83 FR 37504 - Prescription Drug User Fee Rates for Fiscal Year 2019
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 148 (August 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 148 (August 1, 2018)
| Page Range | 37504-37507 | |
| FR Document | 2018-16387 |
[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)] [Notices] [Pages 37504-37507] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16387] ----------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 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 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 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 ---------------------------------------------------------------------------------------------------------------- 3-year Year 2015 2016 2017 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 3-year Percent change Weighting Weighted average average (column 1 to factor percent ending 2017 ending 2018 column 2) (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 .............. .............. .............. .............. 2.9067 Adjuster................... ---------------------------------------------------------------------------------------------------------------- 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 [[Page 37506]] 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 1.017708 Line 2. 2019 (1 plus 1.7708 percent). Inflation Adjusted Amount............ 952,476,486 Line 3. Capacity Planning Adjustment Factor 1.029067 Line 4. for FY 2019 (1 plus 2.9067 percent). Inflation and Capacity Planning 980,162,120 Line 5. Adjusted Amount. ------------------------------------------------------------------------ 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\). --------------------------------------------------------------------------- \1\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf. --------------------------------------------------------------------------- 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, DC-MD- 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 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 three-year period is 78.063013 FAEs. FDA will set fees for [[Page 37507]] FY 2019 based on this estimate as the number of full application equivalents that will pay fees. Table 6--Fee-Paying FAEs ---------------------------------------------------------------------------------------------------------------- 3-year FY 2015 2016 2017 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 rates for Fee category 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
![37504 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices
needed, FDA’s tax identification I. Background application not requiring clinical data
number is 53–0196965. Sections 735 and 736 of the FD&C Act ($1,294,239), and for the prescription
Dated: July 26, 2018. (21 U.S.C. 379g and 379h, respectively) drug program fee ($309,915). These fees
Leslie Kux, establish two different kinds of user are effective on October 1, 2018, and
fees. Fees are assessed as follows: (1) will remain in effect through September
Associate Commissioner for Policy.
Application fees are assessed on certain 30, 2019. For applications that are
[FR Doc. 2018–16416 Filed 7–31–18; 8:45 am]
types of applications for the review of submitted on or after October 1, 2018,
BILLING CODE 4164–01–P the new fee schedule must be used.
human drug and biological products;
and (2) prescription drug program fees II. Fee Revenue Amount for FY 2019
DEPARTMENT OF HEALTH AND are assessed on certain approved
products (section 736(a) of the FD&C The base revenue amount for FY 2019
HUMAN SERVICES is $935,903,507 prior to adjustments for
Act). When specific conditions are met,
Food and Drug Administration FDA may waive or reduce fees (section inflation, capacity planning, additional
736(d) of the FD&C Act). FTE, operating reserve, and additional
For FY 2018 through FY 2022, the direct costs (see section 736(b)(1) of the
[Docket No. FDA–2017–N–0007] FD&C Act).
base revenue amounts for the total
Prescription Drug User Fee Rates for revenues from all PDUFA fees are A. FY 2018 Statutory Fee Revenue
Fiscal Year 2019 established by PDUFA VI. The base Adjustments for Inflation
revenue amount for FY 2019 is
AGENCY: Food and Drug Administration, $935,903,507. The FY 2019 base PDUFA VI specifies that the
HHS. revenue amount is adjusted for inflation $935,903,507 is to be adjusted for
and for the resource capacity needs for inflation increases for FY 2019 using
ACTION: Notice. two separate adjustments—one for
the process for the review of human
SUMMARY: The Food and Drug drug applications (the capacity planning personnel compensation and benefits
Administration (FDA) is announcing the adjustment). An additional dollar (PC&B) and one for non-PC&B costs (see
rates for prescription drug user fees for amount specified in the statute (see section 736(c)(1) of the FD&C Act).
fiscal year (FY) 2019. The Federal Food, section 736(b)(1)(F) of the FD&C Act) is The component of the inflation
Drug, and Cosmetic Act (FD&C Act), as then added to provide for additional adjustment for payroll costs shall be one
amended by the Prescription Drug User full-time equivalent (FTE) positions to plus the average annual percent change
Fee Amendments of 2017 (PDUFA VI), support PDUFA VI initiatives. The FY in the cost of all PC&B paid per FTE
authorizes FDA to collect application 2019 revenue amount may be adjusted positions at FDA for the first 3 of the
fees for certain applications for the further, if necessary, to provide for preceding 4 FYs, multiplied by the
review of human drug and biological sufficient operating reserves of proportion of PC&B costs to total FDA
products, and prescription drug carryover user fees. Finally, the amount costs of the process for the review of
program fees for certain approved is adjusted to provide for additional human drug applications for the first 3
products. This notice establishes the fee direct costs to fund PDUFA VI of the preceding 4 FYs (see section
rates for FY 2019. initiatives. Fee amounts are to be 736(c)(1)(A) and (c)(1)(B) of the FD&C
established each year so that revenues Act).
FOR FURTHER INFORMATION CONTACT: Lola Table 1 summarizes the actual cost
from application fees provide 20 percent
Olajide, Office of Financial of the total revenue, and prescription and FTE data for the specified FYs and
Management, Food and Drug drug program fees provide 80 percent of provides the percent changes from the
Administration, 8455 Colesville Rd., the total revenue. previous FYs and the average percent
COLE–14541B, Silver Spring, MD This document provides fee rates for changes over the first three of the four
20993–0002, 240–402–4244. FY 2019 for an application requiring FYs preceding FY 2019. The 3-year
SUPPLEMENTARY INFORMATION: clinical data ($2,588,478), for an 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 the process for the review of human process for the review of human drug
percent be multiplied by the proportion drug applications. Table 2 shows the applications for the first three of the
of PC&B costs to the total FDA costs of PC&B and the total obligations for the preceding four FYs.
TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS
sradovich on DSK3GMQ082PROD with NOTICES
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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FY 2019 based on this estimate as the number of full application equivalents
that will pay fees.
TABLE 6—FEE-PAYING FAES
3-year
FY 2015 2016 2017 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 TABLE 7—FEE SCHEDULE FOR FY Box 979107, St. Louis, MO 63197–9000.
estimated by dividing the average 2019 If a check, bank draft, or money order
number of full applications that paid is to be sent by a courier that requests
fees over the latest three years, Fee category Fee rates for a street address, the courier should
78.063013, into the fee revenue amount FY 2019 deliver your payment to: U.S. Bank,
to be derived from application fees in Application: Attention: Government Lockbox 979107,
FY 2019, $202,064,400. The result is a Requiring clinical data ....... $2,588,478 1005 Convention Plaza, St. Louis, MO
fee of $2,588,478 per full application Not requiring clinical data 1,294,239 63101. (Note: This U.S. Bank address is
requiring clinical data, and $1,294,239 Program: 309,915 for courier delivery only. If you have
per application not requiring clinical any questions concerning courier
data. VI. Fee Payment Options and delivery contact the U.S. Bank at 314–
Procedures 418–4013. This telephone number is
IV. Fee Calculations for Prescription
A. Application Fees only for questions about courier
Drug Program Fees
delivery). Please make sure that the FDA
The appropriate application fee
PDUFA VI assesses prescription drug post office box number (P.O. Box
established in the new fee schedule
program fees for certain prescription must be paid for any application subject 979107) is written on the check, bank
drug products; in addition, an applicant to fees under PDUFA that is received on draft, or postal money order.
will not be assessed more than five or after October 1, 2018. Payment must If paying by wire transfer, please
program fees for a fiscal year for be made in U.S. currency by electronic reference your unique user fee ID
prescription drug products identified in check, check, bank draft, wire transfer, number when completing your transfer.
a single approved NDA or BLA (see or U.S. postal money order payable to The originating financial institution
section 736(a)(2)(C)). Applicants are the order of the Food and Drug may charge a wire transfer fee. Please
assessed a program fee for a fiscal year Administration. The preferred payment ask your financial institution about the
only for prescription drug products method is online using electronic check fee and add it to your payment to ensure
identified in a human drug application (Automated Clearing House (ACH) also that your fee is fully paid. The account
approved as of October 1 of such fiscal known as eCheck) or credit card information for wire transfers is as
year. (Discover, VISA, MasterCard, American follows: U.S. Department of the
Express). Secure electronic payments Treasury, TREAS NYC, 33 Liberty St.,
FDA estimates 2,683 program fees can be submitted using the User Fees
will be invoiced in FY 2019 before New York, NY 10045, Acct. No.:
Payment Portal at https://
factoring in waivers, refunds, and userfees.fda.gov/pay (Note: Only full 75060099, Routing No.: 021030004,
exemptions. FDA approximates that payments are accepted. No partial SWIFT: FRNYUS33. If needed, FDA’s
there will be 40 waivers and refunds payments can be made online). Once tax identification number is 53–
granted. In addition, FDA approximates you search for your invoice, select ‘‘Pay 0196965.
that another 35 program fees will be Now’’ to be redirected to Pay.gov. B. Prescription Drug Program Fees
exempted in FY 2019 based on the Electronic payment options are based on
orphan drug exemption in section the balance due. Payment by credit card FDA will issue invoices and payment
736(k) of the FD&C Act. FDA estimates is available for balances that are less instructions for FY 2019 program fees
2,608 program fees in FY 2019, after than $25,000. If the balance exceeds this under the new fee schedule in August
allowing for an estimated 75 waivers amount, only the ACH option is 2018. Payment will be due on October
and reductions, including the orphan available. Payments must be made using 1, 2018. FDA will issue invoices in
drug exemptions. The FY 2019 U.S bank accounts as well as U.S. credit December 2018 for FY 2019 program
prescription drug program fee rate is cards. fees that qualify for fee assessments after
calculated by dividing the adjusted total FDA has partnered with the U.S. the August 2018 billing.
revenue from program fees Department of the Treasury to use
Pay.gov, a web-based payment Dated: July 26, 2018.
($808,257,600) by the estimated 2,608
application, for online electronic Leslie Kux,
program fees, for a FY 2019 program fee
payment. The Pay.gov feature is Associate Commissioner for Policy.
of $309,915.
sradovich on DSK3GMQ082PROD with NOTICES
available on the FDA website after [FR Doc. 2018–16387 Filed 7–31–18; 8:45 am]
V. Fee Schedule for FY 2019 completing the Prescription Drug User BILLING CODE 4164–01–P
Fee Cover Sheet and generating the user
The fee rates for FY 2019 are fee ID number.
displayed in table 7: 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.
VerDate Sep<11>2014 20:07 Jul 31, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 9990 E:\FR\FM\01AUN1.SGM 01AUN1](https://thefederalregister.org/doc/83_FR_37652/page/4.svg)
Document Created: 2018-08-01 01:23:40
Document Modified: 2018-08-01 01:23:40
| 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 | Lola Olajide, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14541B, Silver Spring, MD 20993-0002, 240-402-4244. | |
| FR Citation | 83 FR 37504 |
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