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HHS/FDA | RIN: 0910-AF96 | Publication ID: Spring 2007 |
Title: ●Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements | |
Abstract: The proposed rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products (21 CFR part 310.305, 314.80, 314.98, 600.80, and 600.81) to require that safety reports submitted to the Agency by persons subject to mandatory reporting requirements be transmitted electronically in a form that FDA can process, review, and archive. FDA is taking this action to improve the Agencys systems for collecting and analyzing postmarketing safety reports. The proposed rule creates a requirement for manufacturers to submit postmarketing safety reports electronically in a compatible format using either direct submission or a web-based form. The rule will allow the Agency to review safety reports more quickly, and to identify emerging safety problems, and disseminate safety information more rapidly in support of FDAs public health mission. The proposed amendments would be a key element in harmonizing FDAs postmarketing safety reporting regulations with international and ICH standards for the electronic submission of safety information. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 310.305 21 CFR 314.80 21 CFR 314.98 21 CFR 600.80 21 CFR 600.81 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 355a 21 USC 356 21 USC 356a 21 USC 356b 21 USC 360 21 USC 371 21 USC 374 21 USC 375 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
Agency Contact: Marguerita B. Sims Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101, (HFD-007), 5515 Security Lane, Rockville, MD 20852 Phone:301 594-2041 Fax:301 827-5562 Email: marguerita.sims@fda.hhs.gov |