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HHS/FDA RIN: 0910-AF14 Publication ID: Fall 2004 
Title: Treatment Use of Investigational Drugs  
Abstract: The proposed rule would amend FDA regulations governing investigational new drugs (INDs) to describe the way patients may obtain investigational drugs for treatment use. Treatment 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 IND. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 312.42; 21 CFR 312.400; 21 CFR 312.405; 21 CFR 312.410; 21 CFR 312.415; 21 CFR 312.420; 21 CFR 312.425; 21 CFR 312.430; 21 CFR 312.435 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 353; 21 USC 355; 21 USC 371; 42 USC 262 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2005   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
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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