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HHS/FDA RIN: 0910-AC59 Publication ID: Spring 2009 
Title: Reporting Information Regarding Falsification of Data 
Abstract: The proposed rule would require sponsors to promptly report any information indicating that any person has engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in reporting research results. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 16.1    21 CFR 58.11 and 58.12    21 CFR 71.1    21 CFR 101.69 and 101.70    21 CFR 170.101    21 CFR 171.1    21 CFR 190.6    21 CFR 312.56    21 CFR 511.1    21 CFR 571.1    21 CFR 812.46   
Legal Authority: 21 USC 321    21 USC 341 to 343    21 USC 348 and 349    21 USC 351 and 352    21 USC 355    21 USC 360b and 360c    21 USC 360e    21 USC 360i to 360k    21 USC 361    21 USC 371    21 USC 379e    42 USC 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2009    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Previously reported as 0910-AC02 
Agency Contact:
Darin Achilles
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov