SFATA Update on OMB/OIRA Review of FDA Deeming Regulations
From: Vapes
From SFATA:
When the FDA sent the finalized deeming regulations to the Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget (OMB) for the final review process on October 19, 2015, a 90 day clock began ticking.
OIRA review is limited to 90 days. That review period finished two weeks ago and it appears that an extension has been granted. There are two ways to extend the timeline; “the review period may be extended indefinitely by the head of the rulemaking agency; alternatively, the OMB Director may extend the review period on a one-time basis for no more than 30 days.”
