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HHS/HRSA RIN: 0906-AA94 Publication ID: Spring 2013 
Title: 340B Orphan Drug Exclusion 
Abstract: This final rule provides clarity on orphan drug exclusions for covered entities under the 340B Program. 
Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
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
Timetable:
Action Date FR Cite
NPRM  05/20/2011  76 FR 29183   
NPRM Comment Period End  07/19/2011    
Final Action  07/00/2013 
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
Email: blang@hrsa.gov