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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.

Statement of Need:

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.

Summary of the Legal Basis:

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.

Alternatives:

None. This rule implements statutory requirements.

Anticipated Costs and Benefits:

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.

Risks:

None.