FDA At what point should we hear from the FDA about a comment extension?

[Gato del Jugo]

Does it always take this long?


And if they were to deny an extension, would we hear about that, too?

 

[Fitzie]

I'm curious as well, so I tried to find some sort of time frame governing an agency's decision whether or not to extend a commenting period. There may be one, but I couldn't find it (doesn't mean it doesn't exist - I'm just done with this search).

Did I find anything? Yup. If the FDA extends the comment period, they will notify the public via the Federal Register. Do they have to notify anyone if they decide not to extend the time frame? I don't know.

All was not lost though in this wild goose chase, however. I did happen upon Glantz' and other health groups' requests to FDA asking the agency not to extend the comment period. This was my first foray into exploring Glantz' blog. Ugh. Nevertheless, I think it's useful to know what the opposition is up to. Same as I'd bet the opposition visits here regularly to see what we've got up our sleeves.

Perhaps the most useful thing I discovered is that federal agencies frequently extend the commenting periods for their proposed regs (for whatever that's worth). Cause for hope???

 

[aikanae1]

I haven't found where they are posting extension requests or aren't they posted?

 

[DrMA]

Does it always take this long?


And if they were to deny an extension, would we hear about that, too?

AFAIK, there is no law requiring them to even consider requests for deadline extension. Personally, I don't expect we'll hear anything about these requests, either positive or negative.

 

[Gato del Jugo]

I haven't found where they are posting extension requests or aren't they posted?

Regulations.gov


EDIT: Those are just the hard-copy letters (not the electronic submissions, which I'm sure there were more of..)

 

[Gato del Jugo]

I'm curious as well, so I tried to find some sort of time frame governing an agency's decision whether or not to extend a commenting period. There may be one, but I couldn't find it (doesn't mean it doesn't exist - I'm just done with this search).

Did I find anything? Yup. If the FDA extends the comment period, they will notify the public via the Federal Register. Do they have to notify anyone if they decide not to extend the time frame? I don't know.

All was not lost though in this wild goose chase, however. I did happen upon Glantz' and other health groups' requests to FDA asking the agency not to extend the comment period. This was my first foray into exploring Glantz' blog. Ugh. Nevertheless, I think it's useful to know what the opposition is up to. Same as I'd bet the opposition visits here regularly to see what we've got up our sleeves.

Perhaps the most useful thing I discovered is that federal agencies frequently extend the commenting periods for their proposed regs (for whatever that's worth). Cause for hope???

I did a little digging just now..

From past examples, it looks like the FDA typically waits til the last week or 2 of the original comment period to announce any extensions -- or denials of such..


Yeah, Sen. Harkin said in the hearing that he was against an extension, too...

 

[tombaker]

I haven't found where they are posting extension requests or aren't they posted?

The filed ones are available on the FDA cite, I converted Blu's to the forum 2 days ago.

The total comments are about 9000 now, and leveling off as far as growth.

You can submit as many comments as you want, they have to consider them all. Comment now, Comment later.

 

[aubergine]

I haven't got a good idea of what sort of numbers would be impressive here - 9,000 is what? Terrific? Pitiful? Somewhere in between?

 

[cowjelly]

I thought there would be more. Maybe they have only gone through that many thus far.