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View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

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

 
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