The Final Count Down -- Are You Ready?
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Maybe not... Fingers crossed. I just received this email from the VTA. Not a done deal yet, but most definitely a possibility.
BREAKING NEWS:
FDA SEEKS PMTA DEADLINE EXTENSION CITING COVID-19
March 30, 2020
Today, the FDA submitted a letter to the U.S. District Court for the District of Maryland, in American Academy of Pediatrics, et al. v. FDA, et al., asking Judge Grimm to extend the May 12, 2020 court-ordered PMTA deadline by 120-days to September 9, 2020 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”
FDA explained in its submission that “the global coronavirus outbreak poses unforeseen challenges and has made the May 12 deadline a public health risk to those who cannot comply with the deadline through telework.” In addition, FDA explained that telework also will complicate and delay FDA’s review of applications.
In deciding to request a 120-day extension, FDA noted that it had received requests from numerous trade associations and companies, including consultants involved in the PMTA process, for extensions “between 8 weeks and 180 days, with the majority of requests for 180 days.” VTA was one of those entities that submitted a request to FDA and did so on March 20, 2020 outlining the basis and necessity for deadline extensions for large manufacturers and small manufacturers.
At this point in time, no one can predict the length and severity of the COVID-19 commercial shutdown. FDA explicitly recognized this point in the Second Declaration of Mitchell Zeller which accompanied the letter to the Court. In his Declaration, Director Zeller testified: “It is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed.” That is precisely why VTA requested a new deadline of November 2020 (or at least 180 days from business resumption) for large manufacturers, and a new deadline of February 2021 (or at least 270 days from business resumption) for small manufacturers. To that end, VTA explained that “the question of whether these deadline changes are sufficient or ultimately realistic can and must be re-evaluated in the coming months as more information comes to light about the length and severity of the commercial shutdown due to COVID-19.”
Moreover, VTA also encouraged FDA to utilize the additional time to implement PMTA process modifications that will ensure the survival of small businesses and a diverse array of the vapor products on which former smokers now rely.
In its letter to the District Court, FDA notes that the plaintiffs (American Academy of Pediatrics, et al.) will not oppose the FDA’s request, though the plaintiffs have requested the opportunity to “express their misgivings about the extension on the record.” In order to rule, Judge Grimm still will have to have the case remanded to him by the Fourth Circuit and then he would need to make his decision on whether or not to grant the FDA’s request.
However, given the strong case made by the FDA, the obvious insurmountable obstacles created by the coronavirus, and the apparent lack of opposition by the plaintiffs, a ruling extending the deadline is reasonably likely though still not certain.
We will continue to monitor the situation and will keep you apprised.
The commercial shut down in Spain is supposed to end the 9th of april but to be honest by judging the current situation i doubt that will happen.
They will probably extend it for another 15 days minimum.
Most if not all governments are only calling for short 15-30 day shut downs despite knowing this is going to be several months long. They know if they call for 15-30 days at a time with multiple extensions, the public will tolerate that better than if they called for a 6 month shut down all at once. No one really thinks this is going to be over in the next 2 or even 4 weeks. Many areas are still on the rise not the down slope, but if they call for a 6 month shut down, the people would be rioting and looting grocery stores instead of just strip mining them in an orderly fashion, as they are now.
yep,totally agree with what you said.
If this goes all the way thru summer (which i think it will) it is going to mess up even more the economy since Spain is big on tourism.
I just hope the politicians over here stop fighting among themselves and start working together to stop all the screws up they done lately.
cheers man,hope everything is ok in your neck of the woods,keep healthy be safe.
Schools in our state are closed until summer. We all know, but Douglas is a stately place, also filled with government agencies that would slam the hammer down. Yep, it sucks.
What was I Gonna SAY? Oh right, I had my preemie and like, I'm pretty much where I am at with vape Stuff. As in, the kid may have some disabilities and function not exactly perfectly but I am more or less ready.
OH EXCEPT I have to get my sticky little hands on more Nautilus mesh coils. I gotta get on that, man.
I ORDERE 16 replacement rose v3 fumytech tanks at LAST. LOL.
Anna
What was I Gonna SAY? Oh right, I had my preemie and like, I'm pretty much where I am at with vape Stuff. As in, the kid may have some disabilities and function not exactly perfectly but I am more or less ready.
OH EXCEPT I have to get my sticky little hands on more Nautilus mesh coils. I gotta get on that, man.
I ORDERE 16 replacement rose v3 fumytech tanks at LAST. LOL.
Anna
Maybe not... Fingers crossed. I just received this email from the VTA. Not a done deal yet, but most definitely a possibility.
BREAKING NEWS:
FDA SEEKS PMTA DEADLINE EXTENSION CITING COVID-19
March 30, 2020
Today, the FDA submitted a letter to the U.S. District Court for the District of Maryland, in American Academy of Pediatrics, et al. v. FDA, et al., asking Judge Grimm to extend the May 12, 2020 court-ordered PMTA deadline by 120-days to September 9, 2020 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”
FDA explained in its submission that “the global coronavirus outbreak poses unforeseen challenges and has made the May 12 deadline a public health risk to those who cannot comply with the deadline through telework.” In addition, FDA explained that telework also will complicate and delay FDA’s review of applications.
In deciding to request a 120-day extension, FDA noted that it had received requests from numerous trade associations and companies, including consultants involved in the PMTA process, for extensions “between 8 weeks and 180 days, with the majority of requests for 180 days.” VTA was one of those entities that submitted a request to FDA and did so on March 20, 2020 outlining the basis and necessity for deadline extensions for large manufacturers and small manufacturers.
At this point in time, no one can predict the length and severity of the COVID-19 commercial shutdown. FDA explicitly recognized this point in the Second Declaration of Mitchell Zeller which accompanied the letter to the Court. In his Declaration, Director Zeller testified: “It is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed.” That is precisely why VTA requested a new deadline of November 2020 (or at least 180 days from business resumption) for large manufacturers, and a new deadline of February 2021 (or at least 270 days from business resumption) for small manufacturers. To that end, VTA explained that “the question of whether these deadline changes are sufficient or ultimately realistic can and must be re-evaluated in the coming months as more information comes to light about the length and severity of the commercial shutdown due to COVID-19.”
Moreover, VTA also encouraged FDA to utilize the additional time to implement PMTA process modifications that will ensure the survival of small businesses and a diverse array of the vapor products on which former smokers now rely.
In its letter to the District Court, FDA notes that the plaintiffs (American Academy of Pediatrics, et al.) will not oppose the FDA’s request, though the plaintiffs have requested the opportunity to “express their misgivings about the extension on the record.” In order to rule, Judge Grimm still will have to have the case remanded to him by the Fourth Circuit and then he would need to make his decision on whether or not to grant the FDA’s request.
However, given the strong case made by the FDA, the obvious insurmountable obstacles created by the coronavirus, and the apparent lack of opposition by the plaintiffs, a ruling extending the deadline is reasonably likely though still not certain.
We will continue to monitor the situation and will keep you apprised.
That's terrific news, Katya! Let's hope the court will be reasonable. Obviously, the FDA has much more important work to do right now anyway.
Other than climbing the walls, I'm doing great.
It's really nice to see you here, too. I miss so many of the people who I used to see here every day.
I took my nic stash out of the freezer to add one more liter in glass bottles. All my nic is still clear after a year in the freezer except one bottle that turned an orange tint. It's the only bottle I didn't label with buy date and freeze date, so I'm thinking that was part of my room temp nic that wasn't frozen until a year or so after purchase.
Of course, then you have the ban to contend with. However, I have my doubts about it. But still a possibility.
Illinois's 8th congressional district Representative, Raja Krishnamoorthi, sent a letter to FDA Commissioner Stephen Hahn on April 1st requesting for the FDA to “clear the market” of all vaping products, stating in the letter, “The Subcommittee is not necessarily opposing FDA’s request for a delay or suggesting that FDA divert staff away from responding to the coronavirus crisis,” “Instead, the Subcommittee is requesting that FDA clear the market of e-cigarettes during this delay. Allowing e-cigarettes to remain on the market during this period would harm children and adults throughout the country and exacerbate the coronavirus crisis in critical ways,”
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How do people so stupid convince so many that they are the right people to run this country?
So the baby is going to be large for its gestational age? Gosh I'm having a C section most certainly.
Anna
Anna
Yes
https://vaportechnology.org/wp-cont...st-for-Extension-of-PMTA-Deadline-3-30-20.pdf
But the House Oversight Committee is urging the FDA to ban vaping and pull vape products from the market, claiming such an action will somehow help us to combat the corona virus epidemic in the USA. But somehow smoking tobacco isn't an issue for these tyrants. Go figure.
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