The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on drug manufacturers that intentionally charge a covered entity a price above the ceiling price, and define standards and the methodology for the calculation of ceiling prices for purposes of the 340B Program. The text of the rule will be available when the Office of Management and Budget completes its review and the rule is sent to the Federal Register.