22nd Century Group Inc (XXII)

[nonameface13]

COMMISSIONER GOTTLIEB: Yeah. So it would be a Notice of Proposed
Rulemaking, so if you get the Notice of Proposed Rulemaking out of FDA late this summer,
building in some time for that to slip. The last time we were committed to get the ANPRM
out in January, I think we got it out in March instead, so it slipped three months. And so you
have to allow some time buffer in these. You know, if you get that to the department and
OMB it’s hard to predict how long it would be under review, but that would just be an NPRM,
so it’d be out for probably a 90-day comment period and we would have to solicit comments
and then look to finalize the rule. So it’s a long rulemaking process.
You know, the average rule from proposed to final is two to three years if
you look historically just at the average FDA rule. And when you look at more complex rules
that are highly novel, it’s a little bit longer than that. The rulemaking process is long for a reason. We build very good administrative records.
We’ve been sued on the deeming rulemaking, the reg, and it’s been
sustained in court I think a number of times now because FDA develops very careful
administrative records around its rulemaking process

https://www.brookings.edu/wp-content/uploads/2019/03/es_20190319_gottlieb_fda_transcript.pdf