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

HHS/FDA RIN: 0910-AF14 Publication ID: Fall 2003 
Title: ●Treatment Use of Investigational Drugs  
Abstract: The proposed rule would amend FDA regulations governing investigational new drug applications (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; and (3) larger populations under a treatment protocol or IND. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
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  07/00/2004    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
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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