June 27, 2014

Stanton A. Glantz, PhD

How to submit public comments on FDA ecig and cigar deeming (and UCSF comments)

Several people have asked me why we are submitting so many (relatively) short comments rather than one huge one, which is what most groups do.  Others have asked how to comment.
 
First, how to comment:
 
Go to http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0189-20870 and either type your comment into the box, upload a file, or both.  If you upload a file, I suggest including the title or summary in the box together with "See attached file."
 
Why we are supporting so many shorter comments:
 
1. The first thing happens with comments is that they are processed by counting and classifying them.  Limiting the topic of a comment to one subject increases the chances that it will be counted and classified correctly.
 
2.  While the FDA denies it, the number of comments matters.
 
3.  The next thing that will happen is that a contractor will code the comment's content.  It is simple human nature to be able to concentrate longer on something short and relatively simple than something that is very long.  Keeping the length shorter and the comment more focused on a single topic increases the chances that it will be coded properly.
 
4.  To the extent that the FDA and, more importantly, the OMB/White House, pay attention to comments, it will be specific people that are assigned to consider them.  It is easier for someone to consider everything in a 4 page comment than to concentrate on pages 134-138 of a 200 page document.  (Just think about how intimidaiting and confusing plowing through the whole FDA draft rule.)
 
5.  Different people work on different comments.
 
6. By not requiring everyone on the planet to agree on a specific point, sometimes it can be stronger.
 
7. We wanted to get them submitted and out to other people and organizations so  they (as well as FDA) could see what we think to be helpful to others in framing their comments.
 
As other public health experts file comments, if you send them to me I will add them to my list of public health comments and send them around.
 
Here is a list of all the UCSF comments and comments that others have sent me (so far):  http://tobacco.ucsf.edu/list-public-comments-fda-deeming-rule-ucsf-facul...

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