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| HHS/FDA | RIN: 0910-AA97 | Publication ID: Spring 2008 |
| Title: Safety Reporting Requirements for Human Drug and Biological Products | |
| Abstract: These regulations are one component of the Secretary's initiative to reduce medical errors. The final rule would amend the expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: Undetermined | Unfunded Mandates: Undetermined |
| CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 600; 21 CFR 601; 21 CFR 606 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263; 42 USC 263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Undetermined |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: Yes | |
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Agency Contact: Carol Drew Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6306, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 |
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