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HHS/FDA RIN: 0910-AF96 Publication ID: Spring 2013 
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 to require that mandatory safety reports submitted to the Agency be transmitted in an electronic format that FDA can process, review, and archive. 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 also 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 329.100 (New); 21 CFR 600.80; 21 CFR 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  12/00/2013   
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
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6238, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-7577
Fax:301 847-8440
Email: reena.raman@fda.hhs.gov

 
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