DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0007]
Generic Drug User Fee—Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2015
仿制药用户费用---2015财年ANDA、PAS、DMF、制剂工厂、原料药工厂费率
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2015.
摘要：FDA公布其2015财年GDUFA相关的ANDA、PAS、DMF、仿制原料药工厂和制剂工厂用户费率。联邦食品药品化妆品法案修正案GDUFA授权FDA可以对人用仿制药品指定申报类型和变更收取费用，以及2013年收取积压费，对制剂和原料药工厂收取工厂年费，对II类原料药DMF收取审阅费。本文即为2015财年的费用公布。
FOR FURTHER INFORMATION CONTACT: 更多信息请联系：
Rachel Richter, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14216, Silver Spring, MD 20993–0002, 301–796–7111.
SUPPLEMENTARY INFORMATION: 详细信息
I. Background 背景
Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j–41 and 379j–42) establish fees associated with human generic drug products. Fees are assessed on: (1) Certain applications in the backlog as of October 1, 2012 (only applicable to FY 2013); (2) certain types of applications and supplements for human generic drug products; (3) certain facilities where APIs and FDFs are produced; and (4) certain DMFs associated with human generic drug products. (See section 744B(a)(1)–(4) of the FD&C Act).
联邦食药化妆品法案(21 U.S.C. 379j–41 and 379j–42)的744A和744B部分中规定了人用仿制药付费条款。针对以下情况征收费用（1）2012年10月1日时一些积压的申报（仅限于2013财年）（2）人用仿制药特定类型的申报和增补（3）特定的原料药和制剂生产工厂（4）特定的人用仿制药DMF（参见法案第744B（a）条）。
For FY 2015, the generic drug fee rates are: ANDA ($58,730), PAS ($29,370), DMF ($26,720), domestic API facility ($41,926), foreign API facility ($56,926), domestic FDF facility ($247,717), and foreign FDF facility ($262,717). These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.
2015财年，仿制药费率为：ANDA（$58,730），PAS （$29,370）， DMF （$26,720）， 国内原料药工厂年费（$41,926）， 国外原料药工厂年费（$56,926），国内制剂工厂年费（$247,717），国外制剂工厂年费（$262,717）。以上费用自2014年10月1日起生效，有效期至2015年9月30日。
II. Fee Revenue Amount for FY 2015 2015财年总费用
The base revenue amount for FY 2015 is $299 million, as set in the statute prior to the inflation adjustment.
2015财年基本预算数为$29,900万（通膨调整前）。经过通胀调整后为$312,224,000（详细数据和计算略）。
III. ANDA and PAS Fees
Under GDUFA, the FY 2015 ANDA and PAS fees are owed by each applicant that submits an ANDA or a PAS, on or after October 1, 2014. These fees are due on the receipt date of the ANDA or PAS. Section 744B(b)(2)(B) specifies that the ANDA and PAS fees will make up 24 percent of the $312,224,000, which is $74,934,000 (rounded to the nearest thousand dollars), and further specifies that the PAS fee is equal to half the ANDA fee.
根据GDUFA法案， 2014年10月1日之后（含）提交ANDA和PAS的申报人需缴纳2015财年ANDA和PAS费用。这些费用从收到ANDA或PAS之日起产生。第744B(b)(2)(B)部分说明了ANDA和PAS费用占全年预算$312,224,000的24%，即$74,934,000（四舍五入至千美元），且PAS费率为ANDA费率的一半。
In order to calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2015. This is done by assuming ANDAs count as one FAE and PASs (supplements) count as onehalf an FAE, since the fee for a PAS is one half of the fee for an ANDA. GDUFA also requires, however, that 75 percent of the fee paid for an ANDA or PAS filing fee be refunded if the ANDA or PAS is refused due to issues other than failure to pay fees (section 744B(a)(3)(D) of the FD&C Act). Therefore, an ANDA or PAS that is considered not to have been received by the Secretary due to reasons other than failure to pay fees 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 paid the supplement fee (one half of the full application fee amount).
为计算ANDA费率，FDA估计了2015财年会收到的全申报类（FAE）的数量。该估算是设ANDA为一个全FAE，PAS作为半个FAE，因为一个PAS的费率是一个ANDA的费率的一半。GDUFA还要求如果ANDA或PAS因为未付费之外的其它原因被拒时，要退回75%的费用（参见食药化妆品法案第744B（a）(3)(D)部分），因此非付费原因被拒的ANDA和PAS作为1/4个FAE（如果是ANDA申报），或1/8个FAE（如果是PAS申报）。
Using the methodology that follows, FDA determined that approximately 1,065 ANDAs will incur an ANDA filing fee in FY 2015. This number is based on 1,775 ANDAs from October 1, 2012, to May 31, 2014, divided by 20 months and multiplied by 12 months, equaling an estimated 1,065 ANDAs that will be submitted in FY 2015, or 1,065 FAEs.
采用计算方法如下，FDA预计在2015财年会收到约1065份ANDA，该预计来自于2012年10月1日至2014年5月31日收到1775份ANDA申报，除以20个月，乘以12个月，得到预估2015财年会有1065份ANDA，或1065宗FAE。
The estimated number of PASs to be received in FY 2015 is 449. This number is based on the 748 PASs from October 1, 2012, to May 31, 2014, divided by 20 months and multiplied by 12 months, equaling an estimated 449 PASs that will be submitted in FY 2015, equivalent to 225 FAEs (rounded).
预计在2015财年将收到的PAS为449宗。该数量是根据2012年10月1日至2014年5月31日共收到748宗PAS，除以20个月，乘以12个月，得到449宗PAS，等同于225宗FAE（四舍五入）。
Adding the 1,065 FAEs with the 225 FAEs yields a total of 1,290 FAEs. After taking into account estimates of the number of ANDAs and PASs that are likely to be refused due to issues other than failure to pay fees, and the number that are likely to be resubmitted in the same fiscal year, the total number of feepaying FAEs that will be received in FY 2015 is reduced by 14 FAEs to 1,276.
1065宗加上225宗FAE得总计为1290宗FAE。考虑到ANDA和PAS可能会因非付费原因被拒的情况，以及可能会在同一财年再次提交的申报数，将2015财年预计会收到的FAE降为1276宗。
The FY 2015 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2015 (1,276) into the fee revenue amount to be derived from application fees in FY 2015 ($74,934,000). The result, rounded to the nearest $10, is a fee of $58,730 per ANDA. The PAS fee is one-half that amount, or $29,370, rounded to the nearest $10.
将总费用（$74,934,000）除以上述FAE宗数（1276），得到2015财年申报费率为$74,934,000，结果四舍五入至十位得到每个ANDA费率为$58,730。PAS费率为其一半，即$29,370（四舍五入）。
The statute provides that those ANDAs that include information about the production of active pharmaceutical ingredients other than by reference to a DMF will pay an additional fee that is based on the number of such active pharmaceutical ingredients and the number of facilities proposed to produce those ingredients. (See section 744B(a)(3)(F) of the FD&C Act.) FDA considers that this additional fee is unlikely to be assessed often; therefore, FDA has not included projections concerning the amount of this fee in calculating the fees for ANDAs and PASs.
法规还规定如果一份ANDA中包括了原料药生产信息，而不是引用DMF，将需要缴纳与原料药个数和生产场所个数对应的费用。考虑到这种额外费用产生的情况不会太多，因此FDA在计算ANDA和PAS费率时未包括这种情况。
IV. DMF Fee 药物主文件费用
Under GDUFA, the DMF fee is owed by each person that owns a type II active pharmaceutical ingredient DMF that is referenced, on or after October 1, 2012, in a generic drug submission by an initial letter of authorization. This is a one-time fee for each individual DMF.
根据DDUFA，凡在2012年10月1日后被仿制药以初次LOA方式引用的二类活性药用成分DMF持有人，需缴纳DFM费用。每个DMF只需缴纳一次。
This fee is due no later than the date on which the first generic drug submission is submitted that references the associated DMF. Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has successfully undergone an initial completeness assessment and the fee is paid, the DMF will be placed on a publicly available list documenting DMFs available for reference. Thus, some DMF holders may choose to pay the fee prior to the date that it would otherwise be due in order to have the DMF placed on that list.
该费用在DMF被首次引用时即产生。根据食药化妆品法案744B(a)(2)(D)(iii)部分，如果一份DMF成功通过初始完整性审核，并支付了费用，则DMF会被公布的FDA的可被引用DMF清单上。因此有些DMF持有人可能会选择在被引用前即支付该费用，以使其DMF进入该清单。
In order to calculate the DMF fee, FDA assessed the volume of DMF submissions over time. The statistical forecasting methodology of power regression analysis was selected because this model showed a very good fit to the distribution of DMF submissions over time. Based on data representing the total paid DMFs from October 2012 to May 2014 and projecting a 5-year timeline (October 2014 to October 2018), FDA is estimating 701 fee-paying DMFs for FY 2015.
在计算DMF费率时，FDA估计了一段时间内会收到的DMF申报数量。FDA选择使用指数回归统计学预测方法，因为该模式显示出与DMF在一段时间内的申报分布情况非常契合。根据2012年10月至2014年5月支付费用的DMF总数数据，以及五年时间线的项目计算，FDA估计2015财年会有701件DMF付费。
The FY 2015 DMF fee is determined by dividing the DMF revenue by the estimated number of fee-paying DMFs in FY 2015. Section 744B(b)(2)(A) specifies that the DMF fees will make up 6 percent of the $312,224,000, which is $18,734,000 (rounded up to the nearest thousand dollars). Dividing the DMF revenue amount ($18,734,000) by the estimated fee-paying DMFs (701), and rounding to the nearest $10, yields a DMF fee of $26,720 for FY 2015.
2015财年DMF费用是用预计的2015年DMF年预算收入除以预估2015财年的付费DMF数量。在744B(b)(2)(A)中已说明DMF费用为总预算$312,224,000的4%，即$18,734,000（四舍五入至千美元），除以预计付费DMF数量（701件），四舍五入至10美元，得到2015财年的DMF费率为$26,720。
V. Foreign Facility Fee Differential 国外工厂费率差异
Under GDUFA, the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the 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 2015 FDA has determined that the differential for foreign facilities will be $15,000. The differential may be adjusted in future years.
根据GDUFA，国外工厂费率应比国内工厂费率高出$15,000至$30,000。该差异的产生的原因是对国外工厂检查时会产生额外费用。2015财年，FDA确认国内外工厂费率差异为$15,000。将来该差异可能会进行调整。
VI. FDF Facility Fee 制剂工厂费率
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. 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 $312,224,000, which is $174,845,000 (rounded to the nearest thousand dollars).
根据GDUFA，进行了自我识别或有意进行自我识别，至少拥有一个正在审批的仿制药申报，或持有已批准的批文生产一个或多个人用仿制药制剂的制剂工厂所有人需缴纳制剂工厂年费。该费用从每年10月1日起或10月1日起的第一个工作日起生效。联邦食药化妆品法案第744B(b)(2)(C)部分规定，制剂工厂年费收入应占总预算$312,224,000的56%，即$174,845,000（四舍五入至千美元）。
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 in the Federal Register of October 2, 2012 (77 FR 60125). The total number of FDF facilities identified through selfidentification was 681. Of the total facilities identified as FDF, there were 271 domestic facilities and 410 foreign facilities. The foreign facility fee 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 (410) 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 $6,150,000 of the total FDF fee revenue. Subtracting the foreign facility differential fee revenue ($6,150,000) from the total FDF facility target revenue ($174,845,000) results in a remaining fee revenue balance of $168,695,000. To determine the domestic FDF facility fee, we divide the $168,695,000 by the total number of facilities (681) which gives us a domestic FDF facility fee of $247,717. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $262,717.
为计算制剂工厂费率，FDA采用了仿制药自我识别系统中收集的数据。目前通过自我识别的制剂工厂共有681个，其中271个国内工厂，410个国外工厂。国内外工厂费率差异为$15,000，为了计算国内工厂费用，我们必须首先扣除差异费用。我们用国内外工厂差异（$15,000）乘以国外工厂数量（410），得到总差异费为$6,150,000。从总费用($174,845,000)中扣除该数，得到$168,695,000，该数除以总的工厂数量（681）得到国内工厂费率为$247,717。国外工厂费率为国内工厂费率加上$15,000，即$262,717。
VII. API Facility Fee 原料药工厂费用
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 $312,224,000 in fee revenue, which is $43,711,000 (rounded to the nearest thousand dollars).
根据GDUFA，生产原料药、原料药生产在审核中或有意申报至少一种二类活性药用物质DMF的工厂所有人需缴纳原料药工厂年费。该费用从每年10月1日起或10月1日起的第一个工作日起生效。联邦食药化妆品法案第744B(b)(2)(D)部分规定，原料药工厂年费收入应占总预算$312,224,000的14%，即$43,711,000（四舍五入至千美元）。
In order to calculate the API fee, FDA has used the data submitted by generic drug facilities through the self identification process mandated in the GDUFA statute and specified in a Notice of Requirement published on October 2, 2012. The total number of API facilities identified through self-identification was 795. Of the total facilities identified as API facilities, there were 103 domestic facilities and 692 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.
在计算原料药费用时，FDA采用了自我识别系统中的仿制药工厂数据。通过该系统进行识别的原料药工厂为795个，其中103个国内工厂，692个国外工厂。国内外工厂差异为$15,000。为了计算国内工厂费用，我们必须首先扣除差异费用。
We take the foreign facility differential ($15,000) and multiply it by the number of foreign facilities (692) 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 $10,380,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($10,380,000) from the total API facility target revenue ($43,711,000) results in a remaining balance of $33,331,000. To determine the domestic API facility fee, we divide the $33,331,000 by the total number of facilities (795) which gives us a domestic API facility fee of $41,926. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $56,926.
我们用国内外工厂差异（$15,000）乘以国外工厂数量（692），得到总差异费为$10,380,000。从总费用中扣除该数，得到$33,331,000，除以总的工厂数量（795）得到国内工厂费率为$41,926。国外工厂费率为国内工厂费率加上$15,000，即$56,926。
VIII. Fee Payment Options and Procedures 付费方式和流程
The new fee rates are effective October 1, 2014. To pay the ANDA, PAS, DMF, API facility, and FDF facility fee, you must complete a Generic Drug User Fee cover sheet, available at http://www.fda.gov/gdufa , and generate a user fee identification (ID) number.
新的费率自2014年10月1日起生效。在支付ANDA、PAS、DMF、原料药工厂费用和制剂工厂费用时，你必须填写一份仿制药用户付费表，该表在上述官网可以获得，由系统生成一个用户付费识别号（ID）。
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.
必须采用美元，通过美国的银行采用电子支票、支票、银行汇票、美国邮政支付系统或电汇方式支付。
FDA has partnered with the U.S. Department of the Treasury to utilizehttps://www.pay.gov , a Web-based payment application, for online electronic payment. The https://www.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.
FDA已和美国财政部达成合成关系，可以使用上述网址进行网上支付申请，进行在线电子付费。在FDA官网上填写完整仿制药用户付费表，并生成一个用户费用ID号后，可以跳转至该支付网页。
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.
在支票、银行汇单或邮件汇款单上填写清楚你的用户费用ID号，这样FDA才可以接受你的支付。支付地址请填写：如上。（注：该美国银行地址仅供快递收件）。在支票、银行汇票或邮政汇款单上一定要填写FDA的邮政信箱号（P.O.Box 979108）。
If paying by wire transfer, please reference your unique user fee ID number when completing your transfer.
如果通过电汇支付，在填写电汇单时，请写清楚你们的唯一用户付费ID号。
The originating financial institution may charge a wire transfer fee. Please ask your financial institution about the wire transfer fee and include it with your payment to ensure that your fee is fully paid. The account information is as follows:
电汇收款行和中转行可能会需要收取一定的电汇费用。请询问你们的汇款机构关于汇费问题，并在款项中包括该汇费，以免因扣除汇费导致缴纳不足无法支付。收款帐户信息如下：
New York Federal Reserve Bank, U.S. Department of Treasury,
TREAS NYC, 33 Liberty St., New York, （开户行）
NY 10045, account number: 75060099, （帐号）
routing number: 021030004, SWIFT: FRNYUS33,（路由号）
Beneficiary: FDA, 8455 Colesville Rd., Silver Spring, MD 20993–0002. （收款人）
The tax identification number of FDA is 53–0196965. （税号）
Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy. [FR Doc. 2014–18108 Filed 7–31–14; 8:45 am]
BILLING CODE 4164–01–P
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