37504 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 

needed, FDA’s tax identification 

number is 53–0196965. 

Dated: July 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16416 Filed 7–31–18; 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 2019 

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) 2019. The Federal Food, 

Drug, and Cosmetic Act (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 2019. 

FOR FURTHER INFORMATION CONTACT: Lola 

Olajide, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14541B, Silver Spring, MD 

20993–0002, 240–402–4244. 

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 as follows: (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 2019 is 

$935,903,507. The FY 2019 base 

revenue amount is 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 

2019 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 2019 for an application requiring 

clinical data ($2,588,478), for an 

application not requiring clinical data 

($1,294,239), and for the prescription 

drug program fee ($309,915). These fees 

are effective on October 1, 2018, and 

will remain in effect through September 

30, 2019. For applications that are 

submitted on or after October 1, 2018, 

the new fee schedule must be used. 

II. Fee Revenue Amount for FY 2019 

The base revenue amount for FY 2019 

is $935,903,507 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 

$935,903,507 is to be adjusted for 

inflation increases for FY 2019 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 3 of the 

preceding 4 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 3 

of the preceding 4 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 2019. The 3-year 

average is 2.4152 percent. 

TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES

Fiscal year 2015 2016 2017 3-year average 

Total PC&B ...................................... $2,232,304,000 $2,414,728,159 $2,581,551,000 ........................................

Total FTE ......................................... 15,484 16,381 17,022 ........................................

PC&B per FTE ................................. $144,168 $147,408 $151,660 ........................................

Percent Change From Previous 

Year .............................................. 2.1136 2.2474 2.8845 2.4152 

The statute specifies that this 2.4152 

percent 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 the first three of the 

preceding four FYs. 

TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS

Fiscal year 2015 2016 2017 3-year average 

Total PC&B ...................................... $615,483,892 $652,508,273 $711,016,627 ........................................

Total Costs ....................................... $1,127,664,528 $1,157,817,695 $1,206,657,269 ........................................

PC&B Percent .................................. 54.5804 56.3567 58.9245 56.6205 


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Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 37505 

The payroll adjustment is 2.4152 

percent from table 1 multiplied by 

56.6205 percent (or 1.3675 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 

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 3 

years of the preceding 4 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 

website at: https://data.bls.gov/pdq/ 

SurveyOutputServlet?data_tool=

dropmap&series_id=CUURA311SA0,

CUUSA311SA0. 

TABLE 3—ANNUAL AND THREE-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-BALTIMORE AREA

Year 2015 2016 2017 3-year 

average 

Annual CPI ....................................................................................................... 155.353 157.180 159.202 ........................

Annual Percent Change .................................................................................. 0.3268 1.1760 1.2864 0.9297 

The statute specifies that this 0.9297 

percent 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 56.6205 percent was obligated for 

PC&B (as shown in table 2), 43.3795 

percent is the portion of costs other than 

PC&B (100 percent minus 56.6205 

percent equals 43.3795 percent). The 

non-payroll adjustment is 0.9297 

percent times 43.3795 percent, or 0.4033 

percent. 

Next, we add the payroll adjustment 

(1.3675 percent) to the non-payroll 

adjustment (0.4033 percent), for a total 

inflation adjustment of 1.7708 percent 

(rounded) for FY 2019. 

We then multiply the base revenue 

amount for FY 2019 ($935,903,507) by 

1.017708, yielding an inflation-adjusted 

amount of $952,476,486. 

B. FY 2019 Statutory Fee Revenue 

Adjustments for Capacity Planning 

The statute specifies that after 

$935,903,507 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 

2019 fee setting. 

To determine the FY 2019 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, 2017, and 

the average number of each of these 

elements over the most recent three-year 

period that ended June 30, 2018. 

The calculations are summarized in 

table 4. The three-year averages for each 

element are provided in column 1 

(‘‘Three-Year Average Ending 2017’’) 

and column 2 (‘‘Three-Year Average 

Ending 2018’’). 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 2.9067 percent (rounded). 

TABLE 4—CAPACITY PLANNING ADJUSTER (INTERIM METHODOLOGY) CALCULATION FOR FY 2019 

Element Column 1 Column 2 Column 3 Column 4 Column 5 

3-year 

average 

ending 2017 

3-year 

average 

ending 2018 

Percent 

change 

(column 1 to 

column 2) 

Weighting 

factor 

(percent) 

Weighted 

percent 

change 

NDAs/BLAs .......................................................................... 153.0000 162.0000 5.8824 20.5015 1.2060 

Active Commercial INDs ...................................................... 7,846.6667 8,057.0000 2.6805 22.2771 0.5971 

Efficacy Supplements .......................................................... 212.3333 234.3333 10.3611 5.2439 0.5433 

Manufacturing Supplements ................................................ 2,482.6667 2,561.6667 3.1821 3.7243 0.1185 

Meetings Scheduled and WROs ......................................... 2,940.0000 3,136.3333 6.6780 6.6156 0.4418 

FY 2019 Capacity Planning Adjuster ........................... ........................ ........................ ........................ ........................ 2.9067 

Table 5 shows the calculation of the 

inflation and capacity planning adjusted 

amount for FY 2019. The FY 2019 base 

revenue amount, $935,903,507, shown 

on line 1 is multiplied by the inflation 

adjustment factor of 1.017708, resulting 


sradovich on DSK3GMQ082PROD with NOTICES
37506 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 

1The PDUFA VI commitment letter can be 

viewed at https://www.fda.gov/downloads/ 

forindustry/userfees/prescriptiondruguserfee/ 

ucm511438.pdf. 

in the inflation-adjusted amount of 

$952,476,486 shown on line 3. That 

amount is then multiplied by one, plus 

the capacity planning adjustment of 

2.9067 percent, resulting in the inflation 

and capacity planning adjusted amount 

of $980,162,120 shown on line 5. 

TABLE 5—PDUFA INFLATION AND CAPACITY PLANNING ADJUSTED AMOUNT FOR FY 2019, SUMMARY CALCULATION

FY 2019 Revenue Amount ................................................................................................................................................... $935,903,507 Line 1. 

Inflation Adjustment Factor for FY 2019 (1 plus 1.7708 percent) ....................................................................................... 1.017708 Line 2. 

Inflation Adjusted Amount .................................................................................................................................................... 952,476,486 Line 3. 

Capacity Planning Adjustment Factor for FY 2019 (1 plus 2.9067 percent) ....................................................................... 1.029067 Line 4. 

Inflation and Capacity Planning Adjusted Amount ............................................................................................................... 980,162,120 Line 5. 

The capacity planning adjustment 

adds $27,685,634 to the fee revenue 

amount for FY 2019. This increase is 

driven by the fact that the counts of 

elements for 2018 (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 2018 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 2018 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 

2018 to 2015, the first year included in 

the average in column 1 in the 

adjustment, NDA/BLAs are 17 percent 

higher, active commercial INDs are 8 

percent higher, efficacy supplements are 

36 percent higher, manufacturing 

supplements are 10 percent higher, and 

meetings scheduled and WROs are 21 

percent higher. This significant and 

across the board increase in submission 

activity is the driver of the $27,685,634 

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). 

C. FY 2019 Statutory Fee Revenue 

Adjustments for Additional Dollar 

Amounts 

PDUFA VI provides an additional 

dollar amount for each of the five fiscal 

years covered by PDUFA VI for 

additional FTE to support PDUFA VI 

enhancements outlined in the PDUFA 

VI commitment letter. The amount for 

FY 2019 is $21,317,472 (see section 

736(b)(1)(F) of the FD&C Act). Adding 

this amount to the inflation and 

capacity planning adjusted revenue 

amount, $980,162,120, equals 

$1,001,479,592. 

D. FY 2019 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 2019 annual 

base revenue adjusted for inflation and 

capacity planning, $980,162,120, is 

divided by 52, and then multiplied by 

14. The 14-week operating reserve 

amount for FY 2019 is $263,889,802. 

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 2018, 

and forecast collections and obligations 

in the fourth quarter of FY 2018. The 

estimated end of year FY 2018 operating 

reserve is $235,128,646. 

Because the estimated end of year FY 

2019 PDUFA operating reserve does not 

exceed the 14-week operating reserve 

for FY 2019, FDA will not reduce the FY 

2019 PDUFA fee revenue in FY 2019. 

E. FY 2019 Statutory Fee Revenue 

Adjustments for Additional Direct Cost 

PDUFA VI specifies that $8,730,000, 

adjusted for inflation, be added in 

addition to the operating reserve 

adjustment to account for additional 

direct costs in FY 2019. This additional 

direct cost adjustment is adjusted for 

inflation by multiplying $8,730,000 by 

the Consumer Price Index for urban 

consumers (Washington-Baltimore, DCMD-VA-WV; Not Seasonally Adjusted; 

All Items; Annual Index) for 2017, 

which is 159.202, and then divided by 

such Index for 2016, 157.180 (see 

section 736(c)(4)(B) of the FD&C Act). 

This results in an adjustment factor of 

1.012864, making the additional direct 

cost adjustment equal to $8,842,303. 

The final FY 2019 PDUFA target 

revenue is $1,010,322,000 (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 target 

revenue amount, or $202,064,400 in FY 

2019. 

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 

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 three-year period is 

78.063013 FAEs. FDA will set fees for 


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Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 37507 

FY 2019 based on this estimate as the number of full application equivalents 

that will pay fees. 

TABLE 6—FEE-PAYING FAES

FY 2015 2016 2017 3-year 

average 

Fee-Paying FAEs ............................................................................................. 81.955603 70.483437 81.750000 78.063013 

Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the FY. 

The FY 2019 application fee is 

estimated by dividing the average 

number of full applications that paid 

fees over the latest three years, 

78.063013, into the fee revenue amount 

to be derived from application fees in 

FY 2019, $202,064,400. The result is a 

fee of $2,588,478 per full application 

requiring clinical data, and $1,294,239 

per application not requiring clinical 

data. 

IV. Fee Calculations for Prescription 

Drug Program Fees 

PDUFA VI assesses prescription drug 

program fees for certain prescription 

drug products; in addition, 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)). Applicants are 

assessed a program fee for a fiscal year 

only for prescription drug products 

identified in a human drug application 

approved as of October 1 of such fiscal 

year. 

FDA estimates 2,683 program fees 

will be invoiced in FY 2019 before 

factoring in waivers, refunds, and 

exemptions. FDA approximates that 

there will be 40 waivers and refunds 

granted. In addition, FDA approximates 

that another 35 program fees will be 

exempted in FY 2019 based on the 

orphan drug exemption in section 

736(k) of the FD&C Act. FDA estimates 

2,608 program fees in FY 2019, after 

allowing for an estimated 75 waivers 

and reductions, including the orphan 

drug exemptions. The FY 2019 

prescription drug program fee rate is 

calculated by dividing the adjusted total 

revenue from program fees 

($808,257,600) by the estimated 2,608 

program fees, for a FY 2019 program fee 

of $309,915. 

V. Fee Schedule for FY 2019 

The fee rates for FY 2019 are 

displayed in table 7: 

TABLE 7—FEE SCHEDULE FOR FY 

2019 

Fee category Fee rates for 

FY 2019 

Application: 

Requiring clinical data ....... $2,588,478 

Not requiring clinical data 1,294,239 

Program: 309,915 

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, 2018. 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. 

Electronic payment options are based on 

the balance due. 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 website after 

completing the Prescription Drug User 

Fee Cover Sheet and generating the user 

fee ID number. 

Please include the user fee (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 

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. If needed, FDA’s 

tax identification number is 53– 

0196965. 

B. Prescription Drug Program Fees 

FDA will issue invoices and payment 

instructions for FY 2019 program fees 

under the new fee schedule in August 

2018. Payment will be due on October 

1, 2018. FDA will issue invoices in 

December 2018 for FY 2019 program 

fees that qualify for fee assessments after 

the August 2018 billing. 

Dated: July 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16387 Filed 7–31–18; 8:45 am] 

BILLING CODE 4164–01–P 


sradovich on DSK3GMQ082PROD with NOTICES