View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/HRSA RIN: 0906-AA89 Publication ID: Spring 2011 
Title: 340B Drug Pricing Program; Manufacturer Civil Monetary Penalties  
Abstract: This rulemaking is required under the Affordable Care Act. The purpose is to implement an enhancement to the 340B Program. It amends section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity (aka "safety net provider") a price above the ceiling price established under the procedures of the 340B Program. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Sec 7102 of the Affordable Care Act    PL 111-148 amending subsec.(d)    sec 340B PHS Act   
Legal Deadline:
Action Source Description Date
Other  Statutory  ANPRM met deadline  09/20/2010 
Action Date FR Cite
ANPRM  09/20/2010  75 FR 57230   
ANPRM Comment Period End  11/19/2010    
NPRM  07/00/2011    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Bradford Lang
Public Health Analyst/Health Care System Bureau
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, Room 10C-03,
Rockville, MD 20857
Phone:301 443-2671
Fax:301 594-4982