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HHS/FDA RIN: 0910-AC59 Publication ID: Fall 2018 
Title: Reporting Information Regarding Falsification of Data 
Abstract:

On February 19, 2010, FDA issued a proposed rule that would have required sponsors of certain clinical and nonclinical studies (and certain other entities) to promptly report to FDA 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 the course of reporting research results. FDA does not plan to finalize the 2010 proposal.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
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    21 CFR 812.2   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 341 to 343    21 U.S.C. 348 and 349    21 U.S.C. 351 and 352    21 U.S.C. 355    21 U.S.C. 360b and 360c    21 U.S.C. 360e    21 U.S.C. 360i to 360k    21 U.S.C. 361    21 U.S.C. 371    21 U.S.C. 379e    42 U.S.C. 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  02/19/2010  75 FR 7412   
NPRM Comment Period End  05/20/2010    
NPRM; Withdrawl  10/00/2018 
Regulatory Flexibility Analysis Required: No  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 4250, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-3541
Email: brian.pendleton@fda.hhs.gov