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HHS/HRSA

RIN: 0906-AA89

Publication ID: Spring 2011

Title: 340B Drug Pricing Program; Manufacturer Civil Monetary Penalties
Abstract: This rulemaking is required under the Affordable Care Act. The purpose is to implement an enhancement 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: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule 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: Action Source Description Date Other  Statutory  ANPRM met deadline  09/20/2010

Timetable: Action Date FR Cite ANPRM  09/20/2010  75 FR 57230    ANPRM Comment Period End  11/19/2010     NPRM  07/00/2011

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