Deputy Director, Office of Pharmacy Affairs

0906-AB28 202210 The Regulatory Plan and the 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 rule would 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 would establish new requirements and procedures for the 340B Program’s ADR process. This administrative process would 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 Proposed Rule Stage No No 42 CFR 10 Not Yet Determined No NPRM 11/30/2022 87 FR 73516 NPRM Comment Period End 01/30/2023 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