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HHS/HRSA RIN: 0906-AA89 Publication ID: 2012 
Title: 340B Civil Monetary Penalties for Manufacturers  
Abstract: This rule is required under the Affordable Care Act and would 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: Info./Admin./Other 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
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 
Next Action Undetermined  To Be Determined 
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