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| HHS/FDA | RIN: 0910-AC59 | Publication ID: Spring 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; 21 USC 360j; 21 USC 360k; 21 USC 361; 21 USC 371; 21 USC 379e; 42 USC 262 | |
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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 | |
| Related RINs: Previously reported as 0910-AC02 | |
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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 Email: christine.rogers@fda.hhs.gov |
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