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HHS/FDA RIN: 0910-AA97 Publication ID: Spring 2004 
Title: Safety Reporting Requirements for Human Drug and Biological Products 
Abstract: This regulation is one component of the Secretary's initiative to reduce medical errors. The proposed rule would amend the expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and propose other revisions to these regulations to enhance the quality of safety reports received by FDA. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 310    21 CFR 312    21 CFR 314    21 CFR 320    21 CFR 600    21 CFR 601    21 CFR 606   
Legal Authority: 42 USC 216    42 USC 241    42 USC 242a    42 USC 262    42 USC 263    42 USC 263a to 263-n    42 USC 264    42 USC 300aa    21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 360b to 360j    21 USC 361a    21 USC 371    21 USC 374    21 USC 375    21 USC 379e    21 USC 381   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/14/2003  68 FR 12406   
NPRM Comment Period Extended  06/18/2003    
NPRM Comment Period End  07/14/2003    
NPRM Comment Period Extension End  10/14/2003    
Comment Review End  09/00/2004    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Elizabeth J. Sadove
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 Avenue, Bldg. 51, Room 6368,
Silver Spring, MD 20993-0002
Phone:301 796-3522
Fax:301 847-8440
Email: elizabeth.sadove@fda.hhs.gov