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HHS/HRSA RIN: 0906-AB08 Publication ID: Fall 2016 
Title: 340B Program Omnibus Guidelines 

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

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: None     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None

Statement of Need:

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.

Summary of the Legal Basis:

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



Anticipated Costs and Benefits:

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


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

Action Date FR Cite
Notice  08/28/2015  80 FR 52300   
Notice Comment Period End  10/27/2015 
Final Guidance Action  12/00/2016 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Krista Pedley
Director, Office of Pharmacy Affairs
Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 594-4353