0910-AG49 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Disqualification of a Clinical Investigator 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. Other Significant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 16.1 21 CFR 312.70 21 CFR 511.1 21 CFR 511.3 (new) 21 CFR 812.119 28 USC 2112 42 USC 201 to 262 21 USC 321 to 394 42 USC 263b to 263n ... No 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 No None No No Kathleen Pfaender E. 0910 Food and Drug Administration FDA 301 796-8340 301 847-8640 kathleen.pfaender@fda.hhs.gov WO 32, Room 5129, 10903 New Hampshire Avenue, Silver Spring MD 20993