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HHS/FDA RIN: 0910-AF14 Publication ID: Spring 2009 
Title: Expanded Access to Investigational Drugs for Treatment Use 
Abstract: The Food and Drug Administration proposed in the Federal Register of December 14, 2006 (75 FR 75147), to amend the regulations governing investigational new drugs (IND) to describe the ways patients may obtain investigational drugs for treatment use under expanded access programs. Such use of investigational drugs would be available to: (1) Individual patients, including in emergencies; (2) intermediate-size patient populations; and (3) larger populations under a treatment protocol or treatment IND. 
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 312.42    21 CFR 312.300    21 CFR 312.305    21 CFR 312.310    21 CFR 312.315    21 CFR 312.320   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360bbb    21 USC 371    42 USC 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/14/2006  71 FR 75147   
NPRM Comment Period End  03/14/2007    
Final Action  08/00/2009    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Organizations  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Colleen Locicero
Associate Director for Regulatory Affairs
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Building 22, Room 4200,
Silver Spring, MD 20993-0002
Phone:301 796-2270
Fax:301 796-9840
Email: colleen.locicero@fda.hhs.gov