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HHS/HRSA RIN: 0906-AA93 Publication ID: 2012 
Title: 340B Civil Monetary Penalties for Covered Entities 
Abstract: This rule would implement an enhancement to the 340B Program to impose sanctions, in appropriate cases as determined by the Secretary, additional to those to which covered entities are subject under subsection (a)(5)(D) of section 340B of the Public Health Service Act. 
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 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: sec 340B PHS Act (42 USC 256b), as amended   
Legal Deadline:  None
Timetable:
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: No  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