0910-AC59 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Reporting Information Regarding Falsification of Data

The final rule would require 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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Deregulatory 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 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 No NPRM 02/19/2010 75 FR 7412 NPRM Comment Period End 05/20/2010 NPRM; Withdrawl 08/00/2018 No None No No No 0910-AC02 Previously reported as Brian Pendleton L. Senior Policy Advisor 0910 Food and Drug Administration FDA 301 796-4614 301 847-3541 brian.pendleton@fda.hhs.gov Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002