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HHS/FDA RIN: 0910-AG18 Publication ID: Fall 2009 
Title: Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products 
Abstract: This rule would require electronic package inserts for human drug and biological prescription products, in lieu of paper, which is currently used. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. 
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: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.100    21 CFR 201.306    21 CFR 201.310   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 358    21 USC 360    21 USC 360b    21 USC 360gg - 360ss    21 USC 371    21 USC 374    21 USC 379e    42 USC 216    42 USC 241    42 USC 262    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2010    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ilisa B. G. Bernstein
Director of Pharmacy Affairs
Department of Health and Human Services
Food and Drug Administration
Room 15-74 (HF-23), Office of Policy, WO1, Room 4341, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-4830
Email: ilisa.bernstein@fda.hhs.gov