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HHS/FDA RIN: 0910-AG18 Publication ID: Spring 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2009    
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