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HHS/FDA RIN: 0910-AG18 Publication ID: Spring 2018 
Title: Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products 
Abstract:

This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. 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: Long-Term Actions 
Major: No  Unfunded Mandates: Private Sector 
EO 13771 Designation: Other 
CFR Citation: 21 CFR 201.100    21 CFR 201.306    21 CFR 201.310    21 CFR 606.121    21 CFR 606.122    21 CFR 610.60    21 CFR 610.61    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 358    21 U.S.C. 360    21 U.S.C. 360b    21 U.S.C. 360gg to 360ss    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 379e    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 262    42 U.S.C. 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/18/2014  79 FR 75506   
NPRM Comment Period Extended  03/09/2015  80 FR 12364   
NPRM Comment Period End  03/18/2015 
NPRM Comment Period Extended End  05/18/2015 
Final Rule  To Be Determined 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Michael Bernstein
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6240, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3478
Email: michael.bernstein@fda.hhs.gov