谁能翻译一下？
如题Action
Notice of public meeting; request for comments.
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled “Patient-Focused Drug Development for Vitiligo.” The purpose of the public meeting is to allow FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors c**idered when selecting a treatment.
Dates
The public meeting will be held on March 30, 2020, from 1 p.m. to 5 p.m. Submit either electronic or written comments on this public meeting by June 1, 2020. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Addresses
The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer tohttps://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely filed comments will not be c**idered. Electronic comments must be submitted on or before June 1, 2020. Thehttps://www.regulati**.govelectronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 1, 2020. Comments received by mail/hand delivery/courier (for written/paper submissi**) will be c**idered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Electronic Submissi**
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulati**.gov.Follow the instructi** for submitting comments. Comments submitted electronically, including attachments, tohttps://www.regulati**.govwill be posted to the docket unchanged. Because your comment will be made public, you are solely resp**ible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted onhttps://www.regulati**.gov.If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissi**” and “Instructi**”).
Written/Paper Submissi**
Submit written/paper submissi** as follows:
Mail/Hand delivery/Courier (for written/paper submissi**):Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructi**.”
Instructi**:All submissi** received must include the Docket No. FDA-2020-N-0255 for “Patient-Focused Drug Development on Vitiligo; Public Meeting; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissi**,” publicly viewable athttps://www.regulati**.govor at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissi**—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its c**ideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted onhttps://www.regulati**.gov.Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket:For access to the docket to read background documents or the electronic and written/paper comments received, go tohttps://www.regulati**.govand insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For Further Information Contact
Shannon Cole, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-796-9208,PatientFocused@fda.hhs.gov.
Supplementary Information
I. Background
This meeting will provide FDA the opportunity to obtain patient and patient representative input on the aspects of vitiligo that matter most to patients, including how it affects daily life, and on current approaches to treating vitiligo. Vitiligo is an autoimmune disease that causes the loss of skin color. The loss of color can affect skin, hair, and other areas of the body. The area affected by color loss can range in individual patients from small discrete areas to near total involvement. Although there is no cure or FDA-approved treatment for repigmentation, there are available therapies, such as prescription medicati** or non-drug therapies, which may often be used to manage aspects of vitiligo. FDA is interested in patients' (including adult and pediatric patients) perspectives on: (1) The impact of their vitiligo; (2) treatment approaches; and (3) decision factors c**idered when selecting a treatment.
The questi** that will be asked of patients and patient representatives at the meeting are listed in the following section and organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This discussion will be followed by a facilitated discussion inviting comments from other patients and patient representatives. In addition to input generated through this public meeting, FDA is interested in receiving patient and patient representative input addressing these questi** through written comments, which can be submitted to the public docket (see ADDRESSES). When submitting comments, if you are commenting on behalf of a patient, please indicate that you are doing so and answer the following questi** as much as possible from the patient's perspective.
FDA will post the agenda and other meeting materials approximately 5 days before the meeting at:h
公开会议通知；征求意见。
摘要
美国食品和药物管理局（FDA，FDA或we）宣布召开以下公开会议，题为“白癜风患者关注的药物开发”。公开会议的目的是让FDA获得患者对白癜风对日常生活影响的看法，患者对治疗方法的看法，以及在选择治疗方案时考虑的决定因素。
日期
公开会议将于2020年3月30日下午1:00至5:00举行。在2020年6月1日前提交电子或书面意见。有关注册日期和信息，请参阅“补充信息”部分。
地址
公众会议将在FDA的白橡树校区举行，地址：10903 New Hampshire Ave.，Bldg.31 Conference Center，The Great Room（Rm。1503），银弹簧，马里兰州20993。公众会议参与者（非FDA员工）进入1号楼，进行例行安全检查。有关停车和安全信息，请参阅网址：https://www.fda.gov/AboutFDA/WorkingatFDA/buildingsandficilities/whiteoakcampasinformation/ucm241740.htm。
您可以提交以下评论。请注意，迟交、未及时提交的意见将不予考虑。电子评论必须在2020年6月1日或之前提交。网址：https://www.regulation**。政府电子文件系统将接受意见，直至东部时间2020年6月1日晚上11:59。通过邮寄/专人递送/快递（书面/纸质提交）收到的意见，如果加盖邮戳或在该日期当日或之前收到交付服务验收收据，将及时予以确认。
电子版**
以以下方式提交电子评论：
联邦电子制造门户：https://www.regulati网站**.政府跟随提交意见的指示**。以电子方式提交的评论，包括附件，网址：https://www.regulation**。gov将被不加更改地发布到摘要中。由于您的评论将被公开，您有责任确保您的评论不包括您或第三方可能不希望发布的任何机密信息，如医疗信息、您或任何其他人的社会保险号码，或机密业务信息，如制造过程。请注意，如果您在评论正文中包含您的姓名、联系信息或其他识别您身份的信息，则该信息将被发布网址：https://www.regulation**.政府如果你想提交一份带有你不想公开的机密信息的评论，以书面/书面形式提交评论，并以详细的方式提交（见“书面/书面提交**”和“说明**”）。
书面/书面提交**
提交书面/书面提交**如下：
邮寄/亲手递送/快递（书面/纸质提交**）：食品和药品管理局档案管理人员（HFA-305），5630 Fishers Lane，Rm。1061，Rockville，MD 20852。对于提交给档案管理人员的书面/书面意见，如果按照“说明**中的详细说明提交，食品和药物管理局将发布您的意见以及任何附件，但提交、标记和标识为机密的信息除外
指示**：收到的所有提交文件**必须包括FDA-2020-N-0255号“白癜风患者重点药物开发；公开会议；征求意见”的卷宗。收到的意见，及时提交的意见（见地址）将列入卷宗，除了作为“机密提交文件**”提交的意见外，“可公开查看网址：http://www.regulation**.周一至周五上午9点至下午4点，govor在案卷管理人员处。
机密提交**-若要提交不希望公开的带有机密信息的评论，请仅以书面/书面形式提交评论。你应该总共提交两份。一份副本将包括您声称为机密的信息，并附有标题或封面说明，说明“本文件包含机密信息”。代理商将在其评论意见中审查该副本，包括所声称的机密信息。第二份副本将对所声称的机密信息进行编辑/删去，供公众查阅和张贴网址：https://www.regulation**.政府提交两份都交给档案管理人员。如果您不希望公开您的姓名和联系信息，您可以在封面上而不是在您的评论正文中提供此信息，并且您必须将此信息标识为“机密”。任何标记为“机密”的信息将不会被披露，除非符合21 CFR 10.20和其他适用的披露法律。有关FDA在公共档案中发布评论的更多信息，请参见80 FR 56469，2015年9月18日，或访问以下网址：https://www.govinfo.gov/c 色素丢失啊 发表于 2020-6-3 17:03 static/image/common/back.gif
公开会议通知；征求意见。
什么意思
过期了，是个fda药审对白癜风患者的调查，看有没有必要投入力度去解决。 我是来看答案的 不管有没有新药出来，开这个会就证明，，美国FDA重视白白这种病，，，中国呢
然而总共留言的就46个，不确定人家重视么 不能否定国外的科研能力，感觉他们对公民很重视 美国以前就是不太重视，要是重视的话，早就有如，银屑病那种单抗了，还是得指望美国呀!
15541289 发表于 2020-6-3 18:09 static/image/common/back.gif
美国以前就是不太重视，要是重视的话，早就有如，银屑病那种单抗了，还是得指望美国呀!
只有美国才能救我们的白白
再怎么不重视，人家已经起步了，我们还原地踏步呢!
15541289 发表于 2020-6-3 18:14 static/image/common/back.gif
再怎么不重视，人家已经起步了，我们还原地踏步呢!
美国重视了就可以了
大家能认识日本代购啊，问问能不能6.24买到迪高替尼啊 继续期待吧
坛子里集资买微博热搜吧！白癜风患者已经生不如死了，引起大家的关注