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HHS/HRSA RIN: 0906-AA94 Publication ID: Fall 2011 
Title: 340B Orphan Drug Exclusion 
Abstract: Under the changes made by section 2302 Health Care and Education Reconciliation Act (Pub. L. 111-152), orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program. The purpose of issuing this proposed rule is to clarify HHS's stated effort in: (1) Providing clarity in the marketplace, (2) maintaining the 340B savings and interests to the newly-eligible covered entities; and (3) protecting the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act as intended by Congress. 
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: 42 CFR 10   
Legal Authority: 340B PHS Act (42 USC 256b), as amended    sec 215 PHS Act (42 USC 216), as amended    sec 526 FFDC Act (21 USC 360bb)    sec 701(a) FFDC Act (21 USC 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/20/2011  76 FR 29183   
NPRM Comment Period End  07/19/2011    
Final Action  05/00/2012    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Bradford Lang
Public Health Analyst/Health Care System Bureau
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, Room 10C-03,
Rockville, MD 20857
Phone:301 443-2671
Fax:301 594-4982

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