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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. |
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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: Fully or Partially Exempt | |
CFR Citation: 42 CFR 10 | |
Legal Authority: Pub. L. 102-585, Veterans Health Care Act of 1992 |
Legal Deadline:
None |
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Timetable:
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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 |