Prescription Drug User Fee Rates for Fiscal Year 2018, 43244-43248 [2017-19494]
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43244
Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
Focus Group Interviews .......................................................
8,800
1
8,800
1.75
15,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–19492 Filed 9–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0007]
Prescription Drug User Fee Rates for
Fiscal Year 2018
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) 2018. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Prescription Drug
User Fee Amendments of 2017 (PDUFA
VI), authorizes FDA to collect
application fees for certain applications
for the review of human drug and
biological products, and prescription
drug program fees for certain approved
products. This notice establishes the fee
rates for FY 2018.
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:
SUMMARY:
I. Background
Sections 735 and 736 of the FD&C Act
(21 U.S.C. 379g and 379h, respectively)
establish two different kinds of user
fees. Fees are assessed on the following:
(1) Application fees are assessed on
certain types of applications for the
review of human drug and biological
products; and (2) prescription drug
program fees are assessed on certain
approved products (section 736(a) of the
FD&C Act). When specific conditions
are met, FDA may waive or reduce fees
(section 736(d) of the FD&C Act).
For FY 2018 through FY 2022, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA VI. The base
revenue amount for FY 2018 is
$878,590,000. The FY 2018 base
revenue amount is to be adjusted for
inflation and for the resource capacity
needs for the process for the review of
human drug applications (the capacity
planning adjustment). An additional
dollar amount specified in the statute
(see section 736(b)(1)(F) of the FD&C
Act) is then added to provide for
additional full-time equivalent (FTE)
positions to support PDUFA VI
initiatives. The FY 2018 revenue
amount may be adjusted further, if
necessary, to provide for sufficient
operating reserves of carryover user fees.
Finally, the amount is adjusted to
provide for additional direct costs to
fund PDUFA VI initiatives. Fee amounts
are to be established each year so that
revenues from application fees provide
20 percent of the total revenue, and
prescription drug program fees provide
80 percent of the total revenue.
This document provides fee rates for
FY 2018 for an application requiring
clinical data ($2,421,495), for an
application not requiring clinical data
($1,210,748), and for the prescription
drug program fee ($304,162). These fees
are effective on October 1, 2017, and
will remain in effect through September
30, 2018. For applications that are
submitted on or after October 1, 2017,
the new fee schedule must be used.
II. Fee Revenue Amount for FY 2018
The base revenue amount for FY 2018
is $878,590,000 prior to adjustments for
inflation, capacity planning, additional
FTE, operating reserve, and additional
direct costs (see section 736(b)(1) of the
FD&C Act).
A. FY 2018 Statutory Fee Revenue
Adjustments for Inflation
PDUFA VI specifies that the
$878,590,000 is to be adjusted for
inflation increases for FY 2018 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 FTE
positions at FDA for the first three of the
preceding four FYs, multiplied by the
proportion of PC&B costs to total FDA
costs of the 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 the 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 2018. The 3-year
average is 2.2354 percent.
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TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES
Fiscal year
2014
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent Change From Previous Year .....................................
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$2,054,937,000
14,555
$141,184
2.3451
Fmt 4703
Sfmt 4703
2015
$2,232,304,000
15,484
$144,168
2.1136
E:\FR\FM\14SEN1.SGM
2016
$2,414,728,159
16,381
$147,408
2.2474
14SEN1
3-year
average
2.2354
Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices
The statute specifies that this 2.2354
percent should be multiplied by the
proportion of PC&B costs to the total
FDA costs of the process for the review
of human drug applications. Table 2
shows the PC&B and the total
43245
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
2014
Total PC&B ..............................................................................
Total Costs ...............................................................................
PC&B Percent ..........................................................................
The payroll adjustment is 2.2354
percent from table 1 multiplied by
55.0885 percent (or 1.2314 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, DCMD-VA-WV; not seasonally adjusted; all
2015
$585,260,720
$1,077,263,695
54.3285
2016
$615,483,892
$1,127,664,528
54.5804
items; annual index) for the first 3 years
of the preceding 4 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)(B) of the FD&C
Act). Table 3 provides the summary data
for the percent changes in the specified
$652,508,273
$1,157,817,695
56.3567
3-year
average
55.0885
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 THREE-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-BALTIMORE AREA
Fiscal year
2014
Annual CPI .......................................................................................................
Annual Percent Change ..................................................................................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The statute specifies that this 1.0139
percent should be multiplied 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 55.0885 percent was
obligated for PC&B (as shown in table
2), 44.9115 percent is the portion of
costs other than PC&B (100 percent
minus 55.0885 percent equals 44.9115
percent). The non-payroll adjustment is
1.0139 percent times 44.9115 percent, or
0.4554 percent.
Next, we add the payroll adjustment
(1.2314 percent) to the non-payroll
adjustment (0.4554 percent), for a total
inflation adjustment of 1.6868 percent
(rounded) for FY 2018.
We then multiply the base revenue
amount for FY 2018 ($878,590,000) by
1.016868, yielding an inflation-adjusted
amount of $893,410,056.
B. FY 2018 Statutory Fee Revenue
Adjustments for Capacity Planning
The statute specifies that after
$878,590,000 has been adjusted for
inflation, the inflation-adjusted amount
shall be further adjusted to reflect
changes in the resource capacity needs
for the process of human drug
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154.847
1.5390
application reviews (see section
736(c)(2) of the FD&C Act). The statute
prescribes an interim capacity planning
adjustment be utilized until a new
methodology can be developed through
a process involving an independent
evaluation as well as obtaining public
comment. The interim capacity
planning adjustment is applied to FY
2018 fee setting.
To determine the FY 2018 capacity
planning adjustment, FDA calculated
the average number of each of the five
elements specified in the capacity
planning adjustment provision: (1)
Human drug applications (new drug
applications (NDAs)/biologics license
applications (BLAs)); (2) active
commercial investigational new drug
applications (INDs) (IND applications
that have at least one submission during
the previous 12 months); (3) efficacy
supplements; (4) manufacturing
supplements; and (5) formal meetings,
type A, B, B(EoP), C, and written
responses only (WRO) issued in lieu of
such formal meetings, over the 3-year
period that ended on June 30, 2016, and
the average number of each of these
elements over the most recent 3-year
period that ended June 30, 2017.
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2015
2016
155.353
0.3268
157.180
1.1760
3-year
average
1.0139
The calculations are summarized in
table 4. The 3-year averages for each
element are provided in column 1 (‘‘3Year Average Ending 2016’’) and
column 2 (‘‘3-Year Average Ending
2017’’). Column 3 reflects the percent
change from column 1 to column 2.
Column 4 shows the weighting factor for
each element. The weighting factor
methodology has been updated for
PDUFA VI. The previous methodology
relied on the relative value of the
standard costs for the elements included
in the adjuster, and summed to 100
percent. The weighting factor now is the
time invested in activities related to the
element expressed as a percentage of
total time invested in PDUFA activities,
and will adjust only the costs attributed
to the elements included in the model
(hence the weighting factor does not
now sum to 100 percent). Column 5 is
the weighted percent change in each
element. This is calculated by
multiplying the weighting factor in each
line in column 4 by the percent change
in column 3. The values in column 5 are
summed, reflecting an adjustment of
2.5090 percent (rounded).
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Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices
TABLE 4—CAPACITY PLANNING ADJUSTER (INTERIM METHODOLOGY) CALCULATION FOR FY 2018
Column 1
Column 3
Column 4
Column 5
3-year
average
ending 2016
Element
Column 2
3-year
average
ending 2017
Percent
change
(column 1
to column 2)
Weighting
factor
(percent)
Weighted
percent
change
NDAs/BLAs ..........................................................................
Active Commercial INDs ......................................................
Efficacy Supplements ..........................................................
Manufacturing Supplements ................................................
Meetings Scheduled and WROs .........................................
147.3333
7,598.0000
196.3333
2,368.0000
2,720.6667
153.0000
7,846.6667
212.3333
2,482.6667
2,940.0000
3.8462
3.2728
8.1494
4.8423
8.0617
18.0915
23.3890
4.1848
4.3690
6.1417
0.6958
0.7655
0.3410
0.2116
0.4951
FY 2018 Capacity Planning Adjuster ...........................
........................
........................
........................
........................
2.5090
Table 5 shows the calculation of the
inflation and capacity planning adjusted
amount for FY 2018. The FY 2018 base
revenue amount, $878,590,000, shown
on line 1 is multiplied by the inflation
adjustment factor of 1.016868, resulting
in the inflation-adjusted amount of
$893,410,056 shown on line 3. That
amount is then multiplied by one plus
the capacity planning adjustment of
2.5090 percent, resulting in the inflation
and capacity planning adjusted amount
of $915,825,714 shown on line 5.
TABLE 5—PDUFA INFLATION AND CAPACITY PLANNING ADJUSTED AMOUNT FOR FY 2018, SUMMARY CALCULATION
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FY 2018 Revenue Amount ......................................................................................................................................
Inflation Adjustment Factor for FY 2018 (1 plus 1.6868 percent) ...........................................................................
Inflation Adjusted Amount ........................................................................................................................................
Capacity Planning Adjustment Factor for FY 2018 (1 plus 2.5090 percent) ..........................................................
Inflation and Capacity Planning Adjusted Amount ..................................................................................................
The capacity planning adjustment
adds $22,415,658 to the fee revenue
amount for FY 2018. This increase is
driven by the fact that the counts of
elements for 2017 (year ending June 30)
are at or near the highest levels since the
first incorporation of the workload
adjuster in 2003. The NDA/BLA count
in 2017 is equal to the highest annual
number recorded since the advent of the
workload adjuster methodology in 2003.
Active commercial INDs, efficacy
supplements, and meetings/WROs are
higher in 2017 than in any previous year
recorded in the workload adjuster (note:
Meetings/WROs are only counted back
to 2014 while the other elements are
counted back to 2003). The
manufacturing supplement count is
approximately 2 percent below the
highest number recorded in the history
of the workload adjuster. Comparing
2017 to 2014, the first year included in
the average in column 1 in the
adjustment, NDA/BLAs are 12 percent
higher, active commercial INDs are 10
percent higher, efficacy supplements are
25 percent higher, manufacturing
supplements are 15 percent higher, and
meetings scheduled and WROs are 27
percent higher. This significant and
across the board increase in submission
activity is the driver of the $22,415,658
upward adjustment to the fee revenue
amount.
Per the commitments made in PDUFA
VI, this increase in the revenue amount
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will be allocated and used by
organizational review components
engaged in direct review work to
enhance resources and expand staff
capacity and capability (see II.A.4 on
p.37 of the PDUFA VI commitment
letter).1
C. FY 2018 Statutory Fee Revenue
Adjustments for Additional Dollar
Amounts
PDUFA VI provides an additional
dollar amount for each of the next five
fiscal years for additional FTE to
support PDUFA VI enhancements
outlined in the PDUFA VI commitment
letter. The amount for FY 2018 is
$20,077,793 (see section 736(b)(1)(F) of
the FD&C Act). Adding this amount to
the inflation and capacity planning
adjusted revenue amount, $915,825,714,
equals $935,904,000 (rounded to the
nearest thousand dollars).
D. FY 2018 Statutory Fee Revenue
Adjustments for Operating Reserve
PDUFA VI provides for an operating
reserve adjustment to allow FDA to
increase the fee revenue and fees for any
given fiscal year during PDUFA VI to
maintain up to 14 weeks of operating
reserve of carryover user fees. If the
carryover balance exceeds 14 weeks of
1 The PDUFA VI commitment letter can be
viewed at https://www.fda.gov/downloads/
forindustry/userfees/prescriptiondruguserfee/
ucm511438.pdf.
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$878,590,000
1.016868
$893,410,056
1.025090
$915,825,714
Line
Line
Line
Line
Line
1
2
3
4
5
operating reserves, FDA is required to
decrease fees to provide for not more
than 14 weeks of operating reserves of
carryover user fees.
To determine the 14-week operating
reserve amount, the FY 2018 annual
base revenue adjusted for inflation and
capacity planning, $915,825,714, is
divided by 52, and then multiplied by
14. The 14-week operating reserve
amount for FY 2018 is $246,568,461.
To determine the end of year
operating reserve amount, the Agency
must assess actual operating reserve at
the end of the third quarter of FY 2017,
and forecast collections and obligations
in the fourth quarter of FY 2017. The
estimated end of year FY 2017 operating
reserve is $279,856,044.
Because the estimated end of year FY
2017 PDUFA operating reserve exceeds
the 14-week operating reserve for FY
2018, FDA will reduce the FY 2018
PDUFA fee revenue of $935,903,507 by
$33,287,582, resulting in an adjusted fee
revenue of $902,615,925.
E. FY 2018 Statutory Fee Revenue
Adjustments for Additional Direct Cost
PDUFA VI specifies that $8,730,000
be added in addition to the operating
reserve adjustment to account for
additional direct costs in FY 2018. This
additional direct cost adjustment will be
adjusted for inflation each year
beginning in FY 2019.
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Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices
The final FY 2018 PDUFA fee revenue
is $911,346,000 (rounded to the nearest
thousand dollars).
III. Application Fee Calculations
A. Application Fee Revenues and
Application Fees
Application fees will be set to
generate 20 percent of the total revenue
amount, or $182,269,200 in FY 2018.
B. Estimate of the Number of Fee-Paying
Applications and Setting the
Application Fees
FDA will estimate the total number of
fee-paying full application equivalents
(FAEs) it expects to receive during the
next FY by averaging the number of feepaying FAEs received in the three most
recently completed FYs. Prior year FAE
totals are 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. An application that is withdrawn
before filing, or refused for filing, counts
as one-fourth of an FAE if the applicant
initially paid a full application fee, or
43247
one-eighth of an FAE if the applicant
initially paid one-half of the full
application fee amount. Prior to PDUFA
VI, the FAE amount also included
supplements; supplements have been
removed from the FAE calculation as
the supplement fee has been
discontinued in PDUFA VI.
As table 6 shows, the average number
of fee-paying FAEs received annually in
the most recent 3-year period is
75.271347 FAEs. FDA will set fees for
FY 2018 based on this estimate as the
number of full application equivalents
that will pay fees.
TABLE 6—FEE-PAYING FAES
FY
2014
Fee-Paying FAEs .............................................................................................
2015
2016
73.375000
81.955603
70.483437
3-year
average
75.271347
Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the FY.
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The FY 2018 application fee is
estimated by dividing the average
number of full applications that paid
fees over the latest 3 years, 75.271347,
into the fee revenue amount to be
derived from application fees in FY
2018, $182,269,200. The result is a fee
of $2,421,495 per full application
requiring clinical data, and $1,210,748
per application not requiring clinical
data.
IV. Fee Calculations for Prescription
Drug Program Fees
PDUFA VI renamed the product fee
the ‘‘prescription drug program fee’’; in
addition, PDUFA VI introduced a
limitation that an applicant will not be
assessed more than five program fees for
a fiscal year for prescription drug
products identified in a single approved
NDA or BLA (see section 736(a)(2)(C)).
The program fee was also modified so
that applicants are assessed a program
fee only for prescription drug products
identified in a human drug application
approved as of October 1 of such fiscal
year.
FDA estimates 2,461 program fees
will be invoiced in FY 2018 before
factoring in waivers, refunds, and
exemptions. FDA approximates that
there will be 27 waivers and refunds
granted. In addition, FDA approximates
that another 37 program fees will be
exempted in FY 2018 based on the
orphan drug exemption in section
736(k) of the FD&C Act. FDA estimates
2,397 program fees in FY 2018, after
allowing for an estimated 64 waivers
and reductions, including the orphan
drug exemptions. The FY 2018
prescription drug program fee rate is
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calculated by dividing the adjusted total
revenue from program fees
($729,076,800) by the estimated 2,397
program fees, for a FY 2018 program fee
of $304,162.
payments can be made online). Once
you search for your invoice, select ‘‘Pay
Now’’ to be redirected to Pay.gov.
Payment by credit card is available for
balances that are less than $25,000. If
the balance exceeds this amount, only
V. Fee Schedule for FY 2018
the ACH option is available. Payments
The fee rates for FY 2018 are
must be made using U.S bank accounts
displayed in table 7:
as well as U.S. credit cards.
FDA has partnered with the U.S.
TABLE 7—FEE SCHEDULE FOR FY
Department of the Treasury to use
2018
Pay.gov, a web-based payment
application, for online electronic
Fee rates
payment. The Pay.gov feature is
Fee category
for FY 2018
available on the FDA Web site after the
user fee ID number is generated.
Application:
Please include the user fee
Requiring clinical data .......
$2,421,495
Not requiring clinical data
1,210,748 identification (ID) number on your
Program ................................
304,162 check, bank draft, or postal money
order. Mail your payment to: Food and
Drug Administration, P.O. Box 979107,
VI. Fee Payment Options and
St. Louis, MO 63197–9000. If a check,
Procedures
bank draft, or money order is to be sent
A. Application Fees
by a courier that requests a street
The appropriate application fee
address, the courier should deliver your
established in the new fee schedule
payment to: U.S. Bank, Attention:
must be paid for any application subject Government Lockbox 979107, 1005
to fees under PDUFA that is received on Convention Plaza, St. Louis, MO 63101.
or after October 1, 2017. Payment must
(Note: This U.S. Bank address is for
be made in U.S. currency by electronic
courier delivery only. If you have any
check, check, bank draft, wire transfer,
questions concerning courier delivery
or U.S. postal money order payable to
contact the U.S. Bank at 314–418–4013.
the order of the Food and Drug
This telephone number is only for
Administration. The preferred payment
questions about courier delivery). Please
method is online using electronic check make sure that the FDA post office box
(Automated Clearing House (ACH) also
number (P.O. Box 979107) is written on
known as eCheck) or credit card
the check, bank draft, or postal money
(Discover, VISA, MasterCard, American order.
Express). Secure electronic payments
If paying by wire transfer, please
can be submitted using the User Fees
reference your unique user fee ID
Payment Portal at https://
number when completing your transfer.
userfees.fda.gov/pay (Note: only full
The originating financial institution
payments are accepted. No partial
may charge a wire transfer fee. Please
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Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices
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. If needed,
FDA’s tax identification number is 53–
0196965.
B. Prescription Drug Program Fees
FDA plans to issue invoices and
payment instructions for FY 2018
program fees under the new fee
schedule in September 2017. Payment
will be due on October 1, 2017. FDA
plans to issue invoices in December
2017 for FY 2018 program fees that
qualify for fee assessments after the
initial 2017 billing.
Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–19494 Filed 9–13–17; 8:45 am]
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The statute provides in relevant part,
‘‘On request of the Secretary of Defense,
the head of an agency responsible for
the administration of the navigation or
vessel-inspection laws shall waive
compliance with those laws to the
extent the Secretary considers necessary
in the interest of national defense.’’ 46
U.S.C. 501(a).
For the reasons stated above, and in
light of the request from the Department
of Defense and the concurrence of the
Department of Energy, I am exercising
my authority to waive the Jones Act for
a 7-day period, commencing
immediately, to facilitate movement of
refined petroleum products, including
gasoline, diesel, and jet fuel—to be
shipped from New York, Pennsylvania,
Texas, and Louisiana to South Carolina,
Georgia, Florida, and Puerto Rico. This
waiver applies to covered merchandise
laded on board a vessel within the 7 day
period of the waiver.
Executed this 8th day of September, 2017.
Elaine C. Duke,
Acting Secretary of Homeland Security.
[FR Doc. 2017–19523 Filed 9–13–17; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0131]
Agency Information Collection
Activities; Revision of a Currently
Approved Collection: USCIS Electronic
Payment Processing
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 60-Day notice.
AGENCY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration (USCIS) invites the general
public and other Federal agencies to
comment upon this proposed revision of
a currently approved collection of
information. In accordance with the
Paperwork Reduction Act (PRA) of
1995, the information collection notice
is published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
burden (i.e. the time, effort, and
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until
November 13, 2017.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0131 in the body of the letter, the
agency name and Docket ID USCIS–
2014–0005. To avoid duplicate
submissions, please use only one of the
following methods to submit comments:
(1) Online. Submit comments via the
Federal eRulemaking Portal Web site at
https://www.regulations.gov under eDocket ID number USCIS–2014–0005;
(2) Mail. Submit written comments to
DHS, USCIS, Office of Policy and
Strategy, Chief, Regulatory Coordination
Division, 20 Massachusetts Avenue
NW., Washington, DC 20529–2140.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, 20
Massachusetts Avenue NW.,
Washington, DC 20529–2140, telephone
number 202–272–8377 (This is not a
toll-free number. Comments are not
accepted via telephone message). Please
note contact information provided here
is solely for questions regarding this
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS Web site
at https://www.uscis.gov, or call the
USCIS National Customer Service
Center at 800–375–5283 (TTY 800–767–
1833).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Comments
You may access the information
collection instrument with instructions,
or additional information by visiting the
Federal eRulemaking Portal site at:
https://www.regulations.gov and enter
USCIS–2014–0005 in the search box.
Regardless of the method used for
submitting comments or material, all
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43244-43248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19494]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0007]
Prescription Drug User Fee Rates for Fiscal Year 2018
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) 2018. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes
FDA to collect application fees for certain applications for the review
of human drug and biological products, and prescription drug program
fees for certain approved products. This notice establishes the fee
rates for FY 2018.
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 two different kinds of user fees. Fees are
assessed on the following: (1) Application fees are assessed on certain
types of applications for the review of human drug and biological
products; and (2) prescription drug program fees are assessed on
certain approved products (section 736(a) of the FD&C Act). When
specific conditions are met, FDA may waive or reduce fees (section
736(d) of the FD&C Act).
For FY 2018 through FY 2022, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA VI. The base
revenue amount for FY 2018 is $878,590,000. The FY 2018 base revenue
amount is to be adjusted for inflation and for the resource capacity
needs for the process for the review of human drug applications (the
capacity planning adjustment). An additional dollar amount specified in
the statute (see section 736(b)(1)(F) of the FD&C Act) is then added to
provide for additional full-time equivalent (FTE) positions to support
PDUFA VI initiatives. The FY 2018 revenue amount may be adjusted
further, if necessary, to provide for sufficient operating reserves of
carryover user fees. Finally, the amount is adjusted to provide for
additional direct costs to fund PDUFA VI initiatives. Fee amounts are
to be established each year so that revenues from application fees
provide 20 percent of the total revenue, and prescription drug program
fees provide 80 percent of the total revenue.
This document provides fee rates for FY 2018 for an application
requiring clinical data ($2,421,495), for an application not requiring
clinical data ($1,210,748), and for the prescription drug program fee
($304,162). These fees are effective on October 1, 2017, and will
remain in effect through September 30, 2018. For applications that are
submitted on or after October 1, 2017, the new fee schedule must be
used.
II. Fee Revenue Amount for FY 2018
The base revenue amount for FY 2018 is $878,590,000 prior to
adjustments for inflation, capacity planning, additional FTE, operating
reserve, and additional direct costs (see section 736(b)(1) of the FD&C
Act).
A. FY 2018 Statutory Fee Revenue Adjustments for Inflation
PDUFA VI specifies that the $878,590,000 is to be adjusted for
inflation increases for FY 2018 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 FTE positions at FDA for the first three of the preceding four
FYs, multiplied by the proportion of PC&B costs to total FDA costs of
the 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 the 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 2018. The 3-year average is 2.2354 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
Fiscal year 2014 2015 2016 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $2,054,937,000 $2,232,304,000 $2,414,728,159
Total FTE........................... 14,555 15,484 16,381
PC&B per FTE........................ $141,184 $144,168 $147,408
Percent Change From Previous Year... 2.3451 2.1136 2.2474 2.2354
----------------------------------------------------------------------------------------------------------------
[[Page 43245]]
The statute specifies that this 2.2354 percent should be multiplied
by the proportion of PC&B costs to the 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 2014 2015 2016 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $585,260,720 $615,483,892 $652,508,273
Total Costs......................... $1,077,263,695 $1,127,664,528 $1,157,817,695
PC&B Percent........................ 54.3285 54.5804 56.3567 55.0885
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.2354 percent from table 1 multiplied by
55.0885 percent (or 1.2314 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 3 years of the preceding 4 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)(B) 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 Three-Year Average Percent Change in CPI for Washington-Baltimore Area
----------------------------------------------------------------------------------------------------------------
Fiscal year 2014 2015 2016 3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................... 154.847 155.353 157.180
Annual Percent Change........................... 1.5390 0.3268 1.1760 1.0139
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 1.0139 percent should be multiplied
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
55.0885 percent was obligated for PC&B (as shown in table 2), 44.9115
percent is the portion of costs other than PC&B (100 percent minus
55.0885 percent equals 44.9115 percent). The non-payroll adjustment is
1.0139 percent times 44.9115 percent, or 0.4554 percent.
Next, we add the payroll adjustment (1.2314 percent) to the non-
payroll adjustment (0.4554 percent), for a total inflation adjustment
of 1.6868 percent (rounded) for FY 2018.
We then multiply the base revenue amount for FY 2018 ($878,590,000)
by 1.016868, yielding an inflation-adjusted amount of $893,410,056.
B. FY 2018 Statutory Fee Revenue Adjustments for Capacity Planning
The statute specifies that after $878,590,000 has been adjusted for
inflation, the inflation-adjusted amount shall be further adjusted to
reflect changes in the resource capacity needs for the process of human
drug application reviews (see section 736(c)(2) of the FD&C Act). The
statute prescribes an interim capacity planning adjustment be utilized
until a new methodology can be developed through a process involving an
independent evaluation as well as obtaining public comment. The interim
capacity planning adjustment is applied to FY 2018 fee setting.
To determine the FY 2018 capacity planning adjustment, FDA
calculated the average number of each of the five elements specified in
the capacity planning adjustment provision: (1) Human drug applications
(new drug applications (NDAs)/biologics license applications (BLAs));
(2) active commercial investigational new drug applications (INDs) (IND
applications that have at least one submission during the previous 12
months); (3) efficacy supplements; (4) manufacturing supplements; and
(5) formal meetings, type A, B, B(EoP), C, and written responses only
(WRO) issued in lieu of such formal meetings, over the 3-year period
that ended on June 30, 2016, and the average number of each of these
elements over the most recent 3-year period that ended June 30, 2017.
The calculations are summarized in table 4. The 3-year averages for
each element are provided in column 1 (``3-Year Average Ending 2016'')
and column 2 (``3-Year Average Ending 2017''). Column 3 reflects the
percent change from column 1 to column 2. Column 4 shows the weighting
factor for each element. The weighting factor methodology has been
updated for PDUFA VI. The previous methodology relied on the relative
value of the standard costs for the elements included in the adjuster,
and summed to 100 percent. The weighting factor now is the time
invested in activities related to the element expressed as a percentage
of total time invested in PDUFA activities, and will adjust only the
costs attributed to the elements included in the model (hence the
weighting factor does not now sum to 100 percent). Column 5 is the
weighted percent change in each element. This is calculated by
multiplying the weighting factor in each line in column 4 by the
percent change in column 3. The values in column 5 are summed,
reflecting an adjustment of 2.5090 percent (rounded).
[[Page 43246]]
Table 4--Capacity Planning Adjuster (Interim Methodology) Calculation for FY 2018
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Percent
Element 3-year 3-year change Weighting Weighted
average average (column 1 to factor percent
ending 2016 ending 2017 column 2) (percent) change
----------------------------------------------------------------------------------------------------------------
NDAs/BLAs....................... 147.3333 153.0000 3.8462 18.0915 0.6958
Active Commercial INDs.......... 7,598.0000 7,846.6667 3.2728 23.3890 0.7655
Efficacy Supplements............ 196.3333 212.3333 8.1494 4.1848 0.3410
Manufacturing Supplements....... 2,368.0000 2,482.6667 4.8423 4.3690 0.2116
Meetings Scheduled and WROs..... 2,720.6667 2,940.0000 8.0617 6.1417 0.4951
-------------------------------------------------------------------------------
FY 2018 Capacity Planning .............. .............. .............. .............. 2.5090
Adjuster...................
----------------------------------------------------------------------------------------------------------------
Table 5 shows the calculation of the inflation and capacity
planning adjusted amount for FY 2018. The FY 2018 base revenue amount,
$878,590,000, shown on line 1 is multiplied by the inflation adjustment
factor of 1.016868, resulting in the inflation-adjusted amount of
$893,410,056 shown on line 3. That amount is then multiplied by one
plus the capacity planning adjustment of 2.5090 percent, resulting in
the inflation and capacity planning adjusted amount of $915,825,714
shown on line 5.
Table 5--PDUFA Inflation and Capacity Planning Adjusted Amount for FY
2018, Summary Calculation
------------------------------------------------------------------------
------------------------------------------------------------------------
FY 2018 Revenue Amount.................. $878,590,000 Line 1
Inflation Adjustment Factor for FY 2018 1.016868 Line 2
(1 plus 1.6868 percent)................
Inflation Adjusted Amount............... $893,410,056 Line 3
Capacity Planning Adjustment Factor for 1.025090 Line 4
FY 2018 (1 plus 2.5090 percent)........
Inflation and Capacity Planning Adjusted $915,825,714 Line 5
Amount.................................
------------------------------------------------------------------------
The capacity planning adjustment adds $22,415,658 to the fee
revenue amount for FY 2018. This increase is driven by the fact that
the counts of elements for 2017 (year ending June 30) are at or near
the highest levels since the first incorporation of the workload
adjuster in 2003. The NDA/BLA count in 2017 is equal to the highest
annual number recorded since the advent of the workload adjuster
methodology in 2003. Active commercial INDs, efficacy supplements, and
meetings/WROs are higher in 2017 than in any previous year recorded in
the workload adjuster (note: Meetings/WROs are only counted back to
2014 while the other elements are counted back to 2003). The
manufacturing supplement count is approximately 2 percent below the
highest number recorded in the history of the workload adjuster.
Comparing 2017 to 2014, the first year included in the average in
column 1 in the adjustment, NDA/BLAs are 12 percent higher, active
commercial INDs are 10 percent higher, efficacy supplements are 25
percent higher, manufacturing supplements are 15 percent higher, and
meetings scheduled and WROs are 27 percent higher. This significant and
across the board increase in submission activity is the driver of the
$22,415,658 upward adjustment to the fee revenue amount.
Per the commitments made in PDUFA VI, this increase in the revenue
amount will be allocated and used by organizational review components
engaged in direct review work to enhance resources and expand staff
capacity and capability (see II.A.4 on p.37 of the PDUFA VI commitment
letter).\1\
---------------------------------------------------------------------------
\1\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
---------------------------------------------------------------------------
C. FY 2018 Statutory Fee Revenue Adjustments for Additional Dollar
Amounts
PDUFA VI provides an additional dollar amount for each of the next
five fiscal years for additional FTE to support PDUFA VI enhancements
outlined in the PDUFA VI commitment letter. The amount for FY 2018 is
$20,077,793 (see section 736(b)(1)(F) of the FD&C Act). Adding this
amount to the inflation and capacity planning adjusted revenue amount,
$915,825,714, equals $935,904,000 (rounded to the nearest thousand
dollars).
D. FY 2018 Statutory Fee Revenue Adjustments for Operating Reserve
PDUFA VI provides for an operating reserve adjustment to allow FDA
to increase the fee revenue and fees for any given fiscal year during
PDUFA VI to maintain up to 14 weeks of operating reserve of carryover
user fees. If the carryover balance exceeds 14 weeks of operating
reserves, FDA is required to decrease fees to provide for not more than
14 weeks of operating reserves of carryover user fees.
To determine the 14-week operating reserve amount, the FY 2018
annual base revenue adjusted for inflation and capacity planning,
$915,825,714, is divided by 52, and then multiplied by 14. The 14-week
operating reserve amount for FY 2018 is $246,568,461.
To determine the end of year operating reserve amount, the Agency
must assess actual operating reserve at the end of the third quarter of
FY 2017, and forecast collections and obligations in the fourth quarter
of FY 2017. The estimated end of year FY 2017 operating reserve is
$279,856,044.
Because the estimated end of year FY 2017 PDUFA operating reserve
exceeds the 14-week operating reserve for FY 2018, FDA will reduce the
FY 2018 PDUFA fee revenue of $935,903,507 by $33,287,582, resulting in
an adjusted fee revenue of $902,615,925.
E. FY 2018 Statutory Fee Revenue Adjustments for Additional Direct Cost
PDUFA VI specifies that $8,730,000 be added in addition to the
operating reserve adjustment to account for additional direct costs in
FY 2018. This additional direct cost adjustment will be adjusted for
inflation each year beginning in FY 2019.
[[Page 43247]]
The final FY 2018 PDUFA fee revenue is $911,346,000 (rounded to the
nearest thousand dollars).
III. Application Fee Calculations
A. Application Fee Revenues and Application Fees
Application fees will be set to generate 20 percent of the total
revenue amount, or $182,269,200 in FY 2018.
B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees
FDA will estimate the total number of fee-paying full application
equivalents (FAEs) it expects to receive during the next FY by
averaging the number of fee-paying FAEs received in the three most
recently completed FYs. Prior year FAE totals are 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. An application that is
withdrawn before filing, 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. Prior to PDUFA VI, the FAE amount also included
supplements; supplements have been removed from the FAE calculation as
the supplement fee has been discontinued in PDUFA VI.
As table 6 shows, the average number of fee-paying FAEs received
annually in the most recent 3-year period is 75.271347 FAEs. FDA will
set fees for FY 2018 based on this estimate as the number of full
application equivalents that will pay fees.
Table 6--Fee-Paying FAEs
----------------------------------------------------------------------------------------------------------------
3-year
FY 2014 2015 2016 average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs................................. 73.375000 81.955603 70.483437 75.271347
----------------------------------------------------------------------------------------------------------------
Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the
FY.
The FY 2018 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
75.271347, into the fee revenue amount to be derived from application
fees in FY 2018, $182,269,200. The result is a fee of $2,421,495 per
full application requiring clinical data, and $1,210,748 per
application not requiring clinical data.
IV. Fee Calculations for Prescription Drug Program Fees
PDUFA VI renamed the product fee the ``prescription drug program
fee''; in addition, PDUFA VI introduced a limitation that an applicant
will not be assessed more than five program fees for a fiscal year for
prescription drug products identified in a single approved NDA or BLA
(see section 736(a)(2)(C)). The program fee was also modified so that
applicants are assessed a program fee only for prescription drug
products identified in a human drug application approved as of October
1 of such fiscal year.
FDA estimates 2,461 program fees will be invoiced in FY 2018 before
factoring in waivers, refunds, and exemptions. FDA approximates that
there will be 27 waivers and refunds granted. In addition, FDA
approximates that another 37 program fees will be exempted in FY 2018
based on the orphan drug exemption in section 736(k) of the FD&C Act.
FDA estimates 2,397 program fees in FY 2018, after allowing for an
estimated 64 waivers and reductions, including the orphan drug
exemptions. The FY 2018 prescription drug program fee rate is
calculated by dividing the adjusted total revenue from program fees
($729,076,800) by the estimated 2,397 program fees, for a FY 2018
program fee of $304,162.
V. Fee Schedule for FY 2018
The fee rates for FY 2018 are displayed in table 7:
Table 7--Fee Schedule for FY 2018
------------------------------------------------------------------------
Fee rates for
Fee category FY 2018
------------------------------------------------------------------------
Application:
Requiring clinical data............................... $2,421,495
Not requiring clinical data........................... 1,210,748
Program................................................. 304,162
------------------------------------------------------------------------
VI. Fee Payment Options and Procedures
A. Application Fees
The appropriate application fee established in the new fee schedule
must be paid for any application subject to fees under PDUFA that is
received on or after October 1, 2017. 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 (Note: only full payments are accepted. No
partial payments can be made online). Once you search for your invoice,
select ``Pay Now'' to be redirected to Pay.gov. Payment by credit card
is available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using 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. Mail your payment to: Food
and Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000. If
a check, bank draft, or money order is to be sent by a courier that
requests a street address, the courier should deliver your payment 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
[[Page 43248]]
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. If needed, FDA's tax
identification number is 53-0196965.
B. Prescription Drug Program Fees
FDA plans to issue invoices and payment instructions for FY 2018
program fees under the new fee schedule in September 2017. Payment will
be due on October 1, 2017. FDA plans to issue invoices in December 2017
for FY 2018 program fees that qualify for fee assessments after the
initial 2017 billing.
Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19494 Filed 9-13-17; 8:45 am]
BILLING CODE 4164-01-P
