0906-AB08 201610 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 Program Omnibus Guidelines

This guidance addresses key policy issues raised by stakeholders for which HHS does not have statutory rulemaking authority.

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The Omnibus Guidance addresses key policy issues raised by various stakeholders committed to ensuring the integrity of the 340B Program and assisted covered entities and manufacturers in their ability to satisfy 340B Program requirements and expectations.

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HHS is interpreting section 340B of the Public Health Service Act and issuing final guidance in critical areas.

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None.

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Some covered entities and manufacturers may increase spending on 340B Program compliance efforts, including assessments of patients eligible for 340B drugs.  HRSA does not expect any such costs to be significant

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Not issuing the final guidance will result in a lack of clarity in some 340B areas.

]]> Notice 08/28/2015 80 FR 52300 Notice Comment Period End 10/27/2015 Final Guidance Action 12/00/2016 No No None No No No No Krista Pedley Director, Office of Pharmacy Affairs 0906 Health Resources and Services Administration HRSA 301 594-4353 krista.pedley@hrsa.hhs.gov Healthcare Systems Bureau, 5600 Fishers Lane, Rockville MD 20857