The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in 2015 addressing “key policy issues raised by various stakeholders committed to the integrity of the 340B program.”  The agency also plans to release proposed rules on manufacturer civil monetary penalties, calculation of the 340B ceiling price, and administrative dispute resolution.