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HHS/FDA | RIN: 0910-AG49 | Publication ID: Spring 2010 |
Title: ●Disqualification of a Clinical Investigator | |
Abstract: The Food and Drug Administration (FDA) is proposing to amend the regulations to extend clinical investigator disqualification to include all FDA-regulated investigational products. Under this proposal, an investigator determined to be ineligible to receive certain investigational products such as drugs (including biologics), new animal drugs, or devices will be ineligible to receive any FDA-regulated investigational product (including but not limited to drugs, biologics, new animal drugs, devices, and food and color additives). This proposal is based in part upon recommendations from the Government Accountability Office. Also, this proposal harmonizes existing FDA investigator disqualification regulations and enhances transparency. 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: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed 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: 15 USC 1451 to 1461 21 USC 141 to 149 28 USC 2112 42 USC 201 to 262 21 USC 321 to 394 42 USC 263b to 263n 21 USC 467f 21 USC 679 ... |
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 |