FDA仿制药费用(GDUFA)支付(中英文).doc

FDA仿制药费用（GDUFA）支付（中英文）以下内容原文FDA官网网址：/ForIndustry/UserFees/GenericDrugUserFees/ucm322629.htm Generic Drug User Fee Cover Sheet and Payment Information仿制药费用封面页和支付信息The Generic DrugUser Fee Amendments of 2012 authorizes FDA to assess and collect user fees for human generic drug applications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required and to help FDA track the user fee payments. Furthermore, FDAs review of a generic drug submission cannot begin until all relevant user fee obligations have been satisfied.2012仿制药用户费用修正案赋予了FDA权利评估和收取人用仿制药申请、特定的申请增补和相关生产商用户费用。为此FDA设计了3794表格，即GDUFA封面页，用于收集基本信息以决定总的用户费用，并帮助FDA跟踪用户费用的支付。另外，FDA对仿制药申请的审核只有在相关的费用支付后才会开始。ATTENTION 注意FDA issues clarifications for completing the GDUFA Cover Sheet by fee type. Please refer to the appropriate link below to obtain the clarification information. FDA will continue to make updates to these links as it identifies further information that will assist the generic drug industry in completing cover sheets.FDA发布的关于填写GDUFA封面页的说明是按照费用类型来分的。请参见以下相关链接获得申明信息。为使更多信息能帮助仿制药行业完成封面页，FDA会继续更新这些链接。Backlog1 (11/16/2012) 积压费Abbreviated New Drug Application (ANDA) (TBD) 简略新药申请Prior Approval Supplement (PAS) (TBD) 预批准变更申请Drug Master File (TBD) 药物主文件Facility (TBD)工厂When is the GDUFA Cover Sheet required? 什么时候需要GDUFA封面页？The GDUFA Cover Sheet is required for each of the following human generic drug user fees:以下人用仿制药用户费用，每个费用均需要一个GDUFA封面页：Abbreviated new drug application (ANDA) or applicable amendment; 简略新药申请（ANDA）或增补Prior approval supplement (PAS) or applicable amendment; 预批准变更申请（PAS）或增补Type II active pharmaceutical ingredient (API) drug master file (DMF) that is referenced on or after October 1, 2012, in a generic drug submission to the FDA and for which the DMF fee has not already been paid; 二类活性药用成分（API）药物主文件（DMF），在2012年10月1日之后（含）被仿制药申请所引用，尚未支付DMF费用的Generic drug facility which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce a finished dosage form (FDF) of a human generic drug or an API contained in a human generic drug; and 仿制药工厂，生产或将要生产至少一种人用仿制药制剂，且尚未获得批准的，或生产原料药用于人用仿制药制剂的，和Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date.在2012年10月1日因等批准而积压的ANDA，和在此日期之前未收到临时批准的ANDANote: A cover sheet is not required for all ANDA and PAS amendments. It is only applicable to an amendment that is adding API manufacturing information other than by reference to a Type II DMF which is subject to the Section 744B(a)(3)(F) fee under GDUFA.注：并不是所有ANDA和PAS增补都需要封面页。只有当增补中包括增加原料药生产信息而不是引用二类DMF，根据GDUFA才需要缴纳744B(a)(3)(F)费用。How to fill out a GDUFA Cover Sheet?如何填写GDUFA封面页？Read the instructions below and then go to Create GDUFA Cover Sheet2 to fill out the form.A GDUFA Cover Sheet will be completed online using FDAs User Fee System which requires the use of Microsoft Internet Explorer 7.0 or higher. 先阅读以下指南，然后登录Create GDUFA Cover Sheet 填写表格，该表格需要使用FDA用户费用系统在线填写，需要浏览器为微软IE7.0或更高版本。Access the User Fee System at Create GDUFA Cover Sheet3. 登录Create GDUFA Cover Sheet进入用户费用系统。Register your organization by providing information about your organization. 提供组织机构的信息注册你的组织机构Create a user account for your organization and provide contact information. 为你的组织机构创建一个用户帐号，提供联系信息Create a cover sheet by answering a series of questions and making appropriate selections. 依次回答问题，进行适当的选择，创建一个封面页Submit the cover sheet to complete the process and determine the user fee amount owed. Upon submission, a User Fee Payment I.D. Number (PIN), which begins with the letters “GD”, is generated. The PIN must be referenced in your payment submission.提交封面页，完成该过程，确认需要支付的用户费用，会产生一个以“GD”开头的用户费用支付ID编号（PIN）。在进行支付时，必须注明此PIN编号。Additional instructions for the User Fee System and the process to create a GDUFA Cover Sheet can be located under the Frequently Asked Questions (FAQs)4 within the User Fee System. For detailed instructions to complete the GDUFA Cover Sheet, please access Form FDA 3794 - Instructions5.关于用户费用系统和创建GDUFA封面页的过程更多指南可以在用户费用体系中Frequently Asked Questions (FAQs)上找到。关于完成GDUFA封面页的更多细节指南，参见Form FDA 3794 - Instructions。Note: A signed copy of a completed GDUFA Cover Sheet must be included in the following submissions to the FDA: ANDA or PAS submission (placed in the first volume with Form FDA 356h) and Type II API DMF submission.注：在向FDA提交下述申报资料时，必须附入一份已填写完成的GDUFA封面页副本：ANDA或预批准变更申请（放在第一卷，FDA356h表格中）和二类原料药DMF申报。What information is needed to complete a GDUFA Cover Sheet?要完成GDUFA封面页，需要哪些信息？General Information一般信息Name/address/contact information of applicant/holder/owner 姓名/地址/申请人、持有人、所有人联系信息Name/address/contact information of representative/U.S. agent姓名/地址/代表人、美国代理联系信息ANDA/PAS简略新药申请/预批准变更申请ANDA application number assigned by FDA 由FDA给定的ANDA申请编号Established name of product 产品名称If applicable, for Section 744B(a)(3)(F)* only 如果适用时，仅针对744B(a)(3)(F)（见注）类别Name of drug substance(s)/API(s) 药用物质/原料药名称All facilities including facilitys name, address, FEI number, facility DUNS number, and the user fee payment ID number (if Section 744B(a)(3)(F) fee has already been paid)所有工厂，包括工厂名称、地址、FEI号、工厂邓氏号，用户费用支付ID编号（如果744B(a)(3)(F)费用已支付）* GDUFA requires applicants to pay the Section 744B(a)(3)(F) fee if the application includes API manufacturing information other than by reference to a Type II DMF.* GDUFA要求在申请中包括原料药生产信息，而非引用二类DMF的申请人支付744B(a)(3)(F)费用。Type II API DMF二类原料药DMFDMF number assigned by FDA 由FDA给定的DMF编号Drug substance/API name药用物质/原料药名称Facility工厂Facilitys name, address, FEI number, and facility DUNS number 工厂名称、地址、FEI号、工厂邓白氏号Confirmation whether the facility manufactures human drugs that are not human generic drugs确认工厂是生产人用药，而非人用仿制药Backlog积压费ANDA application number assigned by FDA FDA给定的ANDA申请编号Established name of product产品名称How are payments submitted? 如何支付费用？A payment may be submitted by P (electronic payment), check, bank draft, U.S. postal money order, or wire transfer. For all payment options, the payment must be made in U.S. currency drawn on a U.S. financial institution. FDA recommends that user fee payments be made in a timely manner to meet the required payment due date or to be received prior to an application submission. For application submissions, it is recommended that you send manual payments to the bank 4-5 business days before the application submission arrives at FDA so that there is no delay in starting the review of your application submission. Please follow the instructions below for your selected payment option:费用可以通过P（电子支付）、支票、银行汇票、美国邮政汇票或电汇方式支付。所有支付方式均应以美元形式存入一家美国金融机构。FDA建议及时支付用户费用，以免超期，或者保证在申请提交前收到付款。提交申报资料时，建议你在申报资料到达FDA之前4-5天进行人工支付，以保证不会延迟对申报的审核。请根据下列指示选择付费方式：Payment Options付费方式Instructions 付费步骤P网上在线支付P is a web-based payment application that allows electronic payments to be made directly from your bank account. A payment can be initiated after submitting your cover sheet by clicking the “Pay Now”button and following the on-screen instructions to make payment. To pay later, log into your GDUFA User Fee account and access your cover sheet history page by clicking on the “Previous Cover Sheets” icon at the top of the page. Click the “Pay Now”link next to the User Fee Payment I.D. Number (PIN) you need to pay for.P是一个在线支付工具，可以直接从你的帐号进行电子支付。在提交封面页后，点击“Pay Now”按钮，根据屏幕上的提示进行支付。如果要稍后支付，则登录你的GDUFA用户帐号，点击页面顶端“Previous Cover Sheets”进入原来的封面页，点击你所需要支付的用户费用支付ID编号（PIN）旁的“Pay Now”链接。Check, Bank Draft, or U.S. Postal Money Order支票、银行汇票或美国邮政汇款Payment must be made payable to the Food and Drug Administration and make reference to the User Fee Payment I.D. Number (PIN). The payment and a copy of your signed cover sheet must be mailed to one of the addresses shown below.费用必须付至FDA，并可以索引至用户费用支付ID号（PIN）。费用与签字后的封面页副本必须邮至以下地址之一。Payments by mail 邮件支付Food and Drug Administration P.O. Box 979108 St. Louis, MO 63197-9000Payments by courier 快递支付U.S. Bank Attention: Government Lockbox 979108 1005 Convention Plaza St. Louis, MO 63101Note: Contact the U.S. Bank at (314) 418-4013 if you have any questions concerning delivery by courier. Wire Transfer电汇 Contact your financial institution and provide the following information:请与你们的金融机构联系，并给他们提供以下信息Bank Name | Telegraphic Name:银行名称| 电信公司名称U.S. Department of Treasury | TREAS NYCBank Address:银行地址33 Liberty Street | New York, NY 10045Account Number: 帐号75060099Routing Number: 路由号码021030004SWIFT Number: SWIFT代码FRNYUS33Beneficiary:收款人FDA | 1350 Piccard Drive, Suite 200A | Rockville, MD 20850Description:汇款说明Reference the User Fee Payment I.D. Number (PIN)Note: Financial ins