81 FR 49674 - Prescription Drug User Fee Rates for Fiscal Year 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 145 (July 28, 2016)

Page Range		49674-49678
FR Document		2016-17870

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.

Federal Register, Volume 81 Issue 145 (Thursday, July 28, 2016)

[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49674-49678]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-17870]

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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.

-----------------------------------------------------------------------

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: http://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

49674 Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices

deferral period for other men and the feasibility or effectiveness of such DEPARTMENT OF HEALTH AND
women at increased risk for HIV alternative deferral policy options. HUMAN SERVICES
infection, such as those who had a FDA recognizes that many
recent blood transfusion or who have Food and Drug Administration
stakeholders have expressed the desire
been accidentally exposed to the blood
to move from a time-based deferral [Docket No. FDA–2016–N–0007]
of another individual through a needle
period to a deferral policy based on
stick. In reviewing the Agency’s Prescription Drug User Fee Rates for
recommendations to reduce the risk of individual risk assessment. An
individual risk assessment would Fiscal Year 2017
HIV transmission through blood and
blood products, FDA rigorously involve asking potential donors a series AGENCY: Food and Drug Administration,
examined several alternative options, of questions designed to defer donors HHS
including individual risk assessment. with high risk behaviors. In particular, ACTION: Notice.
Ultimately, FDA concluded that the 12- we invite commenters to address the
month deferral period is supported by following and provide supporting SUMMARY: The Food and Drug
the best available scientific evidence, at scientific evidence such as data from Administration (FDA) is announcing the
this point in time, relevant to the U.S. research: rates for prescription drug user fees for
population. fiscal year (FY) 2017. The Federal Food,
1. What questions would most effectively
As described in the December 2015 Drug, and Cosmetic Act (the FD&C Act),
identify individuals at risk of
guidance, throughout the process of as amended by the Prescription Drug
transmitting HIV through blood
comprehensively updating blood donor User Fee Amendments of 2012 (PDUFA
donation?
deferral policies, FDA has worked with 2. Are there specific questions that could be
V), authorizes FDA to collect user fees
other government Agencies, considered asked that might best capture the recent
for certain applications for the review of
input from external advisory risk of a donor acquiring HIV infection,
human drug and biological products, on
committees, reviewed comments from such as within the 2 to 4 weeks establishments where the products are
stakeholders to the draft guidance of the immediately preceding blood donation? made, and on such products. This
same title (80 FR 27973, May 15, 2015), 3. How specific can the questions be notice establishes the fee rates for FY
and carefully examined the most recent regarding sexual practices while 2017.
available scientific evidence. FDA also remaining understandable and FOR FURTHER INFORMATION CONTACT:
has implemented a nationally acceptable to all blood donors? For Robert J. Marcarelli, Office of Financial
representative transfusion-transmissible example, could questions about specific Management, Food and Drug
infections monitoring system for the sexual behaviors be asked if they helped Administration, 8455 Colesville Rd.,
U.S. blood supply with assistance from to identify which donors should be at COLE–14202F, Silver Spring, MD
the National Heart, Lung, and Blood least temporarily deferred because of risk 20993–0002, 301–796–7223.
Institute at the National Institutes of factors? To the extent the questions are
Health. This system provides critical SUPPLEMENTARY INFORMATION:
explicit about sexual practices, how
information to help inform future willing will donors be to answer such I. Background
actions that FDA may take on blood questions accurately?
donor policies. Sections 735 and 736 of the FD&C Act
4. Under what circumstances would a short
When FDA issued the December 2015 (21 U.S.C. 379g and 379h, respectively)
deferral period for high risk behavior be
guidance, it noted that while the establish three different kinds of user
appropriate? For each short deferral
December 2015 guidance represents fees. Fees are assessed on the following:
period identified, please specify the
FDA’s current thinking on the subject, (1) Certain types of applications and
duration of the deferral and provide the
FDA was committed to continuing to supplements for the review of human
scientific rationale.
reevaluate and update blood donor drug and biological products; (2) certain
5. What changes might be necessary within
deferral policies as new scientific establishments where such products are
blood collection establishments to assure
information becomes available. FDA that accurate, individual HIV risk
made; and (3) certain products (section
also noted that, because the process assessments are performed?
736(a) of the FD&C Act). When certain
must be data-driven, FDA could not 6. How best to design a potential study to
conditions are met, FDA may waive or
specify a time for when future policy evaluate the feasibility and effectiveness reduce fees (section 736(d) of the FD&C
changes might occur. of alternative deferral options such as Act).
As part of the effort to continue to individual risk assessment? For FY 2013 through FY 2017, the
assess its donor deferral policies, FDA is base revenue amounts for the total
opening this docket to provide a FDA will consider comments and revenues from all PDUFA fees are
mechanism for the public to submit supporting scientific data received as it established by PDUFA V. The base
additional information regarding continues to reevaluate and update revenue amount for FY 2013, which
potential blood donor deferral policy blood donor deferral policies as new became the base amount for the
options. Specifically, we invite scientific information becomes remaining four FYs of PDUFA V, is
interested persons to submit to the available. $718,669,000, as published in the
docket comments supported by Federal Register of August 1, 2012 (77
scientific evidence regarding possible Dated: July 22, 2016. FR 45639). The FY 2013 base revenue
revisions to FDA’s blood donor deferral Leslie Kux, amount is further adjusted each year
policies to reduce the risk of HIV Associate Commissioner for Policy. after FY 2013 for inflation and
Lhorne on DSK30JT082PROD with NOTICES

transmission by blood and blood [FR Doc. 2016–17804 Filed 7–26–16; 11:15 am] workload. For FY 2017, fee revenue and
products. FDA requests that BILLING CODE 4164–01–P fees may be further adjusted by the final
commenters provide scientific evidence, year adjustment. In addition, for FY
such as data from research, to support 2017, excess collections are offset as
any suggestions. Additionally, required by the FD&C Act. Fees for
comments are invited regarding the applications, establishments, and
design of potential studies to evaluate products are to be established each year

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Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices 49675

by FDA so that revenues from each II. Fee Revenue Amount for FY 2017 The component of the inflation
category will provide one-third of the adjustment for payroll costs shall be one
total revenue to be collected each year. The base revenue amount for FY 2017 plus the average annual percent change
This document provides fee rates for is $718,669,000 prior to adjustments for in the cost of all PC&B paid per full-time
FY 2017 for an application requiring inflation, workload, the offset of excess equivalent (FTE) position at FDA for the
clinical data ($2,038,100), for an collections, and the final year first three of the preceding four FYs,
application not requiring clinical data or adjustment (see sections 736(c)(1), multiplied by the proportion of PC&B
a supplement requiring clinical data 736(c)(2), 736(g)(4), and 736(c)(3) of the costs to total FDA costs of process for
($1,019,050), for an establishment FD&C Act, respectively). the review of human drug applications
($512,200), and for a product ($97,750). A. FY 2017 Statutory Fee Revenue for the first three of the preceding four
These fees are effective on October 1, Adjustments for Inflation FYs (see section 736(c)(1)(A) and
2016, and will remain in effect through (c)(1)(B) of the FD&C Act).
September 30, 2017. For applications PDUFA V specifies that the Table 1 summarizes that actual cost
and supplements that are submitted on $718,669,000 is to be further adjusted and FTE data for the specified FYs, and
or after October 1, 2016, the new fee for inflation increases for FY 2017 using provides the percent changes from the
schedule must be used. Invoices for two separate adjustments—one for previous FYs and the average percent
establishment and product fees for FY personnel compensation and benefits changes over the first three of the four
2017 will be issued in August 2016 (PC&B) and one for non-PC&B costs (see FYs preceding FY 2017. The 3-year
using the new fee schedule. section 736(c)(1) of the FD&C Act). 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 costs of the process for the review of the process for the review of human
percent should be multiplied by the human drug applications. Table 2 shows drug applications for three FYs.
proportion of PC&B costs to total FDA the PC&B and the total obligations for

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 all items; annual index) for the first the specified CPI for the Washington-
percent from table 1 multiplied by three years of the preceding four years Baltimore area. The data are published
55.9064 percent (or 1.0487 percent). of available data multiplied by the by the Bureau of Labor Statistics and
The statute specifies that the portion proportion of all costs other than PC&B can be found on its Web site at: http://
of the inflation adjustment for non- costs to total costs of the process for the data.bls.gov/cgi-bin/surveymost?cu. The
payroll costs is the average annual review of human drug applications for data can be viewed by checking the box
percent change that occurred in the the first three years of the preceding marked ‘‘Washington-Baltimore All
Consumer Price Index (CPI) for urban four FYs (see section 736(c)(1)(C) of the Items, November 1996=100—
consumers (Washington-Baltimore, DC– FD&C Act). Table 3 provides the CUURA311SA0’’ and then selecting
MD–VA–WV; not seasonally adjusted; summary data for the percent changes in ‘‘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
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To calculate the inflation adjustment 55.9064 percent was obligated for PC&B times 44.0936 percent, or 0.4981
for non-payroll costs, we multiply the as shown in Table 2, 44.0936 percent is percent.
1.1297 percent by the proportion of all the portion of costs other than PC&B Next, we add the payroll adjustment
costs other than PC&B to total costs of (100 percent minus 55.9064 percent (1.0487 percent) to the non-payroll
the process for the review of human equals 44.0936 percent). The non- adjustment (0.4981 percent), for a total
drug applications obligated. Since payroll adjustment is 1.1297 percent

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49676 Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices

inflation adjustment of 1.5468 percent inflation, the inflation-adjusted amount column 1 (‘‘3-Year Average Base Years
(rounded) for FY 2017. shall be further adjusted for workload 2010–2012’’) and column 2 (‘‘3-Year
PDUFA V provides for this inflation (see section 736(c)(2) of the FD&C Act). Average 2014–2016’’). Column 3 reflects
adjustment to be compounded after FY To calculate the FY 2017 workload the percent change in workload from
2013 (see section 736(c)(1) of the FD&C adjustment, FDA calculated the average column 1 to column 2. Column 4 shows
Act). This factor for FY 2017 (1.5468 number of each of the four types of the weighting factor for each type of
percent) is compounded by adding one applications specified in the workload application, estimating how much of the
and then multiplying by one plus the adjustment provision: (1) Human drug total FDA drug review workload was
compound inflation adjustment factor applications; (2) active commercial accounted for by each type of
for FY 2016 (6.4414 percent), as
investigational new drug applications application in the table during the most
published in the Federal Register of
(INDs) (applications that have at least recent 3 years. Column 5 is the weighted
August 3, 2015 (80 FR 46028 at 46032),
one submission during the previous 12 percent change in each category of
which equals to 1.080878 (rounded)
months); (3) efficacy supplements; and workload. This was derived by
(1.015468 × 1.064414) for FY 2017. We
(4) manufacturing supplements received multiplying the weighting factor in each
then multiply the base revenue amount
over the 3-year period that ended on line in column 4 by the percent change
for FY 2017 ($718,669,000) by 1.080878,
June 30, 2012 (base years), and the from the base years in column 3. The
yielding an inflation-adjusted amount of
average number of each of these types values in column 5 are summed,
$776,793,511.
of applications over the most recent 3- reflecting an increase in workload of
B. FY 2017 Statutory Fee Revenue year period that ended June 30, 2016. 13.1047 percent (rounded) for FY 2017
Adjustments for Workload The calculations are summarized in when compared to the base years.
The statute specifies that after the table 4. The 3-year averages for each
$718,669,000 has been adjusted for application category are provided in

TABLE 4—WORKLOAD ADJUSTER CALCULATION FOR FY 2017
Column 1 Column 2 Column 3 Column 4 Column 5

3-year Percent
Application type 3-year Weighting Weighted
average change
average factor percent
base years (column 1 to
2014–2016 (percent) change
2010–2012 column 2)

New Drug Applications/Biologics License Applications ....... 124.3000 147.3000 18.5036 35.8514 6.6338
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 1.080878, resulting in the inflation- resulting in the inflation and workload
inflation and workload adjusted amount adjusted amount on line 3, adjusted amount of $878,590,000 on
for FY 2017. The $718,669,000 subject $776,793,511. That amount is then line 5, rounded to the nearest thousand
to adjustment on line 1 is multiplied by multiplied by one plus the workload dollars.
the inflation adjustment factor of adjustment of 13.1047 percent on line 4,

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 $718,669,000 Line 1.
(77 FR 45639) (rounded to nearest thousand dollars).
Inflation Adjustment Factor for FY 2017 (1 plus 8.0878 percent) .............................................................................. 1.080878 Line 2.
Inflation Adjusted Amount ........................................................................................................................................... $776,793,511 Line 3.
Workload Adjustment Factor for FY 2017 (1 plus 13.1047 percent) .......................................................................... 1.131047 Line 4.
Inflation and Workload Adjusted Amount (rounded to nearest thousand dollars) ...................................................... $878,590,000 Line 5.

III. Offset for Excess Collections excess shall be credited to FDA’s 2013, 2014, and 2015 as of June 30,
Through FY 2016 appropriation account and subtracted 2016, and an additional $70,907,000
from the amount of fees that FDA would (rounded to the nearest thousand
Under the provisions of the FD&C otherwise be authorized to collect for dollars) that FDA estimates it will
Act, if the sum of the cumulative FY 2017 under the FD&C Act (see collect in FY 2016 based on historical
amount of the fees collected for FY 2013 section 736(g)(4) of the FD&C Act as data. Table 6 shows the estimated
through 2015, and the amount of fees amended by PDUFA V). cumulative difference between PDUFA
estimated to be collected under this
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Table 6 shows the amounts specified fee amounts specified in appropriation
section for FY 2016, exceeds the in appropriation acts for each year from
acts for FY 2013 through FY 2016 and
cumulative amount appropriated for FY 2013 through FY 2016, and the
PDUFA fee amounts collected.
fees for FYs 2013 through 2016, the amounts FDA has collected for FYs

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Document Created: 2016-07-28 01:47:35
Document Modified: 2016-07-28 01:47:35

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223.
FR Citation		81 FR 49674

81 FR 49674 - Prescription Drug User Fee Rates for Fiscal Year 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 145 (July 28, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration