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HHS/HRSA

RIN: 0906-AA90

Publication ID: Fall 2010

Title: ●340B Drug Pricing Program; Administrative Dispute Resolution Process
Abstract: This rulemaking is required under the Affordbale Care Act (P.L. 111-148). The purpose is to implement one of two enhancements to the 340B Program. This rulemaking establishes an involuntary and binding administrative dispute resolution process to resolve claims raised by covered entities (aka safety net providers) that they have been overcharged for drugs purchased under the 340B Program. This administrative dispute resolution process also is available to drug manufacturers.
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, Pub L 111-148, amending subsection (d) of sec 340B of the Public Health Service Act

Legal Deadline:

Action	Source	Description	Date
Other	Statutory	ANPRM	09/20/2010

Timetable:

Action	Date	FR Cite
ANPRM	12/00/2010
ANPRM Comment Period End	01/00/2011

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