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HHS/HRSA RIN: 0906-AB12 Publication ID: Spring 2018 
Title: 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation 
Abstract:

This proposed rule would amend the definition of 'knowingly and intentionally' at section 10.3 and amend section 10.10(b) regarding 340B ceiling price.  The sections being amended were included in a final rule that published on January 5, 2017 (82 FR 1210; RIN 0906-AA89).  The January 5, 2017, final rule set forth the calculation of the ceiling price and application of civil monetary penalties.

 
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 14192 Designation: Fully or Partially Exempt 
CFR Citation: 42 CFR 10   
Legal Authority: Pub. L. 102-585, Veterans Health Care Act of 1992   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Withdrawn  04/30/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Related RINs: Related to 0906-AA89 
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
Email: krista.pedley@hrsa.hhs.gov