the regulations.gov site is down again. It's been working on and off all week. FDA has not announced an extension due to these technical errors, so comments are still due tomorrow - Friday, November 15 at 11:59pm eastern.
If you are submitting comments, PLEASE mail a hard copy to FDA even if the site starts to work again. Your comments just have to be postmarked November 15, not in their hands.
Send a hard copy of your comments (postmarked November 15) to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
And in case the site starts working again, here are the links: