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| HHS/FDA | RIN: 0910-AF96 | Publication ID: Fall 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, 600.81, and 1271.350) 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 Agency’s 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, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA’s public health mission. The proposed amendments would be a key element in harmonizing FDA’s 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: Previously 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 | |
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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: Undetermined | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Michael D. Bernstein Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Ave., Bldg. 51, rm. 6240, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301-847-8440 Email: michael.bernstein@fda.hhs.gov |
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