April 10, 2014

On April 9, the Office of Information and Regulatory Affairs (OIRA) posted that the 340B Omnibus Notice of Proposed Rulemaking (commonly referred to as the “mega-reg”) was currently under review by the Office of Management and Budget (OMB).  The period for OIRA review is limited by Executive Order 12866 to 90 days, and there is no minimum period for review. Under the Executive Order, 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. Since this is a proposed rule, it is expected to be published with a comment period, and later published in final form. HRSA is unable to comment on the 340B Omnibus Notice of Proposed Rulemaking at this time.

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