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HHS/FDA RIN: 0910-AF13 Publication ID: Spring 2006 
Title: Charging for Investigational Drugs 
Abstract: The proposed rule would amend FDA’s investigational new drug regulation concerning charging for investigational drugs. The proposed rule would 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 to be described in the Agency’s proposed rule on expanded access to investigational drugs for treatment use, and clarify what costs can be recovered for an investigational drug. The proposed 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: 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 312.7    21 CFR 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  08/00/2006    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
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