FDA CASAA FDA Call to Action #2!

[sonicdsl]

Please see this link for the latest CTA on the FDA Deeming Regulations Proposal:
CASAA: Second Call to Action for FDA Proposed Regulations - Consumer Comment on Paperwork Reduction Act

This pertains to the Paperwork Reduction Act, how it affects vendors, and in turn, us.

 

[Jman8]

Completed.

 

[aubergine]

Easy Peasy, done. Thank you, CASAA.

 

[jfreitas1]

Again, my pleasure to do so

 

[Susan W.]

All taken care of.

 

[muldrick]

Done, you need a tracking number on this?

 

[Steelgirl]

Done. Glad to be doing something !

 

[Janusxvii]

Can someone please point me to where the FDA made the estimate of 25 products for premarket review? I don’t recall seeing that in the proposed deeming regulation. I don’t doubt that they said this but it is absurd for them to think that, unless there are some really underhanded shenanigans going on behind the scenes (which I’m fairly certain that there are). As a hypothetical, let’s consider only juice manufacturers that are probably large enough to afford the cost of filing (Halo, Johnson Creek, Niquid, njoy, etc.). If they were all to file their current product offerings in all nicotine strengths that they sell you are looking at a MINIMUM of 300 applications. Keep in mind I’m not even taking into account smaller businesses that would have no hope of affording the cost of filing. Likewise I am not taking hardware manufacturers into account either. I will be following up on this CTA when I get home from work but I would like to see where they are making this ludicrous estimate of 25 applications.

 

[aubergine]

Bumpity bump, Call to Action!

Janus, not sure what you're referring to but someone on one of the FDA Deeming Regs threads might be able to clarify.

 

[Janusxvii]

It is stated in this second CTA that the FDA is estimating that there will only be 25 applications for premarket review for electronic cigarette products. The way I understand it, the whole purpose of this CTA is to bring attention to this ridiculously low estimate. It's the second paragraph in the call to action. What I would like to know is where exactly the FDA made this estimate that there will only be 25 applications for premarket review relating to electronic cigarettes. I'm not suprised that they would make such an absurd claim, but I would still like to read it for myself. I will try asking elsewhere though if this isn't the appropriate thread.

 

[salemgold]

I think that you are speaking of this

In particular, they have estimated that there will be only 25 applications for premarket review of new tobacco products filed in connection with e-cigarette products. They have estimated very low numbers for the various other filings -- not as low as 25, but far fewer than there are merchants and products.


There is somewhere in the deeming reg document where the FDA gave estimates on the costs to the vendors. I believe that those estimates are what the above comment refers to.

I think that is where the estimate of costs were listed. I have read so much in the past few weeks that it may be somewhere else but, I do remember seeing it.

 

[aubergine]

It is stated in this second CTA that the FDA is estimating that there will only be 25 applications for premarket review for electronic cigarette products. The way I understand it, the whole purpose of this CTA is to bring attention to this ridiculously low estimate. It's the second paragraph in the call to action. What I would like to know is where exactly the FDA made this estimate that there will only be 25 applications for premarket review relating to electronic cigarettes. I'm not suprised that they would make such an absurd claim, but I would still like to read it for myself. I will try asking elsewhere though if this isn't the appropriate thread.

I see that now - skimmed it in a rush! Absurd indeed! Didn't mean to be blowing you off at all.

 

[skimmer02]

Done, and done.

 

[LDS714]

Don't often post when acting on the CTAs, but this one is important enough that the thread needs to be kept bumped up.

Oh, done BTW.

 

[Katya]

Can someone please point me to where the FDA made the estimate of 25 products for premarket review? I don’t recall seeing that in the proposed deeming regulation. I don’t doubt that they said this but it is absurd for them to think that, unless there are some really underhanded shenanigans going on behind the scenes (which I’m fairly certain that there are). As a hypothetical, let’s consider only juice manufacturers that are probably large enough to afford the cost of filing (Halo, Johnson Creek, Niquid, Njoy, etc.). If they were all to file their current product offerings in all nicotine strengths that they sell you are looking at a MINIMUM of 300 applications. Keep in mind I’m not even taking into account smaller businesses that would have no hope of affording the cost of filing. Likewise I am not taking hardware manufacturers into account either. I will be following up on this CTA when I get home from work but I would like to see where they are making this ludicrous estimate of 25 applications.

I would like to know that too. I skimmed the Economic Analyses and couldn't find anything--but I was in a hurry.

I would like to know where the number 25 comes from before I comment. Thanks!

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

 

[snork]

I really dig these by-the-numbers Calls To Action. No muss, no fuss. One could think of boiler-plate responses as ineffective, but I think these first two CTAs are best served by sheer volume. Sure, I tweaked them a bit for my attitude and personal story but I'm confident that whatever drone handles it is really only interested in that it was #264.

 

[Cucco]

I really dig these by-the-numbers Calls To Action. No muss, no fuss. One could think of boiler-plate responses as ineffective, but I think these first two CTAs are best served by sheer volume. Sure, I tweaked them a bit for my attitude and personal story but I'm confident that whatever drone handles it is really only interested in that it was #264.

I dig them too! They make it easy for my old/damaged brain.

 

[Katya]

I would like to know that too. I skimmed the Economic Analyses and couldn't find anything--but I was in a hurry.

I would like to know where the number 25 comes from before I comment. Thanks!

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

Never mind. I found it in the Deeming Regs--2. Applications for Premarket Review of New Tobacco Products:

FDA also estimates the number of PMTA applications that FDA expects to receive annually will be 27 (1 each from cigar and pipe tobacco manufacturers, and 25 from other tobacco manufacturers.) Therefore, the total annual burden for submitting PMTA applications is estimated to be 135,000 hours (27 respondents × 5,000 hours).

 

[catilley1092]

Done!

I don't mind a bit participating in the Action Calls, as it's one of our only chances to get heard on these issues.

Cat

 

[Ryedan]

Done! ...........