Prescription Drug User Fee Rates for Fiscal Year 2014, 46980-46984 [2013-18624]

Download as PDF 46980 Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices fee for a facility located in the United States and its territories and possessions, as determined by the Secretary. The basis for this differential is the extra cost incurred by conducting an inspection outside the United States and its territories and possessions. For FY 2014 FDA has determined that the differential for foreign facilities will be $15,000. The differential may be adjusted in future years. sroberts on DSK5SPTVN1PROD with NOTICES VI. FDF Facility Fee Under GDUFA, the annual FDF facility fee is owed by each person that owns a facility which is identified, or intended to be identified, in at least one generic drug submission that is pending or approved to produce one or more finished dosage forms of a human generic drug or an active pharmaceutical ingredient used in a human generic drug. These fees are due no later than the first business day on or after October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF facility fee revenue will make up 56 percent of $305,659,000, which is $171,169,000 (rounded to the nearest thousand dollars). In order to calculate the FDF fee, FDA has used the data submitted by generic drug facilities through the selfidentification process mandated in the GDUFA statute and specified in a Notice of Requirement published on October 2, 2012. The total number of FDF facilities identified through self-identification was 748. Of the total facilities identified as FDF, there were 315 domestic facilities and 433 foreign facilities. The foreign facility differential is $15,000. In order to calculate the fee for domestic facilities, we must first subtract the fee revenue that will result from the foreign facility fee differential. We take the foreign facility differential ($15,000) and multiply it by the number of foreign facilities (433) to determine the total fees that will result from the foreign facility differential. As a result of that calculation the foreign fee differential will make up $6,495,000 of the total FDF fee revenue. Subtracting the foreign facility differential fee revenue ($6,495,000) from the total FDF facility target revenue ($171,169,000) results in a remaining fee revenue balance of $164,674,000. To determine the domestic FDF facility fee, we divide the $164,674,000 by the total number of facilities (748) which gives us a domestic FDF facility fee of $220,152. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $235,152. VerDate Mar<15>2010 18:55 Aug 01, 2013 Jkt 229001 VII. API Facility Fee Under GDUFA, the annual API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more active pharmaceutical ingredients identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II active pharmaceutical ingredient drug master file referenced in such generic drug submission. These fees are due no later than the first business day on or after October 1 of each such year. Section 744B(b)(2)(D) of the FD&C Act specifies that the API facility fee will make up 14 percent of $305,659,000 in fee revenue, which is $42,792,000 (rounded to the nearest thousand dollars). In order to calculate the API fee, FDA has used the data submitted by generic drug facilities through the selfidentification process. The total number of API facilities identified through selfidentification was 903. Of the total facilities identified as API, there were 128 domestic facilities and 775 foreign facilities. The foreign facility differential is $15,000. In order to calculate the fee for domestic facilities, we must first subtract the fee revenue that will result from the foreign facility fee differential. We take the foreign facility differential ($15,000) and multiply it by the number of foreign facilities (775) to determine the total fees that will result from the foreign facility differential. As a result of that calculation the foreign fee differential will make up $11,625,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($11,625,000) from the total API facility target revenue ($42,792,000) results in a remaining balance of $31,167,000. To determine the domestic API facility fee, we divide the $31,167,000 by the total number of facilities (903) which gives us a domestic API facility fee of $34,515. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $49,515. VIII. Fee Payment Options and Procedures The new fee rates are effective October 1, 2013. To pay the ANDA, PAS, DMF, API facility, and FDF facility fee, you must complete a Generic Drug User Fee cover sheet, available at https:// www.fda.gov/gdufa, and generate a user fee identification (ID) number. Payment must be made in U.S. currency drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order, or wire transfer. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a Web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA Web site after completing the generic drug user fee cover sheet and generating the user fee ID number. Please include the user fee ID number on your check, bank draft, or postal money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197–9000. If checks are to be sent by a courier that requests a street address, the courier can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only.) Please make sure that the FDA post office box number (P.O. Box 979108) is written on the check, bank draft, or postal money order. If paying by wire transfer, please reference your unique user fee ID number when completing your transfer. The originating financial institution may charge a wire transfer fee. Please ask your financial institution about the fee and include it with your payment to ensure that your fee is fully paid. The account information is as follows: New York Federal Reserve Bank, U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD 20850. The tax identification number of FDA is 53– 0196965. Dated: July 29, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–18625 Filed 8–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0007] Prescription Drug User Fee Rates for Fiscal Year 2014 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for SUMMARY: E:\FR\FM\02AUN1.SGM 02AUN1 46981 Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA V, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2014 for application fees for an application requiring clinical data ($2,169,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,084,550), for establishment fees ($554,600), and for product fees ($104,060). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014. For applications and supplements that are submitted on or after October 1, 2013, the new fee schedule must be used. Invoices for establishment and product fees for FY 2014 will be issued in August 2013 using the new fee schedule. FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial Management (HFA–100), Food and Drug Administration, 1350 Piccard Dr., PI50, Rm. 210J, Rockville, MD 20850, 301– 796–7103. SUPPLEMENTARY INFORMATION: II. Fee Revenue Amount for FY 2014 The base revenue amount for FY 2014 is $718,699,000, prior to adjustment for inflation and workload (see section 736(c)(1) of the FD&C Act). I. Background A. FY 2014 Statutory Fee Revenue Adjustments for Inflation Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h, respectively) establish three different kinds of user fees. Fees are assessed on the following: (1) Certain types of applications and supplements for approval of drug and biological products; (2) certain establishments where such products are made; and (3) certain products (section 736(a) of the FD&C Act). When certain conditions are met, FDA may waive or reduce fees (section 736(d) of the FD&C Act). For FY 2013 through FY 2017, the base revenue amounts for the total revenues from all PDUFA fees are established by PDUFA V. The base revenue amount for FY 2013, which becomes the base amount for the remaining 4 FYs of PDUFA V, is $718,699,000, as published in the Federal Register of August 1, 2012 (77 FR 45639). That FY 2013 base revenue amount is further adjusted each year after FY 2013 for inflation and workload. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will provide one-third of the total revenue to be collected each year. PDUFA V specifies that the $718,699,000 is to be further adjusted for inflation increases for FY 2014 using 2 separate adjustments—one for payroll costs and one for non-pay costs (see section 736(c)(1) of the FD&C Act). 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 3 of the 4 preceding FYs, multiplied by the proportion of PC&B costs to total FDA costs of the review of human drug applications for the first 3 of the preceding 4 FYs (see section 736(c)(1)(B) of the FD&C Act). 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 of this document summarizes that actual cost and FTE data for the specified FYs, and provides the percent change from the previous FY and the average percent change over the first 3 of the 4 FYs preceding FY 2014. The 3year average is 2.05 percent. TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE Fiscal year 2010 Total PC&B .............................................................................. Total FTE ................................................................................. PC&B per FTE ......................................................................... Percent Change from Previous Year ...................................... The statute specifies that this 2.05 percent should be multiplied by the proportion of PC&B for the review of $1,634,108,000 12,526 $130,457 1.67% 2011 2012 $1,761,655,000 13,331 $132,147 1.30% human drug applications. Table 2 of this document shows the amount of PC&B and the total amount obligated for the $1,824,703,000 13,382 $136,355 3.18% 3-Year average .............................. .............................. .............................. 2.05% process for the review of human drug applications for the same 3 FYs. TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS sroberts on DSK5SPTVN1PROD with NOTICES Fiscal year 2010 Total PC&B .............................................................................. Total Costs ............................................................................... PC&B Percent .......................................................................... The payroll adjustment is 2.05 percent multiplied by 59 percent (or 1.21 percent). VerDate Mar<15>2010 18:55 Aug 01, 2013 Jkt 229001 $573,603,582 $931,845,581 62% 2011 $596,627,595 $1,025,621,707 58% The statute specifies that the portion of the inflation adjustment for nonpayroll costs for FY 2014 is the average annual percent change that occurred in PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 2012 $592,642,252 $1,032,419,218 57% 3-Year average .............................. .............................. 59% the Consumer Price Index (CPI) for urban consumers (WashingtonBaltimore, DC–MD–VA–WV; not seasonally adjusted; all items; annual E:\FR\FM\02AUN1.SGM 02AUN1 46982 Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices index) for the first 3 of the preceding 4 years of available data multiplied by the proportion of all costs of the process for the review of human drug applications other than PC&B (see section 736(c)(1)(C) of the FD&C Act). Table 3 of this document provides the summary data for the percent change in the specified CPI for the BaltimoreWashington area. The data is published by the Bureau of Labor Statistics and can be found on their Web site at https:// data.bls.gov/cgi-bin/surveymost?cu by checking the box marked ‘‘WashingtonBaltimore All Items, November 1996=100—CUURA311SA0’’ and then clicking on the ‘‘Retrieve Data’’ button. TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI Year 2010 Annual CPI ............................................................................... Annual Percent Change .......................................................... sroberts on DSK5SPTVN1PROD with NOTICES To calculate the inflation adjustment for non-pay costs, we multiply the 2.42 percent by the proportion of costs of the process for the review of human drug applications obligated for costs other than PC&B. Since 59 percent was obligated for PC&B as shown in table 2 of this document, 41 percent is the portion of costs other than PC&B (100 percent minus 59 percent equals 41 percent). The non-payroll adjustment is 2.42 percent times 41 percent, or 0.99 percent. To complete the inflation adjustment, we add the payroll component (1.21 percent) to the non-pay component (0.99 percent), for a total inflation adjustment of 2.20 percent (rounded), and then add one, making 1.0220. We then multiply the amount base revenue amount for FY 2014 ($718,669,000) by 1.0220, yielding an inflation adjusted amount of $734,479,718. B. FY 2014 Statutory Fee Revenue Adjustments for Workload Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112–144) specifies that after the $718,699,000 has been adjusted for inflation, the inflation adjusted amount ($734,479,718) shall be further adjusted for workload (see section 736(c)(2) of the FD&C Act). Title I also requires an independent accounting or consulting firm to review the adequacy of the adjustment for workload in FY 2013 and FY 2015 and publish the results of those reviews (see section 103(c)(2) of FDASIA). The reports must evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity of human drug review and present recommendations to discontinue, retain, or modify any elements of the adjustment. After review of the reports and receipt of public comments, FDA may adopt appropriate changes to the workload adjustment methodology. FDA contracted with an independent consulting firm in FY 2013 to conduct the first required assessment of the workload adjuster. This VerDate Mar<15>2010 19:46 Aug 01, 2013 Jkt 229001 142.218 1.72% 2011 146.975 3.34% assessment examined the performance of the workload adjuster and its ability to effectively measure changes in workload volume and complexity during the FY 2009–2013 period. The report is available online at https:// www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/ UCM350567.pdf. The report found that the current methodology reasonably represents workload volume associated with the human drug review process. However, the report concluded that the methodology is flawed with respect to measuring workload complexity, known as the adjustment for changes in review activities (‘‘Complexity Factor’’), because it does not represent the total amount of work per submission. The report further notes that work complexity increased substantially during the evaluation period, but the Complexity Factor produced negative adjustments to the overall Workload Adjuster, indicating that human drug review became less complex over this period. Accordingly, the report recommends that FDA consider removing the current Complexity Factor. The report also found that the statute’s use of 5-year rolling averages to measure changes in workload against the base years was not as sensitive to recent trends as 3-year rolling averages would be. After reviewing the report, FDA is removing the Complexity Factor from the workload adjustment methodology and adopting 3-year averages to measure changes in workload volume, rather than the 5-year averages used in prior adjustments. This is consistent with the use of 3-year averages for inflation adjustment calculations as called for under PDUFA V (section 736(c)(1) of the FD&C Act). The public comment received on the report indicated that changes to the workload adjuster methodology should be considered in the context of other aspects of the PDUFA financial model, including standard costs and time reporting in the human drug review process. FDA agrees with this point and will consider multiple aspects of the PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 2012 150.212 2.20% 3-Year average .............................. 2.42% PDUFA financial model as the Agency investigates alternative methods to more accurately account for work complexity in the workload adjuster. The statute specifies that changes FDA adopts are effective the first FY after FDA adopts the changes and each subsequent FY. Since FDA is adopting the changes in FY 2013, the changes are effective for FY 2014 fees. To calculate the FY 2014 adjustment factor, FDA calculated the average number of each of the four types of applications specified in the workload adjustment provision: (1) Human drug applications; (2) active commercial investigational new drug applications (INDs) (applications that have at least one submission during the previous 12 months); (3) efficacy supplements; and (4) manufacturing supplements received over the 3-year period that ended on June 30, 2012 (base years), and the average number of each of these types of applications over the most recent 3 year period that ended June 30, 2013. The calculations are summarized in table 4 of this document. The 3-year averages for each application category are provided in column 1 (‘‘3-Year Average Base Years 2010–2012’’) and column 2 (‘‘3-Year Average 2011– 2013’’). Column 3 of table 4 of this document reflects the percent change in workload from column 1 to column 2. Column 4 of table 4 of this document shows the weighting factor for each type of application, estimating how much of the total FDA drug review workload was accounted for by each type of application in the table during the most recent 3 years. Column 5 of table 4 of this document is the weighted percent change in each category of workload. This 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 of this document is the sum of the values in column 5 that are added, reflecting an increase in workload of 3.07 percent for FY 2014 when compared to the base years. E:\FR\FM\02AUN1.SGM 02AUN1 46983 Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices TABLE 4—WORKLOAD ADJUSTER CALCULATION FOR FY 2014 Application type Column 1 Column 2 Column 3 Column 4 Column 5 3-year average base years 2010–2012 3-year average 2011–2013 Percent change (Column 1 to Column 2) Weighting factor (percent) Weighted percent change New Drug Applications/Biologics License Applications ............................. Active Commercial INDs ........................ Efficacy Supplements ............................ Manufacturing Supplements .................. 124.4 6830.0 136.3 2548.3 131.0 6965.0 140.3 2524.7 5.39 1.98 2.93 ¥0.93 38.6 41.4 9.3 10.7 2.08 0.82 0.27 ¥0.10 FY 2014 Workload Adjuster ........... .............................. .............................. .............................. .............................. 3.07 The FY 2014 workload adjustment in the last line of Table 4 of this document is 3.07 percent. Table 5 of this document shows the calculation of the revenue amount for FY 2014. The $718,669,000 subject to adjustment on the first line is multiplied by the inflation adjustment factor of 1.0220, resulting in the inflation adjusted amount on the third line, $734,479,718. That amount is then multiplied by one plus the workload adjustment of 3.07 percent, resulting in the inflation and workload adjusted amount of $757,028,000 on the fifth line, rounded to the nearest thousand dollars. TABLE 5—PDUFA REVENUE AMOUNT FOR FY 2014, SUMMARY CALCULATION FY 2013 Revenue Amount and Base Subsequent FYs as published in the Federal Register of August 1, 2012 (77 FR 45639) (rounded to nearest thousand dollars) .......................................................................................................................... Inflation Adjustment Factor for FY 2014 (1 plus 2.20 percent) ..................................................................................................... Inflation Adjusted Amount .............................................................................................................................................................. Workload Adjustment Factor for FY 2013 (1 plus 3.07 percent) .................................................................................................. $718,669,000 1.0220 $734,479,718 1.0307 Inflation and Workload Adjusted Amount (rounded to nearest thousand dollars) ................................................................. $757,028,000 PDUFA specifies that one-third of the total fee revenue is to be derived from application fees, one-third from establishment fees, and one-third from product fees (see section 736(b)(2) of the FD&C Act). Accordingly, one third of the total revenue amount ($757,028,000), or a total of $252,342,667, is the amount of fee revenue that will be derived from each of these fee categories: Application Fees, Establishment Fees, and Product Fees. III. Application Fee Calculations A. Application Fee Revenues and Application Fees Application fees will be set to generate one-third of the total fee revenue amount, or $252,342,667 in FY 2014, as calculated previously in this document. B. Estimate of the Number of Fee-Paying Applications and the Establishment of Application Fees For FY 2013 through FY 2017, FDA will estimate the total number of feepaying full application equivalents (FAEs) it expects to receive the next FY by averaging the number of fee-paying FAEs received in the three most recently completed FYs. This will avoid having FDA try to estimate the number it expects to receive in the current FY. In estimating the number of feepaying FAEs, a full application requiring clinical data counts as one FAE. An application not requiring clinical data counts as one-half an FAE, as does a supplement requiring clinical data. An application that is withdrawn, or refused for filing, counts as onefourth of an FAE if the applicant initially paid a full application fee, or one-eighth of an FAE if the applicant initially paid one-half of the full application fee amount. As table 6 of this document shows, the average number of fee-paying FAEs received annually in the most recent 3year period is 116.333 FAEs. FDA will set fees for FY 2014 based on this estimate as the number of full application equivalents that will pay fees. TABLE 6—FEE-PAYING FAE 3-YEAR AVERAGE 2010 2011 2012 3-year average Fee-Paying FAEs ............................................................................................. sroberts on DSK5SPTVN1PROD with NOTICES FY 118.375 108.250 122.375 116.333 The FY 2014 application fee is estimated by dividing the average number of full applications that paid fees over the latest 3 years, 116.333, into the fee revenue amount to be derived from application fees in FY 2014, $252,342,667. The result, rounded to the nearest $100, is a fee of $2,169,100 per VerDate Mar<15>2010 19:46 Aug 01, 2013 Jkt 229001 full application requiring clinical data, and $1,084,550 per application not requiring clinical data or per supplement requiring clinical data. PO 00000 IV. Fee Calculations for Establishment and Product Fees A. Establishment Fees At the beginning of FY 2013, the establishment fee was based on an estimate that 455 establishments would be subject to and would pay fees. By the Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\02AUN1.SGM 02AUN1 46984 Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices sroberts on DSK5SPTVN1PROD with NOTICES end of FY 2013, FDA estimates that 490 establishments will have been billed for establishment fees, before all decisions on requests for waivers or reductions are made. FDA estimates that a total of 20 establishment fee waivers or reductions will be made for FY 2013. In addition, FDA estimates that another 15 full establishment fees will be exempted this year based on the orphan drug exemption in section 736(k) of the FD&C Act. Subtracting 35 establishments (20 waivers, plus the estimated 15 establishments under the orphan exemption) from 490 leaves a net of 455 fee-paying establishments. FDA will use 455 for its FY 2014 estimate of establishments paying fees, after taking waivers and reductions into account. The fee per establishment is determined by dividing the adjusted total fee revenue to be derived from establishments ($252,342,667) by the estimated 455 establishments, for an establishment fee rate for FY 2014 of $554,600 (rounded to the nearest $100). TABLE 7—FEE SCHEDULE FOR FY 2014—Continued B. Establishment and Product Fees FDA will issue invoices for establishment and product fees for FY 2014 under the new fee schedule in 1,084,550 August 2013. Payment will be due on 554,600 October 1, 2013. FDA will issue 104,060 invoices in November 2014 for any products and establishments subject to fees for FY 2014 that qualify for fee assessments after the August 2013 billing. Fee rates for FY 2014 Fee category Supplements requiring clinical data .... Establishments ............... Products .......................... VI. Fee Payment Options and Procedures A. Application Fees The appropriate application fee established in the new fee schedule must be paid for any application or supplement subject to fees under PDUFA that is received after September 30, 2013. 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. Please include the user fee identification (ID) number on your check, bank draft, or postal money B. Product Fees order. Your payment can be mailed to: Food and Drug Administration, P.O. At the beginning of FY 2013, the Box 979107, St. Louis, MO 63197–9000. product fee was based on an estimate If checks are to be sent by a courier that 2,435 products would be subject to that requests a street address, the and would pay product fees. By the end courier can deliver the checks to: U.S. of FY 2013, FDA estimates that 2,510 Bank, Attention: Government Lockbox products will have been billed for 979107, 1005 Convention Plaza, St. product fees, before all decisions on Louis, MO 63101. (Note: This U.S. Bank requests for waivers, reductions, or exemptions are made. FDA assumes that address is for courier delivery only. Contact the U.S. Bank at 314–418–4013 there will be 45 waivers and reductions granted. In addition, FDA estimates that if you have any questions concerning courier delivery.) another 40 product fees will be Please make sure that the FDA post exempted this year based on the orphan office box number (P.O. Box 979107) is drug exemption in section 736(k) of the written on the check, bank draft, or FD&C Act. FDA estimates that 2,425 products will qualify for product fees in postal money order. Wire transfer payment may also be FY 2013, after allowing for waivers and used. Please reference your unique user reductions, including the orphan drug fee ID number when completing your products, and will use this number for transfer. The originating financial its FY 2014 estimate. The FY 2014 institution may charge a wire transfer product fee rate is determined by fee. Please ask your financial institution dividing the adjusted total fee revenue about the fee and add it to your payment to be derived from product fees to ensure that your fee is fully paid. The ($252,342,667) by the estimated 2,425 account information is as follows: New products for a FY 2014 product fee of York Federal Reserve Bank, U.S. $104,060 (rounded to the nearest $10). Department of the Treasury, TREAS V. Fee Schedule for FY 2014 NYC, 33 Liberty St., New York, NY The fee rates for FY 2014 are set out 10045, Acct. No.: 75060099, Routing in table 7 of this document: No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Drive, TABLE 7—FEE SCHEDULE FOR FY Rockville, MD. Application fees can also be paid 2014 online with an electronic check (ACH). Fee rates for FY FDA has partnered with the U.S. Fee category 2014 Department of the Treasury to use Pay.gov, a Web-based payment Applications: application, for online electronic Requiring clinical data ...................... $2,169,100 payment. The Pay.gov feature is available on the FDA Web site after the Not requiring clinical data ...................... 1,084,550 user fee ID number is generated. VerDate Mar<15>2010 18:55 Aug 01, 2013 Jkt 229001 PO 00000 Frm 00080 Fmt 4703 The tax identification number of FDA is 53–0196965. Sfmt 4703 Dated: July 29, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–18624 Filed 8–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0869] Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for BEXTRA (valdecoxib) 10 milligram (mg) and 20 mg Tablets, held by Pfizer, Inc. (Pfizer), 235 East 42nd St., New York, NY 10017–5755. Pfizer has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing. DATES: Effective August 2, 2013. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: FDA approved BEXTRA (valdecoxib) 10 mg and 20 mg Tablets on November 16, 2001. BEXTRA is indicated for relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea. On April 7, 2005, FDA announced that it had concluded that the overall risk versus benefit profile of BEXTRA was unfavorable and that it had asked Pfizer to voluntarily withdraw BEXTRA from the market. Pfizer agreed and voluntarily suspended all sales and marketing of BEXTRA on July 21, 2005. In letters dated May 27, 2011, August 8, SUMMARY: E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46980-46984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18624]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]

Prescription Drug User Fee Rates for Fiscal Year 2014

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for

[[Page 46981]]

fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Prescription Drug User Fee Amendments of
2012, which was signed by the President on July 9, 2012 (PDUFA V),
authorizes FDA to collect user fees for certain applications for
approval of drug and biological products, on establishments where the
products are made, and on such products. Base revenue amounts to be
generated from PDUFA fees were established by PDUFA V, with provisions
for certain adjustments. Fee revenue amounts for applications,
establishments, and products are to be established each year by FDA so
that one-third of the PDUFA fee revenues FDA collects each year will be
generated from each of these categories. This document establishes fee
rates for FY 2014 for application fees for an application requiring
clinical data ($2,169,100), for an application not requiring clinical
data or a supplement requiring clinical data ($1,084,550), for
establishment fees ($554,600), and for product fees ($104,060). These
fees are effective on October 1, 2013, and will remain in effect
through September 30, 2014. For applications and supplements that are
submitted on or after October 1, 2013, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2014 will be
issued in August 2013 using the new fee schedule.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr.,
PI50, Rm. 210J, Rockville, MD 20850, 301-796-7103.

SUPPLEMENTARY INFORMATION:

I. Background

Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively) establish three different kinds of user fees. Fees are
assessed on the following: (1) Certain types of applications and
supplements for approval of drug and biological products; (2) certain
establishments where such products are made; and (3) certain products
(section 736(a) of the FD&C Act). When certain conditions are met, FDA
may waive or reduce fees (section 736(d) of the FD&C Act).
For FY 2013 through FY 2017, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA V. The base
revenue amount for FY 2013, which becomes the base amount for the
remaining 4 FYs of PDUFA V, is $718,699,000, as published in the
Federal Register of August 1, 2012 (77 FR 45639). That FY 2013 base
revenue amount is further adjusted each year after FY 2013 for
inflation and workload. Fees for applications, establishments, and
products are to be established each year by FDA so that revenues from
each category will provide one-third of the total revenue to be
collected each year.

II. Fee Revenue Amount for FY 2014

The base revenue amount for FY 2014 is $718,699,000, prior to
adjustment for inflation and workload (see section 736(c)(1) of the
FD&C Act).

A. FY 2014 Statutory Fee Revenue Adjustments for Inflation

PDUFA V specifies that the $718,699,000 is to be further adjusted
for inflation increases for FY 2014 using 2 separate adjustments--one
for payroll costs and one for non-pay costs (see section 736(c)(1) of
the FD&C Act).
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 3 of the 4 preceding
FYs, multiplied by the proportion of PC&B costs to total FDA costs of
the review of human drug applications for the first 3 of the preceding
4 FYs (see section 736(c)(1)(B) of the FD&C Act). 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 of this document summarizes that actual cost and FTE data
for the specified FYs, and provides the percent change from the
previous FY and the average percent change over the first 3 of the 4
FYs preceding FY 2014. The 3-year average is 2.05 percent.

Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2010 2011 2012 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $1,634,108,000 $1,761,655,000 $1,824,703,000 .................
Total FTE........................... 12,526 13,331 13,382 .................
PC&B per FTE........................ $130,457 $132,147 $136,355 .................
Percent Change from Previous Year... 1.67% 1.30% 3.18% 2.05%
----------------------------------------------------------------------------------------------------------------

The statute specifies that this 2.05 percent should be multiplied
by the proportion of PC&B for the review of human drug applications.
Table 2 of this document shows the amount of PC&B and the total amount
obligated for the process for the review of human drug applications for
the same 3 FYs.

Table 2--PC&B as a Percent of Fee Revenues Spent on the Process for the Review of Human Drug Applications
----------------------------------------------------------------------------------------------------------------
Fiscal year 2010 2011 2012 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $573,603,582 $596,627,595 $592,642,252 .................
Total Costs......................... $931,845,581 $1,025,621,707 $1,032,419,218 .................
PC&B Percent........................ 62% 58% 57% 59%
----------------------------------------------------------------------------------------------------------------

The payroll adjustment is 2.05 percent multiplied by 59 percent (or
1.21 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2014 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual

[[Page 46982]]

index) for the first 3 of the preceding 4 years of available data
multiplied by the proportion of all costs of the process for the review
of human drug applications other than PC&B (see section 736(c)(1)(C) of
the FD&C Act). Table 3 of this document provides the summary data for
the percent change in the specified CPI for the Baltimore-Washington
area. The data is published by the Bureau of Labor Statistics and can
be found on their Web site at https://data.bls.gov/cgi-bin/surveymost?cu
by checking the box marked ``Washington-Baltimore All Items, November
1996=100--CUURA311SA0'' and then clicking on the ``Retrieve Data''
button.

Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
Year 2010 2011 2012 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 142.218 146.975 150.212 .................
Annual Percent Change............... 1.72% 3.34% 2.20% 2.42%
----------------------------------------------------------------------------------------------------------------

To calculate the inflation adjustment for non-pay costs, we
multiply the 2.42 percent by the proportion of costs of the process for
the review of human drug applications obligated for costs other than
PC&B. Since 59 percent was obligated for PC&B as shown in table 2 of
this document, 41 percent is the portion of costs other than PC&B (100
percent minus 59 percent equals 41 percent). The non-payroll adjustment
is 2.42 percent times 41 percent, or 0.99 percent.
To complete the inflation adjustment, we add the payroll component
(1.21 percent) to the non-pay component (0.99 percent), for a total
inflation adjustment of 2.20 percent (rounded), and then add one,
making 1.0220. We then multiply the amount base revenue amount for FY
2014 ($718,669,000) by 1.0220, yielding an inflation adjusted amount of
$734,479,718.

B. FY 2014 Statutory Fee Revenue Adjustments for Workload

Title I of the Food and Drug Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112-144) specifies that after the $718,699,000
has been adjusted for inflation, the inflation adjusted amount
($734,479,718) shall be further adjusted for workload (see section
736(c)(2) of the FD&C Act). Title I also requires an independent
accounting or consulting firm to review the adequacy of the adjustment
for workload in FY 2013 and FY 2015 and publish the results of those
reviews (see section 103(c)(2) of FDASIA). The reports must evaluate
whether the adjustment reasonably represents actual changes in workload
volume and complexity of human drug review and present recommendations
to discontinue, retain, or modify any elements of the adjustment. After
review of the reports and receipt of public comments, FDA may adopt
appropriate changes to the workload adjustment methodology. FDA
contracted with an independent consulting firm in FY 2013 to conduct
the first required assessment of the workload adjuster. This assessment
examined the performance of the workload adjuster and its ability to
effectively measure changes in workload volume and complexity during
the FY 2009-2013 period. The report is available online at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM350567.pdf. The report found that the current methodology reasonably
represents workload volume associated with the human drug review
process. However, the report concluded that the methodology is flawed
with respect to measuring workload complexity, known as the adjustment
for changes in review activities (``Complexity Factor''), because it
does not represent the total amount of work per submission. The report
further notes that work complexity increased substantially during the
evaluation period, but the Complexity Factor produced negative
adjustments to the overall Workload Adjuster, indicating that human
drug review became less complex over this period. Accordingly, the
report recommends that FDA consider removing the current Complexity
Factor. The report also found that the statute's use of 5-year rolling
averages to measure changes in workload against the base years was not
as sensitive to recent trends as 3-year rolling averages would be.
After reviewing the report, FDA is removing the Complexity Factor from
the workload adjustment methodology and adopting 3-year averages to
measure changes in workload volume, rather than the 5-year averages
used in prior adjustments. This is consistent with the use of 3-year
averages for inflation adjustment calculations as called for under
PDUFA V (section 736(c)(1) of the FD&C Act). The public comment
received on the report indicated that changes to the workload adjuster
methodology should be considered in the context of other aspects of the
PDUFA financial model, including standard costs and time reporting in
the human drug review process. FDA agrees with this point and will
consider multiple aspects of the PDUFA financial model as the Agency
investigates alternative methods to more accurately account for work
complexity in the workload adjuster.
The statute specifies that changes FDA adopts are effective the
first FY after FDA adopts the changes and each subsequent FY. Since FDA
is adopting the changes in FY 2013, the changes are effective for FY
2014 fees.
To calculate the FY 2014 adjustment factor, FDA calculated the
average number of each of the four types of applications specified in
the workload adjustment provision: (1) Human drug applications; (2)
active commercial investigational new drug applications (INDs)
(applications that have at least one submission during the previous 12
months); (3) efficacy supplements; and (4) manufacturing supplements
received over the 3-year period that ended on June 30, 2012 (base
years), and the average number of each of these types of applications
over the most recent 3 year period that ended June 30, 2013.
The calculations are summarized in table 4 of this document. The 3-
year averages for each application category are provided in column 1
(``3-Year Average Base Years 2010-2012'') and column 2 (``3-Year
Average 2011-2013'').
Column 3 of table 4 of this document reflects the percent change in
workload from column 1 to column 2. Column 4 of table 4 of this
document shows the weighting factor for each type of application,
estimating how much of the total FDA drug review workload was accounted
for by each type of application in the table during the most recent 3
years. Column 5 of table 4 of this document is the weighted percent
change in each category of workload. This 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 of this
document is the sum of the values in column 5 that are added,
reflecting an increase in workload of 3.07 percent for FY 2014 when
compared to the base years.

[[Page 46983]]

Table 4--Workload Adjuster Calculation for FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application type Column 1 Column 2 Column 3 Column 4 Column 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-year average Percent change
base years 2010- 3-year average (Column 1 to Weighting factor Weighted percent
2012 2011-2013 Column 2) (percent) change
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Drug Applications/Biologics License Applications..... 124.4 131.0 5.39 38.6 2.08
Active Commercial INDs................................... 6830.0 6965.0 1.98 41.4 0.82
Efficacy Supplements..................................... 136.3 140.3 2.93 9.3 0.27
Manufacturing Supplements................................ 2548.3 2524.7 -0.93 10.7 -0.10
----------------------------------------------------------------------------------------------
FY 2014 Workload Adjuster............................ ................. ................. ................. ................. 3.07
--------------------------------------------------------------------------------------------------------------------------------------------------------

The FY 2014 workload adjustment in the last line of Table 4 of this
document is 3.07 percent.
Table 5 of this document shows the calculation of the revenue
amount for FY 2014. The $718,669,000 subject to adjustment on the first
line is multiplied by the inflation adjustment factor of 1.0220,
resulting in the inflation adjusted amount on the third line,
$734,479,718. That amount is then multiplied by one plus the workload
adjustment of 3.07 percent, resulting in the inflation and workload
adjusted amount of $757,028,000 on the fifth line, rounded to the
nearest thousand dollars.

Table 5--PDUFA Revenue Amount for FY 2014, Summary Calculation
------------------------------------------------------------------------

------------------------------------------------------------------------
FY 2013 Revenue Amount and Base Subsequent FYs as $718,669,000
published in the Federal Register of August 1, 2012
(77 FR 45639) (rounded to nearest thousand dollars).
Inflation Adjustment Factor for FY 2014 (1 plus 2.20 1.0220
percent)............................................
Inflation Adjusted Amount............................ $734,479,718
Workload Adjustment Factor for FY 2013 (1 plus 3.07 1.0307
percent)............................................
------------------
Inflation and Workload Adjusted Amount (rounded $757,028,000
to nearest thousand dollars)....................
------------------------------------------------------------------------

PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the FD&C Act).
Accordingly, one third of the total revenue amount ($757,028,000), or a
total of $252,342,667, is the amount of fee revenue that will be
derived from each of these fee categories: Application Fees,
Establishment Fees, and Product Fees.

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

Application fees will be set to generate one-third of the total fee
revenue amount, or $252,342,667 in FY 2014, as calculated previously in
this document.

B. Estimate of the Number of Fee-Paying Applications and the
Establishment of Application Fees

For FY 2013 through FY 2017, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next FY by averaging the number of fee-paying FAEs received in the
three most recently completed FYs. This will avoid having FDA try to
estimate the number it expects to receive in the current FY.
In estimating the number of fee-paying FAEs, a full application
requiring clinical data counts as one FAE. An application not requiring
clinical data counts as one-half an FAE, as does a supplement requiring
clinical data. An application that is withdrawn, or refused for filing,
counts as one-fourth of an FAE if the applicant initially paid a full
application fee, or one-eighth of an FAE if the applicant initially
paid one-half of the full application fee amount.
As table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 3-year period is 116.333
FAEs. FDA will set fees for FY 2014 based on this estimate as the
number of full application equivalents that will pay fees.

Table 6--Fee-Paying FAE 3-Year Average
----------------------------------------------------------------------------------------------------------------
FY 2010 2011 2012 3-year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs............................. 118.375 108.250 122.375 116.333
----------------------------------------------------------------------------------------------------------------

The FY 2014 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
116.333, into the fee revenue amount to be derived from application
fees in FY 2014, $252,342,667. The result, rounded to the nearest $100,
is a fee of $2,169,100 per full application requiring clinical data,
and $1,084,550 per application not requiring clinical data or per
supplement requiring clinical data.

IV. Fee Calculations for Establishment and Product Fees

A. Establishment Fees

At the beginning of FY 2013, the establishment fee was based on an
estimate that 455 establishments would be subject to and would pay
fees. By the

[[Page 46984]]

end of FY 2013, FDA estimates that 490 establishments will have been
billed for establishment fees, before all decisions on requests for
waivers or reductions are made. FDA estimates that a total of 20
establishment fee waivers or reductions will be made for FY 2013. In
addition, FDA estimates that another 15 full establishment fees will be
exempted this year based on the orphan drug exemption in section 736(k)
of the FD&C Act. Subtracting 35 establishments (20 waivers, plus the
estimated 15 establishments under the orphan exemption) from 490 leaves
a net of 455 fee-paying establishments. FDA will use 455 for its FY
2014 estimate of establishments paying fees, after taking waivers and
reductions into account. The fee per establishment is determined by
dividing the adjusted total fee revenue to be derived from
establishments ($252,342,667) by the estimated 455 establishments, for
an establishment fee rate for FY 2014 of $554,600 (rounded to the
nearest $100).

B. Product Fees

At the beginning of FY 2013, the product fee was based on an
estimate that 2,435 products would be subject to and would pay product
fees. By the end of FY 2013, FDA estimates that 2,510 products will
have been billed for product fees, before all decisions on requests for
waivers, reductions, or exemptions are made. FDA assumes that there
will be 45 waivers and reductions granted. In addition, FDA estimates
that another 40 product fees will be exempted this year based on the
orphan drug exemption in section 736(k) of the FD&C Act. FDA estimates
that 2,425 products will qualify for product fees in FY 2013, after
allowing for waivers and reductions, including the orphan drug
products, and will use this number for its FY 2014 estimate. The FY
2014 product fee rate is determined by dividing the adjusted total fee
revenue to be derived from product fees ($252,342,667) by the estimated
2,425 products for a FY 2014 product fee of $104,060 (rounded to the
nearest $10).

V. Fee Schedule for FY 2014

The fee rates for FY 2014 are set out in table 7 of this document:

Table 7--Fee Schedule for FY 2014
------------------------------------------------------------------------
Fee rates for FY
Fee category 2014
------------------------------------------------------------------------
Applications:
Requiring clinical data.......................... $2,169,100
Not requiring clinical data...................... 1,084,550
Supplements requiring clinical data.............. 1,084,550
Establishments....................................... 554,600
Products............................................. 104,060
------------------------------------------------------------------------

VI. Fee Payment Options and Procedures

A. Application Fees

The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2013. 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. Please
include the user fee identification (ID) number on your check, bank
draft, or postal money order. Your payment can be mailed to: Food and
Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000.
If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: U.S. Bank, Attention:
Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for courier delivery only. Contact the
U.S. Bank at 314-418-4013 if you have any questions concerning courier
delivery.)
Please make sure that the FDA post office box number (P.O. Box
979107) is written on the check, bank draft, or postal money order.
Wire transfer payment may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution may charge a wire transfer fee.
Please ask your financial institution about the fee and add it to your
payment to ensure that your fee is fully paid. The account information
is as follows: New York Federal Reserve Bank, U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA,
1350 Piccard Drive, Rockville, MD.
Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
use Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
The tax identification number of FDA is 53-0196965.

B. Establishment and Product Fees

FDA will issue invoices for establishment and product fees for FY
2014 under the new fee schedule in August 2013. Payment will be due on
October 1, 2013. FDA will issue invoices in November 2014 for any
products and establishments subject to fees for FY 2014 that qualify
for fee assessments after the August 2013 billing.

Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18624 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P

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