HRSA withdrew its Mega-Guidance from White House review. The Office of Budget and Management announced the action on its Reginfo.gov website. White House review is normally the last step before publication of regulations or guidance.
It isn’t clear what HRSA’s next steps will be, but this move will slow down the release of the megaguidance at the very least. The Director of OPA, Krista Pedley, as well as other OPA representatives, will be speaking at the 340B Coalition conference in San Francisco this week and may provide more information. We will keep you posted of any new developments.