仿制药用户付费修正案
正文 · 中文译文
仿制药使用者付费修正案 《仿制药使用者付费修正案》（GDUFA）第四轮重新授权 预简化新药申请（Pre-ANDA）项目 简化新药申请（ANDA）评估项目 受控通信 药物主文件（DMF）评估 设施相关变更 使用者付费资源管理项目 FDA-TRACK：仿制药使用者付费修正案（GDUFA）绩效仪表板 2022年9月30日，总统签署了《2022年FDA使用者付费重新授权法案》，其中包括将《仿制药使用者付费修正案》（GDUFA）重新授权至2027年9月（GDUFA III）。国会于2012年首次颁布GDUFA，此前FDA与产业界进行了谈判，并征求了公共利益相关方的意见。国会颁布GDUFA旨在确保患者能够获得安全、高质量且可负担的仿制药。GDUFA使FDA能够向产业界收取使用者付费，从而为仿制药申请的审评带来更大的可预测性和及时性。 本页面提供面向产业界和相关方的关于GDUFA的新闻和信息，包括其收费结构、支付方式及相关信息。更多信息可在GDUFA第四轮重新授权网页上查阅。 最新新闻 2027财年封面页现已在使用者付费系统中提供。 2027财年（FY）GDUFA费率已于2026年7月30日在《联邦公报》（FR）上公布。有关2027财年费率的更多信息，请参阅可获取的FR公告。 FDA使用者付费项目已过渡至新的集中电子邮箱：FDAUserFees@fda.hhs.gov。请更新您的记录，并在今后的使用者付费通信中使用该电子邮箱地址。 根据总统第14247号行政命令《现代化美国银行账户收付款》，FDA将自2025年10月1日起不再接受纸质付款。向FDA付款必须以美国货币通过电子支票、信用卡或电汇方式从美国银行账户支付。首选付款方式为在线使用电子支票（自动清算所（ACH），也称为eCheck）或信用卡（Discover、VISA、MasterCard、American Express）。 FDA按月报告GDUFA III活动和指标——包括批准、提交、会议、DMF费用及其他行动。 FDA仿制药计划财年活动报告——按年度发布。 仿制药相关问题联系人提供与仿制药计划和GDUFA相关主题的信息和协助。 2026财年和2027财年用户费率 用户费类型 2026财年 2027财年 ANDA $ 358,247 $ 375,684 DMF $ 102,584 $ 109,899 计划 大型 $ 1,918,377 $ 1,927,291 中型 $ 767,351 $ 770,916 小型 $ 191,838 $ 192,729 设施 国内API $ 43,549 $ 39,680 国外API $ 58,549 $ 54,680 国内FDF $ 238,943 $ 230,033 国外FDF $ 253,943 $ 245,033 国内CMO $ 57,346 $ 55,208 国外CMO $ 72,346 $ 70,208 背景与立法 2012年7月9日，GDUFA作为《FDA安全与创新法案》（FDASIA）的一部分由总统签署成为法律。GDUFA旨在加快向公众提供安全有效的仿制药，并提高审评过程的可预测性。GDUFA基于FDA与仿制药行业代表协商达成的协议，以应对日益增多的监管挑战。 GDUFA必须每五年重新授权一次。2022年9月30日，总统签署法案，重新授权GDUFA III至2027年9月30日。 GDUFA反映了在公开过程中收到的意见，该过程包括定期公开会议、公布会议纪要以及考虑来自公共案卷的评论。商定的建议被发送至国会，国会就GDUFA举行了听证会，其中包括来自FDA、仿制药行业和其他利益相关方的证词。 GDUFA旨在使FDA的仿制药项目建立在稳固的财务基础上，并确保及时获得安全、高质量、可负担的仿制药。GDUFA使FDA能够收取使用者费用，为FDA仿制药项目绩效的关键且可衡量的改进提供资金，从而使仿制药申请的审评具有更大的可预测性和及时性。 补充背景和立法来源： 21 USC 第9章，第VII分章，C部分，第7子部分：与仿制药相关的费用 H.R.6833 - 为2023财政年度及其他目的作出持续拨款。2022年仿制药使用者费用修正案 2017年FDA再授权法案（FDARA） 2012年仿制药使用者付费修正案；Pub. L. 112-144，第III篇 2012年FDA使用者付费更正法案，于2012年10月5日签署成为法律，以使2013财年GDUFA使用者付费无需颁布拨款法案即可征收 GDUFA III承诺函：GDUFA再授权绩效目标与项目增强，2023-2027财年 GDUFA II承诺函：GDUFA再授权绩效目标与项目增强，2018-2022财年 GDUFA承诺函：人用仿制药绩效目标与程序，2013至2017财年（PDF - 99 KB） 联邦公报文件与指南 联邦公报文件 2027财年仿制药使用者付费费率 2026财年仿制药使用者付费费率 2025财年仿制药使用者付费费率 2013财年至今仿制药使用者付费费率 如需查找更早的GDUFA联邦公报文件，请查阅联邦公报。 指南文件 根据2022年仿制药使用者付费修正案评估使用者付费——行业指南 GDUFA下的信息请求与纪律审查函 ANDA申报——GDUFA下简化新药申请修正案行业指南 GDUFA下FDA与复杂产品ANDA申请人之间的正式会议行业指南 如需查找更早的GDUFA指南，请查阅GDUFA指南与MAPPs页面。 项目费用 什么是仿制药申请人项目费？ 《仿制药使用者付费法案III》（GDUFA III）包含一项仿制药申请人项目费，每年评估一次。每家公司及其关联公司将根据其产品组合中已批准简化新药申请（ANDA）的数量被评估年度项目费。为确定费用金额，项目费分为三个层级： 大型：20个或以上已批准ANDA； 中型：6至19个已批准ANDA； 小型：5个或以下已批准ANDA “关联公司”一词定义为与第二商业实体存在如下关系的商业实体：直接或间接地，一个商业实体控制或有能力控制另一商业实体；或第三方控制或有能力控制这两个商业实体。 自2018年10月1日起，仿制药申请人及其关联公司，或授权代表，可通过CDER Direct NextGen协作门户提交所有已批准ANDA的清单。提交将针对即将到来的2023-2027财年。 要在CDER Direct NextGen协作门户注册账户，请访问https://edm.fda.gov。 有关登录的更多信息：CDER Direct NextGen协作门户常见问题解答 由于处理时间，您可能会遇到可能对您的产品组合产生影响的数据差异。如果您在产品组合中遇到任何差异，请在门户中更新您的产品组合并酌情提交。请注意，撤回请求和所有权转让必须通过电子提交网关（ESG）发送至ANDA的官方记录。 项目费何时到期？ 项目费应在财政年度的10月1日缴纳。如果10月1日恰逢周末、联邦假日或FDA其他关闭日，则费用应在下一个营业日缴纳。任何在10月1日之后批准的ANDA将被纳入母公司下一财政年度的产品组合。 不缴纳项目费的处罚是什么？ 如果申请人在到期日后20个日历日内未能缴纳项目费，将产生三项后果：(1) 母公司将被列入可公开查阅的欠费名单。(2) 申请人或其关联方提交的任何ANDA将不予接收。(3) 根据该申请人或其关联方持有的任何ANDA上市销售的所有药品将被视为假冒品牌。 已停产的ANDA是否计入项目费的计算？ 是的，除非ANDA被正式撤回，已停产的ANDA在用户付费目的下仍被视为已批准。 如果拥有4个已批准ANDA的A公司与拥有16个已批准ANDA的B公司存在关联关系，它们能否缴纳中小型费用？还是必须缴纳一笔大型费用？ 由于A公司和B公司存在关联关系，它们的产品组合包括20个ANDA，因此必须缴纳一笔大型费用。根据21 U.S.C. § 379j-42(b)(2)(E)，如果一个人拥有关联方，则应评估单一项目费。 如果两家公司存在关联关系，是母公司必须缴纳项目费，还是关联公司可以缴纳该费用？ 母公司或任何关联公司均可代表母公司缴纳项目费。 对已批准简明新药申请（ANDA）清单进行变更的截止日期是什么时候？ 对于2023财年至2027财年，如果申请人在上一财年4月1日之前提交了撤回该ANDA批准状态的请求，则该ANDA应被视为未获批准。 例如，如果一家公司有6个已批准的ANDA，并且在2022年4月1日或之前提交了其中一个ANDA的撤回请求，那么该公司在2023财年的项目费用层级将从中等层级变为小层级。 对于所有权转让、合并以及公司产品组合的其他变更，FDA将使用截至10月1日生效的信息来确定项目费用层级。 例如，如果一家公司有6个已批准的ANDA，并请求将2个ANDA合并为1个，但仿制药办公室直到2022年10月1日之后才批准该合并请求，那么该公司在2023财年将仍处于中等层级。（总数仍为6个ANDA）。 例如，如果一家拥有5个已批准ANDA的公司被认定与另一家拥有1个已批准ANDA的公司存在关联关系，且关联日期在2022年10月1日或之前，那么该公司将被按2023财年的中等层级费用进行评估。如果该公司已经支付了小层级费用，则其需要支付中等层级费用与小层级费用之间的差额。 对于未列出的其他情形，请联系FDAUserFees@fda.hhs.gov寻求帮助。 行业应在何时告知FDA其关联公司？ 每年4月1日前，每个拥有简化新药申请（ANDA）的人，或该人的指定关联方，应代表该人及该人的关联方向管理局提交一份清单，列明（1）该人拥有的所有已批准ANDA，以及（2）如果该人的任何关联方也拥有ANDA，则列明所有拥有任何此类ANDA的关联方以及任何此类关联方拥有的所有已批准ANDA。 请将您的回复提交至CDER Direct NextGen Collaboration Portal。 是否有任何药物或申请被排除在项目费之外？ 以下项目被排除在项目费之外：正电子发射断层扫描（PET）药物，以及州或联邦政府实体提交的用于非商业分销药物的申请。 公司如何支付项目费？ 公司可以通过用户费用系统创建项目费封面页，然后通过支票、电汇或pay.gov支付。 如果封面页上显示的层级错误怎么办？ 请通过CDER Direct NextGen Collaboration Portal报告任何差异。更正后，仿制药用户费用工作人员将在修订后的封面页可用时与您联系。 设施费 GDUFA III下的设施费类型有哪些？ 设施费有三种类型：（1）原料药（API）设施费；（2）成品剂型（FDF）设施费；（3）合同生产组织（CMO）设施费。如果被视为API/FDF生产商或CMO，设施所有者需要支付年度设施费。关于每种设施费类型的确切费用金额，请参阅上文的GDUFA费用表。 每位拥有以下设施的人须缴纳API设施费：该设施被列入（1）至少一份已批准的仿制药申请，且该设施被批准生产一种或多种API；或（2）至少一份已批准的仿制药申请中引用的II型API药物主文件。 每位拥有至少一份被批准生产一种或多种FDF的仿制药申请中所列设施的人须缴纳FDF设施费。部分FDF设施可能符合CMO的资格。每位拥有至少一份已批准简化新药申请（ANDA）中所列FDF设施的人须缴纳年度CMO设施费，前提是该设施未被列入该设施所有者或其关联方持有的已批准ANDA中。CMO设施费为FDF设施费金额的24%。符合CMO资格的设施所有者将缴纳CMO设施费；不评估其他设施费金额。 外国和国内仿制药设施之间的费用是否存在差异？ 是的。GDUFA III规定，位于美国及其领土和属地之外的设施的费用金额应比国内设施的费用金额高15,000美元。这一差异的依据是在美国及其领土和属地之外进行检查所产生的额外费用。 设施费何时到期？ 设施费每年产生，应在每个财政年度10月1日或之后的第一个工作日到期，或在规定该年度费用征收的拨款法案颁布后的第一个工作日到期。 在什么条件下产生设施费？ 根据GDUFA III，设施所有人在设施费到期日同时满足以下两个条件时产生费用： 该设施在已批准的仿制药申报中被引用；且 该设施从事原料药（API）或成品制剂（FDF）的生产或加工。 根据GDUFA III，设施仅因在待审或暂定批准的仿制药申报中被引用而不产生费用。 是否所有必须自我识别的设施、场所和组织都必须支付设施费？ 不。自我识别本身并不会触发支付GDUFA设施费的义务。然而，大多数进行自我识别的设施往往需要支付年度设施使用费。这些设施包括生产人用仿制药中所含原料药（API）和/或成品剂型（FDF）的设施。其他场所和组织必须进行自我识别，但无需支付年度设施使用费。这些包括仅生产正电子发射断层扫描（PET）药物的设施、仅在州和/或联邦政府实体提交的申请中被引用且药物不进行商业分销的设施，或仅执行检测、重新包装或重新贴标签操作的场所和组织。请注意，虽然重新包装商无需支付使用费，但药品包装商在大多数情况下需缴纳FDF或CMO设施费。药品贴标签商和重新贴标签商也是如此。 仅为待批准或暂定批准的仿制药生产的设施也将进行自我识别。然而，如果该仿制药在GDUFA设施费到期日仍处于待批准或暂定批准状态，这些设施将不会产生GDUFA设施费。 如果某设施在某财政年度设施费支付到期日之后首次在已批准的仿制药申报中被识别，该设施是否需要支付该财政年度的费用？ 否。如果某设施在某一财政年度的设施费缴纳截止日期之后，才首次在已批准的仿制药申报中被识别出来，则该设施无需缴纳该财政年度的费用。在大多数情况下，关键问题是在截止日期当天是否存在一份已批准且引用了该设施的仿制药申报。 如果该设施在截止日期之后才首次在已批准的仿制药申报中被识别出来，其所有者将在下一个截止日期欠缴设施费。例如，如果某设施于2022年10月15日（在2022财政年度截止日期之后、2023财政年度期间）首次在一份已批准的简略新药申请中被识别出来，则该设施将从2024财政年度截止日期（2023年10月的第一个工作日）开始产生设施费。如果某设施在截止日期当天已在某份已批准的仿制药申报中被识别出来，而该设施引用或该药品申报此后被撤回，则费用不予退还。 如果某设施仅生产非仿制药活性药物成分（API）或成品剂型（FDF），但在某份已批准的仿制药申报中被引用为产生费用的运营类型，该设施所有者是否需要缴纳GDUFA费用？ 是。 如果某设施在某份已批准的仿制药申报中被引用为产生费用的运营类型，但仅生产供非美国市场销售的药品，该设施所有者是否需要缴纳GDUFA费用？ 是。 当前未生产API或FDF的设施是否需要缴纳适用的设施费？ 只要某生产设施在至少一份已批准的仿制药申报中被列明，该设施就需缴纳年度设施费，即使该设施尚未开始该申报所涵盖的原料药（API）或成品制剂（FDF）的商业规模生产，或者该设施已暂时或永久停止该原料药或成品制剂的生产。 如果该设施不再在任何仿制药申报中被列明，或已停止生产所有原料药和成品制剂（包括仿制药和非……
正文 · 英文原文
Generic Drug User Fee Amendments GDUFA IV Reauthorization Pre-ANDA Program ANDA Assessment Program Controlled Correspondence Drug Master File (DMF) Assessments Changes for Facilities User Fee Resource Management Program FDA-TRACK: Generic Drug User Fee Amendments (GDUFA) Performance Dashboards On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2027 (GDUFA III). Congress first enacted GDUFA in 2012, following negotiations between the FDA and industry and with input from public stakeholders. Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs. GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications. This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information. Additional information can be found on the GDUFA IV Reauthorization web page. Latest News FY 2027 cover sheets are now available in the User Fee System. The fiscal year (FY) 2027 GDUFA fee rates were published in the Federal Register (FR) on July 30, 2026. For more information regarding the FY 2027 fee rates, please see the available FR notice. The FDA User Fee program has transitioned to a new centralized email inbox: FDAUserFees@fda.hhs.gov. Please update your records and use this email address for future user fee communications. In accordance with the President’s Executive Order 14247- Modernizing Payments to and from America’s Bank Account, FDA will no longer be accepting paper-based payments beginning October 1, 2025. Payments made to FDA must be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. The preferred method of payment is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA reports GDUFA III activities and metrics—including approvals, submissions, meetings, DMF fees, and other actions—on a monthly basis. FDA Generic Drugs Program Fiscal Year Activities Report - on an annual basis. Points of Contact for Questions Related to Generic Drugs provides information and assistance on topics related to the Generic Drugs Program and GDUFA. FY 2026 and FY 2027 User Fee Rates User Fee Type FY 2026FY 2027 ANDA $ 358,247$ 375,684 DMF $ 102,584$ 109,899 ProgramLarge Size$ 1,918,377$ 1,927,291 Medium Size$ 767,351$ 770,916 Small Size$ 191,838$ 192,729 FacilityDomestic API$ 43,549$ 39,680 Foreign API$ 58,549$ 54,680 Domestic FDF$ 238,943$ 230,033 Foreign FDF$ 253,943$ 245,033 Domestic CMO$ 57,346$ 55,208 Foreign CMO$ 72,346$ 70,208 Background and Legislation On July 9, 2012, GDUFA was signed into law by the President as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. GDUFA must be reauthorized every five years. On September 30, 2022, the President signed the bill reauthorizing GDUFA III through September 30, 2027. GDUFA reflects input received during an open process that included regular public meetings, posting of meeting minutes, and consideration of comments from a public docket. Agreed upon recommendations were sent to Congress, and Congress held hearings on GDUFA that included testimony from FDA, the generic drug industry, and other interested parties. GDUFA aims to put FDA’s generic drug program on a firm financial footing and ensure timely access to safe, high-quality, affordable generic drugs. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. Sources for Additional Background and Legislation: 21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 7: fees relating to generic drugs H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes.Generic Drug User Fee Amendments of 2022 FDA Reauthorization Act of 2017 (FDARA) Generic Drug User Fee Amendments of 2012; Pub. L. 112-144, Title III FDA User Fee Corrections Act of 2012 signed into law Oct. 5, 2012 to enable collection of FY 2013 GDUFA user fees without enactment of an appropriations Act GDUFA III Commitment Letter: GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 GDUFA II Commitment Letter: GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDF - 99 KB) Federal Register Documents and Guidances Federal Register Documents Generic Drug User Fee Rates for Fiscal Year 2027 Generic Drug User Fee Rates for Fiscal Year 2026 Generic Drug User Fee Rates for Fiscal Year 2025 Generic Drug User Fee Rates for Fiscal Years 2013-Present To find older GDUFA Federal Register documents, please check the Federal Register. Guidance Documents Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 Guidance for Industry Information Requests and Discipline Review Letters Under GDUFA ANDA Submissions - Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry To find older GDUFA guidances, please check the GDUFA Guidances and MAPPs page. Program Fees What is the generic drug applicant program fee? GDUFA III includes a generic drug applicant program fee, which is assessed annually. Each company and its affiliates will be assessed an annual program fee depending on the number of approved ANDAs in their portfolio. To determine the fee amount, there are three tiers of the program fee: Large: 20 or more approved ANDAs; Medium: between 6 and 19 approved ANDAs; Small: 5 or fewer approved ANDAs The term “affiliate” is defined as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third-party controls, or has the power to control, both of the business entities. Effective October 1, 2018, generic drug applicants and their affiliates, or an authorized representative, can submit the list of all approved ANDAs via the CDER Direct NextGen Collaboration Portal. Submissions will be for the upcoming fiscal years 2023-2027. To register for an account with the CDER Direct NextGen Collaboration Portal, navigate to https://edm.fda.gov. For more on logging in: CDER Direct NextGen Collaboration Portal FAQs Due to processing times, you might encounter data discrepancies that might have an impact on your portfolio. If you encounter any discrepancies in your portfolio, please update your portfolio in the portal and submit as appropriate. Please note that Withdrawal Requests and Transfers of Ownership must be sent to the official record of the ANDA via the Electronic Submissions Gateway (ESG). When is the program fee due? The program fee is due on October 1 of the fiscal year. If October 1 falls on a weekend, federal holiday, or day when the FDA is otherwise closed, then the fee is due on the following business day. Any ANDA approved after October 1 will be included in the parent company’s portfolio for the following fiscal year. What is the penalty for not paying the program fee? There are three effects if an applicant fails to pay the program fee within 20 calendar days after the due date: (1) The parent company will be placed on a publicly available arrears list. (2) Any ANDA submitted by the applicant or its affiliates will not be received. (3) All drugs marketed pursuant to any ANDA held by such applicant or an affiliate of such applicant shall be deemed misbranded. Are discontinued ANDAs included in the calculation of program fees? Yes, discontinued ANDAs are still considered approved for user fee purposes unless the ANDAs are officially withdrawn. If Company A that has 4 approved ANDAs is affiliated with Company B that has 16 approved ANDAs, can they pay a small and medium fee? Or, must they pay one large fee? Since Company A and B are affiliated, their portfolio includes 20 ANDAs and they, therefore, must pay one large fee. According to 21 U.S.C. § 379j-42(b)(2)(E), if a person has affiliates, a single program fee shall be assessed. If two companies are affiliated, does the parent company have to pay the program fee or can the affiliate pay the fee? Either the parent company or any of the affiliated companies can pay the program fee on behalf of the parent company. When is the deadline for making changes to the approved ANDA list? For FY 2023 through FY 2027, an ANDA shall be deemed not to be approved if the applicant has submitted a request for withdrawal of approval of such ANDA by April 1 of the previous fiscal year. For example, if a company has 6 approved ANDAs and a withdrawal request is submitted for one ANDA before or on April 1, 2022, then the company’s program fee tier would change from medium tier to small tier for FY 2023. For transfers of ownership, consolidations, and other changes to a company’s portfolio, FDA will use the information effective as of October 1 to determine program fee tier. For example, if a company has 6 approved ANDAs and requests a consolidation of 2 ANDAs into 1, but the Office of Generic Drugs does not grant the consolidation request until after October 1, 2022, then the company would remain medium tier for FY 2023. (Total remains 6 ANDAs). For example, if a company with 5 approved ANDAs is determined to be affiliated with another company with 1 approved ANDA, and the date of affiliation is on or prior to October 1, 2022, then the company would be assessed the medium tier fee for FY 2023. If the company had already paid the small tier, then they would need to pay the difference between the medium tier fee and the small tier fee. For other scenarios not listed, please contact FDAUserFees@fda.hhs.gov for assistance. When should the industry inform the Agency about their affiliates? By April 1 of each year, each person that owns an ANDA, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Agency a list of (1) all approved ANDAs owned by such person, and (2) if any affiliate of such person also owns an ANDA, all affiliates that own any such ANDA and all approved ANDAs owned by any such affiliate. Please submit your responses to the CDER Direct NextGen Collaboration Portal. Are there any drugs or applications excluded from the program fee? The following are excluded from the program fee: Positron emission tomography (PET) drugs, and applications submitted by a State or Federal Government entity for a drug that is not distributed commercially. How does a company pay the program fee? A company can create a program fee cover sheet via the User Fee System and then pay via check, wire transfer, or pay.gov. What if the wrong tier is displayed on the coversheet? Please report any discrepancies via the CDER Direct NextGen Collaboration Portal. Once corrected, the Generic Drug User Fee staff will reach out when the amended cover sheet is available. Facility Fees What are the facility fee types under GDUFA III? There are three types of facility fees: (1) an active pharmaceutical ingredient (API) facility fee; (2) finished dosage form (FDF) facility fee; and (3) Contract Manufacturing Organization (CMO) facility fee. If considered an API/FDF manufacturer or a CMO, a facility owner is required to pay an annual facility fee. Please refer to the GDUFA Fees table above for the exact fee amounts of each facility fee type. Each person who owns a facility that is identified in (1) at least one approved generic drug submission in which the facility is approved to produce one or more APIs, or (2) a Type II API drug master file referenced in at least one approved generic drug submission incurs the API facility fee. Each person who owns a facility that is identified in at least one generic drug submission that is approved to produce one or more FDFs incurs the FDF facility fee. Some FDF facilities may be qualified as CMOs. An annual CMO facility fee is owed by each person who owns an FDF facility that is identified in at least one approved ANDA, where the facility is not identified in an approved ANDA held by the owner of that facility or its affiliates. The CMO facility fee is 24 percent of the amount of the FDF facility fee. A facility owner who qualifies as a CMO will owe the CMO facility fee; no other facility fee amount will be assessed. Is there a difference in fees between foreign and domestic generic drug facilities? Yes. GDUFA III specifies that the amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a domestic facility. The basis for this differential is the extra cost incurred by conducting an inspection outside the United States and its territories and possessions. When are facility fees due? Facility fees are incurred annually and due on the first business day on or after October 1 of each fiscal year, or the first business day after the enactment of an appropriations act providing for the collection of fees for such year. Under what conditions is a facility fee incurred? Under GDUFA III, the owner of a facility incurs a fee when both of the following conditions are met on the facility fee due date: the facility is referenced in an approved generic drug submission; and the facility is engaged in manufacturing or processing an API or FDF A facility does not incur a fee for being referenced only in pending or tentatively approved generic drug submissions under GDUFA III. Do all facilities, sites, and organizations that have to self-identify also have to pay facility fees? No. Self-identification does not, in and of itself, trigger a liability to pay GDUFA facility fees. However, most facilities that self-identify tend to be required to pay an annual facility user fee. These include facilities manufacturing API and/or FDF contained in human generic drugs. Other sites and organizations must self-identify but are not required to pay the annual facility user fee. These include facilities that solely manufacture positron emission tomography (PET) drugs, facilities that are only referenced in applications submitted by State and/or Federal Government entities for drugs that are not distributed commercially, or sites and organizations that only perform testing, repackaging, or relabeling operations. Please note that while repackagers are not required to pay user fees, drug product packagers are, in most cases, subject to FDF or CMO facility fees. This is also the case for drug product labelers and relabelers. Facilities manufacturing for only pending or tentatively approved generic drugs will also perform self-identification. However, these facilities will not incur a GDUFA facility fee if the generic drug is still pending or tentatively approved on the GDUFA facility fee due date. If a facility is first identified in an approved generic drug submission after the due date for payment of the facility fee for a fiscal year, is it required to pay the fee for that fiscal year? No. If a facility is first identified in an approved generic drug submission after the due date for payment of the facility fee for a fiscal year, the facility is not required to pay the fee for that fiscal year. In most cases, the critical question is whether there is a generic drug submission approved on the due date in which the facility is referenced. If the facility is first identified in an approved generic drug submission after the due date, its owner will owe a facility fee on the next due date. For example, if a facility is first identified in an approved abbreviated new drug application on October 15, 2022 (after the fiscal year 2022 due date and during fiscal year 2023), it will start incurring facility fees on the fiscal year 2024 due date (the first business day of October 2023). If a facility is identified in an approved generic drug submission on the due date, and that reference to the facility or the drug submission is later withdrawn, the fee will not be refunded. Is a facility owner required to pay a GDUFA fee if the facility is manufacturing only non-generic APIs or FDFs but is referenced as a fee-incurring operation type in an approved generic drug submission? Yes. Is a facility owner required to pay a GDUFA fee if the facility is referenced as a fee-incurring operation type in an approved generic drug submission but is only manufacturing drugs for the non-US market? Yes. Is a facility that is not currently manufacturing an API or FDF required to pay the applicable facility fees? A facility listed in at least one approved generic drug submission incurs annual facility fees for as long as it is identified in a generic drug submission, even if the facility has not started commercial-scale production of the API or FDF covered by that submission, or if the facility has stopped, temporarily or permanently, the production of that API or FDF. The facility will cease to incur additional fees if it is no longer identified in any generic drug submission or has stopped manufacturing all APIs and FDFs (including both generic and n