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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
Timetable:
Action Date FR Cite
NPRM  12/00/2010   
NPRM Comment Period End  03/00/2011   
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

 
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