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HHS/FDA | RIN: 0910-AF13 | Publication ID: Fall 2004 |
Title: Charging for Investigational Drugs | |
Abstract: The proposed rule would amend FDA's investigational new drug exemption regulations concerning charging for investigational drugs. The proposed rule describes the types of investigational uses for which a sponsor may be able to charge, including uses for which charging was not previously expressly permitted, and the criteria for allowing charging for the identified investigational uses. The proposed rule would also describe the types of costs that can be recovered when charging for an investigational drug. | |
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 |
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Timetable:
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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 |