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HHS/HRSA RIN: 0906-AA89 Publication ID: Spring 2017 
Title: 340(B) Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations 

This final rule is required under the Affordable Care Act. It amends section 340(B) 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 340(B) Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340(B) Program. 

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
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. 340(B) of the PHS Act   
Legal Deadline:
Action Source Description Date
Other  Statutory  ANPRM met deadline for Civil Monetary Penalties for Manufacturers.  09/20/2010 
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   
NPRM Comment Period End  08/17/2015 
Final Rule  01/05/2017  82 FR 1210   
Final Rule Effective  03/06/2017 
Final Rule  03/06/2017  82 FR 12508   
Final Rule Effective  03/03/2017 
Interim Final Rule  03/20/2017  82 FR 14332   
Interim Final Rule Effective  05/22/2017 
Final Rule  05/19/2017  82 FR 22893   
Final Rule Further Delay of Effective Dae  10/01/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Related RINs: Merged with 0906-AA92 
Agency Contact:
CAPT Krista Pedley
Director, Office of Pharmacy Affairs
Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau, 5600 Fishers Lane, 10C-03,
Rockville, MD 20857
Phone:301 443-5294