Generic Drug User Fee Rates for Fiscal Year 2019, 35649-35653 [2018-16067]

Download as PDF 35649 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list metaxalone tablets, 640 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to metaxalone tablets, 640 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: July 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–16031 Filed 7–26–18; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: 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 Total PC&B .............................................................................. Total FTE ................................................................................. PC&B per FTE ......................................................................... Percent Change from Previous Year ...................................... amozie on DSK3GDR082PROD with NOTICES1 The statute specifies that this 2.4152 percent should be multiplied by the proportion of PC&B expended for $2,232,304,000 15,484 $144,168 2.1136 2016 2017 $2,414,728,159 16,381 $147,408 2.2474 human generic drug activities for the first 3 of the preceding 4 fiscal years. Table 2 shows the amount of PC&B and $2,581,551,000 17,022 $151,660 2.8845 3-Year average .............................. .............................. .............................. 2.4152 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 PC&B ....................................................................................... Non-PC&B ............................................................................... Total Costs ............................................................................... VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00046 $201,116,305 $251,589,013 $452,705,318 Fmt 4703 Sfmt 4703 2016 $242,963,571 $250,987,599 $493,951,170 E:\FR\FM\27JYN1.SGM 2017 $271,748,229 $262,058,852 $533,807,081 27JYN1 3-Year average .............................. .............................. .............................. 35650 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS OF HUMAN GENERIC DRUG APPLICATIONS OVER THE LAST 3 YEARS—Continued Fiscal year 2015 PC&B Percent .......................................................................... Non-PC&B Percent .................................................................. 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 nonPC&B costs for FY 2019 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington- 44.4254 55.5746 2016 2017 49.1878 50.8122 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 3-Year average 50.9076 49.0924 48.1736 51.8264 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 Annual CPI ............................................................................... Annual Percent Change .......................................................... amozie on DSK3GDR082PROD with NOTICES1 To calculate the inflation adjustment for non-pay costs, we multiply the 3year 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 nonPC&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 VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 155.353 0.3268 2016 157.180 1.1760 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 2017 159.202 1.2864 3-Year average .............................. 0.9297 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 E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 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 feepaying 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 feepaying DMFs (456), and rounding to the nearest dollar, yields a DMF fee of $55,013 for FY 2019. amozie on DSK3GDR082PROD with NOTICES1 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 VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 generic drug submission is extracted directly from submission data rather than relying on data from selfidentification. 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 onethird 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. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 35651 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 E:\FR\FM\27JYN1.SGM 27JYN1 35652 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 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 onetenth 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 FY 2019 Applications: Abbreviated New Drug Application (ANDA) ................................................................................................................................. Drug Master File (DMF) ............................................................................................................................................................... Facilities: Active Pharmaceutical Ingredient (API) Domestic .............................................................................................................................. API—Foreign ................................................................................................................................................................................ Finished Dosage Form (FDF)—Domestic .................................................................................................................................... FDF—Foreign ............................................................................................................................................................................... Contract Manufacturing Organization (CMO)—Domestic ............................................................................................................ CMO—Foreign .............................................................................................................................................................................. GDUFA Program: Large size operation generic drug applicant ................................................................................................................................ Medium size operation generic drug applicant ............................................................................................................................ Small business operation generic drug applicant ........................................................................................................................ amozie on DSK3GDR082PROD with NOTICES1 Fee category ........................ $178,799 55,013 ........................ 44,226 59,226 211,305 226,305 70,435 85,435 ........................ 1,862,167 744,867 186,217 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. VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 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). PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration amozie on DSK3GDR082PROD with NOTICES1 [Docket No. FDA–2018–D–2456] Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 ACTION: Written/Paper Submissions Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.’’ This document is intended to provide guidance to sponsors on the evidence necessary to demonstrate the effectiveness of new drugs, including biological drugs, or new drug uses intended for slowly progressive, lowprevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects. This guidance applies only to those lowprevalence rare diseases with a wellcharacterized pathophysiology and in which changes in substrate deposition can be readily measured in relevant tissue(s). SUMMARY: Submit either electronic or written comments on the draft guidance by September 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. DATES: You may submit comments on any guidance at any time as follows: ADDRESSES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 35653 Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–D–2456 for ‘‘Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies; Draft Guidance for Industry; Availability.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35649-35653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16067]

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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.

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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
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Year 2015 2016 2017 3-Year average
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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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