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HHS/FDA RIN: 0910-AC59 Publication ID: Spring 2008 
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; 21 CFR 58.12; 21 CFR 71.1; 21 CFR 101.69; 21 CFR 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; 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  06/00/2008   
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:
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 4245, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-8616
Email: brian.pendleton@fda.hhs.gov

 
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