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HHS/FDA RIN: 0910-AF14 Publication ID: Spring 2007 
Title: Expanded Access to Investigational Drugs for Treatment Use 
Abstract: To amend the regulations governing investigational new drugs 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 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  03/00/2008   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Organizations  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6316,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: christine.rogers@fda.hhs.gov

 
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