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HHS/FDA RIN: 0910-AC59 Publication ID: Fall 2003 
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 falsified 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 70.3; 21 CFR 71.1; 21 CFR 170.3; 21 CFR 171.1; 21 CFR 312.3; 21 CFR 312.56; 21 CFR 510.3; 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
Action Date FR Cite
NPRM  12/00/2003   
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:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6316,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440

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