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HHS/FDA RIN: 0910-AB42 Publication ID: Spring 2002 
Title: Electronic Submission of Postmarketing Safety Reports 
Abstract: The proposed rule would set forth requirements on the electronic submission of postmarketing safety reports using internationally accepted electronic data format, and electronic transmission standards. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 310    21 CFR 314    21 CFR 600   
Legal Authority: 21 USC 216    21 USC 355    21 USC 371    21 USC 374    21 USC 262    21 USC 263    21 USC 263a    21 USC 264    21 USC 300aa    21 USC 321    21 USC 331    21 USC 251 to 353   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  11/05/1998  63 FR 59746   
ANPRM Comment Period End  02/03/1999    
Withdrawn - Publication is not projected in the next 12 months  03/06/2002    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Audrey A. Thomas
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6364, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: audrey.thomas@fda.hhs.gov