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HHS/FDA RIN: 0910-AF96 Publication ID: Fall 2010 
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 (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 in an electronic format 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 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 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: 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 600.80 and 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
Timetable:
Action Date FR Cite
ANPRM  11/05/1998  63 FR 59746   
ANPRM Comment Period End  02/03/1999    
NPRM  08/21/2009  74 FR 42184   
NPRM Comment Period End  11/19/2009    
Final Action  09/00/2011    
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
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO Bldg. 51, Room 6284, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-7577
Fax:301 847-8440
Email: reena.raman@fda.hhs.gov