83 FR 48621 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 187 (September 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48621-48625 | |
| FR Document | 2018-20911 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Notices] [Pages 48621-48625] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20911] [[Page 48621]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0007] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2019 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2019. FOR FURTHER INFORMATION CONTACT: Visit FDA's website at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240- 402-6888, [email protected]. For general questions, you may also email the Center for Veterinary Medicine (CVM) at: [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four different types of user fees: (1) Fees for certain types of animal drug applications and supplements; (2) annual fees for certain animal drug products; (3) annual fees for certain establishments where such products are made; and (4) annual fees for certain sponsors of animal drug applications and/or investigational animal drug submissions (21 U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or reduce fees (21 U.S.C. 379j-12(d)). For FY 2019 through FY 2023, the FD&C Act establishes aggregate yearly base revenue amounts for each fiscal year (21 U.S.C. 379j- 12(b)(1)). Base revenue amounts established for years after FY 2019 are subject to adjustment for inflation and workload, and for excess collections to reduce workload-based increases or collection shortfalls after FY 2020 (21 U.S.C. 379j-12(c) and (g)). Fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the percentages of the total revenue that are derived from each type of user fee will be as follows: Revenue from application fees shall be 20 percent of total fee revenue; revenue from product fees shall be 27 percent of total fee revenue; revenue from establishment fees shall be 26 percent of total fee revenue; and revenue from sponsor fees shall be 27 percent of total fee revenue (21 U.S.C. 379j-12(b)(2)). For FY 2019, the animal drug user fee rates are: $449,348 for an animal drug application; $224,674 for a supplemental animal drug application for which safety or effectiveness data are required and for an animal drug application subject to the criteria set forth in section 512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $10,747 for an annual product fee; $146,038 for an annual establishment fee; and $125,990 for an annual sponsor fee. FDA will issue invoices for FY 2019 product, establishment, and sponsor fees by December 31, 2018, and payment will be due by January 31, 2019. The application fee rates are effective for applications submitted on or after October 1, 2018, and will remain in effect through September 30, 2019. Applications will not be accepted for review until FDA has received full payment of application fees and any other animal drug user fees owed under the Animal Drug User Fee program (ADUFA program). II. Revenue Amount for FY 2019 A. Statutory Fee Revenue Amounts ADUFA IV, Title I of Public Law 115-234, specifies that the aggregate fee revenue amount for FY 2019 for all animal drug user fee categories is $30,331,000 (rounded to the nearest thousand dollars) (21 U.S.C. 379j-12(b)(1)(A)). B. Inflation Adjustment to Fee Revenue Amount The fee revenue amounts established in ADUFA IV for FY 2020 and subsequent fiscal years are subject to an inflation adjustment (21 U.S.C. 379j-12(c)(2)). ADUFA IV specifies that the annual fee revenue amount is to be adjusted using two separate adjustments--one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (21 U.S.C. 379j- 12(c)(2)(A)(ii) and (iii)). The component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all PC&B paid per full-time equivalent position (FTE) at FDA for the first 3 of the 4 preceding fiscal years, multiplied by the average proportion of PC&B costs to total FDA costs for the first 3 of the 4 preceding fiscal years. The statute specifies that the portion of the inflation adjustment for non-payroll costs is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items less food and energy; 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 FDA costs. Because the adjustment for inflation does not take effect until FY 2020, FDA will not adjust the FY 2019 fee revenue amount for inflation. C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount The fee revenue amounts established in ADUFA IV for FY 2020 and subsequent fiscal years are also subject to adjustment to account for changes in FDA's review workload. A workload adjustment will be applied to the inflation adjusted fee revenue amount (21 U.S.C. 379j-12(c)(3)). ADUFA IV specifies that FDA shall calculate the weighted average of the change in the total number of each of the five types of applications and submissions specified in the workload adjustment provision (animal drug applications, supplemental animal drug applications for which data with respect to safety or efficacy are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions). Because the adjustment for workload does not take effect until FY 2020, FDA will not adjust the FY 2019 fee revenue amount for workload changes. D. Reduction of Workload-Based Increase by Amount of Certain Excess Collections Under section 740(c)(3)(B) of the FD&C Act, for fiscal years 2021 through 2023, if application of the workload adjustment increases the amount of fee revenues established for the fiscal year, as adjusted for inflation, the fee revenue increase will be reduced by the amount of any excess collections for the second preceding fiscal year, up to the amount of the fee revenue increase. Since this provision will not take effect until FY [[Page 48622]] 2021, FDA will not reduce the FY 2019 fee revenue amount for excess collections. E. Recovery of Collection Shortfalls Under section 740(g)(5)(A) of the FD&C Act, for FY 2021, the amount of fees otherwise authorized to be collected shall be increased by the amount, if any, by which the amount collected and appropriated for FY 2019 falls below the amount of fees authorized for FY 2019. For FY 2022, the amount of fees otherwise authorized to be collected shall be increased by the amount, if any, by which the amount collected and appropriated for FY 2020 falls below the amount of fees authorized for FY 2020. For FY 2023, the amount of fees otherwise authorized to be collected shall be increased by the cumulative amount, if any, by which the amount collected and appropriated for fiscal years 2021 and 2022 (including estimated collections for FY 2022) falls below the cumulative amount of fees authorized for those 2 fiscal years. Because the recovery of collection shortfalls does not take effect until FY 2021, FDA will not adjust the FY 2019 fee revenue amount for the recovery of collection shortfalls. F. Reduction of Shortfall-Based Fee Increase by Prior Year Excess Collections Under section 740(g)(5)(B) of the FD&C Act, where FDA's calculations under section 740(g)(5)(A) result in an increase for that fiscal year to recover a collection shortfall, FDA must reduce the increase by the amount of any excess collections for preceding fiscal years (after fiscal year 2018) that have not already been applied for purposes of reducing workload-based fee increases. Because the recovery of collection shortfalls does not take effect until FY 2021, FDA will not adjust the FY 2019 fee revenue amount for the reduction of shortfall-based fee increases by prior year excess collections. G. FY 2019 Fee Revenue Amounts ADUFA IV specifies that the revenue amount of $30,331,000 (rounded to the nearest thousand dollars) for FY 2019 is to be divided as follows: 20 percent, or a total of $6,066,200, is to come from application fees; 27 percent, or a total of $8,189,370, is to come from product fees; 26 percent, or a total of $7,886,060, is to come from establishment fees; and 27 percent, or a total of $8,189,370, is to come from sponsor fees (21 U.S.C. 379j-12(b)). III. Application Fee Calculations for FY 2019 A. Application Fee Revenues and Numbers of Fee-Paying Applications Each person that submits an animal drug application or a supplemental animal drug application shall be subject to an application fee, with limited exceptions (see 21 U.S.C. 379j-12(a)(1)). The term ``animal drug application'' means an application for approval of any new animal drug submitted under section 512(b)(1) or an application for conditional approval of a new animal drug submitted under section 571 of the FD&C Act (21 U.S.C. 360ccc) (see section 739 of the FD&C Act (21 U.S.C. 379j-11)). As the expanded definition of ``animal drug application'' includes applications for conditional approval submitted under section 571 of the FD&C Act, such applications are now subject to ADUFA fees, except that fees may be waived if the drug is intended solely to provide for a minor use or minor species (MUMS) indication (see 21 U.S.C. 379j-12(d)(1)(D)). Prior to ADUFA IV, FDA only had authority to grant conditional approval for drugs intended for a MUMS indication. Under ADUFA IV, FDA retains authority to grant conditional approval for drugs intended for MUMS indications but also will be able to grant conditional approval for certain drugs not intended for a MUMS indication provided certain criteria are met. Beginning with FY 2019, ADUFA IV provides an exception from application fees for animal drug applications submitted under section 512(b)(1) of the FD&C Act if the application is submitted by a sponsor who previously applied for conditional approval under the new non-MUMS pathway of section 571 for the same product and paid an application fee at the time they applied for conditional approval. The purpose of this exception is to prevent sponsors of conditionally approved products from having to pay a second application fee at the time they apply for full approval of their products under section 512(b)(1) of the FD&C Act, provided the sponsor's application for full approval is filed consistent with the timeframes established in section 571(h) of the FD&C Act. A ``supplemental animal drug application'' is defined as a request to the Secretary of Health and Human Services (Secretary) to approve a change in an animal drug application that has been approved, or a request to the Secretary to approve a change to an application approved under section 512(c)(2) of the FD&C Act for which data with respect to safety or effectiveness are required (21 U.S.C. 379j-11(2)). The application fees are to be set so that they will generate $6,066,200 in fee revenue for FY 2019. The fee for a supplemental animal drug application for which safety or effectiveness data are required and for an animal drug application subject to criteria set forth in section 512(d)(4) of the FD&C Act is to be set at 50 percent of the animal drug application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)). To set animal drug application fees and supplemental animal drug application fees to realize $6,066,200, FDA must first make some assumptions about the number of fee-paying applications and supplements the Agency will receive in FY 2019. The Agency knows the number of applications that have been submitted in previous years, which fluctuates annually. In estimating the fee revenue to be generated by animal drug application fees in FY 2019, FDA is assuming that the number of applications for which fees will be paid in FY 2019 will equal the average number of submissions over the 5 most recent completed years of the ADUFA program (FY 2013 to FY 2017). Over the 5 most recent completed years, the average number of animal drug applications that would have been subject to the full fee was 7.2. Over this same period, the average number of supplemental applications for which safety or effectiveness data are required and applications subject to the criteria set forth in section 512(d)(4) of the FD&C Act that would have been subject to half of the full fee was 12.6. B. Application Fee Rates for FY 2019 FDA must set the fee rates for FY 2019 so that the estimated 7.2 applications for which the full fee will be paid and the estimated 12.6 supplemental applications for which safety or effectiveness data are required and applications subject to the criteria set forth in section 512(d)(4) of the FD&C Act for which half of the full fee will be paid will generate a total of $6,066,200. To generate this amount, the fee for an animal drug application, rounded to the nearest dollar, will have to be $449,348, and the fee for a supplemental animal drug application for which safety or effectiveness data are required and for applications subject to the criteria set forth in section 512(d)(4) of the FD&C Act will have to be $224,674. [[Page 48623]] IV. Product Fee Calculations for FY 2019 A. Product Fee Revenues and Numbers of Fee-Paying Products The animal drug product fee must be paid annually by the person named as the applicant in a new animal drug application or supplemental new animal drug application for an animal drug product submitted for listing under section 510 of the FD&C Act (21 U.S.C. 360) and who had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003 (21 U.S.C. 379j-12(a)(2)). The term ``animal drug product'' means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an animal drug application or a supplemental animal drug application has been approved (21 U.S.C. 379j- 11(3)). The product fees are to be set so that they will generate $8,189,370 in fee revenue for FY 2019. To set animal drug product fees to realize $8,189,370, FDA must make some assumptions about the number of products for which these fees will be paid in FY 2019. FDA developed data on all animal drug products that have been submitted for listing under section 510 of the FD&C Act and matched this to the list of all persons who had an animal drug application or supplement pending after September 1, 2003. As of June 2018, FDA estimates that there are a total of 786 products submitted for listing by persons who had an animal drug application or supplemental animal drug application pending after September 1, 2003. Based on this, FDA estimates that a total of 786 products will be subject to this fee in FY 2019. In estimating the fee revenue to be generated by animal drug product fees in FY 2019, FDA is assuming that 3 percent of the products invoiced, or 24, will not pay fees in FY 2019 due to fee waivers and reductions. FDA has kept this estimate at 3 percent this year, based on historical data over the past 5 completed years of the ADUFA program. Accordingly, the Agency estimates that a total of 762 (786 minus 24) products will be subject to product fees in FY 2019. B. Product Fee Rates for FY 2019 FDA must set the fee rates for FY 2019 so that the estimated 762 products that pay fees will generate a total of $8,189,370. To generate this amount will require the fee for an animal drug product, rounded to the nearest dollar, to be $10,747. V. Establishment Fee Calculations for FY 2019 A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments The animal drug establishment fee must be paid annually by the person who: (1) Owns or operates, directly or through an affiliate, an animal drug establishment; (2) is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product submitted for listing under section 510 of the FD&C Act; (3) had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003; and (4) whose establishment engaged in the manufacture of the animal drug product during the fiscal year (see 21 U.S.C. 379j-12(a)(3)). An establishment subject to animal drug establishment fees is assessed only one such fee per fiscal year. The term ``animal drug establishment'' is defined as a foreign or domestic place of business at one general physical location, consisting of one or more buildings, all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are to be set so that they will generate $7,886,060 in fee revenue for FY 2019. To set animal drug establishment fees to realize $7,886,060, FDA must make some assumptions about the number of establishments for which these fees will be paid in FY 2019. FDA developed data on all animal drug establishments and matched this to the list of all persons who had an animal drug application or supplement pending after September 1, 2003. As of June 2018, FDA estimates that there are a total of 60 establishments owned or operated by persons who had an animal drug application or supplemental animal drug application pending after September 1, 2003. Based on this, FDA believes that 60 establishments will be subject to this fee in FY 2019. In estimating the fee revenue to be generated by animal drug establishment fees in FY 2019, FDA is assuming that 10 percent of the establishments invoiced, or six, will not pay fees in FY 2019 due to fee waivers and reductions. FDA has made this estimate at 10 percent this year, based on historical data over the past 5 completed years. Accordingly, the Agency estimates that a total of 54 establishments (60 minus 6) will be subject to establishment fees in FY 2019. B. Establishment Fee Rates for FY 2019 FDA must set the fee rates for FY 2019 so that the fees paid for the estimated 54 establishments will generate a total of $7,886,060. To generate this amount will require the fee for an animal drug establishment, rounded to the nearest dollar, to be $146,038. VI. Sponsor Fee Calculations for FY 2019 A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors The animal drug sponsor fee must be paid annually by each person who: (1) Is named as the applicant in an animal drug application, except for an approved application for which all subject products have been removed from listing under section 510 of the FD&C Act, or has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive and (2) had an animal drug application, supplemental animal drug application, or investigational animal drug submission pending at FDA after September 1, 2003 (see 21 U.S.C. 379j-11(6) and 379j-12(a)(4)). An animal drug sponsor is subject to only one such fee each fiscal year (see 21 U.S.C. 379j-12(a)(4)). The sponsor fees are to be set so that they will generate $8,189,370 in fee revenue for FY 2019. To set animal drug sponsor fees to realize $8,189,370, FDA must make some assumptions about the number of sponsors who will pay these fees in FY 2019. FDA estimates that a total of 196 sponsors will meet this definition in FY 2019. In estimating the fee revenue to be generated by animal drug sponsor fees in FY 2019, FDA is assuming that 67 percent of the sponsors invoiced, or 131, will not pay sponsor fees in FY 2019 due to fee waivers and reductions. FDA has kept this estimate at 67 percent this year, based on historical data over the past 5 completed years of the ADUFA program. FDA believes that this is a reasonable basis for estimating the number of fee-paying sponsors in FY 2019. Accordingly, the Agency estimates that a total of 65 sponsors (196 minus 131) will be subject to and pay sponsor fees in FY 2019. B. Sponsor Fee Rates for FY 2019 FDA must set the fee rates for FY 2019 so that the estimated 65 sponsors that [[Page 48624]] pay fees will generate a total of $8,189,370. To generate this amount will require the fee for an animal drug sponsor, rounded to the nearest dollar, to be $125,990. VII. Fee Schedule for FY 2019 The fee rates for FY 2019 are summarized in table 1. Table 1--FY 2019 Fee Rates ------------------------------------------------------------------------ Fee rate for Animal drug user fee category FY 2019 ------------------------------------------------------------------------ Animal Drug Application Fees: Animal Drug Application............................. $449,348 Supplemental Animal Drug Application for Which 224,674 Safety or Effectiveness Data are Required or Animal Drug Application Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act............... Animal Drug Product Fee................................. 10,747 Animal Drug Establishment Fee \1\....................... 146,038 Animal Drug Sponsor Fee \2\............................. 125,990 ------------------------------------------------------------------------ \1\ An animal drug establishment is subject to only one such fee each fiscal year. \2\ An animal drug sponsor is subject to only one such fee each fiscal year. VIII. Fee Waiver or Reduction; Exemption From Fees A. Barrier to Innovation Waivers Under section 740(d)(1)(A) of the FD&C Act, an animal drug applicant may qualify for a waiver or reduction of one or more ADUFA fees if the fee would present a significant barrier to innovation because of limited resources available to the applicant or due to other circumstances. FDA CVM's guidance for industry (GFI) #170, entitled ``Animal Drug User Fees and Fee Waivers and Reductions \1\,'' states that for purposes of determining whether to grant a barrier to innovation waiver or reduction of ADUFA fees on financial grounds, FDA has determined an applicant with financial resources of less than $20,000,000 (including the financial resources of the applicant's affiliates), adjusted annually for inflation, has limited resources available. Using the CPI for urban consumers (U.S. city average; not seasonally adjusted; all items; annual index), the inflation-adjusted level for FY 2019 will be $20,742,100; this level represents the financial resource ceiling that will be used to determine if there are limited resources available to an applicant requesting a Barrier to Innovation waiver on financial grounds for FY 2019 in addition to the criteria requiring the product to be innovative. --------------------------------------------------------------------------- \1\ CVM's guidance for industry (GFI) #170 is located at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf. --------------------------------------------------------------------------- B. Exemptions From Fees The types of fee waivers and reductions that applied last fiscal year still exist for FY 2019. However, two new exemptions from fees were established by ADUFA IV, as follows: If an animal drug application, supplemental animal drug application, or investigational submission involves the intentional genomic alteration of an animal that is intended to produce a human medical product, any person who is the named applicant or sponsor of that application or submission will not be subject to sponsor, product, or establishment fees under ADUFA based solely on that application or submission (21 U.S.C. 379j-12(d)(4)(B)). Fees will not apply to any person who not later than September 30, 2023, submits to CVM a supplemental animal drug application relating to a new animal drug application approved under section 512 of the FD&C Act, solely to add the application number to the labeling of the drug in the manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C. 352(w)(3)), if that person otherwise would be subject to user fees under ADUFA based only on the submission of the supplemental application (21 U.S.C. 379j-12(d)(4)(A)). IX. Procedures for Paying the FY 2019 Fees A. Application Fees and Payment Instructions The appropriate application fee established in the new fee schedule must be paid for an animal drug application or supplement subject to fees under ADUFA IV that is submitted on or after October 1, 2018. The payment must be made in U.S. currency 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 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, or the Pay.gov payment option is available to you after you submit a cover sheet. (Note: only full payments are accepted. No partial payments can be made online.) Once you search for and find your invoice, select ``Pay Now'' to be redirected to https://www.pay.gov/. Electronic payment options are based on the balance due. Payment by credit card is available only for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards. When paying by check, bank draft, or U.S. postal money order, please write your application's unique Payment Identification Number (PIN), beginning with the letters AD, on the upper right-hand corner of your completed Animal Drug User Fee Cover Sheet. Also write the FDA post office box number (P.O. Box 979033) on the enclosed check, bank draft, or money order. Mail the payment and a copy of the completed Animal Drug User Fee Cover Sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000. When paying by wire transfer, the invoice number needs to be included; without the invoice number, the payment may not be applied. If the payment amount is not applied, the invoice amount would be referred to collections. 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. Use the following account information when sending a payment by wire transfer: U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, FDA Deposit Account Number: 75060099, U.S. Department of Treasury routing/transit [[Page 48625]] number: 021030004, SWIFT Number: FRNYUS33. To send a check by a courier such as Federal Express, the courier must deliver the check and printed copy of the cover sheet to: U.S. Bank, Attn: Government Lockbox 979033, 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 telephone number is only for questions about courier delivery.) It is important that the fee arrives at the bank at least a day or two before the application arrives at FDA's CVM. FDA records the official application receipt date as the later of the following: The date the application was received by FDA's CVM, or the date U.S. Bank notifies FDA that your payment in the full amount has been received, or when the U.S. Treasury notifies FDA of receipt of an electronic or wire transfer payment. U.S. Bank and the U.S. Treasury are required to notify FDA within 1 working day, using the PIN described previously. The tax identification number of FDA is 53-0196965. (Note: In no case should the payment for the fee be submitted to FDA with the application.) B. Application Cover Sheet Procedures Step One--Create a user account and password. Log on to the ADUFA website at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources, click ``The Animal Drug User Fee Cover Sheet'' and then select ``Create ADUFA User Fee Cover Sheet.'' For security reasons, each firm submitting an application will be assigned an organization identification number, and each user will also be required to set up a user account and password the first time you use this site. Online instructions will walk you through this process. Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it to FDA, and print a copy. After logging into your account with your user name and password, complete the steps required to create an Animal Drug User Fee Cover Sheet. One cover sheet is needed for each animal drug application or supplement. Once you are satisfied that the data on the cover sheet are accurate and you have finalized the cover sheet, you will be able to transmit it electronically to FDA and you will be able to print a copy of your cover sheet showing your unique PIN. Step Three--Send the payment for your application as described in section IX.A of this document. Step Four--Please submit your application and a copy of the completed Animal Drug User Fee Cover Sheet to the following address: Food and Drug Administration, Center for Veterinary Medicine, Document Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855. C. Product, Establishment, and Sponsor Fees By December 31, 2018, FDA will issue invoices and payment instructions for product, establishment, and sponsor fees for FY 2019 using this fee schedule. Payment will be due by January 31, 2019. FDA will issue invoices in November 2019 for any products, establishments, and sponsors subject to fees for FY 2019 that qualify for fees after the December 2018 billing. Dated: September 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20911 Filed 9-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48621
DEPARTMENT OF HEALTH AND for inflation and workload, and for component of the inflation adjustment
HUMAN SERVICES excess collections to reduce workload- for payroll costs shall be one plus the
based increases or collection shortfalls average annual percent change in the
Food and Drug Administration after FY 2020 (21 U.S.C. 379j–12(c) and cost of all PC&B paid per full-time
[Docket No. FDA–2018–N–0007] (g)). Fees for applications, equivalent position (FTE) at FDA for the
establishments, products, and sponsors first 3 of the 4 preceding fiscal years,
Animal Drug User Fee Rates and are to be established each year by FDA multiplied by the average proportion of
Payment Procedures for Fiscal Year so that the percentages of the total PC&B costs to total FDA costs for the
2019 revenue that are derived from each type first 3 of the 4 preceding fiscal years.
of user fee will be as follows: Revenue The statute specifies that the portion of
AGENCY: Food and Drug Administration, from application fees shall be 20 percent the inflation adjustment for non-payroll
HHS. of total fee revenue; revenue from costs is the average annual percent
ACTION: Notice. product fees shall be 27 percent of total change that occurred in the Consumer
fee revenue; revenue from establishment Price Index (CPI) for urban consumers
SUMMARY: The Food and Drug fees shall be 26 percent of total fee (Washington-Baltimore, DC–MD–VA–
Administration (FDA) is announcing the revenue; and revenue from sponsor fees WV; not seasonally adjusted; all items
rates and payment procedures for fiscal shall be 27 percent of total fee revenue less food and energy; annual index) for
year (FY) 2019 animal drug user fees. (21 U.S.C. 379j–12(b)(2)). the first 3 of the preceding 4 years of
The Federal Food, Drug, and Cosmetic For FY 2019, the animal drug user fee available data multiplied by the
Act (FD&C Act), as amended by the rates are: $449,348 for an animal drug proportion of all costs other than PC&B
Animal Drug User Fee Amendments of application; $224,674 for a costs to total FDA costs. Because the
2018 (ADUFA IV), authorizes FDA to supplemental animal drug application adjustment for inflation does not take
collect user fees for certain animal drug for which safety or effectiveness data are effect until FY 2020, FDA will not
applications and supplements, for required and for an animal drug adjust the FY 2019 fee revenue amount
certain animal drug products, for certain application subject to the criteria set for inflation.
establishments where such products are forth in section 512(d)(4) of the FD&C C. Workload Adjustment to Inflation
made, and for certain sponsors of such Act (21 U.S.C. 360b(d)(4)); $10,747 for Adjusted Fee Revenue Amount
animal drug applications and/or an annual product fee; $146,038 for an
investigational animal drug annual establishment fee; and $125,990 The fee revenue amounts established
submissions. This notice establishes the for an annual sponsor fee. FDA will in ADUFA IV for FY 2020 and
fee rates for FY 2019. issue invoices for FY 2019 product, subsequent fiscal years are also subject
FOR FURTHER INFORMATION CONTACT: Visit
to adjustment to account for changes in
establishment, and sponsor fees by
FDA’s website at http://www.fda.gov/ FDA’s review workload. A workload
December 31, 2018, and payment will
ForIndustry/UserFees/ adjustment will be applied to the
be due by January 31, 2019. The
AnimalDrugUserFeeActADUFA/ inflation adjusted fee revenue amount
application fee rates are effective for
default.htm or contact Lisa Kable, (21 U.S.C. 379j–12(c)(3)).
applications submitted on or after ADUFA IV specifies that FDA shall
Center for Veterinary Medicine (HFV– October 1, 2018, and will remain in calculate the weighted average of the
10), Food and Drug Administration, effect through September 30, 2019. change in the total number of each of
7500 Standish Pl., Rockville, MD 20855, Applications will not be accepted for the five types of applications and
240–402–6888, Lisa.Kable@fda.hhs.gov. review until FDA has received full submissions specified in the workload
For general questions, you may also payment of application fees and any adjustment provision (animal drug
email the Center for Veterinary other animal drug user fees owed under applications, supplemental animal drug
Medicine (CVM) at: cvmadufa@ the Animal Drug User Fee program applications for which data with respect
fda.hhs.gov. (ADUFA program). to safety or efficacy are required,
SUPPLEMENTARY INFORMATION: II. Revenue Amount for FY 2019 manufacturing supplemental animal
I. Background drug applications, investigational
A. Statutory Fee Revenue Amounts animal drug study submissions, and
Section 740 of the FD&C Act (21 ADUFA IV, Title I of Public Law 115– investigational animal drug protocol
U.S.C. 379j–12) establishes four 234, specifies that the aggregate fee submissions). Because the adjustment
different types of user fees: (1) Fees for revenue amount for FY 2019 for all for workload does not take effect until
certain types of animal drug animal drug user fee categories is FY 2020, FDA will not adjust the FY
applications and supplements; (2) $30,331,000 (rounded to the nearest 2019 fee revenue amount for workload
annual fees for certain animal drug thousand dollars) (21 U.S.C. 379j– changes.
products; (3) annual fees for certain 12(b)(1)(A)).
establishments where such products are D. Reduction of Workload-Based
made; and (4) annual fees for certain B. Inflation Adjustment to Fee Revenue Increase by Amount of Certain Excess
sponsors of animal drug applications Amount Collections
and/or investigational animal drug The fee revenue amounts established Under section 740(c)(3)(B) of the
submissions (21 U.S.C. 379j–12(a)). in ADUFA IV for FY 2020 and FD&C Act, for fiscal years 2021 through
When certain conditions are met, FDA subsequent fiscal years are subject to an 2023, if application of the workload
will waive or reduce fees (21 U.S.C. inflation adjustment (21 U.S.C. 379j– adjustment increases the amount of fee
daltland on DSKBBV9HB2PROD with NOTICES
379j–12(d)). 12(c)(2)). revenues established for the fiscal year,
For FY 2019 through FY 2023, the ADUFA IV specifies that the annual as adjusted for inflation, the fee revenue
FD&C Act establishes aggregate yearly fee revenue amount is to be adjusted increase will be reduced by the amount
base revenue amounts for each fiscal using two separate adjustments—one for of any excess collections for the second
year (21 U.S.C. 379j–12(b)(1)). Base personnel compensation and benefits preceding fiscal year, up to the amount
revenue amounts established for years (PC&B) and one for non-PC&B costs (21 of the fee revenue increase. Since this
after FY 2019 are subject to adjustment U.S.C. 379j–12(c)(2)(A)(ii) and (iii)). The provision will not take effect until FY
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![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48625
number: 021030004, SWIFT Number: Step Four—Please submit your be submitted on or before November 26,
FRNYUS33. application and a copy of the completed 2018. The https://www.regulations.gov
To send a check by a courier such as Animal Drug User Fee Cover Sheet to electronic filing system will accept
Federal Express, the courier must the following address: Food and Drug comments until 11:59 p.m. Eastern Time
deliver the check and printed copy of Administration, Center for Veterinary at the end of November 26, 2018.
the cover sheet to: U.S. Bank, Attn: Medicine, Document Control Unit Comments received by mail/hand
Government Lockbox 979033, 1005 (HFV–199), 7500 Standish Pl., delivery/courier (for written/paper
Convention Plaza, St. Louis, MO 63101. Rockville, MD 20855. submissions) will be considered timely
(Note: This address is for courier if they are postmarked or the delivery
delivery only. If you have any questions C. Product, Establishment, and Sponsor
service acceptance receipt is on or
concerning courier delivery, contact Fees
before that date.
U.S. Bank at 314–418–4013. This By December 31, 2018, FDA will issue
telephone number is only for questions invoices and payment instructions for Electronic Submissions
about courier delivery.) product, establishment, and sponsor Submit electronic comments in the
It is important that the fee arrives at fees for FY 2019 using this fee schedule. following way:
the bank at least a day or two before the Payment will be due by January 31, • Federal eRulemaking Portal:
application arrives at FDA’s CVM. FDA 2019. FDA will issue invoices in https://www.regulations.gov. Follow the
records the official application receipt November 2019 for any products, instructions for submitting comments.
date as the later of the following: The establishments, and sponsors subject to Comments submitted electronically,
date the application was received by fees for FY 2019 that qualify for fees including attachments, to https://
FDA’s CVM, or the date U.S. Bank after the December 2018 billing. www.regulations.gov will be posted to
notifies FDA that your payment in the the docket unchanged. Because your
Dated: September 20, 2018.
full amount has been received, or when comment will be made public, you are
the U.S. Treasury notifies FDA of Leslie Kux,
solely responsible for ensuring that your
receipt of an electronic or wire transfer Associate Commissioner for Policy. comment does not include any
payment. U.S. Bank and the U.S. [FR Doc. 2018–20911 Filed 9–25–18; 8:45 am] confidential information that you or a
Treasury are required to notify FDA BILLING CODE 4164–01–P third party may not wish to be posted,
within 1 working day, using the PIN such as medical information, your or
described previously. anyone else’s Social Security number, or
The tax identification number of FDA DEPARTMENT OF HEALTH AND confidential business information, such
is 53–0196965. (Note: In no case should HUMAN SERVICES as a manufacturing process. Please note
the payment for the fee be submitted to that if you include your name, contact
FDA with the application.) Food and Drug Administration
information, or other information that
B. Application Cover Sheet Procedures [Docket No. FDA–2018–N–3552] identifies you in the body of your
comments, that information will be
Step One—Create a user account and Agency Information Collection posted on https://www.regulations.gov.
password. Log on to the ADUFA website Activities; Proposed Collection; • If you want to submit a comment
at https://www.fda.gov/ForIndustry/ Comment Request; Experimental with confidential information that you
UserFees/AnimalDrugUserFeeAct Study of Cigarette Warnings do not wish to be made available to the
ADUFA/default.htm and, under Tools public, submit the comment as a
and Resources, click ‘‘The Animal Drug AGENCY: Food and Drug Administration,
HHS. written/paper submission and in the
User Fee Cover Sheet’’ and then select manner detailed (see ‘‘Written/Paper
‘‘Create ADUFA User Fee Cover Sheet.’’ ACTION: Notice.
Submissions’’ and ‘‘Instructions’’).
For security reasons, each firm
SUMMARY: The Food and Drug Written/Paper Submissions
submitting an application will be
Administration (FDA or Agency) is
assigned an organization identification Submit written/paper submissions as
announcing an opportunity for public
number, and each user will also be follows:
comment on the proposed collection of
required to set up a user account and • Mail/Hand Delivery/Courier (for
certain information by the Agency.
password the first time you use this site. written/paper submissions): Dockets
Under the Paperwork Reduction Act of
Online instructions will walk you Management Staff (HFA–305), Food and
1995 (PRA), Federal Agencies are
through this process. Drug Administration, 5630 Fishers
Step Two—Create an Animal Drug required to publish notice in the
Lane, Rm. 1061, Rockville, MD 20852.
User Fee Cover Sheet, transmit it to Federal Register concerning each • For written/paper comments
FDA, and print a copy. After logging proposed collection of information and submitted to the Dockets Management
into your account with your user name to allow 60 days for public comment in Staff, FDA will post your comment, as
and password, complete the steps response to the notice. This notice well as any attachments, except for
required to create an Animal Drug User solicits comments on an experimental information submitted, marked and
Fee Cover Sheet. One cover sheet is study of cigarette warnings that is being identified, as confidential, if submitted
needed for each animal drug application conducted in support of the graphic as detailed in ‘‘Instructions.’’
or supplement. Once you are satisfied label statement provision of the Family Instructions: All submissions received
that the data on the cover sheet are Smoking Prevention and Tobacco must include the Docket No. FDA–
accurate and you have finalized the Control Act (the Tobacco Control Act). 2018–N–3552 for ‘‘Experimental Study
daltland on DSKBBV9HB2PROD with NOTICES
cover sheet, you will be able to transmit DATES: Submit either electronic or of Cigarette Warnings.’’ Received
it electronically to FDA and you will be written comments on the collection of comments, those filed in a timely
able to print a copy of your cover sheet information by November 26, 2018. manner (see ADDRESSES), will be placed
showing your unique PIN. ADDRESSES: You may submit comments in the docket and, except for those
Step Three—Send the payment for as follows. Please note that late, submitted as ‘‘Confidential
your application as described in section untimely filed comments will not be Submissions,’’ publicly viewable at
IX.A of this document. considered. Electronic comments must https://www.regulations.gov or at the
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Document Created: 2018-09-26 00:47:47
Document Modified: 2018-09-26 00:47:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Visit FDA's website at http:// www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240- 402-6888, [email protected] For general questions, you may also email the Center for Veterinary Medicine (CVM) at: [email protected] | |
| FR Citation | 83 FR 48621 |
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