Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2015, 44787-44792 [2014-18110]

Download as PDF 44787 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR 189.5(c) and 700.27(c) Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeper Total hours Domestic facilities ............................. Foreign facilities ................................ 697 916 52 52 36,244 47,632 0.25 (15 minutes) ............................. 0.25 (15 minutes) ............................. 9,061 11,908 Total ........................................... ........................ ........................ ........................ ........................................................... 20,969 1 There are no capital or operating and maintenance costs associated with this collection of information. Except where otherwise noted, this estimate is based on FDA’s estimate of the number of facilities affected by the final rule entitled, ‘‘Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle,’’ published in the Federal Register of October 11, 2006 (71 FR 59653). tkelley on DSK3SPTVN1PROD with NOTICES Reporting FDA’s regulations in §§ 189.5(c)(6) and 700.27(c)(6) impose a reporting burden on importers of human food and cosmetics manufactured from, processed with, or otherwise containing cattle material. Importers of these products must affirm that the human food or cosmetics are not manufactured from, processed with, or otherwise contain prohibited cattle materials and must affirm that the human food or cosmetics were manufactured in accordance with the applicable requirements of §§ 189.5 or 700.27. The affirmation is made by the importer of record to the FDA through FDA’s Operational and Administrative System for Import Support. Affirmation by importers is expected to take approximately 2 minutes per entry line. Table 2 shows 54,825 lines of human food and cosmetics likely to contain cattle materials are imported annually. The reporting burden of affirming whether import entry lines contain cattle-derived materials is estimated to take 1,809 hours annually (54,825 lines multiplied by 2 minutes per line). FDA’s estimate of the reporting burden for designation under §§ 189.5 and 700.27 is based on its experience and the average number of requests for designation received in the past 3 years. In the last 3 years, FDA has not received any requests for designation. Thus, FDA estimates that one or fewer will be received annually in the future. Based on this experience, FDA estimates the annual number of new requests for designation will be one. FDA estimates that preparing the information required by §§ 189.5 and 700.27 and submitting it to FDA in the form of a written request to the CFSAN Director will VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 require a burden of approximately 80 hours per request. Thus, the burden for new requests for designation is estimated to be 80 hours annually, as shown in Table 1, row 1. Under §§ 189.5(e) and 700.27(e), designated countries are subject to future review by FDA and may respond to periodic FDA requests by submitting information to confirm their designations remain appropriate. In the last 3 years, FDA has not requested any reviews. Thus, FDA estimates that one or fewer will occur annually in the future. FDA estimates that the designated country undergoing a review in the future will need one-third of the time it took preparing its request for designation to respond to FDA’s request for review, or 26 hours (80 hours × 0.33 = 26.4 hours, rounded to 26). The annual burden for reviews is estimated to be 26 hours, as shown in Table 1, row 2. The total reporting burden for this information collection is estimated to be 1,915 hours annually. Recordkeeping FDA estimates that there are 697 domestic facility relationships and 916 foreign facility relationships consisting of the following facilities: An input supplier of cattle-derived materials that requires records (the upstream facility) and a purchaser of cattle-derived materials requiring documentation (this may be a human food or cosmetics manufacturer or processor). The recordkeeping burden of FDA’s regulations in §§ 189.5(c) and 700.27(c) is the burden of sending, verifying, and storing documents regarding shipments of cattle material that is to be used in human food and cosmetics. In this estimate of the recordkeeping burden, FDA treats these recordkeeping activities as shared activities between the upstream and downstream facilities. It is in the best interests of both facilities in the relationship to share the burden necessary to comply with the regulations; therefore, FDA estimates the time burden of developing these records as a joint task between the two facilities. Thus, FDA estimates that this recordkeeping burden will be about 15 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 minutes per week, or 13 hours per year, and FDA assumes that the recordkeeping burden will be shared between 2 entities (i.e., the ingredient supplier and the manufacturer of finished products). Therefore, the total recordkeeping burden for domestic facilities is estimated to be 9,061 hours (13 hours multiplied by 697), and the total recordkeeping burden for foreign facilities is estimated to be 11,908 hours (13 hours multiplied by 916), as shown in Table 1. Dated: July 28, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18109 Filed 7–31–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0007] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2015 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) 2015 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 document establishes the fee rates for FY 2015. FOR FURTHER INFORMATION CONTACT: Visit FDA’s Web site at http://www.fda.gov/ ForIndustry/UserFees/ AnimalDrugUserFeeActADUFA/ default.htm or contact Lisa Kable, SUMMARY: E:\FR\FM\01AUN1.SGM 01AUN1 44788 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices Center for Veterinary Medicine (HFV– 10), Food and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240–276–9718. 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 so that the percentages of the total revenue that is 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 2015, the animal drug user fee rates are: $400,600 for an animal drug application; $200,300 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)); $8,075 for an annual product fee; $104,150 for an annual establishment fee; and $94,450 for an annual sponsor fee. FDA will issue invoices for FY 2015 product, establishment, and sponsor fees by December 31, 2014, and payment will be due by January 31, 2015. The application fee rates are effective for applications submitted on or after October 1, 2014, and will remain in effect through September 30, 2015. 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 2015 A. Statutory Fee Revenue Amounts ADUFA III (Title I of Pub. L. 113–14) specifies that the aggregate fee revenue amount for FY 2015 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 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 1 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 preceding four fiscal years (see 21 U.S.C. 379j– 12(c)(2)(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 2015. The 3-year average is 1.8829 percent. TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE Fiscal year 2011 Total PC&B .............................................................................. Total FTE ................................................................................. PC&B per FTE ......................................................................... Percent Change from Previous Year ...................................... The statute specifies that this 1.8829 percent should be multiplied by the $1,761,655,000 13,331 $132,147 1.2954% 2012 2013 $1,824,703,000 13,382 $136,355 3.1843% proportion of PC&B costs to total FDA costs. Table 2 shows the amount of 3-Year average (percent) $1,927,703,000 13,974 $137,949 1.169% 1.8829 PC&B and the total amount obligated by FDA for the same three fiscal years. TABLE 2—PERSONNEL COMPENSATION AND BENEFITS (PC&B) AS A PERCENT OF TOTAL COSTS AT FDA Fiscal year 2011 tkelley on DSK3SPTVN1PROD with NOTICES Total PC&B ...................................................................... Total Costs ....................................................................... PC&B Percent .................................................................. The payroll adjustment is 1.8829 percent multiplied by 50.2257 percent (or .9457 percent). The statute specifies that the portion of the inflation adjustment for nonpayroll costs for FY 2015 is the average annual percent change that occurred in VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 2012 $1,761,655,000 $3,333,407,000 52.8485% $1,824,703,000 $3,550,496,000 51.3929% the Consumer Price Index (CPI) for urban consumers (WashingtonBaltimore, 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 2013 $1,927,703,000 $4,151,343,000 46.4356% 3-Year average 50.2257% 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. E:\FR\FM\01AUN1.SGM 01AUN1 44789 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI LESS FOOD AND ENERGY Year 2011 Annual CPI ....................................................................... Annual Percent Change .................................................. To calculate the inflation adjustment for non-pay costs, we multiply the 2.1586 percent by the proportion of all costs other than PC&B to total FDA costs. Since 50.2257 percent was obligated for PC&B as shown in Table 2, 49.7743 percent is the portion of costs other than PC&B (100%¥50.2257& = 49.7743 percent). The non-payroll adjustment is 2.1586 percent times 49.7743 percent, or 1.0744 percent. To complete the inflation adjustment, we add the payroll component (0.9457 percent) to the non-pay component (1.0744 percent), for a total inflation adjustment of 2.0201 percent, and then add one, making 1.020201. We then multiply the base revenue amount for FY 2015 ($21,600,000) by 1.020201, yielding an inflation adjusted amount of $22,036,000 (rounded to the nearest thousand dollars). 2012 140.963 2.2694% 2013 144.413 2.4475% 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 3-Year average 146.953 1.7588% 2.1586% most recent 5-year period that ended June 30, 2014. 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 the table the sum of the values in column 5 is added, reflecting a total change in workload of ¥0.47 percent for FY 2015. This is the workload adjuster for FY 2015. TABLE 4—WORKLOAD ADJUSTER CALCULATION [Numbers may not add due to rounding] Column 2 latest 5-year avg. New Animal Drug Applications (NADAs) ............................................... Supplemental NADAs with Safety or Efficacy Data .............................. Manufacturing Supplements .................................................................. Investigational Study Submissions ........................................................ Investigational Protocol Submissions .................................................... 9.80 9.6 361.0 216.4 133.6 13.2 11.4 349.6 211.6 133.4 35 19 ¥3 ¥2 0 0.0214 0.0349 0.1385 0.6334 0.1718 0.74 0.65 ¥0.44 ¥1.41 ¥0.03 FY 2015 Workload Adjuster ................................................................... ...................... .................... .................... .................... ¥0.47 tkelley on DSK3SPTVN1PROD with NOTICES ADUFA specifies that the workload adjuster may not result in fees that are less than the fee revenue amount in the statute (21 U.S.C. 379j–12(c)(3)(C)). Because applying the FY 2015 workload adjuster would result in fees less than the statutory amount, the workload adjustment will not be applied in FY 2015. As a result, the statutory revenue target amount for fees in FY 2015 remains at the inflation adjusted fee revenue amount of $22,036,000. from application fees; 27 percent, or a total of $5,950,000 (rounded to the nearest thousand dollars), is to come from product fees; 26 percent, or a total of $5,729,000 (rounded to the nearest thousand dollars), is to come from establishment fees; and 27 percent, or a total of $5,950,000 (rounded to the nearest thousand dollars), is to come from sponsor fees (21 U.S.C. 379j– 12(b)). D. FY 2015 Fee Revenue Amounts III. Application Fee Calculations for FY 2015 ADUFA III specifies that the revenue amount of $22,036,000 for FY 2015 is to be divided as follows: 20 percent, or a total of $4,407,000 (rounded to the nearest thousand dollars), is to come 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)). VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Column 3 percent change Column 4 weighting factor Column 5 weighted percent change Column 1 5-year avg. (base years) Application type 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 $4,407,000 in fee revenue for FY 2015. This is the amount derived in section II.D. 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)). E:\FR\FM\01AUN1.SGM 01AUN1 44790 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices To set animal drug application fees and supplemental animal drug application fees to realize $4,407,000 FDA must first make some assumptions about the number of fee-paying applications and supplements the Agency will receive in FY 2015. The Agency knows the number of applications that have been submitted in previous years. That number fluctuates significantly from year to year. In estimating the fee revenue to be generated by animal drug application fees in FY 2015, FDA is assuming that the number of applications that will pay fees in FY 2015 will equal the average number of submissions over the five most recent completed years (FY 2009– FY 2013). This may not fully account for possible year-to-year fluctuations in numbers of fee-paying applications, but FDA believes that this is a reasonable approach after 10 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 6.2. 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 9.6. B. Fee Rates for FY 2015 FDA must set the fee rates for FY 2015 so that the estimated 6.2 applications that pay the full fee and the estimated 9.6 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 $4,407,000. To generate this amount, the fee for an animal drug application, rounded to the nearest $100, will have to be $400,600, 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 $200,300. IV. Product Fee Calculations for FY 2015 tkelley on DSK3SPTVN1PROD 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 VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 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 $5,950,000 in fee revenue for FY 2015. This is the amount derived in section II.D. To set animal drug product fees to realize $5,950,000, FDA must make some assumptions about the number of products for which these fees will be paid in FY 2015. 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 2014, FDA estimates that there are a total of 768 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 768 products will be subject to this fee in FY 2015. In estimating the fee revenue to be generated by animal drug product fees in FY 2015, FDA is assuming that 4 percent of the products invoiced, or 31, will not pay fees in FY 2015 due to fee waivers and reductions. FDA has reduced the estimate of the percentage of products that will not pay fees from 6 percent to 4 percent this year, based on historical data over the past 5 years. Based on experience with other user fee programs and the first 10 years of ADUFA, FDA believes that this is a reasonable basis for estimating the number of fee-paying products in FY 2015. Accordingly, the Agency estimates that a total of 737 (768 minus 31) products will be subject to product fees in FY 2015. B. Product Fee Rates for FY 2015 FDA must set the fee rates for FY 2015 so that the estimated 737 products that pay fees will generate a total of $5,950,000. To generate this amount will require the fee for an animal drug product, rounded to the nearest $5, to be $8,075. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 V. Establishment Fee Calculations for FY 2015 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 $5,729,000 in fee revenue for FY 2015. This is the amount derived in section II.D. To set animal drug establishment fees to realize $5,729,000, FDA must make some assumptions about the number of establishments for which these fees will be paid in FY 2015. 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 2014, FDA estimates that there are a total of 62 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 62 establishments will be subject to this fee in FY 2015. In estimating the fee revenue to be generated by animal drug establishment fees in FY 2015, FDA is assuming that 12 percent of the establishments invoiced, or 7, will not pay fees in FY 2015 due to fee waivers and reductions. FDA has kept this estimate at 12 percent this year, based on historical data over the past 5 years. Based on experience with the first 10 years of ADUFA, FDA believes that this is a reasonable basis for estimating the number of fee-paying establishments in FY 2015. Accordingly, the Agency estimates that a total of 55 establishments (62 minus 7) will be subject to establishment fees in FY 2015. E:\FR\FM\01AUN1.SGM 01AUN1 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices B. Establishment Fee Rates for FY 2015 FDA must set the fee rates for FY 2015 so that the estimated 55 establishments that pay fees will generate a total of $5,729,000. To generate this amount will require the fee for an animal drug establishment, rounded to the nearest $50, to be $104,150. tkelley on DSK3SPTVN1PROD with NOTICES VI. Sponsor Fee Calculations for FY 2015 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 $5,950,000 in fee revenue for FY 2015. This is the amount derived in section II.D. To set animal drug sponsor fees to realize $5,950,000, FDA must make some assumptions about the number of sponsors who will pay these fees in FY 2015. Based on the number of firms that would have met this definition in each of the past 10 years, FDA estimates that a total of 179 sponsors will meet this definition in FY 2015. 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 116, who will not pay fees in FY 2015 due to fee waivers and reductions. FDA has kept this estimate at 65 percent this year, based on historical data over the past 5 years. FDA believes that this is a reasonable basis for estimating the number of fee-paying sponsors in FY 2015. Accordingly, the Agency estimates that a total of 63 sponsors (179 minus 116) will be subject to and pay sponsor fees in FY 2015. VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 B. Sponsor Fee Rates for FY 2015 FDA must set the fee rates for FY 2015 so that the estimated 63 sponsors that pay fees will generate a total of $5,950,000. To generate this amount will require the fee for an animal drug sponsor, rounded to the nearest $50, to be $94,450. 44791 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 VII. Fee Schedule for FY 2015 20993–0002. You are responsible for any administrative costs associated with The fee rates for FY 2015 are the processing of a wire transfer. summarized in Table 5. Contact your bank or financial institution about the fee and add it to TABLE 5—FY 2015 FEE RATES your payment to ensure that your fee is Fee rate fully paid. Animal drug user fee category for FY If you prefer to send a check by a 2015 courier, the courier may deliver the check and printed copy of the cover Animal Drug Application Fees: sheet to: U.S. Bank, Attn: Government Animal Drug Application ........ $400,600 Lockbox 979033, 1005 Convention Supplemental Animal Drug Plaza, St. Louis, MO 63101. (Note: This Application for which Safeaddress is for courier delivery only. If ty or Effectiveness Data you have any questions concerning are Required or Animal Drug Application Subject to courier delivery contact the U.S. Bank at the Criteria Set Forth in 314–418–4013. This telephone number Section 512(d)(4) of the is only for questions about courier FD&C Act ........................... 200,300 delivery.) Animal Drug Product Fee ............. 8,075 The tax identification number of FDA Animal Drug Establishment Fee 1 104,150 is 53–0196965. (Note: In no case should 2 .......... Animal Drug Sponsor Fee 94,450 the payment for the fee be submitted to 1 An animal drug establishment is subject to FDA with the application.) only one such fee each fiscal year. It is helpful if the fee arrives at the 2 An animal drug sponsor is subject to only bank at least a day or two before the one such fee each fiscal year. application arrives at FDA’s CVM. FDA VIII. Procedures for Paying the FY 2015 records the official application receipt Fees date as the later of the following: The date the application was received by A. Application Fees and Payment FDA’s CVM, or the date U.S. Bank Instructions notifies FDA that your payment in the The appropriate application fee full amount has been received, or when established in the new fee schedule the U.S. Treasury notifies FDA of must be paid for an animal drug receipt of an electronic or wire transfer application or supplement subject to payment. U.S. Bank and the U.S. fees under ADUFA that is submitted on Treasury are required to notify FDA or after October 1, 2014. Payment must within 1 working day, using the PIN be made in U.S. currency by check, described previously. bank draft, or U.S. postal money order B. Application Cover Sheet Procedures payable to the order of the Food and Drug Administration, by wire transfer, Step One—Create a user account and or electronically using http:// password. Log on to the ADUFA Web www.pay.gov. (The Pay.gov payment site at http://www.fda.gov/ForIndustry/ option is available to you after you UserFees/ submit a cover sheet. Click the ‘‘Pay AnimalDrugUserFeeActADUFA/ Now’’ button.) On your check, bank default.htm and, under Tools and draft, or U.S. postal money order, please Resources, click ‘‘The Animal Drug User write your application’s unique Fee Cover Sheet’’ and then click ‘‘Create Payment Identification Number (PIN), ADUFA User Fee Cover Sheet.’’ For beginning with the letters ‘‘AD’’, from security reasons, each firm submitting the upper right-hand corner of your an application will be assigned an completed Animal Drug User Fee Cover organization identification number, and Sheet. Also write the FDA post office each user will also be required to set up box number (P.O. Box 979033) on the a user account and password the first enclosed check, bank draft, or money time you use this site. Online order. Your payment and a copy of the instructions will walk you through this completed Animal Drug User Fee Cover process. Sheet can be mailed to: Food and Drug Step Two—Create an Animal Drug Administration, P.O. Box 979033, St. User Cover Sheet, transmit it to FDA, Louis, MO 63197–9000. and print a copy. After logging into your PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\01AUN1.SGM 01AUN1 44792 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices 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, 2014, FDA will issue invoices and payment instructions for product, establishment, and sponsor fees for FY 2015 using this fee schedule. Payment will be due by January 31, 2015. FDA will issue invoices in November 2015 for any products, establishments, and sponsors subject to fees for FY 2015 that qualify for fees after the December 2014 billing. Dated: July 28, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18110 Filed 7–31–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0007] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2015 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2015 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2015. FOR FURTHER INFORMATION CONTACT: Visit FDA’s Web site at http://www.fda.gov/ ForIndustry/UserFees/AnimalGeneric DrugUserFeeActAGDUFA/default.htm, or contact Lisa Kable, Center for Veterinary Medicine (HFV–10), Food and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240–276– 9718. For general questions, you may also email the Center for Veterinary Medicine (CVM) at cvmagdufa@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 741 of the FD&C Act (21 U.S.C. 379j–21) establishes three different types of user fees: (1) Fees for certain types of abbreviated applications for generic new animal drugs; (2) annual fees for certain generic new animal drug products; and (3) annual fees for certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (21 U.S.C. 379j– 21(a)). When certain conditions are met, FDA will waive or reduce fees for generic new animal drugs intended solely to provide for a minor use or minor species indication (21 U.S.C. 379j–21(d)). For FY 2014 through FY 2018, the FD&C Act establishes aggregate yearly base revenue amounts for each of these fee categories. Base revenue amounts established for fiscal years after FY 2014 may be adjusted for workload. Fees for applications, products, and sponsors are to be established each year by FDA so that the revenue for each fee category will approximate the level established in the statute, after the level has been adjusted for workload. For FY 2015, the generic new animal drug user fee rates are: $189,200 for each abbreviated application for a generic new animal drug other than those subject to the criteria in section 512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $94,600 for each abbreviated application for a generic new animal drug subject to the criteria in section 512(d)(4); $8,500 for each generic new animal drug product; $80,900 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $60,675 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $40,450 for each generic new animal drug sponsor paying 50 percent of the PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 sponsor fee. FDA will issue invoices for FY 2015 product and sponsor fees by December 31, 2014. These fees will be due by January 31, 2015. The application fee rates are effective for all abbreviated applications for a generic new animal drug submitted on or after October 1, 2014, and will remain in effect through September 30, 2015. Applications will not be accepted for review until FDA has received full payment of related application fees and any other fees owed under the Animal Generic Drug User Fee program. II. Revenue Amount for FY 2015 A. Statutory Fee Revenue Amounts AGDUFA II, Title II of Public Law 113–14, specifies that the aggregate revenue amount for FY 2015 for abbreviated application fees is $1,736,000 and each of the other two generic new animal drug user fee categories, annual product fees and annual sponsor fees, is $2,604,000 each (see 21 U.S.C. 379j–21(b)). B. Inflation Adjustment to Fee Revenue Amount The amounts established in AGDUFA II for each year for FY 2014 through FY 2018 include an inflation adjustment; therefore, no further inflation adjustment is required. C. Workload Adjustment Fee Revenue Amount For each FY beginning after FY 2014, AGDUFA provides that statutory fee revenue amounts shall be further adjusted to reflect changes in review workload. (See 21 U.S.C. 379j–21(c)(2).) FDA calculated the average number of each of the four types of applications and submissions specified in the workload adjustment provision (abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new 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 on June 30, 2014. The results of these calculations are presented in the first two columns in Table 1. 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 generic new animal drug review E:\FR\FM\01AUN1.SGM 01AUN1

Agencies

[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44787-44792]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18110]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0007]


Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 
2015

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) 2015 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 document establishes the fee rates for FY 2015.

FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm 
or contact Lisa Kable,

[[Page 44788]]

Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 
7529 Standish Pl., Rockville, MD 20855, 240-276-9718. 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 so that the percentages of the 
total revenue that is 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 2015, the animal drug user fee rates are: $400,600 for an 
animal drug application; $200,300 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)); $8,075 for an annual 
product fee; $104,150 for an annual establishment fee; and $94,450 for 
an annual sponsor fee. FDA will issue invoices for FY 2015 product, 
establishment, and sponsor fees by December 31, 2014, and payment will 
be due by January 31, 2015. The application fee rates are effective for 
applications submitted on or after October 1, 2014, and will remain in 
effect through September 30, 2015. 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 2015

A. Statutory Fee Revenue Amounts

    ADUFA III (Title I of Pub. L. 113-14) specifies that the aggregate 
fee revenue amount for FY 2015 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 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 1 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 preceding four fiscal years 
(see 21 U.S.C. 379j-12(c)(2)(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 2015. The 3-year average is 1.8829 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                                                                                 3-Year average
             Fiscal year                     2011               2012               2013            (percent)
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,761,655,000     $1,824,703,000     $1,927,703,000
Total FTE...........................             13,331             13,382             13,974
PC&B per FTE........................           $132,147           $136,355           $137,949
Percent Change from Previous Year...            1.2954%            3.1843%             1.169%             1.8829
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.8829 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 three 
fiscal years.

             Table 2--Personnel Compensation and Benefits (PC&B) as a Percent of Total Costs at FDA
----------------------------------------------------------------------------------------------------------------
           Fiscal year                   2011                2012                2013           3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B......................      $1,761,655,000      $1,824,703,000      $1,927,703,000
Total Costs.....................      $3,333,407,000      $3,550,496,000      $4,151,343,000
PC&B Percent....................            52.8485%            51.3929%            46.4356%            50.2257%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.8829 percent multiplied by 50.2257 
percent (or .9457 percent).
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs for FY 2015 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.

[[Page 44789]]



     Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI Less Food and Energy
----------------------------------------------------------------------------------------------------------------
              Year                       2011                2012                2013           3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................             140.963             144.413             146.953
Annual Percent Change...........             2.2694%             2.4475%             1.7588%             2.1586%
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we 
multiply the 2.1586 percent by the proportion of all costs other than 
PC&B to total FDA costs. Since 50.2257 percent was obligated for PC&B 
as shown in Table 2, 49.7743 percent is the portion of costs other than 
PC&B (100%-50.2257& = 49.7743 percent). The non-payroll adjustment is 
2.1586 percent times 49.7743 percent, or 1.0744 percent.
    To complete the inflation adjustment, we add the payroll component 
(0.9457 percent) to the non-pay component (1.0744 percent), for a total 
inflation adjustment of 2.0201 percent, and then add one, making 
1.020201. We then multiply the base revenue amount for FY 2015 
($21,600,000) by 1.020201, yielding an inflation adjusted amount of 
$22,036,000 (rounded to the nearest thousand dollars).

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, 2014.
    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 
the table the sum of the values in column 5 is added, reflecting a 
total change in workload of -0.47 percent for FY 2015. This is the 
workload adjuster for FY 2015.

                                     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 avg.    latest 5-     percent     weighting     percent
                                                (base years)   year avg.      change       factor       change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADAs)..........          9.80         13.2           35       0.0214         0.74
Supplemental NADAs with Safety or Efficacy              9.6          11.4           19       0.0349         0.65
 Data.........................................
Manufacturing Supplements.....................        361.0         349.6           -3       0.1385        -0.44
Investigational Study Submissions.............        216.4         211.6           -2       0.6334        -1.41
Investigational Protocol Submissions..........        133.6         133.4            0       0.1718        -0.03
                                               -----------------------------------------------------------------
FY 2015 Workload Adjuster.....................  ............  ...........  ...........  ...........        -0.47
----------------------------------------------------------------------------------------------------------------

    ADUFA specifies that the workload adjuster may not result in fees 
that are less than the fee revenue amount in the statute (21 U.S.C. 
379j-12(c)(3)(C)). Because applying the FY 2015 workload adjuster would 
result in fees less than the statutory amount, the workload adjustment 
will not be applied in FY 2015. As a result, the statutory revenue 
target amount for fees in FY 2015 remains at the inflation adjusted fee 
revenue amount of $22,036,000.

D. FY 2015 Fee Revenue Amounts

    ADUFA III specifies that the revenue amount of $22,036,000 for FY 
2015 is to be divided as follows: 20 percent, or a total of $4,407,000 
(rounded to the nearest thousand dollars), is to come from application 
fees; 27 percent, or a total of $5,950,000 (rounded to the nearest 
thousand dollars), is to come from product fees; 26 percent, or a total 
of $5,729,000 (rounded to the nearest thousand dollars), is to come 
from establishment fees; and 27 percent, or a total of $5,950,000 
(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 2015

    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 $4,407,000 in 
fee revenue for FY 2015. This is the amount derived in section II.D. 
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)).

[[Page 44790]]

    To set animal drug application fees and supplemental animal drug 
application fees to realize $4,407,000 FDA must first make some 
assumptions about the number of fee-paying applications and supplements 
the Agency will receive in FY 2015.
    The Agency knows the number of applications that have been 
submitted in previous years. That number fluctuates significantly from 
year to year. In estimating the fee revenue to be generated by animal 
drug application fees in FY 2015, FDA is assuming that the number of 
applications that will pay fees in FY 2015 will equal the average 
number of submissions over the five most recent completed years (FY 
2009-FY 2013). This may not fully account for possible year-to-year 
fluctuations in numbers of fee-paying applications, but FDA believes 
that this is a reasonable approach after 10 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 6.2. 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 9.6.

B. Fee Rates for FY 2015

    FDA must set the fee rates for FY 2015 so that the estimated 6.2 
applications that pay the full fee and the estimated 9.6 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 $4,407,000. To generate this amount, the fee for an 
animal drug application, rounded to the nearest $100, will have to be 
$400,600, 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 $200,300.

IV. Product Fee Calculations for FY 2015

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 $5,950,000 in fee revenue for 
FY 2015. This is the amount derived in section II.D.
    To set animal drug product fees to realize $5,950,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2015. 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 
2014, FDA estimates that there are a total of 768 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 768 products will be 
subject to this fee in FY 2015.
    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2015, FDA is assuming that 4 percent of the products 
invoiced, or 31, will not pay fees in FY 2015 due to fee waivers and 
reductions. FDA has reduced the estimate of the percentage of products 
that will not pay fees from 6 percent to 4 percent this year, based on 
historical data over the past 5 years. Based on experience with other 
user fee programs and the first 10 years of ADUFA, FDA believes that 
this is a reasonable basis for estimating the number of fee-paying 
products in FY 2015.
    Accordingly, the Agency estimates that a total of 737 (768 minus 
31) products will be subject to product fees in FY 2015.

B. Product Fee Rates for FY 2015

    FDA must set the fee rates for FY 2015 so that the estimated 737 
products that pay fees will generate a total of $5,950,000. To generate 
this amount will require the fee for an animal drug product, rounded to 
the nearest $5, to be $8,075.

V. Establishment Fee Calculations for FY 2015

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 $5,729,000 in fee revenue for FY 2015. 
This is the amount derived in section II.D.
    To set animal drug establishment fees to realize $5,729,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2015. 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 2014, FDA estimates that there are a total of 62 
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 62 establishments 
will be subject to this fee in FY 2015.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2015, FDA is assuming that 12 percent of the 
establishments invoiced, or 7, will not pay fees in FY 2015 due to fee 
waivers and reductions. FDA has kept this estimate at 12 percent this 
year, based on historical data over the past 5 years. Based on 
experience with the first 10 years of ADUFA, FDA believes that this is 
a reasonable basis for estimating the number of fee-paying 
establishments in FY 2015.
    Accordingly, the Agency estimates that a total of 55 establishments 
(62 minus 7) will be subject to establishment fees in FY 2015.

[[Page 44791]]

B. Establishment Fee Rates for FY 2015

    FDA must set the fee rates for FY 2015 so that the estimated 55 
establishments that pay fees will generate a total of $5,729,000. To 
generate this amount will require the fee for an animal drug 
establishment, rounded to the nearest $50, to be $104,150.

VI. Sponsor Fee Calculations for FY 2015

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 $5,950,000 in fee revenue for FY 2015. This is 
the amount derived in section II.D.
    To set animal drug sponsor fees to realize $5,950,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2015. Based on the number of firms that would have met this 
definition in each of the past 10 years, FDA estimates that a total of 
179 sponsors will meet this definition in FY 2015.
    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 116, who will not pay fees in FY 
2015 due to fee waivers and reductions. FDA has kept this estimate at 
65 percent this year, based on historical data over the past 5 years. 
FDA believes that this is a reasonable basis for estimating the number 
of fee-paying sponsors in FY 2015.
    Accordingly, the Agency estimates that a total of 63 sponsors (179 
minus 116) will be subject to and pay sponsor fees in FY 2015.

B. Sponsor Fee Rates for FY 2015

    FDA must set the fee rates for FY 2015 so that the estimated 63 
sponsors that pay fees will generate a total of $5,950,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest $50, to be $94,450.

VII. Fee Schedule for FY 2015

    The fee rates for FY 2015 are summarized in Table 5.

                       Table 5--FY 2015 Fee Rates
------------------------------------------------------------------------
                                                                Fee rate
                Animal drug user fee category                    for FY
                                                                  2015
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application..................................   $400,600
    Supplemental Animal Drug Application for which Safety or     200,300
     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......................................      8,075
Animal Drug Establishment Fee \1\............................    104,150
Animal Drug Sponsor Fee \2\..................................     94,450
------------------------------------------------------------------------
\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 2015 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, 2014. 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 http://www.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 
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

[[Page 44792]]

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, 2014, FDA will issue invoices and payment 
instructions for product, establishment, and sponsor fees for FY 2015 
using this fee schedule. Payment will be due by January 31, 2015. FDA 
will issue invoices in November 2015 for any products, establishments, 
and sponsors subject to fees for FY 2015 that qualify for fees after 
the December 2014 billing.

    Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18110 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P