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HHS/FDA | RIN: 0910-AC59 | Publication ID: Fall 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 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 | |
Legal Authority: 21 USC 321 21 USC 341 to 343 21 USC 348 and 349 21 USC 351 and 352 21 USC 355 21 USC 360b and 360c 21 USC 360e 21 USC 360i to 360k 21 USC 361 21 USC 371 21 USC 379e 42 USC 262 |
Legal Deadline:
None |
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Timetable:
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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 4250, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-4614 Fax:301 847-3541 Email: brian.pendleton@fda.hhs.gov |