以下内容原文FDA官网网址：
v/ForIndustry/UrFees/GenericDrugUrFees/ucm322629.htm
Generic Drug Ur Fee Cover Sheet and Payment Information
仿制药费用封面页和支付信息
The Generic Drug Ur Fee Amendments of 2012 authorizes FDA to asss and collect ur fees for human generic drug applications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug Ur Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable ur fee required and to help FDA track the ur fee payments. Furthermore, FDA’s review of a generic drug submission cannot begin until all relevant ur 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. Plea refer to the appropriate link below to obtain the clarification information. FDA will continue to make updates to the 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 战略合作协议范本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 |
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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 ur 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费用的新车需要打蜡吗
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ANDA
Note: 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 GDUF
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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 FDA’s Ur Fee System which requires the u 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 Ur 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.
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提供组织机构的信息注册你的组织机构
Create a ur account for your organization and provide contact information.
比较研究法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 ries of questions and making appropriate lections.
深夜听雨依次回答问题，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 ur fee amount owed. Upon submission, a Ur 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 Ur Fee System and the process to create a GDUFA Cover Sheet can be located under the Frequently Asked Questions (FAQs)4 within the Ur Fee System. For detailed instructions to complete the GDUFA Cover Sheet, plea access Form FDA 3794 - Instructions那首歌5.
