Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
识林TMwww.shilinx.com版权所有，未经许可不得转载。如需使用请联系admin@shilinx.com
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!
