Generic Drug User Fee Rates for Fiscal Year 2021, 46662-46666 [2020-16687]

Download as PDF 46662 Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices TABLE 4—ESTIMATED FEE RATES FOR OTHER FEE CATEGORIES UNDER THE FSMA THIRD-PARTY CERTIFICATION PROGRAM Fee category khammond on DSKJM1Z7X2PROD with NOTICES Renewal application fee for recognized accreditation body .............. Renewal application fee for directly accredited certification body ........ Annual fee for certification body directly accredited by FDA ............. Estimated fee rates for FY 2021 $25,195 25,195 20,240 V. How must the fee be paid? Accreditation bodies seeking initial recognition must submit the application fee with the application. For recognized accreditation bodies and accredited certification bodies, an invoice will be sent annually. Payment must be made within 30 days of the receipt date. The payment must be made in U.S. currency from a U.S. bank by one of the following methods: Wire transfer, electronically, check, bank draft, or U.S. postal money order made payable to the Food and Drug Administration. The preferred payment method is online using an electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https:// userfees.fda.gov/pay. (Note: Only full payments are accepted. No partial payments can be made online.) Once you have found your invoice, select ‘‘Pay Now’’ to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available only 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. When paying by check, bank draft, or U.S. postal money order, please include the invoice number. Also write the FDA post office box number (P.O. Box 979108) on the enclosed check, bank draft, or money order. Mail the payment including the invoice number on the check stub to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197–9000. When paying by wire transfer, it is required that the invoice number is included; without the invoice number the payment may not be applied. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required to add that amount to the payment to ensure that the invoice is paid in full. For international wire transfers, please inquire with the financial institutions VerDate Sep<11>2014 20:39 Jul 31, 2020 Jkt 250001 prior to submitting the payment. Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account Name: Food and Drug Administration, Account No.: 75060099, Routing No.: 021030004, Swift No.: FRNYUS33. To send a check by a courier such as Federal Express, the courier must deliver the check to: U.S. Bank, Attn: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for courier delivery only. If you have any questions concerning courier delivery, contact U.S. Bank at 314–418–4013. This phone number is only for questions about courier delivery.) The tax identification number of FDA is 53–0196965. (Note: Invoice copies do not need to be submitted to FDA with the payments.) VI. What are the consequences of not paying this fee? The consequences of not paying these fees are outlined in 21 CFR 1.725. If FDA does not receive an application fee with an application for recognition, the application will be considered incomplete and FDA will not review the application. If a recognized accreditation body fails to submit its annual user fee within 30 days of the due date, we will suspend its recognition. If the recognized accreditation body fails to submit its annual user fee within 90 days of the due date, we will revoke its recognition. If an accredited certification body fails to pay its annual fee within 30 days of the due date, we will suspend its accreditation. If the accredited certification body fails to pay its annual fee within 90 days of the due date, we will withdraw its accreditation. Dated: July 29, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–16846 Filed 7–30–20; 11:15 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1692] Generic Drug User Fee Rates for Fiscal Year 2021 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee SUMMARY: PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 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) 2021 rates for GDUFA II fees. FOR FURTHER INFORMATION CONTACT: Andrew Bank, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 62019A, Beltsville, MD 20705– 4304, 301–796–0292. 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 provides that user fees should total $493,600,000 annually adjusted each year for inflation. For FY 2021, the generic drug fee rates are: ANDA ($196,868), DMF ($69,921), domestic API facility ($41,671), foreign API facility ($56,671), domestic FDF facility ($184,022), foreign FDF facility ($199,022), domestic CMO facility ($61,341), foreign CMO facility ($76,341), large size operation generic drug applicant program ($1,542,993), medium size operation generic drug applicant program ($617,197), and small business generic drug applicant program ($154,299). These fees are effective on October 1, 2020, and will remain in effect through September 30, 2021. II. Fee Revenue Amount for FY 2021 GDUFA II directs FDA to use the yearly revenue amount determined under the statute 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 2021 are described in this document. The base revenue amount for FY 2021 is $513,223,160. This is the amount E:\FR\FM\03AUN1.SGM 03AUN1 46663 Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices calculated for the prior fiscal year, FY 2020, pursuant to the statute (see section 744B(b)(1) of the FD&C Act). GDUFA II specifies that the $513,223,160 is to be adjusted for inflation increases for FY 2021 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 FTEs 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 2021. The 3-year average is 1.2644 percent. TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE Fiscal year 2017 Total PC&B .................................................................................... Total FTEs ..................................................................................... PC&B per FTE ............................................................................... Percent Change from Previous Year ............................................ The statute specifies that this 1.2644 percent should be multiplied by the proportion of PC&B expended for 2018 $2,581,551,000 17,022 $151,660 2.8845 2019 $2,690,678,000 17,023 $158,061 4.2206 human generic drug activities for the first 3 of the preceding 4 fiscal years. Table 2 shows the amount of PC&B and $2,620,052,000 17,144 $152,826 ¥3.3120 3-year average ........................ ........................ ........................ 1.2644 the total amount obligated for human generic drug activities from FY 2017 through FY 2019. 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 2017 PC&B ............................................................................................. Non-PC&B ..................................................................................... Total Costs ..................................................................................... PC&B Percent ................................................................................ Non-PC&B Percent ........................................................................ The payroll adjustment is 1.2644 percent multiplied by 53.5363 percent (or 0.6769 percent). The statute specifies that the portion of the inflation adjustment for nonPC&B costs for FY 2021 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (WashingtonBaltimore, 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 2018 $271,748,229 $262,058,852 $533,807,081 50.9076 49.0924 2019 $332,617,643 $276,911,265 $609,528,908 54.5696 45.4304 costs to total costs of human generic drug activities (see section 744B(c)(1)(C) of the FD&C Act). As a result of a geographical revision made by the Bureau of Labor and Statistics in January 2018,1 the ‘‘WashingtonBaltimore, DC-MD-VA-WV’’ index was discontinued and replaced with two separate indices (i.e., ‘‘WashingtonArlington-Alexandria, DC-VA-MD-WV’’ and ‘‘Baltimore-Columbia-Towson, MD’’). In order to continue applying a CPI which best reflects the geographic region in which FDA is headquartered $356,874,114 $290,439,277 $647,313,391 55.1316 44.8684 3-year average ........................ ........................ ........................ 53.5363 46.4637 and which provides the most current data available, the WashingtonArlington-Alexandria index will be used in calculating the relevant adjustment factors for FY 2021 and subsequent years. 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=CUURS35ASA0,CUUSS35ASA0. TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA AREA Year 2017 khammond on DSKJM1Z7X2PROD with NOTICES Annual CPI ....................................................................................................... Annual Percent Change .................................................................................. 256.221 1.1045 To calculate the inflation adjustment for non-pay costs, we multiply the 3year average percent change in the CPI (1.4726 percent) by the proportion of all costs other than PC&B to total costs of human generic drug activities obligated. Because 53.5363 percent was obligated for PC&B as shown in Table 2, 46.4637 1 The Bureau of Labor Statistics’ announcement of the geographical revision can be viewed at https:// www.bls.gov/cpi/additional-resources/geographicrevision-2018.htm. VerDate Sep<11>2014 20:39 Jul 31, 2020 Jkt 250001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 2018 261.445 2.0389 2019 264.777 1.2745 3-year average ........................ 1.4726 percent is the portion of costs other than PC&B. The non-pay adjustment is 1.4726 percent times 46.4637 percent, or 0.6842 percent. E:\FR\FM\03AUN1.SGM 03AUN1 46664 Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices To complete the inflation adjustment for FY 2021, we add the PC&B component (0.6769 percent) to the nonPC&B component (0.6842 percent) for a total inflation adjustment of 1.3611 percent (rounded), and then add 1, making an inflation adjustment multiple of 1.013611. We then multiply the base revenue amount for FY 2021 ($513,223,160) by 1.013611, yielding an inflation-adjusted amount of $520,209,000 (rounded to the nearest thousand dollars). khammond on DSKJM1Z7X2PROD with NOTICES III. ANDA Filing Fee Under GDUFA II, the FY 2021 ANDA filing fee is owed by each applicant that submits an ANDA on or after October 1, 2020. 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 $520,209,000, which is $171,668,970. To calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2021. The submissions are broken down into three categories: New originals (submissions that have not been received by FDA previously); submissions that FDA refused to receive (RTR-ed) for reasons other than failure to pay fees; and applications that are resubmitted after an RTR decision 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-ed 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)(3)(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, 2018, to April 30, 2020, to estimate the number of new original ANDAs that will incur filing fees in FY 2021. For FY 2021, the Agency estimates that approximately 867 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 VerDate Sep<11>2014 20:39 Jul 31, 2020 Jkt 250001 Agency expects that the FAE count for ANDAs will be 872 for FY 2021. The FY 2021 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2021 (872) into the fee revenue amount to be derived from ANDA application fees in FY 2021 ($171,668,970). The result, rounded to the nearest dollar, is a fee of $196,868 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 anticipates 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 API 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 DMF 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 submissions over time. The Agency assessed DMFs from October 1, 2018, to April 30, 2020, and concluded that averaging the number of fee-paying DMFs provided the most accurate model for predicting fee-paying DMFs for FY 2021. The monthly average of paid DMF submissions the Agency received in FY 2019 and FY 2020 is 31. To determine the FY 2021 projected number of feepaying DMFs, the average of 31 DMF submissions is multiplied by 12 months, which results in 372 estimated FY 2021 fee-paying DMFs. FDA is estimating 372 fee-paying DMFs for FY 2021. The FY 2021 DMF fee is determined by dividing the DMF target revenue by the estimated number of fee-paying DMFs in FY 2021. Section 744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up 5 percent of the PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 $520,209,000, which is $26,010,450. Dividing the DMF revenue amount ($26,010,450) by the estimated feepaying DMFs (372), and rounding to the nearest dollar, yields a DMF fee of $69,921 for FY 2021. 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 its 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 $520,209,000, which is $104,041,800. 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 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 188 FDF domestic, 278 FDF foreign, 92 CMO domestic, and 111 CMO foreign facilities for FY 2021. 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 ($104,041,800), FDA must weight a CMO facility as onethird of an FDF facility. FDA set fees based on the estimate of 188 FDF E:\FR\FM\03AUN1.SGM 03AUN1 Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES domestic, 278 FDF foreign, 30.67 CMO domestic (92 multiplied by one-third), and 37 CMO foreign facilities (111 multiplied by one-third), which equals 533.67 total weighted FDF and CMO facilities for FY 2021. 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 ($104,041,800) as follows. The foreign facility fee differential revenue equals the foreign facility fee differential ($15,000) multiplied by the number of FDF foreign facilities (278) plus the foreign facility fee differential ($15,000) multiplied by the number of CMO foreign facilities (111), totaling $5,835,000. This results in foreign fee differential revenue of $5,835,000 from the total FDF and CMO facility fee target collection revenue. Subtracting the foreign facility differential fee revenue ($5,835,000) from the total FDF and CMO facility target collection revenue ($104,041,800) results in a remaining facility fee revenue balance of $98,206,800. To determine the domestic FDF facility fee, FDA divides the $98,206,800 by the total weighted number of FDF and CMO facilities (533.67), which results in a domestic FDF facility fee of $184,022. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $199,022. 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 $61,341, 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 $76,341. 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 $520,209,000 in fee revenue, which is $36,414,630. 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 VerDate Sep<11>2014 20:39 Jul 31, 2020 Jkt 250001 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 664; of that number, 81 were domestic and 583 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 (583) 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 $8,745,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($8,745,000) from the total API facility target revenue ($36,414,630) results in a remaining balance of $27,669,630. To determine the domestic API facility fee, we divide the $27,669,630 by the total number of facilities (664), which gives us a domestic API facility fee of $41,671. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $56,671. 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, 2020, the person and its affiliates shall owe a small business GDUFA program fee. If a person and its affiliates own at least six but not more than 19 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 $520,209,000 in fee revenue, which is $182,073,150. To determine the appropriate number of parent companies for each tier, the Agency asked companies to claim their ANDAs and affiliates in the Center for Drug Evaluation and Research (CDER) NextGen Portal. The companies were able to confirm relationships currently present in the Agency’s records, while also reporting newly approved ANDAs, PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 46665 newly acquired ANDAs, and new affiliations. 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; (3) Center for Biologics Evaluation and Research (CBER) approved ANDAs— applicants and their affiliates with CBER-approved ANDAs in addition to CDER’s approved ANDAs; (4) Withdrawals of approved ANDAs by April 1st— applicants who have submitted a written request for withdrawal of approval by April 1st of the previous fiscal year; and (5) Abbreviated Antibiotic Applications (AADA) conversions—ANDAs (previously AADAs) for bulk antibiotic drug substance converted and refiled as DMFs. The list of original approved ANDAs from the Generic Drug Review Platform as of April 30, 2020, shows 283 applicants in the small business tier, 67 applicants in the medium size tier, and 73 applicants in the large size tier. Factoring in all the variables for the fourth year of GDUFA II, the Agency estimates there will be 220 applicants in the small business tier, 60 applicants in the medium size tier, and 72 applicants in the large size tier for FY 2021. 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 ($182,073,150), 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 22.00 applicants in the small business tier (220 multiplied by 10 percent), 24.00 applicants in the medium size tier (60 multiplied by 40 percent), and 72 applicants in the large size tier, arriving at 118 total weighted applicants for FY 2021. To generate the large size operation GDUFA program fee, FDA divides the target revenue amount of $182,073,150 by 118, which equals $1,542,993. The medium size operation GDUFA program fee is 40 percent of the full fee ($617,197), and the small business operation GDUFA program fee is 10 percent of the full fee ($154,299). E:\FR\FM\03AUN1.SGM 03AUN1 46666 Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices IX. Fee Schedule for FY 2021 The fee rates for FY 2021 are set out in Table 4. TABLE 4—FEE SCHEDULE FOR FY 2021 Fees rates for FY 2021 Fee category 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 ......................... $196,868 69,921 41,671 56,671 184,022 199,022 61,341 76,341 1,542,993 617,197 154,299 khammond on DSKJM1Z7X2PROD with NOTICES X. Fee Payment Options and Procedures The new fee rates are effective October 1, 2020. 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). 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 Cover Sheet and generating the user fee ID number. Secure electronic payments can be submitted using the User Fees Payment Portal at https:// userfees.fda.gov/pay. (Note: Only full payments are accepted; no partial payments can be made online.) Once an VerDate Sep<11>2014 20:39 Jul 31, 2020 Jkt 250001 invoice is located, ‘‘Pay Now’’ should be selected to be redirected to 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. 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 the 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 28, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–16687 Filed 7–31–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3406] Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2021 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2021 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective August 1, 2020, and will remain in effect through September 30, 2021. FOR FURTHER INFORMATION CONTACT: Donald Prater, Office of Food Policy and Response, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3202, Silver Spring, MD 20993, 301–348–3007. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Section 302 of FSMA, Voluntary Qualified Importer Program, amended the FD&C Act to create a new provision, section 806, under the same name. Section 806 of the FD&C Act (21 U.S.C. 384b) directs FDA to establish a program to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program, and a process, consistent with section 808 of the FD&C Act (21 U.S.C. 384d), for the issuance of a facility certification to accompany a food offered for importation by importers participating in the VQIP. Section 743 of the FD&C Act (21 U.S.C. 379j–31) authorizes FDA to assess and collect fees from each importer participating in VQIP to cover FDA’s costs of administering the program. Each fiscal year, fees are to be established based on an estimate of 100 percent of the costs for the year. The fee rates must be published in a Federal Register notice not later than 60 days before the start of each fiscal year (section 743(b)(1) of the FD&C Act). After FDA approves a VQIP application, the user fee must be paid before October 1, the start of the VQIP fiscal year, to begin receiving benefits for that VQIP fiscal year. E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46662-46666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16687]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1692]

Generic Drug User Fee Rates for Fiscal Year 2021

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act or
statute), 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) 2021 rates for GDUFA II fees.

FOR FURTHER INFORMATION CONTACT: Andrew Bank, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
62019A, Beltsville, MD 20705-4304, 301-796-0292.

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 provides that user fees should total $493,600,000 annually
adjusted each year for inflation. For FY 2021, the generic drug fee
rates are: ANDA ($196,868), DMF ($69,921), domestic API facility
($41,671), foreign API facility ($56,671), domestic FDF facility
($184,022), foreign FDF facility ($199,022), domestic CMO facility
($61,341), foreign CMO facility ($76,341), large size operation generic
drug applicant program ($1,542,993), medium size operation generic drug
applicant program ($617,197), and small business generic drug applicant
program ($154,299). These fees are effective on October 1, 2020, and
will remain in effect through September 30, 2021.

II. Fee Revenue Amount for FY 2021

GDUFA II directs FDA to use the yearly revenue amount determined
under the statute 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 2021 are described in this document.
The base revenue amount for FY 2021 is $513,223,160. This is the
amount

[[Page 46663]]

calculated for the prior fiscal year, FY 2020, pursuant to the statute
(see section 744B(b)(1) of the FD&C Act). GDUFA II specifies that the
$513,223,160 is to be adjusted for inflation increases for FY 2021
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 FTEs 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 2021. The 3-year average is 1.2644 percent.

Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2017 2018 2019 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B............................. $2,581,551,000 $2,690,678,000 $2,620,052,000 ..............
Total FTEs............................. 17,022 17,023 17,144 ..............
PC&B per FTE........................... $151,660 $158,061 $152,826 ..............
Percent Change from Previous Year...... 2.8845 4.2206 -3.3120 1.2644
----------------------------------------------------------------------------------------------------------------

The statute specifies that this 1.2644 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 2017 through FY 2019.

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 2017 2018 2019 3-year average
----------------------------------------------------------------------------------------------------------------
PC&B................................... $271,748,229 $332,617,643 $356,874,114 ..............
Non-PC&B............................... $262,058,852 $276,911,265 $290,439,277 ..............
Total Costs............................ $533,807,081 $609,528,908 $647,313,391 ..............
PC&B Percent........................... 50.9076 54.5696 55.1316 53.5363
Non-PC&B Percent....................... 49.0924 45.4304 44.8684 46.4637
----------------------------------------------------------------------------------------------------------------

The payroll adjustment is 1.2644 percent multiplied by 53.5363
percent (or 0.6769 percent).
The statute specifies that the portion of the inflation adjustment
for non-PC&B costs for FY 2021 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). As a result of a geographical revision made by the
Bureau of Labor and Statistics in January 2018,\1\ the ``Washington-
Baltimore, DC-MD-VA-WV'' index was discontinued and replaced with two
separate indices (i.e., ``Washington-Arlington-Alexandria, DC-VA-MD-
WV'' and ``Baltimore-Columbia-Towson, MD''). In order to continue
applying a CPI which best reflects the geographic region in which FDA
is headquartered and which provides the most current data available,
the Washington-Arlington-Alexandria index will be used in calculating
the relevant adjustment factors for FY 2021 and subsequent years. 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=CUURS35ASA0,CUUSS35ASA0.

---------------------------------------------------------------------------

\1\ The Bureau of Labor Statistics' announcement of the
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
Year 2017 2018 2019 3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................... 256.221 261.445 264.777 ..............
Annual Percent Change........................... 1.1045 2.0389 1.2745 1.4726
----------------------------------------------------------------------------------------------------------------

To calculate the inflation adjustment for non-pay costs, we
multiply the 3-year average percent change in the CPI (1.4726 percent)
by the proportion of all costs other than PC&B to total costs of human
generic drug activities obligated. Because 53.5363 percent was
obligated for PC&B as shown in Table 2, 46.4637 percent is the portion
of costs other than PC&B. The non-pay adjustment is 1.4726 percent
times 46.4637 percent, or 0.6842 percent.

[[Page 46664]]

To complete the inflation adjustment for FY 2021, we add the PC&B
component (0.6769 percent) to the non-PC&B component (0.6842 percent)
for a total inflation adjustment of 1.3611 percent (rounded), and then
add 1, making an inflation adjustment multiple of 1.013611. We then
multiply the base revenue amount for FY 2021 ($513,223,160) by
1.013611, yielding an inflation-adjusted amount of $520,209,000
(rounded to the nearest thousand dollars).

III. ANDA Filing Fee

Under GDUFA II, the FY 2021 ANDA filing fee is owed by each
applicant that submits an ANDA on or after October 1, 2020. 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
$520,209,000, which is $171,668,970.
To calculate the ANDA fee, FDA estimated the number of full
application equivalents (FAEs) that will be submitted in FY 2021. The
submissions are broken down into three categories: New originals
(submissions that have not been received by FDA previously);
submissions that FDA refused to receive (RTR-ed) for reasons other than
failure to pay fees; and applications that are resubmitted after an RTR
decision 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-ed 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)(3)(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, 2018, to
April 30, 2020, to estimate the number of new original ANDAs that will
incur filing fees in FY 2021. For FY 2021, the Agency estimates that
approximately 867 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 872 for FY 2021.
The FY 2021 application fee is estimated by dividing the number of
FAEs that will pay the fee in FY 2021 (872) into the fee revenue amount
to be derived from ANDA application fees in FY 2021 ($171,668,970). The
result, rounded to the nearest dollar, is a fee of $196,868 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 anticipates 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 API 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 DMF 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
submissions over time. The Agency assessed DMFs from October 1, 2018,
to April 30, 2020, and concluded that averaging the number of fee-
paying DMFs provided the most accurate model for predicting fee-paying
DMFs for FY 2021. The monthly average of paid DMF submissions the
Agency received in FY 2019 and FY 2020 is 31. To determine the FY 2021
projected number of fee-paying DMFs, the average of 31 DMF submissions
is multiplied by 12 months, which results in 372 estimated FY 2021 fee-
paying DMFs. FDA is estimating 372 fee-paying DMFs for FY 2021.
The FY 2021 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2021. Section
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up
5 percent of the $520,209,000, which is $26,010,450. Dividing the DMF
revenue amount ($26,010,450) by the estimated fee-paying DMFs (372),
and rounding to the nearest dollar, yields a DMF fee of $69,921 for FY
2021.

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 its 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 $520,209,000, which is $104,041,800.
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 188 FDF
domestic, 278 FDF foreign, 92 CMO domestic, and 111 CMO foreign
facilities for FY 2021.
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
($104,041,800), FDA must weight a CMO facility as one-third of an FDF
facility. FDA set fees based on the estimate of 188 FDF

[[Page 46665]]

domestic, 278 FDF foreign, 30.67 CMO domestic (92 multiplied by one-
third), and 37 CMO foreign facilities (111 multiplied by one-third),
which equals 533.67 total weighted FDF and CMO facilities for FY 2021.
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
($104,041,800) as follows. The foreign facility fee differential
revenue equals the foreign facility fee differential ($15,000)
multiplied by the number of FDF foreign facilities (278) plus the
foreign facility fee differential ($15,000) multiplied by the number of
CMO foreign facilities (111), totaling $5,835,000. This results in
foreign fee differential revenue of $5,835,000 from the total FDF and
CMO facility fee target collection revenue. Subtracting the foreign
facility differential fee revenue ($5,835,000) from the total FDF and
CMO facility target collection revenue ($104,041,800) results in a
remaining facility fee revenue balance of $98,206,800. To determine the
domestic FDF facility fee, FDA divides the $98,206,800 by the total
weighted number of FDF and CMO facilities (533.67), which results in a
domestic FDF facility fee of $184,022. The foreign FDF facility fee is
$15,000 more than the domestic FDF facility fee, or $199,022.
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 $61,341, 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 $76,341.

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 $520,209,000 in fee revenue, which is
$36,414,630.
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 664; of that
number, 81 were domestic and 583 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 (583) 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
$8,745,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($8,745,000) from the total API
facility target revenue ($36,414,630) results in a remaining balance of
$27,669,630. To determine the domestic API facility fee, we divide the
$27,669,630 by the total number of facilities (664), which gives us a
domestic API facility fee of $41,671. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $56,671.

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, 2020, the person and
its affiliates shall owe a small business GDUFA program fee. If a
person and its affiliates own at least six but not more than 19
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 $520,209,000 in fee revenue, which is
$182,073,150.
To determine the appropriate number of parent companies for each
tier, the Agency asked companies to claim their ANDAs and affiliates in
the Center for Drug Evaluation and Research (CDER) NextGen Portal. The
companies were able to confirm relationships currently present in the
Agency's records, while also reporting newly approved ANDAs, newly
acquired ANDAs, and new affiliations.
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; (3) Center for Biologics
Evaluation and Research (CBER) approved ANDAs-- applicants and their
affiliates with CBER-approved ANDAs in addition to CDER's approved
ANDAs; (4) Withdrawals of approved ANDAs by April 1st-- applicants who
have submitted a written request for withdrawal of approval by April
1st of the previous fiscal year; and (5) Abbreviated Antibiotic
Applications (AADA) conversions--ANDAs (previously AADAs) for bulk
antibiotic drug substance converted and refiled as DMFs. The list of
original approved ANDAs from the Generic Drug Review Platform as of
April 30, 2020, shows 283 applicants in the small business tier, 67
applicants in the medium size tier, and 73 applicants in the large size
tier. Factoring in all the variables for the fourth year of GDUFA II,
the Agency estimates there will be 220 applicants in the small business
tier, 60 applicants in the medium size tier, and 72 applicants in the
large size tier for FY 2021.
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 ($182,073,150), 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 22.00 applicants in the small business tier (220
multiplied by 10 percent), 24.00 applicants in the medium size tier (60
multiplied by 40 percent), and 72 applicants in the large size tier,
arriving at 118 total weighted applicants for FY 2021.
To generate the large size operation GDUFA program fee, FDA divides
the target revenue amount of $182,073,150 by 118, which equals
$1,542,993. The medium size operation GDUFA program fee is 40 percent
of the full fee ($617,197), and the small business operation GDUFA
program fee is 10 percent of the full fee ($154,299).

[[Page 46666]]

IX. Fee Schedule for FY 2021

The fee rates for FY 2021 are set out in Table 4.

Table 4--Fee Schedule for FY 2021
------------------------------------------------------------------------
Fees rates for
Fee category FY 2021
------------------------------------------------------------------------
Applications:
Abbreviated New Drug Application (ANDA)............. $196,868
Drug Master File (DMF).............................. 69,921
Facilities:
Active Pharmaceutical Ingredient (API) Domestic..... 41,671
API--Foreign........................................ 56,671
Finished Dosage Form (FDF)--Domestic................ 184,022
FDF--Foreign........................................ 199,022
Contract Manufacturing Organization (CMO)--Domestic. 61,341
CMO--Foreign........................................ 76,341
GDUFA Program:
Large size operation generic drug applicant......... 1,542,993
Medium size operation generic drug applicant........ 617,197
Small business operation generic drug applicant..... 154,299
------------------------------------------------------------------------

X. Fee Payment Options and Procedures

The new fee rates are effective October 1, 2020. 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). 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 Cover Sheet and generating the user fee ID
number. Secure electronic payments can be submitted using the User Fees
Payment Portal at https://userfees.fda.gov/pay. (Note: Only full
payments are accepted; no partial payments can be made online.) Once an
invoice is located, ``Pay Now'' should be selected to be redirected to
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.
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 the 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 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16687 Filed 7-31-20; 8:45 am]
BILLING CODE 4164-01-P

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