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HHS/HRSA RIN: 0906-AB28 Publication ID: Spring 2023 
Title: 340B Drug Pricing Program; Administrative Dispute Resolution 

This final rule will revise the Administrative Dispute Resolution (ADR) final rule currently in effect and apply to all drug manufacturers and covered entities that participate in the 340B Drug Pricing Program (340B Program). It will establish new requirements and procedures for the 340B Program’s ADR process. This administrative process will allow covered entities and manufacturers to file claims for specific compliance areas outlined in the statute after good faith efforts have been exhausted by the parties.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 10   
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/30/2022  87 FR 73516   
NPRM Comment Period End  01/30/2023 
Final Action  12/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Michelle Herzog
Deputy Director, Office of Pharmacy Affairs
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, 08W12,
Rockville, MD 20857
Phone:301 443-4353