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HHS/FDA RIN: 0910-AA97 Publication ID: Spring 2000 
Title: Suspected 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 suspected 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 310    21 CFR 312    21 CFR 314    21 CFR 600    21 CFR 320    21 CFR 601   
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 351 to 353   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2000    
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