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HHS/FDA | RIN: 0910-AA97 | Publication ID: Fall 2007 |
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 | |
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 |
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 | |
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, WO 51, Room 6306, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 |