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HHS/HRSA RIN: 0906-AA90 Publication ID: Spring 2016 
Title: 340B Drug Pricing Program; Administrative Dispute Resolution Process 
Abstract:

This proposed rule is required under the Affordable Care Act and would implement an enhancement to the 340B Program by establishing a required and binding administrative dispute resolution process to resolve claims raised by covered entities 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: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
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) of sec 340B of the PHS Act   
Legal Deadline:
Action Source Description Date
Other  Statutory  Advance Notice  09/20/2010 
Timetable:
Action Date FR Cite
ANPRM  09/20/2010  75 FR 57233   
ANPRM Comment Period End  11/19/2010    
NPRM  09/00/2016 
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