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HHS/FDA | RIN: 0910-AF13 | Publication ID: Spring 2009 |
Title: Charging for Investigational Drugs Under an Investigational New Drug Application | |
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 and 312.8 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 356 21 USC 371 21 USC 381 to 383 21 USC 393 42 USC 262 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Colleen Locicero Associate Director for Regulatory Affairs Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Building 22, Room 4200, Silver Spring, MD 20993-0002 Phone:301 796-2270 Fax:301 796-9840 Email: colleen.locicero@fda.hhs.gov |