) for FY 2017
when compared to the base years.
TABLE 4—WORKLOAD ADJUSTER CALCULATION FOR FY 2017
Column 1
Column 3
Column 4
Column 5
3-year
average
base years
2010–2012
Application type
Column 2
3-year
average
2014–2016
Percent
change
(column 1 to
column 2)
Weighting
factor
(percent)
Weighted
percent
change
New Drug Applications/Biologics License Applications .......
Active Commercial INDs ......................................................
Efficacy Supplements ..........................................................
Manufacturing Supplements ................................................
124.3000
6830.0000
136.3000
2548.3000
147.3000
7598.0000
196.3000
2368.0000
18.5036
11.2445
44.0205
¥7.0753
35.8514
41.0966
6.8122
16.2399
6.6338
4.6211
2.9988
¥1.1490
FY 2017 Workload Adjuster .........................................
........................
........................
........................
........................
13.1047
Table 5 shows the calculation of the
inflation and workload adjusted amount
for FY 2017. The $718,669,000 subject
to adjustment on line 1 is multiplied by
the inflation adjustment factor of
1.080878, resulting in the inflationadjusted amount on line 3,
$776,793,511. That amount is then
multiplied by one plus the workload
adjustment of 13.1047 percent on line 4,
resulting in the inflation and workload
adjusted amount of $878,590,000 on
line 5, rounded to the nearest thousand
dollars.
TABLE 5—PDUFA INFLATION AND WORKLOAD ADJUSTED AMOUNT FOR FY 2017, SUMMARY CALCULATION
FY 2013 Revenue Amount and Base Subsequent FYs as published in the Federal Register of August 1, 2012
(77 FR 45639) (rounded to nearest thousand dollars).
Inflation Adjustment Factor for FY 2017 (1 plus 8.0878 percent) ..............................................................................
Inflation Adjusted Amount ...........................................................................................................................................
Workload Adjustment Factor for FY 2017 (1 plus 13.1047 percent) ..........................................................................
Inflation and Workload Adjusted Amount (rounded to nearest thousand dollars) ......................................................
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III. Offset for Excess Collections
Through FY 2016
Under the provisions of the FD&C
Act, if the sum of the cumulative
amount of the fees collected for FY 2013
through 2015, and the amount of fees
estimated to be collected under this
section for FY 2016, exceeds the
cumulative amount appropriated for
fees for FYs 2013 through 2016, the
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excess shall be credited to FDA’s
appropriation account and subtracted
from the amount of fees that FDA would
otherwise be authorized to collect for
FY 2017 under the FD&C Act (see
section 736(g)(4) of the FD&C Act as
amended by PDUFA V).
Table 6 shows the amounts specified
in appropriation acts for each year from
FY 2013 through FY 2016, and the
amounts FDA has collected for FYs
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$718,669,000
Line 1.
1.080878
$776,793,511
1.131047
$878,590,000
Line
Line
Line
Line
2.
3.
4.
5.
2013, 2014, and 2015 as of June 30,
2016, and an additional $70,907,000
(rounded to the nearest thousand
dollars) that FDA estimates it will
collect in FY 2016 based on historical
data. Table 6 shows the estimated
cumulative difference between PDUFA
fee amounts specified in appropriation
acts for FY 2013 through FY 2016 and
PDUFA fee amounts collected.
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TABLE 6—OFFSETS TO BE TAKEN FOR PDUFA V
Fiscal year
2013
2014
2015
2016
Collection amount
specified in
appropriation acts
($)
Collections
realized
($)
Amount in excess
of collection
amount specified
in appropriation
acts
($)
...........................................................................................................................
...........................................................................................................................
...........................................................................................................................
...........................................................................................................................
721,224,494
805,856,366
852,746,867
872,388,000
718,669,000
760,000,000
798,000,000
851,481,000
2,555,494
45,856,366
54,746,867
20,907,000
Net Balance to be Offset When Fees are Set for FY 2017 ...............................
..............................
..............................
124,065,726
Note: FY 2016 ‘Collections Realized’ is the amount FDA estimates it will collect in FY 2016 based on historical data.
The cumulative fees collected for FYs
2013 through 2016 are estimated to be
$124,065,726 greater than the
cumulative fee amounts specified in
appropriation acts during this same
period. Reducing the inflation and
workload adjusted amount of
$878,590,000 by the PDUFA V offset of
$124,066,000 (rounded to the nearest
thousand dollars) results in an amount
of $754,524,000, before the final year
adjustment.
IV. Final Year Adjustment
Under the provisions of the FD&C
Act, as amended, for FY 2017 the
Secretary of Health and Human Services
may, in addition to the inflation and
workload adjustments, further increase
the fees and fee revenues if such an
adjustment is necessary to provide for
not more than 3 months of operating
reserves of carryover user fees for the
process for the review of human drug
applications for the first 3 months of FY
2018. If such an adjustment is
necessary, the rationale for the amount
of this increase shall be contained in the
annual notice establishing fee revenues
and fees for FY 2017 (see section
736(c)(3) of the FD&C Act).
After running analyses on the status
of PDUFA’s operating reserves and its
estimated balance as of the beginning of
FY 2018, FDA estimates that the PDUFA
program will have sufficient funds for
the operating reserves, thus FDA will
not be performing a final year
adjustment for FY 2018 because FDA
has determined such an adjustment to
be unnecessary.
The FD&C Act specifies that one-third
of the total fee revenue is to be derived
from application fees, one-third from
establishment fees, and one-third from
product fees (see section 736(b)(2) of the
FD&C Act). Accordingly, one-third of
the total revenue amount
($754,524,000), or a total of
$251,508,000, is the amount of fee
revenue that will be derived from each
fee type: Application fees, establishment
fees, and product fees.
V. Application Fee Calculations
A. Application Fee Revenues and
Application Fees
Application fees will be set to
generate one-third of the total fee
revenue amount, or $251,508,000 in FY
2017.
B. Estimate of the Number of Fee-Paying
Applications and Setting the
Application Fees
paying full application equivalents
(FAEs) it expects to receive the next FY
by averaging the number of fee-paying
FAEs received in the three most recently
completed FYs. Beginning with FY
2016, prior year FAE totals will be
updated annually to reflect refunds and
waivers processed after the close of the
FY.
In estimating the number of feepaying FAEs, a full application
requiring clinical data counts as one
FAE. An application not requiring
clinical data counts as one-half of an
FAE, as does a supplement requiring
clinical data. An application that is
withdrawn, or refused for filing, counts
as one-fourth of an FAE if the applicant
initially paid a full application fee, or
one-eighth of an FAE if the applicant
initially paid one-half of the full
application fee amount.
As Table 7 shows, the average number
of fee-paying FAEs received annually in
the most recent 3-year period is 123.405
FAEs. FDA will set fees for FY 2017
based on this estimate as the number of
full application equivalents that will
pay fees.
For FY 2013 through FY 2017, FDA
will estimate the total number of fee-
TABLE 7—FEE-PAYING FAES
FY
2013
2014
2015
3-year
average
Fee-Paying FAEs .............................................................................................
109.010
128.750
132.456
123.405
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Note: Beginning with FY 2016, prior year FAE totals will be updated annually to reflect refunds and waivers processed after the close of the
FY.
The FY 2017 application fee is
estimated by dividing the average
number of full applications that paid
fees over the latest 3 years, 123.405, into
the fee revenue amount to be derived
from application fees in FY 2017,
$251,508,000. The result, rounded to the
nearest hundred dollars, is a fee of
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$2,038,100 per full application requiring
clinical data, and $1,019,050 per
application not requiring clinical data or
per supplement requiring clinical data.
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VI. Fee Calculations for Establishment
and Product Fees
A. Establishment Fees
At the beginning of FY 2016, the
establishment fee was based on an
estimate that 485 establishments would
be subject to and would pay fees. By the
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end of FY 2016, FDA estimates that 523
establishments will have been billed for
establishment fees, before all decisions
on requests for waivers or reductions are
made. FDA estimates that a total of 16
establishment fee waivers or reductions
will be made for FY 2016. In addition,
FDA estimates that another 16 full
establishment fees will be exempted this
year based on the orphan drug
exemption in section 736(k) of the FD&C
Act. Subtracting 32 establishments (16
waivers, plus the estimated 16
establishments under the orphan
exemption) from 523 leaves a net of 491
fee-paying establishments. FDA will use
491 to estimate the FY 2017
establishments paying fees. The fee per
establishment is determined by dividing
the adjusted total fee revenue to be
derived from establishments
($251,508,000) by the estimated 491
establishments, for an establishment fee
rate for FY 2017 of $512,200 (rounded
to the nearest hundred dollars).
TABLE 8—FEE SCHEDULE FOR FY
2017—Continued
Fee rates
for FY
2017
($)
Fee category
Not requiring clinical data .......
Supplements requiring clinical
data ......................................
Establishments ...........................
Products ......................................
1,019,050
1,019,050
512,200
97,750
VIII. Fee Payment Options and
Procedures
A. Application Fees
The appropriate application fee
established in the new fee schedule
must be paid for any application or
supplement subject to fees under
PDUFA that is received on or after
October 1, 2016. Payment must be made
in U.S. currency by electronic check,
check, bank draft, wire transfer, or U.S.
postal money order payable to the order
B. Product Fees
of the Food and Drug Administration.
At the beginning of FY 2016, the
The preferred payment method is online
product fee was based on an estimate
using electronic check (Automated
that 2,480 products would be subject to
Clearing House (ACH) also known as
and would pay product fees. By the end eCheck) or credit card (Discover, VISA,
of FY 2016, FDA estimates that 2,646
MasterCard, American Express). Secure
products will have been billed for
electronic payments can be submitted
product fees, before all decisions on
using the User Fees Payment Portal at
requests for waivers, reductions, or
https://userfees.fda.gov/pay. Once you
exemptions are made. FDA assumes that search for your invoice, click ‘‘Pay
there will be 41 waivers and reductions
Now’’ to be redirected to Pay.gov. Note
granted. In addition, FDA estimates that that electronic payment options are
another 32 product fees will be
based on the balance due. Payment by
exempted this year based on the orphan credit card is available for balances less
drug exemption in section 736(k) of the
than $25,000. If the balance exceeds this
FD&C Act. FDA estimates that 2,573
amount, only the ACH option is
products will qualify for and pay
available. Payments must be drawn on
product fees in FY 2016, after allowing
U.S bank accounts as well as U.S. credit
for an estimated 73 waivers and
cards.
reductions, including the orphan drug
FDA has partnered with the U.S.
products, and will use this number for
Department of the Treasury to use
its FY 2017 estimate. The FY 2017
Pay.gov, a Web-based payment
product fee rate is determined by
application, for online electronic
dividing the adjusted total fee revenue
payment. The Pay.gov feature is
to be derived from product fees
available on the FDA Web site after the
($251,508,000) by the estimated 2,573
user fee ID number is generated.
products for a FY 2017 product fee of
Please include the user fee
$97,750 (rounded to the nearest ten
identification (ID) number on your
dollars).
check, bank draft, or postal money
VII. Fee Schedule for FY 2017
order. Your payment can be mailed to:
Food and Drug Administration, P.O.
The fee rates for FY 2017 are
Box 979107, St. Louis, MO 63197–9000.
displayed in table 8:
If checks are to be sent by a courier
that requests a street address, the
TABLE 8—FEE SCHEDULE FOR FY
courier can deliver the checks to: U.S.
2017
Bank, Attention: Government Lockbox
979107, 1005 Convention Plaza, St.
Fee rates
for FY
Louis, MO 63101. (Note: This U.S. Bank
Fee category
2017
address is for courier delivery only. If
($)
you have any questions concerning
courier delivery contact the U.S. Bank at
Applications:
Requiring clinical data .............
2,038,100 314–418–4013. This telephone number
VerDate Sep<11>2014
14:44 Jul 27, 2016
Jkt 238001
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
is only for questions about courier
delivery).
Please make sure that the FDA post
office box number (P.O. Box 979107) is
written on the check, bank draft, or
postal money order.
If paying by wire transfer, please
reference your unique user fee ID
number when completing your transfer.
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 fee is fully paid. The account
information for wire transfers is as
follows: 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.
The tax identification number of FDA
is 53–0196965.
B. Establishment and Product Fees
FDA will issue invoices for
establishment and product fees for FY
2017 under the new fee schedule in
August 2016. Payment will be due on
October 1, 2016. FDA will issue
invoices in November 2017 for any
products and establishments subject to
fees for FY 2017 that qualify for fee
assessments after the August 2016
billing.
Dated: July 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17870 Filed 7–27–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pre-Submission
Program for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
SUMMARY:
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49674-49678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17870]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0007]
Prescription Drug 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 rates
for prescription drug user fees for fiscal year (FY) 2017. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA
to collect user fees for certain applications for the review of human
drug and biological products, on establishments where the products are
made, and on such products. This notice establishes the fee rates for
FY 2017.
FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively) establish three different kinds of user fees. Fees are
assessed on the following: (1) Certain types of applications and
supplements for the review of human drug and biological products; (2)
certain establishments where such products are made; and (3) certain
products (section 736(a) of the FD&C Act). When certain conditions are
met, FDA may waive or reduce fees (section 736(d) of the FD&C Act).
For FY 2013 through FY 2017, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA V. The base
revenue amount for FY 2013, which became the base amount for the
remaining four FYs of PDUFA V, is $718,669,000, as published in the
Federal Register of August 1, 2012 (77 FR 45639). The FY 2013 base
revenue amount is further adjusted each year after FY 2013 for
inflation and workload. For FY 2017, fee revenue and fees may be
further adjusted by the final year adjustment. In addition, for FY
2017, excess collections are offset as required by the FD&C Act. Fees
for applications, establishments, and products are to be established
each year
[[Page 49675]]
by FDA so that revenues from each category will provide one-third of
the total revenue to be collected each year.
This document provides fee rates for FY 2017 for an application
requiring clinical data ($2,038,100), for an application not requiring
clinical data or a supplement requiring clinical data ($1,019,050), for
an establishment ($512,200), and for a product ($97,750). These fees
are effective on October 1, 2016, and will remain in effect through
September 30, 2017. For applications and supplements that are submitted
on or after October 1, 2016, the new fee schedule must be used.
Invoices for establishment and product fees for FY 2017 will be issued
in August 2016 using the new fee schedule.
II. Fee Revenue Amount for FY 2017
The base revenue amount for FY 2017 is $718,669,000 prior to
adjustments for inflation, workload, the offset of excess collections,
and the final year adjustment (see sections 736(c)(1), 736(c)(2),
736(g)(4), and 736(c)(3) of the FD&C Act, respectively).
A. FY 2017 Statutory Fee Revenue Adjustments for Inflation
PDUFA V specifies that the $718,669,000 is to be further adjusted
for inflation increases for FY 2017 using two separate adjustments--one
for personnel compensation and benefits (PC&B) and one for non-PC&B
costs (see section 736(c)(1) of the FD&C Act).
The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all PC&B
paid per full-time equivalent (FTE) position at FDA for the first three
of the preceding four FYs, multiplied by the proportion of PC&B costs
to total FDA costs of process for the review of human drug applications
for the first three of the preceding four FYs (see section 736(c)(1)(A)
and (c)(1)(B) of the FD&C Act).
Table 1 summarizes that actual cost and FTE data for the specified
FYs, and provides the percent changes from the previous FYs and the
average percent changes over the first three of the four FYs preceding
FY 2017. The 3-year average is 1.8759 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
Fiscal year 2013 2014 2015 3-year 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
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 1.8759 percent should be multiplied
by the proportion of PC&B costs to total FDA costs of the process for
the review of human drug applications. Table 2 shows the PC&B and the
total obligations for the process for the review of human drug
applications for three FYs.
Table 2--PC&B as a Percent of Fee Revenues Spent on the Process for the Review of Human Drug Applications
----------------------------------------------------------------------------------------------------------------
Fiscal year 2013 2014 2015 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $568,206,210 $585,260,720 $615,483,892 .................
Total Costs......................... $966,169,007 $1,077,263,695 $1,127,664,528 .................
PC&B Percent........................ 58.8102 54.3285 54.5804 55.9064
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 1.8759 percent from table 1 multiplied by
55.9064 percent (or 1.0487 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs 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 three years of the preceding four years of
available data multiplied by the proportion of all costs other than
PC&B costs to total costs of the process for the review of human drug
applications for the first three years of the preceding four FYs (see
section 736(c)(1)(C) of the FD&C Act). Table 3 provides the summary
data for the percent changes in the specified CPI for the Washington-
Baltimore area. The data are published by the Bureau of Labor
Statistics and can be found on its Web site at: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking the box
marked ``Washington-Baltimore All Items, November 1996=100--
CUURA311SA0'' and then selecting ``Retrieve Data''.
Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Baltimore Area
----------------------------------------------------------------------------------------------------------------
Year 2013 2014 2015 3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 152.500 154.847 155.353 .................
Annual Percent Change............... 1.5232 1.5390 0.3268 1.1297
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-payroll costs, we
multiply the 1.1297 percent by the proportion of all costs other than
PC&B to total costs of the process for the review of human drug
applications obligated. Since 55.9064 percent was obligated for PC&B as
shown in Table 2, 44.0936 percent is the portion of costs other than
PC&B (100 percent minus 55.9064 percent equals 44.0936 percent). The
non-payroll adjustment is 1.1297 percent times 44.0936 percent, or
0.4981 percent.
Next, we add the payroll adjustment (1.0487 percent) to the non-
payroll adjustment (0.4981 percent), for a total
[[Page 49676]]
inflation adjustment of 1.5468 percent (rounded) for FY 2017.
PDUFA V provides for this inflation adjustment to be compounded
after FY 2013 (see section 736(c)(1) of the FD&C Act). This factor for
FY 2017 (1.5468 percent) is compounded by adding one and then
multiplying by one plus the compound inflation adjustment factor for FY
2016 (6.4414 percent), as published in the Federal Register of August
3, 2015 (80 FR 46028 at 46032), which equals to 1.080878 (rounded)
(1.015468 x 1.064414) for FY 2017. We then multiply the base revenue
amount for FY 2017 ($718,669,000) by 1.080878, yielding an inflation-
adjusted amount of $776,793,511.
B. FY 2017 Statutory Fee Revenue Adjustments for Workload
The statute specifies that after the $718,669,000 has been adjusted
for inflation, the inflation-adjusted amount shall be further adjusted
for workload (see section 736(c)(2) of the FD&C Act).
To calculate the FY 2017 workload adjustment, FDA calculated the
average number of each of the four types of applications specified in
the workload adjustment provision: (1) Human drug applications; (2)
active commercial investigational new drug applications (INDs)
(applications that have at least one submission during the previous 12
months); (3) efficacy supplements; and (4) manufacturing supplements
received over the 3-year period that ended on June 30, 2012 (base
years), and the average number of each of these types of applications
over the most recent 3-year period that ended June 30, 2016.
The calculations are summarized in table 4. The 3-year averages for
each application category are provided in column 1 (``3-Year Average
Base Years 2010-2012'') and column 2 (``3-Year Average 2014-2016'').
Column 3 reflects the percent change in workload from column 1 to
column 2. Column 4 shows the weighting factor for each type of
application, estimating how much of the total FDA drug review workload
was accounted for by each type of application in the table during the
most recent 3 years. Column 5 is the weighted percent change in each
category of workload. This was derived by multiplying the weighting
factor in each line in column 4 by the percent change from the base
years in column 3. The values in column 5 are summed, reflecting an
increase in workload of 13.1047 percent (rounded) for FY 2017 when
compared to the base years.
Table 4--Workload Adjuster Calculation for FY 2017
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application type 3-year average Percent change Weighting
base years 3-year average (column 1 to factor Weighted
2010-2012 2014-2016 column 2) (percent) percent change
----------------------------------------------------------------------------------------------------------------
New Drug Applications/Biologics 124.3000 147.3000 18.5036 35.8514 6.6338
License Applications...........
Active Commercial INDs.......... 6830.0000 7598.0000 11.2445 41.0966 4.6211
Efficacy Supplements............ 136.3000 196.3000 44.0205 6.8122 2.9988
Manufacturing Supplements....... 2548.3000 2368.0000 -7.0753 16.2399 -1.1490
-------------------------------------------------------------------------------
FY 2017 Workload Adjuster... .............. .............. .............. .............. 13.1047
----------------------------------------------------------------------------------------------------------------
Table 5 shows the calculation of the inflation and workload
adjusted amount for FY 2017. The $718,669,000 subject to adjustment on
line 1 is multiplied by the inflation adjustment factor of 1.080878,
resulting in the inflation-adjusted amount on line 3, $776,793,511.
That amount is then multiplied by one plus the workload adjustment of
13.1047 percent on line 4, resulting in the inflation and workload
adjusted amount of $878,590,000 on line 5, rounded to the nearest
thousand dollars.
Table 5--PDUFA Inflation and Workload Adjusted Amount for FY 2017,
Summary Calculation
------------------------------------------------------------------------
------------------------------------------------------------------------
FY 2013 Revenue Amount and Base $718,669,000 Line 1.
Subsequent FYs as published in the
Federal Register of August 1, 2012
(77 FR 45639) (rounded to nearest
thousand dollars).
Inflation Adjustment Factor for FY 1.080878 Line 2.
2017 (1 plus 8.0878 percent).
Inflation Adjusted Amount.......... $776,793,511 Line 3.
Workload Adjustment Factor for FY 1.131047 Line 4.
2017 (1 plus 13.1047 percent).
Inflation and Workload Adjusted $878,590,000 Line 5.
Amount (rounded to nearest
thousand dollars).
------------------------------------------------------------------------
III. Offset for Excess Collections Through FY 2016
Under the provisions of the FD&C Act, if the sum of the cumulative
amount of the fees collected for FY 2013 through 2015, and the amount
of fees estimated to be collected under this section for FY 2016,
exceeds the cumulative amount appropriated for fees for FYs 2013
through 2016, the excess shall be credited to FDA's appropriation
account and subtracted from the amount of fees that FDA would otherwise
be authorized to collect for FY 2017 under the FD&C Act (see section
736(g)(4) of the FD&C Act as amended by PDUFA V).
Table 6 shows the amounts specified in appropriation acts for each
year from FY 2013 through FY 2016, and the amounts FDA has collected
for FYs 2013, 2014, and 2015 as of June 30, 2016, and an additional
$70,907,000 (rounded to the nearest thousand dollars) that FDA
estimates it will collect in FY 2016 based on historical data. Table 6
shows the estimated cumulative difference between PDUFA fee amounts
specified in appropriation acts for FY 2013 through FY 2016 and PDUFA
fee amounts collected.
[[Page 49677]]
Table 6--Offsets To Be Taken for PDUFA V
----------------------------------------------------------------------------------------------------------------
Amount in excess
Collection amount of collection
Fiscal year Collections specified in amount specified
realized ($) appropriation in appropriation
acts ($) acts ($)
----------------------------------------------------------------------------------------------------------------
2013................................................... 721,224,494 718,669,000 2,555,494
2014................................................... 805,856,366 760,000,000 45,856,366
2015................................................... 852,746,867 798,000,000 54,746,867
2016................................................... 872,388,000 851,481,000 20,907,000
--------------------------------------------------------
Net Balance to be Offset When Fees are Set for FY ................. ................. 124,065,726
2017..............................................
----------------------------------------------------------------------------------------------------------------
Note: FY 2016 `Collections Realized' is the amount FDA estimates it will collect in FY 2016 based on historical
data.
The cumulative fees collected for FYs 2013 through 2016 are
estimated to be $124,065,726 greater than the cumulative fee amounts
specified in appropriation acts during this same period. Reducing the
inflation and workload adjusted amount of $878,590,000 by the PDUFA V
offset of $124,066,000 (rounded to the nearest thousand dollars)
results in an amount of $754,524,000, before the final year adjustment.
IV. Final Year Adjustment
Under the provisions of the FD&C Act, as amended, for FY 2017 the
Secretary of Health and Human Services may, in addition to the
inflation and workload adjustments, further increase the fees and fee
revenues if such an adjustment is necessary to provide for not more
than 3 months of operating reserves of carryover user fees for the
process for the review of human drug applications for the first 3
months of FY 2018. If such an adjustment is necessary, the rationale
for the amount of this increase shall be contained in the annual notice
establishing fee revenues and fees for FY 2017 (see section 736(c)(3)
of the FD&C Act).
After running analyses on the status of PDUFA's operating reserves
and its estimated balance as of the beginning of FY 2018, FDA estimates
that the PDUFA program will have sufficient funds for the operating
reserves, thus FDA will not be performing a final year adjustment for
FY 2018 because FDA has determined such an adjustment to be
unnecessary.
The FD&C Act specifies that one-third of the total fee revenue is
to be derived from application fees, one-third from establishment fees,
and one-third from product fees (see section 736(b)(2) of the FD&C
Act). Accordingly, one-third of the total revenue amount
($754,524,000), or a total of $251,508,000, is the amount of fee
revenue that will be derived from each fee type: Application fees,
establishment fees, and product fees.
V. Application Fee Calculations
A. Application Fee Revenues and Application Fees
Application fees will be set to generate one-third of the total fee
revenue amount, or $251,508,000 in FY 2017.
B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees
For FY 2013 through FY 2017, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next FY by averaging the number of fee-paying FAEs received in the
three most recently completed FYs. Beginning with FY 2016, prior year
FAE totals will be updated annually to reflect refunds and waivers
processed after the close of the FY.
In estimating the number of fee-paying FAEs, a full application
requiring clinical data counts as one FAE. An application not requiring
clinical data counts as one-half of an FAE, as does a supplement
requiring clinical data. An application that is withdrawn, or refused
for filing, counts as one-fourth of an FAE if the applicant initially
paid a full application fee, or one-eighth of an FAE if the applicant
initially paid one-half of the full application fee amount.
As Table 7 shows, the average number of fee-paying FAEs received
annually in the most recent 3-year period is 123.405 FAEs. FDA will set
fees for FY 2017 based on this estimate as the number of full
application equivalents that will pay fees.
Table 7--Fee-Paying FAEs
----------------------------------------------------------------------------------------------------------------
FY 2013 2014 2015 3-year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs............................. 109.010 128.750 132.456 123.405
----------------------------------------------------------------------------------------------------------------
Note: Beginning with FY 2016, prior year FAE totals will be updated annually to reflect refunds and waivers
processed after the close of the FY.
The FY 2017 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
123.405, into the fee revenue amount to be derived from application
fees in FY 2017, $251,508,000. The result, rounded to the nearest
hundred dollars, is a fee of $2,038,100 per full application requiring
clinical data, and $1,019,050 per application not requiring clinical
data or per supplement requiring clinical data.
VI. Fee Calculations for Establishment and Product Fees
A. Establishment Fees
At the beginning of FY 2016, the establishment fee was based on an
estimate that 485 establishments would be subject to and would pay
fees. By the
[[Page 49678]]
end of FY 2016, FDA estimates that 523 establishments will have been
billed for establishment fees, before all decisions on requests for
waivers or reductions are made. FDA estimates that a total of 16
establishment fee waivers or reductions will be made for FY 2016. In
addition, FDA estimates that another 16 full establishment fees will be
exempted this year based on the orphan drug exemption in section 736(k)
of the FD&C Act. Subtracting 32 establishments (16 waivers, plus the
estimated 16 establishments under the orphan exemption) from 523 leaves
a net of 491 fee-paying establishments. FDA will use 491 to estimate
the FY 2017 establishments paying fees. The fee per establishment is
determined by dividing the adjusted total fee revenue to be derived
from establishments ($251,508,000) by the estimated 491 establishments,
for an establishment fee rate for FY 2017 of $512,200 (rounded to the
nearest hundred dollars).
B. Product Fees
At the beginning of FY 2016, the product fee was based on an
estimate that 2,480 products would be subject to and would pay product
fees. By the end of FY 2016, FDA estimates that 2,646 products will
have been billed for product fees, before all decisions on requests for
waivers, reductions, or exemptions are made. FDA assumes that there
will be 41 waivers and reductions granted. In addition, FDA estimates
that another 32 product fees will be exempted this year based on the
orphan drug exemption in section 736(k) of the FD&C Act. FDA estimates
that 2,573 products will qualify for and pay product fees in FY 2016,
after allowing for an estimated 73 waivers and reductions, including
the orphan drug products, and will use this number for its FY 2017
estimate. The FY 2017 product fee rate is determined by dividing the
adjusted total fee revenue to be derived from product fees
($251,508,000) by the estimated 2,573 products for a FY 2017 product
fee of $97,750 (rounded to the nearest ten dollars).
VII. Fee Schedule for FY 2017
The fee rates for FY 2017 are displayed in table 8:
Table 8--Fee Schedule for FY 2017
------------------------------------------------------------------------
Fee rates
Fee category for FY
2017 ($)
------------------------------------------------------------------------
Applications:
Requiring clinical data................................... 2,038,100
Not requiring clinical data............................... 1,019,050
Supplements requiring clinical data....................... 1,019,050
Establishments.............................................. 512,200
Products.................................................... 97,750
------------------------------------------------------------------------
VIII. Fee Payment Options and Procedures
A. Application Fees
The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received on or after October 1, 2016. Payment must be
made in U.S. currency by electronic check, check, bank draft, wire
transfer, or U.S. postal money order payable to the order of the Food
and Drug Administration. 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.
FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
Please include the user fee identification (ID) number on your
check, bank draft, or postal money order. Your payment can be mailed
to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197-
9000.
If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: U.S. Bank, Attention:
Government Lockbox 979107, 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 the FDA post office box number (P.O. Box
979107) is written on the check, bank draft, or postal money order.
If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. 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 fee is fully paid. The account information for wire transfers is
as follows: 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.
The tax identification number of FDA is 53-0196965.
B. Establishment and Product Fees
FDA will issue invoices for establishment and product fees for FY
2017 under the new fee schedule in August 2016. Payment will be due on
October 1, 2016. FDA will issue invoices in November 2017 for any
products and establishments subject to fees for FY 2017 that qualify
for fee assessments after the August 2016 billing.
Dated: July 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17870 Filed 7-27-16; 8:45 am]
BILLING CODE 4164-01-P
