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HHS/HRSA | RIN: 0906-AA89 | Publication ID: Fall 2010 |
Title: ●340B Drug Pricing Program; Manufacturer Civil Monetary Penalties | |
Abstract: This rulemaking is required under the Affordable Care Act (Pub. L. 111-148). The purpose is to implement one of two enhancements to the 340B Program. It 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 (aka safety net provider) a price above the ceiling price established under the procedures of the 340B Program. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Prerule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: Not Yet Determined (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 | |
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 |