FDA仿制药2018财年费率通知

翻译：JULIA  来源：Julia法规翻译

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and DrugAdministration [Docket No. FDA-2016-N-0007]

Generic Drug User Fee Rates for Fiscal Year 2018

AGENCY: Food and Drug Administration, HHS. ACTION:  Notice.

FDA仿制药2018财年费率通知

SUMMARY:  The Federal Food, Drug, and Cosmetic Act (theFD&C Act), as amended by the Generic Drug User Fee Amendments of 2017(GDUFA II), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees.  In this document the Food and Drug Administration (FDA or Agency) is announcing fiscalyear (FY) 2018 rates for GDUFA fees.

摘要：联邦食品药品化妆品法案（FDCA）2017修正案GDUFA（GDUFA II)授权FDA可以对简略新药申报（ANDA）、药物主文件（DMF）、仿制药活性药物成分（API）生产场所、制剂(FDF）生产场所、委托生产组织（CMO）生产场所和仿制药申报人项目收取费用。在本文件中，FDA公布了2018财年的GDUFA费用。

FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial Management, Food and Drug Administration, 8455Colesville Rd., COLE-14202I, Silver Spring, MD 20993- 0002, 240-402-9845.

更多信息请联系：David Haas，FDA财务管理办室，8455 Colesville Rd., COLE-14202I, Silver Spring, MD 20993- 0002, 240-402-9845.

SUPPLEMENTARY INFORMATION: 补充信息

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 drugproducts. Fees are assessed on: (1) certain types of applications for humangeneric drug products; (2) certain facilities where APIs and FDFs areproduced;(3) certain DMFs associated with human generic drug products; and (4) thegeneric drug applicant program (see section 744B(a)(1)-(5) of the FD&CAct).

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）。

GDUFA II fees vary greatly from those in GDUFA I because of two fundamental adjustments to the fee structure:

由于对费用结构进行了2项大的调整，因此GDUFAII费用与GDUFA I费用有很大差异：

(1) The revenue base for GDUFA II is $493.6 million versus $323 million in the final year of GDUFA I--ANDAs are the primary workload driver of the program.  GDUFA I was built on the assumption that FDA would receive 750 ANDAs per year.  Over the first 4 years of GDUFA I, AND Areceipts have averaged approximately 1,000 per year. To address the increased workload, FDA hired additional staff and is projected to spend about $430million in the final year of GDUFA I.  To maintain FDA’s current productivity and implement negotiated improvements, GDUFA II stipulates that user fees should total $493.6 million annually adjusted each year for inflation.

GDUFA II的年度收入基数为$4.936亿，而GDUFA I的最后一年收入只有$3.23亿---ANDA是项目的主要工作量。GDUFA I是基于FDA每年会收到750件ANDA的假定基础上的。在GDUFA I的前4年，ANDA接收数量平均为1000件/年。为了解决增加的工作量，FDA聘请了更多员工，为此在GDUFA I的财年中花费了约$4.30亿。为了维持FDA当前的工作能力，实施协定的改进工作，GDUFA II约定用户费用总数$4.936亿，并且每年根据通化膨胀进行调整。

(2) GDUFA II will for the first time rely on annual program fees--GDUFA II shifts the fee burden somewhat from facilityfees.

GDUFA II将首次依赖于年度项目费用—GDUFAII将费用从工厂费用中减压一部分。

For FY 2018, the generic drug fee rates are: ANDA ($171,823), DMF ($47,829), domestic API facility ($45,367), foreign API facility ($60,367), domestic FDF facility ($211,087), foreign FDF facility ($226,087), domestic CMO facility ($70,362), foreign CMO facility ($85,362), large size operation generic drug applicant program ($1,590,792), medium size operation drug applicant program ($636,317), and small business generic drug applicant program ($159,079).  These fees are effective on October 1, 2017, and will remain in effect through September 30, 2018.

2018财年，仿制药费率为：ANDA（$171,823），DMF （$47,829），国内原料药工厂年费（$45,367），国外原料药工厂年费（$60,367），国内制剂工厂年费（$211,087），国外制剂工厂年费（$226,087），国内CMO工厂费用（$70,362），国外CMO工厂费用（$85,362），大型运营仿制药申报项目（$1,590,792），中等规模运营药品申报者项目（$636,317），小规模业务仿制药申报者项目（$159,079）。以上费用自2017年10月1日起生效，有效期至2018年9月30日。

 III.Fee RevenueAmount for FY 2018 2018财年费用总数

The base revenue amount for FY 2018 is $493,600,000, as set in the statute (see section 744B(b)(1) of the FD&C Act). GDUFA II directs FDA to use the yearly revenue amount as a starting point to set the fee rates for each fee type.  For more information about GDUFA II, pleaserefer to the FDA website (http://www.fda.gov/gdufa).  The ANDA, DMF, API facility, FDF facility,CMO facility, and generic drug applicant program fee (GDUFA Program Fee) calculations for FY 2018 are described in this document.

2018财年基本年度收入数字为$493,600,000，这是法定的（参见FDCA744B(b)(1)部分）数字。GDUFA II要求FDA使用年度收入数字作为起始数字，设定每类费用的费率。关于GDUFA II更多信息，请参见FDA官网（http://www.fda.gov/gdufa）。2018财年ANDA、DMF、API工厂、FDF工厂、CMO工厂以及仿制药申报人项目费用（GDUFA项目费用）计算均在本文中进行叙述。

GDUFA II specifies that the $493,600,000 is to be adjusted for inflation increases for FY 2019 through FY 2022 using two separate adjustments--one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (seesection 744B(c)(1) of the FD&C Act).

根据GDUFA II，2019-2022财年将依据GDUFA总额在$493,600,000基础上采用2个指标独立进行通货膨胀调整----一个是人员补偿和收益（PC&B）调整，另一个是非PC&B调整（参见食药化妆品法案第744B（c）（1）部分）。

 Because the adjustment for inflation does not take effect until FY 2019, FDA will not adjust the base revenue amount for inflation in FY 2018.

由于通货膨胀调整截至2019财年前不会产生影响，因此FDA不会对2018财年的收入总额进行通膨调整。

II.ANDA FeeANDA费用

Under GDUFA II,the FY 2018 ANDA fee is owed by each applicant that submits an ANDA on or afterOctober 1, 2017. This fee is due on the receipt date of the ANDA. Section744B(b)(2)(B) specifies that the ANDA fee will make up 33 percent of the $493,600,000, which is $162,888,000.

依据GDUFA II，自2017年10月1日起，提交ANDA的所有申报者均应缴纳2018财年费用。该费用自其ANDA收到之日起生效。第744B(b)(2)(B)部分指明ANDA费用占总费用$493,600,000的33%，即$162,888,000。

To calculatethe ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2018. An ANDA counts as one FAE; however, 75 percent of the fee paid for an ANDA shall be refunded according to GDUFA II if(1) the ANDA is refused for a cause other than failure to pay fees or (2) the ANDA has been withdrawn prior to receipt (section 744B(a)(2)(D)(i) of theFD&C Act).  Therefore, an ANDA that is considered not to have been received by FDA due to reasons other than failure to pay fees or withdrawn prior toreceipt counts as one-fourth of an FAE if the applicant initially paid a full application fee. One hundred percent of the fee paid for an ANDA shall be refunded if FDA initially receives the ANDA and subsequent to initial receipt, FDA determines that exclusivity should have prevented receipt of the ANDA, and thus FDA determines that the ANDA is no longer received (section 744B(a)(2)(D))(ii) of the FD&C Act).

为计算ANDA费用，FDA估算了将于2018财年提交的全申报等同者（FAE）的数量。一份ANDA计为一个FAE，但是，如果（1）ANDA由于费用支付以外的原因被拒收，或者（2）ANDA在接收（依FDCA的744B(a)(2)(D)(i)规定）之前被撤回，则FDA需退还75%的ANDA费用。因此，由于支付失败以外的原因或接收之前被撤回导致FDA未接收ANDA，而申报人当初支付了全申报费用时，该ANDA计为1/4个FAE。如果FDA初始接收ANDA，之后FDA认为有专利阻碍接收该ANDA，因此不能接收（依FDCA的744B(a)(2)(D)(i)规定）该ANDA时，FDA会退回所有支付的费用。

FDA utilized data from ANDAs submitted from October 1, 2013, to April 30, 2017, to estimate the number of new original ANDAs that will incur filing fees in FY 2018. For FY2018, the Agency estimates that approximately 938 new original ANDAs will besubmitted and incur filing fees. Not all of the new original ANDAs will be received by the Agency and some of those not received will be resubmitted inthe same fiscal year. Therefore, the Agency expects that the FAE count for ANDAs will be 948 for FY 2018.

FDA利用2013年10月日是至2017年4月30日之间所提交的ANDA数据来估算2018财年可能会产生申报费用的新的初始ANDA数目。FDA估计在2018财年，会有约938份新的初始ANDA提交并产生申报费用。不是所有新的原始ANDA都会被FDA接受，有些未被接受的会在相同的财年再次提交。因此，FDA预期在2018财年FAE计数为948个。

The FY 2018 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2018 (948) into the fee revenue amount to bederived from ANDA application fees in FY 2018 ($162,888,000).  The result, rounded to the nearest dollar, is a fee of $171,823 per ANDA.

将2018财年的ANDA申报总费用（$162,888,000）除以估算2018财年的FAE数量（948份），得到2018财年申报费用，结果修约至美元整数，即每份ANDA费用为$171,823。

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.

法令规定如果ANDA中包括了API的信息，相比较引用DMF的ANDA需要缴纳额外费用，该费用依据此API数量以及拟报生产场所数量来确定（参见FDCA的744B(a)(3)(F)部分）。FDA考虑到此额外费用不大可能经常评估，因此，FDA在计算ANDA费用时未包括此费用数目的项目。

IV.DMF Fee DMF费用

Under GDUFA II, the DMF fee is owed by eachperson that owns a type II active pharmaceutical ingredient DMF that is referenced, on or after October 1, 2012, in a generic drug submission by aninitial letter of authorization.  This isa one-time fee for each DMF. This fee is due on the earlier of the date on whichthe first generic drug submission is submitted that references the associated DMF or the date on which the drug master file holder requests the initial completeness assessment.  Under section744B(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.

根据GDUFA II，凡在2012年10月1日或之后由仿制药申请首封授权信被引用的二类原料药DMF文件持有人需缴纳DMF费用。这个费用是一次性。该费用在首次引用该DMF的仿制药申请提交时，或者是DMF持有人要求进行初始完整性评估之日产生。根据FDCA的744B(a)(2)(D)(iii) 部分，如果DMF成功通过首次完整性评估，并已支付费用，DMF将会被放在公开的DMF清单中，处于可被引用状态，

To calculate the DMF fee, FDA assessed the volume of DMF submissions over time.

为了计算DMF费用，FDA评估了在一定时段内的DMF申报数量。

The Agency assessed DMFs from October 1, 2015, to April 30, 2017, and concluded that averaging the number of fee-paying DMFs provided the most accurate model forpredicting fee- paying DMFs for FY 2018. FDA is estimating 516 fee-paying DMFs for FY 2018.

FDA评估了2015年10月日至2017年4月30日之间的DMF，结论认为付费DMF的数量平均值能为2018财年的预期付费DMF数量提供最为准确的模型。FDA估算2018财年会有516份付费DMF。

The FY 2018 DMF fee is determined by dividing the DMF target revenue by the estimated number of fee-paying DMFs in FY 2018.  Section 744B(b)(2)(A) specifies that the DMF fees will make up five percent of the $493,600,000, which is$24,680,000.  Dividing the DMF revenue amount ($24,680,000) by the estimated fee-paying DMFs (516), and rounding to the nearest dollar, yields a DMF fee of $47,829 for FY 2018.

2018财物上的DMF费用是将2018财年DMF目标收入除以预测2018年DMF数量。FDCA 744B(b)(2)(A)指定DMF费用将占总数$493,600,000的5%，计为$24,680,000。将2018财年的DMF申报总费用（$24,680,000）除以估算2018财年的DMF数量（516份），得到2018财年申报费用，结果修约至美元整数，即每份DMF费用为$47,829。

 V. Foreign Facility Fee Differential 国外场所费用差异

Under GDUFA II,the fee for a facility located outside the United States and its territoriesand possessions shall be $15,000 higher than the amount of the fee for afacility located in the United States and its territories and possessions. The basis for this differential is the extra cost incurred by conducting an inspection outside the United States and its territories and possessions.

依据GDUFA II，位于美国及其领土以外的场所费用应比国内场所费用高出$15,000。此差异是基于对海外场所进行检查所产生的额外成本而计算的。

VI. FDF and CMOFacility Fees  FDF和CMO场所费用

Under GDUFA II,the annual FDF facility fee is owed by each person who owns an FDF facility that is identified in at least one approved generic drug submission owned by that person or his affiliates.  The CMO facility fee is owed by each person who owns an FDF facility that is identifiedin at least one approved ANDA but is not identified in an approved ANDA held by the owner of that facility or its affiliates. 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 Actspecifies that the FDF and CMO facility fee revenue will make up 20 percent ofthe $493,600,000, which is $98,720,000.

依据GDUFA II，持有一份或一份以上已批准仿制药申报的FDF场所的所有人或其附属企业应缴纳年度FDF场所费用。不持有已批准ANDA，但在已批准的ANDA中识别为FDF生产场所的所有人应缴纳CMO场所费用。这些费用自每年10月1日或之后的第一个工作日产生。依据FDCA的744B(b)(2)(C)部分，FDF和CMO场所费用总收入应为GDUFA费用$493,600,000的20%，即$98,720,000。

To calculate the fees, data from FDA’s Integrity Services (IS) were utilized as the primary source of facility information for determining the denominators of each facility fee type. IS is the master data steward for all facility information provided in generic drug submissions received by FDA. A facility’s reference status in an approved generic drug submission is extracted directly from submission data rather than relying on data from self-identification.  This information provided the number of facilities referenced as FDF manufacturers in at least one approved generic drug submission.  Based on FDA’s IS data for FY 2018, the FDF and CMO facility denominators are 182 FDF domestic, 208 FDFforeign, 71 CMO domestic, and 97 CMO foreign facilities.

为计算该费用，FDA利用了FDA的诚信服务（IS）数据作为确定各类型场所费用的基础信息来源。IS是FDA接收的仿制药申报中提供所有场所信息的主要数据管家。FDA从申报数据中直接提取了已批准仿制药申报中场所的引用状态，而没有依赖于自我识别中的数据。此信息提供了在至少一份批准的仿制药申报中被指为FDF生产商的场所数目。依据FDA的2018财年IS数据，FDF和CMO场所数据为182家国内FDF场所，208家国外FDF场所，71家国内CMO场所，97家国外CMO场所。

GDUFA II specifies that the CMO facility fee is to be equal to one-third the amount ofthe FDF facility fee.  Therefore, to generate the target collection revenue amount from FDF and CMO facility fees ($98,720,000), FDA must weight a CMO facility as one-third of an FDF facility.  FDA set fees based on the estimate of 182 FDFdomestic, 208 FDF foreign, 23.67 CMOdomestic(71 multiplied by one-third), and 32.33 CMO foreign facilities (97 multiplied by one- third), which equals 446 total weighted FDF and CMO facilities for FY2018.

GDUFAII明确CMO场所费用等于FDF场所费用的1/3金额，因此，为了达到FDF和CMO场所费用收取目标（$98,720,000），FDA必须取CMO场所权重为FDF场所的1/3。FDA基于182家国内FDF场所，208家国外FDF场所，23.67家国内CMO场所（71乘以1/3），和32.33家国外CMO场所（97乘以1/3），权重分配后的2018财年FDF和CMO场所总和得数为446。

To calculate the fee for domestic facilities, FDA first determines the total fee revenue that will result from the foreign facility differential by subtracting the fee revenue resulting from the foreign facility fee differential from the target collection revenue amount ($98,720,000) as follows.  The foreign facility fee differential revenue equals the foreign facility fee differential ($15,000) multiplied by the number of FDF foreign facilities (208) plus the foreign facility fee differential ($15,000) multiplied by the number of CMO foreign facilities (97), totaling$4,575,000.  This results in foreign fee differential revenue of $4,575,000 from the total FDF and CMO facility fee target collection revenue.  Subtracting the foreign facility differential fee revenue ($4,575,000) from the total FDF and CMO facility target collection revenue ($98,720,000) results in a remaining facility fee revenue balance of $94,145,000. To determine the domestic FDF facility fee, FDA divides the $94,145,000 by the total weighted number of FDF and CMO facilities (446), which results in a domestic FDF facility fee of$211,087. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $226,087.

为了计算国内场所费用，FDA首先计算了国外场所差异。将国外场所费用差异从目标收费总额（$98,720,000）中扣除如下：国外场所差异收入等于国外场所差异（$15,000）乘以国外FDF场所数目（208）加上国外场所费差异（$15,000）乘以国外CMO场所数目（97），总数为$4,575,000。这样，FDF和CMO的国外场所费用差异收入总额为$4,575,000。从总的FDF和CMO场所收入目标（$98,720,000）中减去该数（$4,575,000），得到场所费用收入余额为$94,145,000。将$94,145,000除以权重计算后FDF和CMO场所总数（446），得国内FDF场所费用为$211,087。国外FDF场所费用比国内多$15,000，因此为$226,087。

CMO fees are as follows.  According to GDUFA II, the domestic CMO fee is calculated as one-third the amount of the domestic FDF facility fee. Therefore, the domestic CMO fee is$70,362, rounded to the nearest dollar.  The foreign CMO fee is calculated as the domestic CMO fee plus the foreign fee differential of $15,000.  Therefore, the foreign CMO fee is $85,362.

CMO场所费用计算如下：依据GDUFA II，国内CMO费用计为国内FDF场所费用的1/3，因此国内CMO费用为$70,362，修约至美元整数；国外CMO费用为国内CMO费用加上海外场所差异$15,000，即$85,362。

VII. API Facility Fee  API场所费用

Under GDUFA II, the annual API facility fee is owed by each person who owns a facility that is identified in (1) at least one approved generic drug submission or (2) in a Type II API DMF referenced in at least one approved generic drug submission.  These fees are due no laterthan the first business day on or after October 1 of each such year.  Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee will make up seven percent of $493,600,000 in fee revenue, which is $34,552,000.

依据GDUFA II，（1）在至少一份已批准仿制药申报中识别，或（2）在被至少一份已批准仿制药申报引用的II类API DMF中识别的API场所所有人应缴纳年度API场所费用。这些费用自每年10月1日起或之后的第一个工作日开始产生。FDCA的744B(b)(2)(D)部分指明API场所费用为总GDUFA收入$493,600,000的7%，即$34,552,000。

To calculatethe API facility fee, data from FDA’s IS were utilized as the primary source of facility information for determining the denominator.  As stated above, IS is the master data steward for all facility information provided in generic drug submissions received by FDA.  A facility’s reference status in an approved generic drug submission is extracted directly from submission data rather than relying on data from self-identification.  This information provided the number of facilities referenced as API manufacturers in at least one approved generic drug submission.

为了计算API场所费用，FDA使用了其IS数据作为场所信息基础来源。如上所述，IS是FDA所收到的仿制药申报中提供的所有场所信息的主数据管家。FDA从申报数据中直接提取了已批准仿制药申报中场所的引用状态，而没有依赖于自我识别中的数据。此信息提供了在至少一份批准的仿制药申报中被引用为API生产商的场所数目。

The total number of API facilities identified was 592. Of the total facilities identified as API facilities, there were 79 domestic facilities and 513 foreign facilities. The foreign facility differential is $15,000.  To calculate the fee for domestic facilities, FDA must first subtract the fee revenue that will result from the foreign facility fee differential. FDA takes the foreign facility differential ($15,000) and multiplies it by the number of foreign facilities (513) to determine the total fee revenue that will result from theforeign facility differential. As a result of that calculation, the foreign feedifferential revenue will make up $7,695,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($7,695,000) from the total API facility target revenue ($34,552,000) results in a remaining balance of $26,857,000.  To determine the domestic API facility fee, we divide the $26,857,000 by the total number of facilities (592), which gives us a domestic API facility fee of $45,367. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $60,367.

据此识别出的API场所总数为592家，其中有79家国外场所，513家国外场所。国内外场所差异额为$15,000，因此为了计算国内场所费用，FDA必须首先扣除国外场所费用差异所产生的收入。将国外场所费用差异额（$15,000）乘以国外场所总数（513），得到国外场所差异收入额为$7,695,000，从API场所费用目标收入（$34,552,000）中扣除此数（$7,695,000），余额为$26,857,000。将该余额$26,857,000除以场所总数（592），得国内场所费用为$45,367。国外API场所费用为国内API场所费用加上$15,000，即$60,367。

VIII.        Generic Drug Applicant Program Fee    仿制药申报人项目费用

Under GDUFA II,if a person and its affiliates own at least one but not more than five approved ANDAs on October 1, 2017, the person and its affiliates shall owe a smallbusiness GDUFA Program Fee.  If a personand its affiliates own at least 6 but not more than 19 approved ANDAs, theperson and its affiliates shall owe a medium size operation GDUFA Program Fee.

依据GDUFA II，如果某人及其附属公司截止2017年10月1日拥有至少一个但不超过5个已批准ANDA，则该人及其附属公司应缴纳小型企业GDUFA项目费用。如果某人及其附属公司拥有至少6个但不超过19个已批准ANDA，则该人及其附属公司应缴纳中等规模企业GDUFA项目费用。

If a person andits affiliates own at least 20 approved ANDAs, the person and its affiliates shall owe a large size operation GDUFA Program Fee.  These fees are due no later than the first business day on or after October 1 of each such year.  Section 744B(b)(2)(E) of the FD&C Act specifies the GDUFA Program Fee will make up 35 percent of $493,600,000 in fee revenue, which is $172,760,000.

如果某人及其附属公司拥有至少20个已批准的ANDA，则该人及其附属公司应缴纳大型公司GDUFA项目费用。这些费用自该年度10月1日或之后的第一个工作日开始产生。FDCA的第744B(b)(2)(E)部分指明GDUFA计划费用为总费用收入$493,600,000的35%，即$172,760,000。

To determine the appropriate number of applicants for each tier, the Agency has posted listsof approved ANDAs on the FDA website (http://www.fda.gov/gdufa) and asked applicants on the list to claim which ANDAs and affiliates belong to the parent company. The original list of approved ANDAs came from the Agency’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS), which included all ANDAs with the status of “approved” as of April 30, 2017.

为了确定每个级别的申报人数量，FDA在官网上贴出了批准的ANDA清单，并且要求清单上的申报人呈报哪个ANDA和分支机构属于母公司。原始的已批准ANDA清单是来自FDA的文件档案、报告和注册追踪系统（DARRTS），它包括了截止2017年4月30日为止时所有处于“已批准”状态的ANDA。

In determining the appropriate number of approved ANDAs, the Agency has factored in a numberof variables that could affect the collection of the target revenue: (1) inactive ANDAs-- applicants who have not submitted an annual report for one ormore of their approved applications within the past 2 years; (2) unclaimed affiliations--a risk of undercollecting the target revenue if companies do not claim their ANDAs and their affiliates before the Program Fee is calculated; and (3) potential portfolio adjustment--applicants may choose to withdraw someof their approved ANDAs in order to move to a lower tier and reduce their feeexposure.

在确定已批准ANDA的数量时，FDA已考虑了可能会影响目标收入的变量因素（1）未激活的ANDA----申报人在过去2年中未提交一份或多份其已批准申报的年报；（2）未申明的分支机构---如果在项目费用计算开始之前公司不呈报其ANDA及其分支机构则可能会导致目标收入少收的风险；以及（3）可能会有组合调整----申报人可能会选择撤回一些其已批准的ANDA以进入低一层级分类，降低其应缴费率。

The list oforiginal approved ANDAs from the DARRTS database as of April 30, 2017, shows 339 applicants in the small business tier, 74 applicants in the medium size tier, and 65 applicants in the large size tier. This list also takes into account all the withdrawals, consolidations, and transfer of ownerships from industry as of April 30, 2017.  Factoringin all the variables for the first year of GDUFA II, the Agency estimates there will be 258 applicants in the small business tier, 52 applicants in the mediumsize tier, and 62 applicants in the large size tier for FY 2018.

2017年4月30日截止从DARRTS中提取的原始已批准的ANDA清单显示小规模业务层有339家申报人，中等规模有74家，大型则有65家。该清单也考虑了截止2017年4月30时企业中所有撤回、整合以及所有权转让情况。考虑到GDUFA II首年的所有变动因素，FDA预测2018财年中小规模申报人有258家，中等规模54家，大型申报人62家。

To calculatethe GDUFA Program Fee, GDUFA II provides that large size operation generic drug applicants pay the full fee, medium size operation applicants pay two-fifths ofthe full fee, and small business applicants pay one-tenth of the full fee.  To generate the target collection revenue amount from GDUFA Program Fees ($172,760,000), we must weigh medium and small tiered applicants as a subset of a large size operation generic drug applicant.FDA will set fees based on the weighted estimate of 25.8 applicants in the small business tier (258 multiplied by 10 percent), 20.8 applicants in the medium size tier (52 multiplied by 40 percent), and 62 applicants in the largesize tier, arriving at 108.6 total weighted applicants for FY 2018.

在GDUFA项目费用计算中，GDUFAII规定了大型仿制药申报人支付全额费用，中等规模申报人支付全额费用的25%，小型申报人支付全额费用的10%。要计算GDUFA项目费目标收入数目（$172,760,000），我们必须对三类申报人进行权重加合。FDA依据权重计算后小型申报人数25.8（258乘以10%），中型申报人数20.8（52乘以40%）以及大型申报人62，权重加和结果为108.6。

To generate the large size operation GDUFA Program Fee, FDA divides the target revenue amount of $172,760,000 by 108.6, which equals $1,590,792. The medium size operation GDUFA Program Fee is 40 percent of the full fee ($636,317), and the smallbusiness operation GDUFA Program Fee is 10 percent of the full fee ($159,079).

计算大型GDUFA项目申报人费用时，FDA将总目标收入额$172,760,000除以108.6，得$1,590,792。中等规模GDUFA项目费用为全额费用的40%（$636,317），小规模申报人GDUFA费用为全额费用的10%（$159,079）。

IX. Fee Schedule for FY 2018 2018财年费用列表

The fee ratesfor FY 2018 are set out in table 1. 2018财年费用列表参见表1。

Table 1.--Fee Schedule for FY 20182018财年费用表

X. Fee PaymentOptions and Procedures 费用支付方法和程序

The new feerates are effective October 1, 2017.  Topay the ANDA, DMF, API facility, FDF facility, CMO facility, and GDUFA Program Fee, you must complete a Generic Drug User Fee Cover Sheet, available through https://www.fda.gov/gdufa and athttps://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and generate a user feeidentification (ID) number.  Payment mustbe made in U.S. currency drawn on a U.S. bank by electronic check, check, bankdraft, U.S. postal money order, credit card, or wire transfer. The preferred payment method is online using electronic check (Automated Clearing House (ACH)also known as eCheck) or credit card (Discover, VISA, MasterCard, AmericanExpress).  Secure electronic payments canbe submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay(Note: only full payments are accepted. No partial payments can be made online.)Once you search for your invoice, select “Pay Now” to be redirected toPay.gov.  Note that electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000.  If thebalance exceeds this amount, only the ACH option is available.

新的费率自2017年10月1日起生效。ANDA费、DMF费、原料药工厂费、制剂工厂费、CMO费和GDUFA程序费支付时必须填写仿制药费用封面表（可以在https://www.fda.gov/gdufa和https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp填写），生成用户费用识别码编号（ID）。必须通过使用美国银行所存的美元支付，可以是电子支票、支票、银行汇票、美国邮政汇票、信用卡或电汇。优选支付方式是在线使用电子支票（自动清算房（ACH），也称为eCheck电子支票）或者是信用卡（发现卡/Discover, 维萨卡/VISA, 万事通卡/MasterCard, 美国运通卡/American Express）。使用用户费用支付端口https://userfees.fda.gov/pay可以安全提交电子支付（注意：只接受全额支付，不能在线仅支付一部分）。在查阅发票时，选择“现在支付/Pay Now”转到Pay.gov页面。注意，电子支付方法是基于应付账款的。应付款低于$25,000时可以用信用卡支付。如果应付款项超出此金额，则只能使用ACH方法支付。

Payments must be made using U.S bank accounts as well as U.S. creditcards.

支付必须使用美国银行账号和美国信用卡。

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 featureis available on the FDA website after completing the Generic Drug User FeeCover Sheet and generating the user fee ID number.

FDA与美国财政部已有合作，互联网用户可以采用Pay.gov进行在线电子支付。Pay.gov的使用在FDA官网上有链接，在填写完仿制药用户费用封面函后，会生成一个用户付费ID。

Please includethe user fee ID number on your check, bank draft, or postal money order andmake payable to the order of the Food and Drug Administration.  Your payment can be mailed to:  Food and Drug Administration, P.O. Box979108, 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:

请将该用户付费ID号写在你的支票、银行汇票、邮政汇票上，支付给食品药品管理局。如果通过快递寄交支票，会需要地址，支票寄交地址：Food and Drug Administration, P.O. Box 979108, St. Louis, MO63197–9000.

U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO63101.  (Note:  This U.S. Bank address is for courier delivery only.  If you have any questions concerning courier delivery, contact the U.S. Bank at 314-418-4013. Thistelephone number is only for questions about courier delivery).  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.

美国银行，收件人：Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO63101. （注：此美国银行地址仅供快递寄送用。如果你有任何关于快递寄送问题，联系美国银行314-418-4013。该电话仅能解决关于快递寄送的问题）。请务必将FDA邮箱编号（(P.O. Box 979108）写在支票、银行汇票、或邮政汇票上。

If paying by wire transfer, please reference your unique user fee ID number when completing your transfer.  Without your unique userfee ID number, the payment may not be applied. If the payment amount is not applied, the invoice amount would be referred to collections.  The originating financial institution may charge a wire transfer fee.  Please ask your financial institution aboutthe wire transfer fee and include it with your payment to ensure that your feeis fully paid.  Use the following account information when sending a payment by wire transfer:

如果采用电汇，请将你的唯一的用户付费ID号填写在汇单上。如果没有该唯一的用户费用ID号，将无法付款。电汇会产生费用，请咨询你的汇出行电汇费用，要保证支付足额的汇费。帐户信息如下：

U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY10045, account number:  75060099, routingnumber: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14thFloor, Silver Spring, MD 20993-0002.  Ifneeded, FDA’s tax identification number is 53-0196965.

如需填写税号，FDA税号为53-0196965

Dated: August 24, 2017.

AnnaK. Abram,

DeputyCommissioner for Policy, Planning, Legislation, and Analysis.

[FR Doc. 2017-18377Filed: 8/28/2017 8:45 am; Publication Date: 8/29/2017]