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HHS/FDA RIN: 0910-AG49 Publication ID: 2012 
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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
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
Timetable:
Action Date FR Cite
NPRM  04/13/2011  76 FR 20575   
NPRM Comment Period End  07/12/2011    
Final Action  04/30/2012  77 FR 25353   
Final Action Effective  05/30/2012 
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