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Comment Request
- Thread starter Kent Brooks
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done...edited slightly to be from me...I never could follow directions well, and have an aversion to form letters.
There were comments elsewhere that we're not able to comment on the same regulations more than once. I work in the land of red tape and loop holes so that was my first concern too. There is nothing I could find in the terms, explanations or FAQ that specifically says one way or the other...but there are several places that allude to multiple comments being allowed.
"Can I edit my comment after submitting?
Comments are not retrievable once submitted. To make changes, submit another comment referring to your previous comment correcting any errors and/or re-stating your position or opinion."
*regulations dot gov FAQ (underline added)
There were comments elsewhere that we're not able to comment on the same regulations more than once. I work in the land of red tape and loop holes so that was my first concern too. There is nothing I could find in the terms, explanations or FAQ that specifically says one way or the other...but there are several places that allude to multiple comments being allowed.
"Can I edit my comment after submitting?
Comments are not retrievable once submitted. To make changes, submit another comment referring to your previous comment correcting any errors and/or re-stating your position or opinion."
*regulations dot gov FAQ (underline added)
First, thank you to everyone who went out and submitted requests for the extension of the comment period.
We are not limited to a single comment. I was instructed by multiple people at the SFATA conference, including several lawyers, that the best course of action was to request an extension to the comment period immediately. We were asked to disseminate this to our respective customer bases. The bottom line is, the home team needs time to gather evidence to support our testimony.
We were told to "withhold further commentary" for two primary reasons. First, the are still sorting through the intricacies of the Deeming Regulations. We need comments to be "well thought out, structured, and overall helpful" to the FDA (whom does not understand our industry). They are working diligently to provide a general guideline you can use to "tell your story." Secondly - they expect the ANTZ to go through and rebuttal the publicly viewable comments. Saving our content rich comments for the end of the comment period gives them less time to cherry pick through them and provide rebuttals.
The net net - there is nothing to lose by requesting an extension of the comment period - you can submit as many comments as you deem necessary. The industry heavy hitters at the SFATA Spring Conference ask that we comment requesting the period be extended to 180 days. We're probably get less than 180 days, but if they ask for 180, they'll get 120.
Further commentary should be reserved until additional guidance is provided from leadership (SFATA, CASAA, etc)If I got this information from anything other than the horses mouth, I would stay silent.
It makes sense.
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My Comment Tracking Number: 1jy-8byw-f9yu
To keep from making it look too "cloned"....I "expanded" my entry a bit...but did NOT alter any info...
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1jy-8byz-ibk5
First, thank you to everyone who went out and submitted requests for the extension of the comment period.
We are not limited to a single comment. I was instructed by multiple people at the SFATA conference, including several lawyers, that the best course of action was to request an extension to the comment period immediately. We were asked to disseminate this to our respective customer bases. The bottom line is, the home team needs time to gather evidence to support our testimony.
We were told to "withhold further commentary" for two primary reasons. First, the are still sorting through the intricacies of the Deeming Regulations. We need comments to be "well thought out, structured, and overall helpful" to the FDA (whom does not understand our industry). They are working diligently to provide a general guideline you can use to "tell your story." Secondly - they expect the ANTZ to go through and rebuttal the publicly viewable comments. Saving our content rich comments for the end of the comment period gives them less time to cherry pick through them and provide rebuttals.
The net net - there is nothing to lose by requesting an extension of the comment period - you can submit as many comments as you deem necessary. The industry heavy hitters at the SFATA Spring Conference ask that we comment requesting the period be extended to 180 days. We're probably get less than 180 days, but if they ask for 180, they'll get 120.
If I got this information from anything other than the horses mouth, I would stay silent.
thanks for this explanation- I shared it over in the Reo forum- folks are hesitant, because they are "scared" of using their one and only comment to ask for an extension, and because this direction did not come directly from CASAA in the form of a Call to Action.
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