如何对FDA的法规提出建议

julia朱玉姣

GMP News
12/08/2015

How to comment on FDA regulations

如何对FDA的法规提出建议

The FDA regularly issues drafts of guidances. What most people do not know is that anyone may comment on these drafts. Normally, the FDA also allows the public enough time to do so.

FDA定期发布指南草案。很多人并不知道其实每个人都可以对这些草案进行评论提出意见的。一般来说，FDA会让公众有足够的时间来提出建议。

When the FDA publishes a new guidance or revises an existing one, it announces its intention in the Federal Register. This is also accessible on the internet. As soon as the announcement is published, the period for comments begins.

当FDA公布新的指南或对现有指南进行的修订的时候，它会在联邦注册上公布其目的，同时也可以从网上获得相关信息。一旦公布，则开始征求意见。

The procedure is described in detail on the page How to Use Regulations.gov. It explains how to search for documents.

在如何使用法规网页上，有对这个程序进行详细的描述。它解释了如何搜索这些文件。

Comments are typically submitted online. People can do this on the page Comment on Proposed Regulations and Submit Petitions. A variety of search options lead to the document required. The direct link to the relevant section of the Federal Register is also located here. People who want to submit comments must follow the instructions to the letter

建议一般是通过在线提交。人们可以在“提交草拟法规建议和提交申诉”网页上提交建议。有很多种方法来搜索所需的文件。到联邦注册各相关部门的直接链接也在这些。想要提交建议的人必须遵守这些指示来操作。