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HHS/FDA

RIN: 0910-AF13

Publication ID: Spring 2008

Title: Charging for Investigational Drugs
Abstract: On December 14, 2006, (71 FR 75168), FDA published a proposed rule to amend FDA's investigational new drug regulation concerning charging for investigational drugs. The rule will 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 described in the Agency's rule on expanded access to investigational drugs for treatment use, and clarify what costs can be recovered for an investigational drug. The 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: 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 312.7 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	12/14/2006	71 FR 75168
NPRM Comment Period End	03/14/2007
Final Action	10/00/2008

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: 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