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Docket Management Process - Draft Proposal 2

View PDF of the Docket Management Process Section (31 KB)


Background

Summary of Public Comments

Considerations

View All Docket Management Process Draft Proposals

View Comments for this Proposal


Average Rating for this proposal (Based on 44 Ratings):

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Draft Proposal

FDA should change its current practice so that comments submitted at www.regulations.gov from people self-identified as individual consumers are posted on that Web site in the same manner as other comments.  In the Federal Register notice soliciting public comment, FDA should adequately inform commenters about the public disclosure of their comments on www.regulations.gov.

Reasoning: Publication of consumer comments will allow the public to learn about the viewpoints of individual members of the public, not only trade associations or academic institutions, for example.  With respect to posting comments online, most comments from individual consumers should be treated in the same manner as comments submitted by others.  But before doing so, FDA must adequately inform the public of the ways they can submit comments to the docket.  The public should be adequately informed that comments submitted to www.regulations.gov are subject to disclosure online.  


Comments for this proposal 

(Total Received: 33)

Comment: Yes, yes, yes. The non-posting of consumer comments is one of the most misguided things I've ever heard of.
Date Submitted: 5/26/2010

Comment: Consumers have unique ideas and perspectives which should be part of the public discussion regarding FDA activities such as rulemaking. After being informed that comments are subject to disclosure online, individuals can use their own discretion in deciding how much personal information they would like to include in their comments. FDA should probably either allow anonymous individual comments, or allow individuals the option of requesting that their names remain confidential (especially when relating to medical issues to protect patient privacy). In a situation where an individual consumer is required to submit personal information in order to participate in certain FDA activities, could the submitter be given the option of keeping personally identifying information confidential? An example of such a case would be the individual submitting a Citizen Petition (21CFR10.30) where a name, address, and phone number are required. I strongly support this proposal. Thank you FDA.
Date Submitted: 7/15/2010

Comment: If there is to be an open process, comments need to be seen. Ideas develop and people's combined experience--not as possible if ideas are not share-able--can lead to great results. Openness minimizes only trade associations & paid consultants dominating. In some cases, what is good for a trade association may not be the best overall policy.
Date Submitted: 7/15/2010

Comment: Thank you for the work well done. I really appreciate the great effort put into this proposal. Please keep up the good work.
Date Submitted: 7/16/2010

Comment: For many unserviced constituencies this would be a major benefit. Many voices are being drowned out by the interests of a few, powerful lobbyists at the detriment of society as a whole.
Date Submitted: 7/16/2010

Comment: I absolutely support the posting of individual consumer comments - how else are we going to learn how problems actually affect individuals in real life?
Date Submitted: 7/16/2010

Comment: Bravo! The posting of consumer comments would be another step toward openness and transparancy. In our democratic society, you never know where a brilliant idea will emerge from. This would give the ordinary citizen a voice in FDA proceedings and a source for the commercial associations and manufacturers to draw upon when making their decisions, knowing what the public is requesting in the product development process. Anonimity could be preserved by keeping identifying info on file and assigning a number to the comment. Please FDA, make this proposal happen!
Date Submitted: 7/17/2010

Comment: Good addition.
Date Submitted: 7/17/2010

Comment: Yes, I strongly agree with this proposal. I also agree that processes need to be open and comments need to be seen. The more voices, the better.
Date Submitted: 7/17/2010

Comment: I do stand postively for that proposal.
Date Submitted: 7/17/2010

Comment: I support the posting of individual consumer comments.
Date Submitted: 7/17/2010

Comment: Absolutely - consumer comments should be given the same weight. Thank you for this proposal.
Date Submitted: 7/17/2010

Comment: i am supporting the posting of individual consumer comments on the regulations.gov Web site by the FDA
Date Submitted: 7/17/2010

Comment: The ideas of many people can result in a better solution.
Date Submitted: 7/18/2010

Comment: Consumers are well educated
Date Submitted: 7/19/2010

Comment: I also agree with this proposal and think it would be a great addition.
Date Submitted: 7/19/2010

Comment: Absolutely agreed--as previous commenters have mentioned, this is particularly vital for members of otherwise underrepresented groups, who are often the same people affected most profoundly by FDA policy
Date Submitted: 7/19/2010

Comment: OMB Watch, a nonprofit, nonpartisan research and advocacy organization, supports this proposal. Other rulemaking agencies routinely post public comments, including names and other personal information provided by commenters. Comments filed during notice-and-comment rulemaking are part of the public record and should be made available online. In response to concerns surrounding the disclosure of personal information, it should be noted that individuals are not obligated to provide agencies with personal information when commenting. FDA, or any other agency, should not discriminate against anonymous comments. In addition to posting public comments in the online docket at Regulations.gov, FDA should include additional material in its online dockets. FDA should make the online dockets stored in the federal e-rulemaking system the authoritative docket. Each and every item found in the agency’s paper docket should be posted on Regulations.gov thereby allowing for wide and easy public a
Date Submitted: 7/19/2010

Comment: I agree whole heartedly and strongly support this proposal. Thank you.
Date Submitted: 7/19/2010

Comment: Without a public comment publication there can be no true transparency. Without transparency lobbyists will be served rather than the consumer
Date Submitted: 7/19/2010

Comment: As others have noted, this proposal would allow consumers who have a vested interest in policy decisions the opportunity to interact meaningfully with other stake-holders. This would serve to enrich the quality and variety of viewpoints that the FDA can obtain from the public. NOT posting such commentary means that individual stake-holders are "blind" to the very constituency that should be heard most clearly, and synergistic thought and commentary is also silenced. People can have innovative and insightful ideas that are collectively much more than the sum of their parts. The FDA should harness that power
Date Submitted: 7/19/2010

Comment: the comments should absolutely be posted thank you!
Date Submitted: 7/19/2010

Comment: I strongly support this proposal.
Date Submitted: 7/20/2010

Comment: Great Idea!!!
Date Submitted: 7/20/2010

Comment: Yes, I think that this is a great idea
Date Submitted: 7/20/2010

Comment: THANK YOU for this proposal. I strongly support it.
Date Submitted: 7/20/2010

Comment: This would be greatly helpful to my family. We deal with food allergies and the experience of others is all we have to go on at times.
Date Submitted: 7/20/2010

Comment: I strongly agree with this proposal.
Date Submitted: 7/20/2010

Comment: Yes, I support this proposal and it should be enacted immediately.
Date Submitted: 7/20/2010

Comment: Yes this is incredibly important- I strongly support this proposal
Date Submitted: 7/20/2010

Comment: I stronly support this proposal. Thank you!
Date Submitted: 7/20/2010

Comment: why are comments anonymous?that is very abnormal
Date Submitted: 7/20/2010

Comment: Thanks for opening up the discussion about posting consumer comments. Many voices are not heard just because they don't have political power although they have the experience and the honesty.I absolutely support the posting of individual consumer comments - We need to learn about true life experiences.
Date Submitted: 7/20/2010