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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 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, 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: 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   
Legal Deadline:  None
Action Date FR Cite
ANPRM  11/05/1998  63 FR 59746   
ANPRM Comment Period End  02/03/1999    
NPRM  02/00/2008    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Michael D. Bernstein
Supervisory 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, Room 6240,
Silver Spring, MD 20993-0002
Phone:301 796-3478
Fax:301 847-8440

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