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HHS/FDA RIN: 0910-AF13 Publication ID: Fall 2008 
Title: Charging for Investigational Drugs Under An Investigational New Drug Application 
Abstract: On December 14, 2006, (71 FR 75168), FDA published a proposed rule to amend FDA's investigational new drug regulation concerning charging for investigational drugs. The rule will clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, set forth criteria for charging for an investigational drug for the different types of treatment uses described in the Agency's rule on expanded access to investigational drugs for treatment use, and clarify what costs can be recovered for an investigational drug. The rule is intended to permit charging for a broader range of investigational uses than is explicitly permitted in current regulations. 
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: 21 CFR 312.7 and 312.8   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 371    42 USC 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/14/2006  71 FR 75168   
NPRM Comment Period End  03/14/2007    
Final Action  11/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Elena N. Cohen
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Room 6356,
Silver Spring, MD 20993-0002
Phone:301 796-3602
Fax:301 847-8440
Email: elena.cohen@fda.hhs.gov