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HHS/FDA RIN: 0910-AA97 Publication ID: Spring 1999 
Title: Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products 
Abstract: 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 Harmonization and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to make other revisions to these regulations to enhance the quality of adverse drug reaction 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: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 20    21 CFR 310    21 CFR 312    21 CFR 314    21 CFR 600   
Legal Authority: 21 USC 216    21 USC 262    21 USC 263    21 USC 263a    21 USC 264    21 USC 300aa    21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 371    21 USC 374   
Timetable:
Action Date FR Cite
NPRM  10/00/1999    
NPRM Comment Period End  01/00/2000    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Lee D. Korb
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Veterinary Medicine, 7519 Standish Place, Room 164, MPN-4, HFV-200,
Rockville, MD 20855
Phone:240 276-9258
Fax:240 276-7692
Email: lee.korb@fda.hhs.gov