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HHS/FDA RIN: 0910-AF96 Publication ID: Spring 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, and 600.81) 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, and 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: First time 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
Timetable:
Action Date FR Cite
ANPRM  11/05/1998  63 FR 59746 
ANPRM Comment Period End  02/03/1999   
NPRM  11/00/2007   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Marguerita B. Sims
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101, (HFD-007), 5515 Security Lane,
Rockville, MD 20852
Phone:301 594-2041
Fax:301 827-5562
Email: marguerita.sims@fda.hhs.gov

 
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