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HHS/FDA | RIN: 0910-AG49 | Publication ID: Fall 2011 |
Title: Disqualification of a Clinical Investigator | |
Abstract: The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain investigational products such as drugs (including biologics), new animal drugs, or devices, the investigator also will be ineligible to conduct a clinical investigation that supports an application for a research or marketing permit for products regulated by the FDA. This proposal is based in part upon recommendations from the Government Accountability Office. Also, this proposal harmonizes existing FDA investigator disqualification regulations. This proposal is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. | |
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 16.1 21 CFR 312.70 21 CFR 511.1 21 CFR 511.3 (new) 21 CFR 812.119 | |
Legal Authority: 28 USC 2112 42 USC 201 to 262 21 USC 321 to 394 42 USC 263b to 263n ... |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Kathleen E. Pfaender Senior Health Policy Analyst Department of Health and Human Services Food and Drug Administration WO 32, Room 5129, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-8340 Fax:301 847-8640 Email: kathleen.pfaender@fda.hhs.gov |