82 FR 35966 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 147 (August 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 147 (August 2, 2017)
| Page Range | 35966-35971 | |
| FR Document | 2017-16180 |
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)] [Notices] [Pages 35966-35971] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16180] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0007] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2018 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) 2018 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013 (ADUFA III), 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 2018. FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site 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. 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 2014 through FY 2018, 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 2014 are subject to adjustment for inflation and workload (21 U.S.C. 379j- 12(c)). 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 2018, the animal drug user fee rates are: $238,100 for an animal drug application; $119,050 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)); $6,175 for an annual product fee; $88,750 for an annual establishment fee; and $75,150 for an annual sponsor fee. FDA will issue invoices for FY 2018 product, establishment, and sponsor fees by December 31, 2017, and payment will be due by January 31, 2018. The application fee rates are effective for applications submitted on or after October 1, 2017, and will remain in effect through September 30, 2018. 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 2018 A. Statutory Fee Revenue Amounts ADUFA III, Title I of Public Law 113-14, specifies that the aggregate fee revenue amount for FY 2018 for all animal drug user fee categories is $21,600,000 (21 U.S.C. 379j-12(b)(1)(B)). B. Inflation Adjustment to Fee Revenue Amount The fee revenue amount established in ADUFA III for FY 2015 and subsequent fiscal years are subject to an inflation adjustment (21 U.S.C. 379j-12(c)(2)). The component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all personnel compensation and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA for the first three of the four preceding fiscal years, multiplied by the proportion of PC&B costs to total FDA costs for the first three of the four preceding fiscal years (see 21 U.S.C. 379j-12(c)(2)(A) and (B)). The data on total PC&B paid and numbers of FTE paid, from which the average cost per FTE can be derived, are published in FDA's Justification of Estimates for Appropriations Committees. Table 1 summarizes that actual cost and FTE data for the specified fiscal years, and provides the percent change from the previous fiscal year and the average percent change over the first of the 4 fiscal years preceding FY 2018. The 3-year average is 2.2354 percent. Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change ---------------------------------------------------------------------------------------------------------------- Fiscal year 2014 2015 2016 3-Year average ---------------------------------------------------------------------------------------------------------------- Total PC&B.......................... $2,054,937,000 $2,232,304,000 $2,414,728,159 ................. Total FTE........................... 14,555 15,484 16,381 ................. PC&B per FTE........................ $141,184 $144,168 $147,408 ................. Percent Change from Previous Year... 2.3451% 2.1136% 2.2474% 2.2354% ---------------------------------------------------------------------------------------------------------------- [[Page 35967]] The statute specifies that this 2.2354 percent should be multiplied by the proportion of PC&B costs to total FDA costs. Table 2 shows the amount of PC&B and the total amount obligated by FDA for the same 3 FYs. Table 2--PC&B as a Percent of Total Costs at FDA ---------------------------------------------------------------------------------------------------------------- Fiscal year 2014 2015 2016 3-Year average ---------------------------------------------------------------------------------------------------------------- Total PC&B.......................... $2,054,937,000 $2,232,304,000 $2,414,728,159 ................. Total Costs......................... $4,298,476,000 $4,510,565,000 $4,666,236,000 ................. PC&B Percent........................ 47.8062% 49.4906% 51.7490 49.6819% ---------------------------------------------------------------------------------------------------------------- The payroll adjustment is 2.2354 percent multiplied by 49.6819 percent (or 1.1106 percent). The statute specifies that the portion of the inflation adjustment for non-payroll costs for FY 2018 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 (see 21 U.S.C. 379j-12(c)(2)(C)). Table 3 provides the summary data for the percent change in the specified CPI for the Baltimore-Washington area. The data from the Bureau of Labor Statistics is shown in table 3. Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI Less Food and Energy ---------------------------------------------------------------------------------------------------------------- Year 2014 2015 2016 3-Year average ---------------------------------------------------------------------------------------------------------------- Annual CPI.......................... 149.581 152.242 154.702 ................. Annual Percent Change............... 1.7883% 1.7790% 1.6158% 1.7277% ---------------------------------------------------------------------------------------------------------------- To calculate the inflation adjustment for non-pay costs, we multiply the 1.7277 percent by the proportion of all costs other than PC&B to total FDA costs. Since 49.6819 percent was obligated for PC&B as shown in table 2, 50.3181 percent is the portion of costs other than PC&B (100 percent -49.6819 percent = 50.3181 percent). The non-payroll adjustment is 1.7277 percent times 50.3181 percent, or 0.8693 percent. Next, we add the payroll component (1.1106 percent) to the non-pay component (0.8693 percent), for a total inflation adjustment of 1.9799 percent for FY 2018. ADUFA III provides for the inflation adjustment to be compounded each fiscal year after FY 2014 (see 21 U.S.C. 379j-12(c)(2)). The factor for FY 2018 (1.9799 percent) is compounded by adding 1 and then multiplying by 1 plus the inflation adjustment factor for FY 2017 (6.0746 percent), as published in the Federal Register of July 28, 2016 (81 FR 49664 to 49669), which equals 1.081748 (rounded) (1.019799 x 1.060746) for FY 2018. We then multiply the base revenue amount for FY 2018 ($21,600,000) by 1.081748, yielding an inflation adjusted amount of $23,365,757. C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount A workload adjustment will be calculated to the inflation adjusted fee revenue amount established in ADUFA III for FY 2015 and subsequent fiscal years (21 U.S.C. 379j-12(c)(3)). FDA calculated the average 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) received over the 5-year period that ended on September 30, 2013 (the base years), and the average number of each of these types of applications and submissions over the most recent 5-year period that ended June 30, 2017. The results of these calculations are presented in the first two columns of table 4. Column 3 reflects the percent change in workload over the two 5-year periods. Column 4 shows the weighting factor for each type of application, reflecting how much of the total FDA animal drug review workload was accounted for by each type of application or submission in the table during the most recent five years. Column 5 is the weighted percent change in each category of workload, and was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right of table 4 the sum of the values in column 5 is added, reflecting a total change in workload of 5.4599 percent for FY 2018. This is the workload adjuster for FY 2018. Table 4--Workload Adjuster Calculation [Numbers may not add due to rounding] ---------------------------------------------------------------------------------------------------------------- Column 5 Column 1 5- Column 2 Column 3 Column 4 weighted Application type year average latest 5-year percent weighting percent (base years) average change factor change ---------------------------------------------------------------------------------------------------------------- New Animal Drug Applications 9.8000 16.0 63.2653 0.030373 1.9216 (NADAs)........................ Supplemental NADAs with Safety 9.6000 10.6 10.4167 0.026491 0.2759 or Efficacy Data............... Manufacturing Supplements....... 361.0000 334.6 -7.3130 0.162018 -1.1848 Investigational Study 216.4000 189.8 -12.2921 0.579781 -7.1267 Submissions.................... Investigational Protocol 133.6000 210.4 57.4850 0.201337 11.5739 Submissions.................... [[Page 35968]] FY 2018 Workload Adjuster....... .............. .............. .............. .............. 5.4599 ---------------------------------------------------------------------------------------------------------------- FDA experienced an increase in the number of new animal drug applications (NADAs) and supplemental NADAs with safety or effectiveness data. Over the last several years FDA has seen an increase in the number of animal drug products brought by animal drug sponsors for review in the drug evaluation process. These new animal drug products come from both existing animal drug sponsors as well as sponsors new to the animal drug market. The increase in new animal drug products has contributed to an increase in the number of protocol submissions and NADAs submitted for many novel drug classes and novel indications for both food-producing animals and companion animals. FDA can expect that the increases in reviewed protocols will lead in the near future to an increase in the number of Investigational Study Submissions and NADAs or supplemental NADAs as sponsors work their products through the regulatory review process. Additionally, FDA has seen an increase in the number of animal drug sponsors pursuing multiple changes to their existing NADAs (e.g., new indications, new species, changes in dosage). For this reason we are seeing an increase in the number of supplemental NADAs with safety or effectiveness data. The increases in these submissions are consistent with an overall increase in workload including all submissions and communications with sponsors. In addition, CVM is not seeing a corresponding decrease in any of the other submission types that might have served to offset workload. As a result, the statutory revenue amount after the inflation adjustment ($23,365,757) must now be increased by 5.4599 percent to reflect the changes in review workload (workload adjustment), for a total fee revenue target of $24,641,504. D. Offset for Excess Collections Through FY 2017 Under section 740(g)(4) of the FD&C Act, if the sum of the cumulative amount of the fees collected for FY 2014 through FY 2016, and the amount of fees estimated to be collected for FY 2017, exceeds the cumulative amount appropriated for fees for FY 2014 through FY 2017, the excess shall be credited to FDA's appropriation account and subtracted from the amount of fees that FDA would otherwise be authorized to collect for FY 2018 under the FD&C Act. (21 U.S.C. 379j- 12(g)(4)). Table 5 shows the amounts specified in appropriation acts for each year from FY 2014 through FY 2017, and the amounts FDA has collected for FY 2014, FY 2015, FY 2016, and FY 2017 as of June 30, 2017, and an additional $21,941,000 (rounded to the nearest thousand dollars) that FDA estimates it will collect in FY 2017 based on historical data. Table 5 shows the estimated cumulative difference between ADUFA fee amounts specified in appropriation acts for FY 2014 through FY 2017 and ADUFA fee amounts collected. Table 5--Offsets To Be Taken for ADUFA III ---------------------------------------------------------------------------------------------------------------- Amount in Collection excess of amount collection Fiscal year Collections specified in amount realized appropriation specified in acts appropriation acts ---------------------------------------------------------------------------------------------------------------- 2014............................................................ $27,184,831 $23,600,000 $3,584,831 2015............................................................ 24,535,338 22,464,000 2,071,338 2016............................................................ 25,442,477 22,818,000 2,624,477 2017............................................................ 21,941,000 23,673,000 -1,732,000 ----------------------------------------------- Net Balance to be Offset When Fees are Set for FY 2018...................................... 6,548,646 ---------------------------------------------------------------------------------------------------------------- Note: FY 2017 `Collections Realized' is the amount FDA estimates it will collect in FY 2017 based on historical data. The cumulative fees collected for FY 2014 through FY 2017 are estimated to be $6,548,646 greater than the cumulative fee amounts specified in appropriation acts during this same period. Reducing the inflation and workload adjusted amount of $24,641,504 by the ADUFA III offset of $6,548,646 results in an amount of $18,093,000 (rounded to the nearest thousand), before the final year adjustment. E. Final Year Adjustment Under section 740(c)(4) of the FD&C Act, for FY 2018 the Secretary of Health and Human Services (the Secretary) may, in addition to the inflation and workload adjustments, further increase the fees if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for the process for the review of animal drug applications for the first 3 months of FY 2019. If such an adjustment is necessary, the rationale for the amount of this increase must be included in the annual notice establishing fees for FY 2018 (21 U.S.C. 379j-12(c)(4)). After calculating the operating reserves and estimating the balance as of the beginning of FY 2019, FDA estimates that the ADUFA program will have sufficient funds for the operating reserves, thus FDA will not be performing a final year adjustment for [[Page 35969]] FY 2019 because FDA has determined such an adjustment to be unnecessary. F. FY 2018 Fee Revenue Amounts ADUFA III specifies that the revenue amount of $18,093,000 for FY 2018 is to be divided as follows: 20 percent, or a total of $3,619,000 (rounded to the nearest thousand dollars), is to come from application fees; 27 percent, or a total of $4,885,000 (rounded to the nearest thousand dollars), is to come from product fees; 26 percent, or a total of $4,704,000 (rounded to the nearest thousand dollars), is to come from establishment fees; and 27 percent, or a total of $4,885,000 (rounded to the nearest thousand dollars), is to come from sponsor fees (21 U.S.C. 379j-12(b)). III. Application Fee Calculations for FY 2018 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) of the FD&C Act (21 U.S.C. 379j-11(1)). A ``supplemental animal drug application'' is defined as a request to the Secretary to approve a change in an animal drug application which 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 $3,619,000 in fee revenue for FY 2018. 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 $3,619,000 FDA must first make some assumptions about the number of fee-paying applications and supplements the Agency will receive in FY 2018. The Agency knows the number of applications that have been submitted in previous years. That number fluctuates from year to year. In estimating the fee revenue to be generated by animal drug application fees in FY 2018, FDA is assuming that the number of applications that will pay fees in FY 2018 will equal the average number of submissions over the five most recent completed years of the ADUFA program (FY 2012 to FY 2016). FDA believes that this is a reasonable approach after 13 completed years of experience with this program. Over the five most recent completed years, the average number of animal drug applications that would have been subject to the full fee was 8.2. 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 14.0. B. Application Fee Rates for FY 2018 FDA must set the fee rates for FY 2018 so that the estimated 8.2 applications that pay the full fee and the estimated 14.0 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 pay half of the full fee will generate a total of $3,619,000. To generate this amount, the fee for an animal drug application, rounded to the nearest $100, will have to be $238,100, 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 $119,050. IV. Product Fee Calculations for FY 2018 A. Product Fee Revenues and Numbers of Fee-Paying Products The animal drug product fee (also referred to as the 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 $4,885,000 in fee revenue for FY 2018. To set animal drug product fees to realize $4,885,000, FDA must make some assumptions about the number of products for which these fees will be paid in FY 2018. 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 2017, FDA estimates that there are a total of 815 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 815 products will be subject to this fee in FY 2018. In estimating the fee revenue to be generated by animal drug product fees in FY 2018, FDA is assuming that 3 percent of the products invoiced, or 24, will not pay fees in FY 2018 due to fee waivers and reductions. FDA has kept this estimate at 3 percent this year, based on historical data over the past five completed years of the ADUFA program. Based on experience over the first 13 completed years of the ADUFA program, FDA believes that this is a reasonable basis for estimating the number of fee-paying products in FY 2018. Accordingly, the Agency estimates that a total of 791 (815 minus 24) products will be subject to product fees in FY 2018. B. Product Fee Rates for FY 2018 FDA must set the fee rates for FY 2018 so that the estimated 791 products that pay fees will generate a total of $4,885,000. To generate this amount will require the fee for an animal drug product, rounded to the nearest $5, to be $6,175. V. Establishment Fee Calculations for FY 2018 A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments The animal drug establishment fee (also referred to as the 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 [[Page 35970]] 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 which is 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 $4,704,000 in fee revenue for FY 2018. To set animal drug establishment fees to realize $4,704,000, FDA must make some assumptions about the number of establishments for which these fees will be paid in FY 2018. 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 2017, 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 2018. In estimating the fee revenue to be generated by animal drug establishment fees in FY 2018, FDA is assuming that 11 percent of the establishments invoiced, or seven, will not pay fees in FY 2018 due to fee waivers and reductions. FDA has kept this estimate at 11 percent this year, based on historical data over the past 5 completed years. Based on experience over the past 13 completed years of the ADUFA program, FDA believes that this is a reasonable basis for estimating the number of fee-paying establishments in FY 2018. Accordingly, the Agency estimates that a total of 53 establishments (60 minus 7) will be subject to establishment fees in FY 2018. B. Establishment Fee Rates for FY 2018 FDA must set the fee rates for FY 2018 so that the estimated 53 establishments that pay fees will generate a total of $4,704,000. To generate this amount will require the fee for an animal drug establishment, rounded to the nearest $50, to be $88,750. VI. Sponsor Fee Calculations for FY 2018 A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors The animal drug sponsor fee (also referred to as the 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 $4,885,000 in fee revenue for FY 2018. To set animal drug sponsor fees to realize $4,885,000, FDA must make some assumptions about the number of sponsors who will pay these fees in FY 2018. Based on the number of firms that would have met this definition in each of the past 13 completed years of the ADUFA program, FDA estimates that a total of 198 sponsors will meet this definition in FY 2018. A review of our records indicates that 35 percent of these sponsors will qualify for a minor use/minor species fee waiver or reduction (21 U.S.C. 379j-12(d)(1)(D)). Based on the Agency's experience to date with sponsor fees, FDA's current best estimate is that an additional 32 percent will qualify for other waivers or reductions, for a total of 67 percent of the sponsors invoiced, or 133, who will not pay fees in FY 2018 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 2018. Accordingly, the Agency estimates that a total of 65 sponsors (198 minus 133) will be subject to and pay sponsor fees in FY 2018. B. Sponsor Fee Rates for FY 2018 FDA must set the fee rates for FY 2018 so that the estimated 65 sponsors that pay fees will generate a total of $4,885,000. To generate this amount will require the fee for an animal drug sponsor, rounded to the nearest $50, to be $75,150. VII. Fee Schedule for FY 2018 The fee rates for FY 2018 are summarized in Table 6. Table 6--FY 2018 Fee Rates ------------------------------------------------------------------------ Fee rate for Animal drug user fee category FY 2018 ------------------------------------------------------------------------ Animal Drug Application Fees: Animal Drug Application............................. $238,100 Supplemental Animal Drug Application for Which 119,050 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................................. 6,175 Animal Drug Establishment Fee\1\........................ 88,750 Animal Drug Sponsor Fee\2\.............................. 75,150 ------------------------------------------------------------------------ \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. [[Page 35971]] VIII. Procedures for Paying the FY 2018 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 III that is submitted on or after October 1, 2017. 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 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 number: 021030004, SWIFT Number: FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver Spring, MD 20993-0002. 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 Web site at http://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 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 is 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 VIII.A. 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, 2017, FDA will issue invoices and payment instructions for product, establishment, and sponsor fees for FY 2018 using this fee schedule. Payment will be due by January 31, 2018. FDA will issue invoices in November 2018 for any products, establishments, and sponsors subject to fees for FY 2018 that qualify for fees after the December 2017 billing. Dated: July 26, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-16180 Filed 8-1-17; 8:45 am] BILLING CODE 4164-01-P
![35966 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
will include presentations by FDA staff Administration, 7500 Standish Pl., issue invoices for FY 2018 product,
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register through Eventbrite by 12 a.m. Medicine (CVM) at: cvmadufa@ application fee rates are effective for
EDT, Saturday, August 19, 2017: https:// fda.hhs.gov. applications submitted on or after
www.eventbrite.com/e/over-the-counter- SUPPLEMENTARY INFORMATION: October 1, 2017, and will remain in
monograph-user-fees-stakeholder- effect through September 30, 2018.
meeting-registration-33593404778. FDA I. Background Applications will not be accepted for
will email the registered attendees a Section 740 of the FD&C Act (21 review until FDA has received full
URL to join the webinar at least 1 day U.S.C. 379j–12) establishes four payment of application fees and any
before the meeting. different types of user fees: (1) Fees for other animal drug user fees owed under
Dated July 27, 2017. certain types of animal drug the Animal Drug User Fee program
Anna K. Abram, applications and supplements; (2) (ADUFA program).
Deputy Commissioner for Policy, Planning, annual fees for certain animal drug
II. Revenue Amount for FY 2018
Legislation, and Analysis. products; (3) annual fees for certain
[FR Doc. 2017–16229 Filed 8–1–17; 8:45 am]
establishments where such products are A. Statutory Fee Revenue Amounts
made; and (4) annual fees for certain
BILLING CODE 4164–01–P
sponsors of animal drug applications ADUFA III, Title I of Public Law 113–
and/or investigational animal drug 14, specifies that the aggregate fee
submissions (21 U.S.C. 379j–12(a)). revenue amount for FY 2018 for all
DEPARTMENT OF HEALTH AND
When certain conditions are met, FDA animal drug user fee categories is
HUMAN SERVICES
will waive or reduce fees (21 U.S.C. $21,600,000 (21 U.S.C. 379j–
Food and Drug Administration 379j–12(d)). 12(b)(1)(B)).
For FY 2014 through FY 2018, the B. Inflation Adjustment to Fee Revenue
[Docket No. FDA–2017–N–0007] FD&C Act establishes aggregate yearly Amount
Animal Drug User Fee Rates and base revenue amounts for each fiscal
Payment Procedures for Fiscal Year year (21 U.S.C. 379j–12(b)(1)). Base The fee revenue amount established
revenue amounts established for years in ADUFA III for FY 2015 and
2018
after FY 2014 are subject to adjustment subsequent fiscal years are subject to an
AGENCY: Food and Drug Administration, for inflation and workload (21 U.S.C. inflation adjustment (21 U.S.C. 379j–
HHS. 379j–12(c)). Fees for applications, 12(c)(2)).
ACTION: Notice. establishments, products, and sponsors
are to be established each year by FDA The component of the inflation
SUMMARY: The Food and Drug so that the percentages of the total adjustment for payroll costs shall be one
Administration (FDA) is announcing the revenue that are derived from each type plus the average annual percent change
rates and payment procedures for fiscal of user fee will be as follows: Revenue in the cost of all personnel
year (FY) 2018 animal drug user fees. from application fees shall be 20 percent compensation and benefits (PC&B) paid
The Federal Food, Drug, and Cosmetic of total fee revenue; revenue from per full-time equivalent position (FTE)
Act (the FD&C Act), as amended by the product fees shall be 27 percent of total at FDA for the first three of the four
Animal Drug User Fee Amendments of fee revenue; revenue from establishment preceding fiscal years, multiplied by the
2013 (ADUFA III), authorizes FDA to fees shall be 26 percent of total fee proportion of PC&B costs to total FDA
collect user fees for certain animal drug revenue; and revenue from sponsor fees costs for the first three of the four
applications and supplements, for shall be 27 percent of total fee revenue preceding fiscal years (see 21 U.S.C.
certain animal drug products, for certain (21 U.S.C. 379j–12(b)(2)). 379j–12(c)(2)(A) and (B)). The data on
establishments where such products are For FY 2018, the animal drug user fee total PC&B paid and numbers of FTE
made, and for certain sponsors of such rates are: $238,100 for an animal drug paid, from which the average cost per
animal drug applications and/or application; $119,050 for a FTE can be derived, are published in
investigational animal drug supplemental animal drug application FDA’s Justification of Estimates for
submissions. This notice establishes the for which safety or effectiveness data are Appropriations Committees.
fee rates for FY 2018. required and for an animal drug Table 1 summarizes that actual cost
FOR FURTHER INFORMATION CONTACT: Visit application subject to the criteria set and FTE data for the specified fiscal
FDA’s Web site at http://www.fda.gov/ forth in section 512(d)(4) of the FD&C years, and provides the percent change
ForIndustry/UserFees/AnimalDrugUser Act (21 U.S.C. 360b(d)(4)); $6,175 for an from the previous fiscal year and the
FeeActADUFA/default.htm or contact annual product fee; $88,750 for an average percent change over the first of
Lisa Kable, Center for Veterinary annual establishment fee; and $75,150 the 4 fiscal years preceding FY 2018.
Medicine (HFV–10), Food and Drug for an annual sponsor fee. FDA will The 3-year average is 2.2354 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year 2014 2015 2016 3-Year average
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Total PC&B .............................................................................. $2,054,937,000 $2,232,304,000 $2,414,728,159 ..............................
Total FTE ................................................................................. 14,555 15,484 16,381 ..............................
PC&B per FTE ......................................................................... $141,184 $144,168 $147,408 ..............................
Percent Change from Previous Year ...................................... 2.3451% 2.1136% 2.2474% 2.2354%
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![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35967
The statute specifies that this 2.2354 proportion of PC&B costs to total FDA PC&B and the total amount obligated by
percent should be multiplied by the costs. Table 2 shows the amount of FDA for the same 3 FYs.
TABLE 2—PC&B AS A PERCENT OF TOTAL COSTS AT FDA
Fiscal year 2014 2015 2016 3-Year average
Total PC&B .............................................................................. $2,054,937,000 $2,232,304,000 $2,414,728,159 ..............................
Total Costs ............................................................................... $4,298,476,000 $4,510,565,000 $4,666,236,000 ..............................
PC&B Percent .......................................................................... 47.8062% 49.4906% 51.7490 49.6819%
The payroll adjustment is 2.2354 the Consumer Price Index (CPI) for costs other than PC&B costs to total FDA
percent multiplied by 49.6819 percent urban consumers (Washington- costs (see 21 U.S.C. 379j–12(c)(2)(C)).
(or 1.1106 percent). Baltimore, DC-MD-VA-WV; not Table 3 provides the summary data for
The statute specifies that the portion seasonally adjusted; all items less food the percent change in the specified CPI
of the inflation adjustment for non- and energy; annual index) for the first for the Baltimore-Washington area. The
payroll costs for FY 2018 is the average 3 of the preceding 4 years of available data from the Bureau of Labor Statistics
annual percent change that occurred in data multiplied by the proportion of all is shown in table 3.
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI LESS FOOD AND
ENERGY
Year 2014 2015 2016 3-Year average
Annual CPI ............................................................................... 149.581 152.242 154.702 ..............................
Annual Percent Change .......................................................... 1.7883% 1.7790% 1.6158% 1.7277%
To calculate the inflation adjustment 1.081748 (rounded) (1.019799 × 2013 (the base years), and the average
for non-pay costs, we multiply the 1.060746) for FY 2018. We then number of each of these types of
1.7277 percent by the proportion of all multiply the base revenue amount for applications and submissions over the
costs other than PC&B to total FDA FY 2018 ($21,600,000) by 1.081748, most recent 5-year period that ended
costs. Since 49.6819 percent was yielding an inflation adjusted amount of June 30, 2017.
obligated for PC&B as shown in table 2, $23,365,757. The results of these calculations are
50.3181 percent is the portion of costs presented in the first two columns of
C. Workload Adjustment to Inflation
other than PC&B (100 percent ¥49.6819 table 4. Column 3 reflects the percent
Adjusted Fee Revenue Amount
percent = 50.3181 percent). The non- change in workload over the two 5-year
payroll adjustment is 1.7277 percent A workload adjustment will be periods. Column 4 shows the weighting
times 50.3181 percent, or 0.8693 calculated to the inflation adjusted fee factor for each type of application,
percent. revenue amount established in ADUFA reflecting how much of the total FDA
Next, we add the payroll component III for FY 2015 and subsequent fiscal animal drug review workload was
(1.1106 percent) to the non-pay years (21 U.S.C. 379j–12(c)(3)). accounted for by each type of
component (0.8693 percent), for a total FDA calculated the average number of application or submission in the table
inflation adjustment of 1.9799 percent each of the five types of applications during the most recent five years.
for FY 2018. and submissions specified in the Column 5 is the weighted percent
ADUFA III provides for the inflation workload adjustment provision (animal change in each category of workload,
adjustment to be compounded each drug applications, supplemental animal and was derived by multiplying the
fiscal year after FY 2014 (see 21 U.S.C. drug applications for which data with weighting factor in each line in column
379j–12(c)(2)). The factor for FY 2018 respect to safety or efficacy are required, 4 by the percent change from the base
(1.9799 percent) is compounded by manufacturing supplemental animal years in column 3. At the bottom right
adding 1 and then multiplying by 1 plus drug applications, investigational of table 4 the sum of the values in
the inflation adjustment factor for FY animal drug study submissions, and column 5 is added, reflecting a total
2017 (6.0746 percent), as published in investigational animal drug protocol change in workload of 5.4599 percent
the Federal Register of July 28, 2016 (81 submissions) received over the 5-year for FY 2018. This is the workload
FR 49664 to 49669), which equals period that ended on September 30, adjuster for FY 2018.
TABLE 4—WORKLOAD ADJUSTER CALCULATION
[Numbers may not add due to rounding]
Column 1 Column 2 Column 5
Column 3 Column 4
5-year latest weighted
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Application type percent weighting
average 5-year percent
change factor
(base years) average change
New Animal Drug Applications (NADAs) ............................. 9.8000 16.0 63.2653 0.030373 1.9216
Supplemental NADAs with Safety or Efficacy Data ............ 9.6000 10.6 10.4167 0.026491 0.2759
Manufacturing Supplements ................................................ 361.0000 334.6 ¥7.3130 0.162018 ¥1.1848
Investigational Study Submissions ...................................... 216.4000 189.8 ¥12.2921 0.579781 ¥7.1267
Investigational Protocol Submissions .................................. 133.6000 210.4 57.4850 0.201337 11.5739
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![35968 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
TABLE 4—WORKLOAD ADJUSTER CALCULATION—Continued
[Numbers may not add due to rounding]
Column 1 Column 2 Column 5
Column 3 Column 4
5-year latest weighted
Application type percent weighting
average 5-year percent
change factor
(base years) average change
FY 2018 Workload Adjuster ................................................. ........................ ........................ ........................ ........................ 5.4599
FDA experienced an increase in the Additionally, FDA has seen an increase amount of the fees collected for FY 2014
number of new animal drug in the number of animal drug sponsors through FY 2016, and the amount of
applications (NADAs) and supplemental pursuing multiple changes to their fees estimated to be collected for FY
NADAs with safety or effectiveness existing NADAs (e.g., new indications, 2017, exceeds the cumulative amount
data. Over the last several years FDA new species, changes in dosage). For appropriated for fees for FY 2014
has seen an increase in the number of this reason we are seeing an increase in through FY 2017, the excess shall be
animal drug products brought by animal the number of supplemental NADAs credited to FDA’s appropriation account
drug sponsors for review in the drug with safety or effectiveness data. The and subtracted from the amount of fees
evaluation process. These new animal increases in these submissions are that FDA would otherwise be
drug products come from both existing consistent with an overall increase in authorized to collect for FY 2018 under
animal drug sponsors as well as workload including all submissions and the FD&C Act. (21 U.S.C. 379j–12(g)(4)).
sponsors new to the animal drug communications with sponsors. In
addition, CVM is not seeing a Table 5 shows the amounts specified
market. The increase in new animal in appropriation acts for each year from
corresponding decrease in any of the
drug products has contributed to an FY 2014 through FY 2017, and the
other submission types that might have
increase in the number of protocol served to offset workload. As a result, amounts FDA has collected for FY 2014,
submissions and NADAs submitted for the statutory revenue amount after the FY 2015, FY 2016, and FY 2017 as of
many novel drug classes and novel inflation adjustment ($23,365,757) must June 30, 2017, and an additional
indications for both food-producing now be increased by 5.4599 percent to $21,941,000 (rounded to the nearest
animals and companion animals. FDA reflect the changes in review workload thousand dollars) that FDA estimates it
can expect that the increases in (workload adjustment), for a total fee will collect in FY 2017 based on
reviewed protocols will lead in the near revenue target of $24,641,504. historical data. Table 5 shows the
future to an increase in the number of estimated cumulative difference
Investigational Study Submissions and D. Offset for Excess Collections Through between ADUFA fee amounts specified
NADAs or supplemental NADAs as FY 2017 in appropriation acts for FY 2014
sponsors work their products through Under section 740(g)(4) of the FD&C through FY 2017 and ADUFA fee
the regulatory review process. Act, if the sum of the cumulative amounts collected.
TABLE 5—OFFSETS TO BE TAKEN FOR ADUFA III
Amount in
Collection excess of
amount collection
Collections
Fiscal year specified in amount
realized appropriation specified in
acts appropriation
acts
2014 ............................................................................................................................................. $27,184,831 $23,600,000 $3,584,831
2015 ............................................................................................................................................. 24,535,338 22,464,000 2,071,338
2016 ............................................................................................................................................. 25,442,477 22,818,000 2,624,477
2017 ............................................................................................................................................. 21,941,000 23,673,000 ¥1,732,000
Net Balance to be Offset When Fees are Set for FY 2018 ......................................................................................................... 6,548,646
Note: FY 2017 ‘Collections Realized’ is the amount FDA estimates it will collect in FY 2017 based on historical data.
The cumulative fees collected for FY E. Final Year Adjustment an adjustment is necessary, the rationale
2014 through FY 2017 are estimated to for the amount of this increase must be
be $6,548,646 greater than the Under section 740(c)(4) of the FD&C included in the annual notice
cumulative fee amounts specified in Act, for FY 2018 the Secretary of Health establishing fees for FY 2018 (21 U.S.C.
appropriation acts during this same and Human Services (the Secretary) 379j–12(c)(4)).
may, in addition to the inflation and
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period. Reducing the inflation and After calculating the operating
workload adjusted amount of workload adjustments, further increase
the fees if such an adjustment is reserves and estimating the balance as of
$24,641,504 by the ADUFA III offset of the beginning of FY 2019, FDA
$6,548,646 results in an amount of necessary to provide for not more than
3 months of operating reserves of estimates that the ADUFA program will
$18,093,000 (rounded to the nearest have sufficient funds for the operating
thousand), before the final year carryover user fees for the process for
the review of animal drug applications reserves, thus FDA will not be
adjustment. performing a final year adjustment for
for the first 3 months of FY 2019. If such
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![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35971
VIII. Procedures for Paying the FY 2018 New York, NY 10045, FDA Deposit able to print a copy of your cover sheet
Fees Account Number: 75060099, U.S. showing your unique PIN.
Department of Treasury routing/transit Step Three—Send the payment for
A. Application Fees and Payment
number: 021030004, SWIFT Number: your application as described in section
Instructions
FRNYUS33, Beneficiary: FDA, 8455 VIII.A.
The appropriate application fee Colesville Rd., 14th Floor, Silver Spring, Step Four—Please submit your
established in the new fee schedule MD 20993–0002. application and a copy of the completed
must be paid for an animal drug To send a check by a courier such as Animal Drug User Fee Cover Sheet to
application or supplement subject to Federal Express, the courier must the following address: Food and Drug
fees under ADUFA III that is submitted deliver the check and printed copy of Administration, Center for Veterinary
on or after October 1, 2017. The the cover sheet to: U.S. Bank, Attn: Medicine, Document Control Unit
payment must be made in U.S. currency Government Lockbox 979033, 1005 (HFV–199), 7500 Standish Pl.,
by one of the following methods: Wire Convention Plaza, St. Louis, MO 63101. Rockville, MD 20855.
transfer, electronically, check, bank (Note: This address is for courier
draft, or U.S. postal money order made delivery only. If you have any questions C. Product, Establishment, and Sponsor
payable to the Food and Drug concerning courier delivery contact U.S. Fees
Administration. The preferred payment Bank at 314–418–4013. This telephone By December 31, 2017, FDA will issue
method is online using electronic check number is only for questions about invoices and payment instructions for
(Automated Clearing House (ACH) also courier delivery.) product, establishment, and sponsor
known as eCheck) or credit card It is important that the fee arrives at fees for FY 2018 using this fee schedule.
(Discover, VISA, MasterCard, American the bank at least a day or two before the Payment will be due by January 31,
Express). Secure electronic payments application arrives at FDA’s CVM. FDA 2018. FDA will issue invoices in
can be submitted using the User Fees records the official application receipt November 2018 for any products,
Payment Portal at https:// date as the later of the following: The establishments, and sponsors subject to
userfees.fda.gov/pay or the Pay.gov date the application was received by fees for FY 2018 that qualify for fees
payment option is available to you after FDA’s CVM, or the date U.S. Bank after the December 2017 billing.
you submit a cover sheet. (Note: only notifies FDA that your payment in the
Dated: July 26, 2017.
full payments are accepted. No partial full amount has been received, or when
payments can be made online.) Once the U.S. Treasury notifies FDA of Leslie Kux,
you search for and find your invoice, receipt of an electronic or wire transfer Associate Commissioner for Policy.
select ‘‘Pay Now’’ to be redirected to payment. U.S. Bank and the U.S. [FR Doc. 2017–16180 Filed 8–1–17; 8:45 am]
Pay.gov. Electronic payment options are Treasury are required to notify FDA BILLING CODE 4164–01–P
based on the balance due. Payment by within 1 working day, using the PIN
credit card is available only for balances described previously.
that are less than $25,000. If the balance The tax identification number of FDA DEPARTMENT OF HEALTH AND
exceeds this amount, only the ACH is 53–0196965. (Note: In no case should HUMAN SERVICES
option is available. Payments must be the payment for the fee be submitted to
made using U.S. bank accounts as well FDA with the application.) Food and Drug Administration
as U.S. credit cards. [Docket No. FDA–2011–D–0689]
When paying by check, bank draft, or B. Application Cover Sheet Procedures
U.S. postal money order, please write Step One—Create a user account and Agency Information Collection
your application’s unique Payment password. Log on to the ADUFA Web Activities; Submission for Office of
Identification Number (PIN), beginning site at http://www.fda.gov/ForIndustry/ Management and Budget Review;
with the letters AD, on the upper right- UserFees/AnimalDrugUser Comment Request; De Novo
hand corner of your completed Animal FeeActADUFA/default.htm and, under Classification Process (Evaluation of
Drug User Fee Cover Sheet. Also write Tools and Resources, click ‘‘The Animal Automatic Class III Designation)
the FDA post office box number (P.O. Drug User Fee Cover Sheet’’ and then
Box 979033) on the enclosed check, select ‘‘Create ADUFA User Fee Cover AGENCY: Food and Drug Administration,
bank draft, or money order. Mail the Sheet.’’ For security reasons, each firm HHS.
payment and a copy of the completed submitting an application will be ACTION: Notice.
Animal Drug User Fee Cover Sheet to: assigned an organization identification
Food and Drug Administration, P.O. number, and each user will also be SUMMARY: The Food and Drug
Box 979033, St. Louis, MO 63197–9000. required to set up a user account and Administration (FDA) is announcing
When paying by wire transfer, the password the first time you use this site. that a proposed collection of
invoice number needs to be included; Online instructions will walk you information has been submitted to the
without the invoice number, the through this process. Office of Management and Budget
payment may not be applied. If the Step Two—Create an Animal Drug (OMB) for review and clearance under
payment amount is not applied, the User Cover Sheet, transmit it to FDA, the Paperwork Reduction Act of 1995.
invoice amount would be referred to and print a copy. After logging into your DATES: Fax written comments on the
collections. The originating financial account with your user name and collection of information by September
institution may charge a wire transfer password, complete the steps required 1, 2017.
to create an Animal Drug User Fee ADDRESSES: To ensure that comments on
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fee. If the financial institution charges a
wire transfer fee, it is required to add Cover Sheet. One cover sheet is needed the information collection are received,
that amount to the payment to ensure for each animal drug application or OMB recommends that written
that the invoice is paid in full. supplement. Once you are satisfied that comments be faxed to the Office of
Use the following account the data on the cover sheet is accurate Information and Regulatory Affairs,
information when sending a payment by and you have finalized the cover sheet, OMB, Attn: FDA Desk Officer, FAX:
wire transfer: U.S. Department of you will be able to transmit it 202–395–7285, or emailed to oira_
Treasury, TREAS NYC, 33 Liberty St., electronically to FDA and you will be submission@omb.eop.gov. All
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Document Created: 2017-08-02 07:09:16
Document Modified: 2017-08-02 07:09:16
| 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 Web site 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. For general questions, you may also email the Center for Veterinary Medicine (CVM) at: [email protected] | |
| FR Citation | 82 FR 35966 |
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