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HHS/FDA | RIN: 0910-AF96 | Publication ID: Fall 2013 |
Title: Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements | |
Abstract: The final rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products to require that mandatory safety reports submitted to the Agency be transmitted in an electronic format that FDA can process, review, and archive. The rule will allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The amendments also would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and International Conference on Harmonization standards for the electronic submission of safety information. | |
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: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 310.305 21 CFR 314.80 21 CFR 314.98 21 CFR 329.100 (new) 21 CFR 600.80 21 CFR 600.81 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 to 355a 21 USC 356 to 356c 21 USC 360 21 USC 371 21 USC 374 21 USC 375 21 USC 379aa 21 USC 381 42 USC 241 42 USC 262 42 USC 264 |
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 | |
Agency Contact: Reena Raman Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 51, Room 6238, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-7577 Fax:301 847-8440 Email: reena.raman@fda.hhs.gov |