Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2016, 45993-45998 [2015-18913]

Download as PDF Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices [FR Doc. 2015–18904 Filed 7–31–15; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Supplemental Nutrition Assistance Program (SNAP) State Agency Performance Reporting Tool. OMB No.: New Collection. Description: State agencies administering a Supplemental Nutrition Assistance Program (SNAP) are mandated to participate in a computer matching program with the federal Office of Child Support Enforcement (OCSE). The outcomes of the computerized comparisons with information maintained in the National Directory of New Hires (NDNH) provide the state SNAP agencies with information to help administer their programs and determine an individual’s eligibility. State agencies must enter into a computer matching agreement and adhere to its terms and conditions, including providing OCSE with annual performance outcomes attributable to the use of NDNH information. The Office of Management and Budget (OMB) requires OCSE to periodically report performance measurements demonstrating how NDNH information supports OCSE’s strategic mission, goals, and objectives. OCSE will provide the annual SNAP performance outcomes to OMB. The information collection activities for the SNAP performance reports are authorized by: (1) Subsection 453 (j)(10) 45993 of the Social Security Act (42 U.S.C. 653(j)(10)), which allows the Secretary of the U.S. Department of Health and Human Services to disclose information maintained in the NDNH to state agencies administering SNAP under the Nutrition Act of 2008, as amended by the Agriculture Act of 2014; (2) the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988 (5 U.S.C. 552a), which sets for the terms and conditions of a computer matching program; and (3) the Government Performance and Results Modernization Act of 2010 (Pub. L. 111–352), which requires agencies to report program performance outcomes to OMB and for the reports to be available to the public. Respondents: State SNAP Agencies. ANNUAL BURDEN ESTIMATES Number of respondents (SNAP agencies) Number of responses per respondent Average burden hours per response Total burden hours SNAP Agency Matching Program Performance Reporting Tool ..................... mstockstill on DSK4VPTVN1PROD with NOTICES Instrument 52 1 1.625 84 Estimated Total Annual Burden Hours: 84. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–18952 Filed 7–31–15; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0007] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2016 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2016 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 2016. FOR FURTHER INFORMATION CONTACT: Visit FDA’s Web site at http://www.fda.gov/ ForIndustry/UserFees/ AnimalDrugUserFeeActADUFA/ default.htm or contact Lisa Kable, SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Center for Veterinary Medicine (HFV– 10), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6888. For general questions, you may also email the Center for Veterinary Medicine (CVM) at: cvmadufa@fda.hhs.gov. 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 E:\FR\FM\03AUN1.SGM 03AUN1 45994 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 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 2016, the animal drug user fee rates are: $351,100 for an animal drug application; $175,550 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)); $7,790 for an annual product fee; $105,950 for an annual establishment fee; and $101,000 for an annual sponsor fee. FDA will issue invoices for FY 2016 product, establishment, and sponsor fees by December 31, 2015, and payment will be due by January 31, 2016. The application fee rates are effective for applications submitted on or after October 1, 2015, and will remain in effect through September 30, 2016. 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 ADUFA. II. Revenue Amount for FY 2016 A. Statutory Fee Revenue Amounts ADUFA III (Title I of Pub. L. 113–14) specifies that the aggregate fee revenue amount for FY 2016 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 three of the four fiscal years preceding FY 2016. The 3-year average is 2.2328 percent. TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE Fiscal year 2012 Total PC&B .............................................................................. Total FTE ................................................................................. PC&B per FTE ......................................................................... Percent Change from Previous Year ...................................... The statute specifies that this 2.2328 percent should be multiplied by the $1,824,703,000 13,382 $136,355 3.1843% 2013 2014 $1,927,703,000 13,974 $137,949 1.169% proportion of PC&B costs to total FDA costs. Table 2 shows the amount of $2,054,937,000 14,555 $141,184 2.3451% 3-Year average 2.2328% 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 2012 Total PC&B .............................................................................. Total Costs ............................................................................... PC&B Percent .......................................................................... The payroll adjustment is 2.2328 percent multiplied by 48.5449 percent (or 1.0839 percent). The statute specifies that the portion of the inflation adjustment for nonpayroll costs for FY 2016 is the average annual percent change that occurred in $1,824,703,000 $3,550,496,000 51.3929% 2013 2014 $1,927,703,000 $4,151,343,000 46.4356% $2,054,937,000 $4,298,476,000 47.8062% 3-Year average 48.5449% 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. 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 TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI LESS FOOD AND ENERGY mstockstill on DSK4VPTVN1PROD with NOTICES Year 2012 Annual CPI ............................................................................... Annual Percent Change .......................................................... To calculate the inflation adjustment for non-pay costs, we multiply the 1.9982 percent by the proportion of all VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 2013 144.413 2.4475% 146.953 1.7588% costs other than PC&B to total FDA costs. Since 48.5449 percent was obligated for PC&B as shown in table 2, PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 2014 149.581 1.7883% 3-Year average 1.9982% 51.4551 percent is the portion of costs other than PC&B (100 percent minus 48.5449 percent equals 51.4551 E:\FR\FM\03AUN1.SGM 03AUN1 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices percent). The non-payroll adjustment is 1.9982 percent times 51.4551 percent, or 1.0282 percent. Next, we add the payroll component (1.0839 percent) to the non-pay component (1.0282 percent), for a total inflation adjustment of 2.1121 percent for FY 2016. 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 2016 (2.1121 percent) is compounded by adding 1 and then multiplying by 1 plus the inflation adjustment factor for FY 2015 (2.0201 percent), as published in the Federal Register of August 1, 2014 (79 FR 44787 to 44792), which equals 1.041749 (rounded) (1.021121 times 1.020201) for FY 2016. We then multiply the base revenue amount for FY 2016 ($21,600,000) by 1.041749, yielding an inflation adjusted amount of $22,501,778. 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 45995 most recent 5-year period that ended June 30, 2015. 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 5 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 1.4066 percent for FY 2016. This is the workload adjuster for FY 2016. TABLE 4—WORKLOAD ADJUSTER CALCULATION [numbers may not add due to rounding] Column 1 5-year average (base years) Application type mstockstill on DSK4VPTVN1PROD with NOTICES New Animal Drug Applications (NADAs) Supplemental NADAs with Safety or Efficacy Data ......................................... Manufacturing Supplements .................. Investigational Study Submissions ........ Investigational Protocol Submissions .... FY 2016 Workload Adjuster ................... 18:35 Jul 31, 2015 Jkt 235001 Column 3 percent change Column 4 weighting factor Column 5 weighted % change 9.80 11.6 18.4% 0.0215 0.3945% 9.6 361.0 216.4 133.6 .............................. 12.8 345.8 210.8 149.4 .............................. 33.3% ¥4.2% ¥2.6% 11.8% .............................. 0.0352 0.1437 0.6254 0.1742 .............................. 1.1749% ¥0.6049% ¥1.6184% 2.0605% 1.4066% Over the last several years FDA has seen an increase in the number of animal drug sponsors requesting meetings to discuss new animal drug product development. These meeting requests come from both existing animal drug sponsors as well as sponsors new to the animal drug market. These factors have contributed to an increase in the number of protocol submissions and New Animal Drug Applications (NADAs) submitted for many novel drug classes and novel indications for both food-producing animals and companion animals. 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. As a result, the statutory revenue amount after the inflation adjustment ($22,501,778) must now be increased by 1.4066 percent to reflect the changes in review workload (workload adjustment), for a total fee revenue target of VerDate Sep<11>2014 Column 2 latest 5-year average $22,818,000 (rounded to the nearest thousand dollars). A. Application Fee Revenues and Numbers of Fee-Paying Applications D. FY 2016 Fee Revenue Amounts The application fee must be paid for any animal drug application or supplemental animal drug application that is subject to fees under ADUFA and that is submitted on or after September 1, 2003. The application fees are to be set so that they will generate $4,564,000 in fee revenue for FY 2016, after workload adjustment ($4,500,000 times 1.014066, rounded to the nearest thousand dollars). 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 $4,564,000 FDA must first make some assumptions about the number of fee-paying applications and supplements the Agency will receive in FY 2016. ADUFA III specifies that the revenue amount of $22,818,000 for FY 2016 is to be divided as follows: 20 percent, or a total of $4,564,000 (rounded to the nearest thousand dollars), is to come from application fees; 27 percent, or a total of $6,161,000 (rounded to the nearest thousand dollars), is to come from product fees; 26 percent, or a total of $5,932,000 (rounded to the nearest thousand dollars), is to come from establishment fees; and 27 percent, or a total of $6,161,000 (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 2016 The terms ‘‘animal drug application’’ and ‘‘supplemental animal drug application’’ are defined in section 739 of the FD&C Act (21 U.S.C. 379j–11(1) and (2)). PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1 45996 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 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 2016, FDA is assuming that the number of applications that will pay fees in FY 2016 will equal the average number of submissions over the 5 most recent completed years of ADUFA (FY 2010 to FY 2014). FDA believes that this is a reasonable approach after 11 completed years of experience with this program. Over the 5 most recent completed years, the average number of animal drug applications that would have been subject to the full fee was 6.8. Over this same period, the average number of supplemental applications 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 12.4. B. Application Fee Rates for FY 2016 FDA must set the fee rates for FY 2016 so that the estimated 6.8 applications that pay the full fee and the estimated 12.4 supplemental applications 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 $4,564,000. To generate this amount, the fee for an animal drug application, rounded to the nearest $100, will have to be $351,100, 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 $175,550. IV. Product Fee Calculations for FY 2016 mstockstill on DSK4VPTVN1PROD with NOTICES 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. (See 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 VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 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 $6,161,000 in fee revenue for FY 2016, after workload adjustment ($6,076,000 times 1.014066, rounded to the nearest thousand dollars). To set animal drug product fees to realize $6,161,000, FDA must make some assumptions about the number of products for which these fees will be paid in FY 2016. 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 2015, 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 2016. In estimating the fee revenue to be generated by animal drug product fees in FY 2016, FDA is assuming that 3 percent of the products invoiced, or 24, will not pay fees in FY 2016 due to fee waivers and reductions. FDA has reduced the estimate of the percentage of products that will not pay fees from 4 percent to 3 percent this year, based on historical data over the past 5 completed years of the ADUFA program. Based on experience over the first 11 completed years of ADUFA, FDA believes that this is a reasonable basis for estimating the number of feepaying products in FY 2016. Accordingly, the Agency estimates that a total of 791 (815 minus 24) products will be subject to product fees in FY 2016. B. Product Fee Rates for FY 2016 FDA must set the fee rates for FY 2016 so that the estimated 791 products that pay fees will generate a total of $6,161,000. To generate this amount will require the fee for an animal drug product, rounded to the nearest $5, to be $7,790. V. Establishment Fee Calculations for FY 2016 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, PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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. (See 21 U.S.C. 379j–12(a)(3).) The term ‘‘animal drug establishment’’ is defined in 21 U.S.C. 379j–11(4). The establishment fees are to be set so that they will generate $5,932,000 in fee revenue for FY 2016, after workload adjustment ($5,850,000 times 1.014066, rounded to the nearest thousand dollars). To set animal drug establishment fees to realize $5,932,000, FDA must make some assumptions about the number of establishments for which these fees will be paid in FY 2016. 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 2015, FDA estimates that there are a total of 64 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 64 establishments will be subject to this fee in FY 2016. In estimating the fee revenue to be generated by animal drug establishment fees in FY 2016, FDA is assuming that 12 percent of the establishments invoiced, or 8, will not pay fees in FY 2016 due to fee waivers and reductions. FDA has kept this estimate at 12 percent this year, based on historical data over the past 5 completed years. Based on experience over the past 11 completed years of ADUFA, FDA believes that this is a reasonable basis for estimating the number of fee-paying establishments in FY 2016. Accordingly, the Agency estimates that a total of 56 establishments (64 minus 8) will be subject to establishment fees in FY 2016. B. Establishment Fee Rates for FY 2016 FDA must set the fee rates for FY 2016 so that the estimated 56 establishments that pay fees will generate a total of $5,932,000. To generate this amount will require the fee for an animal drug E:\FR\FM\03AUN1.SGM 03AUN1 45997 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices establishment, rounded to the nearest $50, to be $105,950. VI. Sponsor Fee Calculations for FY 2016 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 $6,161,000 in fee revenue for FY 2016, after workload adjustment ($6,076,000 times 1.014066, rounded to the nearest thousand dollars). To set animal drug sponsor fees to realize $6,161,000, FDA must make some assumptions about the number of sponsors who will pay these fees in FY 2016. Based on the number of firms that would have met this definition in each of the past 11 completed years of ADUFA, FDA estimates that a total of 173 sponsors will meet this definition in FY 2016. Careful review indicates that 33 percent of these sponsors will qualify for minor use/minor species 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 65 percent of the sponsors invoiced, or 112, who will not pay fees in FY 2016 due to fee waivers and reductions. FDA has kept this estimate at 65 percent this year, based on historical data over the past 5 completed years of ADUFA. FDA believes that this is a reasonable basis for estimating the number of fee-paying sponsors in FY 2016. Accordingly, the Agency estimates that a total of 61 sponsors (173 minus 112) will be subject to and pay sponsor fees in FY 2016. B. Sponsor Fee Rates for FY 2016 FDA must set the fee rates for FY 2016 so that the estimated 61 sponsors that pay fees will generate a total of $6,161,000. To generate this amount will require the fee for an animal drug sponsor, rounded to the nearest $50, to be $101,000. VII. Fee Schedule for FY 2016 The fee rates for FY 2016 are summarized in table 5. TABLE 5—FY 2016 FEE RATES Fee rate for FY 2016 Animal drug user fee category Animal Drug Application Fees: Animal Drug Application ............................................................................................................................................................... Supplemental Animal Drug Application for which 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 .................................................................................................................................................................... Animal Drug Establishment Fee 1 ........................................................................................................................................................ Animal Drug Sponsor Fee 2 ................................................................................................................................................................. 1 An 2 An 175,550 7,790 105,950 101,000 animal drug establishment is subject to only one such fee each fiscal year. animal drug sponsor is subject to only one such fee each fiscal year. VIII. Procedures for Paying the FY 2016 Fees A. Application Fees and Payment Instructions mstockstill on DSK4VPTVN1PROD with NOTICES $351,100 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 that is submitted on or after October 1, 2015. Payment must be made in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration, by wire transfer, or electronically using Pay.gov. (The Pay.gov payment option is available to you after you submit a cover sheet. Click the ‘‘Pay Now’’ button.) On your check, bank draft, or U.S. postal money order, please write your application’s unique Payment Identification Number (PIN), beginning with the letters AD, from the upper right-hand corner of your completed Animal Drug User Fee Cover Sheet. Also write the FDA post office VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 box number (P.O. Box 979033) on the enclosed check, bank draft, or money order. Your payment and a copy of the completed Animal Drug User Fee Cover Sheet can be mailed to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197–9000. If payment is made by wire transfer, send payment to: 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., Silver Spring, MD 20993–0002. You are responsible for any administrative costs associated with the processing of a wire transfer. Contact your bank or financial institution about the fee and add it to your payment to ensure that your fee is fully paid. If you prefer to send a check by a courier, the courier may deliver the check and printed copy of the cover PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 the U.S. Bank at 314–418–4013. This telephone number is only for questions about courier delivery.) 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.) It is helpful if 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 E:\FR\FM\03AUN1.SGM 03AUN1 45998 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES B. Application Cover Sheet Procedures Food and Drug Administration 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 click ‘‘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. [Docket No. FDA–2015–N–0001] C. Product, Establishment, and Sponsor Fees mstockstill on DSK4VPTVN1PROD with NOTICES within 1 working day, using the PIN described previously. Jacqueline Brooks-Leighton, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 21, Rm. 4521, Silver Spring, MD 20993, 240–402– 5292, FAX: 301–796–9907, jacqueline.brooks-leighton@fda.hhs.gov. SUPPLEMENTARY INFORMATION: By December 31, 2015, FDA will issue invoices and payment instructions for product, establishment, and sponsor fees for FY 2016 using this fee schedule. Payment will be due by January 31, 2016. FDA will issue invoices in November 2016 for any products, establishments, and sponsors subject to fees for FY 2016 that qualify for fees after the December 2015 billing. Dated: July 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18913 Filed 7–31–15; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the sixth annual scientific workshop cosponsored by the Agency and the Coalition Against Major Diseases (CAMD) Consortium of the Critical Path Institute (C-Path). The purpose of this public workshop is to initiate constructive discussion among scientists from FDA, the CAMD Consortium, and other interested parties regarding ongoing efforts to develop tools and methods to facilitate drug development for Alzheimer’s disease and Parkinson’s disease. DATES: The public scientific workshop will be held on October 15, 2015, from 8 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993–0002. Entrance for the public scientific workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to http:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. SUMMARY: community, patient advocacy groups, and governmental institutions; including, the National Institute of Aging, the National Institute of Neurological Disorders and Stroke, and the European Medicines Agency. The objectives of the workshop include: 1. Understanding the accomplishments of CAMD scientific projects 2. Discussing how these tools are currently or will be applied in drug development 3. Obtaining commitment for sharing information/data to begin quantifying benefits of these tools 4. Facilitating robust and open discussion among all parties of drug development in Alzheimer’s and Parkinson’s diseases I. Background II. Attendance and Registration The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Individuals who wish to participate in the scientific workshop (in person or via the Internet) must register on or before October 1, 2015, by visiting https://www.SignUp4.net/ public/ap.aspx?EID=SIXT10E. Early registration is recommended; registration is free and will be on a firstcome, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Onsite registration on the day of the scientific workshop will be based on space availability. The registration deadline is October 14, 2015. An agenda will be provided approximately 2 weeks before the scientific workshop at the FDA Meeting Information page, which is available online at: http://www.fda.gov/Drugs/ NewsEvents/ucm410863.htm. If you need special accommodations because of a disability, please contact Jacqueline Brooks-Leighton (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the scientific workshop. A live webcast of this scientific workshop will be viewable at Adobe Connect Link: https:// collaboration.fda.gov/camd101515/ on the day of the scientific workshop. A video record of the scientific workshop will be available at the same Web address for 1 year. FDA and C-Path seek to leverage their combined strengths to create new tools and methods to increase the efficiency of the drug development process and bring new treatments for Alzheimer’s disease and Parkinson’s disease. This annual public workshop brings together representatives from the pharmaceutical industry, the academic research III. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at http:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45993-45998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18913]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]


Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 
2016

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) 2016 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 2016.

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, 7519 Standish Pl., Rockville, MD 20855, 240-
402-6888. For general questions, you may also email the Center for 
Veterinary Medicine (CVM) at: cvmadufa@fda.hhs.gov.

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

[[Page 45994]]

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 2016, the animal drug user fee rates are: $351,100 for an 
animal drug application; $175,550 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)); $7,790 for an annual 
product fee; $105,950 for an annual establishment fee; and $101,000 for 
an annual sponsor fee. FDA will issue invoices for FY 2016 product, 
establishment, and sponsor fees by December 31, 2015, and payment will 
be due by January 31, 2016. The application fee rates are effective for 
applications submitted on or after October 1, 2015, and will remain in 
effect through September 30, 2016. 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 ADUFA.

II. Revenue Amount for FY 2016

A. Statutory Fee Revenue Amounts

    ADUFA III (Title I of Pub. L. 113-14) specifies that the aggregate 
fee revenue amount for FY 2016 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 three of the four 
fiscal years preceding FY 2016. The 3-year average is 2.2328 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2012               2013               2014          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,824,703,000     $1,927,703,000     $2,054,937,000
Total FTE...........................             13,382             13,974             14,555
PC&B per FTE........................           $136,355           $137,949           $141,184
Percent Change from Previous Year...            3.1843%             1.169%            2.3451%            2.2328%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 2.2328 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                     2012               2013               2014          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,824,703,000     $1,927,703,000     $2,054,937,000
Total Costs.........................     $3,550,496,000     $4,151,343,000     $4,298,476,000
PC&B Percent........................           51.3929%           46.4356%           47.8062%           48.5449%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.2328 percent multiplied by 48.5449 
percent (or 1.0839 percent).
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs for FY 2016 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                         2012               2013               2014          3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            144.413            146.953            149.581
Annual Percent Change...............            2.4475%            1.7588%            1.7883%            1.9982%
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we 
multiply the 1.9982 percent by the proportion of all costs other than 
PC&B to total FDA costs. Since 48.5449 percent was obligated for PC&B 
as shown in table 2, 51.4551 percent is the portion of costs other than 
PC&B (100 percent minus 48.5449 percent equals 51.4551

[[Page 45995]]

percent). The non-payroll adjustment is 1.9982 percent times 51.4551 
percent, or 1.0282 percent.
    Next, we add the payroll component (1.0839 percent) to the non-pay 
component (1.0282 percent), for a total inflation adjustment of 2.1121 
percent for FY 2016.
    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 2016 (2.1121 percent) is compounded by adding 1 and then 
multiplying by 1 plus the inflation adjustment factor for FY 2015 
(2.0201 percent), as published in the Federal Register of August 1, 
2014 (79 FR 44787 to 44792), which equals 1.041749 (rounded) (1.021121 
times 1.020201) for FY 2016. We then multiply the base revenue amount 
for FY 2016 ($21,600,000) by 1.041749, yielding an inflation adjusted 
amount of $22,501,778.

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, 2015.
    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 5 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 1.4066 percent for FY 2016. This is the workload 
adjuster for FY 2016.

                                                         Table 4--Workload Adjuster Calculation
                                                          [numbers may not add due to rounding]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Column 1 5-year
                     Application type                        average (base    Column 2 latest 5-  Column 3 percent       Column 4      Column 5 weighted
                                                                 years)          year average          change        weighting factor       % change
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADAs).....................               9.80               11.6              18.4%             0.0215            0.3945%
Supplemental NADAs with Safety or Efficacy Data..........                9.6               12.8              33.3%             0.0352            1.1749%
Manufacturing Supplements................................              361.0              345.8              -4.2%             0.1437           -0.6049%
Investigational Study Submissions........................              216.4              210.8              -2.6%             0.6254           -1.6184%
Investigational Protocol Submissions.....................              133.6              149.4              11.8%             0.1742            2.0605%
FY 2016 Workload Adjuster................................  .................  .................  .................  .................            1.4066%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Over the last several years FDA has seen an increase in the number 
of animal drug sponsors requesting meetings to discuss new animal drug 
product development. These meeting requests come from both existing 
animal drug sponsors as well as sponsors new to the animal drug market. 
These factors have contributed to an increase in the number of protocol 
submissions and New Animal Drug Applications (NADAs) submitted for many 
novel drug classes and novel indications for both food-producing 
animals and companion animals. 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. As a result, the 
statutory revenue amount after the inflation adjustment ($22,501,778) 
must now be increased by 1.4066 percent to reflect the changes in 
review workload (workload adjustment), for a total fee revenue target 
of $22,818,000 (rounded to the nearest thousand dollars).

D. FY 2016 Fee Revenue Amounts

    ADUFA III specifies that the revenue amount of $22,818,000 for FY 
2016 is to be divided as follows: 20 percent, or a total of $4,564,000 
(rounded to the nearest thousand dollars), is to come from application 
fees; 27 percent, or a total of $6,161,000 (rounded to the nearest 
thousand dollars), is to come from product fees; 26 percent, or a total 
of $5,932,000 (rounded to the nearest thousand dollars), is to come 
from establishment fees; and 27 percent, or a total of $6,161,000 
(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 2016

    The terms ``animal drug application'' and ``supplemental animal 
drug application'' are defined in section 739 of the FD&C Act (21 
U.S.C. 379j-11(1) and (2)).

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    The application fee must be paid for any animal drug application or 
supplemental animal drug application that is subject to fees under 
ADUFA and that is submitted on or after September 1, 2003. The 
application fees are to be set so that they will generate $4,564,000 in 
fee revenue for FY 2016, after workload adjustment ($4,500,000 times 
1.014066, rounded to the nearest thousand dollars). 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 $4,564,000 FDA must first make some 
assumptions about the number of fee-paying applications and supplements 
the Agency will receive in FY 2016.

[[Page 45996]]

    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 2016, FDA is assuming that the number of 
applications that will pay fees in FY 2016 will equal the average 
number of submissions over the 5 most recent completed years of ADUFA 
(FY 2010 to FY 2014). FDA believes that this is a reasonable approach 
after 11 completed years of experience with this program.
    Over the 5 most recent completed years, the average number of 
animal drug applications that would have been subject to the full fee 
was 6.8. Over this same period, the average number of supplemental 
applications 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 12.4.

B. Application Fee Rates for FY 2016

    FDA must set the fee rates for FY 2016 so that the estimated 6.8 
applications that pay the full fee and the estimated 12.4 supplemental 
applications 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 $4,564,000. To generate this amount, the fee for an 
animal drug application, rounded to the nearest $100, will have to be 
$351,100, 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 $175,550.

IV. Product Fee Calculations for FY 2016

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. (See 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 $6,161,000 in fee revenue for 
FY 2016, after workload adjustment ($6,076,000 times 1.014066, rounded 
to the nearest thousand dollars).
    To set animal drug product fees to realize $6,161,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2016. 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 
2015, 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 2016.
    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2016, FDA is assuming that 3 percent of the products 
invoiced, or 24, will not pay fees in FY 2016 due to fee waivers and 
reductions. FDA has reduced the estimate of the percentage of products 
that will not pay fees from 4 percent to 3 percent this year, based on 
historical data over the past 5 completed years of the ADUFA program. 
Based on experience over the first 11 completed years of ADUFA, FDA 
believes that this is a reasonable basis for estimating the number of 
fee-paying products in FY 2016.
    Accordingly, the Agency estimates that a total of 791 (815 minus 
24) products will be subject to product fees in FY 2016.

B. Product Fee Rates for FY 2016

    FDA must set the fee rates for FY 2016 so that the estimated 791 
products that pay fees will generate a total of $6,161,000. To generate 
this amount will require the fee for an animal drug product, rounded to 
the nearest $5, to be $7,790.

V. Establishment Fee Calculations for FY 2016

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 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. 
(See 21 U.S.C. 379j-12(a)(3).) The term ``animal drug establishment'' 
is defined in 21 U.S.C. 379j-11(4). The establishment fees are to be 
set so that they will generate $5,932,000 in fee revenue for FY 2016, 
after workload adjustment ($5,850,000 times 1.014066, rounded to the 
nearest thousand dollars).
    To set animal drug establishment fees to realize $5,932,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2016. 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 2015, FDA estimates that there are a total of 64 
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 64 establishments 
will be subject to this fee in FY 2016.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2016, FDA is assuming that 12 percent of the 
establishments invoiced, or 8, will not pay fees in FY 2016 due to fee 
waivers and reductions. FDA has kept this estimate at 12 percent this 
year, based on historical data over the past 5 completed years. Based 
on experience over the past 11 completed years of ADUFA, FDA believes 
that this is a reasonable basis for estimating the number of fee-paying 
establishments in FY 2016.
    Accordingly, the Agency estimates that a total of 56 establishments 
(64 minus 8) will be subject to establishment fees in FY 2016.

B. Establishment Fee Rates for FY 2016

    FDA must set the fee rates for FY 2016 so that the estimated 56 
establishments that pay fees will generate a total of $5,932,000. To 
generate this amount will require the fee for an animal drug

[[Page 45997]]

establishment, rounded to the nearest $50, to be $105,950.

VI. Sponsor Fee Calculations for FY 2016

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 $6,161,000 in fee revenue for FY 2016, after 
workload adjustment ($6,076,000 times 1.014066, rounded to the nearest 
thousand dollars).
    To set animal drug sponsor fees to realize $6,161,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2016. Based on the number of firms that would have met this 
definition in each of the past 11 completed years of ADUFA, FDA 
estimates that a total of 173 sponsors will meet this definition in FY 
2016.
    Careful review indicates that 33 percent of these sponsors will 
qualify for minor use/minor species 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 65 
percent of the sponsors invoiced, or 112, who will not pay fees in FY 
2016 due to fee waivers and reductions. FDA has kept this estimate at 
65 percent this year, based on historical data over the past 5 
completed years of ADUFA. FDA believes that this is a reasonable basis 
for estimating the number of fee-paying sponsors in FY 2016.
    Accordingly, the Agency estimates that a total of 61 sponsors (173 
minus 112) will be subject to and pay sponsor fees in FY 2016.

B. Sponsor Fee Rates for FY 2016

    FDA must set the fee rates for FY 2016 so that the estimated 61 
sponsors that pay fees will generate a total of $6,161,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest $50, to be $101,000.

VII. Fee Schedule for FY 2016

    The fee rates for FY 2016 are summarized in table 5.

                       Table 5--FY 2016 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                   FY 2016
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................        $351,100
    Supplemental Animal Drug Application for which               175,550
     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.................................           7,790
Animal Drug Establishment Fee \1\.......................         105,950
Animal Drug Sponsor Fee \2\.............................         101,000
------------------------------------------------------------------------
\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. Procedures for Paying the FY 2016 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 that is submitted on or after October 1, 2015. Payment 
must be made in U.S. currency by check, bank draft, or U.S. postal 
money order payable to the order of the Food and Drug Administration, 
by wire transfer, or electronically using Pay.gov. (The Pay.gov payment 
option is available to you after you submit a cover sheet. Click the 
``Pay Now'' button.) On your check, bank draft, or U.S. postal money 
order, please write your application's unique Payment Identification 
Number (PIN), beginning with the letters AD, from 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. Your payment and a copy of the completed 
Animal Drug User Fee Cover Sheet can be mailed to: Food and Drug 
Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
    If payment is made by wire transfer, send payment to: 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., Silver Spring, MD 20993-0002. You are 
responsible for any administrative costs associated with the processing 
of a wire transfer. Contact your bank or financial institution about 
the fee and add it to your payment to ensure that your fee is fully 
paid.
    If you prefer to send a check by a courier, the courier may 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 the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier 
delivery.)
    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.)
    It is helpful if 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

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within 1 working day, using the PIN described previously.

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 click ``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, 2015, FDA will issue invoices and payment 
instructions for product, establishment, and sponsor fees for FY 2016 
using this fee schedule. Payment will be due by January 31, 2016. FDA 
will issue invoices in November 2016 for any products, establishments, 
and sponsors subject to fees for FY 2016 that qualify for fees after 
the December 2015 billing.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18913 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P