0906-AA89 201410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS 340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations

This proposed rule is required under the Affordable Care Act.  It would amend section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5000 per instance) on drug manufacturers who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340B Program. 

]]> Info./Admin./Other Previously Published in The Unified Agenda Proposed Rule Stage No No None sec 7102 of the Affordable Care Act PL 111-148 amending subsec(d) sec 340B PHS Act Statutory Other 09/20/2010 ANPRM met deadline for Civil Monetary Penalties for Manufacturers No ANPRM 09/20/2010 75 FR 57230 ANPRM Comment Period End 11/19/2010 NPRM 04/00/2015 Undetermined None No No No No 0906-AA92 Merged with Bradford Lang Public Health Analyst/Health Care System Bureau 0906 Health Resources and Services Administration HRSA 301 443-2671 301 594-4982 blang@hrsa.gov 5600 Fishers Lane, Room 10C-03, Rockville MD 20857