FDA将公布提交到卷宗的所有个人评议
出自识林
FDA将公布提交到卷宗的所有个人评议
笔记 2015-09-20 Lachman CONSULTANTS FDA将公布提交到Regulations.gov卷宗的所有个人评议 对于那些经常回顾regulations.gov上FDA相关公告的人来说，这确实有些意外，因为一些卷宗项目有数以千计的评议 ( comments )。18日发布的联邦公报通告中表示，早在2007年，FDA将自己的公告整合进regulation.gov时，FDA决定不公开发布来自个人消费者（与企业、组织或社团不相关的 ）的评议。根据该通告，将公开发布2015年10月15日及之后提交的所有评议，另有在补充资料部分所述不受公开发布限制的除外。 过去那些未以电子形式提交的评议可在FDA公共卷宗室查看，现在将以电子形式在网络上公布。FDA对公布个人消费者评议感到犹豫的原因之一是，FDA担心可能包含评议者不愿公开的个人标识信息。FDA花费大量资源审查评议，试图编篡这些信息（例如，社会保障号码和其它保密信息），但由于评议数量庞大，FDA已无法做到这一点。 FDA将改变在联邦公报通告上的措辞，告知潜在评议者这一变化，并警告评议者不要在电子提交中包括任何保密信息。如果评议者希望递交一些包含保密信息的内容，建议他们以纸质形式提交一份未经编篡的版本供FDA内部使用，和一份经过编篡的版本供公开显示。 FDA决定做出改变的部分原因来自于几个组织建议公布个人消费者的评议将提高评议过程的透明度。因此，请注意在提交的评论中不要出现任何你不希望在网络上公开的内容，并且最大程度的保护你的个人信息。 当FDA 过去发布这些评议（尤其是在旧卷宗管理页面），在阅览室筛选时，显然肯定有一些人花半天时间撰写含有空洞内容的对FDA文件的评议。现在，我们可能将不得不翻阅regulations.gov上更多帖子和页面才能找到中肯和密切相关的评议。我想这就是对更高透明度的代价。 Lachman CONSULTANTS - Bob Pollock先生 FDA to Publish ALL Comments Submitted by Individuals to Dockets on Regulations.gov By Bob Pollock | September 17, 2015 Well, as someone who routinely reviews regulations.gov postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through. Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to regulations.gov, FDA made a decision NOT to post comments from individual consumers not associated with a firm, organization or society. Well, according to the notice, the practice of not posting those comments will stop on October 15, 2015. Those comments that were not electronically posted previously were available at the FDA public docket room for review, but will now be posted electronically on line. One of the reasons FDA hesitated to post individual consumer comments is that the Agency was afraid that they may contain personal individual identifying information that the commenter did not want publically available. FDA spent a lot of resources reviewing comments to try to redact such information (e.g., social security numbers and other confidential information), but due to the sheer volume of comments, FDA is no longer able to do so. FDA will be changing the wording in Federal Register notices to advise potential commenters of this change and to warn commenters not to include any confidential information in their electronic filings. If a commenter wants to submit something to the docket that contains confidential information, they are advised to submit it in paper form to the docket with an unredacted copy for the FDA’s internal use and a redacted copy for public display. FDA’s decision to make this change comes, in part, from recommendations from a couple of groups suggesting that posting individual consumer comments will improve the transparency in the comment process by making those comments more publically available by posting them on regulations.gov. So here is your warning- be certain that there is nothing in the comment submission you don’t want on the internet and protect your personal information to the greatest extent possible. When FDA was posting these comments previously (especially at the old Dockets Management page), when sifting through them in the Reading Room, it was obvious that there were some individuals that must have spent half of their day composing missives containing inane comments to the FDA documents. And now, for those of us that are searching for FDA postings, we will likely have to slog through many more postings and pages on regulations.gov to find really pertinent and germane comments. I guess this is the price for greater transparency! |