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HHS/HRSA RIN: 0906-AA89 Publication ID: Fall 2010 
Title: ●340B Drug Pricing Program; Manufacturer Civil Monetary Penalties  
Abstract: This rulemaking is required under the Affordable Care Act (Pub. L. 111-148). The purpose is to implement one of two enhancements 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
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 
Timetable:
Action Date FR Cite
ANPRM  12/00/2010    
ANPRM Comment Period End  01/00/2011    
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
Email: blang@hrsa.gov