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HHS/HRSA

RIN: 0906-AB08

Publication ID: Fall 2016

Title: 340B Program Omnibus Guidelines
Abstract: 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.

Alternatives:

None.

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

Risks:

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

Timetable:

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 Email: krista.pedley@hrsa.hhs.gov