Yesterday, August 4, 2015, the Office of Management and Budget (OMB) posted that the review of the 340B Program Omnibus Guidelines (mega-guidance) has been extended. Yesterday marked 90 days that the Omnibus Guidelines had been before the OMB. After 90 days, the OMB can extend the review period on a one-time basis for no more than 30 days or the review period may be extended indefinitely by the head of the rulemaking agency which in this case, is HRSA. At this time, it is unknown which agency extended the review.
Here is the link to the OMB website: http://www.reginfo.gov/public/jsp/EO/eoDashboard.jsp The extension can be found under the Department of Health and Human Services section or you can view the screen shot here:
If you remember, the Health Resources and Services Administration (HRSA) sent the 340B Omnibus Guidance (Mega-Guidance) to the Office of Management and Budget (OMB) on May 6, 2015. After the OMB has completed their review, the proposed guidance will be published in the Federal Register for a comment period.
SCA will post an update to alert you of additional delays or as soon as the proposed guidance is published in the Federal Register for viewing. Subscribe to our blog so that you don't miss the next update!
