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HHS/HRSA RIN: 0906-AA89 Publication ID: Fall 2015 
Title: 340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations 
Abstract:

This final rule is required under the Affordable Care Act.  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 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. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: None     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: sec 7102 of the Affordable Care Act    Pub. L. 111-148, amending subsec(d)    sec 340B of the PHS Act   
Legal Deadline:
Action Source Description Date
Other  Statutory  ANPRM met deadline for Civil Monetary Penalties for Manufacturers.  09/20/2010 
Timetable:
Action Date FR Cite
ANPRM  09/20/2010  75 FR 57230   
ANPRM Comment Period End  11/19/2010 
NPRM  06/17/2015  80 FR 34583   
Final Rule  05/00/2016 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Merged with 0906-AA92 
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