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HHS/HRSA | RIN: 0906-AA89 | Publication ID: Fall 2014 |
Title: 340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations | |
Abstract:
This proposed rule is required under the Affordable Care Act. It would amend section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5000 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: Info./Admin./Other |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
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 PL 111-148 amending subsec(d) sec 340B PHS Act |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Related RINs: Merged with 0906-AA92 | |
Agency Contact: Bradford Lang Public Health Analyst/Health Care System Bureau Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 10C-03, Rockville, MD 20857 Phone:301 443-2671 Fax:301 594-4982 Email: blang@hrsa.gov |