FDA Comment period extension letters from Altria & Cigar Assn of America

[Roger_Lafayette]

Altria (formerly Phillip Morris) letter to the FDA, requesting an extension to the comment period which is currently slated to end at the beginning of July: http://www.tobacco.ucsf.edu/sites/t...for_Extension_from_Altria_Client_Services.pdf

Cigar Assn. of America request:
http://www.tobacco.ucsf.edu/sites/t...from_the_Cigar_Association_of_America_Inc.pdf

P.S.: As some of you may know, CASAA is also requesting an extension for the comment period:
http://www.e-cigarette-forum.com/fo...-releases-e-cigarette-rules.html#post12970402

And here's their press release: CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

 

[KODIAK (TM)]

That looks simple enough. Was wondering how detailed an extension request would need to be. I spent a good portion of an evening looking for references to any kind of formal process by which the FDA accepts or denies extension requests. I have met fda.gov and have lost.

I believe it's a coin flip and the extension grantee (us) requires 9 out of 10.

"Heads."

 

[Roger_Lafayette]

That looks simple enough. Was wondering how detailed an extension request would need to be. I spent a good portion of an evening looking for references to any kind of formal process by which the FDA accepts or denies extension requests. I have met fda.gov and have lost.

I believe it's a coin flip and the extension grantee (us) requires 9 out of 10.

"Heads."

I have four totally uninformed thoughts about extension requests, all of which are based on wild ignorant speculation:

1) I suspect that at least Altria if not some of these other deep-pocketed firms have lobbyists who are working on the FDA and sympathetic members of Congress. So what we see in the letter means nothing. It's just a way of saying "Hey, have you been out to lunch with our lobbyist this week?" Or: "This is just a friendly reminder about the fact that our lobbyists are contributing money to important political organizations!"

2) At the very least, I don't think the likelihood of getting an extension depends on the number of letters, and/or what's in them.

3) However it may be that a well-argued letter will be effective for some other purpose besides persuading the FDA. Such as "building a record" that can later be used either in a court case, or to nudge members of congress etc. (Perhaps CASAA will ask us to contact our elected representatives in support of their extension request, when their CTA comes out? That's more speculation on my part, of course.)

4) Since the FDA is required by law to respond to factual comments (i.e. not personal stories or expressions of opinions), it makes sense to me that they would prefer to use their discretion to deny extension requests. After all, the shorter the comment period, the fewer comments they will get. 60 days is the statutory minimum, so they've already exceeded that. However it's hard not to notice that most of the comment period occurs between Memorial Day and July 4th.

 

[aikanae1]

5) If the big 3 or 4 tobacco companies publically ask for it, then they've already arranged for it. The public letters are otherwise known as CYA so that important decisions can appear to be "evidence-based" and "scientific" to the public and media, and other interested parties who weren't in on making the arrangement.

 

[DC2]

Just FYI for those itching to comment...
CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

Which brings us to the first Call to Action, which will be issued in the next day or two.

The first Call to Action will be for all consumers to request an extension of the comment period. Such an extension is needed for anyone who is going to attempt to compile the information required to answer FDA’s substantive questions. The Call to Action will provide details on how to do that. We expect that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers. The cigar interests are doing the same.

For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline. Submitting comments earlier than that has no benefit and might have substantial costs.

 

[dmska]

So forgive me for being dumb, but are we or are we not, to go to FDA website now to ask for an extension?

 

[Roger_Lafayette]

So forgive me for being dumb, but are we or are we not, to go to FDA website now to ask for an extension?

As far as I can tell, no.

 

[Ryedan]

So forgive me for being dumb, but are we or are we not, to go to FDA website now to ask for an extension?

From: CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

" We appreciate that vapers and harm reduction advocates are anxious to make substantive comments sooner rather than later, but CASAA is asking that you continue to wait. There is absolutely no benefit to making substantive comments now, and, in fact, it can undercut the very reasonable and truthful position that we have taken that the comment period must be extended. Early comments will lack the useful information that we will be able to assemble over the coming months. While FDA is required to read all comments, it would not be surprising or unreasonable if they were to gloss over those that are submitted early as being completely uninformative (as, indeed, many are, based on our spot review of what has been submitted and posted to the web). Moreover, organized interests who support the regulations, or who want to suggest that they become even more prohibitionist, will undoubtedly wait until near the deadline to submit; they will take advantage of what they can learn about our arguments by reviewing the early submissions.

For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline. Submitting comments earlier than that has no benefit and might have substantial costs."

IMO waiting until we hear from CASAA is the best deal for all of us. Sit tight and stay cool. Making this count, doing it right, is more important than getting in there early

 

[Katya]

So forgive me for being dumb, but are we or are we not, to go to FDA website now to ask for an extension?

CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

The first Call to Action will be for all consumers to request an extension of the comment period. Such an extension is needed for anyone who is going to attempt to compile the information required to answer FDA’s substantive questions. The Call to Action will provide details on how to do that. We expect that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers.

 

[DC2]

So forgive me for being dumb, but are we or are we not, to go to FDA website now to ask for an extension?

See Katya's quote above...

Yes, we are supposed to go ask for an extension.
But not until we get the CASAA Call to Action in a couple of days.

 

[Roger_Lafayette]

I'm a little confused. Are comments used to request an extension?

See Katya's quote above...

Yes, we are supposed to go ask for an extension.
But not until we get the CASAA Call to Action in a couple of days.

 

[zoiDman]

See Katya's quote above...

Yes, we are supposed to go ask for an extension.
But not until we get the CASAA Call to Action in a couple of days.

What do you think would be some of the Best Basis to site when Requesting an Extension?

 

[Vocalek]

I'm a little confused. Are comments used to request an extension?

Yes, comments are used to ask for an extension of the commenting period.

To address an earlier question, comments on a regulation are submitted on the Regulations.gov website, not on the agency's own web site. This is true of any agency and of any regulation.

CASAA's CTA will provide very detailed, step-by-step directions.

 

[DC2]

I'm a little confused. Are comments used to request an extension?

I am not clear on that yet, but I have no doubt that CASAA will clarify.


EDIT: Speak of the CASAA
EDIT:

 

[aikanae1]

There's more information on FB; CASAA page, American Vaping FB page (very good too), and Vaping Malitia's FB page. From my understanding (at this time) they are requesting comments be added the final 2 weeks. One of the reasons is that anti-vaping zealots are using comments posted to tailor their comments. Of course we can do the same with them (it's almost feels like high school again ).

Reasons for extension were covered in CASAA's last blog, at least a few of them. This is a 241 page document that took FDA 5 years to prepare. They are specifically asking for additional information on 99 questions. That is a lot of information they are requesting in 2-1/2 months. If the FDA wants well considered, reasonable information it will take more than a couple of months to prepare.

Idk if this is off topic or not (and I haven't had time to look around today) but there is going to be an auction May 17th with 100% of the proceeds going towards CASAA. It's hosted by Vaping Malitia.

I found out about it because the whole town I'm in is gathering donations / they don't want to be out done by another local city or neighboring state, etc. and if that's any gauge it's going to be one helluva auction. It's also not restricted to vaping.

 

[dmska]

See Katya's quote above...

Yes, we are supposed to go ask for an extension.
But not until we get the CASAA Call to Action in a couple of days.

Thank you, I was unsure if they wanted us to wait still or not.

 

[WorksForMe]

Idk if this is off topic or not (and I haven't had time to look around today) but there is going to be an auction May 17th with 100% of the proceeds going towards CASAA. It's hosted by Vaping Malitia.

This auction should be promoted here on ECF and elsewhere. This is the first I've heard of it. CASAA and other vaping organizations need some professional fundraising people.

J.R.

 

[Roger_Lafayette]

Thank you, I was unsure if they wanted us to wait still or not.

As I understand what Elaine is saying, we need to wait for the CTA in order to see when we should comment and also on what issues (procedural ones, like asking for and extension) and/or substantive ones (like answering the Qs in the FDAs PDF or making other substantive comments about the proposal).

I could be wrong about that.

 

[Katya]

And in related news--here we go!

CASAA: First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

 

[tombaker]

I have four totally uninformed thoughts about extension requests, all of which are based on wild ignorant speculation:

Agreed

Otherwise here is the BLU asking for extension. I converted it from PDF publicly posted to FDA to ASCII. It also asks for 75 days added, others I have seen were asking for 105 to get to 180 total, making me wonder if 75 extension is a number being picked for a reason.

The BLU version is really only addressing E-Cigs and cites examples of Regs it quotes, so it could be a better template than SFATA's very very generic template..

As follows:

Re: Request for Extension of Comment Period: Docket No. FDA-2014-N-0189-0001; Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act

Lorillard Tobacco Company (Lorillard) respectfully requests that the Food and Drug Administration (FDA) extend by 75 days the comment period for its Proposed Rule, Deeming Tobacco Products To Be Su bject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Famil y Smok ing Prevention and Tobacco Cont rol Act, Docket No. FDA-2014-N-0189-000 I , for a total of 150 days. As further explained below, the additional time is necessary to appropriatel y ana l yze and research the Proposed Rule, i ts lengthy and extensi ve Preamble, and the references relied upon by the FDA within the Proposed Rule and Preamble released by FDA to compile responsive comments to address the issues raised by FDA in its publication.

I. Proposal Involved and Action Requested

Pursuant to 21 C.F.R. § 10.40, Lorillard seeks a 75-day extension of the comment period for FDA 's Proposed Ru le, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Famil y Smoking Prevention and Tobacco Control Act. The Proposed Rule was published in the Federal Register on April 25, 2014, and it was requested that comments be submitted to FDA by July 9, 2014.1 Lori liard 's request for an extension of 75 days for a total of 150 days would allow for comments to be submitted until September 22,2014.

II. Statement of Grounds

Lorillard is diligently working to prepare comments to FDA's Proposed Rule, and specifica ll y the Preamble to the Proposed Rule, but believes that an extension of the comment period is warranted. First, Lorillard and interested parties should be allowed sufficient time to analyze the scientific content of the Proposed Rule and its Preamble that FDA made publicly available. This document consists of 241 pages, including information regarding Continuum of Nicotine. Delivering Products, Public Health Benefits of Deeming, Addictive Nature of Products, and Health Risks of Products. FDA has relied upon, or made reference to, 194 references within its Proposed Rule and Preamble. Due to the voluminous nature of the reference material within the FDA Proposed Rule and Preamble, ample time will be required to allow Lorillard and all other interested parties to analyze the cited material and make comment based upon its interpretation and analysis of the materials. Extension of the comment period for a reasonable 75 additional days is thus appropriate, and will better allow Lorillard and other interested parties to analyze the agency's Proposed Rule and Preamble, including the numerous references upon which FDA has relied.

Second, FDA has requested comment to various topics within the Preamble to the Proposed Rule, including a Request for Comments Regarding Scope, Request for Comments Regarding Regulation of E-Cigarettes and Request for Comments Regarding Components, Parts and Accessories. Specifically, FDA has requested research and data regarding e-cigarettes. Lorillard is in the process of conducting, concluding and publishing the results of several studies pertaining to the use of e-cigarettes and the toxicology of the product. Lorillard desires to provide FDA with the results of these studies to aid FDA with their objective to gather science, research and data and to help further FDA's task of promulgating science-based regulations. However, Lorillard needs sufficient time to conclude the studies, analyze the data from the studies and publish the data in a manner which will aid FDA. Extension of the comment period for 75 additional days is thus reasonable, and will better allow Lorillard to complete these studies and publish accurate data.

In sum, a 75-day extension of the comment period is a reasonable request and will support development of a more complete administrative record to assist FDA in making a science-based determination regarding any regulation of deemed tobacco products. Lorillard therefore respectfully requests that FDA extend the comment period for the Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act for 150 days, to September 22, 2014.



1 See 79 Fed. Reg. 23,142 (A p r. 25, 201 4).