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HHS/HRSA | RIN: 0906-AA89 | Publication ID: Spring 2017 |
Title: 340(B) Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations | |
Abstract:
This final rule is required under the Affordable Care Act. It amends section 340(B) 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 340(B) Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340(B) Program. |
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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 |
CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: sec. 7102 of the Affordable Care Act Pub. L. 111-148, amending subsec(d) sec. 340(B) of the PHS Act |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: No | |
Related RINs: Merged with 0906-AA92 | |
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 |