处方药使用者付费修正案
正文 · 中文译文
处方药使用者付费修正案 最新消息： 2027财年PDUFA项目费发票已于2026年8月18日通过电子邮件发送。发票全额付款截止日期为2026年10月1日。如果您在2026年8月21日前未收到发票，请通过FDAUserFees@fda.hhs.gov联系PDUFA使用者付费工作人员。 2027财年（FY）PDUFA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通知。 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，并在未来的使用者付费通信中使用此电子邮箱地址。 根据总统第14247号行政命令——《现代化美国银行账户收付款》，FDA自2025年10月1日起将不再接受纸质付款。向FDA付款必须以美元通过电子支票、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eCheck）或信用卡（Discover、VISA、MasterCard、American Express）。 2026财年和2027财年使用者付费费率 费用类别 | 2026财年费率 | 2027财年费率 申请—— 需要临床数据 | $4,682,003 | $4,600,753 不需要临床数据 | $2,341,002 | $2,300,376 项目 | $442,213 | $416,857 背景与立法 《处方药使用者付费法案》（PDUFA）由国会于1992年设立，授权FDA向提交某些人用药品申请以供审评的人员、或在已批准申请中被列为某些处方药产品申办者的人员收取使用者费用。自PDUFA通过以来，使用者费用在加快药品审评和批准流程方面发挥了重要作用。 PDUFA必须每五年重新授权，并分别于1997年（PDUFA II）、2002年（PDUFA III）、2007年（PDUFA IV）、2012年（PDUFA V）、2017年（PDUFA VI）和2022年（PDUFA VII）获得续期。2022年9月30日，总统签署《2022年FDA使用者费用重新授权法案》成为法律，其中包括将PDUFA重新授权至2027年9月。PDUFA VII将为新药和生物制品许可申请的持续及时审评提供保障。 联邦公报文件与指南 联邦公报文件 2025财年使用优先审评券的费用标准 Genus Medical Technologies LLC诉美国食品药品监督管理局案；信息与意见征集 1998财年至今处方药使用者费用标准的设立 指南 指南文件与MAPPs 如需查找更早的联邦公报文件，请访问存档页面。 申请费用 什么是人用药品申请？ 《处方药使用者付费法案》（PDUFA）对某些人用药品申请征收使用者费。根据PDUFA，“人用药品申请”一词是指根据《联邦食品、药品和化妆品法案》（FD&C法案）第505(b)条提交的新药批准申请，或根据《公共卫生服务法案》（PHS法案）第351(a)条提交的某些生物制品许可申请。 “人用药品申请”一词不包括以下内容： 对此类申请的补充申请； 关于全血或输血用血液成分的申请； 关于1992年9月1日之前获得许可的局部用牛血产品的申请； 关于2022年10月1日之前获得许可的变应原提取物产品的申请； 关于依据卫生与公众服务部部长向申请人发出的通知而提交的标准化变应原提取物产品的申请，该通知涉及存在一种可测定申请人在2022年10月1日之前获得许可的变应原提取物产品变应原活性的效价试验； 关于根据PHS法案第351条获得许可的体外诊断生物制品的申请； 关于1992年9月1日之前获批的大容量胃肠外药品的申请； 仅用于进一步生产用途的生物制品许可申请； 由州或联邦政府实体提交的、针对非商业流通药品的申请或补充申请。 申请费是什么？ 每提交一份人用药品申请的人均需按如下标准缴纳申请费： 凡需提供有关安全性或有效性的临床数据（生物利用度或生物等效性研究除外）方可获得批准的人用药品申请，需缴纳全额申请费。 凡无需提供有关安全性或有效性的临床数据即可获得批准的人用药品申请，需缴纳全额费用的一半。 人用药品申请费应在提交申请时缴纳。 费用要求是否存在任何例外情况？ 先前已提交的申请： 如相同产品的原申请由已缴纳该申请费用的人提交，且该申请已被受理立案，且未获批准或在批准前被撤回（未获豁免），则重新提交该申请无需缴纳申请费。 指定孤儿药或适应症： 根据《联邦食品、药品和化妆品法案》第526条被指定为罕见疾病或病症治疗药物之处方药品申请，无需缴纳申请费，除非该申请包含罕见疾病或病症以外的适应症。 皮肤试验诊断产品： 皮肤试验诊断产品的人用药品申请无需缴纳申请费。 “皮肤试验诊断产品”一词是指用于以下给药途径的产品（包括解释此类试验结果所需的阳性和阴性对照品）：针刺、划痕、皮内或皮下给药； 预期在给药部位产生有限的局部反应（如果为阳性），而非全身效应； 不用于预防或治疗干预；以及 用于检测速发型或迟发型皮肤超敏反应，以辅助诊断：对某种抗菌药物的过敏； 对非抗菌药物的过敏，前提是该诊断产品在2022年10月1日之前已获准上市；或 真菌或分枝杆菌病原体感染。 我如何支付费用？ 请访问我们的“付款信息和封面页”选项卡，获取支付申请费所需的全部信息。 处方药项目费用 处方药产品的定义是什么？ 处方药产品指处于最终剂型、具有特定规格或效价的药物，其人体药物申请已获批准，且根据《联邦食品、药品和化妆品法案》第503(b)条只能凭处方调配，并且也列入第505(j)(7)(A)条所述的产品清单，或列入由部长创建并维护的、根据《公共卫生服务法案》第351条人体药物申请批准的产品清单。 什么是处方药项目费用？ 处方药项目费用（项目费用）每年对符合条件的产品进行评估。项目费用针对每一起草于该财政年度10月1日已获批准的此类人体药物申请中所确定的每个处方药产品进行评估。 此外，在某些情况下，某药品不被视为处方药产品，因为截至相关财政年度的10月1日，该药品属于《橙皮书》或CBER可计费生物制品清单或CDER可计费生物制品清单的已停产品部分。但是，如果该药品在该财政年度10月1日之后的任何一天成为处方药产品，申请人应支付为该财政年度确定的年度项目费。 对于单一已批准申请中标识的处方药产品，申请人在一个财政年度内被征收的处方药项目费不得超过五项。 是否有药物不属于“处方药产品”这一术语的范围？ 是的。“处方药产品”这一术语不包括以下药物： 全血或用于输血的血液成分； 1992年9月1日之前获得许可的局部用牛血制品； 2022年10月1日之前获得许可的变应原提取物产品； 根据卫生与公众服务部部长向申请人发出的关于存在某种效价试验的通知而提交的标准化变应原提取物产品，该试验用于测定申请人在2022年10月1日之前获得许可的变应原提取物产品的变应原活性； 根据《公共卫生服务法》第351条获得许可的体外诊断生物制品； 仅获许可用于进一步生产用途的生物制品； 一种不进行商业分销且由州或联邦政府实体提交申请或补充申请的药物。 费用要求是否有任何例外情况？ 有。如果处方药产品属于以下情况，则不收取年度项目费： 大容量肠外给药产品（一种包装在单剂量容器中、体积大于或等于100 mL的无菌水性药品，不包括用于复溶的粉末或药房大包装产品），且列于根据第505(j)(7)条编制的清单中；或 在药学上等同于（定义见《联邦法规汇编》第21篇第314.3条（或任何后续法规））根据第505(j)(7)条编制的产品清单上的另一产品（不包括该清单的已停产部分）；或 皮肤试验诊断产品。“皮肤试验诊断产品”一词是指一种产品（包括解释此类试验结果所需的阳性和阴性对照品）：用于点刺、划痕、皮内或皮下给药； 预期在给药部位产生有限的局部反应（如果为阳性），而非全身效应； 不打算作为预防或治疗性干预措施；且 旨在检测速发型或迟发型皮肤超敏反应，以辅助诊断：对抗菌药物的过敏； 对非抗菌药物的过敏，如果该诊断产品在2022年10月1日之前已获准上市；或 真菌或分枝杆菌病原体感染。 我如何支付费用？ 请访问我们的“付款信息和封面页”选项卡，获取支付项目费用所需的全部信息。 付款信息和封面页 用户费用何时到期？ 申请费在向FDA提交申请时到期。 FDA每年8月使用下一财年的费用表开具下一财年年度项目费用的发票。付款应在每个财年10月1日或之后的第一个工作日，或规定该财年费用征收和承付的拨款法案颁布后的第一个工作日到期，以较晚者为准。 FDA可根据需要开具额外发票。这些发票也称为清理发票，用于收取此前未开具发票的项目费用。清理发票通常在财年12月中旬开具，费用通常在财年1月中旬前到期。 联邦政府的财年是什么？ 联邦政府的财年从10月1日开始，到9月30日结束。例如，2022财年从2021年10月1日开始，到2022年9月30日结束。 什么是PDUFA用户费用封面页？ FDA 3397表，即PDUFA用户费用封面页，旨在提供确定审查申请是否需要收费、确定所需费用金额以及帮助FDA跟踪付款所需的最低限度信息。以下情况应填写PDUFA封面页FDA 3397表： 505(b)和351(a)原始申请 在拒绝受理后重新提交505(b)和351(a)原始申请 在提交日期前撤回的505(b)和351(a)原始申请的重新提交。 该表格通过使用唯一编号跟踪系统分配用户费用支付识别号（PIN），提供申请所提交费用与实际申请的交叉参照。所收集的信息由FDA药物评价与研究中心（CDER）和生物制品评价与研究中心（CBER）用于启动新药申请和生物制品许可申请的行政筛选。注：您无需为年度项目费用支付填写3397表格。 如何在线填写PDUFA用户费用封面页？ FDA为您提供在线填写PDUFA用户费用封面页并以电子方式提交的功能。请访问PDUFA用户费用封面页网页填写表格。要在线填写表格，您需要Microsoft Internet Explorer 5.5或更高版本。有关如何填写封面页的分步说明，请访问： https://userfees.fda.gov/OA_HTML/PDUFACScreation.pdf 填写完PDUFA用户费用封面页后如何提交付款？ 可通过用户费用支付门户以电子方式提交付款。对于所有付款选项，付款必须以美国金融机构开具的美国货币进行。 电汇付款 美国财政部 TREAS NYC 33 Liberty Street New York, NY 10045 FDA存款账户号：75060099 美国财政部路由/中转号码：021030004 SWIFT号码：FRNYUS33 FDA纳税人识别号：53-0196965 收款人：FDA 10903 New Hampshire Ave 75号楼，1427室 Silver Spring, MD 20903 注意：对于电汇，请注明以“PD”开头的用户费用支付识别号（PIN）、BLA/NDA编号，并确保将贵银行就电汇收取的费用加到您的费用付款中。 请注意，对于年度项目费用付款，附上发送给您的年度项目费用（或产品费用或设施费用）发票单会有所帮助。 如果您遇到问题，或不确定是否需要向FDA提交申请，或不确定提交何种类型的申请： 处方药用户费用工作人员联系方式： FDAUserFees@fda.hhs.gov 或 301-796-7900 生物制品评价与研究中心联系方式： CBERuserfeestaff@fda.hhs.gov 如果您需要关于封面页的技术协助，或不确定如何继续： 联系方式：FDA用户费用财务支持团队，电话 (301) 796-7200 或 userfees@fda.gov。 PDUFA用户费用封面页 OMB编号 0910-0297 FDA表格 3397 (03/19) 豁免、减免、免除和退款 是否有任何用户费用豁免？ 根据《FD&C法案》第736(d)条，在以下情况下可授予一项或多项用户费用的豁免： 为保护公众健康所必需的豁免或减免； 由于资源有限或其他情况，用户费用的评估会对创新构成重大障碍；或 所涉申请人为一家小型企业，其首次向FDA提交人用药物申请以供审评。 人用药物申请人必须提交书面豁免请求方可获得豁免。申请人可通过电子邮件向FDAUserFees@fda.hhs.gov提交书面请求（CDER和CBER产品均可）。 对于因拒绝受理而被退回或在受理前后被撤回的人用药物申请，是否减免费用？ 是。可提供以下减免或退款： 任何因拒绝受理而被退回或在受理前被撤回的申请，退还75%的申请费。 如果申请在受理后被撤回，且未对申请或补充材料开展实质性工作，FDA可退还全部或部分费用。FDA对是否退还全部或部分费用拥有唯一裁量权。FDA据此作出的退款决定不可复审。 申请豁免、减免、豁免或退费的时间框架是什么？ 为符合审议资格，豁免、减免、豁免或退费的书面请求必须在不迟于该费用到期后180个日历日内提交（包括声称费用系错误缴纳的情形）。 如何申请小型企业豁免和退款？ 申请人应向FDAUserFees@fda.hhs.gov提交FDA 3971表（小型企业豁免和退款请求），以确定其是否符合小型企业豁免资格。 如对如何提交豁免、减免、豁免或退费请求有疑问，应联系谁？ 如有关于提交请求的任何问题，请联系 FDAUserFees@fda.hhs.gov。 我应该将请求发送到哪里？ 请通过电子邮件将您的请求提交至处方药用户付费工作人员，邮箱为 FDAUserFees@fda.hhs.gov。 我的请求中应包含哪些信息？ 有关提交豁免、减免、豁免或退款请求的更多信息，请阅读 FDA 的行业指南《药品和生物制品的用户付费豁免、减免和退款》。 重新授权活动 PDUFA VIII：2028 – 2032 财年 PDUFA VII：2023 - 2027 财年 PDUFA VI 五年财务计划（PDF - 480 KB） PDUFA 会议 PDUFA VI 信息技术目标与进展 PDUFA VI：2018 - 2022 财年 联邦公报通知：关于 PDUFA 重新授权拟议建议的公开会议 PDUFA VI 拟议承诺函 PDUFA V：2013-2017 财年 相关信息 FDA 针对遵循 STAR 模式的原始申请的试点 关于与 FDA 进行面对面正式会议的更新 CDER 与 CBER 净招聘数据 PDUFA 5 年财务计划 PDUFA 函件 年度报告和计划 橙皮书 CDER 可计费生物制品清单（PDF - 376 KB） CBER 可计费生物制品清单（PDF - 307 KB） PDUFA 用户付费费率档案 Com
正文 · 英文原文
Prescription Drug User Fee Amendments Latest News: The FY 2027 PDUFA program fee invoices were emailed on August 18, 2026. Full payment of the invoice is due on October 1, 2026. If you do not receive your invoice by August 21, 2026, please contact the PDUFA User Fee staff at FDAUserFees@fda.hhs.gov The fiscal year (FY) 2027 PDUFA 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). FY 2026 and FY 2027 User Fee Rates Fee CategoryFee Rates for FY 2026Fee Rates for FY 2027 Application-- Requiring clinical data$4,682,003$4,600,753 Not requiring clinical data$2,341,002$2,300,376 Program$442,213$416,857 Background and Legislation The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products. Since the passage of PDUFA, user fees have played an important role in expediting the drug review and approval process. PDUFA must be reauthorized every five years, and was renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V), 2017 (PDUFA VI), and 2022 (PDUFA VII). On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of PDUFA through September 2027. PDUFA VII will provide for the continued timely review of new drug and biologic license applications. Federal Register Documents and Guidances Federal Register Documents Fee Rate for Using a Priority Review Voucher in Fiscal Year 2025 Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments Establishment of Prescription Drug User Fee Rates for Fiscal Years 1998 – present Guidances Guidance Documents and MAPPs To find older Federal Register Documents, please visit the Archive Page. Application Fees What is a human drug application? PDUFA levies a user fee on certain human drug applications. Under PDUFA, the term human drug application means an application for approval of a new drug submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or licensure of certain biological products under section 351(a) of the Public Health Service Act (PHS Act). The term human drug application does not include the following: A supplement to such an application; An application with respect to whole blood or a blood component for transfusion; An application with respect to a bovine blood product for topical application licensed before September 1, 1992; An application with respect to an allergenic extract product licensed before October 1, 2022; An application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022; An application with respect to an in vitro diagnostic biologic product licensed under section 351 of the PHS Act; An application with respect to a large volume parenteral drug product approved before September 1, 1992; An application for a licensure of a biological product for further manufacturing use only; An application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. What are Application Fees? Each person that submits a human drug application is assessed an application fee as follows: A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval is assessed a full application fee. A human drug application for which clinical data with respect to safety or effectiveness are not required for approval is assessed one-half of a full fee. Human drug application fees are due when the application is submitted. Are there any exceptions to the fee requirements? Previously Filed Applications: An application fee is not required for the resubmission of an application if the original application of the same productwas submitted by a person that paid the fee for the application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver). Designated Orphan Drug or Indication: An application for a prescription drug product that has been designated as a drug for a rare disease or condition under section 526 of the FD&C Act is not subject to an application fee unless the application includes an indication for other than a rare disease or condition. Skin-Test Diagnostic Products: A human drug application for a skin-test diagnostic product shall not be subject to an application fee. The term “skin-test diagnostic product” means a product (including positive and negative controls required to interpret the results of such tests):For prick, scratch, intradermal, or subcutaneous administration; Expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; Not intended to be preventive or therapeutic intervention; and Intended to detect an immediate or delayed-type skin hypersensitivity reaction to aid in the diagnosis of:An allergy to an antimicrobial agent; An allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or Infection with fungal or mycobacterial pathogens. How do I Pay fees? Visit our Payment Information and Cover Sheet tab for all the information you will need to pay your application fee. Prescription Drug Program Fees What is the definition of a prescription drug product? Prescription drug product means a specific strength or potency of a drug in final dosage form for which a human drug application has been approved and which may be dispensed only by prescription under section 503(b) of the FD&C Act, and is also on the list of products described in section 505(j)(7)(A), or is on a list created and maintained by the Secretary of products approved under human drug applications under section 351 of the Public Health Service Act. What are prescription drug program fees? Prescription drug program fees (program fees) are assessed annually for eligible products. The program fees are assessed for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. In addition, there are instances when a drug product is not considered a prescription drug product because the drug product is in the discontinued section of the Orange Book or the CBER Billable Biologics List or CDER Billable Biologics List as of October 1 of the relevant fiscal year. However, if the drug product becomes a prescription drug product on any subsequent day after October 1 of such fiscal year, the applicant shall pay the annual program fee established for that fiscal year. Applicants may not be assessed more than five prescription drug program fees for a fiscal year for prescription drug products identified in a single approved application. Are there drugs that are not included in the term prescription drug product? Yes. The term prescription drug product does not include the following drugs: Whole blood or a blood component for transfusion; A bovine blood product for topical application licensed before September 1, 1992; An allergenic extract product licensed before October 1, 2022; A standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022; An in vitro diagnostic biologic product licensed under section 351 of the PHS Act; A biological product that is licensed for further manufacturing use only; A drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Are there any exceptions to the fee requirements? Yes. An annual program fee is not assessed if the prescription drug product is: A large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 505(j)(7); or Pharmaceutically equivalent (as defined in section 314.3 of Title 21, Code of Federal Regulations (or any successor regulation)), to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or A skin-test diagnostic product. The term “skin-test diagnostic product” means a product (including positive and negative controls required to interpret the results of such tests):For prick, scratch, intradermal, or subcutaneous administration; Expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; Not intended to be a preventive or therapeutic intervention; and Intended to detect an immediate or delayed-type skin hypersensitivity reaction to aid in the diagnosis of:An Allergy to an antimicrobial agent; An allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or Infection with fundal or mycobacterial pathogens. How do I pay a fee? Visit our Payment Information and Cover Sheet tab for all the information you will need to pay your program fee. Payment Information and Cover Sheet When are user fees due? An application fee is due when the application is submitted to FDA. FDA issues invoices for annual program fees for the coming fiscal year in August of each year using the fee schedule for the coming fiscal year. Payments are due either 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 and obligation of fees for that fiscal year, whichever occurs later. FDA may issue additional invoices as needed. These invoices are also known as clean-up invoices to capture program fees that were not previously invoiced. The clean-up invoices are generally issued in mid-December of the fiscal year and the fees are generally due by mid-January of the fiscal year. What is the Federal government's fiscal year? The Federal government's fiscal year begins on October 1 and ends on September 30. For example, fiscal year 2022 begins October 1, 2021, and ends September 30, 2022. What is the PDUFA User Fee Cover Sheet? Form FDA 3397, the PDUFA user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to help FDA track payments. The PDUFA Cover Sheet Form FDA 3397 should be completed for the following: 505(b) and 351(a) Original Applications Resubmission of 505(b) and 351(a) Original Application after a Refuse to File Resubmission of 505(b) and 351(a) Original Applications Withdrawn before the filing date. The form provides a cross-reference of the fee submitted for an application with the actual application by using a unique number tracking system to assign the user fee payment identification number (PIN). The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new drug applications and biologics license applications. Note: You do not need to fill out a Form 3397 for annual program fee payments. How do I fill out the PDUFA User Fee Cover Sheet Online? FDA offers you the ability to complete a PDUFA User Fee Cover Sheet online and submit it electronically. Please visit PDUFA User Fee Coversheet webpage to fill out the form. To fill out the form online, you need Microsoft Internet Explorer 5.5 or higher. For Step-by-Step Instructions on how to fill out the cover sheet, please visit: https://userfees.fda.gov/OA_HTML/PDUFACScreation.pdf How do I submit payment after completing the PDUFA User Fee Cover Sheet? A payment may be submitted electronically via the User Fees Payment Portal. For all payment options, the payment must be made in U.S. currency drawn on a U.S. financial institution. Wire Transfer Payment US Department of Treasury TREAS NYC 33 Liberty Street New York, NY 10045 FDA Deposit Account Number: 75060099 US Department of Treasury routing/transit number: 021030004 SWIFT Number: FRNYUS33 FDA TIN: 53-0196965 Beneficiary: FDA 10903 New Hampshire Ave Bldg. 75, Room #1427 Silver Spring, MD 20903 Note: For wire transfers, please include the user fee payment identification number (PIN), beginning with "PD", the BLA/NDA number and ensure that the fee that your bank will charge for the wire transfer is added to your fee payment. Please note for payments for annual program fees, it is helpful to include the invoice sheet that was sent to you for the annual program fees (or product or establishment fees). If you have problems or if you are unsure on whether or not you need to file an application with FDA or are unsure what type of application to file: Prescription Drug User Fee Staff Contact: FDAUserFees@fda.hhs.gov or 301-796-7900 Center for Biologics Evaluation and Research Contact: CBERuserfeestaff@fda.hhs.gov If you need technical assistance with your cover sheet or are unsure how to proceed: Contact: FDA User Fee Financial Support Team at (301) 796-7200 or userfees@fda.gov. PDUFA User Fee Cover Sheet OMB No. 0910-0297 Form FDA 3397 (03/19) Waiver, Reductions, Exemptions, and Refunds Are there any waivers of user fees? Under section 736(d) of the FD&C Act, a waiver may be granted for one or more user fees where: A waiver or reduction is necessary to protect the public health; The assessment of the user fee would present a significant barrier to innovation due to limited resources or other circumstances; or The applicant involved is a small business submitting its first human drug application to FDA for review. To be granted a waiver, the human drug applicant must submit a written request for the waiver. Applicants may submit written requests (for both CDER and CBER products) via email to FDAUserFees@fda.hhs.gov. Is there a reduction of fees for human drug applications that are refused for filing or are withdrawn before or after filing? Yes. The following reductions or refunds are available: 75 percent of the application fee is refunded for any application that is refused for filing or is withdrawn before filing. If an application is withdrawn after it is filed, FDA may refund the fee or a portion of the fee if no substantial work was performed on the application or supplement. FDA has the sole discretion to refund a fee or a portion of the fee. FDA's determination concerning a refund on this basis is not reviewable. What is the timeframe for requesting a waiver, reduction, exemption, or refund of fees? To qualify for consideration, a written request for a waiver, reduction, exemption, or refund must be submitted not later than 180 calendar days after such fee is due (including if the fee is claimed to have been paid in error). How do I request a small business waiver and refund? An applicant should submit Form FDA 3971 (Small Business Waiver and Refund Request) to FDAUserFees@fda.hhs.gov to see if they qualify for a small business waiver. Who should I contact with questions about how to submit a waiver, reduction, exemption, or refund request? Please contact FDAUserFees@fda.hhs.gov with any questions about submitting your request. Where should I send my request? Please submit your request by electronic mail to the Prescription Drug User Fee staff at FDAUserFees@fda.hhs.gov. What information should I include in my request? For more information about submitting a request for a waiver, reduction, exemption, or refund request, please read FDA’s guidance for industry User Fee Waivers, Reductions, and Refunds for Drug and Biological Products. 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