0910-AF96 200710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements 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. Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 310.305 21 CFR 314.80 21 CFR 314.98 21 CFR 600.80 21 CFR 600.81 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 No ANPRM 11/05/1998 63 FR 59746 ANPRM Comment Period End 02/03/1999 NPRM 02/00/2008 Undetermined None No Not Collected Michael Bernstein D. 0910 Food and Drug Administration FDA 301 796-3478 301 847-8440 michael.bernstein@fda.hhs.gov Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Ave., Bldg. 51, Room 6240, Silver Spring MD 20993-0002