Deputy Director, Office of Pharmacy Affairs

0906-AB28 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Completed Actions No No 42 CFR 10 42 U.S.C. 256b Yes NPRM 11/30/2022 87 FR 73516 NPRM Comment Period End 01/30/2023 Final Action 04/19/2024 89 FR 28643 Final Action Effective 06/18/2024 No No None No No No No Michelle Herzog Deputy Director, Office of Pharmacy Affairs 0906 Health Resources and Services Administration HRSA 301 443-4353 mherzog@hrsa.gov 5600 Fishers Lane, 08W12, Rockville MD 20857