0906-AB12 201710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation

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.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No Fully or Partially Exempt 42 CFR 10 Pub. L. 102-585: Veterans HealthCare Act of 1992 Yes

This statutorily required rule defines the standards and methodology for the calculation of ceiling prices within the 340B Program and imposes civil monetary penalties on drug manufacturers who knowingly and intentionally charge a covered entity a price above the 340B ceiling price.

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This rule would implement provisions of section 340B of the Public Health Service Act (PHSA), referred to as the 340B Drug Pricing Program or the 340B Program.

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None. This rule implements statutory requirements.

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This proposed rule will not have economic impacts of $100 million or more in any 1 year, and, therefore, has not been designated an economically significant rule under section 3(f)(1) of Executive Order 12866. This proposed rule proposes to modify current policy regarding calculation of the 340B ceiling price.

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None.

]]> NPRM 12/00/2017 No Undetermined Undetermined No No No 0906-AA89 Related to Krista Pedley CAPT Director, Office of Pharmacy Affairs 0906 Health Resources and Services Administration HRSA 301 443-5294 krista.pedley@hrsa.hhs.gov Healthcare Systems Bureau, 5600 Fishers Lane, 10C-03, Rockville MD 20857