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HHS/FDA RIN: 0910-AC59 Publication ID: Fall 2004 
Title: Reporting Information Regarding Falsification of Data 
Abstract: The proposed rule would require sponsors to promptly report any information indicating that any person has or may have 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 58.11    21 CFR 71.1    21 CFR 101.69    21 CFR 101.70    21 CFR 171.1    21 CFR 190.6    21 CFR 312.3    21 CFR 312.56    21 CFR 511.1    21 CFR 812.46   
Legal Authority: 21 USC 321    21 USC 341 to 343    21 USC 348    21 USC 349    21 USC 351    21 USC 352    21 USC 355    21 USC 360b    21 USC 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  05/00/2005    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Previously reported as 0910-AC02 
Agency Contact:
Brian L. Pendleton
Senior Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-3541
Email: brian.pendleton@fda.hhs.gov