83 FR 35649 - Generic Drug User Fee Rates for Fiscal Year 2019
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 145 (July 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 145 (July 27, 2018)
| Page Range | 35649-35653 | |
| FR Document | 2018-16067 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Pages 35649-35653] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16067] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0007] Generic Drug User Fee Rates for Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2019 rates for GDUFA II fees. FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14202J, Silver Spring, MD 20993-0002, 240-402-4585. SUPPLEMENTARY INFORMATION: I. Background Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j- 42) establish fees associated with human generic drug products. Fees are assessed on: (1) Certain types of applications for human generic drug products; (2) certain facilities where APIs and FDFs are produced; (3) certain DMFs associated with human generic drug products; and (4) generic drug applicants who have approved ANDAs (the program fee) (see section 744B(a)(2)-(5) of the FD&C Act). GDUFA II stipulates that user fees should total $493,600,000 annually adjusted each year for inflation. For FY 2019, the generic drug fee rates are: ANDA ($178,799), DMF ($55,013), domestic API facility ($44,226), foreign API facility ($59,226), domestic FDF facility ($211,305), foreign FDF facility ($226,305), domestic CMO facility ($70,435), foreign CMO facility ($85,435), large size operation generic drug applicant program ($1,862,167), medium size operation generic drug applicant program ($744,867), and small business generic drug applicant program ($186,217). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019. II. Fee Revenue Amount for FY 2019 The base revenue amount for FY 2019 is $493,600,000, as set in the statute (see section 744B(b)(1) of the FD&C Act). GDUFA II directs FDA to use the yearly revenue amount as a starting point to set the fee rates for each fee type. For more information about GDUFA II, please refer to the FDA website (https://www.fda.gov/gdufa). The ANDA, DMF, API facility, FDF facility, CMO facility, and generic drug applicant program fee (GDUFA program fee) calculations for FY 2019 are described in this document. GDUFA II specifies that the $493,600,000 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 sections 744B(c)(1)(B) and (C) of the FD&C Act). The component of the inflation adjustment for PC&B costs shall be one plus the average annual percent change in the cost of all PC&B paid per full-time equivalent position (FTE) at FDA for the first 3 of the 4 preceding fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of human generic drug activities for the first 3 of the preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act). Table 1 summarizes the actual cost and total FTE for the specified fiscal years, and provides the percent change from the previous fiscal year and the average percent change over the first 3 of the 4 fiscal years preceding FY 2019. The 3-year average is 2.4152 percent. Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change ---------------------------------------------------------------------------------------------------------------- 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 should be multiplied by the proportion of PC&B expended for human generic drug activities for the first 3 of the preceding 4 fiscal years. Table 2 shows the amount of PC&B and the total amount obligated for human generic drug activities from FY 2015 through FY 2017. Table 2--PC&B as a Percent of Fee Revenues Spent on the Process of Human Generic Drug Applications Over the Last 3 Years ---------------------------------------------------------------------------------------------------------------- Fiscal year 2015 2016 2017 3-Year average ---------------------------------------------------------------------------------------------------------------- PC&B................................ $201,116,305 $242,963,571 $271,748,229 ................. Non-PC&B............................ $251,589,013 $250,987,599 $262,058,852 ................. Total Costs......................... $452,705,318 $493,951,170 $533,807,081 ................. [[Page 35650]] PC&B Percent........................ 44.4254 49.1878 50.9076 48.1736 Non-PC&B Percent.................... 55.5746 50.8122 49.0924 51.8264 ---------------------------------------------------------------------------------------------------------------- The payroll adjustment is 2.4152 percent multiplied by 48.1736 percent (or 1.1635 percent). The statute specifies that the portion of the inflation adjustment for non-PC&B costs for FY 2019 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 of the preceding 4 years of available data multiplied by the proportion of all costs other than PC&B costs to total costs of human generic drug activities (see section 744B(c)(1)(C) of the FD&C Act). Table 3 provides the summary data for the percent change in the specified CPI. 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 3-Year Average Percent Change in CPI for Baltimore-Washington 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 ---------------------------------------------------------------------------------------------------------------- To calculate the inflation adjustment for non-pay costs, we multiply the 3-year average percent change in the CPI (0.9297 percent) by the proportion of all costs other than PC&B to total costs of human generic drug activities obligated. Because 48.1736 percent was obligated for PC&B as shown in table 2, 51.8264 percent is the portion of costs other than PC&B. The non-pay adjustment is 0.9297 percent times 51.8264 percent, or 0.4818 percent. To complete the inflation adjustment for FY 2019, we add the PC&B component (1.1635 percent) to the non-PC&B component (0.4818 percent) for a total inflation adjustment of 1.6453 percent (rounded), making 1.016453. We then multiply the base revenue amount for FY 2019 ($493,600,000) by 1.016453, yielding an inflation-adjusted amount of $501,721,000 (rounded to the nearest thousand dollars). III. ANDA Filing Fee Under GDUFA II, the FY 2019 ANDA filing fee is owed by each applicant that submits an ANDA on or after October 1, 2018. This fee is due on the submission date of the ANDA. Section 744B(b)(2)(B) of the FD&C Act specifies that the ANDA fee will make up 33 percent of the $501,721,000, which is $165,567,930. To calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2019. The submissions are broken down into three categories: New originals (submissions that have not been received by FDA previously); submissions that have been refused to receive (RTR) for reasons other than failure to pay fees; and applications that are resubmitted after having been RTR for reasons other than failure to pay fees. An ANDA counts as one FAE; however, 75 percent of the fee paid for an ANDA that has been RTR shall be refunded according to GDUFA II if (1) the ANDA is refused for a cause other than failure to pay fees, or (2) the ANDA has been withdrawn prior to receipt (section 744B(a)(2)(D)(i) of the FD&C Act). Therefore, an ANDA that is considered not to have been received by FDA due to reasons other than failure to pay fees or withdrawn prior to receipt counts as one-fourth of an FAE. After an ANDA has been RTR, the applicant has the option of resubmitting. For user fee purposes, these resubmissions are equivalent to new original submissions--ANDA resubmissions are charged the full amount for an application (one FAE). FDA utilized data from ANDAs submitted from October 1, 2013, to April 30, 2018, to estimate the number of new original ANDAs that will incur filing fees in FY 2019. For FY 2019, the Agency estimates that approximately 918 new original ANDAs will be submitted and incur filing fees. Not all of the new original ANDAs will be received by the Agency and some of those not received will be resubmitted in the same fiscal year. Therefore, the Agency expects that the FAE count for ANDAs will be 926 for FY 2019. The FY 2019 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2019 (926) into the fee revenue amount to be derived from ANDA application fees in FY 2019 ($165,567,930). The result, rounded to the nearest dollar, is a fee of $178,799 per ANDA. The statute provides that those ANDAs that include information about the production of active pharmaceutical ingredients other than by reference to a DMF will pay an additional fee that is based on the number of such active pharmaceutical ingredients and the number of facilities proposed to produce those ingredients (see section 744B(a)(3)(F) of the FD&C Act). FDA considers that this additional fee is unlikely to be assessed often; therefore, FDA has not included projections concerning the amount of this fee in calculating the fees for ANDAs. IV. DMF Fee Under GDUFA II, the DMF fee is owed by each person that owns a type II active pharmaceutical ingredient DMF that is referenced, on or after October 1, 2012, in a generic drug submission by an initial letter of authorization. This is a one-time fee for each DMF. This fee is due on the earlier of the date on which the first generic drug submission is submitted that references the associated DMF or the date on which the drug master file holder requests the initial completeness assessment. Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has successfully undergone an initial completeness assessment and the fee is paid, the DMF will be placed on a publicly available list documenting DMFs available for reference. To calculate the DMF fee, FDA assessed the volume of DMF [[Page 35651]] submissions over time. The Agency assessed DMFs from October 1, 2016, to April 30, 2018, and concluded that averaging the number of fee- paying DMFs provided the most accurate model for predicting fee-paying DMFs for FY 2019. The monthly average of paid DMF submissions the Agency received in FY 2017 and FY 2018 is 38. To determine the FY 2019 projected number of fee-paying DMFs, the average of 38 DMF submissions is multiplied by 12 months, which results in 456 estimated FY 2019 fee- paying DMFs. FDA is estimating 456 fee-paying DMFs for FY 2019. The FY 2019 DMF fee is determined by dividing the DMF target revenue by the estimated number of fee-paying DMFs in FY 2019. Section 744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up 5 percent of the $501,721,000, which is $25,086,050. Dividing the DMF revenue amount ($25,086,050) by the estimated fee-paying DMFs (456), and rounding to the nearest dollar, yields a DMF fee of $55,013 for FY 2019. V. Foreign Facility Fee Differential Under GDUFA II, the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions. The basis for this differential is the extra cost incurred by conducting an inspection outside the United States and its territories and possessions. VI. FDF and CMO Facility Fees Under GDUFA II, the annual FDF facility fee is owed by each person who owns an FDF facility that is identified in at least one approved generic drug submission owned by that person or his affiliates. The CMO facility fee is owed by each person who owns an FDF facility that is identified in at least one approved ANDA but is not identified in an approved ANDA held by the owner of that facility or its affiliates. These fees are due no later than the first business day on or after October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF and CMO facility fee revenue will make up 20 percent of the $501,721,000, which is $100,344,200. To calculate the fees, data from FDA's Integrity Services (IS) were utilized as the primary source of facility information for determining the denominators of each facility fee type. IS is the master data steward for all facility information provided in generic drug submissions received by FDA. A facility's reference status in an approved generic drug submission is extracted directly from submission data rather than relying on data from self-identification. This information provided the number of facilities referenced as FDF manufacturers in at least one approved generic drug submission. Based on FDA's IS data, the FDF and CMO facility denominators are 180 FDF domestic, 216 FDF foreign, 73 CMO domestic, and 97 CMO foreign facilities for FY 2019. GDUFA II specifies that the CMO facility fee is to be equal to one- third the amount of the FDF facility fee. Therefore, to generate the target collection revenue amount from FDF and CMO facility fees ($100,344,200), FDA must weight a CMO facility as one-third of an FDF facility. FDA set fees based on the estimate of 180 FDF domestic, 216 FDF foreign, 24.33 CMO domestic (73 multiplied by one-third), and 32.33 CMO foreign facilities (97 multiplied by one-third), which equals 452.66 total weighted FDF and CMO facilities for FY 2019. To calculate the fee for domestic facilities, FDA first determines the total fee revenue that will result from the foreign facility differential by subtracting the fee revenue resulting from the foreign facility fee differential from the target collection revenue amount ($100,344,200) as follows. The foreign facility fee differential revenue equals the foreign facility fee differential ($15,000) multiplied by the number of FDF foreign facilities (216) plus the foreign facility fee differential ($15,000) multiplied by the number of CMO foreign facilities (97), totaling $4,695,000. This results in foreign fee differential revenue of $4,695,000 from the total FDF and CMO facility fee target collection revenue. Subtracting the foreign facility differential fee revenue ($4,695,000) from the total FDF and CMO facility target collection revenue ($100,344,200) results in a remaining facility fee revenue balance of $95,649,200. To determine the domestic FDF facility fee, FDA divides the $95,649,200 by the total weighted number of FDF and CMO facilities (452.66), which results in a domestic FDF facility fee of $211,305. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $226,305. According to GDUFA II, the domestic CMO fee is calculated as one- third the amount of the domestic FDF facility fee. Therefore, the domestic CMO fee is $70,435, rounded to the nearest dollar. The foreign CMO fee is calculated as the domestic CMO fee plus the foreign fee differential of $15,000. Therefore, the foreign CMO fee is $85,435. VII. API Facility Fee Under GDUFA II, the annual API facility fee is owed by each person who owns a facility that is identified in (1) at least one approved generic drug submission or (2) in a Type II API DMF referenced in at least one approved generic drug submission. These fees are due no later than the first business day on or after October 1 of each such year. Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee will make up 7 percent of $501,721,000 in fee revenue, which is $35,120,470. To calculate the API facility fee, data from FDA's IS were utilized as the primary source of facility information for determining the denominator. As stated above, IS is the master data steward for all facility information provided in generic drug submissions received by FDA. A facility's reference status in an approved generic drug submission is extracted directly from submission data rather than relying on data from self-identification. This information provided the number of facilities referenced as API manufacturers in at least one approved generic drug submission. The total number of API facilities identified was 613; of that number, 79 were domestic and 534 were foreign facilities. The foreign facility differential is $15,000. To calculate the fee for domestic facilities, FDA must first subtract the fee revenue that will result from the foreign facility fee differential. FDA takes the foreign facility differential ($15,000) and multiplies it by the number of foreign facilities (534) to determine the total fee revenue that will result from the foreign facility differential. As a result of that calculation, the foreign fee differential revenue will make up $8,010,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($8,010,000) from the total API facility target revenue ($35,120,470) results in a remaining balance of $27,110,470. To determine the domestic API facility fee, we divide the $27,110,470 by the total number of facilities (613), which gives us a domestic API facility fee of $44,226. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $59,226. VIII. Generic Drug Applicant Program Fee Under GDUFA II, if a person and its affiliates own at least one but not more than five approved ANDAs on October 1, 2018, the person and its affiliates shall owe a small business GDUFA program fee. If a person and its affiliates own at least 6 but not more than 19 [[Page 35652]] approved ANDAs, the person and its affiliates shall owe a medium size operation GDUFA program fee. If a person and its affiliates own at least 20 approved ANDAs, the person and its affiliates shall owe a large size operation GDUFA program fee. These fees are due no later than the first business day on or after October 1 of each such year. Section 744B(b)(2)(E) of the FD&C Act specifies the GDUFA program fee will make up 35 percent of $501,721,000 in fee revenue, which is $175,602,350. To determine the appropriate number of applicants for each tier, the Agency has posted lists of approved ANDAs on the FDA website (https://www.fda.gov/gdufa) and asked applicants on the list to claim which ANDAs and affiliates belong to the parent company. The original list of approved ANDAs came from the Agency's Document Archiving, Reporting, and Regulatory Tracking System (DARRTS), which included all ANDAs with the status of ``approved'' as of April 30, 2018. In determining the appropriate number of approved ANDAs, the Agency has factored in a number of variables that could affect the collection of the target revenue: (1) Inactive ANDAs--applicants who have not submitted an annual report for one or more of their approved applications within the past 2 years; (2) FY 2018 Program Fee Arrears List--applicants who failed to satisfy the FY 2018 program fee and were unresponsive to attempts to collect; and (3) Prediction of Approvals Due to Goal Dates and Office of Generic Drugs Approval Rate--Due to the low percentage of additional approved ANDAs for a specified time period and the difficulties in determining how this population would affect the program fee tier of each company, this variable was not included in the determination of the FY 2019 GDUFA program fee. The list of original approved ANDAs from the DARRTS database as of April 30, 2018, shows 259 applicants in the small business tier, 62 applicants in the medium size tier, and 58 applicants in the large size tier. This list also takes into account all the withdrawals, consolidations, and transfer of ownerships from industry as of April 30, 2018. Factoring in all the variables for the second year of GDUFA II, the Agency estimates there will be 177 applicants in the small business tier, 49 applicants in the medium size tier, and 57 applicants in the large size tier for FY 2019. To calculate the GDUFA program fee, GDUFA II provides that large size operation generic drug applicants pay the full fee, medium size operation applicants pay two-fifths of the full fee, and small business applicants pay one-tenth of the full fee. To generate the target collection revenue amount from GDUFA program fees ($175,602,350), we must weigh medium and small tiered applicants as a subset of a large size operation generic drug applicant. FDA will set fees based on the weighted estimate of 17.70 applicants in the small business tier (177 multiplied by 10 percent), 19.60 applicants in the medium size tier (49 multiplied by 40 percent), and 57 applicants in the large size tier, arriving at 94.30 total weighted applicants for FY 2019. To generate the large size operation GDUFA program fee, FDA divides the target revenue amount of $175,602,350 by 94.30, which equals $1,862,167. The medium size operation GDUFA program fee is 40 percent of the full fee ($744,867), and the small business operation GDUFA program fee is 10 percent of the full fee ($186,217). IX. Fee Schedule for FY 2019 The fee rates for FY 2019 are set out in table 4. Table 4--Fee Schedule for FY 2019 ------------------------------------------------------------------------ Fees rates for Fee category FY 2019 ------------------------------------------------------------------------ Applications: .............. Abbreviated New Drug Application (ANDA)............. $178,799 Drug Master File (DMF).............................. 55,013 Facilities: .............. Active Pharmaceutical Ingredient (API) Domestic......... 44,226 API--Foreign........................................ 59,226 Finished Dosage Form (FDF)--Domestic................ 211,305 FDF--Foreign........................................ 226,305 Contract Manufacturing Organization (CMO)--Domestic. 70,435 CMO--Foreign........................................ 85,435 GDUFA Program: .............. Large size operation generic drug applicant......... 1,862,167 Medium size operation generic drug applicant........ 744,867 Small business operation generic drug applicant..... 186,217 ------------------------------------------------------------------------ X. Fee Payment Options and Procedures The new fee rates are effective October 1, 2018. To pay the ANDA, DMF, API facility, FDF facility, CMO facility, and GDUFA program fees, a Generic Drug User Fee Cover Sheet must be completed, available at https://www.fda.gov/gdufa and https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and a user fee identification (ID) number must be generated. Payment must be made in U.S. currency drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order, credit card, or wire transfer. 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: IOnly full payments are accepted; no partial payments can be made online.) Once an invoice is located, ``Pay Now'' should be selected to be redirected to https://www.pay.gov/public/home (Pay.gov). Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be 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 utilize Pay.gov, a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website after completing the Generic Drug User Fee [[Page 35653]] Cover Sheet and generating the user fee ID number. The user fee ID number must be included on the check, bank draft, or postal money order and must be made payable to the order of the Food and Drug Administration. Payments can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be sent by a courier that requests a street address, the courier can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. For questions concerning courier delivery, U.S. Bank can be contacted at 314-418-4013. This telephone number is only for questions about courier delivery.) The FDA post office box number (P.O. Box 979108) must be written on the check, bank draft, or postal money order. For payments made by wire transfer, the unique user fee ID number must be referenced. Without the unique user fee ID number, the payment may not be applied. If the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. Applicable wire transfer fees must be included with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is 53-0196965. Dated: July 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16067 Filed 7-26-18; 8:45 am] BILLING CODE 4164-01-P
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not withdrawn from sale for reasons of assess and collect fees for abbreviated applicant program ($744,867), and small
safety or effectiveness. new drug applications (ANDAs), drug business generic drug applicant program
Accordingly, the Agency will master files (DMFs), generic drug active ($186,217). These fees are effective on
continue to list metaxalone tablets, 640 pharmaceutical ingredient (API) October 1, 2018, and will remain in
mg, in the ‘‘Discontinued Drug Product facilities, finished dosage form (FDF) effect through September 30, 2019.
List’’ section of the Orange Book. The facilities, contract manufacturing
II. Fee Revenue Amount for FY 2019
‘‘Discontinued Drug Product List’’ organization (CMO) facilities, and
delineates, among other items, drug generic drug applicant program user The base revenue amount for FY 2019
products that have been discontinued fees. In this document, FDA is is $493,600,000, as set in the statute (see
from marketing for reasons other than announcing fiscal year (FY) 2019 rates section 744B(b)(1) of the FD&C Act).
safety or effectiveness. ANDAs that refer for GDUFA II fees. GDUFA II directs FDA to use the yearly
to metaxalone tablets, 640 mg, may be FOR FURTHER INFORMATION CONTACT: revenue amount as a starting point to set
approved by the Agency as long as they Melissa Hurley, Office of Financial the fee rates for each fee type. For more
meet all other legal and regulatory Management, Food and Drug information about GDUFA II, please
requirements for the approval of Administration, 8455 Colesville Rd., refer to the FDA website (https://
ANDAs. If FDA determines that labeling COLE–14202J, Silver Spring, MD www.fda.gov/gdufa). The ANDA, DMF,
for this drug product should be revised 20993–0002, 240–402–4585. API facility, FDF facility, CMO facility,
to meet current standards, the Agency SUPPLEMENTARY INFORMATION:
and generic drug applicant program fee
will advise ANDA applicants to submit (GDUFA program fee) calculations for
such labeling. I. Background FY 2019 are described in this document.
Dated: July 20, 2018. Sections 744A and 744B of the FD&C GDUFA II specifies that the
Leslie Kux, Act (21 U.S.C. 379j–41 and 379j–42) $493,600,000 is to be adjusted for
establish fees associated with human inflation increases for FY 2019 using
Associate Commissioner for Policy.
generic drug products. Fees are assessed two separate adjustments—one for
[FR Doc. 2018–16031 Filed 7–26–18; 8:45 am]
on: (1) Certain types of applications for personnel compensation and benefits
BILLING CODE 4164–01–P
human generic drug products; (2) (PC&B) and one for non-PC&B costs (see
certain facilities where APIs and FDFs sections 744B(c)(1)(B) and (C) of the
are produced; (3) certain DMFs FD&C Act).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES associated with human generic drug The component of the inflation
products; and (4) generic drug adjustment for PC&B costs shall be one
Food and Drug Administration applicants who have approved ANDAs plus the average annual percent change
(the program fee) (see section in the cost of all PC&B paid per full-time
[Docket No. FDA–2016–N–0007] 744B(a)(2)–(5) of the FD&C Act). equivalent position (FTE) at FDA for the
GDUFA II stipulates that user fees first 3 of the 4 preceding fiscal years,
Generic Drug User Fee Rates for Fiscal
should total $493,600,000 annually multiplied by the proportion of PC&B
Year 2019
adjusted each year for inflation. For FY costs to total FDA costs of human
AGENCY: Food and Drug Administration, 2019, the generic drug fee rates are: generic drug activities for the first 3 of
HHS. ANDA ($178,799), DMF ($55,013), the preceding 4 fiscal years (see section
ACTION: Notice. domestic API facility ($44,226), foreign 744B(c)(1)(B) of the FD&C Act).
API facility ($59,226), domestic FDF Table 1 summarizes the actual cost
SUMMARY: The Federal Food, Drug, and facility ($211,305), foreign FDF facility and total FTE for the specified fiscal
Cosmetic Act (FD&C Act), as amended ($226,305), domestic CMO facility years, and provides the percent change
by the Generic Drug User Fee ($70,435), foreign CMO facility from the previous fiscal year and the
Amendments of 2017 (GDUFA II), ($85,435), large size operation generic average percent change over the first 3
authorizes the Food and Drug drug applicant program ($1,862,167), of the 4 fiscal years preceding FY 2019.
Administration (FDA, Agency, or we) to medium size operation generic drug The 3-year average is 2.4152 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
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 human generic drug activities for the the total amount obligated for human
percent should be multiplied by the first 3 of the preceding 4 fiscal years. generic drug activities from FY 2015
proportion of PC&B expended for Table 2 shows the amount of PC&B and through FY 2017.
TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS OF HUMAN GENERIC DRUG APPLICATIONS
amozie on DSK3GDR082PROD with NOTICES1
OVER THE LAST 3 YEARS
Fiscal year 2015 2016 2017 3-Year average
PC&B ....................................................................................... $201,116,305 $242,963,571 $271,748,229 ..............................
Non-PC&B ............................................................................... $251,589,013 $250,987,599 $262,058,852 ..............................
Total Costs ............................................................................... $452,705,318 $493,951,170 $533,807,081 ..............................
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Cover Sheet and generating the user fee ACTION: Notice of availability. Written/Paper Submissions
ID number. Submit written/paper submissions as
The user fee ID number must be SUMMARY: The Food and Drug follows:
included on the check, bank draft, or Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
postal money order and must be made announcing the availability of a draft written/paper submissions): Dockets
payable to the order of the Food and guidance for industry entitled ‘‘Slowly Management Staff (HFA–305), Food and
Drug Administration. Payments can be Progressive, Low-Prevalence Rare Drug Administration, 5630 Fishers
mailed to: Food and Drug Diseases with Substrate Deposition That Lane, Rm. 1061, Rockville, MD 20852.
Administration, P.O. Box 979108, St. Results from Single Enzyme Defects: • For written/paper comments
Louis, MO 63197–9000. If checks are to Providing Evidence of Effectiveness for submitted to the Dockets Management
be sent by a courier that requests a street Replacement or Corrective Therapies.’’ Staff, FDA will post your comment, as
address, the courier can deliver checks This document is intended to provide well as any attachments, except for
to: U.S. Bank, Attention: Government guidance to sponsors on the evidence information submitted, marked and
Lockbox 979108, 1005 Convention necessary to demonstrate the identified, as confidential, if submitted
Plaza, St. Louis, MO 63101. (Note: This effectiveness of new drugs, including as detailed in ‘‘Instructions.’’
U.S. Bank address is for courier delivery biological drugs, or new drug uses Instructions: All submissions received
only. For questions concerning courier intended for slowly progressive, low- must include the Docket No. FDA–
delivery, U.S. Bank can be contacted at prevalence rare diseases that are 2018–D–2456 for ‘‘Slowly Progressive,
314–418–4013. This telephone number associated with substrate deposition and Low-Prevalence Rare Diseases with
is only for questions about courier are caused by single enzyme defects. Substrate Deposition That Results from
delivery.) The FDA post office box This guidance applies only to those low- Single Enzyme Defects: Providing
number (P.O. Box 979108) must be prevalence rare diseases with a well- Evidence of Effectiveness for
written on the check, bank draft, or characterized pathophysiology and in Replacement or Corrective Therapies;
postal money order. which changes in substrate deposition Draft Guidance for Industry;
For payments made by wire transfer, can be readily measured in relevant Availability.’’ Received comments will
the unique user fee ID number must be tissue(s). be placed in the docket and, except for
referenced. Without the unique user fee those submitted as ‘‘Confidential
ID number, the payment may not be DATES: Submit either electronic or Submissions,’’ publicly viewable at
applied. If the payment amount is not written comments on the draft guidance https://www.regulations.gov or at the
applied, the invoice amount will be by September 25, 2018 to ensure that Dockets Management Staff between 9
referred to collections. The originating the Agency considers your comment on a.m. and 4 p.m., Monday through
financial institution may charge a wire this draft guidance before it begins work Friday.
transfer fee. Applicable wire transfer on the final version of the guidance. • Confidential Submissions—To
fees must be included with payment to ADDRESSES: You may submit comments submit a comment with confidential
ensure fees are fully paid. Questions on any guidance at any time as follows: information that you do not wish to be
about wire transfer fees should be made publicly available, submit your
addressed to the financial institution. Electronic Submissions comments only as a written/paper
The following account information submission. You should submit two
should be used to send payments by Submit electronic comments in the
following way: copies total. One copy will include the
wire transfer: U.S. Department of information you claim to be confidential
Treasury, TREAS NYC, 33 Liberty St., • Federal eRulemaking Portal: with a heading or cover note that states
New York, NY 10045, account number: https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
75060099, routing number: 021030004, instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
SWIFT: FRNYUS33. FDA’s tax Comments submitted electronically, Agency will review this copy, including
identification number is 53–0196965. including attachments, to https:// the claimed confidential information, in
Dated: July 24, 2018.
www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
Leslie Kux,
comment will be made public, you are claimed confidential information
Associate Commissioner for Policy. solely responsible for ensuring that your
[FR Doc. 2018–16067 Filed 7–26–18; 8:45 am]
redacted/blacked out, will be available
comment does not include any for public viewing and posted on
BILLING CODE 4164–01–P confidential information that you or a https://www.regulations.gov. Submit
third party may not wish to be posted, both copies to the Dockets Management
such as medical information, your or Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
HUMAN SERVICES contact information to be made publicly
confidential business information, such available, you can provide this
as a manufacturing process. Please note information on the cover sheet and not
Food and Drug Administration
that if you include your name, contact in the body of your comments and you
[Docket No. FDA–2018–D–2456] information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
Slowly Progressive, Low-Prevalence comments, that information will be
Rare Diseases With Substrate as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
amozie on DSK3GDR082PROD with NOTICES1
Deposition That Results From Single
Enzyme Defects: Providing Evidence • If you want to submit a comment and other applicable disclosure law. For
of Effectiveness for Replacement or with confidential information that you more information about FDA’s posting
Corrective Therapies; Draft Guidance do not wish to be made available to the of comments to public dockets, see 80
for Industry; Availability public, submit the comment as a FR 56469, September 18, 2015, or access
written/paper submission and in the the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. Submissions’’ and ‘‘Instructions’’). 23389.pdf.
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35794/page/5.svg)
Document Created: 2018-07-27 04:04:52
Document Modified: 2018-07-27 04:04:52
| 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 | Melissa Hurley, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14202J, Silver Spring, MD 20993-0002, 240-402-4585. | |
| FR Citation | 83 FR 35649 |
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