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HHS/HRSA | RIN: 0906-AB18 | Publication ID: Spring 2018 |
Title: ●340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Further Delay of Effective Date | |
Abstract:
This proposed rule would further delay the effective date of the January 5, 2017, final rule (82 FR 1210; RIN 0906-AA89) that sets forth the calculation of the 340B ceiling price and application of civil monetary penalties to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The final rule is required under the Affordable Care Act and amends section 340B 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 340B Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340B Program. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Fully or Partially Exempt | |
CFR Citation: 45 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: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
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 |